Spinal Cord Injury Rehabilitation Evidence

Janice Eng, PhD, Robert Teasell, MD, William Miller, PhD, Dalton Wolfe, PhD,
Andrea Townson, MD, Jo-Anne Aubut, BA, Caroline Abramson, MA,

Jane Hsieh, MSc, Sandra Connolly, BHScOT, and the SCIRE Research Team
Editors:
Janice J. Eng, PhD, BSc (PT/OT), Robert Teasell, MD, FRCPC,

William C. Miller, PhD, OT, Dalton Wolfe, PhD,
Andrea F. Townson, MD, FRCPC, Jo-Anne Aubut, BA,
Caroline Abramson, MA, Jane Hsieh, MSc,
Sandra Connolly, BHScOT(C), OTReg. (Ont.)
This review has been prepared based on the scientific and professional
information available in 2005. The SCIRE information (print, CD or web site
www.icord.org/scire) is provided for informational and educational purposes only.
Please feel free to use this information, as seen fit, without alteration. If you have
or suspect you have a health problem, you should consult your health care
provider. The SCIRE editors, contributors and supporting partners shall not be
liable for any damages, claims, liabilities, costs or obligations arising from the use
or misuse of this material.
Table of Contents
Start End
Page Page
Forward ....................................................................................................................i i
Acknowledgements ................................................................................................ii ii
Executive Summary ................................................................................................iii viii
Editors ......................................................................................................................ix ix
Contributors ............................................................................................................x xi
Chapter 1 Rehabilitation: From Bedside to Community Following

Spinal Cord Injury (SCI) .................................................................... 1-1 1-11
Chapter 2 Methods of the Systematic Reviews ................................................ 2-1 2-11
Chapter 3 Rehabilitation Practice and Associated Outcomes Following

Spinal Cord Injury ............................................................................. 3-1 3-44
Chapter 4 Community Reintegration Following Spinal Cord Injury .................... 4-1 4-37
Chapter 5 Upper Limb Rehabilitation Following Spinal Cord Injury ................... 5-1 5-58
Chapter 6 Lower Limb Rehabilitation Following Spinal Cord Injury ................... 6-1 6-34
Chapter 7 Cardiovascular Health and Exercise Following Spinal Cord Injury.... 7-1 7-28
Chapter 8 Respiratory Management Following Spinal Cord Injury .................... 8-1 8-30
Chapter 9 Bone Health Following Spinal Cord Injury ......................................... 9-1 9-18
Chapter 10 Depression Following Spinal Cord Injury .......................................... 10-1 10-19
Chapter 11 Sexual Health Following Spinal Cord Injury ...................................... 11-1 11-40
Chapter 12 Neurogenic Bowel Following Spinal Cord Injury ............................... 12-1 12-17
Chapter 13 Bladder Health and Function Following Spinal Cord Injury .............. 13-1 13-77
Chapter 14 Pain Following Spinal Cord Injury .................................................... 14-1 14-32
Chapter 15 Venous Thromboembolism Following Spinal Cord Injury ................. 15-1 15-25
Chapter 16 Orthostatic Hypotension Following Spinal Cord Injury ...................... 16-1 16-17
Table of Contents (Cont.)
Start End
Page Page
Chapter 17 Autonomic Dysreflexia Following Spinal Cord Injury ......................... 17-1 17-27
Chapter 18 Heterotopic Ossification Following Spinal Cord ................................ 18-1 18-8
Chapter 19 Nutrition Issues Following Spinal Cord Injury .................................... 19-1 19-13
Chapter 20 Pressure Ulcers Following Spinal Cord Injury ................................... 20-1 20-26
Chapter 21 Spasticity Following Spinal Cord Injury ............................................. 21-1 21-56
Chapter 22 Outcome Measures .......................................................................... 22- 1 22-89
Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors.
Spinal Cord Injury Rehabilitation Evidence. 2006: Vancouver.
www.icord.org/scire
FORWARD
Over the past few years, the volume of publications encompassing a broad definition of
rehabilitation after spinal cord injury (SCI) has expanded exponentially. As in all rapidly
expanding research fields, it is helpful, from time to time, to review what has been published and
assess the quality of the data and conclusions of these reports. Thus was born the SCIRE
project.
This manual represents the first comprehensive synthesis of the published evidence on
rehabilitation strategies and community-based programs designed to improve the functional
outcomes and quality of life for people living with a SCI. It is primarily intended as a guide for
professionals in the areas of SCI health care and community care. It should also prove useful to
SCI researchers, public policy makers, and people with SCI and their families. The goal is to
provide everyone with the necessary objective information to make better-informed decisions as
to the strength and validity of current rehabilitation programs and emerging strategies, as well
as to identify gaps in our knowledge and possible research priorities.
A knowledge translation project as large as SCIRE requires clearly identified validation criteria
and the coordinated efforts of a large number of individuals. The more than 40 invited reviewers
from across Canada have long-standing expertise on the topics they reviewed. Drs. Janice
Eng, Robert Teasell and William Miller provided the vision, framework and critical leadership for
SCIRE and the ensuing team work between the Vancouver and London sites. Their tireless
efforts ensured the timely release of this first version. Version 1 is just the beginning of SCIRE
activities. In the years to come, we can anticipate revised versions of SCIRE, as new SCI
research evidence comes to light and future best practices in SCI rehabilitation are validated. In
addition, this compilation can form a basis for activities such as the development of clinical
practice guidelines and identification of disparities between current practice and best practice.
On behalf of ICORD, The Ontario Neurotrauma Foundation, and The Rick Hansen Foundation,
we offer thanks and congratulations to everyone who contributed to the successful launch of
SCIRE.
John D. Steeves
John and Penny Ryan BC Leadership Professor
Director of ICORD
Vancouver, Canada
September 2006
i
ACKNOWLEDGEMENTS
This large-scale project represents the collaborations and tremendous efforts of so many
dedicated people.
We would like to thank the funding agencies that provided financial support – the Rick Hansen
Man in Motion Foundation and the Ontario Neurotrauma Foundation.
The SCIRE Advisory Committee met regularly to provide feedback on the process and
translation methods for the SCIRE project and their input was invaluable.
The SCIRE Advisory Committee members:

Caroline Abramson, Research Coordinator, GF Strong Rehab Centre/University of BC
Jo-Anne Aubut, Research Coordinator (Parkwood, London)
Karen Anzai, Rehab Consultant, SCI Program, GF Strong Rehab Centre
Sandra Connolly, OT, Spinal Cord Program (Parkwood, London)
Armin Curt, MD, Research Chair, ICORD
Chris Fraser, Reg. Dietician, SCI & ABI Programs, SCI consumer (Parkwood, London)
Chris McBride, PhD, Managing Director, ICORD
Dave Metcalf, Vocational Counselor, SCI consumer (GF Strong Rehab Centre)
Kelly Moore, Educator, SCI Program, GF Strong Rehab Centre
Steve Orenczuk, PsyD, SCI program (Parkwood, London)
Andrea Townson, MD, FRCPC, GF Strong Rehab Centre, Co-PI, SCIRE Project
Dalton Wolfe, PhD, SCI (Parkwood, London)
Daryl Rock, Associate Director, Knowledge Exchange Canadian Council on Learning
In addition to the editors and contributors already recognized, several individuals made
significant contributions to assessing and extracting data from Vancouver: Jennifer Cumal,
Nicole Elfring, Marcia Fukunaga, Chihya Hung, Emily Procter, and Jeff Tan and from London:
Joan Conlon and Dr. Jeff Jutai.
We are grateful to the GF Strong Rehab Centre (Vancouver Coastal Health), Parkwood Hospital
(St. Joseph’s Health Care) and Lawson Health Research Institute which provided the space and
infrastructure support for undertaking the project.
We’d also like to recognize the support from ICORD, in particular, Cheryl Niamath for her
graphic designs and endless patience, Dave Pataky for his web and CD development and Dr.
John Steeves for his guidance.
Lastly, we’d like to express our gratitude to the many SCI rehabilitation scientists and clinicians
who spent endless hours putting the chapters together and made this project possible.
ii
EXECUTIVE SUMMARY
1. SCIRE Project overview
The Spinal Cord Injury Rehabilitation Evidence (SCIRE) is a synthesis of the research evidence
underlying rehabilitation interventions to improve the health of people living with SCI. SCIRE
covers a comprehensive set of topics relevant to SCI rehabilitation and community re-integration.
This project is intended to translate existing knowledge to health professionals to inform them of
best practice. This research synthesis will also enable relevant decision-making in public policy
and practice settings applicable to SCI rehabilitation. In addition, transparent evidence-based
reviews can guide the research community and funding organizations to strategically focus their
time and resources on the gaps in knowledge and identify research priorities. People with SCI
and their families may also find the information useful to understanding their health care.
The Spinal Cord Injury Rehabilitation Evidence developed from a research collaboration
between Vancouver and London (Ontario) and involved their respective health centres (GF
Strong Rehab Centre, St. Joseph’s Health Care), research institutions (International
Collaboration on Repair Discoveries, Lawson Health Research Institute) and universities
(University of BC, University of Western Ontario).
2. Methods
Systematic Review
An exhaustive search (keyword literature search, previous practice guidelines and systematic
reviews, review articles) was used to identify published literature evaluating the effectiveness of
any treatment or therapy related to SCI rehabilitation. Topics relevant to rehabilitation were
selected with input from scientists and clinicians in the field of SCI rehabilitation, in addition to
the SCIRE Advisory Committee (which included consumers with SCI and policy-makers).
This search involved the review of over 17,000 titles and 8400 abstracts, and a final extraction
and synthesis of almost 700 articles. A variety of study designs were included (from
randomized controlled trials to case reports), however, controlled trials were given priority in
generating conclusions. In order to provide transparent and unbiased evidence-based reviews,
the rigor and quality of each study was scored on standardized scales by two independent
reviewers (Physiotherapy Evidence Database Scale for randomized controlled trials and the
Downs and Black Tool for all other studies). Following this individual study assessment,
conclusions were drawn about the accumulated studies for each topic of interest (e.g., pressure
ulcers) using a modified version of Sackett’s description of levels of evidence. In this 5 point
scale, the strongest evidence, level 1, was assigned if the intervention was supported by at least
one randomized controlled trial, while a level 5 was assigned if no critical appraisal existed, but
perhaps was supported by clinical consensus. Conclusions were based on the levels, quality
and concurring evidence. When conflicting data was present, an explanation was provided as
to how the conclusions were derived.
Outcome measure assessment

Outcome measures used in spinal cord injury evaluation were identified by keyword search of
the major electronic databases and through hand searches of noted spinal cord journals. Only
measures with published studies of the psychometric (reliability and validity) properties within
the spinal cord population were identified for review. The measures were categorized into the
iii
domains of the World Health Organization’s International Classification of Functioning, Disability
and Health (body function/structure, activity and participation). A fourth category was created for
quality of life measures. Approximately 160 measures were identified of which 63 were selected
for review based on clinician interest. The measures were evaluated using elements of the
Health Technology Assessment to assess the psychometric properties, interpretability,
acceptability, and feasibility. Summary tables identifying the rigor and quality of the
psychometric properties were constructed. A clinical conclusion is offered based on the
synthesis of the review.
3. Findings from the Systematic Review of SCI Rehabilitation
Given that the SCIRE consists of over 800 pages of evidence, we cannot represent all the
findings here. What follows are selected findings which demonstrate the scope of the research
and the value of the results.
Rehabilitation Practice
Earlier admission to specialized, interdisciplinary SCI care is associated with reduced length of
total hospital stay and greater and faster rehabilitation gains with fewer medical secondary
complications (especially pressure sores).
Community Re-integration
The average level of quality of life after SCI is slightly lower than in people without disability but
a substantial number of people with SCI report good or excellent levels of quality of life. The
severity of injury and other diagnostic factors do not significantly impact quality of life. Their
influence may become significant through restrictions in community integration or social
participation.
Upper Limb Rehabilitation

Upper limb muscle strength is identified as an important contributor to functional independence.
Neuromuscular stimulation-assisted exercise (e.g., during arm ergometry) following a spinal
cord injury is effective in improving muscle strength, preventing injury and increasing
independence in all phases of rehabilitation. Practice of repetitive movements in conjunction
with low intensity peripheral nerve stimulation may induce beneficial brain cortical changes, in
addition to improved arm and hand function.
Lower Limb Rehabilitation

Body-weight supported treadmill exercise using a suspended harness is a relatively new
treatment of interest. For patients less than 6 months post-SCI, body weight supported treadmill
training has equivalent effects on gait outcomes to conventional rehabilitation consisting of
overground mobility practice. Body weight-support gait training strategies can improve gait
outcomes in chronic, incomplete SCI, but no single specific body weight-support strategy
(overground, treadmill, with functional electrical stimulation) is more effective.
Cardiovascular Health and Exercise

There appears to be an earlier onset and increased prevalence of cardiovascular disease in
individuals with SCI in comparison to the general population. Tetraplegics and paraplegics can
improve their cardiovascular fitness and physical work capacity through aerobic exercise
training (e.g., arm cycle or wheelchair ergometry), which are of moderate intensity, performed
20-60 min day, at least three times per week for a minimum of six to eight weeks.
iv
Respiratory Management
Respiratory complications continue to be one of the leading causes of morbidity and mortality in
people with spinal cord injury, especially among cervical and higher thoracic injuries. Unlike the
cardiovascular system, the lungs and airways do not change appreciably in response to
exercise training. For exercise training to improve respiratory function, the training intensity must
be relatively high (70-80% of maximum heart rate) performed three times per week for six
weeks.
Bone Health
There is a significant risk for lower extremity fragility fractures after SCI. Early assessment and
ongoing monitoring of bone health is an essential element of SCI care. There is strong evidence
from randomized controlled trials that support the use of medications for the prevention and
treatment of bone loss following SCI. Non-pharmacological treatments have not been found to
prevent bone loss in the first year, however, electrical stimulation can increase bone density
over the area stimulated in people with SCI more than 1 year post-injury.
Depression
Depression is a common consequence of SCI. Cognitive behavioural interventions provided in
a group setting appear helpful in reducing post-SCI depression. The benefits of drug treatment
(including selective serotonin reuptake inhibitors and tricyclic antidepressants) in combination
with psychotherapy may alleviate depression. However, pharmacological management for post-
SCI depression is largely extrapolated from studies in non-SCI populations. Programs to
encourage regular exercise, reduce stress, and improve or maintain health are beneficial in
reducing reports of depressive symptoms in persons with SCI.
Sexual Health
In men with SCI, erections are often not reliable or adequate for sexual intercourse since there
may be difficulties with maintenance of the erection. The pharmacological agent,
Phosphodiesterase Type 5 Inhibitors (PDE5i, Viagra®) can be used safely and effectively for
treatment of erectile dysfunction in men with SCI and are recommended as first line treatment
for erectile dysfunction after SCI.
Bowel Management
Multifaceted programs incorporating intereventions such as, nutrition, fluid consumption, routine
bowel evacuation, may improve movement of substances through the colon as well as decrease
the incidences of difficult bowel evacuations. Pharmacological agents such as cisapride,
prucalopride, and metoclopramide are effective for the treatment of chronic constipation in
persons with SCI.
Bladder Management
Disruption of the signals from the brain resulting from a SCI prevents normal voluntary voiding
without assistance. Intermittent catheterization and spontaneous triggered voiding are
associated with the lower complications compared to indwelling catheters. Intermittent
catheterization may be difficult to continue at home for those with tetraplegia and complete
injuries. Assistive devices may enhance compliance with intermittent catheterization for those
with impaired hand function.
Pain Management
Pain following a SCI is common, often severe and has a significant effect on quality of life. A
shoulder exercise protocol (consisting of shoulder stretching and strengthening) reduces the
intensity of shoulder pain post-SCI. Reduce pain may be achieved from massage, heat,
v
acupuncture or hypnosis. A number of pharmacological agents can provide pain relief,
including the anticonvulsant Gabapentin, Intrathecal Baclofen, and Lidocaine through a
subarachnoid lumbar catheter. Tricyclic antidepressants and Intrathecal Clonidine have not
been shown to reduce post-SCI pain.
Venous Thromboembolism
Venous thromboembolism (blood clot) is very common in untreated spinal cord-injured patients.
The pharmacological agent low molecular weight heparin is more effective than standard
heparin in reducing the risk of venous thromboembolism post-SCI with less bleeding
complications. Physical interventions such as pneumatic compression or pressure stockings
may have some additional benefits when used in combination with pharmacological agents.
Orthostatic Hypotension
Orthostatic hypotension is an excessive reduction in blood pressure with changes in body
position and can result in lightheadedness or dizziness. It is commonly experienced following
SCI due to the loss of muscle activation. Although a wide array of physical and pharmacological
measures are recommended for the general management of orthostatic hypotension, very few
have been evaluated for use in SCI. Of the pharmacological interventions, only midodrine was
found to be effective, while functional electrical stimulation is one of the only non-
pharmacological interventions which demonstrates some evidence to support its use.
Autonomic Dysreflexia
Autonomic dysreflexia is a potentially life-threatening acute elevation of blood pressure
commonly experienced post-SCI. The identification of the possible trigger and decrease of
sensory stimulation to the spinal cord is the most effective prevention strategy. Urinary bladder
irritation is one of the major triggers of autonomic dysreflexia following SCI. The
pharmacological agents, nifedipine or captopril are commonly used and can prevent or control
autonomic dysreflexia in SCI individuals.
Heterotopic Ossification
Heterotopic ossification, the formation of pathological bone in muscle or soft tissue, occurs
frequently in the first two months following SCI. Anti-inflammatory medications or warfarin (anti-
coagulant) can reduce the risk of heterotopic ossification post-SCI. Once ossification is
identified, the pharmacological agent, etidronate or radiation therapy can reduce the
progression of heterotopic ossification.
Nutrition
There is an increased risk for obesity, abnormal lipid metabolism, cardiovascular disease,
impaired glucose regulation and diabetes mellitus post-SCI. Standard dietary counseling (daily
total fat <30% of total daily calories, saturated fat <10% of total daily calories, cholesterol <300
mg, carbohydrates equal to 60% of total daily calories) can reduce total cholesterol. A holistic
wellness program can help people adopt healthy nutritional behaviours following a SCI. Vitamin
deficiency is common post-SCI, therefore individuals should be screened and if needed,
replacement therapy should be initiated.
Pressure Ulcers
Pressure ulcers are a serious, lifelong secondary complication of SCI. A number of prevention
strategies exist to reduce the risk of pressure ulcers and appropriate seating is one important
consideration. No one cushion is suitable for all individuals with SCI. Cushion selection should
be based on a combination of pressure mapping results, individual characteristics and
preference. Adding lumbar support to the wheelchairs of individuals with chronic SCI is unlikely
vi
to have a role in pressure ulcer prevention post-SCI. A forward leaning position or the
wheelchair tilted back position (> 65º) are effective methods of pressure relief.
Spasticity
Spasticity is the excessive involuntary motor activity of a muscle or muscle group reacting to
external stimuli. It is a major obstacle for community and workplace integration following SC.
Oral baclofen or intrathecal baclofen reduces muscle spasticity following SCI. A number of non-
pharmacological interventions (transcutanous electrical stimulation, massage, assisted standing,
ice) have short term effects on spasticity lasting several minutes to hours.
Outcome measures
Numerous outcome measures are available for use in SCI practice and research. Many SCI
specific measures are gaining acclaim such as the Spinal Cord Independence Measure which is
slowly replacing the Functional Independence Measure as the outcome of choice for assessing
personal activities of daily living. Several new generic measures of participation in higher order
social activities and life habits are available. These tools are conceptually well developed and
support for psychometric properties is accumulating.
4. Limitations in SCI Rehabilitation Literature
The task of compiling this vast amount of literature provided the SCIRE team a unique
opportunity to appraise the body of SCI rehabilitation literature as a whole. There is a
substantial amount of literature available in SCI rehabilitation as highlighted in the previous
section. However, the SCIRE team noted several gaps and recurring methodological issues
across different topics in SCI rehabilitation and highlight these limitations here.
Our topics were selected by clinicians, researchers and consumers with SCI and not necessarily
by the abundance of research papers in a particular area. Little or no information was available
in several areas. Despite the inherent value we place on integrating an individual in their
community, we do not know the best methods to facilitate successful re-entry into community
life and literature was either absent or based on observational studies for this topic. There was
also a dearth of literature concerning sexual and reproductive health of women with SCI that
would potentially guide selection of contraception, enhancement of sexual adjustment and
response or access to routine gynecological procedures. Women make up a significant
proportion of the SCI population (one-quarter to one-third) and were underrepresented across
all areas of SCI rehabilitation literature.
For many areas, we rely on information based primarily on other medical conditions. Although
guidelines exist for SCI related conditions such as depression, autonomic dysreflexia, and deep
vein thrombosis, many of the recommendations are based on other patient populations (not
SCI). SCI is a complex condition with effects and interactions on multiple systems and
responses that are not always predictable. For example, a simple dietary intervention such as
increased fibre, had a response in SCI (worsened constipation) which was opposite to what
would be expected in able-bodied individuals (reduced constipation).
The SCI rehabilitation literature suffers from several methodological shortcomings, including
small, heterogeneous samples, few controlled trials, and a lack of consensus as to common
outcome measures. Study samples consisted of people who had sustained different injuries:
paraplegia and tetraplegia, complete and incomplete injuries, and acute and chronic injuries.
This was prevalent throughout the current literature, despite the knowledge that physiological
responses from interventions are different in these subgroups. As a result, a heterogeneous
vii
sample can also wash out what might have been important effects for a subsample of the
population. For example, bone health interventions depend on the stage of injury; preventing
bone loss during the rapid bone mineral loss in the first 4-6 months compared with maintaining
or improving bone during the relative stabilization after 1-2 years after SCI. However, some of
the bone health studies included participants within a few months to several years post-injury
representing physiologically different phases.
Pharmacological interventions were supported by the largest proportion of randomized

controlled trials (level 1 evidence) while other rehabilitation interventions were primarily
supported by single group, pre-test/post-test studies (level 4 evidence). Without a comparable
control group, one cannot determine if improvements are attributed to the intervention or other
factors such as increased familiarity with the outcome measures, time post-injury or attention
from the clinician. Furthermore, randomizing the subjects into the treatment and control group
reduces the biases associated with patient selection. It was not surprising to see a number of
interventions where the weaker evidence demonstrated positive effects, but the more rigorous
controlled trials did not. For example, lower levels of study design (pre-test/post-test study or
non-randomized trial) suggested that body-weight support treadmill training in sub-acute SCI
resulted in better outcomes than conventional rehabilitation; however, stronger evidence from a
single-blinded RCT suggested that no differences between body weight support treadmill
training and conventional rehabilitation.
Rigorous randomized trials with homogeneous groups require a large available source of
patients. The number of new spinal cord injuries is relatively small compared to conditions like
arthritis or heart disease. There is no doubt that multi-site trials are required if we strive to
increase the certainty as to whether a treatment is effective or not in SCI rehabilitation.
There is a lack of standardization when selecting the outcome measures for an intervention.
For example, the chapter authors (Hsieh et al. 2006) noted that the spasticity interventions
included 66 different outcome measures. No single outcome measure can capture the multi-
dimensional nature of spasticity and its effects and studies should include effective outcome
measures that meet minimum standards and that encompass the range of health outcomes
relevant to the treatment and the patients. In addition, consensus on some common measures
would assist the interpretation of results across studies.
5. Conclusions
The SCIRE combined the efforts of expert scientists, clinicians, consumers and stakeholders to
increase the accessibility of quality information in SCI rehabilitation. A broad range of topics are
evaluated, and future editions will continue to update, improve and add new topics for people
seeking information relevant to SCI rehabilitation from bed side to community. The pre-
appraised, synthesized research from SCIRE can translate into improved health for Canadians
by keeping health care professionals, scientists, policy-makers and consumers with SCI
informed of the latest evidence.
viii
EDITORS
Janice J Eng, PhD, BSc (PT/OT), is Professor, School of Rehabilitation Sciences,

University of BC, GF Strong Rehab Centre and ICORD (Vancouver, Canada). Her
program in neurological rehabilitation spans mechanistic research, clinical trials to
knowledge translation. She is a Canadian Institutes of Health Research Scholar and
Michael Smith Scholar.
Robert Teasell, MD, FRCPC is Professor/Chair/Chief of the Department of Physical

Medicine and Rehabilitation at the University of Western Ontario and Parkwood Hospital
(SJHC). Dr. Teasell’s research interests are in evidence-based applications to clinical
rehabilitation practice with a specific interest in neurorehabilitation, and chronic pain,
particularly the role of personality in coping with pain.
William C Miller, PhD, OT, is Associate Professor, School of Rehabilitation Sciences,

University of BC and ICORD faculty. An epidemiologist by background, his expertise is
in the area of measurement and examination of mobility limitations and daily occupations
across diagnoses in older adults. He is a Canadian Institutes of Health Research
Scholar.
Dalton Wolfe, PhD is an Associate Scientist in the Program of Aging, Rehabilitation and
Geriatric Care in the Lawson Health Research Institute, London, ON, Canada. Dr. Wolfe
has a background in clinical neurophysiology and research methods. His current
research interests are in the areas of health promotion and FES-assisted exercise for
people with SCI.
Andrea F Townson, MD, FRCPC is Clinical Assistant Professor in the Division of

Physical Medicine and Rehabilitation, University of British Columbia and ICORD. She is
Medical Manager, SCI Rehab Program at GF Strong Rehab Centre. Research interests
include high lesion spinal cord injuries, ventilator dependency, fatigue and outcome
measures.
Jo-Anne Aubut, BA is a research assistant in the Department of Physical Medicine &

Rehabilitation located at Parkwood Hospital. She has worked on a variety of research
projects through the University of Western Ontario and the Lawson Health Research
Institute in London, ON.
Caroline Abramson, MA, is the Clinical Research Coordinator for the Division of
Physical Medicine and Rehabilitation. She works with physiatrists and residents on a
variety of research projects through the University of British Columbia and GF Strong
Rehab Centre.
Jane Hsieh, MSc, has over 15 years in clinical research in both the academic and
biotechnology industry settings. Previously as the senior director of Clinical Program at
AcordaTherapeutics, she oversaw a variety of phase 1, 2 & 3 studies mainly in SCI and
MS populations. Her current activities inlcude consultation to both academic and
industrial research groups.
Sandra Connolly, BHScOT(C), OTReg. (Ont.) is an occupational therapist in the Spinal

Cord Injury Rehabilitation Program at Parkwood Hospital, St. Joseph's Health Care
London.
ix
CONTRIBUTORS
Maureen Ashe, PhD, PT Chris Fraser, HBSc, RD

School of Rehabilitation Sciences Rehabilitation Program
University of BC Parkwood Hospital
Vancouver, BC London, ON
Najib Ayas, MD, MPH, FRCPC Tal Jarus, PhD, OT

Faculty of Medicine School of Rehabilitation Sciences
University of BC University of BC
Vancouver, BC Vancouver, BC
Jeff Blackmer, MD, FRCPC Lyn Jongbloed, PhD, OT(C)

Physical Medicine and Rehab School of Rehabilitation Sciences
University of Ottawa University of BC
Ottawa, ON Vancouver,BC
Sally Breen, RN, BSN, CRRN David Keast, MD, FRCPC

Sexual Health Outpatient Chronic Wound Management
GF Strong Rehab Centre Parkwood Hospital
Geri Claxton, RN Andrei Krassioukov, MD, PhD

Outpatient Nursing Department of Medicine
GF Strong Rehab Centre University of BC, ICORD
B. Cathy Craven, MD FRCPC Tania Lam, PhD, PT

Bone Density Lab School of Human Kinetics
Toronto Rehabilitation Institute University of BC, ICORD
Toronto, ON Vancouver, BC
Armin Curt, MD, FRCPC Kate McBride, RN

Faculty of Graduate Studies Sexual Health
University of BC, ICORD GF Strong Rehab Centre
Stacy Elliot, MD William B Mortensen, BScOT, MSc

Department of Psychiatry School of Rehabilitation Sciences
University of BC, ICORD University of BC
Susan J Forwell, PhD, OT(C) Stephanie Muir-Derbyshire, MSc, SLP(C),

School of Rehabilitation Sciences Reg CASLPA
University of BC, ICORD Parkwood Hospital
x
Vanessa Noonan, BScPT, MSc A William Sheel, PhD
Dept of Orthopaedic Surgery School of Human Kinetics
University of BC University of BC, ICORD
Luc Noreau, PhD Jim Slivinski, MA

Department of Rehabilitation Psychology Intern
Laval University Parkwood Hospital
Quebec City, QC London, ON
Steven Orenczuk, PsyD Shannon Sproule, PT

Rehabilitation Program GF Strong Rehab Centre
Parkwood Hospital Vancouver, BC
London, ON
Emily Procter, BSc John Steeves, PhD

GF Strong Rehab Centre John and Penny Ryan BC Leadership
Vancouver, BC Chair, ICORD, UBC/VCHRI
Vancouver, BC
MaryAnn Regan, RN, BScN Linh Tu, BHSc
Spinal Cord Injury Rehabilitation Program Physical Medicine and Rehabilitation
Parkwood Hospital Parkwood Hospital, SJHC
London, ON London, ON
W Darlene Reid, PhD, PT Darren Warburton, PhD

School of Rehabilitation Sciences School of Human Kinetics
University of BC University of BC, ICORD
Candice Rideout, PhD (Candidate) Maura Whittaker, PT

Human Nutrition GF Strong Rehab Centre
University of BC Vancouver, BC
Vancouver, BC
Bonita Sawatzky, PhD Shannon Wilkinson, BScOT

Dept of Orthopaedic Surgery Spinal Cord Unit
University of BC GF Strong Rehab Centre
Keith Sequeira, MD, FRCPC

Physical Medicine & Rehab
University of Western Ontario, Parkwood
Hospital, London, ON
xi
CHAPTER ONE
Rehabilitation: From Bedside To Community

Following Spinal Cord Injury (SCI)
Janice J Eng, PhD, BSc (PT/OT)
William C Miller, PhD, OT
Table of Contents
1.1 Background ......................................................................................................................1-1
1.2 Epidmiology .....................................................................................................................1-2

1.2.1 Traumatic SCI .................................................................................................................1-2
1.2.2 Non-traumatic SCI ..........................................................................................................1-3
1.3 Recovery...........................................................................................................................1-3
1.3.1 Neuroplasticity ................................................................................................................1-4
1.3.2 Measures of Recovery ....................................................................................................1-4
1.4 Rehabilitation ...................................................................................................................1-6
1.5 Community Re-integration..............................................................................................1-7
References................................................................................................................................1-9
This review has been prepared based on the scientific and professional information available in 2005. The SCIRE
information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If
you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors,
contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising
from the use or misuse of this material.
Eng JJ, Miller WC (2006). Rehabilitation: From Bedside To Community Following Spinal Cord Injury. In: Eng JJ,
Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord
Injury Rehabilitation Evidence. Vancouver, p 1.1-1.11.
www.icord.org/scire
Rehabilitation: From Bedside To Community
Following Spinal Cord Injury (SCI)
1.1 Background
The spinal cord extends from the foramen magnum (opening at the base of the skull) to the
conus medullaris (most distal bulbous part of the cord) at the level of the first and second
lumbar vertebrae. It consists of 31 segments associated with 31 pairs of spinal nerves (8
cervical, 12 thoracic, 5 lumbar, 5 sacral and 1 coccygeal). The ascending sensory nerves within
the spinal cord receive and transmit sensory information to the brain. The descending motor
nerves transmit information from the higher brain structures to various parts of the body to
initiate motor functions such as movement and to regulate autonomic functions such as
respiration and blood pressure. The spinal cord is also critical for transmitting and integrating
information within the spinal cord.
Figure 1.1
C2-3 Sternomastoid
Cervical C3-5 Diaphragm
C5 Elbow Flexors
C6 Wrist Extensors
C7 Elbow Extensors
C8 Long Fingers Flexors
T1 Small Finger Abductors
Thoracic T1-11 Intercostals

T7-L1 Abdominals Muscle
T11-L2 Ejaculation
L2 Hip Flexors
Conus medullaris
L3 Knee Extensors
Cauda Equina L4 Ankle Dorsiflexors
Lumbar
L5 Long Toe Extensor
S1 Ankle Plantarflexors
S2-3 Bowel / Bladder
Sacral S2-4 Penile Erection
Coccygeal
Spinal cord injury (SCI) which results in disruption of the nervous transmission can have
considerable physical and emotion consequences to an individual’s life. Paralysis, altered
sensation, or weakness in the parts of the body innervated by areas below the injured region
almost always occur. In addition to a loss of sensation, muscle functioning and movement,
individuals with SCI also experience many other changes which may affect bowel and bladder,
presence of pain, sexual functioning, gastrointestinal function, swallowing ability, blood
pressure, temperature regulation and breathing ability. Numerous secondary complications
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may arise from SCI including deep vein thrombosis, heterotopic ossification, pressure ulcers
and spasticity.
The recovery can be long from the acute hospital admission to the return of full participation in
the individual’s community. Even those individuals who make significant gains in rehabilitation
may experience difficulty when returning to pre-injury activities. Thus, SCI has a severe effect
on quality of life. It also has an enormous cost on the health care system. Dryden et al. (2005)
examined the health care costs following a SCI in Canada. The acute and rehabilitation care
represented 68.2% of the total health care costs incurred over the first 6 years for an individual
following an injury to the spinal cord. The direct costs of a spinal cord injury were estimated at
$146,000 Canadian in the first year for a person with a complete traumatic injury and $42,000
for an incomplete injury. Annual costs in the subsequent 5 years post-injury were reported to be
$5400 Canadian per person with a complete injury and $2800 for an incomplete injury (Dryden
et al. 2005). Compared to age and gender-matched controls, individuals with SCI discharged
from hospital are more likely to be re-hospitalized, have physician contact and use more hours
of home care services (Dryden et al. 2004). The need for evidence-based SCI rehabilitation
programs has never been greater given the enormous cost of SCI rehabilitation, the growing
demands on the Canadian health care system and the devastating impact that an SCI has on
the quality of lives of individuals.
1.2 Epidemiology
Injuries to the spinal cord have been classified as either traumatic in cause (e.g., motor vehicle
accidents, falls, violent incidences, diving) or non-traumatic (e.g., tumors, spinal stenosis,
vascular). Traumatic SCI accounts for the larger proportion of SCI injuries, however, the exact
proportion compared to non-traumatic SCI is difficult to ascertain because reporting of non-
traumatic SCI has been inconsistent. The percent of traumatic SCI to overall SCI injury has
been reported to range from 75% in Germany (Exner & Meinecke 1997), 61% in the United
States (McKinley et al. 1999a) and 48% in the Netherlands (Schonherr et al. 1996).
1.2.1 Traumatic SCI
Much of the following epidemiology data on traumatic spinal cord injury in Canada has been
extracted from the 2006 Canadian Institute of Health Information Report on Traumatic SCI (CIHI
2006a) using 2003-2004 data from the Canadian National Trauma Registry (NTR). Over 950
traumatic spinal cord injuries occurred in 2003-2004 (CIHI 2006a). Reports of the annual
incidence vary in part due to differing methods of identifying and tracking injuries, and due to
regional differences. The annual incidence has been estimated at 52.5 per million population in
Alberta (Dryden et al. 2003) and 46.2 to 37.1 per million population over the 1994 to 1999
period in Ontario (Pickett et al. 2003). The global incidence of SCI estimated primarily from
developed countries ranges between 10.4 to 83 per million population per year when including
only patients who survived before hospital admission (Wyndaele & Wyndaele 2006).
In Canada, males comprise over three-quarters of these traumatic injuries with the majority
occurring in those under 35 years of age. Motor vehicle accidents are the leading cause of SCI
injury (43%), while falls are the second leading cause (36%) (NTR 1999). The number of spinal
cord injuries resulting from falls are increasing due to the growing older adult segment of the
population. This has contributed to the increase in age of a person with traumatic SCI (from
average age 46 in 1994 to average 49 in 1998). In fact, we are now seeing a bimodal
distribution of SCI in the population with one mode centralizing at approximately 30 years of age
and another mode centralizing at 60 years of age. Interestingly, falls are the primary cause of
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spinal cord injury admissions in seniors (64%), while motor vehicle accidents are the leading
cause in young adults (NRT 1999). Fractures of the vertebral column, in addition to spinal cord
injury represent 71% of all SCI hospital admissions (NTR 1999). Of the SCI admissions, 44%
result in paraplegia and 56% tetraplegia (NTR 1999).
Traumatic SCI can be complex as motor vehicle accidents or other violent incidents often result
in more than injury to the spinal cord. In particular, patients with the dual diagnosis of traumatic
brain injury and spinal cord injury present a challenge to the rehabilitation professional as they
are often agitated and have poor concentration. The percentage of SCI injuries which are
accompanied by a traumatic brain injury are substantial, for example, Lida et al. (1999) reported
that 35% of SCI had a traumatic brain injury.
There appears to be a trend towards more severe injuries in Canada. In the 1970s, the
Canadian Paraplegic Association (CPA) reported that about 25% of injuries resulted in
tetraplegia and 75% paraplegia. Of the new injuries reported to CPA during 1999, 47% resulted
in tetraplegia and 53% resulted in paraplegia. This increase in tetraplegic injuries concurs with
a slight significant increase from 53.5% tetraplegia in the 1970s to 56.5% in 2000 at the facilities
with the Model Spinal Cord Systems in the US (Jackson et al. 2004). A survey of the
epidemiology literature (Wyndaele and Wyndaele 2006) suggests increasing proportions of
tetraplegia with a global proportion of approximately two-thirds tetraplegia.
There have been some suggestions that there are increasing numbers of incomplete lesions in
some regions (Calancie et al. 2005). However, these finding are not consistent. The Model
Spinal Cord Systems in the US (Jackson et al. 2004) reported an increase in complete injuries
in the 1990s which has since dropped back to pre-1990 levels with just less than half of the
injuries being complete. The Australian Spinal Cord Injury Registry reported increasing rates in
elderly males, fall-related injury and incomplete tetraplegia and complete paraplegia over an
eleven year period (O’Connor 2006).
1.2.2 Non-traumatic SCI
There are many different causes of non-traumatic SCI, the more common conditions include
spinal stenosis (narrowing of the spinal canal), tumor compression and vascular ischemia.
Individuals with a non-traumatic SCI do not necessarily enter major trauma or rehabilitation
centres and thus are not easily tracked in SCI registries or databases. Non-traumatic SCI has
different demographics than traumatic SCI as spinal stenosis and spinal tumors are more
common in adults over 50 years of age. In addition, specific diseases such as multiple
sclerosis, paediatric spina bifida or poliomyelitis can also contribute to non-traumatic spinal cord
injury and each has demographics specific to the condition.
Overall, compared to traumatic SCI, individuals with non-traumatic SCI tend to be older with
less severe injuries, more likely to be female, married, retired, and have an incomplete
paraplegic injury (McKinley et al. 1999, 2002a, 2002b). Differences in demographics, clinical
presentation and rehabilitation outcomes have important implications for management of non-
traumatic SCI.
1.3 Recovery
The majority of individuals experience some neurological recovery (changes in motor or sensory
status) following a SCI, in addition to functional recovery. Given that all patients receive some
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treatment (e.g., pharmacological, self-care and mobility training), it is difficult to separate the
contributions of spontaneous recovery with those from active rehabilitation in humans.
1.3.1 Neuroplasticity
Spontaneous neuronal plasticity occurs through various mechanisms and has been
demonstrated primarily in animal models. Recovery mechanisms following complete injuries
may include recovery of nerve roots beside the lesion level, changes in the gray matter of the
spinal cord at the lesion level, reorganization of existing spinal circuits and peripheral changes
(Bradbury & McMahon 2006; Kern et al. 2005; Ding et al. 2005; Hagg & Oudega 2006; Ramer
et al. 2005). The evidence for spontaneous axonal regeneration is limited as a small proportion
of fibres regenerate and over a modest distance (Bradbury & McMahon 2006). However,
cortical re-organization can occur, for example, Lotze et al. (2006) showed that cortical
representation of elbow movements following a complete thoracic injury in humans was moved
toward cortical areas which represented the injured thoracic regions. There is evidence that a
pattern-generating spinal circuitry (also known as a central pattern generator) is retained
following a complete injury which can produce stepping-like movements and activation patterns
with epidural lumbar cord stimulation (Kern et al. 2005) or treadmill stimulation (Dietz et al.
2002). However, the functional consequences of these observations are yet to be determined.
Incomplete injuries may have a greater extent of axonal sprouting and axonal growth (Ding et al.
2005; Hagg & Oudega 2006). In incomplete spinal cord injury in rats, transected hindlimb
corticospinal tract axons sprouted into the cervical gray matter to contact short and long
propriospinal neurons (Bareyre et al. 2004). Following cervical lesions of the rat dorsal
corticospinal motor pathway which contains more than 95% of all corticospinal axons, there was
spontaneous sprouting from the ventral corticospinal tract onto medial motoneuron pools
(Weidner et al. 2001). This sprouting was paralleled by functional recovery. Ramer et al.
(2005) suggested that if axonal regeneration occurs or if synaptic spaces become occupied with
different axons, functional recovery will require retraining to optimize these new circuits. The
neuroplastic changes which underlie spontaneous recovery may be enhanced by physical
interventions (e.g., exercise, electrical stimulation) and pharmacological agents (Ramer et al.
2005).
1.3.2 Measures of Recovery
Changes in the American Spinal Injury Association (ASIA) International Classification of Spinal
Cord Injury, neurological level of injury and completeness of injury are often used to indicate
human neurological recovery.
ASIA International Standards for Neurological Classification of Spinal Cord Injury consists of 1)
5 category ASIA Impairment Scale (A-E), 2) motor score and 3) sensory score (ASIA 2002).
Twenty-eight dermatomes are assessed bilaterally using pinprick and light touch sensation for
the sensory score (maximum of 112 for pinprick and 112 for light touch sensation). Ten key
muscles are assessed bilaterally with manual muscle testing for the motor score (maximum of
50 for lower limbs and 50 for upper limbs). The results are used in combination with evaluation
of anal sensory and motor function as a basis for the determination of the ASIA Impairment
Scale and the 5 categories are summarized below (ASIA 2002).
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Table 1.1 Descriptions of Categories from ASIA Impairment Scale
ASIA A: Complete injury where no sensory or motor function is preserved in sacral segments S4-S5.
ASIA B: Incomplete injury where sensory, but not motor, function is preserved below the neurologic level and
extends through sacral segments S4-S5.
ASIA C: Incomplete injury where motor function is preserved below the neurologic level, and most key muscles
below the neurologic level have muscle grade less than 3 (active full-range movement against gravity).
ASIA D: Incomplete injury where motor function is preserved below the neurologic level, and most key muscles
below the neurologic level have muscle grade greater than or equal to 3.
ASIA E: Normal sensory and motor functions.
Neurological level of injury is the most caudal level at which both motor and sensory levels are
intact and has been shown to change in some individuals over recovery.
Completeness of injury are based on the ASIA standards where the absence of sensory and
motor functions in the lowest sacral segments indicates a complete injury and preservation of
sensory or motor function below the level of injury, including the lowest sacral segments
indicates an incomplete injury. Sacral-sparing is an important indicator of motor recovery and
provides evidence of the physiologic continuity of spinal cord long tract fibers with the sacral
fibers at the end of the cord. The requirement of sacral sparing to identify an incomplete injury
provides a more rigorous definition and less patients will convert from incomplete to complete
injury over time when using this definition.
Stauffer (1976) proposed that individuals with tetraplegia would recover one neurological level,
although this has been revised in recent years to qualify that recovery of one neurologic level in
subjects with tetraplegia depends on severity, initial level of the injury and the strength of
muscles below the level of injury (Dittuno et al. 2005). Dittuno et al. (1992) reported that 70 to
80% of motor-complete tetraplegia subjects with some motor strength at the injury level would
recover to the next neurologic level within 3 to 6 months. Although those with complete lesions
are generally limited to improvements of one or two levels, subjects with incomplete lesions may
exhibit recovery at multiple levels below the injury site (Dittuno et al. 2005). Triceps elbow
extension (C7) is a significant determinant for functional independence in self-care for
community-living individuals with tetraplegia (Welch et al. 1986).
For those with complete paraplegia, Waters et al. (1992) reported that 73% of 108 patients (T2-
L2) did not change in neurological level at one year post-injury compared to the rehabilitation
admission assessment. 18% recovered to the next neurological level, while 7% had 2 levels of
recovery. For incomplete paraplegia, 78% of 45 cases (T1-L3) had no changes in neurological
level between the first and 12th month but there was substantial improvement in motor function
particularly within the first 3 months (Waters et al. 1994). 70% of this sample were able to
ambulate within 1 or 2 years post-injury (27% without any devices). Patients with initial grade 2
hip flexor and knee extensor motor strength achieved community ambulation. In terms of
function, individuals with a T2-T9 injury have some trunk control and may be able to stand using
braces and an assistive device such as a walker. Although injuries below T11 have increased
potential for ambulation with bracing, successful community ambulation often involves
individuals with an injury at the L3 level or below.
Marino et al. (1999) assessed data from 21 Model System SCI systems with 3585 individuals
with SCI over the first year of recovery. They found that 10 to 15% of those with initial complete
1-5
ASIA A injuries converted to incomplete injuries. For ASIA B injuries, 1/3 converted to ASIA C
and 1/3 to ASIA D or E. For ASIA C injuries, over 2/3 converted to ASIA D. However, the
accurate prediction of ASIA conversion can be fraught with problems. Burns et al. (2003) found
that individuals with cognitive factors (e.g., traumatic brain injury, alcohol intoxication, analgesic
administration, psychological disorders) and communication barriers (e.g., language barriers,
ventilatory dependency) had a higher percent of ASIA conversion over the first year likely due to
an inaccurate initial assessment.
1.4 Rehabilitation
Rehabilitation has been defined by the World Health Organization as a progressive, dynamic,
goal-oriented and often time-limited process, which enables an individual with an impairment to
identify and reach his/her optimal mental, physical, cognitive and social functional level.
Enhancing quality of life is regarded as an inherent goal of rehabilitation services and programs
given their focus on interventions to minimize the impact of pain and physical and cognitive
impairment, and on enhancing participation in work and everyday activities. SCI rehabilitation
involves a multitude of services and health professionals and is initiated in the acute phase and
continues with extensive and specialized inpatient services during the sub-acute phase.
Inpatient rehabilitation is an important stepping stone towards regaining and learning new skills
for independent living. Here patients engage in an intensive full day program with services
which may include nursing, physical therapy, occupational therapy, respiratory management,
medical management, recreation and leisure, psychology, vocational counseling, driver training,
nutritional services, speech pathology, social worker, sexual health counseling, assistive device
prescription and pharmaceutical services. Rehabilitation continues with planning for discharge
back to the community and finally, re-integration into former or new roles and activities within
the community. Family and peers have important roles throughout the rehabilitation process.
In Canada, the median length of inpatient rehabilitation stay for traumatic SCI is 59 days with
longer stays for those with complete injuries or tetraplegic injuries ranging from 49 days for
those with incomplete paraplegia to 101 days to those with complete tetraplegia (CIHI 2006a).
SCI has the longest inpatient rehab length of stay over all other rehabilitation patient groups
except for burns (CIHI 2006b).
Functional recovery is often measured by the Functional Independence Measure (FIM), an 18

item scale that is intended to measure caregiver burden and includes tasks related to cognition,
mobility, bowel and bladder management and self-care. During inpatient rehabilitation, patients
with complete tetraplegia have the lowest FIM admission score and make less change
compared to those with incomplete or paraplegic injuries (CIHI 2006a). Persons with the dual
diagnosis of spinal cord injury and traumatic brain injury achieve smaller functional gains in
rehabilitation (Macciocchi et al. 2004).
Compared to traumatic SCI, the non-traumatic SCI rehabilitation length of stay is shorter, with a
lower FIM change and fewer medical complications including deep venous thrombosis,
orthostatic hypotension, pressure ulcers, wound infections, spasticity, autonomic dysrelfexia
were less likely (McKinley et al. 2002a, 2002b). The shorter length of stay may be a result of
the less severe injury. However, the earlier discharge in metastatic tumors may reflect the
terminal nature of the disease and patients and family may wish for the remaining time to be
spent at home.
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1.5 Community Re-integration
There is a fundamental belief among consumers with SCI that there needs to be a paradigm
shift in the approach to rehabilitation from an institutionally based physical restoration model to
a community-based independent living model (Rick Hansen SCI Network 2005). Going home is
a frequent goal established by patients newly admitted to hospital and 79% of individuals with
traumatic SCI injuries return home. Only 62% of individuals with complete tetraplegia return
home with 15% discharged back to acute care and 18% to long term care (CIHI 2006a). In a
study of high lesion SCI (C1-C4), it was found that 40% of these clients were discharged to
extended care units post rehabilitation, while the majority of these respiratory dependent
patients returned to the community (Anzai et al. 2006).
Life expectancy is less than normal, particularly for people with tetraplegia and who are
ventilator-dependent (NSCISC 2004). The life expectancy of a 40 year old paraplegic who has
survived at least 1 year post-injury is 10 years less than a person without a SCI (NSCISC 2004).
Although the mortality rate during the first 2 years after SCI has been reduced over the past 30
years, Strauss et al. (2006) noted that there has not been a substantial change in life
expectancy following the second year post-injury. In contrast, there has been an increase in life
expectancy over the last 2 decades in the general population.
Given that the majority of traumatic SCI occur in young adults, return to work or school is of high
importance, but often necessitates a change in vocation. Less than 18% of those employed at
the time of injury were able to return to the same job (CPA 1997). Within 3-6 months post
inpatient rehabilitation, 14% of people with SCI are employed, while 64% were employed prior
to injury. Approximately 9% are students (roughly double the pre-injury status). The majority
are unemployed (26%) or on disability status (35%) at 3-6 months follow-up (CIHI 2006a).
Canadians living with SCI tend to have a higher level of education than the general Canadian
population (CPA 1997). In a survey of Canadians who had been injured at least 5 years, 62%
were unemployed while 38% are employed (CPA 1997). Education is key to employment –
higher education or increasing education following injury result in more success with
employment. Of those who find employment, 44% do so within 2 years of injury while 77% find
employment within 5 years.
Accessible infrastructure and disability support are two major areas which people with SCI feel
would improve quality of life (RHMIMF 2004). When considering priorities for research,
individuals living with SCI rank finding a cure for SCI similarly to developing advances in
rehabilitation/therapy (RHMIMF 2004). Regaining arm and hand function has been cited as one
of the most important priorities to tetraplegics, while regaining sexual function has been cited as
the highest priority for paraplegics (Anderson 2004). Improving bladder and bowel function was
important to both injury groups (Anderson 2004). Although the majority of participants indicated
that exercise was important to functional recovery, more than half did not have access to
exercise (Anderson 2004). Anderson (2004) emphasized the need for researchers to be aware
of the needs of SCI consumers in their quest for discovery.
The continuum of health care in the community includes mechanisms for people to access
information resources about living with a SCI. However, it appears that people with SCI do not
approach traditional health care sources for their information (e.g., physician, hospital). For
people living with SCI, the internet was by far the number one source for information about SCI
(48%), while support groups and media ranked higher than hospitals, books, rehab centres,
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physicians and peers (RHMIMF 2004). It appears that the internet can be an ideal medium for
promoting health-related education. To facilitate accessibility of information, the SCIRE
information is available on CD, print version, as well as through web-access
(www.icord.org/scire).
In a recent survey, the majority (70%) of individuals with SCI rated the quality of life of people
with SCI as good or very good while 23% rated it as poor or very poor (RHMIMF 2004). It is
encouraging that 65% of individuals with SCI felt that the quality of life of people with SCI has
improved over the past 5 years (RHMIMF 2004). As enhancing quality of life is an inherent goal
of rehabilitation, there is a continual challenge to close the gap between treatment activities and
functional competence in the individual’s actual environment.
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CHAPTER TWO
Methods of Systematic Reviews

Table of Contents
2.1 Introduction ......................................................................................................................2-1
2.2 Article Assessment..........................................................................................................2-2

2.2.1 Literature Search Strategy ..............................................................................................2-2
2.2.2 Quality Assessment Tool and Data Extraction................................................................2-2
2.3 Determining Levels of Evidence and Formulating Conclusions .................................2-3
Appendix 1. Specific Search Terms .....................................................................................2-5
Appendix 2. The PEDro Scale...............................................................................................2-8
Appendix 3. Downs and Black tool (Downs and Black 1998) ..........................................2-10
References..............................................................................................................................2-11
Methods of the Systematic Reviews. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson
C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. 2006: Vancouver, p 2.1-2.11.
www.icord.org/scire
Methods of the Systematic Reviews
2.1 Introduction
Providing a framework for evidence-base practice was championed in the early 1990s, although
it was practiced and discussed in medical circles long before this. In 1992, the Evidence-Based
Practice Working Group (EBPWG) described a new framework of using research to guide and
augment the practice of medicine (Evidence-based Medicine Working Group 1992). Dr. David
Sackett, a pioneer in the field and also a member of the original working group described
evidence-based practice as:
“Evidence based medicine is the conscientious, explicit, and judicious use of current best
evidence in making decisions about the care of individual patients. The practice of evidence
based medicine means integrating individual clinical expertise with the best available external
clinical evidence from systematic research.” (Sackett et al. 1996)
Although the original definitions were framed for the practice of medicine, the practice has
spread to all fields of health care with the more generic term “evidence-based practice”.
Evidence-based practice does not ignore clinical experience and patient preferences, but
weights these against a background of the highest quality scientific evidence that is available.
The importance of clinical judgement was emphasized by Dr. Sackett in his original editorial:
“Because it [evidence-based medicine] requires a bottom up approach that integrates the best
external evidence with individual clinical expertise and patients' choice, it cannot result in
slavish, cookbook approaches to individual patient care. External clinical evidence can inform,
but can never replace, individual clinical expertise, and it is this expertise that decides whether
the external evidence applies to the individual patient at all and, if so, how it should be
integrated into a clinical decision.” Sackett et al. (1996)
Acquiring and interpreting the evidence from the research literature can be daunting. Not only is
there a wealth of ever changing information from multiple sources, but it is often difficult for a
front-line clinician not intimately familiar with the research methods to interpret the results of a
study. In addition, the interpretation is further complicated by the presence of multiple studies
on an intervention, often with what appears to be conflicting messages. The Spinal Cord Injury
Rehabilitation Evidence (SCIRE) is dedicated to providing up-to-date, accurate information
about the effect of rehabilitation health-care for people with SCI. The SCIRE used a systematic
and transparent procedure to assess and synthesize the evidence of the effects of rehabilitation
healthcare interventions in SCI and is designed for health professionals inform them of best
practice. Consumers with SCI and their families may also find the synthesis useful to better
understand their health care. In addition, such a research synthesis will enable relevant
decision-making in public policy and practice settings applicable to SCI rehabilitation. Lastly,
transparent and unbiased evidence-based reviews will guide the research community and
funding organizations to strategically focus their time and resources on the gaps in knowledge
and identify research priorities.
2-1
2.2 Article Assessment
2.2.1 Literature Search Strategy
A systematic review was undertaken using multiple databases (MEDLINE/PubMed, CINAHL®,

EMBASE, PsycINFO) to identify and synthesize all relevant literature published from 1980-
2005. An initial broad search was performed with five types of SCI therapies searched: drug
therapy, radiotherapy, diet therapy, rehabilitation therapy and therapy. To further refine the
search, the search was limited to human subjects and articles published in English.
Based on the above search criteria, the total number of references from all databases was
8007. Two investigators reviewed both the title of the citation and the abstract (of all 8007
references) to determine its suitability for inclusion. Articles’ suitability was based on the above
inclusion criteria as well as the following exclusion criteria: less than half the reported population
had a spinal cord injury; no measurable outcome associated with treatment; animal studies.
Unless there were no other supporting literature, studies with less than 3 subjects were
excluded.
Meta-analyses, systematic reviews and review articles were identified at this point and studies
cited with these works that were not identified in the original literature search, were also sought,
through hand searching. The review was restricted to published works.
MeSH headings were used with the keywords. Key words were paired with spinal cord injury,
tetraplegia, quadriplegia or paraplegia
Specific SCI rehabilitation topics (e.g., pressure ulcers) were identified by a multi-disciplinary
team of expert scientists, clinicians, consumers with SCI and policy-makers. These specific
topics were searched with additional keywords generated from expert scientists and clinicians in
SCI rehabilitation familiar with the topic and more titles and abstracts were reviewed. The
reference lists of previous review articles, key articles, systematic reviews and clinical practice
guidelines were hand searched. It is known that hand searching may provide higher rates of
return than electronic searching within a particular subject area (Hopewell et al. 2002). The
number of titles and abstracts reviewed is approximately 8400. Additional keywords used for
each specific topic are outlined in Appendix 1.
2.2.2 Quality Assessment Tool and Data Extraction
Methodological quality of individual RCTs was assessed using the Physiotherapy Evidence
Database (PEDro) tool (http://www.pedro.fhs.usyd.edu.au/scale_item.html). PEDro was
developed for the purpose of accessing bibliographic details and abstracts of randomized-
controlled trials (RCT), quasi-randomized studies and systematic reviews in physiotherapy.
PEDro has been used to assess both pharmacological and non-pharmacological studies with
good agreement between raters at an individual item level and in total PEDro scores (Foley et
al. 2006). Maher et al. (2003) found the reliability of PEDro scale item ratings varied from "fair"
to "substantial," while the reliability of the total PEDro score was "fair" to "good. Studies
included in this review using a non-experimental or uncontrolled design (non-randomized
comparative trials, cohort studies or retrospective studies) could not be assigned a PEDro score
and were given a not applicable (n/a) designation.
The PEDro is an 11-item scale, in which the first item relates to external validity and the other
ten items assess the internal validity of a clinical trial. One point was given for each satisfied
2-2
criterion (except for the first item, which was given a YES or NO), yielding a maximum score of
ten. The higher the score, the better the quality of the study and the following cut-points were
used where 9-10: excellent; 6-8: good; 4-5: fair; <4: poor. A point for a particular criterion was
awarded only if the article explicitly reported that the criterion was met. The scoring system is
detailed in Appendix 2. Two independent raters reviewed each article. Scoring discrepancies
were resolved through discussion.
All other studies with an intervention were assessed with the Downs and Black Tool (Downs and
Black 1998) for methodological quality. This tool consists of 27 questions in the following sub-
sections: Reporting, External Validity, Internal Validity – bias and Internal Validity – confounding
(selection bias). The original tool range from 0 to 32. However, we modified the last question
form a scale of 0 to 5 to a scale of 0 to 1 where 1 was scored if a power calculation or sample
size calculation was present while 0 was scored if there was no power calculation, sample size
calculation or explanation whether the number of subjects was appropriate. Thus, our modified
version ranged from 0 to 28, with a higher score indicating higher methodological quality. The
Downs and Black tool is attached in Appendix 3.
Data were extracted to form tables. Sample subject characteristics (Population), nature of the
treatment (Intervention), measurements (Outcome Measures) and key results are presented in
the tables. In cases, where a single study overlapped into multiple chapters (e.g., treadmill
training has effects on the cardiorespiratory, lower extremity and bone health), the results focus
on the outcomes relevant to that chapter.
2.3 Determining Levels of Evidence and Formulating Conclusions
Table 2.1 Five levels of evidence

Level Research Design Description
Randomized controlled trial, PEDro score ≥ 6. Includes within
Level 1 Randomized controlled trial (RCT) subjects comparison with randomized conditions and cross-
over designs
RCT Randomized controlled trial, PEDro score < 6.
Prospective controlled trial Prospective controlled trial (not randomized)
Level 2
Prospective longitudinal study using at least 2 similar groups
Cohort
with one exposed to a particular condition.
A retrospective study comparing conditions, including
Level 3 Case control
historical controls
A prospective trial with a baseline measure, intervention, and
Pre-post
a post-test using a single group of subjects.
A prospective post-test with two or more groups – intervention,
Level 4 Post-test then post-test (no pre-test or baseline measurement) using a
single group of subjects.
A retrospective study usually collecting variables from a chart
Case Series
review.
Observational Study using cross-sectional analysis to interpret relations.
Expert opinion without explicit critical appraisal, or based on
Level 5 Clinical Consensus
physiology, biomechanics or "first principles"
Case Report Pre-post or case series involving one subject
The levels of evidence used to summarize the findings are based on the levels of evidence
developed by Sackett et al. (2000). The levels proposed by Sackett et al. (2000) were modified
to collapse the subcategories within a level (e.g., level 1a, 1b, 1c) into a single level. This was
performed to reduce the 10 categories from Sackett et al. (2000) to a less complex system from
level 1 to level 5. We provided additional descriptions specific to the types of research designs
encountered in SCI rehabilitation to facilitate the decision-making process. Sackett et al. (2000)
2-3
distinguishes high and low quality randomized controlled trials (RCTs) into level 1b and level 2b,
respectively. To provide a more reliable decision-making process, we required that a level 1
RCT had a PEDro score of greater than or equal to 6 (good to excellent quality), while a level 2
RCT had a PEDro score of 5 or less. The appropriateness of the control group was assessed
per study. In some studies, an able-bodied group may not have been an adequate control for
the particular intervention used, but simply provided “normative’ values for comparison. In those
studies, the study was considered “not controlled” and the level of evidence reduced (e.g., level
4 pre-post).
RCTs received priority when formulating conclusions. Conclusions were not difficult to form
when the results of multiple studies were in agreement. However, interpretation became difficult
when the study results conflicted. In cases where studies differed in terms of quality, the results
of the study (or studies) with the higher quality score were more heavily weighted to arrive at the
final conclusions. Sometimes, interpretation was difficult, for example, the authors needed to
make a judgment when the results of a single study of higher quality conflicted with those of
several studies of inferior quality. In these cases we attempted to provide a rationale for our
decision and to make the process as transparent as possible.
As emphasized by Sackett et al. (1996), the evidence from systematic research should be
integrated with clinical expertise and patients' choice to form best practice.
2-4
Appendix 1. Specific Search Terms
Specific SCI rehabilitation topics were identified by a multi-disciplinary team of expert scientists,
clinicians, consumers with SCI and policy-makers. These specific topics were searched with
additional keywords generated from expert scientists and clinicians in SCI rehabilitation familiar
with the topic and more titles and abstracts are reviewed. MeSH headings were used with the
keywords. Key words were paired with spinal cord injury, tetraplegia, quadriplegia or
paraplegia. The reference lists of previous review articles, systematic reviews and clinical
practice guidelines were hand searched. It is known that hand searching may provide higher
rates of return than electronic searching within a particular subject area (Hopewell et al. 2002).
Chapter 3: Rehabilitation Practice: ("rehabilitation"[Subheading] OR "Rehabilitation"[MeSH])

AND "Spinal Cord Injuries"[MeSH] AND "Treatment Outcome"[MeSH]
Chapter 4: Community Reintegration: accessibility, attendant care, attitudes, community +

leisure + recreation, community involvement, community Involvement, community living,
community participation, community reintegration, community reintegration, daily functioning,
domestic life, employment, empowerment, environment + functioning, environment +
reintegration, environment + social, environment + social + home, environmental policy, family
involvement, HRQOL, intervention – trial, control group, treatment group; income support,
independent living, interpersonal relations, leisure – intervention, control group, treatment,
clinical trials, leisure + use of time, life happiness, life satisfaction, living independent,
occupations, personal assistance, personal satisfaction, productivity, psychosocial rehabilitation,
QOL – intervention, trial, control group, treatment group, recreation therapy, school education,
self care, social environment, social interactions, social network, social policy, social roles,
social support, socializing, use of technology, volunteer
Chapter 5: Upper Limb: upper limb, FES and upper limb, exercise programs, upper limb
injuries, splinting, specific researchers [Popovic…]
Chapter 6: Lower Limb: 4-AP, 4-AP + ambulation, assisted walking device, walking, assisted
rehabilitation device, biofeedback, body weight support, body weight supported treadmill training
(BWSTT), brace, bracing, Clonidine, Cyproheptadine, EMG + feedback, epidural stimulation /
epidural lumbar stimulation, FES + muscle, flexibility, gait, gait + bracing, gait + orthotics, gait
devices, GM-1 ganglioside, knee-ankle-foot, leg + bracing, leg + FES, locomotion, locomotor
training, lower extremity spasticity, orthotics, orthotics + lower limb, parawalker, robotics,
salbutamol, scott-craig knee ankle foot orthosis, spasticity management, stepping, stretching,
treadmill, trendelenburg gait, Vannini-rizzoli stabilizing orthosis, virtual reality, walking,
weakness
Chapter 7: Cardiovascular Exercise: cardiac output, cardiovascular disease, cardiovascular

fitness, coronary heart disease, endothelium, epoetin alfa, FES + blood pressure,
fludrocortisone, glucose intolerance, glucose sensitivity, hydralazine, lipid, lipid + metabolism,
neuromuscular + blood, nifedipine, orthostatic hypotension, oxygen consumption,
phenazopyridine, physiotherapy + blood, stroke volume, thromboembolism, ventilation,
ventilatory threshold, VO2
Chapter 8: Respiratory: abdominal binder, acapello, assisted cough, asthma – incidence,

prevalence, atelectasis, autogenic drainage, barotraumas, BiPAP, breathing exercises,
bronchial lavage, bronchitis, bronchoscopy, cardiopulmonary function, chest physiotherapy,
COPD – incidence, prevalence, CPAP, diaphragmatic pacemaker, dysphagia, exsufflation,
2-5
flutter, flutter device, flutter valve, forced expiratory technique, Garshick, glossopharyngeal
breathing, incentive spirometry, insufflation, intermittent positive pressure breathing,
intrapulmonary percussive ventilation, IPPB stretch, manual percussion, manual vibration,
mechanical vibration, paripep , PEP / PEEP, percussion, phrenic pacemaker, pneumonia -
incidence, prevalence, positive pressure breathing, postural drainage, progressive ventilatory
free breathing, pulmonary capacity, pulmonary complications – incidence, prevalence,
pulmonary embolism, pulmonary health, pulmonary secretions, respiratory complications –
incidence, prevalence, secretion removal, sleep apnea, smoking – incidence, prevalence,
spirometry, synchronous intermittent mandatory ventilation, TheraPep, tidal volume,
tracheostomy, ventilator weaning, ventilatory capacity, ventilatory failure – incidence,
prevalence
Chapter 9 Bone Health alendronate, Amino-bisphosphonates, bone + fracture, bone health,

cyclic etidonate, exercise therapy, FES, heterotopic ossification, incidence + fracture,
osteoporosis, pamidronate, skeletal + fracture, vibration
Chapter 10 Depression: alcohol abuse, drug abuse, depression, anxiety, gender differences,
sexuality, [specific researches: Krause, Noreau…], aging, sexual health, male and female,
spinal cord, vocational issues, sexual issues, psychosocial
Chapter 11 Sexual Health: autonomic dysreflexia, birth control, birthing, bladder + sex, bladder
management + body image, bladder management + mitrofanoff, bladder management + sexual
life, bladder management + suprapubic, body image, bowel + sex, Cesarean section,
contraception, dysparunia, dyspareunia + infertility, ejaculation, ejaculatory disorder,
electroejaculation, erection, female fertility, hypogonadism, ICSI, infertility + pregnancy,
intercavernosal injection, intraurethral palette, intraurethro palette, urethra palette, IVF, labour,
labour + delivery, marital, marital status + sexuality, menopause, menstruation, penile injection,
post-partum, pregnancy, premature labour, semen quality, seminal emissions, sex, sex +
depression, sex/sexual + foley catheter, sex/sexual + intermittent catheter, sexual adjustment,
sexual changes, sexual function + medications, sexual functioning + foley catheter, sexual
position, sexual relationships, sexual self-esteem, sexual self-views, sexuality, sexuality +
depression, sperm/semen quality, sperm/semen retrieval, vacuum device, vaginal lubrication,
Viagra, vibrator, vibrostimulation
Chapter 12 Bowel Management: bowel management, cisapride, colonic, colostomy,

constipation, dietary fibre, hemorrhoids, incontinence, irregular, laxative, neurogenic bowel,
suppositories
Chapter 13 Bladder: Bladder, Neurogenic"[MeSH] AND "Spinal Cord Injuries"[MeSH]
Chapter 14 Pain: pain treatment, pharmacology, pain, surgical intervention, pain management
Secondary complications
Chapter 15 Venous Thromboembolism: Deep venous thrombosis, thrombosis, emboli, DVT,

thromboembolism, heparin, vena cava filtration
Chapter 16 Orthostatic hypotension: orthostatic hypotension, dysreflexia, autonomic,

hyperreflexia, midodrine, postural hypotension, orthostatic intolerance, orthostatic tolerance,
orthostatic stress, blood flow, blood flow + exercise, blood pressure, blood vessel health
2-6
Chatper 17 Autonomic dysreflexia: AD, autonomic, dyreflexia, hyperreflexia, midodrine,
fludrocortisone, beta-blockers, Viagra, nifedipine, phenazopyridine
Chapter 18 Heterotopic Ossification: heterotopic ossification, excision surgery, etidronate
Chapter 19 Nutrition: diabetes, energy requirements, energy needs, caloric intake, weight
gain, obesity, overweight, prevention, body composition, cardiovasular disease risk, nutrient,
supplementation, supplements, dietary, nutrition intervention, folate, vitamin B6, vitamin B12,
omega 3 fatty acids, essential fatty acids, pressure ulcers, vitamin supplementation, mineral
supplementation, vitamin C, vitamin A, zinc, iron, protein, diabetes risk, hydration/optimal
hydration, cranberry juice, neurogenic bowel, dietary fibre, soluble fibre, insoluble fibre, fibre
supplements, peristalsis, osteoporosis, osteopenia, bone mineral density, calcium, vitamin D,
magnesium, renal stone/kidney stone and calcium intake/supplementation, urinary tract,
hypercalcemia
Chapter 20 Pressure Sores: pressure sores, ulcers
Chapter 21 Spasticity: botox, baclofen, spasticity
2-7
Appendix 2. The PEDro Scale (www.pedro.fhs.usyd.edu.au/scale_item.html)
1. “Subjects were randomly allocated to groups.” (in a crossover study, subjects were randomly
allocated an order in which treatments were received). A point for random allocation was
awarded if random allocation of patients was stated in its methods. The precise method of
randomization need not be specified. Procedures such as coin-tossing and dice-rolling were
considered random. Quasi-randomization allocation procedures such as allocation by bed
availability did not satisfy this criterion.
2. “Allocation was concealed.” A point was awarded for concealed allocation if this was explicitly
stated in the methods section or if there was reference that allocation was by sealed opaque
envelopes or that allocation involved contacting the holder of the allocation schedule who
was "off-site."
3. “The groups were similar at baseline regarding the most important prognostic indicators.” A
trial was awarded a point for baseline comparability if at least one key outcome measure at
baseline was reported for the study and control groups. This criterion was satisfied even if
only baseline data of study completed-only subjects were presented.
4. “There was blinding of all subjects.” The person in question (subject, therapist or assessor)
was considered blinded if he/she did not know which group the subject had been allocated
to. In addition, subjects and therapists were only considered to be "blind" if it could be
expected that they would have been unable to distinguish between the treatments applied to
different groups. In drug therapy trials, the administrator of the drug was considered the
therapist and was considered blinded if he/she did not prepare the drug and was unaware of
the drug being administered.
5. “There was blinding of all therapists who administered the therapy.” (criteria 4.)
6. “There was blinding of all assessors who measured at least one key outcome” (criteria 4).
7. “Adequacy of follow-up.” For the purposes of this review, follow-up was considered adequate
if all of the subjects that had been originally randomized could be accounted for at the end of
the study. The interpretation of this criterion differs from that described by PEDro, where
adequacy is defined as the measurement of the main outcome in more than 85% of
subjects.
8. “Intention to treat.” All subjects for whom outcome measures were available received the
treatment or control condition as allocated or, where this was not the case, data for at least
one key outcome was analyzed by "intention to treat". For purpose of the present evidence-
based review, a trial was awarded a point for intention-to-treat if the trial explicitly stated that
an intention-to-treat analysis was performed.
9. “The results of between-group statistical comparisons are reported for at least one key
outcome.” Scoring of this criterion was design dependent. As such, between groups
comparison may have involved comparison of two or more treatments, or comparison of
treatment with a control condition. The analysis was considered a between-group analysis if
either a simple comparison of outcomes measured after the treatment was administered
was made, or a comparison of the change in one group with the change in another was
made. The comparison may be in the form of hypothesis testing (e.g. p-value) or in the form
of an estimate (e.g. the mean, median difference, difference in proportion, number needed
to treat, relative risk or hazard ratio) and its confidence interval. A trial was awarded a point
for this criterion if between group comparison on at least one outcome measure was made
and its analysis of comparison was provided.
10. “The study provides both point measures and measures of variability for at least one key
outcome.” A point measure was referred as to the measure of the size of the treatment
effect. The treatment effect was described as being either a difference in group outcomes,
or as the outcome in (each of) all groups. Measures of variability included standard
deviations, standard errors, confidence intervals, interquartile ranges (or other quartile
2-8
ranges), and ranges. Point measures and/or measures of variability that were provided
graphically (for example, SDs may be given as error bars in a Figure) were awarded a point
as long as it was clear what was being graphed (e.g. whether error bars represent SDs or
SEs). For those outcomes that were categorical, this criterion was considered to have been
met if the number of subjects in each category was given for each group.
2-9
Appendix 3. Downs and Black tool (Downs and Black 1998)
Reporting
1) Is the hypothesis/aim/objective of the study clearly described?
2) Are the main outcomes to be measured clearly described in the Introduction or Methods
section?
3) Are the characteristics of the patients included in the study clearly described ? I4) Are the
interventions of interest clearly described?
5) Are the distributions of principal confounders in each group of subjects to be compared
clearly described?
6) Are the main findings of the study clearly described?
7) Does the study provide estimates of the random variability in the data for the main
outcomes?
8) Have all important adverse events that may be a consequence of the intervention been
reported?
9) Have the characteristics of patients lost to follow-up been described?
10) Have actual probability values been reported (e.g. 0.035 rather than <0.05) for the main
outcomes except where the probability value is less than 0.001?
External validity
11) Were the subjects asked to participate in the study representative of the entire population
from which they were recruited?
12) Were those subjects who were prepared to participate representative of the entire
population from which they were recruited?
13) Were the staff, places, and facilities where the patients were treated, representative of the
treatment the majority of patients receive?
Internal validity - bias

14) Was an attempt made to blind study subjects to the intervention they have received?
15) Was an attempt made to blind those measuring the main outcomes of the intervention?
16) If any of the results of the study were based on “data dredging”, was this made clear?
17) In trials and cohort studies, do the analyses adjust for different lengths of follow-up of
patients, or in case-control studies, is the time period between the intervention and
outcome the same for cases and controls ?
18) Were the statistical tests used to assess the main outcomes appropriate?
19) Was compliance with the intervention/s reliable?
20) Were the main outcome measures used accurate (valid and reliable)?
Internal validity – confounding (selection bias)

21) Were the patients in different intervention groups (trials and cohort studies) or were the
cases and controls (case-control studies) recruited from the same population?
22) Were study subjects in different intervention groups (trials and cohort studies) or were the
cases and controls (case-control studies) recruited over the same period of time?
23) Were study subjects randomised to intervention groups?
24) Was the randomised intervention assignment concealed from both patients and health
care staff until recruitment was complete and irrevocable?
25) Was there adequate adjustment for confounding in the analyses from which the main
findings were drawn?
26) Were losses of patients to follow-up taken into account?
27) Did the study have sufficient power to detect a clinically important effect where the
probability value for a difference being due to chance is less than 5%?
2-10
References
Downs SH and Black N. The feasibility of creating a checklist for the assessment of the
methodological quality both of randomised and non-randomised studies of health care
interventions. J Epidemiol Community Health (1998); 52:377-384.
Evidence-Based Medicine Working Group (1992): A new approach to teaching the practice of
medicine. JAMA: The Journal of the American Medical Association 268: 2420-2425.
Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluation of patient-based outcome measures
for use in clinical trials. Health Technology Assessment 1998;2:1 – 74.
Foley NC, Bhogal SK, Teasell RW, Bureau Y, Speechley MR. Estimates of quality and reliability
with the physiotherapy evidence-based database scale to assess the methodology of
randomized controlled trials of pharmacological and nonpharmacological interventions. Phys
Ther. 2006;86:817-24.
Hopewell S, Clarke M, Lefebvre C, Scherer R. Handsearching versus electronic searching to
identify reports of randomized trials. The Cochrane Database of Methodology Reviews
2002, Issue 4. Art. No. MR000001.
Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M. Reliability of the PEDro scale for
rating quality of randomized controlled trials. Phys Ther. 2003;83:713-21.
PEDro: http://www.pedro.fhs.usyd.edu.au/scale_item.html
Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine:
how to practice and teach EBM. Toronto, Ontario: Churchill Livingstone, 2000.
Sackett DL. Rules of evidence and clinical recommendations on the use of antithrombotic
agents. Chest 1989;95:2S-3S.
Sackett DL, Rosenberg WM, et al. Evidence based medicine: what it is and what it isn't. BMJ
1996;312:71-72. 52.
2-11
CHAPTER THREE
Rehabilitation Practice And Associated Outcomes

Following Spinal Cord Injury
Dalton L. Wolfe, PhD

Jane TC Hsieh, MSc
Key Points
Those with higher level and more severe injuries have longer rehabilitation LoS
(Length of Stay.
Rehabilitation LoS in the US has become progressively shorter up to the mid-

1990s.
Most individuals make significant functional gains during inpatient rehabilitation.
A significant proportion of people improve 1 AIS (ASIA Impairment Scale) grade in

the first few months post-injury particularly those initially assessed AIS B and C.
Increased therapeutic intensity may not necessarily lead to functional benefits, but
data is scarce.
Younger individuals with paraplegia are more likely to have shorter rehabilitation
LoS than older individuals.
Younger individuals are more likely to make greater functional gains during
rehabilitation than older individuals.
Younger individuals with tetraplegia (or in a mixed traumatic, non-traumatic

sample) are more likely to make gains in neurological status during rehabilitation
than older individuals.
Individuals with non-traumatic SCI have reduced LoS and less functional
improvement with rehabilitation as compared to those with traumatic SCI although
controlled comparisons are limited to data from the US Model Systems.
Neither gender nor race effects have been demonstrated for discharge destination,
rehabilitation LoS and neurological or functional status in US Model Systems data.
More specialized, interdisciplinary acute SCI care is associated with faster

transfers to rehabilitation and may result in fewer medical secondary
complications, more efficient functional gains and reductions in overall mortality.
Earlier admission to specialized, interdisciplinary SCI care is associated with

reduced length of total hospital stay and greater and faster rehabilitation gains
with fewer medical secondary complications.
Prospective studies with stronger designs are needed to strengthen the evidence
and provide more direction as to the optimal model of care.
Routine, comprehensive, specialist follow-up services may result in improved

health.
Table of Contents
3.1 Introduction ......................................................................................................................3-1
3.2 Common Abbreviations Used In SCI Rehabilitation.....................................................3-1
3.3 Description of SCI Rehabilitation Outcomes ................................................................3-2

3.3.1 Describing SCI Rehabilitation Outcomes ........................................................................3-2
3.3.1.1 Health Delivery Indicators ............................................................................................3-3
3.3.1.1.1 Rehabilitation Length of Stay ....................................................................................3-3
3.3.1.2 Neurological and Functional Status .............................................................................3-6
3.4 Factors for Optimal Outcomes .......................................................................................3-9

3.4.1 Effect of Intensity on Rehabilitation Outcomes ...............................................................3-9
3.4.2 Effect of Age on Rehabilitation Outcomes ....................................................................3-10
3.4.3 Differences in Traumatic vs Non-Traumatic SCI Rehabilitation Outcomes...................3-14
3.4.4 Effect of Gender and Race on Rehabilitation Outcomes ..............................................3-18
3.5 Specialized vs General SCI Units (Acute Care)...........................................................3-21
3.6 Early vs Delayed Admission to Specialized SCI Units ...............................................3-24
3.7 Outpatient and Follow-up Care.....................................................................................3-30
3.8 Summary.........................................................................................................................3-31
Appendix – Studies Describing Rehabilitation Outcomes.................................................3-34
References..............................................................................................................................3-41
Wolfe DL, Hsieh, JTC (2006). Rehabilitation Practices and Associated Outcomes Following Spinal Cord Injury.
In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors.
Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 3.1-3.44.
www.icord.org/scire
Rehabilitation Practice And
Associated Outcomes
3.1 Introduction
The SCI rehabilitation practices of today were influenced greatly by the pioneering efforts of Sir
Ludwig Guttman who was instrumental in the creation of specialized spinal units to care for
injured soldiers returning to England during and after WWII (Guttmann 1967). Eventual adoption
of this more specialized and integrated approach followed in many additional jurisdictions (Bors
1967; Bedbrook 1979), bolstered by reports of reduced mortality and enhanced long-term
survival which was attributed in part to more effective management of secondary conditions
associated with SCI (e.g., UTI’s, pressure sores, respiratory conditions) (Richardson & Meyer
Jr. 1981; Le & Price 1982;. Geisler et al.1983).
At present, the “ideal” scenario for modern SCI care is purported to be treatment in specialized,
integrated centres with an interdisciplinary team of health care professional providing care as
early as possible following injury and throughout the rehabilitation process with appropriate
discharge to the community characterized by ongoing outpatient care and follow-up (Donovan et
al. 1984; Tator et al. 1995). This is best facilitated under one roof or within an organized
“system” which is distinguished by seamless transitions as patients proceed from acute care
through rehabilitation to outpatient care. While it is generally accepted that this “ideal” more
specialized, integrated approach should result in better outcomes, there is very little robust
evidence that supports this directly. This is understandable, given the relatively low incidence of
SCI, limitations in designing trials with adequate controls and the inherent difficulty in ascribing
potential outcomes to such a multi-faceted process as rehabilitation. For these reasons, we
have adopted a more lenient approach within the present chapter with respect to the reviewed
articles as compared to most other chapters. Many of the articles presented in the current
chapter do not investigate a specific intervention although they do describe rehabilitation
outcomes and the various factors that are associated with producing optimal outcomes.
Accordingly, when no specific intervention is assessed experimentally, a PEDro or Downs and
Black (Downs & Black 1998) score is not provided. These articles were separated into five
categories: Description of Rehabilitation Outcomes, Factors for Optimal Outcomes, Specialized
vs. General SCI Units, Early vs. Delayed Admission to Specialized Units and Outpatient and
Follow-up Care.
In addition, in some studies the distinction between acute vs. rehabilitative care is somewhat
blurred as studies may have been conducted in centers or systems where these services are
more integrated. The present chapter is focused on issues associated with rehabilitation care
and we have attempted to clearly identify when acute care practice may have been merged
within the reporting of rehabilitation research results.
3.2 Common Abbreviations Used In SCI Rehabilitation
AIS – ASIA Impairment Scale

ASIA – American Spinal Injury Association (and associated International Guidelines for
Neurological Classification)
BI – Barthel Index
3-1
FIM – Functional Independence Measure
LoS – Length of Stay
MBI – Modified Barthel Index
OT – Occupational Therapy
SLT – Speech & Language Therapy
PT – Physical Therapy (Physiotherapy)
UTI – Urinary Tract Infection
3.3 Description of SCI Rehabilitation Outcomes
Much research has been directed at describing outcomes following SCI rehabilitation and
examining various factors that might be associated with good (or poor) outcomes. Ethical and
practical considerations limit the application of randomized controlled designs or other
experimental designs in investigating methods for enhancing patient outcomes. Typically,
investigators employ case series, case control or pre-post trial designs and often utilize
correlational or predictive analyses (e.g., univariate or multivariate regression) of large single or
multi-centre patient databases to determine specific associations or factors that are associated
with optimal rehabilitation outcomes. Often these studies are quite large in scope as
investigators explore relationships among a variety of socio-demographic and injury-related
variables as they endeavour to determine optimal rehabilitation practice. Given the inherent
breadth of findings present in individual studies in this area in which large databases are mined
for relationships among large arrays of variables, it is difficult to follow the same pattern of
brevity and topic focus found in most chapters of the present review. In the present section we
have taken a slightly different approach. First, a comprehensive table can be found in Section
3.9 Appendix 3.1 that lists specific studies in more detail and which outlines various findings
directed at describing outcomes associated with comprehensive inpatient SCI rehabilitation.
This is intended as an overall resource for those interested in the specific findings relating to
outcomes associated with rehabilitation practice. In the text are more focused tables
summarizing specific data culled from the more comprehensive table, thereby permitting an
assessment of similar types of rehabilitation outcomes. This is intended for those interested in
more specific information about particular issues pertaining to rehabilitation outcomes. The
subsequent section then describes more focused investigations that examine the effect of the
various factors in producing optimal outcomes. These include studies that assess the effect of
the intensity of rehabilitation, age, gender and race on rehabilitation outcomes.
3.3.1 Describing SCI Rehabilitation Outcomes
There are many types of outcomes that have been associated with SCI rehabilitation. In the
present review, we will focus on the most commonly employed measures and have outlined
these along with a few typical examples of outcome measurement tools in Table 3.1. In
particular, these include measures that examine the effectiveness of health delivery as well as
measures that assess functional, neurological and general health status of patients. As noted
earlier, each of these measurement types will form the basis of separate summary tables
following the overall more comprehensive table. It should be noted that other measures of
obvious importance to SCI rehabilitation care providers and people with SCI such as measures
of health-related quality of life and those that assess different facets of community integration
(e.g., employment status, Reintegration to Normal Living Index) have not been included in the
present chapter as they are considered in the chapter entitled “Community Reintegration Issues
3-2
Post Spinal Cord Injury”. In addition, studies examining health status have not been addressed
in the present chapter as these typically report the incidence of specific secondary conditions
(most notably, pressure sores and UTIs) and these will be described more fully in the specific
chapters devoted to these issues.
Table 3.1 Outcome Measure Types and Examples Relevant to SCI Rehabilitation
Outcome Measure Type Specific Outcome Measures
Health Delivery Indicators LoS, Hospital Charges, Discharge Destination
Functional Status FIM, MBI
Neurological Status AIS, ASIA motor scores, Frankel Index
Health Status Incidence of secondary complications
It should also be noted that specific outcome measurement tools can combine 2 of these
outcome measure types such as in measures of efficiency. Most commonly, change scores for
functional (e.g., FIM) or neurological (e.g., ASIA motor scores) measures are divided by LoS to
get an average change for that particular measure, thereby providing an indication of the
efficiency of the rehabilitation process in effecting change. Measures of this nature will be
profiled in the sub-section for which the numerator is related. For example, ASIA motor score
efficiency would be addressed under findings associated with neurological status. However,
before these specific summary tables are presented, see Section 3.9 Appendix 3.1 for a more
comprehensive table summarizing studies describing various SCI rehabilitation outcomes.
3.3.1.1 Health Delivery Indicators
3.3.1.1.1 Rehabilitation Length of Stay
Several authors have made comparisons of rehabilitation length of stay (LoS) between
countries or across other jurisdictions (Burke et al. 1985; Muslumanoglu et al. 1997; Pagliacci et
al. 2003; Chan & Chan 2005). Additionally, others have noted the trend for progressively shorter
LoS over the past several decades, especially in the US (De Vivo et al. 1991; Morrison &
Stanwyck 1999; Eastwood et al. 1999). Stover noted that reductions in the 1970s and early
1980s were likely due to increased efficiency of rehabilitation teams (Stover 1995). More recent
reductions in the US have been attributed to restrictions imposed by payers (Morrison &
Stanwyck 1999). Table 3.2 summarizes various reports in the literature for LoS organized by
jurisdiction and also by the time period for which the data was collected. Data were only
included in this table if the underlying sample was deemed representative of an overall
heterogeneous population of individuals with SCI (i.e., unselected sample of a single or multi-
centre study). Some data grouped for evaluating specific hypotheses has been included and
this has been appropriately indicated. In addition, data from studies for which it was not clear
that the purpose of admission was for comprehensive inpatient rehabilitation (and may have
involved acute care) were not included.
Table 3.2 Rehabilitation Length of Stay (by Country and Sample Period)
Population Sample
Study Jurisdiction Length of Stay Result
(N, Trauma &/or Nontrauma) Period
Australia 167,
Tooth et al. 2003 1993-1998 83.0 (Median)
(single centre) Trauma
3-3
Population Sample
Study Jurisdiction Length of Stay Result
Scivoletto et al. Italy 150,

1997-2001 112.4±69.3
2005 (single centre) Trauma & Nontrauma
Scivoletto et al. Italy 150,

1997-2001 98.7±68.13
2003 (single centre) Trauma & Nontrauma
Pagliacci et al. Italy 684,

1997-1999 135.5
2005 (multi-centre) Trauma
1
185.6±130.4 (N=60)
Sumida et al. Japan 123,
1994-1997 267.8±171.6 (N=63)2
2001 (multi-centre) Trauma 1
Early vs 2delayed admission
1997 60.8±38.7
1996 54.3±34.9
1995 60.1±37.1
Eastwood et al. USA 3,904, 1994 57.6±35.5
1999 (multi-centre) Trauma 1993 70.1±44.0
1992 80.9±46.9
1991 77.3±42.0
1990 74.0±41.1
1995 95.8 (N=66)

Morrison & USA 127,
Stanwyck 1999 (single centre) Trauma
1991 54.2 (N=61)
Yarkony et al. USA 1382,

1972-1986 68.1 (1986 data only)
1990 (single centre) Trauma
84.9 (N=185)1
Heinemann et al. USA 338, 87.7 (N=153)2
1981-1985 1
1989 (single centre) unknown Specialist vs 2more general
care
84.9 (N=185)1
2
Yarkony et al. USA 711, 87.7 (N=153)
1973-1980 1 2
1987 (single centre) Trauma Specialist vs more general
care
Rehabilitation LoS is also known to vary according to neurological status and data from studies
reporting LoS organized by level of injury (i.e., paraplegia vs. tetraplegia) or completeness are
shown in Table 3.3. Again this is organized by jurisdiction (country) and the time period over
which the sample was analyzed.
Table 3.3 Rehabilitation Length of Stay (by Neurological Status

Length of Stay Result
Population Sample
Study Jurisdiction (Mean – in days)
(±SD if available)
Incomplete paraplegia – 43.0

(All Medians)
Australia 167,
Tooth et al. 2003 1993-1998 Complete paraplegia – 96.5
(single centre) Trauma
Incomplete tetraplegia – 64.5
Complete tetraplegia – 206.0
3-4
Length of Stay Result
Population Sample
Study Jurisdiction (Mean – in days)
(±SD if available)
AIS D paraplegia –
79.42±20.07 (N=3)
AIS ABC low paraplegia –
52.00±1.41 (N=2)
AIS ABC high paraplegia –
China (Hong
Chan & Chan 33, 55.8±43.0 (N=2)
Kong) 2002
2005 Trauma AIS D tetraplegia –
(single centre)
143.75±69.25 (N=4)
AIS ABC low tetraplegia –
215.9±56.1 (N=7)
AIS ABC high tetraplegia –
146.5±75.4 (N=6)
Paraplegia - 46.7
1995
Morrison & USA 127, Tetraplegia – 61.9
Stanwyck 1999 (single centre) Trauma Paraplegia - 82.2
1991
Tetraplegia – 110.9
Paraplegia – 54.3 (1986 data

1972-1986 only)
Tetraplegia – 82.8
Paraplegia – 68.71, 70.72

Heinemann et al. USA Tetraplegia – 98.0, 103.4
338, unknown 1981-1985 1
1989 (single centre) Specialist (N=185) vs 2more
general (N=153) care.
Incomplete paraplegia –
1 2
46.3 , 50.6
Complete paraplegia – 62.2,
62.9
DeVivo et al. USA 661, Incomplete tetraplegia – 59.7,
1973-1985
1990 (single centre) Trauma 71.3
Complete tetraplegia – 90.4,
83.8
1 2
( Early (N=284) vs later
(N=377) admitted patients)
Woolsey et al. USA 100, Unknown Paraplegia – ~105

1985 (single centre) Trauma (pre 1985) Tetraplegia – ~165
Incomplete paraplegia – 78.2

Complete paraplegia – 83.4
1973-1980 Incomplete tetraplegia –
107.6
Complete tetraplegia – 135.3
Discussion
As seen in Tables 3.2 and 3.3, rehabilitation LoS varies widely from country to country. While no
investigators have systematically analyzed country-by-country variation it is apparent that the
US has typically shorter rehabilitation LoS times than other countries reporting data. Most data
has originated in the US, bolstered by the development of the US model systems database, with
reports from other countries for the most part limited to a handful of descriptions of single-centre
experience.
3-5
Within the US, it is clear that the trend for progressively shorter rehabilitation LoS has continued
to at least the mid 1990’s. In 2 separate investigations, Morrison and Stanwyck (1999) and
Eastwood et al. (1990) described reduced LoS from the period between the early 1990’s to the
mid 1990’s. Eastwood et al. (1990) examined the large US Model systems database of
individuals with traumatic SCI (N=3,904) and reported annual mean LoS values from 1990
to1997. For these years, the highest value was 80.9 days in 1992 and the lowest was 54.3 days
in 1996. Mean LoS values for 1990-1992 seemed fairly stable at higher values, with 1994-1997
values lower and 1993 at an intermediate value. Morrison and Stanwyck (1999) performed a
direct comparison of 1991 vs 1995 mean LoS values in the largest SCI rehabilitation in the US
in order to assess the effect of shorter rehabilitation LoS on functional outcomes. These authors
confirmed an even more striking difference between these 2 years given an average LoS of
95.8 days in 1991 as compared to 54.2 days in 1995 (p<0.001). Other reports have described
reductions over earlier periods, most notably multi-centre investigations associated with the US
Model Systems databases (De Vivo et al. 1991). It is uncertain if these trends have continued or
if the same patterns have been seen in other countries.
Also apparent from Table 10.5 is the relationship of longer LoS associated with higher level of
injury and greater severity of injury. Similar patterns were seen in all studies describing
rehabilitation LoS for individuals with varying injuries. That is, the greatest mean rehabilitation
LoS values were seen for those with complete tetraplegia (especially high level) whereas the
shortest mean values occurred for those with incomplete paraplegia (DeVivo et al. 1990; Tooth
et al. 2003; Chan & Chan 2005).
Conclusions
There is Level 3 evidence (with US data only) that rehabilitation LoS has become
progressively shorter up to the mid-1990s. No other jurisdiction has published data that
supports this contention.
There is Level 3 evidence that those with higher level and more severe injuries have
longer rehabilitation LoS.
Those with higher level and more severe injuries have longer rehabilitation LoS. (Length of Stay)
Rehabilitation LoS in the US has become progressively shorter up to the mid-1990s.
3.3.1.2 Neurological and Functional StatusError! Bookmark not defined.
Several studies have identified patterns of neurological and/or functional improvement over the
first few months post-injury. The majority of these studies examine neurological and/or
functional status and associated changes between rehabilitation admission and discharge. In
addition, the Consortium for Spinal Cord Medicine (1999) has published a review of expected
neurological and functional outcomes following SCI. This Clinical Practice Guideline refers to
the work of Bracken et al. (1993, 1997), Geisler et al. (1991) and Waters et al. (1994a, 1994b) in
noting that over half of the expected recovery occurs in the first 2 months following injury and
recovery may continue but slows noticeably after 3-6 months. This change in neurological status
may represent the natural course of recovery, however, it is uncertain as to the extent that
rehabilitation practices play in enhancing this recovery.
3-6
In addition, the reader is directed to the Consortium for Spinal Cord Medicine (1999) Clinical
Practice Guideline for a comprehensive consensus review itemizing expected functional
achievements for individuals at every level of SCI. Table 3.4 summarizes various reports in the
literature for neurological and/or functional status organized by jurisdiction and also by the time
period for which the data was collected. As above, data were only included in this table if the
underlying sample was deemed representative of an overall heterogeneous population of
individuals with SCI (i.e., unselected sample of a single or multi-centre study).
Table 3.4 Neurological and/or Functional Status (by Country and Sample Period)
Jurisdiction Population
Neurological and/or Functional
and (N, Outcome
Study Change with Rehabilitation
Sample Trauma &/or Measure
Period Nontrauma)
• ↑ from 68.7 (admission) to 102.2

(discharge) due almost entirely to
gains in motor FIM scores.
Australia • Total FIM scores were lowest for
167,
Tooth et al. 2003 (single centre) FIM those with complete tetraplegia
Trauma
1993-1998 and highest for those with
incomplete paraplegia. Those with
complete tetraplegia had the least
change in FIM scores.
• 31% of people improved, 66%

remained unchanged, and 3%
Australia 262, deteriorated. 23% initially
Burke et al. 1985 Frankel
(single centre) Trauma complete became incomplete and
40% of those initially incomplete
improved.
• All groups showed ↑ in FIM motor

scores from admission to
discharge but these were only
China (Hong
significant for tetraplegia ASIA D.
Chan & Chan Kong) 33,
FIM • All patient groups (i.e., levels and
severity of injury) had similar FIM
2002
motor scores at discharge as
noted by American Consortium for
Spinal Cord Medicine (1999).
• ↑ was associated with ASIA B and

Italy
Pagliacci et al. 684, C, shorter LoS, earlier admission
(multi-centre) AIS
2003 Trauma and no complications (especially
1997-1999
pressure sores).
• ↑ in ASIA motor scores and light

touch scores for those with
incomplete injuries but not
Turkey
Mϋslϋman-oğlu 52, ASIA complete injuries.
(single centre)
et al. 1997 Trauma & Nontrauma FIM • FIM showed ↑ f for those with
1992-1995
incomplete injuries and those with
complete paraplegia but not
complete tetraplegia.
3-7
Jurisdiction Population
Neurological and/or Functional
and (N, Outcome
Study Change with Rehabilitation
Sample Trauma &/or Measure
Period Nontrauma)
• Proportion showing ↑ were 10.3%

(A), 45.2% (B), 55.9% (C), 7.3%
(D) vs no change 89% (A), 50.3%
(B), 41.5% (C), 90.5% (D) vs
declined 4.5% (B), 2.6% (C), 2.0%
(D)
USA
DeVivo et al. 13,763, AIS • From 1973-1990 the proportion of
(multi-centre)
1991 Trauma FIM incomplete patients increased
1973-1990
from 40% to 55.2%.
• Average FIM gain was 37
(incomplete paraplegia, 36
(complete paraplegia), 34
(incomplete tetraplegia and 15
(complete tetraplegia).
• ↑ in total scores & self-care and

USA mobility subscores.
Yarkony et al. 711,
(single centre) MBI • greater ↑ for incomplete vs
1987 Trauma
1973-1980 complete and for those with
paraplegia vs tetraplegia.
Discussion
The AIS represents an internationally recognized system for the classification of individuals with
SCI, and as such, has been employed to characterize overall improvement in the neurological
status of people with SCI (ASIA 2002). The AIS is an ordinal 5 grade scale classifying
individuals from “A” to “E” with “A” designating those with complete SCI and “E” designating
individuals with normal sensory and motor function. Most notably, Pagliacci et al. (2003) and
DeVivo et al. (1991) employed large multi-centre databases and found that individuals with
incomplete injuries (especially AIS B or C) were more likely to improve at least 1 grade over the
course of rehabilitation. In particular, DeVivo et al. (1991) reported that 45.2% and 55.9% of
those initially admitted as AIS B and C respectively improved at least 1 AIS grade as compared
to only 10.3% and 7.3% of individuals initially classified as AIS A or D respectively.
Similarly, many individuals also make significant functional gains during comprehensive
inpatient rehabilitation. Most often functional status has been assessed at admission and
discharge from rehabilitation using the FIM (Vivo et al. 1991; Muslumanoglu et al. 1997; Tooth
et al. 2003; De Chan & Chan 2005) or MBI (Yarkony et al. 1987). Typically, functional gains are
greater with rehabilitation for those with incomplete injuries as compared to complete injuries
and for those with paraplegia as compared to those with tetraplegia (De Vivo et al. 1991;
Muslumanoglu et al. 1997;Tooth et al. 2003; Chan & Chan 2005). In particular, DeVivo et al.
(1991) reported similar average FIM gains for those with incomplete and complete paraplegia
and incomplete tetraplegia (i.e., 37, 36 and 34 respectively) but much reduced gains for those
with complete tetraplegia (i.e., 15). For the most part increases seen in the FIM have been
attributed to motor FIM changes with little change in cognitive FIM scores at least partly due to
an apparent ceiling effect (Chan & Chan 2005).
Conclusions
There is Level 4 evidence that a significant proportion of people (~50%) initially assessed
as AIS B and C will improve by at least 1 AIS grade in the first few months post-injury
3-8
concomitant with inpatient rehabilitation. Fewer individuals (~10%) initially assessed as
AIS A and D will improve by 1 AIS grade.
There is Level 4 evidence that individuals make significant functional gains during
inpatient rehabilitation, more so for those with complete and incomplete paraplegia and
incomplete tetraplegia.
Most individuals make significant functional gains during inpatient rehabilitation.

A significant proportion of people improve 1 AIS (ASIA Impairment Scale) grade in the first few
months post-injury particularly those initially assessed AIS B and C.
3.4 Factors for Optimal Outcomes
3.4.1 Effect of Intensity on Rehabilitation Outcomes
Although it is commonly assumed that the therapies delivered during inpatient rehabilitation are
effective, there is generally little direct evidence that demonstrates a clear relationship between
typical therapeutic practice and enhanced functional outcomes (Heinemann et al. 1995).
Moreover, there is no evidence that establishes a recommended intensity or amount of therapy
that should be delivered to produce a desired result. In SCI rehabilitation, there exists a paucity
of studies that examine this issue.
Table 3.5 Individual Studies - Intensity of Rehabilitation

Author Year; Country
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI and ABI, SCI subjects (SCI findings only)

had a mean of 38.9 years old and were 1. When analysed together, none of the
79% male. individual therapy intensities were
Treatment: Variation in therapy intensity predictive of improved outcomes.
(OT, PT, SLT, Psych). Also examined When analysed individually, very little
effect of various other factors including was significant in the prediction with
LoS, Interruptions, Onset days, Admission only greater LoS associated with
scores and age. greater achievement of potential motor
Outcome Measures: FIM (motor, gains (p<.05) and interrupted rehab
cognitive, total), FIM Efficiency (motor or associated with less achievement of
Heinemann et al. 1995;
cognitive) all collected at Discharge. potential motor gains (p<.05).
USA
2. Patients with > intervals between
Downs & Black score=18
onset and admission had less motor
Case Series
function at discharge, achieved less of
Initial N=264;
their potential motor gains and made
Final N=246
less efficient motor gains (all p<.05).
3. Therapy intensity was predicted to a
small degree by the various functional,
demographic and medical variables
(psychology intensity had highest
explained variance with 26.3% ; SLT
17.2%, All therapies combined 16.6%,
OT 7.3%, PT 6.5%).
4. People with lower cognitive and motor
function at admission receive more
3-9
Score
Methods Outcome
Research Design
Total Sample Size
intense therapy (psychology and all -

p<.001, speech & OT - p<.01, PT -
p<.05);
Discussion
Heinemann et al. (1995) employed a case series design to examine the effect of increased
therapeutic intensity on functional rehabilitation outcomes as indicated by motor, cognitive and
total FIM scores as well as FIM efficiencies. These investigators performed a comprehensive
chart review of patients with SCI (N=106) and traumatic brain injury (N=140) to determine the
number of 15-minute therapy units delivered in the provision of PT, OT, SLT and Psychology
services. They then performed multiple regression analyses to determine if the amount of
therapy was associated with positive outcomes. For the most part, there was little evidence that
increased therapeutic intensity had any effect on improving outcomes for the SCI sub-sample
although the paucity of well-controlled studies in this area limits the strength of the conclusions
that can be drawn.
Conclusions
There is Level 4 evidence based on a single case series that increased therapeutic
intensity may not be associated with any functional benefit as measured by the FIM.
Increased therapeutic intensity may not necessarily lead to functional benefits,

but data is scarce.
3.4.2 Effect of Age on Rehabilitation Outcomes
Historically, traumatic SCI has been viewed as a young, male concern although there have
been recent shifts in the demographics of SCI such that an increasing proportion of recently
injured individuals are older (both male and female). In fact, recent epidemiological evidence
from Ontario, Canada found that the highest rates of SCI-related hospital admission following
trauma in this jurisdiction was for those over 70 years of age although the frequency of specific
etiologies (e.g., falls vs motor vehicle crashes) varied with age (Pickett et al. 2003). In the US
the average age at injury has increased steadily over the last 30 years with the US Model
Systems National SCI Statistical Center (2006) reporting an average age of injury of 38.0 years
for the period from 2000-2006 as compared to 28.7 years for the period from 1973-1979. In
addition, many centers in various jurisdictions around the world also provide rehabilitation
services to individuals with spinal cord damage as the result of a variety of non-traumatic
etiologies and often these people are much older than those injured due to trauma (McKinley et
al. 2001; McKinley et al. 2002; Scivoletto et al. 2003; New 2005).
Given these trends for increasing age in those undergoing rehabilitation it is important to
understand the effects of age on rehabilitation outcomes. Several investigators have employed
retrospective assessments of single or multi-centre patient databases to examine this issue
(Cifu et al. 1999a; Cifu et al. 1999b; Seel et al. 2001; Scivoletto et al. 2003; Kennedy et al.
2003).
3 - 10
Table 3.6 Individual Studies – The Effect of Age on Rehabilitation Outcomes
Research Design Methods Outcome
Total Sample Size
Population: Traumatic and non-traumatic 1. Improvements were noted in ↓

SCI, 147 males, 45 females, Mean “percentage to be achieved" scores for
age=40.7±16.5 years, (152 aged 16-54, 40 all 9 areas of need (p<0.0001). No
aged 55-85), incomplete tetraplegia (23%), significant differences were seen
complete tetraplegia (21%), complete between age groups.
paraplegia (34%) and incomplete 2. Those with complete lesions showed
paraplegia (22%), Mean time post-injury to greater improvement in bowel
admission=28.8 days. management than those with
Treatment: No treatment per se, but incomplete lesions (p<0.005) and
various outcomes associated with inpatient those with tetraplegia showed greater
rehabilitation focusing on goal attainment improvement in the area of skin care
Kennedy et al. 2003;UK
in younger vs. older patients. than those with paraplegia group
Case Control
Outcome Measures: Needs Assessment (p<0.005) Otherwise no other
(Inadequate control)
Checklist (NAC) collected within 2 weeks differences.
Initial N=200;
of mobilization and within 6 weeks of 3. Mobility needs of older subjects were
Final N=192
discharge. significantly higher compared to the
younger subjects (p<0.005) initially,
but lower for the community score
(p=0.01). Higher scores (i.e., more
unmet need) assessed close to
discharge were noted for older vs
younger for the areas of skin
management (p<0.01), bladder
management (p<0.01), bowel
management (p<0.05) and mobility
(p<0.01).
Population: Traumatic (105) and non- 1. Although LoS was longer for younger
traumatic (179) SCI, 184 males, 100 patients (111.3±63.88 vs 89±69.9,
females, Mean age=50.4±19.3 (12-86) p<0.008) which was related to a
years, cervical (81), thoracic (148), lumbo- higher incidence of incomplete lesions
sacral (55), ASIA A-D, and etiology, a matched-block sub-
Mean time post-lesion to admission was analysis (N=130) showed differences
56.9±43.9 days. were not significant.
Treatment: No treatment per se, but 2. Neurological recovery was more
various outcomes associated with inpatient frequent with younger group (p=0.006)
rehabilitation focusing on younger (<50) vs and for those at ASIA C. Matched
older (>50) patients. Mean LoS was group sub-analysis showed more
98.7±68.1 days. ASIA grade (p=0.027) and motor
Scivoletto et al. 2003; Outcome Measures: LoS, ASIA score improvements in younger group.
Italy Impairment Scale, ASIA Motor Index, 3. Gains for independence of daily living
Case Control Barthel Index (BI), Rivermead Mobility measures (BI and RMI) were
Initial N=284; Index (RMI), Walking Index for SCI significantly greater for younger group
Final N=284 (WISCI), Discharge Destination. All (p<0.001).
collected at admission and discharge. 4. Younger age group had more people
reach independent walking levels on
WISCI than in older group (p<0.004).
Similar findings for related subscales
in BI and RMI.
5. Younger age group had more people
reach autonomous bladder (p=0.005)
and bowel control (p=0.014) than in
older group. Similar findings for
bladder subscales in BI.
3 - 11
Total Sample Size
Population: Traumatic SCI from US Model 1. FIM improvement was less for people
Systems database, 83% male, Mean ≥ 60 than those younger.
age=31.72±12.68 (18-92) years, 2. There were no significant differences
paraplegia, ASIA A-D. in ASIA motor index scores, change
Treatment: No treatment per se, but scores or efficiency scores across
various outcomes associated with inpatient different ages.
acute and rehabilitation care focusing on 3. No systematic significant differences
age effects by comparing results between were noted for acute care LoS or
Cifu et al.1999; USA
11 age categories. Mean acute LoS was hospital charges.
Case Control
13.2±16.92 days. Mean rehabilitation LoS 4. Rehabilitation LoS was longer and
(Inadequate control)
was 56.76±34.28 days. associated hospital charges greater
Initial N=2,169;
Outcome Measures: LoS, Charges, ASIA for older individuals (trend beginning
Final N=2,169
motor index score, Functional for those > 54 and peaking in the 60-
Independence Measure (FIM), change 64 age group).
scores and efficiencies for FIM and ASIA 5. Younger age groups were more likely
motor index. All collected at admission to injured as a result of vehicular crashes
acute care and admission to rehabilitation or violence while older groups were
care and discharge. more likely injured as a result of falls
or other events including being struck
by falling objects, pedestrian accidents
and medical/surgical complications.
Population: Traumatic SCI from US Model 1. The younger the age group, the
Systems database, male and female, 3 greater the FIM motor score
equal (N=125) age groups (18-34, 35-64, improvement and greater FIM motor
>64) matched for neurological level and efficiency.
completeness, tetraplegia, ASIA A-D, 85% 2. The younger and middle age groups
admitted within 21 days post-injury. had significantly greater ASIA motor
Treatment: No treatment per se, but index score increases and efficiency
Cifu et al. 1999; USA various outcomes associated with inpatient than the older age group.
Case Control acute and rehabilitation care focusing on 3. No systematic significant differences
Initial N=375; age effects by comparing results between related to age were noted for acute
Final N=375 3 age categories. care or rehabilitation Length of Stay or
Outcome Measures: LoS, Charges, ASIA hospital charges.
motor index score, Functional 4. The older the age group, the more
Independence Measure (FIM), change likely individuals would be discharged
scores and efficiencies for FIM and ASIA to an institutional setting.
motor index, Discharge destination. All
collected at admission to acute care and
admission to rehabilitation care and
discharge.
Population: Traumatic SCI from US Model 1. FIM improvement was greater for the
Systems database, male, female, 3 equal younger and middle group that for the
(N=60) age groups (18-39, 40-59, >59) older group (p<0.001). FIM efficiency
matched for neurological level and ASIA was greater for the young group as
classification, paraplegia, ASIA A-D, 84% compared to the 2 older groups
admitted within 21 days post-injury. (p<0.001).
Seel et al. 2001; USA
Treatment: No treatment per se, but 2. There were no significant differences
Case Control
various outcomes associated with inpatient in ASIA motor index scores at any of
Initial N=180;
acute and rehabilitation care focusing on the time points across the different
Final N=180
age effects by comparing results between ages.
3 age categories. 3. No systematic significant differences
Outcome Measures: LoS, Charges, ASIA were noted between the 3 age groups
motor index score, Functional for acute care LoS or hospital charges.
Independence Measure (FIM), change 4. Rehabilitation LoS was significantly
scores and efficiencies for FIM. All shorter for younger than middle or
collected at admission to acute care and older groups. There was no difference
3 - 12
Total Sample Size
admission to rehabilitation care and in associated hospital charges for the

discharge. 3 groups.
5. All age groups were equally likely to
be discharged to a private residence
(≥92%).
Discussion
Similar approaches involving case control study designs have been employed by various
investigators to examine the effect of age on rehabilitation outcomes. However, in the present
review, studies employing some form of matching across different age groups were assessed
as representing a higher level of evidence (i.e., Level 3) (Cifu et al. 1999b; Seel et al. 2001;
Scivoletto et al. 2003) as compared to those deemed as having an inadequate method of
controlling for potential confounds (i.e., Level 4) (Cifu et al. 1999a; Kennedy et al. 2003).
Several of these studies have demonstrated differences between age groups for a variety of
rehabilitation outcomes although there were also some contradictory findings within these
studies, albeit some of this may have been due to variation between the sampling frames and
methods employed in each study.
For example, Seel et al. (2001) and Cifu et al. (1999a) reported reduced rehabilitation LoS for
those with paraplegia due to trauma whereas no differences were seen in investigations of
those with tetraplegia due to trauma (Cifu et al. 1999b) and also with the mixed sample of
people with both traumatic and non-traumatic SCI (Scivoletto et al. 2003).
Conversely, all studies examining functional change showed that younger individuals
demonstrated greater functional improvements as indicated by increases with the FIM (i.e.,
motor FIM scores, change scores, efficiencies) (Cifu et al. 1999a; Cifu et al. 1999b; Seel et al.
2001) or BI (Scivoletto et al. 2003). These similar results were obtained from studies involving
those with paraplegia (Cifu et al. 1999a; Seel et al. 2001), tetraplegia (Cifu et al. 1999b) and a
mixed sample comprised of those with both traumatic and non-traumatic SCI (Scivoletto et al.
2003). On the other hand, Kennedy et al. (2003) employed the Needs Assessment Checklist
(NAC) developed internally at Stoke-Mandeville, UK and demonstrated that there were few
systematic age-related differences associated with goal attainment in a mixed traumatic, non-
traumatic sample. The NAC is a client-focused outcome measure that assesses the degree to
which specific behavioural outcomes particularly relevant to the client are achieved.
In addition to functional outcomes, effective rehabilitation has also been associated with
increases in neurological status as indicated by AIS or ASIA motor scores. Of the studies
reviewed and possessing measures of neurological status, both studies limited to those with
paraplegia showed no age effects (Cifu et al. 1999a; Seel et al. 2001;). Conversely, similar
studies of those with tetraplegia or a mixed traumatic and non-traumatic SCI sample
demonstrated that younger individuals were more likely to make significant neurological gains
during inpatient rehabilitation (Cifu et al. 1999b; Scivoletto et al. 2003).
Conclusions
There is Level 3 evidence that significantly shorter rehabilitation LoS is associated with
younger vs older individuals with paraplegia. The same may not be true for those with
tetraplegia or for mixed cohorts involving traumatic and non-traumatic SCI.
3 - 13
There is Level 3 evidence that younger as compared to older individuals are more likely
to obtain greater functional benefits during rehabilitation.
There is Level 3 evidence that significant increases in neurological status during

rehabilitation are more likely with younger than older individuals with tetraplegia or for
mixed cohorts involving traumatic and non-traumatic SCI. The same may not be true for
those with paraplegia.
Younger individuals with paraplegia are more likely to have shorter rehabilitation
LoS than older individuals.
Younger individuals are more likely to make greater functional gains during
rehabilitation than older individuals.
Younger individuals with tetraplegia (or in a mixed traumatic, non-traumatic sample) are more
likely to make gains in neurological status during rehabilitation than older individuals.
3.4.3 Differences in Traumatic vs Non-Traumatic SCI Rehabilitation Outcomes
Those individuals sustaining damage to the spinal cord due to non-traumatic causes are often
treated in specialized inpatient SCI rehabilitation centres more commonly associated with those
with SCI due to traumatic etiologies. Various reports have estimated that one-quarter to one half
of all cases seen in specialized SCI rehabilitation centers are associated with non-traumatic
etiologies (Muslumanoglu et al. 1997; McKinley et al. 1999b; van der Putten et al. 2001).
Despite these significant numbers, relatively little systematic research is directed at non-
traumatic SCI (van der Putten et al. 2001; McKinley et al. 2002). Common causes of non-
traumatic SCI includes space occupying lesions such as tumours or prolapsed intervertebral
discs, spondylosis such as that seen with degenerative spinal changes resulting in compression
of the spinal cord, vascular ischemia as in arteriovenous malformations or spinal infarction,
inflammation (e.g., idiopathic transverse myelitis, tropical spastic paraparesis, sarcoid) and
those associated with congenital or familial etiologies ( Adams & Salam-Adams 1991; McKinley
et al. 1999b; McKinley et al. 2001). Although estimates of the incidence of non-traumatic SCI
have been provided (e.g., 8 per 100,000) (Kurtzke 1975), it is difficult to ensure accuracy given
the heterogeneous nature of non-traumatic SCI and the variety of facilities and programs where
these patients may receive care.
Studies comparing those with damage to the spinal cord due to non-traumatic vs. traumatic
etiologies have demonstrated a variety of systematic differences between these 2 patient
groups. In general, those with non-traumatic SCI are more likely to be older, female, have
paraplegia and have an incomplete injury than those with traumatic SCI (McKinley et al. 1996;
McKinley et al. 2001; McKinley et al. 2002; New 2005). In the present section, we review the
studies characterizing rehabilitation outcomes between those with SCI due to non-traumatic vs
traumatic causes.
Table 3.7 Individual Studies – Non-Traumatic SCI and Rehabilitation Outcomes

Total Sample Size
McKinley et al. 2001; Population: Non-traumatic SCI (n=87) 1. As compared to those with trauma
USA from a single centre vs traumatic SCI (after matching), those with non-
Case Control (n=87) from the US Model Systems traumatic SCI had …
3 - 14
Total Sample Size
Initial N=174; database; Matched on level and 2. ↓ rehabilitation LoS (22.46 vs

Final N=174 completeness of lesion and age; 2/3rds 30- 41.49days) (p=0.000)
59 years, 1/3rd 60+ years; 93% were 3. ↓ overall charges (p=0.003) and ↓
admitted within 21 days of injury; 68% daily charges (p=0.019)
were paraplegic; AIS C 36%, AIS D 41%. 4. no difference on motor FIM at
Treatment: No treatment per se, outcomes admission and motor FIM efficiency
associated with non-traumatic vs traumatic with rehabilitation
rehabilitation. 5. ↓ motor FIM at discharge and ↓ motor
Outcome Measures: LoS, charges, motor FIM change
FIM (score, change and efficiency). 6. no difference in discharge destination.
Collected at admission to and discharge
from rehabilitation.
Population: Non-traumatic SCI secondary 1. As compared to those with trauma

to stenosis (n=81) vs traumatic SCI (before matching), those with stenosis
(n=102) within a single centre; Matching were significantly (p<0.01) …
from N=381 sample on paraplegia vs • older (64.1 vs 44.4).
tetraplegia and completeness. • more likely female (38.8 vs
Treatment: No treatment per se, but 21.2%)
various outcomes associated with non- • more likely to have paraplegia
traumatic (stenosis) vs traumatic SCI (69.4% vs 45.5%)
rehabilitation. • more likely to be incomplete injury
McKinley et al. 2002; Outcome Measures: LoS, charges, (AIS C or D) (100% vs 49.3%)
USA Discharge rates to home, FIM (score, 2. As compared to those with trauma
Case Control change and efficiency). Collected at (after matching), those with stenosis
Initial N=381; admission to and discharge from had significantly (p<0.05) …
Final N=183 rehabilitation. • ↓ LoS (22.1 vs 32.2 days)
• ↓ charges
• ⁭ admission FIM and FIM motor
scores
• ↓ total and motor FIM change and
FIM efficiency
• no difference in discharge FIM
totals
• No difference in discharge
destination.
Population: Non-traumatic SCI secondary 1. As compared to those with trauma

to neoplastic cord compression admitted (before matching), those with
over 5 years (within a single centre (n=29) neoplastic cord compression were …
vs traumatic SCI (n=29) from the US Model • older (57.8 vs 30.45).
Systems database matched by age, level • more likely to have paraplegia
of injury and AIS; Age = 57.8 years; AIS A- (88.2% vs 52.5%)
D; C4-L2. • more likely to be incomplete
McKinley et al. 1999; Treatment: No treatment per se, but (88.2% vs 56.7%
USA various outcomes associated with 2. As compared to those with trauma
Case Control rehabilitation care of non-traumatic (after matching), those with neoplastic
Initial N = 4,035; (neoplastic cord compression) vs traumatic cord compression …
Final N=58 SCI. • had ↓ LoS (25.17 vs 57.46 days)
Outcome Measures: LoS, Discharge • had ↓ motor FIM change
destination, FIM (total score, change and • had ↓ motor FIM scores at
efficiency). Collected at admission to and discharge
discharge from rehabilitation. • no different FIM efficiency
• no different for discharge
destination
3 - 15
Total Sample Size
Population: Non-traumatic SCI; median 1. LoS =55.8 days (7-413 days).

age=69 years (29-86); AIS B-D tetraplegia 2. ⁭ FIM motor scores during rehabilitation
32.9%, AIS A paraplegia=8.6%, AIS B-D= from 40.8 to 67.1, cognitive FIM
58/6%; 78.6% had relatively fast onset (<7 showed no change due to initial ceiling
days) and were admitted to effect.
rehabilitation=30.9 days, 21.4% had 3. 17.7% overall and 26.9% over the age
gradual onset and were admitted=11.0 of 70 were discharged to a nursing
New et al. 2005;
months. home.
Australia
Treatment: No treatment per se, outcomes 4. Those subjects male, younger, more
Case Series
associated with non-traumatic SCI mobile, more independent bowel and
Initial N=70; Final N=62
rehabilitation. bladder function and less severe AIS
Outcome Measures: Demographics, grades were more likely to be
clinical characteristics, LoS, Discharge discharged home.
setting, level of lesion and AIS, FIM, 5. Major non-traumatic classifications
mobility, bowel and bladder function. were tumour (32.9%), degenerative
Collected at admission to and discharge (25.7%), vascular (14.3%) and other
from rehabilitation. (27.1%).
Population: Non-traumatic SCI; mean 1. LoS = 31.5 days (9-184 days).
age=55 years (16-88); 54% male; cervical 2. ⁭ FIM motor score was associated with
49%, upper thoracic 21%, lower thoracic lower score on admission and reduced
and lumbar 22%; Time from onset to time between onset-admission (overall
rehabilitation=4.8 years (0.1-32 years). predictive model).
Van der Putten et al.
Treatment: No treatment per se, but 3. Age (i.e., younger), etiology (i.e.,
2001; England, UK
optimal outcomes were regressed against hereditary pathology) and lesion level
Case Series
various factors associated with non- (i.e., cervical) were individually
Initial N=100;
traumatic rehabilitation. associated with improved functional
Final N=100
Outcome Measures: Demographics, outcomes but did not improve
clinical characteristics, level of lesion and prediction of overall model.
AIS, FIM motor score and change score.
Collected at admission to and discharge
from rehabilitation.
Population: Non-traumatic SCI secondary 1. LoS = 27 days (7-54 days).
to neoplastic cord compression admitted 2. People showed significant ⁭ in 9 FIM
over 5 years within a single centre; Mean categories (0<0.005) associated with
age=64 years; 18 men, 14 women. mobility and self-care during
Treatment: No treatment per se, but rehabilitation.
outcomes associated with rehabilitation 3. 11 individuals improved from AIS C to
care. D at discharge.
McKinley et al. 1996;
Outcome Measures: Medical 4. 27/32 were discharged home, 4
USA
complications, AIS, LoS, bladder function, transferred for medical reasons (and
Case Series
FIM, Discharge destination. All collected at died within 2 months) and 1 died
admission to and discharge from before discharge.
rehabilitation. Level of ambulation and 5. Of 20 people with assessed at 3-15
dressing ability assessed at 3-15 months month follow-up, 16 had maintained
post-discharge. mobility and dressing function as
compared to discharge. However,
12/20 had eventually died at a mean
of 101 days post-discharge.
Discussion
Studies examining non-traumatic SCI typically make use of retrospective case series designs
describing rehabilitation outcomes directly (McKinley et al. 1996; van der Putten et al. 2001;
New 2005) or involve case control designs employing matching techniques to make
comparisons with traumatic SCI while controlling for such things as age and level and
3 - 16
completeness of injury (McKinley et al. 1999; McKinley et al. 2001; McKinley et al. 2002). As
noted above, those with non-traumatic SCI were more likely to be older, female, have
paraplegia and have an incomplete injury than those with traumatic SCI (McKinley et al. 1996;
McKinley et al. 2001; McKinley et al. 2002; New 2005).
When direct comparisons of traumatic and non-traumatic SCI of various etiologies have been
conducted using matching procedures, it is clear that shorter rehabilitation LoS was seen for
those with non-traumatic SCI (McKinley et al. 2001). In addition, this shorter LoS was
associated with reduced hospital charges for both an overall and a per diem basis (McKinley et
al. 2001). These findings were replicated with similar studies examining subsets of those with
non-traumatic SCI including those with stenosis (McKinley et al. 2002) and those with neoplastic
cord compression (McKinley et al. 1999). However, these findings have only been established
with data from the US Model Systems. For example, others have reported longer rehabilitation
LoS (van der Putten et al. 2001; New 2005) although these reports were conducted in other
jurisdictions (i.e., Australia, UK respectively) and employed case series designs such that direct
comparisons with traumatic SCI were not possible.
None of the studies employing matching procedures noted differences in discharge destinations
for those with non-traumatic SCI as compared to those with traumatic SCI (McKinley et al. 1999;
McKinley et al. 2001; McKinley et al. 2002). although New et al. (2005) did note that within non-
traumatic subjects, those individuals male, younger, more mobile, more independent with bowel
and bladder function and having less severe AIS grades were more likely to be discharged
home. In addition, the relatively poor prognosis and low survival rate of those with neoplastic
cord compression has specific implications for discharge disposition (McKinley et al. 1996)
although no specific differences were noted in a matched comparison (McKinley et al. 1999).
All studies reviewed employed the FIM to assess the functional status of individuals and
generally demonstrated improved function with rehabilitation. Typically, motor FIM scores were
employed or in the event total FIM scores were used it was acknowledged that changes were
due primarily to the motor FIM subscale given a ceiling effect associated with the cognitive FIM
subscale (McKinley et al. 1999; New 2005). For the most part, improvements seen in FIM during
rehabilitation for non-traumatic SCI were lesser as those compared to traumatic SCI as reflected
by lower FIM change scores (McKinley et al. 1999; McKinley et al. 2001; McKinley et al. 2002).
When examining a mixed population of non-traumatic SCI, there were no differences between
trauma and non-trauma groups with respect to admission FIM but there was a reduced FIM at
discharge for the non-traumatic group accounting for the lower FIM change score (McKinley et
al. 2001). This lower FIM change did not result in a lower FIM efficiency given the reduced LoS
for the non-traumatic group. When examining only those with stenosis vs those with traumatic
SCI, those with non-traumatic SCI had higher FIM scores on admission, similar scores on
discharge, resulting in reduced change scores and lower efficiency (McKinley et al. 2002). On
the other hand, those with neoplastic cord compression demonstrated similar FIM scores on
admission, reduced scores on discharge, resulting in reduced change scores but no difference
in efficiency (McKinley et al. 1999).
Van der Putten (2001) assessed a variety of factors using multiple linear regression techniques
in order to predict those most associated with increases in FIM motor scores during
rehabilitation. They included 100 consecutively admitted patients with non-traumatic SCI with
rehabilitation periods of > 1 week. The primary factors associated with improved motor FIM
scores accounting for 54% of the variance were having a lower score on admission and reduced
time between symptom onset-admission. Age, specific diagnostic subgroup (i.e., space-
occupying, vascular, spondylosis, inflammation or hereditary), or lesion level did not improve the
prediction significantly.
3 - 17
Conclusions
There is Level 4 evidence that those with non-traumatic SCI are more likely to be older,
female, have paraplegia and have an incomplete injury as compared to those with
traumatic SCI.
There is Level 3 evidence that those with non-traumatic SCI have generally reduced
rehabilitation LoS, reduced hospital charges but similar discharge destinations as
compared to those with traumatic SCI.
motor FIM improvement during rehabilitation as compared to those with traumatic SCI.
Individuals with non-traumatic SCI have reduced LoS and less functional improvement with
rehabilitation as compared to those with traumatic SCI although controlled comparisons are
limited to data from the US Model Systems.
3.4.4 Effect of Gender and Race on Rehabilitation Outcomes
Potentially, there are many additional factors that may affect rehabilitation outcomes following
inpatient SCI rehabilitation. Two of these factors include gender and race, although neither has
been examined comprehensively. With respect to gender effects, studies investigating
rehabilitation outcomes associated with women have focused on long-term psychosocial
outcomes associated with issues such as marriage or motherhood or issues associated with
community and vocational reintegration (Westgren & Levi 1994; DeVivo et al. 1995; Shackelford
et al. 1998; Krause et al. 1998). Studies of the effects of race on rehabilitation outcomes have
been limited to evaluations of the differences between whites and African Americans using US
Model Systems data (Meade et al. 2004a; Putzke et al. 2002), although as with studies of
gender, investigations of the effects of race have focused more on vocational issues and
satisfaction with life (James et al. 1993; Krause et al. 1998; Krause 1998; Meade et al. 2004b).
Table 3.8 Individual Studies – The Effect of Gender and Race on Rehabilitation Outcomes
Total Sample Size
Population: Traumatic SCI from US Model 1. No significant differences between

Systems database; matched white vs whites vs African Americans for ASIA
African American subjects matched by and FIM motor index scores.
level of function, ASIA Impairment Scale, 2. No significant differences for
age and primary care sponsor; 84.2% discharge disposition (P=0.622).
Meade et al., 2004; male; age=34.2±15.3 years; tetraplegia, 3. African Americans were more likely to
USA paraplegia; ASIA A-D. be injured as a result of violence and
Case Control Treatment: No treatment per se, but whites were more likely to be injured in
Initial N=628; various outcomes associated with inpatient MVCs.
Final N=628 acute and rehabilitation care focusing on 4. African Americans were significantly
race effects by comparing outcomes of more likely to receive laparotomies
African Americans and whites. (p<0.001) and be catheter free in
Outcome Measures: ASIA motor index comparison to caucasians.
scores, FIM motor score, Medical 5. Whites were more likely to receive
complications, discharge disposition, spine surgeries (p<0.001) and have
3 - 18
Total Sample Size
medical procedures and medical more suprapubic cystomies in

management. Collected at admission to comparison to African Americans.
acute care and admission to and discharge 6. No significant differences between
from rehabilitation. racial groups in the occurrence of
medical complications during either
acute care or rehabilitation.
Population: Traumatic SCI from US 5. No significant differences were seen

Model Systems database; matched male for acute care or rehabilitation Length
vs female by level of function, AIS and age; of Stay or charges between males and
50% were 18-34 years, 42% were 36-64 females.
years and 8% were >64 years old; 6. No significant differences were seen in
tetraplegia, paraplegia; ASIA A-D; 86% discharge destinations between males
were admitted to Model systems within 21 and females.
days post-injury. 7. No significant differences were seen in
Treatment: No treatment per se, outcomes admission, discharge, or change
associated with inpatient acute and scores for both functional (i.e., FIM)
rehabilitation care focusing on gender and neurological (i.e., ASIA)
Greenwald et al., 2001; effects. assessments between males and
USA Outcome Measures: Length of Stay, females.
Case Control Charges, ASIA motor index total score, 8. Gender differences in the
Initial N=1074; FIM motor score, FIM motor change development of complications during
Final N=1074 scores, FIM motor efficiency scores, and rehabilitation, notably, pressure sores
medical complications. Collected at (p<0.001) and DVTs (p=0.003) were
admission to acute care and admission to more likely in men.
and discharge from rehabilitation. 9. Younger patients had better functional
outcomes than older patients with
significantly higher FIM motor scores
at discharge.
10. Older patients had significantly greater
ASIA motor scores on admission and
discharge than middle-aged patients,
who had significantly greater scores
than younger patients.
Population: Traumatic SCI admitted within Study 1
1 day of injury to integrated (acute and 1. Significant differences between race
rehabilitation) US Model Systems Center were not found relating to any of the
(Study 1: eligible N=2438) or having 1 year outcome measures including FIM,
or later follow-up data in the US Model Length of Stay (acute or rehabilitation
Systems database (Study 2: eligible care), Discharge destination and
N=3301), matched white and African charges (p>0.05).
Putzke et al. 2002; American by various injury and 2. The 2 groups were significantly
USA demographic factors, tetraplegia, different (p<0.001) on numerous other
Case Control paraplegia, complete, incomplete, Study 1: demographic and injury-related factors
Study 1: Age=34.8±15.9 (white) & 35.3±15.6 including age, education, gender,
Initial N=2438; (African American) years, Gender 90% race, marital and occupational status,
Final N=374 male (both groups), Study 2: lesion level, and injury duration.
Study 2: Age=37.7±12.2 (white) & 37.8±12.0 Study 2
Initial N=3301; (African American) years, Gender 93% No significant differences were seen
Final N=316 male (both groups). with SWLS, SF-12 and CHART
Treatment: No treatment per se, but race (p=0.25).
effects on various outcomes associated None of the medical outcome
with integrated acute and rehabilitation variables differed significantly (p>0.05)
care (study 1) or long-term (study 2) with race, including days
studied by comparing results between rehospitalized and number of
whites and African Americans. rehospitalizations in the previous year,
Outcome Measures: Study 1: FIM motor impairment level, and total medical
3 - 19
Total Sample Size
and efficiency scores, Length of Stay, complications.

Discharge destination, medical Despite non-significant results with
complications, Charges. Study 2: FIM multivariate analyses, univariate
motor and efficiency scores, CHART, analyses were also conducted and
Satisfaction with Life Scale (SWLS), SF-12 were generally non-significant except
(measured the individual’s perception of that whites reported less handicap on
his/her health status), medical the CHART mobility subscale
complications and number of (p=0.03).
hospitalizations. All collected at admission, As with Study 1, both groups differed
discharge or at annual follow-up (Study 2 significantly on numerous
only). demographic and injury-related factors
(p<0.001).
Discussion
Greenwald et al. (2001) employed a mixed, block design, matching male and female subjects so
as to control for covariant effects of injury characteristics (level and AIS) and age at injury. They
retrospectively analyzed 1,074 subjects over a 10-year period from 1988-1998 by using US
Model Systems data culled from 20 different SCI centers from a variety of geographic regions.
In general, there were no significant differences between males and females for rehabilitation
outcomes including discharge disposition, LoS, FIM motor scores (including change scores and
efficiencies) or ASIA motor scores. There were also no reported gender-related differences for
the incidence of most medical complications encountered during rehabilitation stay including
pneumonia, autonomic dysreflexia, pulmonary embolism, cardiac arrest, kidney calculi or
gastrointestinal hemorrhage. However, men did have significantly higher rates for DVT and
pressure sores although the authors reported that these differences were not robust and did not
result in increased stays, charges or lower functional outcomes.
Similar case control designs employing matched groups of whites vs. African Americans from
the US Model Systems database have also been employed to examine race effects on
rehabilitation outcomes. Putzke et al. (2002) matched race groups according to age, education,
gender, occupational status, impairment level, etiology, primary sponsor of care and geographic
region whereas Meade et al. (2004) matched according to level of injury, AIS, age and primary
sponsor of care. By controlling for all these variables, these authors were able to establish that
race acts more as a proxy variable than a predictor of outcomes (Putzke et al. 2002). For
example, differences did exist in a wide variety of demographic, rehabilitation outcomes and
specific medical conditions provided to African Americans vs. whites when considering but
these were generally accounted for by socio-demographic and etiological differences associated
with these groups (Putzke et al. 2002; Meade et al. 2004). For example, African Americans
were significantly more likely to be injured as the result of violence and have 11th grade
education or less while whites were more likely injured as a result of motor vehicle crashes and
had high school education or more (Putzke et al. 2002; Meade et al. 2004). For the most part,
there were no differences between the two groups with respect to rehabilitation outcomes when
the variables noted above were accounted for in the matching process.
Conclusions
There is Level 3 evidence that there is no difference with respect to gender on discharge
destination, rehabilitation LoS and neurological or functional outcomes associated with
rehabilitation.
3 - 20
There is Level 3 evidence that there is no difference with respect to race (white vs
African-American) on rehabilitation LoS and neurological or functional outcomes
associated with rehabilitation that are not otherwise explained by socio-demographic or
etiological differences.
Neither gender nor race effects have been demonstrated for discharge destination,
rehabilitation LoS and neurological or functional status in US Model Systems data.
3.5 Specialized vs General SCI Units (Acute Care)
Donovan et al. (1984) contend that best practice for SCI care consists of a situation in which
every individual sustaining a SCI is admitted to an integrated, comprehensive system where
expertise, facilities and equipment are focused on optimal patient care and cost effectiveness.
At the other extreme is the situation condemned by Bedbrook and Sedgley (1980), of piecemeal
care for those with SCI characterized by “the occasional patient being treated by the occasional
doctor”. In practice, care provided by most SCI centers likely falls somewhere in between these
extremes of specialized vs. general care. The present section outlines the studies that are
focused on examining the hypothesis that care provided through specialized SCI centers is
more efficient and effective than that delivered at general centers.
The reader should note that while the majority of these studies were conducted from
rehabilitation centers the experimental manipulation of interest concerns the degree to ehich
specialist care is delivered during acute care period.
Table 3.9 Individual Studies – Specialized vs General SCI Units

Total Sample Size
Population: 338 SCI admitted to 1. Those receiving specialized care

Rehabilitation, paraplegia, tetraplegia, made functional gains with
complete, incomplete. significantly greater efficiency and
Treatment: N=185 initially treated in a were transferred to rehabilitation
specialized short-term acute care unit; significantly faster (p<.001).
Heinemann et al. 1989;
Control: N=153 initially treated in general 2. A significantly greater number of
USA
hospitals. people were transferred from general
Case Control
Outcome Measures: Modified Barthel centers with spine instability than from
Initial N=338;
index (MBI), MRSCICS Patient Functional specialized SCI centers (p=.02).
Final N=338
Level Scheme, Length of Rehabilitation 3. There was no difference between
Stay (LoS), Efficiency of Rehabilitation specialized and general acute care
Gains (MBI / natural logarithm of LoS) with respect to functional status at
rehabilitation admission or discharge
nor on rehabilitation LoS.
Population: Traumatic SCI admitted to a 1. Those admitted from the specialized

specialized rehabilitation unit; Males SCI unit had significantly improved
Yarkony et al. 1985; (n=149) and females (n=32); Avg age 28 joint motions (i.e., reduced
USA years; Tetraplegia (54%), paraplegia contractures). More had normal range
Case Control (46%); incomplete (58%), complete (42%). of motion (p<0.05) and fewer
Initial N=181; Treatment: Comparison of those treated abnormalities.
Final N=181 acutely in a specialized interdisciplinary 2. Those admitted from the specialized
spinal unit (n=90) vs a general hospital unit SCI unit were admitted significantly
(n=91). earlier for rehabilitation as compared
3 - 21
Total Sample Size
Outcome Measures: Joint motion, time to to those admitted from the general
rehabilitation admission, all collected at hospital unit (p<0.01). Those admitted
admission to rehabilitation. earlier to rehabilitation had reduced
numbers of contractures (p<0.01).
3. Those with tetraplegia had an
increased incidence of contractures
(p<0.01).
Population: Traumatic SCI, admitted to a 1. Subjects who were cared for in the
specialized, integrated rehabilitation unit in integrated, specialized unit (Australia)
Australia (n=66) vs those admitted to the encountered the fewest complications.
US Model Systems (n=1606); tetraplegia, (no statistical analysis was performed)
paraplegia; incomplete, complete. 2. People sustained progressively more
Donovan et al. 1984; Treatment: Those treated in an integrated, complications with longer periods of
USA / Australia specialized interdisciplinary spinal unit delayed admission (US Model
Case Control (Australia) admitted <48 hours post-injury Systems). Individuals admitted at
Initial N=1,672; vs those admitted to the US Model these longer delays were cared for
Final N=1,672 Systems at 1-15, 16-30, 31-45 or 46-60 initially in general hospital units.
days post-injury (reflecting progressively
less specialized care).
Outcome Measures: Incidence of 7
complications collected at 1-15, 16-30, 31-
45 or 46-60 days post-injury.
Population: traumatic SCI; 201/220 1. Subjects who were admitted to the
consecutive admissions to a newly specialized SCI unit had significantly
established specialized interdisciplinary shorter acute care LoS than those
acute SCI unit vs 351 admissions to one of admitted to the general units
two general hospital trauma units; (p<0.001). Within the specialized unit
tetraplegia, paraplegia; incomplete, subsample, an increased delay from
Tator et al. 1995; complete; Male/female ~ 4/1; Median age - accident to admission resulted in
Canada 27 years (SCI Specialist unit), 32.0 years longer LoS (p=0.032).
Case Control (general hospital). 2. Subjects who were admitted to the
Initial N=552; Treatment: Comparison of those treated in specialized SCI unit had significantly
Final N=552 a SCI specialist spinal unit (1973-1981) vs reduced mortality than those admitted
a general hospital trauma unit (1947-1973). to the general units (p=0.022). This
Outcome Measures: LoS, Mortality rate, was especially evident in those with
Cord Injury Neurological Recovery Index. complete SCI.
All collected at 6 months (complete) or 12 3. Subjects who were admitted to the
months (incomplete). specialized SCI unit had significantly
greater neurologic recovery (p<0.001).
Discussion
The majority of the studies examining the effect of specialist vs. general SCI care settings
focused on this issue during the acute period of care only, with the primary outcome measures
being taken at admission to rehabilitation and no follow-up after this point. Of the four studies
reviewed, only one investigated the results associated with a specialized, integrated unit
comprised of both acute and rehabilitation services (Donovan et al. 1984). In this study, rates of
six of seven different medical secondary complications typically encountered by individuals with
SCI were lowest for the cohort admitted initially (i.e., typically within 48 hours post-injury) to the
specialist SCI centre. This cohort was analyzed retrospectively with complication rates
determined at various times throughout rehabilitation (i.e., 1-15, 16-30, 31-45, 46-60 days) and
compared with those being admitted to specialist SCI centers from more general care settings
at similar time periods. Most striking was the absence of decubitis ulcers during any time period
3 - 22
for those under more specialized care vs. a progressively greater incidence for those with
greater time spent in general care. No statistical analysis was conducted for this study.
In the remaining 3 studies all comparisons were limited to specialized vs. general acute care
and were retrospective in nature. Two of these studies compared subjects as they were being
admitted for comprehensive rehabilitation (Yarkony et al. 1985; Heinemann et al. 1989). In both
studies, patients were transferred significantly faster to comprehensive inpatient rehabilitation
from more specialized acute care settings than from general hospital settings. In the remaining
study by Tator et al. (1995), the same issue was investigated by examining outcomes
associated with a seven year experience of a newly developed specialist SCI unit as compared
to historical data culled from pre-existing trauma units reflecting more general settings (Tator et
al. 1995). In this study, subjects were also transferred to rehabilitation faster from the specialist
SCI unit resulting in a reduced length of stay (LoS) in acute care.
In general, all of these studies demonstrated improved medical outcomes associated with more
specialized care. In addition to the reduced complication rates noted above by Donovan et al.
(1984), others have noted that more specialized acute care resulted in less spine instability
(Heinemann et al. 1989) and significantly improved joint motion with reduced incidence of
contractures (Yarkony et al. 1985) upon admission to a comprehensive rehabilitation program.
In addition, reduced mortality and improved neurological recovery (as demonstrated by higher
scores on the Cord Injury Neurological Recovery Index) were seen in the newly developed
specialist SCI unit as compared to the data from pre-existing general trauma units (Tator et al.
1995). It should be noted that a gradual reduction of mortality was seen over the entire study
period and that reductions attributed to the specialist unit might also be due to many general
gradual improvements in medical care, especially as a historical control was used as the
primary basis for comparison.
Only one study has examined the functional benefits realized during rehabilitation associated
with SCI-specific acute care vs. that delivered in more general settings. Heinemann et al. (1989)
used the Modified Barthel Index to show that those individuals receiving more specialist care
made functional gains during subsequent rehabilitation with significantly greater efficiency (i.e.,
functional change/LoS) than those referred from general settings. No statistically significant
differences were seen between the specialist vs. general groups for either admission or
discharge functional levels nor were significant differences seen with LoS. There was, however,
a significant reduction in the time from injury to rehabilitation admission for those receiving care
in the specialist SCI unit. This implies an overall reduced length of total hospitalization for this
group, although this data was not reported. Functional benefits associated with early admission
and reduced LoS will be reviewed in the next section.
A primary limitation of all studies reported here was the use of retrospective data collection
methods and in the case of Tator et al. (1995), the use of historical controls. Another important
limitation of some of these studies is the failure to control for (or at least adequately describe)
the time to admission to initial care following injury, especially with respect to control subjects
(e.g., Donovan et al. 1984; Yarkony et al. 1985; Heinemann et al. 1989). This is an important
confounding variable as early admission to a specialized system of care is likely associated with
better outcomes as demonstrated in the following section. Therefore, the present conclusions
are limited to a Grade 3 level of evidence and some findings have been reduced to Grade 4 if
not corroborated and involving inadequate controls. While more carefully controlled prospective
studies would be difficult to implement, they would be required to strengthen the evidence in this
area.
3 - 23
Conclusions - Benefits of Specialized vs General SCI Units
Based on several retrospective, case-control studies there is Type 3 evidence that

individuals cared for in interdisciplinary, specialist SCI acute care units soon after injury
(most being admitted within 48 hours) begin their rehabilitation program earlier.
There is Level 3 evidence that individuals cared for in interdisciplinary, specialist acute
care SCI units have fewer complications upon entering and during their rehabilitation
programs.
There is Level 4 evidence that individuals initially cared for in interdisciplinary, specialist
acute care SCI units make more efficient functional gains during rehabilitation (i.e., more
or faster improvement).
There is Level 4 evidence that individuals cared for in interdisciplinary, specialist SCI
units have reduced mortality.
More specialized, interdisciplinary acute SCI care is associated with faster transfers to
rehabilitation and may result in fewer medical secondary complications, more efficient functional
gains and reductions in overall mortality.
3.6 Early vs Delayed Admission to Specialized SCI Units
As noted by others and in the previous section, earlier as opposed to delayed admission to
interdisciplinary, specialized SCI units has been associated with a variety of beneficial outcomes
(DeVivo et al., 1990). The question of whether earlier admission to an organized system leads
to enhanced outcomes is inexorably linked to the question of specialist vs general care for
individuals with SCI. In all studies in this and the preceding section the authors framed their
studies as addressing either the question of delay or the question of interdisciplinary, specialist
care yet similar designs were employed for each (i.e., retrospective case control). For those
subjects experiencing a delay to admission to a specialized SCI unit, it was either presumed or
established that preceding acute care was conducted at a general hospital unit. The author
simply chose to characterize this as either a delay or more general care. For the present review
we have maintained this distinction as originally intended by each author, especially, as in some
cases, there is little or no verification of the general nature of the pre-admission care or the time
of first admission, respectively. However, the reader is advised that the specific findings and
conclusions reached in both sections are most likely associated with a delay to an
interdisciplinary, specialized acute or rehabilitation SCI unit with prior care delivered at a general
hospital facility.
In addition, much variation exists in the literature that addresses the question of delayed
admission. There is no uniform or accepted definition of what constitutes a delay and this varies
depending on the context of the study, most notably whether it is conducted from an acute vs
rehabilitation perspective. For the present review, all studies which examine this question by
comparing 2 or more groups within the first week post-injury have been examined separately
3 - 24
from those with an initial time period greater than 1 week post-injury. These have been termed
1) Acute and 2) Post-acute studies, respectively.
Table 3.10 Individual Studies – Early vs Delayed Admission (Acute Studies)

Total Sample Size
Population: 661 people with SCI admitted 1. Those with complete paraplegia
to a US Model Care System Centre with (p=0.0169) & incomplete tetraplegia
specialized SCI rehabilitation services. (p=0.0001) admitted earlier (<24
Subjects included those with tetraplegia hours) had significantly shorter total
and paraplegia and also those with hospitalization LoS. A similar trend for
incomplete vs complete injuries but those with incomplete paraplegia
frequencies were not provided. Average (p=0.0568), no difference for those
ages for early vs delayed admission with complete tetraplegia (p=0.928).
groups were 29.5 and 32.0 years old 2. Mean hospital charges were less for
respectively. subjects with complete (p=0.0099) and
Treatment: No tx per se, comparison of incomplete (p=0.0134) tetraplegia who
those admitted earlier (< 24 hours post were admitted earlier. Similar trend for
injury) vs later (> 24 hours) to a specialized those with incomplete paraplegia
integrated spinal unit (i.e., combined acute (p=0.0607), no difference for complete
DeVivo et al. 1990; USA care and rehabilitation). Subjects were paraplegia (p=0.4777).
Case Control sub-grouped into i) paraplegia, incomplete, 3. In general, no overall differences were
Initial N=661; ii) paraplegia, complete, iii) tetraplegia, seen in the development of medical
Final N=661 incomplete, iv) tetraplegia, complete. complications between the early vs
Outcome Measures: Length of Stay late admission groups. A few
(LoS), Hospital charges, Incidence of differences for incidence specific
medical complications, Neurologic complications.
recovery, Mortality all collected at 4. Trend for increased neurologic
Discharge. recovery with early admission in that
10/315 (3.2%) vs 4/401 (1.0%) in early
vs late groups had complete recovery
(p=0.08). Author warns of bias in this
finding.
5. Mortality comparisons not possible
within sample for early vs late
admission groups. Comparison with
historical data suggests enhanced
survival rates with early admission.
Population: 482 men and women with 1. Subjects who were admitted earlier
traumatic SCI admitted to a US Model (<24 hours) had significantly fewer
Systems SCI Centre with specialized SCI contractures than those admitted later
acute care and rehabilitation services. (>24 hours – 60 days) (p=0.05).
Subjects included those with tetraplegia 2. Other factors associated with an
(256) & paraplegia (226) and ASIA A, B, C increased incidence of contractures
Daylan et al. 1998; USA
(362) & D (120). included tetraplegia vs paraplegia
Case Control
Treatment: No tx per se, comparison of (p<0.01), presence of a pressure ulcer
Initial N=482;
those admitted 1. (< 24 hours post injury) (p=0.05), co-existence of head injury
Final N=482
vs 2. (> 24 hours – 60 days post-injury) to (p<0.05).
a specialized spinal acute care and
rehabilitation unit.
Outcome Measures: Incidence of
contractures during initial post-traumatic
hospitalization.
3 - 25
Table 3.11 Individual Studies – Early vs Delayed Admission (Post-Acute Studies)
Total Sample Size
Population: SCI, tetraplegia, paraplegia, 1. Those admitted earliest (<30 days)

complete, incomplete, traumatic. had significantly ⁭ performance on
Treatment: No tx per se, comparison of activities of daily living (i.e., Barthel
those admitted to a specialized Spinal Index scores) at discharge than those
Rehabilitation unit at one of 3 time periods with longer delays (>60 days)
following injury (<30 days, 31-60 days, > (p=.006). They also demonstrated
60 days). significantly greater changes (p=.003)
Outcome Measures: LoS, ASIA motor and greater efficiency (p<.001) for the
scores and impairment grade, Barthel Barthel Index.
Scivoletto et al. 2005; Index (BI), Rivermead Motor Index (RMI), 2. Those admitted the earliest (<30 days)
Italy Walking Index for SCI (WISCI), Efficiency had significantly better mobility (i.e.,
Case Control measures for all were calculated by RMI) at discharge than those with
Initial N=150; dividing by LoS. longer delays (>60 days) (p=.03).
Final N=150 They also demonstrated significantly
greater changes (p=.001) and greater
efficiency (p=.04) for the RMI.
3. There were no significant differences
between the early vs later admissions
with respect to walking (WISCI) or
ASIA motor scores (p=.63 or p=.81).
4. Those admitted earliest had the
shortest LoS; these differences were
not significant (p=.15).
Population: SCI, tetraplegia, paraplegia, 1. Those admitted with a delay (> 7
traumatic. days) following referral had
Treatment: No tx per se, comparison of significantly longer LoS (p<.001). This
those admitted to a specialized integrated was for people with both complete
spinal unit (i.e., combined acute and (N=59) and incomplete (N=29) injuries
rehabilitation) with or without a delay but not for those without spinal cord
between injury and referral (>3 days) and damage (N=24).
between referral and admission (>7 days). 2. More severe injuries (as determined
Outcome Measures: LoS. by Injury Severity Scores) were more
Amin et al. 2005; likely to have longer LoS (Spearman’s
England = 0.593, p<0.0001).
Case Control 3. Those who were admitted with a delay
Initial N=432; between injury and referral (>3 days)
Final N=432 did not differ on LoS with those who
did not experience a delay (p=0.44).
4. The primary reasons for delays
between referral and admission for
those with complete injuries were I)
achieving medical stability and ii)
absence of beds. For those with
incomplete injuries the same primary
reasons were identified but in reverse
order.
Population: 197 people with traumatic SCI 1. Those admitted earlier had
admitted within 1 year of injury to a Level 1 significantly shorter total
trauma Centre with specialized SCI hospitalization LoS (p<.01).
Oakes et al. 1990; USA
rehabilitation services. Male / female (158 / 2. Those admitted earlier with tetraplegia
Case Control
39); Tetraplegia / paraplegia (102 / 95); had fewer medical complications and
Initial N=197;
Average ages for groups were 27.2 –32 less frequent spinal surgery vs those
Final N=197
years old. admitted later (no group analysis
Treatment: No tx per se, comparison of performed). Those admitted earlier
those admitted earlier (< median) vs later with paraplegia had no difference in
3 - 26
Total Sample Size
(> median) to a specialized integrated medical complications and more

spinal unit (i.e., combined acute care and frequent spinal surgery.
rehabilitation). Subjects were grouped by 3. Similar reductions in total
tetra vs para and by early vs late hospitalization LoS with earlier
admission by median admission values of admissions for both those with
11 (Tetra) vs 21 (Para) days. tetraplegia (p<.01) and paraplegia
Outcome Measures: LoS, incidence of (p<.05) in a re-analysis of the sample
medical complications, incidence of with groupings based on admissions <
surgical intervention. 24 hours vs > 24 hours post-injury.
Population: 123 people with SCI admitted 1. Subjects who were admitted earlier
to a Japanese Hospital System with (<2 weeks) had significantly shorter
specialized SCI rehabilitation services LoS than those admitted later
following acute care. Subjects included (p<0.0005).
those with tetraplegia and paraplegia 2. FIM gain (p<0.0001) and FIM
(frequencies not provided) with ASIA A efficiency (p<0.0001) were
(51), B (8), C (35) and D (29). significantly greater for subjects
Sumida et al. 2001; Treatment: No tx per se, comparison of admitted earlier vs later. Note: the
Japan those admitted earlier (< 2 weeks post early admission subjects had lower
Case Control injury) vs later (> 2 weeks) to a specialized initial motor and total FIM scores than
Initial N=139; spinal rehabilitation unit. Subjects were did the delayed admission group
Final N =123 sub-grouped into i) tetraplegia, ii) (p<0.05).
paraplegia, iii) central cord. 3. Correlations between ASIA motor and
Outcome Measures: LoS, FIM, FIM motor FIM scores in various subgroups and
score, FIM gain, FIM efficiency all collected at admission and discharge yielded a
at Discharge. variety of associations ranging from
very weak to strong correlations
(r=0.03-0.92) with the majority of these
correlations significant (p<.05).
Population: 173 men (mean age 35.5) 1. Subjects with paraplegia who were
and 46 women (mean age 44.2) with admitted earlier (<1 week and < 2
traumatic SCI admitted to a Spinal Injuries months) had significantly shorter LoS
Centre with specialized SCI acute care and than those admitted later (p<0.05).
rehabilitation services. Subjects included 2. Subjects with tetraplegia who were
those with tetraplegia (116) and paraplegia admitted earlier (<1 week) had
Aung & El Masry 1997;
(103). significantly shorter LoS than those
UK (Wales)
Treatment: No tx per se, comparison of admitted later (>2 months) (p<0.05).
Case Control
those admitted 1. (< 1 week post injury) vs 3. The incidence of most secondary
Initial N=219;
2. (< 2 month) vs 3. (> 2 months) to a conditions did not differ between early
Final N=219
specialized spinal acute care and vs later admissions for those with
rehabilitation unit. paraplegia or tetraplegia. However,
Outcome Measures: LoS, incidence of those with paraplegia or tetraplegia did
secondary complications all collected at have lower incidence of pressure
discharge (i.e, during initial post-traumatic sores with earlier admission (<1 week)
hospitalization). (p<0.001).
Discussion
The present section describes a series of studies in which investigators examined the effect of
delayed admission to a specialist SCI unit. However, there is not a common definition of what
constitutes a “delayed” admission. Therefore, to assist the reader in summarizing these delays,
the details of the various time frames under examination are outlined along with their respective
results in Table 3.12.
3 - 27
Table 3.12 Studies Examining Delayed Admission to SCI Unit
Study Experimental Groups (time post-injury) Outcome Measure Result
LoS +
• <= 24 hours*
DeVivo et al. 1990 Secondary complications -
• > 24 hours
Neurological Status ~
• <= 24 hours* Secondary complications +

Daylan et al. 1998
• > 24 hours (contractures)
• <= 30 days* LoS ~

Scivoletto et al. 2005 • 30-59 days Functional Status +
• > 60 days Neurological Status -
• <= 3 days LoS -

• > 3 days
Amin et al. 2005 or
• <= 7 days from referral* LoS +
• > 7 days from referral
• <= 11 days (for tetra)* LoS +

• > 11 days Secondary complications + (tetra only)
Oakes et al. 1990 or
• <= 21 days (for para)*
• > 21 days
LoS +
• <= 2 weeks*
Sumida et al. 2001 Functional Status +
• > 2 weeks
Neurological Status
• <= 1 week* LoS +

Aung & El Masry 1997
• < 2 months Secondary complications -
(*= Condition with most positive result, + = Positive results, ~ = Trend, - = No effect)
Two acute studies were reviewed which each employed retrospective, 2 group (case control)
designs with a definition of 24 hours as to what constituted an “early” vs a “delayed” admission
(DeVivo et al. 1990; Dalyan et al. 1998). Each study examined a fairly large cohort admitted to a
multidisciplinary, specialized SCI unit (i.e., US model system center) within 24 hours post-injury
vs those admitted after 24 hours. Neither study reported the actual injury to admission times for
the “delayed” admission group and both failed to provide information about the referral sources
(e.g., specialist vs. general nature). DeVivo et al. (1990) noted that total hospital LoS (i.e., acute
and rehabilitation) was reduced for all patient groups except for those with complete tetraplegia
when admission was not delayed. Mean hospital charges were also reduced for early admission
subjects except those with complete paraplegia and there were some reductions in the
incidence of specific medical complications with early admission for some patient groups, most
notably a trend for a reduction in pressure sores for all but those with incomplete paraplegia. In
addition these authors also reported a trend for increased neurologic recovery and reduced
mortality with earlier admission, although they also noted methodological concerns associated
with the actual measures employed. Dalyan et al. (1998), in a study focusing on the
development of contractures, noted an increased incidence of contractures for those admitted
within 24 hours to a specialized unit.
Of the studies examining time periods longer than one week (i.e., post-acute), five studies have
been reviewed (Oakes et al. 1990; Aung & el Masry 1997; Sumida et al., 2001; Amin et al.
2005; Scivoletto et al. 2005). The initial admission delays examined ranged from 1 week (Aung
& el Masry, 1997) to 1 month (Scivoletto et al. 2005). All studies employed retrospective case
3 - 28
control designs and all examined LoS for the entire period of initial hospitalization as a primary
outcome measure. In all cases, those admitted earlier had reduced LoS, regardless of the
considerable variation between studies in the definition of what constituted a delay in admission.
It should be noted that this difference was statistically significant for all studies but one; for
which it was reported as a trend (p=0.15). This study examined the longest delay of 1 month
(Scivoletto et al. 2005).
Functional benefits were also demonstrated for individuals admitted earlier. Scivoletto et al.
(2005) reported that those admitted earlier than 1 month had significantly greater gains and
greater efficiency associated with the Barthel Index as well as greater mobility gains and
efficiency as measured by the Rivermead Mobility Index but there was no difference with
respect to walking as measured by the Walking Index for SCI (WISCI). Similarly, Sumida et al.
(2001) reported increased Functional Independence Measure (FIM) gains and efficiencies for
those admitted earlier than 2 weeks post-injury as compared to those admitted later.
Interestingly, these investigators also showed that for a majority of the various patient groups
tested (i.e., paraplegia and tetraplegia, early and late), significant associations were seen
between a measure of function (i.e., FIM) and a measure of impairment (i.e., ASIA motor
scores). However, Scivoletto et al. (2005) found no effect of early vs. late admission on ASIA
motor scores.
Other investigators examined the role of early vs late admission on the incidence of secondary
medical complications. Oakes et al. (1990) reported that earlier admissions were associated
with a reduced incidence of secondary medical complications in those with tetraplegia and Aung
and el Masry (1997) noted a reduction in the number of pressure sores for all subjects with
earlier admission.
Despite the apparent benefits of earlier admission to a multidisciplinary, specialized integrated
SCI unit, there are significant issues which serve to constrain the strength of evidence in this
area. First and foremost is the retrospective nature of all studies conducted to date. It is difficult
to ascertain how comparable the “early” vs “later” groups truly are with respect to potential
confounding variables. In particular, there is a paucity of information on the pre-admission level
of care and medical status, especially for the delayed admission groups. In addition, it is difficult
to discern the potential role that medical status or the presence of secondary medical
complications may have played in admission delays. The retrospective nature of the studies
outlined in this and the previous section makes it difficult to determine if individuals prone to
complications and with poorer medical status would have naturally comprised a greater
proportion of the delayed admission groups. Therefore, as noted earlier, more carefully
controlled prospective studies would be required to strengthen the evidence in this area.
Conclusions - Benefits of Early vs Later Admission

individuals admitted earlier to interdisciplinary, integrated specialist SCI units have a
shorter total hospitalization length of stay than those admitted later.
There is Level 3 evidence that individuals admitted earlier to interdisciplinary, integrated

specialist SCI units make greater functional gains in a shorter period of time (i.e., greater
efficiency) than those admitted later.

specialist SCI units have fewer secondary medical complications (especially pressure
sores) than those admitted later.
3 - 29
Because of the variability between studies as to what constitutes “early” admission to
interdisciplinary, specialist integrated SCI units it is not possible to determine a specific
period for optimal admission. At least one study has demonstrated benefits with an early
admission described as anything within 30 days post-injury. The majority of studies
defined early admissions as 1-2 weeks post-injury, while studies focused on acute care
describe early admission as within 24 hours post-injury.
Earlier admission to specialized, interdisciplinary SCI care is associated with reduced length of
total hospital stay and greater and faster rehabilitation gains with fewer medical secondary
complications.
Prospective studies with stronger designs are needed to strengthen the evidence and provide
more direction as to the optimal model of care.
3.7 Outpatient and Follow-up Care
Various authors have noted the importance of providing continued, regular, specialized follow-
up care following discharge from rehabilitation (Ernst et al. 1998; Cox et al. 2001; Dryden et al.,
2004). In a recent review, Bloemen-Vrencken et al. (2005) described various follow-up
programmes for persons with SCI. These authors noted that the vast majority of the papers in
this area offered little more than a description of the program with 5 of these being identified as
either experimental or quasi-experimental in nature. Of these, 3 studies were focused on
evaluations of telemedicine or nursing education for the prevention of pressure sores or UTIs
(Barber et al. 1999; Phillips et al. 1999; Phillips et al., 2001), whereas the remaining two had
broader goals of general heath and well-being (Dinsdale et al. 1981; Dunn et al. 2000). Those
articles evaluating programs addressing specific goals (i.e., pressure sores or UTIs) will be
reviewed in the chapters related to these specific issues. The present section focuses on those
studies with more generic aims.
Cox et al. (2001) performed a needs assessment of 54 community-dwelling individuals with SCI
using structured telephone interviews and reported a perceived high need for a specialist,
multidisciplinary SCI outreach service. Some of the issues identified as the greatest areas of
need included dealing with physical changes, transportation, work issues, ongoing education
and pain management. The primary barriers to needs being met were overwhelmingly related to
limitations of local expert knowledge but also included inadequate funding, complicated
processes or service fragmentation and no knowing where to go for help. Preferred service
delivery options in order of preference included telephone advice, home visits, SCI outpatient
clinics, community-based service and regional hospital clinics (Cox et al. 2001). Similar
suggestions have been provided by clinicians, especially as they observe the consequences of
inadequate care received by some individuals upon discharge from inpatient rehabilitation
programmes (Vaidyanathan et al. 2004). Despite these reports, little direct evidence has been
established for the effectiveness of different methods of providing follow-up care.
Table 3.13 Individual Studies – Outpatient and Follow-up Care

Score
Methods Outcome
Research Design
Total Sample Size
Dunn et al. 2000; USA Population: People with SCI receiving 1. Those receiving regular follow-up
Downs & Black score=12 SCI-specialist follow-up care (N=235) vs scored higher on all 3 subscales of
3 - 30
Prospective Controlled those not (N=136); Age = 56.6 vs 47.9; CYH, Health (p=0.0068),
Trial Gender = 99% Male vs 66% Male; Independence (p=0.005) and Absence
(inadequate control) paraplegic, tetraplegic; complete, of Depression (p<0.0001).
Initial N=371; incomplete; Time since injury = 19.4 vs 2. Those receiving regular follow-up
Final N=371 18.2 years. reported similar secondary conditions
Treatment: Follow-up care (routine check- as those without routine follow-up but
ups in SCI Outpatient Clinic) vs no Follow- with reduced frequency and rated it as
up care (presumably problem-based less severe.
primary care).
Outcome Measures: Secondary Condition
Surveillance Instrument (SCSI), Check
Your Health (CYH) Questionnaire. One
time survey of both groups.
Discussion
Dunn et al. (2000) performed an exploratory study of the value of receiving regular,
comprehensive outpatient health care follow-up as compared to those who were deemed to
have no access to these services. Although this investigation was limited by a poor description
of the specific services offered to both the experimental and control groups, there were
significant differences in the perceived health, independence, and absence of depression in
those seen regularly in outpatient clinics. In addition, this group had significantly less frequent
occurrences of specific secondary conditions and also rated the severity of these conditions as
less than those having no access to these clinics (Dunn et al. 2000). Although this trial was
prospective in nature and attempted a quasi-experimental controlled methodology, the potential
confounds (i.e., gender, completeness, race, age, veteran status) varied greatly between the
experimental and control groups. In addition, it was uncertain if selection bias may also have
been an issue, as the authors did not specify what percentage of individuals within their own
service provision cohort refused or did not receive regular outpatient care. These limitations
resulted in this study being assessed as having a Level 4 level of evidence.
Conclusions
There is Level 4 evidence that provision of routine, comprehensive, specialist follow-up

services may result in perceived improvements of health, independence and less
feelings of depression.
Routine, comprehensive, specialist follow-up services may result in improved health
3.8 Summary
There is Level 3 evidence (with US data only) that rehabilitation LoS has become
progressively shorter up to the mid-1990s. No other jurisdiction has published data that
supports this contention.
There is Level 3 evidence that those with higher level and more severe injuries have
longer rehabilitation LoS.
There is Level 4 evidence that a significant proportion of people (~50%) initially assessed
as AIS B and C will improve by at least 1 AIS grade in the first few months post-injury
3 - 31
concomitant with inpatient rehabilitation. Fewer individuals (~10%) initially assessed as
AIS A and D will improve by 1 AIS grade.
There is Level 4 evidence that individuals make significant functional gains during
inpatient rehabilitation, more so for those with complete and incomplete paraplegia and
incomplete tetraplegia.
There is Level 4 evidence based on a single case series that increased therapeutic
intensity may not be associated with any functional benefit as measured by the FIM.
There is Level 3 evidence that significantly shorter rehabilitation LoS is associated with
younger vs older individuals with paraplegia. The same may not be true for those with
tetraplegia or for mixed cohorts involving traumatic and non-traumatic SCI.
There is Level 3 evidence that younger as compared to older individuals are more likely
to obtain greater functional benefits during rehabilitation.
There is Level 3 evidence that significant increases in neurological status during

rehabilitation are more likely with younger than older individuals with tetraplegia or for
mixed cohorts involving traumatic and non-traumatic SCI. The same may not be true for
those with paraplegia.
There is Level 4 evidence that those with non-traumatic SCI are more likely to be older,
female, have paraplegia and have an incomplete injury as compared to those with
traumatic SCI.
rehabilitation LoS, reduced hospital charges but similar discharge destinations as
compared to those with traumatic SCI.
motor FIM improvement during rehabilitation as compared to those with traumatic SCI.
There is Level 3 evidence that there is no difference with respect to gender on discharge
destination, rehabilitation LoS and neurological or functional outcomes associated with
rehabilitation.
There is Level 3 evidence that there is no difference with respect to race (white vs
African-American) on rehabilitation LoS and neurological or functional outcomes
associated with rehabilitation that are not otherwise explained by socio-demographic or
etiological differences.

individuals cared for in interdisciplinary, specialist SCI acute care units soon after injury
(most being admitted within 48 hours) begin their rehabilitation program earlier.
There is Level 3 evidence that individuals cared for in interdisciplinary, specialist acute
care SCI units have fewer complications upon entering and during their rehabilitation
programs.
3 - 32
There is Level 4 evidence that individuals initially cared for in interdisciplinary, specialist
acute care SCI units make more efficient functional gains during rehabilitation (i.e., more
or faster improvement).
There is Level 4 evidence that individuals cared for in interdisciplinary, specialist SCI
units have reduced mortality.

individuals admitted earlier to interdisciplinary, integrated specialist SCI units have a
shorter total hospitalization length of stay than those admitted later.

specialist SCI units make greater functional gains in a shorter period of time (i.e., greater
efficiency) than those admitted later.

specialist SCI units have fewer secondary medical complications (especially pressure
sores) than those admitted later.
Because of the variability between studies as to what constitutes “early” admission to

interdisciplinary, specialist integrated SCI units it is not possible to determine a specific
period for optimal admission. At least one study has demonstrated benefits with an early
admission described as anything within 30 days post-injury. The majority of studies
defined early admissions as 1-2 weeks post-injury, while studies focused on acute care
describe early admission as within 24 hours post-injury.
There is Level 4 evidence that provision of routine, comprehensive, specialist follow-up

services may result in perceived improvements of health, independence and less
feelings of depression
3 - 33
Appendix – Studies Describing Rehabilitation Outcomes
Table 3.14 Individual Studies Describing SCI Rehabilitation Outcomes

Total Sample Size
Population: Traumatic SCI, 82% male, 1. Tetraplegics had significantly longer
Mean age=28.3 years, tetraplegia (55%), stays in rehabilitation than the
paraplegia (45%), incomplete, complete, paraplegic group (121 vs 81 days,
Mean time post-injury to admission=28.8 p<0.001). Those who were diagnosed
days. with incomplete lesions also had
Treatment: No treatment per se, but significantly shorter stays than those
outcomes associated with inpatient diagnosed with complete injuries
Yarkony et al. 1987; rehabilitation. LoS 69.6 + 39.2 days. regardless of level of injury (p=0.001).
USA Outcome Measures: LoS, Modified Barthel Incomplete (107.6 days) vs complete
Case series Index (MBI) collected at admission and (135.3) tetraplegia and incomplete
Initial N=711 discharge. (78.2 days) vs complete (83.4)
Final N=711 paraplegia.
2. Overall, patients showed significant
increases in total MBI and self-care
and mobility MBI subscores (p<0.001).
Improvements and discharge scores
were greater for incomplete vs
complete (p<0.001) and for those with
paraplegia vs tetraplegia (p<0.001).
Population: Traumatic central cord 1. Significant improvements were noted

syndrome, 67 males, 14 females, in the MBI self care subscores, MBI
Age=45.5±20.0 years Tetraplegia, Frankel mobility subscores and MBI total
C and D, Mean time post-injury to scores from admission to discharge
admission=29.8±18.0 days. Treatment: No (p<0.001 for all). At least 70% of
treatment per se, but outcomes associated patients were independent on each of
with inpatient rehabilitation. LoS 69.6 + 39.2 the individuals tasks comprising the
days. MBI at discharge.
Roth et al. 1990; USA
Outcome Measures: Modified Barthel 2. 89% of patients were discharged
Case series
Index (MBI) collected at admission and home.
Initial N=81
discharge. 3. Continent spontaneous voiding was
Final N=81
achieved by 84% at discharge as
compared to 23% at admission.
4. Regulation of bowel management was
achieved by 99% at discharge as
compared to 54% at admission.
5. Medical complications requiring
management occurred in 66.7% of
patients during rehabilitation.
Population: Patient Database (N=412), 1. Most gains in motor and sensory

traumatic, incomplete tetraplegia admitted scores were found in first year. An
within 90 days post-injury (N=95). average of 35 motor points (18%
Treatment: No treatment per se, but during acute care, 53% during
various outcomes associated with inpatient rehabilitation, 8% during the remainder
Pollard & Apple 2003;
acute care and rehabilitation. Main factors of the year) and 46 sensory points
USA
examined were effect of intravenous (46% during acute care, 46% during
Case Series
steroids, early definitive surgery (<24 hours rehabilitation, 8% during the remainder
Initial N=412
after injury) and early decompression of the year) were recovered.
Final N=95
surgery. Mean acute care LoS was 15±16 2. Younger individuals (<18) had more
days and mean rehabilitation LoS was improvement in motor scores but not
47±30 days. sensory scores than older people
Outcome Measures: Change in sensory (p=0.002).
score, final sensory score, change in motor 3. People with Brown Sequard and
3-34
Total Sample Size
score, final motor score. All collected at Central Cord injuries had more
admission and discharge (also for some at improvement in motor scores but not
time of injury and 1, 2, 3 years post-injury sensory scores than those with anterior
or the latest anniversary). cord (p=0.019).
4. There was no effect of
methylprednisolone (MP)
administration, early anterior
decompression, decompression of
stenosis without fracture, gender or
race. Those with MP administration did
have greater improvements in sensory
scores (p=0.027) although there was
no difference in the final sensory score
for those with and without MP.
Population: Traumatic Complete Thoracic 1. Overall, significant increases were
SCI, 81% male, Mean age=27.2±11.4 seen from admission to discharge with
years, Mean time post-injury to total MBI (p<0.001), self care subscore
admission=46 days. (p<0.001) and mobility subscore
Treatment: No treatment per se, but (p<0.001).
outcomes presented associated with 2. Discharge functional status was
Yarkony et al. 1990; inpatient rehabilitation. Length of stay 84 dependent on the admission functional
USA days. status (p<0.001) and the rehab LoS
Case series Outcome Measures: Modified Barthel (p<0.05) but not on acute care LoS,
Initial N=184 Index (MBI) collected at admission and level of paraplegia or presence of
Final N=184 discharge. surgical stabilization.
3. No statistically significant differences
were noted between those with high vs
low paraplegia on 14 of the 15
components of the MBI other than low
paraplegic patients were more likely to
walk 50 yards (p<0.001).
Population: Traumatic SCI, 30 males, 3 1. All patient groups (i.e., levels and
females, Age=48.4±15.6 years, 24 severity of injury) had similar FIM
tetraplegia and 9 paraplegia. motor scores at discharge as noted by
Treatment: No treatment per se, but American Consortium for Spinal Cord
various outcomes associated with inpatient Medicine.
rehabilitation. 2. All groups showed increases in FIM
Outcome Measures: FIM, LoS. All motor scores from admission to
collected at admission, discharge, and 1 discharge but these were only
and 3 months post-discharge. significant for tetraplegia ASIA D
(p<0.05) given small group sizes.
Chan & Chan 2005;
3. Little change in cognitive FIM was
Hong Kong, China
seen between admission and
Case Series
discharge due to ceiling effects.
Initial N=33
4. FIM motor scores generally continued
Final N=33
to increase at 1 and 3 months post-
injury although small N sizes and
missed follow-ups precluded statistical
significance.
5. LoS was generally longer for
tetraplegia (low level was significant,
p<0.0005) although there were low N’s
for each group (varied from 52.0-215.9
days).
3 - 35
Total Sample Size
Population: Gender: 51 males, 17 1. Performance on ADLs was the only

females, Age=43 years. direct predictor of LoS, while subjective
Treatment: No treatment per se, but LoS is well-being and gender affect LoS
Chung et al. 2003;
modeled (predicted) by various measures indirectly through other predictors
Taiwan
associated with inpatient rehabilitation. (subjective well-being via ADLs).
Case Series
Outcome Measures: LoS and various 2. LoS increases as ADL performance
Initial N=68
predictor variables (age, gender, ADLs, deteriorates. Clients with good
Final N=68
subjective well-being and cognitive-social subjective well-being scores will tend
skills). Predictor variables collected at to perform better on ADLs, resulting in
admission to inpatient rehabilitation. shorter LoS.
Population: Traumatic (42) and non- 1. Neurological assessments (Motor

traumatic (10) SCI, 32 males, 20 females, scores and light touch scores) showed
Age=36.4 ±17.7 (5-75) years, complete (6) increases from admission to discharge
and incomplete (18) tetraplegia and for those with incomplete injuries
complete (9) and incomplete (19) (p<0.001) but not complete injuries.
Mϋslϋmanoğlu et al. paraplegia. 2. FIM showed increases from admission
1997; Turkey Treatment: No treatment per se, but to discharge for those with incomplete
Pre-Post various outcomes associated with inpatient injuries (p<0.05) and those with
Initial N=52 rehabilitation of 93.9 ±44.95 (14-258) days. complete paraplegia (p<0.05) but not
Final N=10 Outcome Measures: Motor scores, light complete tetraplegia.
touch scores and FIM. All collected at 3. FIM scores (p<0.05), but not motor
admission, discharge, and 1 year post- scores or light touch scores showed
discharge (N=10 only). significant increases from discharge to
1 year post-discharge in a subsample
of 10 with paraplegia.
Population: 127 males and females with 1. In general, the group with shorter LoS
acute traumatic SCI with motor complete did not differ dramatically from the
paraplegia or tetraplegia (C5-L2) admitted group with longer LoS. Subjects also
for acute rehabilitation. Ages range from spent less time in PT and OT from
11-60 years (mean 28.81). 1991 to 1995 (p<0.001).
Treatment: No treatment per se, but effect 2. There were higher discharge scores for
of Length of Stay on functional and medical bowel management, stairs, manual
status was examined by comparing those locomotion, rolling supine to prone and
admitted in 1991 vs those in 1995. (LoS rolling side to side for those with longer
was significantly reduced in 1995, LoS in paraplegics. No significant
p<0.001). differences were seen in tetraplegic
Outcome Measures: FIM (Individual patients. (Many results showing no
Morrison & Stanwyck, scores for 11 items), Functional motor skills differences not presented).
1999; USA (5 skills, custom), Locomotor skill (5 skills, 3. Post discharge performance skills in
Case Control custom), incidence of medical those with tetraplegia showed that
N = 127 complications (pressure sores, UTIs, pain), those with shorter LoS had higher
employment status all collected at function in the following areas: bathing
discharge and 2 month post-discharge. (p=0.39), bed transfer (p=0.27), and
toilet transfer (p=0.047). For those
with paraplegia, the shorter LoS group
was higher in the following areas:
grooming (p<0.011), upper body
dressing (p=0.003), car transfer
(p=0.018) and manual locomotion
(p=0.031).
4. The proportion of subjects who
reported UTIs, pressure sores and pain
was higher in the shorter LoS group.
Yarkony et al. 1990; Population: Traumatic SCI, 83% male, 1. Rehabilitation Length of Stay
USA incomplete tetraplegia (30%), complete decreased over study period from 56.5
3 - 36
Total Sample Size
Case Series tetraplegia (27%), complete paraplegia days in 1974 to 68.1 days in 1986
N=1,382 (27%) and incomplete paraplegia (16%). (82.8 for tetraplegia and 54.3 for
Treatment: No treatment per se, but paraplegia).
various outcomes associated with inpatient 2. Days hospitalized prior to rehabilitation
rehabilitation. admission decreased over the years of
Outcome Measures: LoS, Discharge the study from 56.5 days in 1974 to
destination. 33.4 days in 1986.
3. 93% were discharged to a private
residence 5% to nursing homes.
Population: US Model Systems database, 1. Of 4,934 admitted within 24 hours
Traumatic SCI, Gender: 82.3% males, post-injury, the proportion showing
Age=30.5±14.9 years, Tetraplegia, increases in ASIA were 10.3% (A),
Paraplegia, ASIA A-E. 45.2% (B), 55.9& (C), 7.3% (D) vs no
Treatment: No treatment per se, but change 89% (A), 50.3% (B), 41.5%
various outcomes associated with inpatient (C), 90.5% (D) vs declined 4.5% (B),
acute care, rehabilitation and follow-up. 2.6% (C), 2.0% (D). Some people
Outcome Measures: ASIA, FIM, Total continued to improve neurologically for
hospital LoS, Discharge destination, up to 18 months after discharge,
Education, Employment, Marital status, thereafter only rarely.
Readmission, Mortality. Collected at 2. From 1973-1990 the proportion of
admission, discharge and in some cases incomplete patients discharged
annually thereafter. increased from 40% to 55.2% whereas
the proportion of complete patients
decreased accordingly.
3. Of 751 patients, average FIM gain was
37 (incomplete paraplegia, 36
(complete paraplegia), 34 (incomplete
tetraplegia and 15 (complete
tetraplegia).
4. Total hospital LoS declined from 1974-
1989. For tetraplegia it went from
DeVivo et al. 1991; USA 149.6 to 92.4 days and for paraplegia
Case Series from 122.3 to 74.9 days.
Initial N=13,763 5. 94.1% patients were discharged to a
Final N=13,763 private residence, 4.0% to nursing
homes, 1.5% to other hospitals. Of
1,306 followed 10 years, 98.0%
resided in private residences.
6. 51.2% of those with grade 9-11
completed high school within 5 years
after injury and 11.6% of those with
high school education completed a
higher academic degree within 5 years.
7. The proportion of people employed
increased from 12.6% 2 years after
injury to 38.3% 12 years after injury.
8. In the second year post-discharge,
35.7% of people were rehospitalized
and this declined to 25% at 12 years.
9. Overall survival rate was 76.9%.
During the first 12 years after injury,
cumulative survival rate increased to
88% of what it would be in the absence
of injury. Highest causes of death were
pneumonia, pulmonary embolism and
septicemia (due to pressure sores,
respiratory infections or UTIs).
3 - 37
Total Sample Size
Population: Multi-centre Italian prospective 1. Neurological improvement was

survey, Traumatic SCI, Gender: 80.1 % associated with ASIA B and C, shorter
males, Age: mean=38.5, median=33.7 (11- LoS, greater chance of seeing
94) years, Tetraplegia, Paraplegia, ASIA A- neurological improvement with earlier
E. admission (3-30 days vs > 30 days,
Treatment: No treatment per se, but p<0.001). Presence of complications
various outcomes associated with inpatient (especially pressure sores) on
acute care and rehabilitation. 7 participating admission or during stay reduced
centers provided integrated acute and likelihood of attaining neurological
rehabilitation care while 30 centres improvement. Multivariate analysis
provided only rehabilitation care. also showed incompleteness was
Outcome Measures: ASIA (neurological independently predictive of
status), various complication incidence, improvement.
LoS, Bladder management method, Bowel 2. Average rehabilitation LoS was 135.5
status, Feeling of dependency, Discharge days (median 122 days). Longer LoS
destination. Collected at admission and was associated with younger age,
discharge. longer time from injury to admission,
previous place of management,
surgical management, tetraplegia,
completeness, presence of
complications at admission or during
Pagliaccu et al. 2003; stay and marginally, admission to an
Italy integrated (vs Rehab only) centre.
Case Series 3. 81.9% of people were discharged to
Initial N=684 home (private residence). Increased
Final N=684 likelihood of being discharged home
were seen with paraplegia, bladder
and bowel autonomy, absence of
pressure sore on discharge, longer
Length of Stay and marginally, younger
age.
4. Bladder autonomy was attained in 65%
of patients. Reduced likelihood of
achieving bladder autonomy was seen
with tetraplegia, completeness, at least
1 complication, longer time from injury
to admission, longer LoS.
5. Reduced likelihood of feelings of
dependency was associated with
paraplegia, neurological improvement,
discharge home, bladder and bowel
autonomy, no pressure sores and
incompleteness. Multivariate analysis
also showed a shorter time between
injury and admission was
independently predictive of lower
feelings of dependency.
Population: Traumatic SCI, 77.8% males, 1. Mean acute care LoS was 45.6±35.9
Age=34.9±17.1 (13-90) years, incomplete days and median rehabilitation LoS
tetraplegia (47.9%), complete tetraplegia was 83 days (3-317 days) (Mean =
Tooth et al. 2003;
(13.2%), incomplete paraplegia (16.2%) 99.6 days).
Australia
and complete paraplegia (22.8%). 2. Rehabilitation LoS was significantly
Case Series-
Treatment: No treatment per se, but longer for those with complete
Initial N=587
various outcomes associated with tetraplegia as compared to those with
Final N=167
admission to an integrated unit for acute incomplete tetraplegia or
and rehabilitation care. Sub-analysis incomplete/complete paraplegia
focused on effects of level of impairment as (p<0.001).
3 - 38
Total Sample Size
measured by neurological status and by the 3. Mean total FIM increased from 68.7
Australian National Sub-acute and Non- (admission) to 102.2 (discharge) due
acute Patient Classification System (AN- almost entirely to gains in motor FIM
SNAP) on Length of Stay. scores. Total FIM scores were lowest
Outcome Measures: LoS, FIM (motor, for those with complete tetraplegia and
cognitive and total), Discharge destination. highest for those with incomplete
All collected at admission and discharge. paraplegia with significant differences
found between the various neurological
categories. Those with complete
tetraplegia had the least change in FIM
scores.
4. 75.4% were discharged to a
community dwelling and 10.8% to a
transitional rehabilitation program.
Those with greater impairment were
less likely to be discharged to a
community setting (i.e., 92.6% with
incomplete paraplegia vs 72.7% with
complete tetraplegia).
5. AN-SNAP-predicted LoS was generally
much shorter than actual LoS.
Population: 209 males, 53 females, 1. 31% of people improved neurologically
Frankel A-E, tetraplegia and paraplegia. as indicated by Frankel, 66% remained
Treatment: No treatment per se, but unchanged, and 3% deteriorated. 23%
various outcomes associated with initially complete became incomplete
admission to an integrated unit for acute and 40% of those initially incomplete
and rehabilitation care. improved.
Outcome Measures: Frankel scale, 2. Of those discharged “normally”, Total
Mortality, Urinary tract management and hospital LoS ranged from 113 (D, E
pathogen status, physical independence paraplegia) to 282 (A, B tetraplegia)
(Walking, Dressing, Transfers, Driving, days with completeness having a
Burke et al. 1985; Finances), Total hospital LoS. All collected greater impact on stay than level.
Australia at admission and discharge. 3. 69.1% of people were discharged
Case Series catheter-free with 14.9% (26.4% of
Initial N=352 females and 12.0% of males)
Final N=262 discharged with an indwelling catheter.
77.9% were discharged with sterile
urine.
4. 77% could dress themselves
independently at discharge (95% with
complete paraplegia and 27% with
complete tetraplegia).
5. 79% could transfer independently at
discharge.
6. 40% with complete tetraplegia could
drive with hand controls at discharge.
Population: 100 traumatic SCI in VA SCI No statistical analysis.

Service, all males, tetraplegia (62) and 1. The higher the injury, the more likely
Woolsey, 1985; USA paraplegia (38), incomplete (27) and an individual did not meet goals of self-
Downs & Black complete (73), time post-injury: < 1 month care and mobility.
score:n/a (59), < 2 months (28), > 2 months (13). 2. 83/100 were discharged to their
Case Series Treatment: No treatment per se, but homes, 13 to nursing homes.
Initial N=100 various outcomes associated with inpatient
Final N=96 rehabilitation. LoS = 3.3 (paraplegia) and
5.5 months (tetraplegia).
Outcome Measures: Attainment of
3 - 39
Total Sample Size
functional goals by discharge or in some

cases later follow-up.
Population: Traumatic SCI from US Model 1. Rehabilitation LoS was reduced from
Systems database, age categories from 74.1 days in 1990 to 60.8 days in 1997
<21 to >51, 80.9% males, tetraplegia and (p<0.001). Acute care LoS was 21
paraplegia, incomplete and complete. days in 1990 and 20 days in 1991.
Treatment: No treatment per se, but 2. Many variables significantly predicted
various outcomes associated with inpatient increases in LoS at p<0.001 level of
rehabilitation to predict LoS, significance (in descending order): low
rehospitalization, residence, days out of admission FIM, earlier discharge year,
residence (QoL) and pressure sores. complete tetraplegia, indwelling
Outcome Measures: Rehabilitation LoS, catheter, intermittent catheterization,
rehospitalization, residence, days out of condom catheter. Other variables
residence (QoL), pressure sore incidence included being African-American,
and many predictor variables. Collected at having a high-school education or less,
admission, discharge and 1 year post- being married, being <21 years old and
injury. being retired or engaged in other non-
paid activities.
Eastwood et al. 1999;
3. Individuals initially discharged to a
USA
skilled nursing facility were more likely
Case Series
to return home by 1 year if they were
Initial N=5,180
young, had higher admission and
Final N=3,904
discharge FIM scores, greater FIM
change, if they were able to leave the
institution more frequently and more
likely to use IC vs indwelling catheter.
4. Individuals were more likely to be
rehospitalized if they had lower
discharge FIM scores, complete
paraplegia, having an indwelling
catheter or using intermittent
catheterization and with a shorter
rehabilitation Length of Stay.
5. Predictors of having pressure sores at
year 1 were having complete
paraplegia, not having incomplete
tetraplegia, lower FIM scores and older
age.
3 - 40
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3 - 44
CHAPTER FOUR
Community Reintegration

Susan J Forwell, PhD, OT(C), FCAOT
Luc Noreau, PhD
Lyn Jongbloed, PhD, OT
Emily S Procter, BSc
Caroline Abramson, MA
Key Points
Attitudes towards disability may be positively influenced by having contact with an

individual with SCI.
For women with SCI, a supportive social network may positively influence their ability
to participate in an occupation.
The main barriers to community reintegration are barriers in the natural environment,
transport, home services, health care and government policies.
Assistive equipment, such as modified vans and environmental control units, may
contribute to better reintegration.
Consumer-directed personal assistance services and independent living programs
may facilitate community reintegration; however, services are not always available.
Successful community reintegration may promote productivity and physical and
mental well-being.
Employment specialists may aid in the process of job placement and work
reintegration.
There is a dearth of high quality research in this field therefore conclusions are based
on observational research methodology.
At discharge from a rehabilitation unit there is improvement in self care and mobility
that is preserved for 1 year.
Persons with tetraplegia who completed a driving training program were more likely to
drive if younger in age, were able to perform transfers independently, had a lower level
of SCI, drove prior to SCI and were employed and involved in sports.
Employment following SCI was positively correlated to being male, and having more
years since injury, younger age, the ability to drive a car, a higher education and a
professional job prior to the SC.
Having tetraplegia has a negative impact on gaining and maintaining employment.
Employed persons with SCI had greater satisfaction with employment and finances
while those unemployed had lower activity levels and higher economic dissatisfaction.
Persons with disabilities experience discrimination and are less likely to obtain an
interview or be hired.
Facilitators for leisure involvement are social support, being healthy and being
employed or attending school. Barriers are lack of physical ability, health concerns,
cost, and lack of opportunity or interest.
Participation in leisure occupations have a positive impact on adjustment to SCI,
physical independence, mobility, hours in activities of daily living and social
integration.
Use of the GAMEWHEELS system showed physiological and motivational benefits for
engaging in wheelchair exercise.
FES is a motivator to engage in exercise and standing, augments ability to do more
things and enhances the sense of well-being. Drawbacks included lack of time to use
the system and reluctance to wear all day.
Average level of QOL after SCI is slightly lower than in people without disability but a
substantial number of people with SCI report good or excellent QOL.
Severity of injury and other diagnostic factors do not significantly impact QOL. There
influence may become significant through restrictions in community integration/social
participation.
A limited amount of variation in QOL has been explained by quantitative research methods.
Qualitative reports suggest that factors affecting QOL after SCI do not seem to differ
from those impacting QOL in people without disability. They are related to life issues
such as achieving meaningful social roles, having control over one’s life and
maintaining adequate access to the environment.
Overall, there is a paucity of information from clinical trials on the most appropriate
interventions favouring subjective QOL on people with SCI and their significant others.
QOL can be indirectly enhanced through use of an exercise program designed to
reduce pain and stress.
Providing group therapy to spouses of individuals with SCI can decrease their symptoms
of depression, anxiety, psychological distress with a potential impact on QOL.
Table of Contents
4.1 Introduction ......................................................................................................................4-1
4.2 Environment .....................................................................................................................4-2

4.2.1 Social Environment .........................................................................................................4-3
4.2.2 Other Environmental Factors ..........................................................................................4-4
4.2.2.1 Physical Environment ..................................................................................................4-5
4.2.2.2 Institutional Environment..............................................................................................4-7
4.2.3 Summary – Environment ..............................................................................................4-10
4.3 Occupation .....................................................................................................................4-11

4.3.1 Daily Living Activities ....................................................................................................4-11
4.3.2 Work..............................................................................................................................4-13
4.3.3 Leisure and Recreation.................................................................................................4-17
4.4 Quality of Life .................................................................................................................4-20

4.4.1 QOL Definitions and Models .........................................................................................4-21
4.4.2 Exploring QOL after SCI from a Scientific Perspective .................................................4-22
4.4.3 Quantitative Measurement Approach of QOL Determinants.........................................4-22
4.4.4 Qualitative Research Methods to Understand QOL and its Determinants....................4-25
4.4.5 Trials Examining QOL as an Outcome .........................................................................4-25
4.4.6 Summary – QOL ...........................................................................................................4-28
4.5 Summary – Community Reintegration.........................................................................4-28
References..............................................................................................................................4-31
Miller WC, Forwell SJ, Noreau L, Jongbloed L, Procter ES, Abramson C. (2006). Community Reintegration Following
Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC,
Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 4.1-4.37.
www.icord.org/scire
Community Reintegration
4.1 Introduction
There are more than 286,000 North Americans currently living with a spinal cord injury (SCI)
and incidence rates suggest that approximately 1000 Canadians and 11,000 Americans survive
a traumatic SCI each year (Canadian Paraplegics Association [CPA] 2000; National Spinal Cord
Injury Database 2005). The majority of injuries occur in males (75%) and over 60% occur in
individuals under the age of 50 (median age 35 years) (Dryden et al. 2003). Over the past 20
years, the life expectancies of individuals have improved vastly due to advances in medicine
with life expectancy reaching to within 10% of the general population. As a result the number of
individuals living with SCI is steadily increasing (CPA 2000).
The journey from acute care through inpatient rehabilitation and back to community living
following a spinal cord injury is one that is filled with challenges. Individuals with SCI face
numerous secondary medical conditions including spacticity, pain, pressure ulcers, bladder
infections, depression and anxiety, all of which can make daily tasks of living demanding and, at
times, impossible. Beyond impairments the severity of disability for SCI survivors spans the
dependence – independence continuum. The usual simple self-care activities of dressing,
bathing or getting around, for example, can be monumental. For instance, even individuals who
are capable of dressing independently often don’t because of the time (up to an hour) and effort
required (Weingarden & Martin 1989). Walking with or without a walking aid(s) or use of a
wheelchair for mobility can result in an increased energy cost that ranges from 9-74%
depending on the floor surface (Waters & Lundsford 1985; Glasser et al. 1995) and the
condition of the wheelchair (Sawatzky et al. 2005) compared typical bipedal walking.
Returning home after rehabilitation is the most common goal of individuals with SCI. On
average 75% of those who survive their trauma return to a private residence including over 60%
with complete tetraplegia (CIHI 2006). Interestingly even the majority of individuals with high
cervical lesions who are respiratory dependent can return to the community to live out the
majority of their lives (Anzai et al. 2006).
The direct cost of SCI to the Canadian healthcare system is estimated to be $750 million each
year (Rick Hansen Foundation 2006) with an average $530,000 resulting from new injury for
hospitalization alone (SmartRisk 1998). The overall economic burden of healthcare for idividuals
with SCI in Canada is between $1.25 million and $25 million each during their lifetime
depending on injury severity (Rick Hansen Foundation 2006).
Sixty-two percent of individuals with SCI are employed prior to injury and only 10-14% return to
work post injury (CIHI 2006). The lost contributions from these potentially employable
individuals to the economy and tax base is substantial in addition to the loss of productivity by
family caregivers who stop or reduce employment to take on this role.
The environment surrounding the delivery of rehabilitation services has changed substantially
over the decade. Cost containment strategies have emphasized efficiency and effectiveness
resulting in reduced hospital length of stay (Rhoads et al. 1992; Holcomb 2000). As a result of
4-1
the shorter hospitalization prior to discharge, people with spinal cord injuries have more
complex needs, are more dependent and use more equipment than they did 10-15 years ago.
An advantage associated with reduced length of stay is that the home environment usually
promotes recovery. But the transition to the community needs to occur with appropriate
supports to facilitate successful integration. The complex requirements of those with SCI and
the fact that their disabilities are permanent, suggest there are wider gaps in supports which
have profound impact for these people and their family members. Transition is a difficult
process, made even more challenging by lack of/gaps in support. Successful transition from
hospital to the community is influenced by a combination of factors at the individual,
social/family, environmental and provincial policy levels (White & Holloway 1990; Pollack et al.
1992; Clandinin & Connelly 1994).
The term community reintegration is used to refer to returning to the mainstream of family and
community life, engaging in normal roles and responsibilities, actively contributing to ones social
groups and of society as a whole (Dijkers 1998). Thus successful reintegration means
resumption of those occupations that are important to each individual, such as taking care of
oneself and participating in productive occupations of work and leisure. The environment,
whether social, institutional, cultural or physical, can either create barriers or facilitate access to
the community at large. Without exception successful reintegration can lead to improved quality
of life (Anderson 2004).
This chapter summarizes the results of selected studies to provide an overview of community
reintegration post SCI. The chapter incorporates research about the person engaging in
occupations and in context to the environment. The issues related to participation are described
as self care, work and leisure while the environmental issues are primarily related to social
aspects of study in SCI. This chapter closes with a review of evidence related to quality of life,
an area of research that brings together the impact of participation and the environment relative
to community reintegration.
4.2 Environment
Rehabilitation assists persons with spinal cord injuries to regain independence and during this
time, the primary focus is on the individual. Following discharge into the community, the
emphasis shifts to people engaging, or attempting to engage, in activities that are important to
them and this is strongly influenced by the environment. Broadly defined as the cultural,
institutional, physical and social aspects that surround the individual (Law et al. 1997), the
environment is the dynamic and inseparable situational context that shapes what a person
chooses to do, how successful and how satisfied they are in doing it. The environment can
support people or constrain them in their performance of activities and thus has a powerful
impact on community re-integration.
A review of studies on the impact of the environment on the community integration of those with
spinal cord injuries indicates that the term ‘environment’ is infrequently used. This is likely
because the environment is a broad construct which includes the social environment as well as
health and social policies. Many of the studies below focus on one aspect of the environment.
In this chapter, studies related to the environment are divided into two areas: the social
environment, and other environmental factors. The social environment includes the individual’s
network of friends and family members as well as societal attitudes about disability and spinal
cord injury. Other environmental factors include adapted vans for transportation, environmental
control units, government policies that influence the availability and accessibility of
4-2
transportation and the availability of personal assistance in the home. The studies are
summarized in Table 4.1 below.
4.2.1 Social Environment
The social environment can be defined as social and cultural institutions and processes that
influence the life of an individual. Family members and friends form the person’s social network
and provide him/her with social support and encouragement. People who experience a spinal
cord injury have to deal with changes in their social network as well as changes in how they are
perceived by society.
Table 4.1 Social Environment

Score
Methods Outcome
Research Design
Total Sample Size
Population: 45 non-disabled students (27 1. There was a significant difference
treatment, 18 control) and 18 disabled between the groups on their pre- and
patients, mean age 27.4 years, 13 C2-C6 post-scores for the Attitude Toward
(quadriplegic), 5 T7-T12 (paraplegic); DOI Disabled Persons scale (F=7.36,
2wk - >1yr. p=.001) (treatment group (t=5.6,
Treatment: Information and social p<.001), comparison group (t=2.5,
meetings between female students and p<.05)).
Haney & Rabin 1984; individuals with SCI. The comparison group 2. Significant positive correlation between
USA had information alone. After the activity the prior degree of contact and changes in
Downs & Black score=13 students had posttest measurements, and ATDP scores of the treatment group
Post-test patients had a verbal posttest (r=.49, p<.01).
Initial N=45; Final N=18 Outcome Measures: Attitude Toward 3. 60%-100% of the patients found that
Disabled Person (ATDP) scale, Student the contact experience affected
Comfort Level Scale (SCLS), Patient boredom, morale, social skills and a
Comfort Level Scale (PCLS), Student sense of attractiveness to the opposite
Satisfaction Measurement Form (SSMF), sex from moderately to very much so.
Patient Satisfaction Measurement Form 4. 67% of the women students returned to
(PSMF), Patient Post-Measurement (PPM) see the patients whom they were
form. originally introduced (~weekly).
Population: all female, age range 25- 1. The women described an emotional
61yrs, traumatic or non-traumatic, 4 need for social support and practical
cervical (tetraplegia) and 9 thoracic social support in order to participate in
(paraplegia), DOI 2-11yrs. occupation.
Isaksson et al. 2005; Treatment: Two interviews obtaining 2. The women reported having developed
Sweden etiology info and current situation regarding new habits through close cooperation
Downs & Black score=8 social network and their ability to with members in the social network.
Observational participate in occupation. 3. They felt that they had become more
N=13 Outcome Measures: perceptions of responsible for the development of their
change in social network and participation. relations. Some relations improved,
others deteriorated and several new
ones were made with other persons
with disabilities.
Discussion
The social environment includes societal attitudes and values as well as networks of
relationships. The studies above suggest that the social environment may be a powerful factor
in community integration of people with SCI.
The complex interactions between the social environment and those with spinal cord injuries are
difficult to study. Popular culture tends to present people with disabilities as tragic victims and
4-3
attitudes towards those with SCI may be biased by these stereotypes, by the lack of social
recognition of people with SCI and other disabilities and by a lack of exposure to individuals with
disabilities. Simply reading or watching a television program about a person with SCI may not
be sufficient to change attitudes. In their experiment, Haney & Rabin (1984) demonstrate that
individuals’ attitudes can be positively influenced by exposure to people with SCI. Developing a
relationship with a person with SCI will likely reduce stigma by enabling people to recognize that
those with SCI are similar to them and contribute to the opportunity for individuals with SCI to
reintegrate into the community. Introducing people with spinal cord injuries to young people
who have never been exposed to someone with a severe disability may also be a good strategy
to influence society’s invisible barrier, thereby promoting community re-integration.
Isaksson et al. (2005) describe how practical and emotional support assisted women with SCI to
participate in occupation. Although not evidenced in the literature, it seems plausible that
individuals who have experienced a SCI may need support following the injury as they deal with
changed relationships. Strategies that encourage them to be assertive in developing new
relationships may be warranted.
Conclusion
There is Level 4 evidence from a single post-test study that having contact with a person
who has an SCI has a significant impact on attitudes towards disability.
There is Level 5 evidence based on a qualitative study that SCI results in a changed
social network - some relationships are lost but others improve.
Attitudes towards disability may be positively influenced by having contact

with an individual with SCI.
For women with SCI, a supportive social network may positively influence their ability to
participate in an occupation.
4.2.2 Other Environmental Factors
In this chapter, studies on other environmental factors focus on equipment and services that
assist people with SCI to function in the community. These include adapted vans and
environmental control units (physical environment, see Table 4.2) as well as follow-up services
after discharge, independent living services, personal assistance services and support to re-
enter competitive employment (institutional environment, see Table 4.3). Government policies
have a large impact on availability of equipment and services and on definitions of eligibility.
Policies are purposeful sets of actions aimed to address identified social problems in a particular
way. Policy may address structures (e.g. resources), processes (e.g. access, roles) and
outcomes (e.g. justice, equity) (Boyce 2002).
4-4
4.2.2.1 Physical Environment
Table 4.2 Physical Environment

Score
Methods Outcome
Research Design
Total Sample Size
Population: 2762 subjects (78%M, 22%F), 1. The top five environmental barriers
DOI: 30% 1yr, 20% 5yrs, 15% 10yrs, 13% reported by the CHIEF scores were
15yrs, 13% 20yrs, 10% 25yrs. barriers in the natural environment,
Treatment: Initial information from National transportation, help at home, health
Spinal Cord Injury database. Also in- care and government policy.
person or telephone interviews. 2. Significant predictors of higher CHIEF
Outcome Measures: Craig Hospital total scores (i.e. more perceived
Inventory of Environmental Factors - Short environmental barriers): mid age range
Form (CHIEF-SF), Craig Handicap at time of injury, female, minority
Assessment and Reporting Technique ethnicity, more recent injury, more
Whiteneck et al. 2004; (CHART-SF), FIM instrument, Satisfaction severe injury, higher degree of activity
USA with Life Scale (SWLS). limitations (p<0.05 for all).
Downs & Black=12 3. Significant predictors of low CHART
Observational total scores (i.e. low participation): older
N=2762 age at time of injury, minority ethnicity,
less education, being unmarried at
injury, higher level of injury, injury by
falling or violence and low FIM scores.
4. Significant predictors of low life
satisfaction: more recent injury, high
scores of physical/structural,
services/assistance and
attitudes/support (CHIEF) and low
scores on mobility, occupation and
social integration (CHART).
Population: from initial sample, n=58 Equipment Utilization
completed all three phases of testing 1. No significant changes over time in use
mean age 43yrs, 40 C1-C4, 11 C3, 6 C2, 1 of power wheelchairs, house hold lifts,
C1, mean DOI 18.5yrs. adaptive bathroom equipment or vans.
Treatment: In-person interviews and chart Participation
review. 2. Hours/day out of bed and # of days out
Outcome Measures: High Quadriplegia of the house remained constant.
Questionnaire (HQQ), Level of Free Time 3. Hours spent reading and listening to
Activities Scale, and Rosenberg Self radio were significantly higher in phase
Esteem Scale (RSE). 1 compared to phase 2 (p=0.02).
4. Participation was correlated to age –
Bushnik 2002; USA
older individuals spent fewer hours out
of bed and out of the house compared
Observational
to younger individuals and participated
N=168
in fewer leisure activities at home
(phase 3) (p<0.01).
Self Esteem and QOL
5. 94% of participants stated they were
glad to be alive.
Access to Equipment
6. Having a van with a lift caused
increased time spent out of bed
(p<0.02) and correlated to increased
hours spent out of the house (p<0.01)
in phases 2 and 3.
4-5
Score
Methods Outcome
Research Design
Total Sample Size
Population: mean age 24.2yrs, 89.7% 1. 93% of the subjects perceived the ECU
males, injuries C6 and above, tetraplegia. as increasing their independence.
Treatment: Structured interview. 2. Operation of the telephone was
Outcome Measures: Environmental indicated as the most important function
Control Unit (ECU) use. (61%), followed by TV (21%).
McDonald et al. 1989; 3. Of the subjects who worked or went to
USA school, only two used their ECUs for
Downs & Black score=5 those purposes.
Observational 4. Subjects felt comfortable for longer
N=29 periods without attendant care when
the ECU was available.
5. Some of the subjects felt that they had
received inadequate training (30%) and
that their attendants lacked
understanding of the ECU (36%).
Discussion
People with SCI have reduced physical abilities and consequently require specific equipment to
function in their environment. The studies above illustrate the following associations: a) various
demographic characteristics and perceived environmental barriers, b) having a van with a lift
and increased time out of bed and out of the house, and c) the increased control of telephones
and televisions with the use of environmental control units; however, the study designs limit the
conclusions that can be drawn from these associations. It should be noted that obtaining
equipment such as environmental control units and vans requires considerable personal
financial means and/or public support. The support team should investigate an individual’s
eligibility for various sources of income, services and equipment.
Conclusion
There is very limited (Level 5) evidence that people with SCI consider the following
factors as the main barriers to community integrations: barriers in the natural
environment, transport, help at home, health care and government policy.
There is very limited (level 5) evidence from two observational studies that assistive
equipment may promote increased activity and participation in and outside of the home.
The main barriers to community reintegration are barriers in the natural environment,
transport, home services, health care and government policies.
Assistive equipment, such as modified vans and environmental control units, may contribute
to better reintegration.
4-6
4.2.2.2 Institutional Environment
Table 4.3 Institutional Environment

Score
Methods Outcome
Research Design
Total Sample Size
Population: sex, age, injury location and Physical Well Being
etiology-matched groups. 1. Bladder function: Community based
Treatment: Randomization into a n=12 (residual urine 100cc's n=4 sterile
community based or hospital based SCI urine n=4 requires catheter n=1)
rehabilitation program. (Hospital = Hospital based n=11 (residual urine
physiatrist and physician, assessments at 100cc's n=5; sterile urine n=4; requires
6wks and 6-12mo post-injury; Community = catheter n=3)
physician, with rehabilitation nurse to lead 2. Bowel function: more use of enemas by
assessment/follow-up). the hospital based program.
Outcome Measures: Comparison of 3. Hospital Readmissions: n=7
Dinsdale et al. 1981;
physical and psychosocial variables at one community; n=13 hospital.
Canada
year post-discharge from the Rehab 4. ADL’s: similar between groups.
PEDro=1
Centre. Psychological Functioning
RCT
1. Professional emotional support: n=5
N=23
community; n=2 hospital.
2. Major emotional crisis: n=3 community;
n=1 hospital.
3. “Good” adjustment: n=8 community;
n=6 hospital.
Social Vocational Functioning
1. Both groups have similar integration,
spare more extensive use of health
agency and vocational support by the
community group.
Population: 440 SCI, mean age 39.7yrs, 1. Participants with TBI were significantly
46.5% paraplegia, 53.6% tetraplegia, more productive than participants with
89.7% incomplete, 10.4% % complete, SCI (74.5% of TBI vs. 28.9% of SCI).
Harker et al. 2002; mean DOI 27.4yrs. (Demographics for TBI 2. 70% of SCI participants reported
Canada patients not reported here, n=47.) receiving weekly assistance compared
Downs & Black score=13 Treatment: mailed surveys (SCI patients), to less than 15% of TBI participants.
Observational in-person interviews (TBI patients). 3. Productivity status was correlated to the
N=487 Outcome Measures: Independent living subjective experience of community
outcomes (DeJong & Hughes 1982), integration (r=-.4013, p<.0001).
Reintegration to Normal Living Index,
environmental support.
Population: mean age 44yrs, 16 women 1. Changed personal relationships owing
and 14 men, cerebral palsy, multiple to lack of access to primary care
sclerosis and SCI (10 in each category). services or durable medical equipment.
Treatment: semi-structured, in-depth And greater need to rely on others due
Neri & Kroll 2003; USA
telephone interviews. to this.
Outcome Measures: perceptions of 2. Depression, frustration, stress, and
Observational
barriers, access, participation, experience. devaluation were frequently reported,
N=30
but 4x as much by women (p=0.012).
3. A general deterioration in health was
the most frequent complaint regarding
physical health.
Population: Agency-Provided Model 1. An initial MANOVA showed significant
(n=29, mean age=35.3 yrs, tetraplegia C1- differences (Wilk's Lamda=.32; p<.01)
Prince et al. 1995; USA C4, complete, mean 7.9yrs post-injury), in outcomes between the 2 groups.
Downs & Black score=12 Self-Managed Model ( n=42, mean age 2. In terms of overall health, those in the
Observational 37.1 yrs, tetraplegia C1-C4, complete, self managed care group had
N=71 mean 11.5yrs post-injury). significantly higher scores on Rand-36
Treatment: Telphone interview. (i.e. perceived better health).
Outcome Measures: Personal Assistance 3. Fewer persons in the self managed
4-7
Score
Methods Outcome
Research Design
Total Sample Size
Satisfaction Index (PASI), Personal group reported hospitalization during
Independence Profile (PIP), Craig the past 6 mos (19% vs. 31%).
Handicap Reporting Technique (CHART), 4. The self-managed care group
Rand-36, Life Satisfaction Index-Acute perceived having more control over
(LSI-A). their day-to-day lives and personal care
(from mean PIP scores, p<0.01).
Population: n=24 (intervention), mean Independent Living Services (ILS)
age: 38.6yrs, 14% ASIA D, 35% paraplegia Received and Reported Needs
ASIA A,B,C, 51% tetraplegia ASIA A,B,C; 1. Both groups reported a similar number
n=56 (control) mean age 34.4yrs. of unmet and met needs.
Treatment: Questionnaires. 2. Participants of the program used
Outcome Measures: The Independent support services more frequently and
Living Services Evaluation Questionnaire, were more satisfied compared to
Craig Handicap Reporting Technique program non-participants and (p<0.01).
(CHART), Satisfaction With Life Scale 3. Program participants were more likely
(SWLS), Personal Independence Profile to report assistance from government
(PIP), Institutional and CIL Surveys. benefits, vocational services and legal
advocacy while non participants were
more likely to report assistance from
insurance sponsors and from personal
attendants.
Forchheimer & Tate
4. The most commonly reported unmet
2004; USA
needs while using ILS were legal rights,
recreation, and obtaining government
Case Series
benefits.
N=81
Program Intervention
1. Participants and non-participants levels
of control, QOL and societal
participation along the five domains of
CHART were not significantly different.
2. PIP - personal independence was
significantly lower for those who
received housing services or had unmet
needs compared to those without
housing or unmet needs (p<0.005).
Those without needs for legal services
had higher PIP, QOL and CHART
scores (p<0.01).
3. Overall there was no benefit noted for
the ILS follow-up program.
Population: n=92 (n=60 consumer- 1. PAS were more likely to be "extremely"
directed PA, n=32 on waiting list), mean or "very" satisfied than the WL grp
age: 41.7yrs (PAS group), 43.7yrs (WL (non-consumer directed) on the 6
group), 51 males and 41 females. individual PASI items.
Treatment: Mail or telephone survey. 2. 85% of PAS and 59.4% of WL were
Outcome Measures: Personal Assistance “extremely” or “very” satisfied with the
Satisfaction Index (PASI). cost of PA.
Beatty et al. 1998; USA 3. 88.3% of PAS and 46.9% of WL were
Downs & Black score=8 “extremely” or “very” satisfied with the
Observational amount of control they had over the
N=92 choice of PA.
4. 93.3% of PAS and 59.4% of WL were
satisfied with the amount of authority
they had to direct their PA’s.
5. 53.3% of PAS and 31.3% of WL were
“extremely” or “very” satisfied with the
availability of assistance in an
emergency.
4-8
Score
Methods Outcome
Research Design
Total Sample Size
Population: 2 males, 1 female, age range 1. Two individuals required only low
38-53yrs, traumatic SCI, C5-C7 technological accommodations (e.g.
tetraplegics, DOI range 11-34 yrs. learning a computerized cash and book
Treatment: Employment specialists lead database system, electronic letter
Inge et al. 1998; USA
job development and restructuring opener) to support their return to work.
ventures, involving the SCI individual and 2. One individual required more intense
Observational
identified potential businesses. support, as well as more conscious
N=3
Outcome Measures: the effect of workplace cooperation, prior to
supported employment and assistive independent work. An employment
technology on job placement. specialist stayed on the job site full-time
for ~3mos.
Population: Individuals with cerebral 1. 56.5% and 39.6% indicated that they
palsy, multiple sclerosis, or SCI. needed assistive equipment in the last
Bingham & Beatty 2003; Treatment: Survey. 12 and 3 months, respectively.
USA Outcome Measures: rates of access to 2. Of those who indicated a need in each
Downs & Black score=7 assistive equipment and medical area, 28.4% and 52.2% did not receive
Observational rehabilitation services, health plan type. assistive equipment and rehabilitation
N=500 services, respectively, each time they
were needed.
Population: 7 physicians, 8 PTs, 7 OTs, 9 1. A positive relationship was found
social workers, and 10 nurses in 5 rehab between the adequacy of personal
hospitals. assistance and the ability of individuals
Treatment: Standardized, open-ended, disabled primarily by stroke, SCI, or
taped interviews by trained interviewers traumatic brain injury (TBI) to maintain
who were also users of PA services. good physical & mental health.
Nosek 1993; USA Outcome Measures: views and Inadequate PA led to extended hospital
Downs & Black score=4 experience of/with PA services. stays, threats to safety, poor nutrition, &
Observational poor personal hygiene.
N=41 2. Reliance on family alone for assistance
was considered inadequate and
common adverse effects were burnout,
family role changes & economic strain.
3. Persons with the best health combined
assistance by relatives & unrelated
persons.
Discussion
The above studies illustrate aspects of the institutional environment faced by those with SCI –
independent living services, consumer and non-consumer directed personal assistance
services, financial aid services and job placement.
The health care system is of primary importance during the acute care and rehabilitation phases
of treatment of people with SCI. Once these people have been discharged and are in the
community, other factors and resources assume considerable importance. People want
assistance with self-care at home, they desire the ability to move around freely in their
communities, and they want to work. As noted previously, it can be a considerable financial
burden to access personal assistance services and government or insurance support is not
always obvious or available.
4-9
Conclusion
There is moderate (Level 2) evidence from one RCT study that a community based
system for post discharge monitoring in no more effective in terms of community
integration than a hospital based system.
There is very limited (Level 5) evidence from one observational study that productivity
was correlated to the individuals’ subjective experience of community reintegration.
There is very limited (Level 5) evidence from two observational studies that a positive
relationship exists between the adequacy of personal assistance and the physical and
mental health of those with SCI.
There is very limited (Level 5) evidence from two observational studies that people who
receive consumer directed personal assistance services are more satisfied with services
than those who receive services that are not consumer directed.
There is limited (Level 4) evidence from one case series that an independent living
follow-up program is more beneficial than no program.
There is very limited (Level 5) evidence from one observational study that supported
employment assists job placement of some people with SCI.
There is very limited (Level 5) evidence from one observational study that individuals
with disabilities did not receive adequate equipment or services on more than half of the
occasions in which they were requested.
Consumer-directed personal assistance services and independent living programs may

facilitate community reintegration; however, services are not always available.
Successful community reintegration may promote productivity and physical and mental well-
being.
Employment specialists may aid in the process of job placement and work reintegration.
There is a dearth of high quality research in this field therefore conclusions are based on
observational research methodology.
4.2.3 Summary – Environment
There are limitations to examining the impact of the environment on community reintegration of
persons with spinal cord injuries. The environment is not easily manipulated as an independent
variable. Consequently, many of the studies are not experimental in design. They describe the
impact of social policies or access to health care on a sample and may use regression analysis
to assess which factors are the most significant influences on an outcome. Overall, the
evidence provided in most of the above studies is insufficient to warrant firm conclusions in this
field of study.
4-10
4.3 Occupation
Occupation, meaning the way and means by which people occupy themselves in meaningful
activities, may refer to time limited activities such as preparing meals, enormous undertakings
such as years of training to compete in the Olympics, or monumental milestones such as taking
the first steps after a SCI or returning to work after months of retraining. Because occupation
refers to a broad range of activities that occupy daily lives it is useful to have a system to
organize such activities into occupational groupings. Occupations may be categorized by the
routines or sequences, the physical environment(s) in which they are completed, the social
network involved (or not, as the case may be) or the nature of the activities. For the purposes of
community integration for persons with SCI, which involves the transition to daily occupations in
one’s relevant community, the nature or type of activity as typically described in the literature is
used in this chapter. As such, the following occupational groupings are described: activities of
daily living, work, and leisure. The literature that examines interventions that enhance the
experience of activities of daily living tasks, work and leisure is in its infancy and is limited to
evidence level 4 and 5 studies. It is these preliminary studies that are summarized here.
4.3.1 Daily Living Activities
Daily living activities refers to tasks completed to take care of oneself and the surroundings and
includes eating, dressing, bathing, grooming, dental hygiene, meal preparation and maintaining
the home. Also grouped in this category is function related to mobility and includes standing,
transfers, walking and driving. Often it is these very basic occupations that are interrupted with
SCI, though following rehabilitation, there is improved performance in self care and mobility
skills (Lysack et al. 2001). In the community, the use of standing frames showed several
benefits and few drawbacks (Dunn et al. 1998) and a driver-training program was successful for
persons with tetraplegia who had driven prior to SCI, had a lower level of SCI, were able to
perform bed, tub and toilet transfers and dressed their lower extremity (Kiyono et al. 2001).
In society, ability for adults to perform personal self care functions is a basic and assumed
independent skill set. The impact of traumatic SCI can dramatically alter that independence and
change subjective evaluation of oneself and future possibilities. Lysack and colleagues (2001)
show that with rehabilitation most function, though modified, can be restored.
Table 4.4 Daily Living Activities

Score
Methods Outcome
Research Design
Total Sample Size
Population: 21 complete, 34 incomplete, 1. Self Care Importance: at admission
mean age at admit: 38.8 yrs, at discharge: 76% eating independence was of
37.7 yrs, at f/u: 43.2 yrs. "upmost importance", 84% at
Intervention: 3 structured questionnaires discharge & 92% at 12 mo f/u. Bathing
administered by an OT assistant at independently, dressing, & grooming
admission, at discharge, and at 1 year post followed a similar trend.
Lysack et al. 2001; USA
injury. 2. Self Care Expectations- at admission
Outcome Measures: Functional 70% of pts expected to eat "all by
Observational
Independence measure (FIM), self-care themselves without any help at all",
Cross-sectional Design
questionnaires (focused on eating, bathing, 15% had goal of independence & 15%
N=55
dressing, and grooming). thought they would need some
personal assistance.
3. Actual Self Care Performance -
subjects underestimated their skills at
admission for eating, bathing, dressing
(p<0.001) & grooming (p<0.003), but
showed improvements in mean FIM
4-11
Score
Methods Outcome
Research Design
Total Sample Size
motor scores from 22.2 to 47.6
(p<0.0005).
4. Subjects tended to rank skills that they
did well with more importance that
other life tasks. This was apparent for
all skills, but was significant only for
grooming & dressing (p<0.02 and
p<0.05, respectively).
Discussion
The data suggests that over 90% of persons with SCI are eating and feeding themselves
independently (Lysack et al. 2001). This prospective study (n=55) that included three data
collection points (admission to a rehabilitation unit, discharge and 1-year follow-up) showed that
at discharge (n=45) significant gains were demonstrated in the performance of the daily
activities specifically related to personal self care and mobility and that this function was
preserved at the 1-year follow-up (n=25). Regrettably, there are no intervention trials for other
daily living tasks such as bathing, maintaining the home, or meal preparation.
Conclusion
There is level 5 evidence (1 cross sectional study) that suggests that at discharge from a
rehabilitation unit there is improvement in self care and mobility that is preserved for 1
year.
At discharge from a rehabilitation unit there is improvement in self care and

mobility that is preserved for 1 year.
Driving is one of the key elements of community reintegration. It provides access to the larger
community and is highly valued. The consequences of SCI can complicate the level of
independence related to driving.
Table 4.5 Driver Training

Score
Methods Outcome
Research Design
Total Sample Size
Population: mean age 34.5 yrs; all 1. As SCI level and age increased, the
complete injuries. ability to drive decreased.
Intervention: Subjects completed the 2. 20/33 subjects that were able to drive
Driver training program at Nagano after training had driven before their
Kiyono et al. 2001; Japan
Rehabiliation Centre. Driving ability was SCI.
subdivided into three categories - 3. Toilet transfer was most correlated
Observational
independant, assisted, or unable. with driving ability.
N=62
Outcome Measures: car driving status, 4. 27/31 (87%) of subjects who could
vocational and sport questions. transfer from the toilet independently
were able to drive independently
(p<0.0001).
4-12
Discussion
Kiyono et al. (2001) showed that of the 62 patients with tetraplegia involved in a driver-training
program 33 were able to drive following the training. Ability to drive was positively related to
independence in activities of daily living (p<.001), specifically toilet, bed and tub transfers as
well as lower extremity dressing. It was also related to lower level of SCI, a younger age,
driving a car prior to SCI, being employed and active participation in sports.
Conclusion
There is level 5 evidence (1 observational study) suggesting that following a driving

training program, persons with tetraplegia who drove tended to be of younger age, have
a lower level of SCI, drove prior to injury, were able to perform independent transfers,
employed and involved in sports.
Persons with tetraplegia most likely to drive following a driver training program were younger in
age, were able to perform transfers independently, had a lower level of SCI, drove prior to SCI
and were employed and involved in sports.
4.3.2 Work
Being employed or having productive and meaningful responsibility is an important and critical
aspect for adults in society, despite disability. It is, however, acknowledged that for persons with
SCI certain work is better suited for individuals with injuries at different lesions and is related to
several factors. The literature related to employment for persons with SCI primarily focuses on
factors contributing to obtaining, returning to, and staying employed as well as adjustment after
SCI.
There is general consensus in level 5 evidence cross-sectional studies that a number of factors
are associated with or predictive of post-injury employment. Table 4.6 provides a summary of
these factors as well as the positive or negative direction of the impact.
Table 4.6 Factors Contributing to Employment Among Individuals with SCI

Factors identified to have a
Impact
relationship with employment Study (N) Study reference
( + positive; - negative)
among SCI
Demographic Characteristics
+ 234 Tomassen et al. 2000
+ 259 Krause 2003
Male gender
+ 277 Ville & Ravaud 1996
- 195 Anderson & Vogel 2002
- 259 Krause 2003
- 301 Krause 1996
- 195 Anderson & Vogel 2002
Level of injury - 231 Krause & Anson 1996
(cervical or tetraplegia) - 418 Noreau et al. 1999
- 192 Young & Murphy 2002
- 114 Castle 1994
- 170 Tate et al. 1993
+ (more yrs) 5925 Meade et al. 2004
Years since injury
+ (more yrs) 154 Crewe & Krause 1990
4-13
Impact
among SCI
+ (more yrs) 170 Tate et al. 1993
+ (less yrs) 301 Krause & Anson 1996
+ (ages 36-45yrs) 234 Tomassen et al. 2000
Age
+ (younger) 301 Krause & Anson 1996
+ (younger) 170 Tate et al. 1993
+ (younger) 418 Noreau et al. 1999
Age at time of injury
+ (before 15 yr) 277 Ville & Ravaud 1996
+ 259 Krause 2003
+ 301 Krause & Anson 1996
+ 266 MacKenzie et al. 1986
Higher education pre-injury
+ 24 Goldberg & Freed 1982
+ 277 Ville & Ravaud 1996
+ 418 Noreau et al. 1999
+ 114 Castle 1994
Education & training post injury
+ 259 Krause 2003
Higher number of children + 24 Goldberg & Freed 1982
Higher income + 301 MacKenzie et al. 1986
Private insurance + 170 Tate et al. 1993
Racial & ethnic minorities - 5925 Meade et al. 2004
Pre-injury job factors
Ability to return to pre-injury job1 + 259 Krause 2003
Pre-injury work of light to 234 Tomassen et al. 2000
+
moderate physical intensity
+ 259 Krause 2003
Professional job-type pre-injury1 + 277 Ville & Ravaud 1996
+ 192 Young & Murphy 2002
Personal issues
Independent living + 195 Anderson & Vogel 2002
Independence in daily activities
+ 195 Anderson & Vogel 2002
+ 195 Anderson & Vogel 2002
Ability to drive independently + 418 Noreau et al. 1999
+ 114 Castle 1994
Health issues (UTIs, spasticity, - 195 Anderson & Vogel 2002
pressure sores etc.) - 231 Krause & Anson. 1996
Lower activity level - 256 Krause 1996
Use of illicit drugs - 195 Anderson & Vogel 2002
Psycho-social factors
Presence of social network + 301 MacKenzie et al. 1986
Quality of Life with SCI + 362 Krause & Anson 1997
Motivation to work + 24 Goldberg & Freed 1982
Discharge planning
from hospital/rehab
Includes vocation and/or 24 Goldberg & Freed 1982
+
education goals
Workplace issues
- 231 Krause & Anson. 1996
In-accessibility of the workplace
- 70 Yavuzer & Ergin 2002
Job accommodations + 96 McNeal et al. 1999
School participation
and performance
among adolescents
Curriculum changes/ modifications + 53 Dudgeon et al. 1997
Human assistance + 53 Dudgeon et al. 1997
In-accessibility of school - 53 Dudgeon et al. 1997
4-14
Impact
among SCI
- (extra-curricular Dudgeon et al. 1997
Lack of transportation 53
participation)
- (extra-curricular Dudgeon et al. 1997
Health concerns 53
participation)
Adaptive writing techniques + 53 Dudgeon et al. 1997
1
Also associated with a much shorter interval between injury and return to work.
Discussion
Several factors emerged in repeated studies to have significant impact on the employment of
persons with SCI. In 4 studies, the factor of being male was shown to have a significant impact,
of which 3 studies suggested it was positive (across studies total n = 770) and one study (n =
195) indicated it had a negative impact. There are 4 studies that suggest years since injury had
an impact on employment with 3 of these showing that more years had a positive impact (total n
= 6249 across studies) and one study (n = 301) indicated that fewer years post-injury was
positively related. In 8 studies, having tetraplegia (total n = 1880) was found to have a negative
impact, while higher education prior to the SCI (total n = 1893 across studies) had a positive
impact on employment. Employment is also positively related to the factors of younger age (3
studies, total n = 705), professional pre-injury job (3 studies, total n = 728) and ability to drive a
car (3 studies, total n = 727).
Conclusion
There are several level 5 evidence studies that show the following factors have a positive
impact on employment: male, more years since injury, younger age, car driving ability,
higher education and professional job prior to the SCI. Many studies also show that
having tetraplegia has a negative impact on gaining and maintaining employment.
Being male, more years since injury, younger age, the ability to drive a car and having a higher
education and a professional job prior to the SCI positively impact employment.
Having tetraplegia has a negative impact on gaining and maintaining employment.
In terms of adjustment to SCI, being employed significantly facilitates the coping and adjustment
to disability.
Table 4.7 Employment

Score
Methods Outcome
Research Design
Total Sample Size
Population: n=559 highly qualified Effect of Qualifications
disabled applications, n=557 highly 1. Across all company sizes,
Ravaud et al. 1992; France qualified AB applications, n=556 modestly disabled persons had less
PEDro=2 qualified disabled applicants n=556, chance of obtaining an interview
RCT modestly qualified AB applicants. irrespective of their qualifications
N=2228 Intervention: Fictional resumes of (p<0.01).
varying qualities were randomly assigned 2. Highly qualified disabled
to be sent to one of four companies in applicants had fewer favorable
4-15
Score
Methods Outcome
Research Design
Total Sample Size
France. responses (2.60%) compared to
Outcome Measures: level of response to highly qualified AB applicants
application (negative or positive), effect of (4.54%).
qualification, effect of company size. 3. Modestly qualified disabled
applicants had fewer favorable
responses (1.24%) compared to
modestly qualified AB applicants
(3.95%).
Effect of Company Size
4. The larger the company (>500),
the greater the chance of
discrimination against highly
qualified disabled applicants
(p<0.01).
5. For modestly qualified
applicants, discrimination was
more visible in smaller
companies (200-499 employees;
p<0.001) compared to larger
ones (>500 employees; p<0.06).
Population: age at beginning of study: 1. During 15 yrs there was an increase
45.6 yrs, mean DOI: 24.4 yrs, 82% men, in married individuals (1974=31.9%,
68% had tetraplegia, 32% had paraplegia. 1985=48.9%) and a decrease in the
Sample size n=154 (in 1985) and n=135 number of single people
(in 1992 at follow-up). (1974=60.7%, 1989=37.8%).
Intervention: Completion of a 2. More participants were working in
Krause 1992; USA questionnaire. This was the 15-year 1989 (50%) than in 1974 (44%).
Downs & Black score=11 follow-up from phase one of an earlier 3. There were significant increases in
Observational study. years of education (p<0.001), sitting
N=135 Outcome Measures: Life Situation tolerance (p<0.05), satisfaction with
Questionnaire (LSQ). employment (p<0.05) and
satisfaction with finances (p<0.05).
4. There were significant correlations
between the two times for
interpersonal (r=+.31) and activity
(+.45) items.
Population: age at time 2 40.5±7.3yrs, 1. Those who made positive

mean DOI 20±5.3yrs. transitions (POS) into work were
Intervention: Survey at time 1 and time 2 significantly younger (p<0.05) and
(11 year follow-up). had a shorter DOI (p<0.01).
Outcome Measures: Life Situation 2. POS and employed individuals had
Questionnaire (LSQ). significantly higher education than
those chronically unemployed
Krause 1996; USA (p<0.001).
Downs & Black score=15 3. Unemployed and POS groups had
Observational a significantly higher proportion of
N=142 quadriplegics (p<0.05) and
chronically unemployed individuals
had lower activity scores compared
to the employed groups (p<0.001).
4. POS group had significantly lower
interpersonal dissatisfaction
compared to the other grps
(p<0.05).
4-16
Discussion
A longitudinal study showed, that over a 15-year period post-SCI (n=135), significant gains were
realized in work, satisfaction, a reduction in the need for medical services, and improved sitting
tolerance (Krause 1992). The greatest gains were related to employment where significant
improvements were demonstrated in satisfaction with employment and finances and more
individuals were employed (Krause 1992). In another longitudinal study, Krause (1996) showed
that after 11 years (n=142) persons with SCI who were unemployed had significantly lower
activity levels (F(3, 130)=5.0, p<.01) and high levels of economic dissatisfaction (F(3,118)=3.8,
p<.05) than those with SCI who were employed. In addition, having a disability was a significant
discriminating factor for gaining employment.
In a study completed in France, Ravaud and colleagues (1992) reported that persons with
disabilities were significantly less likely to obtain an interview or be hired than their able-bodied
counterparts (p<.01). Larger companies were more likely to discriminate against highly qualified
individuals, while modest qualifications were less discriminated against in medium and large
companies though remained a source of discrimination in small companies.
Conclusion
There are level 5 evidence studies (2 longitudinal) that show that those persons with SCI
that were employed 15 years post-SCI had greater satisfaction with employment and
finances while those who were unemployed 11 years post-SCI had lower activity levels
and greater economic dissatisfaction.
There is level 5 evidence (one cross-sectional study) that persons with disabilities in
France experience discrimination related to employment, as they are less likely to obtain
an interview or be hired.
Employed persons with SCI had greater satisfaction with employment and finances while those
unemployed had lower activity levels and higher economic dissatisfaction.
Persons with disabilities experience discrimination and are less likely to obtain an interview or
be hired.
4.3.3 Leisure and Recreation
In the face of catastrophic events such as a SCI, adjustment generally involves engaging in the
necessary or important tasks to sustain life. Typically these activities consume available time
with leisure and recreational occupations relegated to one’s memory. This, however, is
unfortunate as the enjoyment and satisfaction of participating in leisure occupations have
positive effects on other aspects of life and should not be disregarded.
The studies in leisure and recreation among persons with SCI primarily use cross-sectional
research designs. Collectively this research investigates the influence of engaging in leisure
and its impact on adjustment to SCI, community integration, and employment. Table 4.8
provides a summary of these studies and the factors related to leisure and recreational
engagement of persons with SCI.
4-17
Table 4.8 Factors Relating to Leisure Among Individuals with SCI
Factors identified
Impact Study Study reference
to have a relationship with
( + positive; - negative) N
leisure among SCI
Involvement in leisure + adjustment to SCI 178 Loy et al. 2003
activities
+ physical independence 48 Hanson et al. 2001
+ mobility
1
+ occupation
+ social integration
Characteristics of
leisure occupations
Leisure Diversity + subjective well-being 178 Loy et al. 2003
Leisure Intensity + subjective well-being 178 Loy et al. 2003
Facilitators to leisure
participation
Social support system + 178 Loy et al. 2003
+ 14 Dattilo et al. 1998
- if lack of support 72 Scelza 2005
Being healthy + 178 Loy et al. 2003
Being employed or attending + 48 Hanson et al. 2001
school
Expectations for leisure
participation
Adventure activities - 388 Kennedy & Smith 1990
Crafts -
Intellectual activities -
Perceived Barriers to
Leisure Participation
Health concerns - (tetraplegia) 72 Scelza 2005
Cost of program - 72 Scelza 2005
Lack of leisure opportunities in 14 Dattilo et al. 1998
the community
Intrinsic (Intrapersonal)2 - 72 Scelza 2005
Physical ability3 - 14 Dattilo et al. 1998
72 Scelza 2005
Having a SCI
Engaging in sporting activities - 45 Tasiemski et al. 2000
Engaging in recreation activities - 45 Tasiemski et al. 2000
1
Items include # of hours per week to engage in homemaking, working, school, self improvement, maintenance,
recreation and volunteering.
2
Refers to lack of motivation, energy and interest in exercise.
3
Refers to lack or loss of physical balance, mobility and strength.
Discussion
Studies suggest that the primary facilitator for leisure involvement is a supportive social network
(3 studies, total n = 264). Other facilitators are being healthy and being employed or attending
school. The main barrier to leisure participation was lack of physical ability (2 studies, total n=
86) with other barriers noted as health concerns, cost, and lack of opportunity or interest.
Participation in leisure occupations were shown to have a positive impact on adjustment to SCI,
physical independence, mobility, hours in activities of daily living and social integration.
Conclusion
Level 5 evidence (several cross-sectional studies) suggests that facilitators for leisure
involvement are social support, being healthy and being employed or attending school.
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Facilitators for leisure involvement are social support, being healthy and being employed or
attending school. Barriers are lack of physical ability, health concerns, cost,
and lack of opportunity or interest.
Participation in leisure occupations have a positive impact on adjustment to SCI, physical
independence, mobility, hours in activities of daily living and social integration.
Limited research has also been reported on the use of 2 technologies to support the
engagement in leisure activities. These are a computer video game called GAMEWHEELS and
functional electrical stimulation (FES). Each of these is described in turn.
Table 4.9 Wheelchair Exercise

Score
Methods Outcome
Research Design
Total Sample Size
Population: 10 males, 5 females, age 1. Mean Ve was significantly higher
34.7yrs (male) and 39.6yrs (female), all for the GAME group at the 16 and
incomplete injuries at C6-L2. 20 min time points (during
Intervention: Submaximal oxygen exercise); however, there were no
O’Connor et al. 2001; consumption test with and without significant differences in Ve max
USA simultaneous use of the GAME system (a values at these time points.
Downs & Black score=12 video game device). The order in which the 2. Mean VO2 was significantly higher
Prospective Controlled trials were administered was randomized. for the GAME group at the 16 and
Trial Outcome Measures: HR, ventilation rate 20 min time points (during
N=15 (Ve), VO2. exercise).
3. There were significant differences
in Ve and VO2 between conditions
during transition points (warm-up
to exercise).
Discussion
A study (n = 15) investigated the effects of the GAMEWHEELS system (an interface between a
portable roller system and a computer that is controlled by propulsion of a wheelchair’s wheels
on the roller) on physiological responses during and motivators for engaging in fitness and
exercise activities when wheeling a wheelchair. Results suggest that metabolic activity was
greater and significantly different (specifically, oxygen consumption (p<.05) and ventilation rate
(p<.05) when exercising using the GAMEWHEELS than when not. There was no difference in heart
rate between the two conditions. The system also allowed individuals to achieve their target
exercise training zone faster and to maintain it for the entire session. 87% (13) reported that the
system assisted them to work out on a regular basis.
Conclusion
Level 2 evidence (1 non-randomized controlled study) showed the physiological and

motivational benefits of using the GAMEWHEELS system when engaging in wheelchair
exercise.
Use of the GAMEWHEELS system showed physiological and motivational benefits

for engaging in wheelchair exercise.
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Table 4.10 FES Assisted Exercise

Score
Methods Outcome
Research Design
Total Sample Size
Population: N=5, age 17-20yrs, LOI T4- 1. FES was used mainly for exercise
T11, all complete, at least 1 year post- purposes (51%-84% of total days
injury, all ASIA A. used) and less for mobility.
Intervention: FES system implanted into 2. Even though all subjects had
the major muscles used for standing previous brace training, standing
(quadriceps, gluteus maximus, gluteus balance training was needed
medius, and posterior fibers of the before progressing to functional
adductor magnus). Sometimes erector skills training with FES. Eventually,
spinae, hamstrings, adductor longus, and subjects showed a range of
Moynahan et al. 1996; tibialis anterior were included. Stimulation proficiency at manoeuvring and
USA patterns were conducted every 1-4 weeks. short-distance ambulation.
Downs & Black score=12 The protocol was changed in order to fine- 3. The primary factor that motivated
Post-test tune the timing, intensity and coordination FES standing was enjoyment of
N=5 of muscle activity. Subjects wore either being able to stand.
hinged, molded ankle-foot orthosis or 4. Most common reason for non-use
molded shoe inserts depending on was not having time during the day,
requirement for ankle stability. All subjects not wanting to wear the device all
underwent an 8-week FES exercise day and not wearing it in public.
program designed to increase muscle
strength and endurance.
Outcome Measures: FES usage,
adherence, functional skill level and
mobility.
Discussion
Home use of FES training was investigated in a 1 year study with 5 adolescents who had
paraplegia. Results showed that the FES was primarily used for exercise and standing, both of
which were regarded as motivators for use. Other benefits were ability to do more things and a
sense of well-being. Barriers were lack of time to use the system and reluctance to wear the
FES all day.
Conclusion
There is level 4 evidence (one uncontrolled study) that suggests that FES is beneficial as
a motivator to engage in exercise and standing. Drawbacks included lack of time to use
FES is a motivator to engage in exercise and standing, augments ability to do more things and
enhances the sense of well-being. Drawbacks included lack of time to use
4.4 Quality of Life
Spinal cord injury (SCI) is a devastating life situation that occurs suddenly and unexpectedly.
After the initial (acute) phase of care, individuals start a long period of rehabilitation that aims at
4-20
returning them to the community and allowing them to resume, as much as possible, daily
activities and social roles so that they may ultimately begin to enjoy life again. It might be seen
as irrelevant to discuss quality of life (QOL) shortly after SCI, however, being part of the
fundamental nature of life, QOL becomes a significant issue after rehabilitation discharge. Some
reports suggest that compared to the general population people with SCI might experience a
slightly lower QOL (Westgren & Levi 1998) but a substantial number of these individuals regain
a good to excellent QOL after a period of time (Post et al. 1998a). As expressed by Albrecht and
Devlieger (1999), it may be seen as a paradox that “many people with disabilities report
experiencing a good or excellent QOL when to most observers these people seem to live an
undesirable daily existence” (p. 977).
This situation brings out a fundamental issue in the assessment of QOL – unlike other QOL-
related constructs that are described below, subjective QOL (life satisfaction, well-being) is such
an intimate feeling that any process trying to measure QOL from an external observer
indubitably remains imperfect. As it is mostly influenced by one’s personal experiences,
comparisons with societal values usually brought about by an external point of view, are likely to
misjudge one’s QOL. Furthermore, making QOL more difficult to understand, it has been
observed that individuals sustaining alterations in health status or a life event such as a SCI,
may change their internal standards, their values or their conceptualization of QOL (Spranger
1999). These phenomena might partly explain why it is likely that a difference exists between
the external vision of QOL and what is really experienced by people with SCI.
4.4.1 QOL Definitions and Models
Although the term “goodness of life” (Baker & Intagliata 1982) seems appropriate to express the
overall concept of QOL, its apparent simplicity hides a multidimensional concept that is among
the most difficult to define and translate into a functioning and operating reality. Nonetheless,
two main conceptualizations of QOL are well-accepted: (1) the subjective approach, whose
focal point is the person’s emotional or cognitive assessment of the congruence between his/her
life expectations and achievements, usually associated with life satisfaction or well-being and
(2) the objective approach, based on one’s characteristics that can be objectively measured by
an external appraiser (Dijkers 2003). The latter includes the concept of Health-Related Quality
of Life (HRQOL) that focuses mostly on physical and mental health, social and role
achievements, and thus it is more oriented toward functional performance than is subjective
QOL (Wood-Dauphinee et al. 2002).
Several models explaining the overall concepts of QOL and its determinants have been
presented in the field of disability with a particular link to the disablement process (Wood-
Dauphinee & Kuchler 1992; Whiteneck 1994; Post et al. 1999; Dijkers 2003). Post and
collegues (Post et al. 1999; Post & Noreau 2005) proposed a conceptual model that integrates
1) the dimensions of The International Classification of Functioning, Disability and Health (ICF)
(World Health Organization 2001) seen as observable deviations from normal functioning and 2)
a subjective dimension based on one’s perception of satisfaction, perceived health and well-
being. For example, paralysis (Body Function), inability to walk (Activities), level of social
support (Environment) and employment restrictions (Participation) can be assessed from an
external observer and some of these dimensions will potentially influence QOL. Conversely,
perceived health, satisfaction with social participation and general well-being can only be
reported by the person him/herself. All these dimensions form the global (superordinate)
construct of QOL that include the objective and subjective approach. Dijkers (2003; 2005)
proposed a more generic model that integrates different conceptualizations: 1) QOL as
subjective well-being, reflecting the congruence between one’s expectations, values and
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achievements, 2) QOL as achievements focusing on one’s accomplishments, performances and
statuses and including the concept of HRQOL (health and functioning), and 3) QOL as a utility
that compares achievements/statuses with societal norms and standards. These models can
help clinicians to differentiate between QOL as subjective well-being and its objective
determinants. Needless to say, depending on the conceptualization of QOL that would be
valued for a specific research or clinical purpose, the choice of an appropriate measure is a
critical issue.
Some concerns exist regarding the use of the term HRQOL for the conceptualization of QOL
given its emphasis on health status and functioning (Moons 2004) especially given that a shift in
QOL may occur after SCI, and therefore, just because people may have significant health
problems does not necessarily mean they have poor QOL (Smith et al. 1999). Health status
should be considered an important determinant of QOL instead of being regarded as an integral
dimension of QOL itself. Consequently, QOL as an outcome seems to be more appropriately
defined in terms of life satisfaction and this review will mainly focus on that concept.
4.4.2 Exploring QOL after SCI from a Scientific Perspective
An impressive number of studies have addressed Health-related and subjective QOL after SCI.
Several reports have attempted to identify the potential determinants of QOL from different
perspectives but it remains difficult to compare this substantial bulk of information due to the
methodological discrepancy between the studies and the lack of consistency in the assessment
of the construct of QOL (well-being, life satisfaction) with different measures. Moreover, most
studies focused on a single or limited number of variables as very few studies have been
conducted with a conceptual framework that takes into account the spectrum of factors that
influence QOL. As a result, these studies predict only a small percentage of the variance in QOL
(Dijkers 2005) and therefore give a limited scope of the QOL determinants.
4.4.3 Quantitative Measurement Approach of QOL Determinants
To overcome the problem of reduced statistical power in many studies with small sample sizes,
common with SCI studies, researchers recommend the use of meta-analyses which consist of
combining the results of several studies that address similar research hypotheses (e.g. impact
of SCI on QOL). Because of limited rigor of research design and poor validity of measurements
in the reviewed studies, Evans et al. (1994) failed to determine whether or not rehabilitative care
improves QOL. Unlike an overwhelming number of recent reports, this meta-analysis supported
an association between QOL and the level of injury. In his meta-analysis, Dijkers (1997b)
focused on determining the relationships between QOL and each dimension of the International
Classification of Impairment Disability and Handicap (the disablement process). Results showed
that overall, slightly lower mean QOL scores are observed in individuals with a SCI than in
people without disability, but the relationship between the level of injury and QOL (mostly
paraplegia vs. tetraplegia) was almost non existent or weak at best. Conversely, consistent
relationships (r = .30 - .50) were observed between QOL and some aspects of handicap (social
integration, occupation). It remains possible that severity of injury indirectly affects QOL through
its influence on societal participation (Post et al. 1998; Dijkers 1999). If the level of societal
participation valued by a person is not affected because of favourable conditions (e.g.
education, appropriate environmental adaptations, social support), it is likely that subjective
well-being will not be affected, regardless the severity of injury.
The potential predictors of QOL that have been mentioned in studies are summarized in Table
4.11. They were grouped into global dimensions for the purpose of this review and not
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surprisingly, predictors related to community integration/participation are among those most
often cited in the literature, which supports their importance to enhance QOL. However, it is not
necessarily all dimensions of participation that strongly influence QOL. Mobility, occupation, and
community life (including interpersonal relationships) are seen as the most important predictors.
Poor health status and the occurrence of secondary impairments are also known to diminish
QOL.
Interestingly, there is growing interest regarding the impact of the environment on societal
participation and QOL. Perceived social support (particularly from a spouse) has been
considered in several studies as a major predictor of QOL but it is unclear if this variable is a
mediator that will promote the level of community integration/social participation or a direct
contributor to QOL. The physical environment also has the potential to influence QOL. Richards
et al. (1999) observed that access to the environment (home and transportation) was positively
and linearly associated with satisfaction with life. It contributed to the explanatory model
predicting life satisfaction even after all the other independent measures were considered.
As previously mentioned, few studies have used a conceptual framework in order to account for
the spectrum of factors that influence QOL. Even with a strong conceptualization, difficulties still
exist in attempting to capture the complete picture of QOL determinants using quantitative
research methods. For example, Whiteneck et al. (2004) studied the relative impact of
environmental barriers on life satisfaction compared to injury-related variables, demographics
and activity/participation limitations. A limited amount of variance in QOL (10%) was explained
by the environmental barriers compared to participation (15%) and demographics (11%).
Overall, 26% of the variance was explained by all subsets of predictors, meaning that about
75% of the variance is unknown or unexplained by factors measured in such a study. This lack
of prediction is probably attributable to methodological difficulties such as using measures that
do not fully translate the concepts into good metrics rather than a misidentification of the
potential factors that influence QOL.
Despite the large number of studies on QOL after SCI that applied a quantitative approach, our
objective knowledge of how well-being after SCI develops and what factors have a positive or
negative influence on the course of QOL remains limited (Post & Noreau 2005). Further
research is needed using an integrative approach with measures that strongly fit distinct
constructs as those defined in the ICF or other models explaining the consequences of health,
disease and trauma.
Table 4.11 Potential Predictors of Subjective QOL

Issues perceived to influence subjective QOL References
Meta analyses or relationships with the disablement Fuhrer et al. 1992; Evans et al. 1994; Dijkers 1997b;
process Pierce et al. 1999; Whiteneck et al. 2004
Demographics
Age, time since injury, ethnicity, education, marital status Post et al. 1998; Dijkers 1999; Holicky & Charlifue 1999;
McColl et al. 1999; Kennedy & Rogers 2000; Putzke et al.
2001
Injury-related factors Post et al. 1998; Westgren & Levi 1998; Hall et al. 1999;
Putzke et al. 2001
Health-related factors
Mobility, perceived health, rehospitalization, secondary Decker & Schulz 1985; Schulz & Decker 1985; Crisp
impairments (respiratory problems, pressure sores, 1992; Fuhrer et al. 1992; Lin et al. 1997; Post et al. 1998;
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Issues perceived to influence subjective QOL References
spasticity) Kemp & Krause 1999; Pierce et al. 1999 Putzke et al.
2002; Anderson & Vogel 2003; Franceschini et al. 2003
Pain Siösteen et al. 1990; Lundqvist & Siösteen 1991;
Stensman 1994; Anke et al. 1995; Krause 1997; Post et
al. 1998; Vogel et al. 1998; Westgren & Levi 1998; Ville et
al. 2001; Bénony et al. 2002
Psychological factors
Loneliness, boredom Krause & Kjorsvig 1992
Perceived control on life Decker & Schulz 1985; Schulz & Decker 1985; Crisp
1992; Fuhrer et al. 1992; Krause 1992; Krause 1997;
Mcneil et al. 1998; Tate & Forcheimer 1998; Putzke et al.
2002; Franceschini et al. 2003
Community integration/participation
Social functioning/integration Decker & Schulz 1985; Schulz & Decker 1985; Krause &
Crewe 1987; Siösteen et al. 1990; Lundqvist & Siösteen
1991; Crisp 1992; Clayton & Chubon 1994; Dijkers
1997b; Post et al. 1998; Dijkers 1999; Pierce et al. 1999;
Kemp & Ettelson 2001; Ville et al. 2001; May & Warren
2002; Putzke et al. 2002
Interpersonal relationships/social interactions Krasue 1997; Bénony et al. 2002; Putzke et al. 2003;
Franceschini et al. 2003
Community access/participation Schulz & Decker 1985; Fuhrer et al. 1992; Cayton &
Chubon 1994; Nosek et al. 1995; Dijkers 1997a; Hansen
et al. 1998
Occupation/employment status (including satisfaction Krause & Crewe 1987; Lundqvist & Siösteen 1991; Crisp
with), life opportunities 1992; Fuhrer et al. 1992; Krause 1992; Krause & Kjorsvig
1992; Dijkers 1997b; Krause 1997; Lin et al. 1997;
Pentland et al. 1998; Westgren & Levi 1998; Dijkers
1999; Kemp & Krause 1999; McColl et al. 1999; Ville et
al. 2001; Putzke et al. 2002; Franceschini et al. 2003
Environmental issues Decker & Schulz 1985; Schulz & Decker 1985; Crisp
1992; Fuhrer et al. 1992; Rintala et al. 1992; Warren et al.
Perceived social support 1996; Dijkers 1997b; Kemp & Krause 1999
Accessibility (home/health care) Richards et al. 1999; Deconinck 2003
Preferred living situation Cushman & Hassett 1992
Gerhart 1991; Krause 1992; Clayton & Chubon 1994;

Level of income
Vogel et al. 1998; Heck & Makuc 2000; Ville et al. 2001
Residence (nursing home) Dijkers 1999; Putzke & Richards 2001
4-24
Average level of QOL after SCI is slightly lower than in people without disability but a
substantial number of people with SCI report good or excellent QOL.
Severity of injury and other diagnostic factors do not significantly impact QOL. There influence
may become significant through restrictions in community integration and social participation.
A limited amount of variation in QOL has been explained by quantitative research methods.
4.4.4 Qualitative Research Methods to Understand QOL and its Determinants
Because of the difficulty quantitatively capturing complete information on QOL and its
determinants, few reports have used qualitative methods and shed light on the issue of QOL
when living with SCI (Bach & McDaniel 1994; Hillebrand et al. 2001; Manns & Chad 2001;
Whalley Hammell 2004). These studies confirm that several people with SCI enjoy life and have
a good or excellent QOL, even those with a severe injury. Overall, QOL is seen as something
dynamic and subjective. It is generated by the individual’s personal experiences and changes
over the course of life in response to changing priorities and values. The latter is a concept
frequently mentioned and corresponds to the response shift theory (Rapkin 2004).
Several elements that make life enjoyable do not differ in persons with SCI compared to those
without disability. These elements include satisfying interpersonal relationships, financial
security, meaningful social roles (including those related to work and productivity) and
opportunity to pursue leisure and community services. In general, factors reflecting participation
in life situations or reintegration into the community are very influential to QOL. Having control
over one’s life, assertiveness and balance between dependence and independence have all
been reported as major QOL determinants. Access to various resources (physical, emotional,
social) is seen as a necessary foundation to QOL and refers to the overall contribution of the
environment.
There is an interactive process between correlates of QOL that suggests a complex

interrelationship between the domains influencing QOL. Moreover, each domain, taken
independently, is insufficient to maintain QOL and rather, it is the interaction between personal
attributes, meaningful roles and environmental assets that build an optimal QOL. Albrecht and
Devlieger (1999) nicely summarize this perspective by stating that it refers to “the ability of the
self to build and manage a balance between the body, mind and spirit in searching for a state of
well-being and to maintain an harmonious relationship with the environment” (page 986).
Qualitative reports suggest that factors affecting QOL after SCI do not seem to differ from
those impacting QOL in people without disability. They are related to life issues
such as achieving meaningful social roles, having control over one’s life
and maintaining adequate access to the environment
4.4.5 Trials Examining QOL as an Outcome
Unlike the concept of HRQOL, which has been the object of an infinite number of clinical trials,
there is a paucity of experimental studies that examine QOL as subjective well-being or use this
concept as a primary outcome. One reason for this is related to the concept of subjective QOL
itself, resulting from subjective feelings where the appraisal is built on the accomplishment of
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valued life dimensions. Therefore, subjective QOL cannot be the primary outcome of a clinical
intervention and thus, the aim of a study must be to examine the life dimensions valued by the
person (e.g., health status, functional independence, occupation, etc.) and to presume an
indirect effect of enhanced life dimensions on QOL.
The aforementioned findings suggest that dimensions related to community integration (in
particular, active participation and full citizenship) are the most likely to enhance QOL after SCI.
Thus, interventions to enhance QOL should pay careful attention to these determinants. In
Table 4.12 we present 4 studies which use experimental and quasi-experimental designs to
examine changes in QOL after an intervention. Three studies focus on people with SCI while
another one involves spouses.
Table 4.12 Clinical Trials Examining the Effect of Specific Interventions on QOL
Score
Methods Outcome
Research Design
Total Sample Size
Population: 34 subjects (23 men, 11 1. Exercisers reported less pain,
women), complete-incomplete, LOI: 10±11 depression, stress and greater
years. perceived QOL and self-concept.
Martin Ginis et al. 2003; Treatment: exercise training ( aerobic and 2. Stress and pain mediated exercise
Canada resistive) performed in groups of 3-5 induced-changes in QOL.
PEDro=5 people, twice weekly (24 sessions: avg. 15
RCT wks to complete; range 12-22 weeks).
N=34 Mediators: pain perception, self-efficacy,
stress.
Outcome Measures: self-concept,
depression, subjective well-being.
Population: Total n=111 1. The standard care group spent an
Treatment n=72, Control n=39; average of 8.0 days/yr in the hospital
acute phase and 1 yr post-discharge. vs. 5.2 for the telephone and 3.0 for
Phillips et al. 2001; USA Treatment: Participants randomly the video group.
PEDro=4 assigned into 3 groups (n=36 video, n=36 2. At 1 yr post-discharge, QWB scores
RCT telephone, n=39 standard care) for were slightly higher in the intervention
N=111 education on various SCI issued. groups (video-telephone) (n = only
Follow-up (1 yr) to monitor QOL. 42% of the initial sample).
Outcome Measures: Depression (CES-D),
HRQOL-QALY (Quality of Well-Being).
Population: 36 SCI spouses: 19 treatment 1. All values from QOL were significantly
subjects, 17 controls, Age: Support group improved after the treatment in the
32.5yrs, Control spouse 38.5yrs, DOI: support group compared to the control
Support=21 mo, Control= 36 mo. group (physical, psychological, social
Sheija & Manigandan,
Intervention: Support groups met 7 times relation (p<0.0001).
2005; India
(1 h) over a 2-wk period. Controls did not. 2. Significant reduction in anxiety and
Program: discussions on previous sessions depression in the support group.
Prospective Controlled
home task, topic specific performance,
Trial
assignment of home task, wind down.
N=36
Outcome Measures: General Health
Questionnaire (GHQ), Hospital anxiety and
depression rating scale (HAD) and QOL
(WHOQOL-BREF).
Population: 25 treatment subjects, 25 1. Significant improvement in all domains
Daniel & Manigandan
control subjects. of the LSS and WHO QOL-BREF in
2005; India
Treatment: Experimental group had five the experimental group (except for
leisure group sessions (1 hr) included: 1) social relationships) as compared with
intro and group interaction, 2) importance the control group (p=0.0001).
Trial
of leisure, 3) problems faced in leisure
N=50
participation, 4) strategies to overcome
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Score
Methods Outcome
Research Design
Total Sample Size
them, & 5) revision and summary, along
with carrying out an activity suggested by
the group members] as intervention while
the control group had none.
Outcome Measures: leisure (Leisure
satisfaction scale), QOL (WHOQOL-BREF)
Discussion
Even though reality is more complex, some studies support the straightforward hypothesis that
an intervention can modify a particular dimension of life, and the latter will directly influence
QOL. For example, Martin Ginis et al. (2003) suggest that the effect of an exercise program on
QOL is mediated by modifying pain and stress. Sometimes, weaker designs and less
sophisticated analyses (prospective controlled trial) can also be used to suggest the indirect
impact of an intervention on QOL, as shown by Daniel and Manigandan (2005). These authors
attempt to determine if a leisure intervention program would influence subjects’ attitudes toward
leisure, the level of leisure satisfaction and, consequently, QOL. One experiment that we
located did not lead to an obvious effect on QOL. In their post-discharge follow-up conducted by
telehealth or telephone Philips et al. (2001) found that telehealth lead to a more positive
outcome than standard care but this did not translate into better subjective QOL. The
aforementioned hypothesis could also be validated with the partners of people with SCI who are
impacted by the new life context. A good example is Sheija and Manigandan’s investigation of a
spouse support program (2005). They found significant improvements in all domains of QOL
and psychological variables while marginal changes were observed in the control group.
Overall, only one study (Martin Ginis et al. 2003) provided strong evidence that a specific
intervention on life domains will have an impact on QOL. The conclusions from the other studies
would have been stronger if secondary analyses had been conducted to demonstrate an
association between the changes in an intermediate outcome (depression, anxiety,
psychological distress, etc.) and QOL. At present we can only assume that eliciting changes in
an individual’s characteristics or life situations would enhance subjective QOL.
Conclusion
There is Level 1 evidence in 1 RCT study that supports the use of exercise to reduce pain
and stress which in turn mediates changes in QOL.
There is level 1 evidence from 1 RCTstudy that suggests that telehealth provides better
prevention education than telephone or standard care, however, there was little influence
on the QOL.
There is level 2 evidence from 1 non-RCT study that suggests the positive impact of a 2-
week leisure educational program (group therapy) on leisure satisfaction and, potentially,
QOL.
There is level 2 evidence from 1 non-RCT study that suggests the use of group therapy to
support spouses of individuals with SCI will decrease the symptoms of depression,
anxiety and psychological distress with a potential impact on QOL.
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Overall, there is a paucity of information from clinical trials on the most appropriate
interventions favouring subjective QOL in people with SCI and their significant others.
QOL can be indirectly enhanced through the use of an exercise program
designed to reduce pain and stress.
Providing group therapy to spouses of individuals with SCI can decrease their symptoms of
depression, anxiety and psychological distress with a potential impact on QOL.
4.4.6 Summary – QOL
One of the highlights of this section refers to the inherent difficulty in studying the concept of
QOL as an outcome. QOL, being such an intimate feeling and influenced by one’s personal
experiences, is difficult but not impossible to study as the primary outcome of an intervention
study. Moreover, the theory of response shift suggests that the essence of QOL (values,
personal standards, expectations) might change over time, making this concept changeable
over the course of life. Nonetheless, some methodological considerations could facilitate the
design of proper QOL studies. Firstly, there is a need to identify and define what construct of
QOL will be the focus of the study as well as the underlying conceptualization (e.g. subjective
vs. objective, general well-being vs. life satisfaction per domain). The proposed measure must
fit the selected construct of QOL and must have sound psychometric properties (validity,
reliability, responsiveness). Secondly, studies that aim to identify predictors of QOL must use
strong conceptual models that will include all the potentially important facets of life (individual
characteristics, environmental dimensions and societal involvement, etc.). Again, appropriate
measures are a critical issue. Thirdly, in the case of clinical trials designed to enhance QOL, the
interventions should be appropriately selected, such that there is a sensical indirect connection
between the intervention and QOL. For example, one could exam the influence of placement in
a long term care facility versus the return to community living on QOL. The outcome should,
therefore, be identified from the dimensions of a conceptual model, such as the ICF model of
health and disability (body functions and structures, activities, participation, contextual factors).
Finally, there is a necessity to carry out further statistical analyses (multivariate analyses, group
differences, path analyses) to provide evidence of the association between the intermediate or
mediating factors and QOL.
4.5 Summary – Community Reintegration
There is Level 4 evidence from a single post-test study that having contact with a person
who has an SCI has a significant impact on attitudes towards disability.
There is Level 5 evidence based on a qualitative study that SCI results in a changed
social network - some relationships are lost but others improve.
There is very limited (Level 5) evidence that people with SCI consider the following
factors as the main barriers to community integrations: barriers in the natural
environment, transport, help at home, health care and government policy.
There is very limited (level 5) evidence from two observational studies that assistive
equipment may promote increased activity and participation in and outside of the home.
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There is moderate (Level 2) evidence from one RCT study that a community based
system for post discharge monitoring in no more effective in terms of community
integration than a hospital based system.
There is very limited (Level 5) evidence from one observational study that productivity
was correlated to the individuals’ subjective experience of community reintegration.
There is very limited (Level 5) evidence from two observational studies that a positive
relationship exists between the adequacy of personal assistance and the physical and
mental health of those with SCI.
There is very limited (Level 5) evidence from two observational studies that people who
receive consumer directed personal assistance services are more satisfied with services
than those who receive services that are not consumer directed.
There is limited (Level 4) evidence from one case series that an independent living
follow-up program is more beneficial than no program.
There is very limited (Level 5) evidence from one observational study that supported
employment assists job placement of some people with SCI.
There is very limited (Level 5) evidence from one observational study that individuals
with disabilities (SCI, cerebral palsy, multiple sclerosis) did not receive adequate
equipment or services on more than half of the occasions in which they were requested.
There is level 5 evidence (1 cross sectional study) that suggests that at discharge from a
rehabilitation unit there is improvement in self care and mobility that is preserved for 1
year.
There is level 5 evidence (1 observational study) suggesting that following a driving

training program, persons with tetraplegia who drove tended to be of younger age, have
a lower level of SCI, drove prior to injury, able to perform independent transfers,
employed and involved in sports.
There are several level 5 evidence studies that show the following factors have a positive
impact on employment: male, more years since injury, younger age, car driving ability,
higher education and professional job prior to the SCI. Many studies also show that
having tetraplegia has a negative impact on gaining and maintaining employment.
There are level 5 evidence studies (2 longitudinal) that show that those persons with SCI
that were employed 15 years post-SCI had greater satisfaction with employment and
finances while those who were unemployed 11 years post-SCI had lower activity levels
and greater economic dissatisfaction.
There is level 5 evidence (one cross-sectional study) that persons with disabilities in
France experience discrimination related to employment, as they are less likely to obtain
an interview or be hired regardless of qualification or size of company.
Level 5 evidence (several cross-sectional studies) suggests that facilitators for leisure
involvement are social support, being healthy and being employed or attending school.
4-29
Level 2 evidence (1 non-randomized controlled study) showed the physiological and
motivational benefits of using the GAMEWHEELS system when engaging in wheelchair
exercise.
There is level 4 evidence (one uncontrolled study) that suggests that FES is beneficial as
a motivator to engage in exercise and standing. Drawbacks included lack of time to use
There is Level 1 evidence in 1 RCT study that supports the use of exercise to reduce pain
and stress which in turn mediates changes in QOL.
There is level 1 evidence from 1 RCTstudy that suggests that telehealth provides better
prevention education than telephone or standard care, however, there was little influence
on the QOL.
There is level 2 evidence from 1 non-RCT study that suggests the positive impact of a 2-
week leisure educational program (group therapy) on leisure satisfaction and, potentially,
QOL.
There is level 2 evidence from 1 non-RCT study that suggests the use of group therapy to
support spouses of individuals with SCI will decrease the symptoms of depression,
anxiety and psychological distress with a potential impact on QOL.
4-30
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CHAPTER FIVE

Sandra Connolly, BHScOT, OT Reg (Ont.)

JoAnne Aubut, BA
Robert W Teasell MD FRCPC
Tal Jarus, PhD, OTR
Key Points
Neuromuscular stimulation-assisted exercise following a spinal cord injury is

effective in improving muscle strength, preventing injury and increasing
independence in all phases of rehabilitation.
Augmented feedback does not improve motor function of the upper extremity in SCI
rehabilitation patients.
Intrathecal baclofen may be an effective intervention for upper extremity hypertonia of

spinal cord origin.
Afferent inputs in the form of sensory stimulation associated with repetitive

movement and peripheral nerve stimulation may induce beneficial cortical
neuroplasticity.
Restorative therapy interventions need to be associated with meaningful change in

functional motor performance and incorporate technology that is available in the
clinic and at home.
The use of concomitant auricular and electrical acupuncture therapies when

implemented early in acute spinal cord injured persons may contribute to neurologic
and functional recoveries in spinal cord injured individuals with ASIA A and B.
There is clinical and intuitive support for the use of splinting for the prevention of
joint problems and promotion of function for the tetraplegic hand. However, there is
very little research evidence to validate its overall effectiveness.
Shoulder exercise and stretching protocol reduces post SCI shoulder pain intensity.
Acupuncture and Trager therapy may reduce post-SCI upper limb pain.
Prevention of upper limb injury and subsequent pain is critical.
Reconstructive surgery appears to improve pinch, grip and elbow extension functions
that improve both ADL performance and quality of life in tetraplegia.
The use of neuroprostheses appears to have a positive impact on pinch and grip
strength and ADL functions in C5-C6 complete tetraplegia, however, access to the
devices are limited and continue to be expensive in use.
Table of Contents
5.1 Introduction ......................................................................................................................5-1
5.2 Acute Phase of Rehabilitation ........................................................................................5-2

5.2.1 Exercise and Strengthening............................................................................................5-3
5.3 Augmented Feedback on Motor Functions ...................................................................5-6
5.4 Pharmacological Interventions.......................................................................................5-9
5.5 Restorative Strategies ...................................................................................................5-11

5.5.1 Plasticity of Motor Systems ...........................................................................................5-11
5.5.2 Complimentary Alternative Therapies (CAM) ...............................................................5-13
5.5.3 Splinting of the Hand.....................................................................................................5-14
5.6 Sub Acute Phase of Rehabilitation ..............................................................................5-16

5.6.1 Upper Limb Injuries.......................................................................................................5-16
5.6.1.1 Shoulder Injuries ........................................................................................................5-17
5.6.1.2 Elbow/Wrist and Hand Injuries...................................................................................5-18
5.7 Reconstructive Surgery ................................................................................................5-22

5.7.1 Hand .............................................................................................................................5-22
5.7.2 Elbow Extension ...........................................................................................................5-29
5.7.2.1 Elbow Extension (Biceps to Triceps) .........................................................................5-30
5.7.3 Multiple Reconstructions...............................................................................................5-31
5.8 Neuroprostheses ...........................................................................................................5-35

5.8.1 Types of Neuroprostheses............................................................................................5-36
5.8.1.1 Freehand System.......................................................................................................5-36
5.8.1.2 HandMaster-NMS-1 ...................................................................................................5-42
5.8.1.3 Bionic Glove...............................................................................................................5-43
5.8.1.4 ETHZ-ParaCare System ............................................................................................5-44
5.8.2 Other Surface or Percutaneous Neuroprosthesis Systems ..........................................5-45
5.8.2.1 NEC-FES System ......................................................................................................5-45
5.8.2.2 Neuroprosthesis developed by Rebersek and Vodovik (1973)..................................5-45
5.8.2.3 Belgrade Grasping-Reaching System (BGS).............................................................5-46
5.8.3 Reported Benefits of Neuroprosthesis Use...................................................................5-46
5.8.4 Clinical Results of Neuroprosthesis Use.......................................................................5-46
5.8.5 Challenges in Neuroprosthesis Use..............................................................................5-46
5.9 Summary.........................................................................................................................5-48
References..............................................................................................................................5-50
Connolly S, Aubut J, Teasell RW, Jarus T (2006). Upper Limb Rehabilitation Following Spinal Cord Injury. In: Eng JJ,
www.icord.org/scire
5.1 Introduction
Raineteau and Schwab (2001) defined a spinal cord injury as a lesion within the spinal cord that
results in the disruption of nerve fibre bundles that convey ascending sensory and descending
motor information. A spinal cord injury (SCI) at the cervical level results in tetraplegia, the loss
of hand and upper limb function with impairment or loss of motor and/or sensory function. In
incomplete spinal cord injuries, some neural transmissions can still pass through the spinal cord
but it is often fragmentary or distorted which leads to additional neurological complications such
as chronic pain or spasticity. Tetraplegia results in impairment of function in the arms as well
as in the trunk, legs and pelvic organs. Individuals with tetraplegia rely on the use of their hands
and upper limbs in order to complete basic activities of daily living such as self-feeding,
dressing, bathing and toileting. Mobility needs such as transfers from surface to surface,
transitional movements such as rolling, bridging and sit to lying down, crutch walking and
wheeled mobility are also completed by using their arms (Snoek et al. 2004). The level at which
the injury or lesion occurs and the completeness of the lesion (incomplete or complete) indicate
the level of independence of the person (Ditunno1999).
The Paralyzed Veterans of America (PVA) have published a clinical practice guideline (CPG),
“Outcomes Following Traumatic Spinal Cord Injury: Clinical Practice Guidelines for Health Care
Professionals,” that outlines the expected skills and outcomes that a person is expected to
acquire and achieve at each significant level of injury (Consortium for Spinal Cord Medicine
1999). As medical care of the spinal cord injured person has improved, life expectancy now
approaches the rest of the population. Secondary complications from SCI and aging are
ongoing challenges and include pain and upper limb musculoskeletal injuries (Sipski and
Richards 2006).
Hanson and Franklin (1976) compared sexual function to three other impairments in patients
with SCI. 75.7% of the subjects gave the highest priority to upper extremity function. Snoek et
al. (2004) surveyed the needs of patients with SCI and found a high impact and high priority for
improvement in hand function in tetraplegics comparable to that for bladder and bowel
dysfunction.
Given the above, the initial care, management, rehabilitation and prevention of injuries in the
upper limb of tetraplegics are of great importance in maximizing and maintaining independence.
According to Murphy and Chuinard (1998), management and care of the upper limb can be
divided into three phases: the acute, the sub acute and the reconstructive phase. The aim of
the first two phases is to: prevent complications; to achieve optimal functioning within the limits
of the neurological deficit; and to create optimal conditions for the reconstructive phase
(Bedbrook 1981; Keith et al. 1991; Curtin 1994; Harvey 1996). In the latter phase, various
surgical options and functional electrical stimulation (FES) are available to improve positioning
and stabilization of the arm as well as key and palmar grasp function (Waters et al. 1996; Triolo
et al. 1996; Johnstone et al. 1988; Snoek et al. 2000; Peckham et al. 2001). In the new clinical
practice guidelines by the Consortium for Spinal Cord Medicine (2005) emphasizes prevention
of upper limb injuries of tetraplegic individuals in maintaining independence.
5-1
Although, there is no overall consensus regarding the management of the tetraplegic upper
limb, Hummel et al. (2005), Snoek et al. (2005) and the Consortium for Spinal Cord Medicine
(2005) provide excellent discussions and recommendations.
There is agreement that restoration of hand function is an important goal in rehabilitation. It is

also worth noting that there are very few upper extremity tests that accurately evaluate upper
limb function in this population (van Truijl et al. 2002). Curtin (1994) and Krajnik and Bridle
(1992) noted a great inconsistency in evaluation and documentation of the tetraplegic upper
limb between therapists.
The main focus in rehabilitation of the spinal cord injured person is compensation of functional
loss and using those parts of the sensorimotor system, which are still intact (van Truijl et al.
2002). Research findings regarding neuroplasticity and neurological recovery of the spinal cord
also include current rehabilitation practices that should focus on strategies to restore function
lost after SCI.
Several studies have explored increased hand function as a result of reconstructive surgery
and/or neuroprothesis. Although these and many other treatment options exist, and have
proven to improve the overall functioning and functional independence of the person with
tetraplegia, clinical practice has shown that suitable candidates for reconstructive surgery or
FES interventions often do not accept the treatment that is offered (Snoek et al. 2004).
According to Moberg (1975), over 60% of the tetraplegic population could benefit from
reconstructive surgery and it continues to be widely advocated (Snoek et al. 2004).
Reconstructive surgeries such as muscle/tendon transpositions of the intact arm or hand
muscles are designed to substitute for lost motor function (van Truijl et al. 2002). Despite this,
controversy still exists among clinicians as to whether or not to perform reconstructive surgeries
and the benefits of reconstructive surgery have not been clarified with good quality randomized
clinical trials (Harvey et al. 2001). Gorman et al. (1997) deduced that 11% of the tetraplegic
population could be candidates for an implanted FES device (Freehand System). Most
implanted FES devices are usually combined with augmentative and substitutional
reconstructive surgery (Keith et al. 1996).
Using the framework proposed by Murphy and Chuinard (1998), this chapter will be divided into
the following sections: acute phase of rehabilitation, sub acute phase of rehabilitation and
reconstructive phase.
5.2 Acute Phase of Rehabilitation
Rehabilitation and management of the person with a spinal cord injury requires an
interdisciplinary team approach during the acute phase of rehabilitation. The level and
classification of the injury is determined and the goals of maintaining range of motion (ROM),
improving strength, managing tone, spasticity, and the prevention of secondary complications in
order to achieve the person’s maximum functional ability for independent transfers, activities of
daily living and mobility are developed (Haisma et al. 2006; Sipski and Richards 2006; Drolet et
al. 1999). Clinicians must be knowledgeable about the change in physical capacity based on
level of injury as a prerequisite to developing optimal rehabilitation programs and for setting
realistic individual rehabilitation goals.
5-2
5.2.1 Exercise and Strengthening
In the acute phase of rehabilitation, the person with a spinal cord injury has a reduced physical
capacity because of muscle weakness, loss of autonomic control below the level of injury,
reduced activity and subsequent changes in metabolic and vascular function (Haisma et al.
2006). The inability to reach one’s maximum potential will result in an increased risk of medical
and secondary complications and has been correlated to a reduced level of functioning and
quality of life. One of the important goals of rehabilitation is to reverse the debilitative cycle of
reduced physical capacity that leads to reduced activity and functioning (Haisma et al. 2006).
With shorter hospital lengths of stay, spinal cord injured person have less training opportunities.
It is important to determine whether people with SCI can maintain their levels of physical
capacity after discharge.
There are very few evidence-based analyses of the effectiveness of specific exercise therapies
(Sipski and Richards 2006). Most research has only focused on one component of physical
capacity (e.g., peak oxygen uptake [VO2 peak] or muscle strength, or respiratory function).
Many physical factors have been associated with optimal functional independence individual
post-SCI and muscle strength is identified as an important contributor to functional
independence (Drolet et al. 1999). Studies by Noreau et al. (1993), Marciello et al. (1995) and
Durand et al. (1996) all noted a correlation between the level of the lesion, performance in
functional abilities in relationship to peak oxygen intake and level of muscle strength. These
associations were significant in individuals with tetraplegia especially in areas of sitting balance,
spasticity of the lower limb, hand-grip strength, wrist extensor strength and global upper
extremity strength. These functional areas have also been related to Functional Independence
Measure (FIM) motor and self-care scores. It was also identified that upper extremity strength
must be adequate to support the body weight during transfers and lower limb strength for
walking. Optimal recovery of muscle strength following a spinal cord injury is an essential
objective of functional rehabilitation of individuals with a SCI (Drolet et al. 1999).
Changes in motor function observed six months after an injury may be partially explained by
collateral sprouting within the spinal cord (Mange et al. 1990). Changes between 2 to 8 months
may be related to peripheral nerve sprouting and muscle fiber hypertrophy after partial
denervation (Mange et al. 1990; Yang et al. 1990). Natural muscle strength recovery may occur
up to two years post injury, with the recovery rate being more important for the first six months
as measured by manual muscle testing (Ditunno et al. 1992; Mange et al. 1992; Waters et al.
1993). Muscle strength gains have been attributed to two different mechanisms in healthy
subjects. In healthy subjects, short-term gains (2-4 weeks) might be explained by improved
capacity to recruit motor units (neural adaptation) and gains observed after 4 weeks have been
attributed to morphological changes within the contractile tissue inducing muscle fiber
hypertrophy (Sale 1988). Additional studies regarding cardiovascular and exercise interventions
will be discussed in another chapter.
Table 5.1 Exercise and Strengthening

Score
Methods Outcome
Research Design
Total Sample Size
Needham-Shrophire et Population: age 18-45yrs, gender m=31, 1. No significant difference was found at
al. 1997;USA/CA f=3, tetraplegia, time since injury- the 4-week evaluation between
Pedro=8 mean=3yrs. Groups 1 and 2 (p=0.22) or between
RCT Treatment: Subjects randomly assigned to Groups 2 and 3 (p=0.07).
5-3
Score
Methods Outcome
Research Design
Total Sample Size
Initial N=43; Final N=32 one of three groups: 2. Subjects in Group 1 had a higher
Group 1 – received 8 wks of proportion of muscles improving one
neuromuscular stimulation (NMS) assisted or more muscle grades after 4 weeks
arm ergometry exercise of NMS cycling compared with Group
Group 2 – received 4 wks of NMS assisted 3 (p<0.003).
exercise, then 4 wks of voluntary arm crank 3. Following the second 4 weeks of
exercise training, a significant difference was
Group 3 (control group) - voluntarily found between Groups 1 and 3
exercise for 8 wks without the application (p<0.0005) and between Groups 2 and
on NMS. 3 (p<0.03).
Outcome Measures: Manual muscle test. 4. No statistically difference was found
between Groups1 and 2 (p=0.15).
Population: age19-65 yrs; C4-L1; ASIA A- 1. Overall 11 in the ex group (exercise
D; 1-24 yrs duration adherence 82.5%) and 13 in the
Treatment: Experimental group (EX) control group completed the study
participated in progressive exercise training 2. No sign differences were noted
twice weekly for 9 months-each session between the two groups at baseline
offered on alternative days lasing 90-120 3. Following training, EX gr. had
Hicks et al. 2003;
minutes. significant increases in sub maximal
Canada
Outcome Measures: Perceived stress arm ergometry power output (81%;
scale, muscle strength, depression, p<0.05) and significant increases in
PEDro=7
physical self-concept pain, perceived upper body muscle strength (19-34%;
RCT
health and Q of L were assessed p<0.05)
4. EX gr. reported less pain, stress and
depression after training + scored
higher than CON in indices of
satisfaction with physical function,
level of perceived health + overall
quality of life (p<0.05)
Population: Age: approx 40 yrs, Gender: 1. Age was related to the PO peak and
75% male, Level of Injury: both para and handheld dynamometry (HHD) score
tetraplegia; Injury completeness: approx (p<0.05), the older the subject the
67.5% complete injuries; Time since injury: more improvement in either of these
approx 105 days measures was significantly less than it
Treatment: No treatment provided was in younger subjects.
Outcome Measures: Power output (PO) 2. Men had greater PO peak, VO2peak
peak, VO2 peak, strength of upper and HHD score than women did
Haisma et al. 2006; extremity, respiratory function (p<0.05), thus improvement in men
Netherlands was greater than women.
Downs & Black score=13 3. In tetraplegia subjects the PO peak,
Cohort VO2peak, muscle strength and % of
Initial N=186; Final N=42 forced vital capacity (FVC) was lower
(p<0.05) than it was in paraplegics but
tetraplegics improved more in muscle
strength and % of forced expiratory
flow (FEV1).
4. Those with a complete lesion had
greater HHD score and lower % of
FVC than those with incomplete
lesions (p<0.05).
Population: Gender: m=27, f=4; Age: 1. Strength values at admittance were
approx 29.5yrs; ASIA: A-D; length of stay: inversely repeated to strengthen
Drolet et al. 1999; CA approx 4.5 months; time since injury: changes during rehab (Pearson
Downs & Black score=15 approx 2 months correlation coefficients ranging from -
Pre-post Treatment: Rehab included PT, OT and .47 (p=.001 shoulder flexors) to -.73
Initial N=40; Final N=31 physical conditioning. There were 4 1hr (p<.001 shoulder adductors).
sessions of each intervention 2. For those with paraplegia the range
Outcome Measures: Meaning muscle was from -.48 (p=0.049 shoulder
5-4
Score
Methods Outcome
Research Design
Total Sample Size
strength was assessed for 6 muscle groups abductors to -.72 (p=.001 elbow
4 times. Muscle strength changes during & flexors) compared to those with
after functional rehab tetraplegia, the correlation coefficients
ranged from -.28 (p=.345 elbow
extensors) to -.68 (p=.010 shoulder
adductors).
3. Patterns of change in muscle strength
from admittance to the 15 month follow
up differed between the 2 groups.
4. Differences in strength have been
observed for: elbow flexors (p=.001)
and shoulder extensors (p=0.04)
Population: Gender m=10, f=1, age 18- 1. All subjects showed improvement in
45yrs, >1yr post injury, level of injury C4- one or more of their manual muscle
C7, neurologically stable score with the most dramatic occurring
Cameron et al. 1998;
Treatment: Testing of hybrid device, 8 wks in the tricep muscle group (average
USA
of NMS assisted exercise with training increase 1.1 +/- 0.2 for L triceps, 0.7
sessions 3x/wk +/- 0.1 for R)
Case Series
Outcome Measures: Manual muscle test 2. Results show NMS in combination with
N=11
scores biceps, triceps, wrist flexors and resistive exercise can be used safely
extensors. and assists in the strengthening of
voluntary contractions
Discussion
The five studies presented address the long-term change of upper limb strength after the spinal
cord injured person has returned to community living.
Needham-Shophire et al. (1997) found that Neuromuscular stimulation (NMS)-assisted

exercise ergometry alone and in combination with voluntary arm crank exercise was effective for
strengthening of the upper limb for SCI injured individuals well after injury (mean time since
injury 3 years).
Hicks et al. (2003) demonstrated all study participants had progressive increases in muscle
strength in each of the muscle groups tested and that the change scores were significant from
the control group except for the left anterior deltoid. Study participants self-reported decreases
in stress, pain, depression, enhanced physical self-concept and overall quality of life.
Drolet et al. (1999) conducted one of the first longitudinal studies published in muscle strength
changes in individuals with SCI during rehabilitation. Significant improvement of muscle
strength during rehabilitation for individuals with both paraplegia and tetraplegia was noted.
Significant improvements were noted at the three-month post discharge evaluation period with
the tetraplegia group in the four muscle groups (elbow flexors and extensors and shoulder
flexors and extensors) and then began to plateau. One year later elbow flexors showed
significant improvement in both paraplegia and tetraplegia groups and shoulder extension
showed significant gains only on individuals with paraplegia. Large variability was noted
indicating the recovery of strength maybe influenced by a variety of individual factors such as
level and severity of injury, associated health conditions, age, gender, motivation and physical
condition before SCI. Improvements in strength realized in rehabilitation continue to be
maintained or improved when the person with a SCI returned to community living.
5-5
Haisma et al. (2006) found positive changes in the different components of physical capacity
both during and after inpatient rehabilitation. SCI subjects continued to improve and this study
illustrates the importance of regularly assessing the physical capacity of people with SCI after
discharge. It is important to create conditions (education, exercise facilities) that facilitate
further improvements (Haisma et al. 2006).
Cameron et al. (1998) also reported improvements in upper limb strengths in combination with
neuromuscular stimulation.
Haisma et al. (2006) and Sipski and Richards (2006) recommended further research in this
area:
• Further research is needed to document benefits of exercise interventions post-SCI
including optimal methods for strengthening muscles, merits of endurance versus
strength training, range of motion, gait, ADL, and transfer training.
• Due to impact of body composition, age, concomitant medical problems and our limited
knowledge of recovery post SCI, research needs to be performed through well-designed
multicentre trials.
• Longitudinal studies are needed to gain more insight into the changes that occur after
inpatient rehabilitation and the factors which influence these changes.
• Exercise and strengthening of the upper limb in both the acute and subacute phase of
rehabilitation are important in promoting independence and prevention of injury.
Conclusions
For exercise and strengthening of the SCI individual following injury:
There is level 1 evidence based on one RCT that physical capacity continues to improve
after 1- year post discharge.
There is level 2 evidence based on one pre/post study that neuromuscular stimulation-
assisted ergometry alone and in conjunction with voluntary arm crank exercise was an
effective strengthening intervention for chronically injured individuals.
There is level 2 evidence based on one study that muscle strength continues to improve
up to 15 months post hospital discharge for both tetraplegic and paraplegic individuals.
There is level 4 evidence based on one study that neuromuscular stimulation-assisted

exercise improves muscle strength over conventional therapy.
Neuromuscular stimulation-assisted exercise following a spinal cord injury is effective in

improving muscle strength, preventing injury and increasing independence in all phases of
rehabilitation.
5.3 Augmented Feedback on Motor Functions
Several studies have addressed the use of augmented feedback such as biofeedback with
spinal cord injured populations. Van Dijk et al. (2005) conducted a systematic review of RCTs
on the effect of augmented feedback on motor function of the affected upper extremity in
5-6
rehabilitation patients. Much of the information about augmented feedback comes from the
motor learning literature where it has been noted that feedback combined with practice is a
potent variable for affecting motor skill learning (Newell 1991; Schmidt and Lee 1999). There
are two types of performance-related information or feedback. The first type of feedback, task
intrinsic or inherent feedback, is sensory-perceptual information and is a natural part of
performing a skill. The second type of feedback is augmented feedback or information-based
extrinsic or artificial feedback. Augmented feedback refers to enhancing task intrinsic feedback
with an external source (Schmidt et al. 1999; Magill 2001), such as a therapist or device
(biofeedback or timer) (van Dijk et al. 2005). It has been suggested that augmented feedback
may have practical implications for rehabilitation therapy since re-acquisition of motor skills is an
important part of functional motor recovery (Winstein 1991; Kilduski and Rice 2003; Jarus 1994;
Jarus and Ratzon 2005).
The ability to use intrinsic feedback to guide performance is impaired in patients with cognitive
and perceptual impairments (Flinn and Radomski 2002). In persons who are compromised by
neurological sensory impairments, augmented feedback is important (Sabari 2001).
van Dijk et al. (2005) systematic review found three randomized clinical control trials which
studied augmentative feedback in the SCI population (Klose et al. 1993; Klose et al. 1990 and
Kohlmeyer et al.1996). In our literature search we were able to find an additional two other
studies with lower level of evidence that studied augmented feedback applications.
Table 5.2 Augmented Feedback on Motor Functions

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender m=40, f=5, age 1. Comparison of Groups (Increment or
mean=39yrs, injury level C4 –C6, complete Decrement or No Change): no
& incomplete injuries, relationship between treatment group
Treatment: Extremities were randomly and observed change; no treatment
assigned to 1 of 4 treatment groups: 1. produced a significantly higher
conventional strengthening; 2. electrical proportion of individuals that improved
stimulation; 3. biofeedback and electrical relative to the proportion showing no
stimulation; 4. biofeedback. Participation change or a decrement; no change
ranged from 5 to 6 weeks post SCI between treatment groups.
Kohlmeyer et al. 1996;
Outcome Measures: manual muscle test- 2. Influence of Initial Muscle Grade: a
USA
scoring and ADL performance correlation between the initial muscle
PEDro=10
grade and increment in muscle grade
RCT
was seen at the end of treatment;
poorer initial muscle grades, more
likely to see a larger increment in
muscle grade as a result of treatment.
3. Conclusion-biofeedback and electrical
stimulation both alone + together did
not prove to be more effective than
standard therapy for wrist extensor
recovery during the acute phase of
rehabilitation
Population: Age: 25-70; ASIA A-D 1. A great deal of variance between
incomplete; Time Since Injury: 15-243 participants in most measures due to
Popovic et al. 2005;
days; acute/subacute; tetraplegic low numbers of subjects, no significant
Canada
Treatment: The control group received differences was found between the
PEDro=6
conventional Occupational Therapy; Control and Intervention groups.
RCT
Intervention group received Functional
N=21
Electrical Therapy and conventional
Occupational Therapy
5-7
Score
Methods Outcome
Research Design
Total Sample Size
Outcome Measures: Functional
Independence Measure (FIM); Spinal Cord
Independence Measure (SCIM);
Rehabilitation Engineering Laboratory
Hand Function Test (REL Test); Consumer
Perceptions.
Population: Age 18 to 35 yrs, Gender 1. Scores after training indicated no
m=24, f=4, level of injury C5-C7, at least significant differences for the muscle
1yr post injury test score and functional activities
Treatment: Both groups received 45 mins score between groups.
Klose et al. 1993; USA
of aggressive exercise therapy 3/wk for 12 2. Analysis of the repeated measures
PEDro=5
weeks along with 30 min of neuromuscular factor showed a significant change
RCT
stimulation to assist with upper extremity (p<0.05) for the manual muscle test
muscle strength. EX group also received (F=25.17, df=2, 52) and functional
12 wks of 30 min EMG biofeedback 3/wk. activities score (F=8, 86, df=2, 52).
Outcome Measures: Manual muscle test,
functional activities score
Population: Age 18-45 yrs, level of injury 1. No statistically significant differences
C4-C6, incomplete injury, at least 1yr post were noted between the groups.
injury 2. Differences were noted for the
Treatment: All received 3days/wk of repeated measures of mobility, self-
therapy in 2 consecutive eight week care, and the left arm muscle test
treatment blocks. Treatment blocks were scores (p<0.05).
as follows; 3. The repeated measures factor was
Group 1: Biofeedback followed by statistically significant in all of the
Klose et al. 1990; USA
supervised physical therapy exercise (PET) analyses looking at measures of
PEDro=3
Group 2: Biofeedback followed by physical function (p<0.01) but not in
RCT
neuromuscular stimulation (NMS) those that compared EMG values.
Group 3: NMS followed by PET
Group 4: 16 weeks PET
Outcome Measures: Manual muscle test
assessed the biceps, triceps, wrist flexors
and wrist extensors. Self care measures
looking at feeding, hygiene and dressing.
Mobility measure and a muscle electrical
activity were also measured
Population: Gender m=81, f=19, injury 1. T-test analysis of the differences
level C2-C6, age 17-63yrs, time since before and after initial biofeedback
injury 1-29.7yrs. treatment an increase of 19.21% of
Treatment: EMG biofeedback treatment normal EMG scores for right triceps
sessions. and increase of 19.59% of normal
Outcome Measures: EMG scores. EMG scores from the left triceps from
one biofeedback treatment session,
significant (p<.001).
2. T-test analysis of the difference from
Brucker & Bulaeva 1996;
before initial biofeedback treatments to
USA
after additional treatments, increase in
percentage of normal EMG scores of
Pre-post
41.55% right triceps and 38.31% left
N=100
triceps, significant (p<.001). Increases
in percentage of normal EMG scores
after initial biofeedback treatment to
after additional biofeedback treatment
22.3% right triceps and 18.72% for left
triceps, significant (p<.001).
3. Correlation coefficient for manual
muscle test score and EMG pretest
before initial treatment was r=.569 for
5-8
Score
Methods Outcome
Research Design
Total Sample Size
right triceps and r=.437 for left triceps,
significant (p<.001).
4. Increases in percentage of normal
EMG before, after, and after additional
treatments was significant in right and
left triceps regardless of initial manual
muscle test.
Discussion
All of the studies concluded that there was no firm evidence of the effectiveness of the use of
augmented feedback to improve arm function in rehabilitation.
van Dijk et al. (2005) in their systematic review recommended the following be considered in
future research in this area:
• future studies need to focus on content, form and timing of the augmented feedback to
clarify its importance in rehabilitation
• studies should recognize the difference between performance and learning effects
concerning reacquisition of motor skills by re-examining the study population after a
follow up period
Conclusion
There is level 1 evidence (from 2 RCTs) that augmented feedback is not effective in
improving upper limb function in tetraplegia.
Augmented feedback does not improve motor function of the upper extremity
in SCI rehabilitation patients.
5.4 Pharmacological Interventions
Cervical injuries of the spinal cord frequently lead to hypertonia characterized by disabling
spasticity and dystonia involving the upper and lower limb. Spasticity has been defined by
Lance (1980) as “a velocity exaggerated increase in the tonic stretch reflexes (muscle tone)
resulting from hyperactivity of the stretch reflex.” The EU-SPASM Thematic Network or
Consortium (Support Network for the Assembly of Database for Spasticity Measurement) has
presented an updated definition of spasticity that reflects a recent research findings and current
clinical interpretations. Spasticity has been re-defined as “disordered sensori-motor control,
resulting from an upper motor neurone lesion, presenting as intermittent or sustained
involuntary activation of muscles” (Pandyan et al. 2005).
5-9
Table 5.3 Pharmacological Interventions
Score
Methods Outcome
Research Design
Total Sample Size
Population: age 25-64yrs, injury level C4- 1. Significant decline in UE hypertonia
C7, ASIA A-D, length of time since injury during 12 month follow up period.
1.2-24yrs. 2. Average baseline Ashworth score was
Treatment: Intrathecal baclofen. 2.4 ± 1.1 (SD) compared to 1.8 ± 1.0
Outcome Measures: Ashworth Scale; (SD) at 12 months (P<0.0001,
Spasm Frequency Scale; Reflex Scale Friedman).
3. The average spasm score decreased
from 2.3 ± 1.6 (SD) to 0.5 ± 0.9 (SD),
not significant at P=0.2503 (Friedman
test).
4. The difference was significant
Burns & Meythaler 2001;
(P=0.0012 Wilcoxon signed rank test).
USA
UE reflexes, average baseline reflex
score was 2.3 ± 0.2 (SD) compared to
Case Series
0.9± 0.2 (SD) at 12 months (P<0.0001
N=14
Friedman).
5. Dosage requirements increased during
the 12-month follow-up period,
statistically significant (P<0.0001,
Friedman).
6. Statistically significant declines in
upper extremity spasm scores (1.8
points, p=0.012), reflex scores (1.4
points, P<0.0001) and Ashworth
scores (0.6 points, P<0.0001) for the
1-year follow-up period.
Discussion
The management of severe cases of hypertonia can be challenging as it can be refractory to

oral medications. Many studies have shown that intrathecal delivery of balcofen has been
effective for refractory hypertonia in the lower extremity. Baclofen, 4-amino-3 (p-chlorophenyl)
butyric acid works by binding to the inhibitory presynaptic GABA-B receptors in the spinal cord
(Meythaler et al. 1999). Intrathecal delivery of the drug facilitates achievement of therapeutic
levels in the cerebral spinal fluid (CSF) while minimizing systemic side effects (drowsiness,
confusion). Burns and Meythaler (2001) is the only study published which deals with hypertonia
involving the upper extremity post-SCI. Further discussion regarding the management of
hypertonia can be found in the spasticity chapter.
Burns and Meythaler (2001) showed statistically significant decrease in Ashworth (tone) and
reflex scores in upper extremity hypertonia due to pathology at the level of the spinal cord.
Conclusion
There is level 4 evidence that intrathecal baclofen may be an effective treatment for
upper extremity hypertonia of spinal cord origin.
Intrathecal baclofen may be an effective intervention for upper extremity

hypertonia of spinal cord origin.
5-10
5.5 Restorative Strategies
5.5.1 Plasticity of Motor Systems
It has been reported that 55% of all spinal cord injured persons are classified as having
complete injuries. Through the use of magnetic resonance imaging (MRI) and histopathology
indicates that approximately 65% of the traumatic injuries initially classified as ‘neurologically
complete’ (absence of sensory and motor function in lowest sacral segment) show some tissue
and axonal sparing across the lesion (Bunge et al. 1997). It is now accepted that the CNS is
capable of substantial reorganization, especially in incomplete SCI because cortical, sub cortical
and much of the local spinal cord circuitry remains largely intact and still partially interconnected
by unlesioned fibres (Raineteau et al. 2001). Information may still pass through the level of the
lesion on spared fiber tracts but the information maybe fragmented or distorted (Beekhuizen et
al. 2005). Functional recovery can occur for several years after injury in incomplete spinal cord
injury, with the degree of recovery dependent upon the reorganization of circuits that have been
spared by the lesion (Green et al. 1999). Cortical reorganization occurs after SCI with evidence
that the sensorimotor cortex may play a role in the recovery of function in individuals with SCI
(Green et al. 1999). Results of neuroimaging and neurophysiological techniques (functional
magnetic resonance imaging (fMRI), transcranial magnetic stimulation (TMS) and positron
emission tomography (PET) demonstrate that changes occur in the cortex following damage to
the spinal cord with expansion of cortical areas corresponding to muscles spared after SCI into
the cortical areas previously associated with control of muscle reinnervated at spinal cord levels
below the level of the lesion (Raineteau et al. 2001; Bruehlmeier et al. 1998; Cohen et al. 1991;
Levy et al. 1990).
In ISCI, reorganization might occur at two levels; in pre-existing circuits by modifications of

synaptic strength (synaptic plasticity) or by new circuits through sprouting or anatomical
reorganization, including growth of axonal branches and dendrites (anatomical plasticity)
(Raineteau et al. 2001). Laboratory work is currently explaining and researching cortical
reorganization, cortical plasticity, sub cortical plasticity, plasticity at the red nucleus, plasticity
and spontaneous adaptation of the central pattern generators (CPG) and plasticity of unlesioned
descending pathways. The strengthening and weakening of synapses, axonal and dendritic
sprouting can occur at different levels of motor system in response to spinal cord lesions, in the
cortex, the brainstem, and the spinal descending pathways and in the intraspinal circuits. All
interact with each other; therefore it is difficult to interpret functional recovery processes. A
spinal cord injury interrupts distinct descending fibre populations. The overall complexity of an
incomplete spinal cord injury resides first in the organization of descending spinal tracts. Most
of the descending systems terminate on spinal interneurons, but some direct excitatory or
inhibitory connections to motor neurons also exist. Different tracts are involved in specific
functions. For example, lesions of the cortical and rubrospinal systems lead to more severe and
longer lasting deficits for movement of the distal extremities and lesions of the reticulo and
vestibulospinal systems affect movements of proximal and axial muscles. Functional outcomes
of given spinal cord lesions therefore depends on type of fibres that are interrupted (Raineteau
et al. 2001).
Functional reorganization is based on two mechanisms; synaptic plasticity in pre-existing

circuits and sprouting and anatomical reorganization that leads to the formation of new circuits.
The study of animal models provides further understanding of rehabilitation treatments and
development of new therapeutic approaches for people with spinal cord injury (Raineteau et al.
2001).
5-11
Two studies were found that tested the use of massed practice, a form of constraint therapy,
and repetitive transcranial magnetic stimulation (rTMS) in changing the cortex.
Table 4: Restorative Strategies

Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: range 22-63 yrs; 1. Pinch grip scores: differences were
Gender: m=9, f=1; ASIA score: C N=4, D noted in the MP+SS group (Z=-2.023,
N=6; Level of injury: C5-C7: time since p<0.05) only.
injury: 12 to 154 mths 2. The MP+SS group also showed
Treatment: Subjects participated in 2h of greater increase in pinch grip strength
massed practice (MP) therapy 5/wk for 3 than the MP group (U=2.0, p<0.05).
wks or MP+median nerve somatosensory 3. Upper extremity Functional tests: the
stimulation (SS). Massed practice training Pre/post Wolf Motor Function Test
focused on continuous repetitions of the timed scores in the MP+SS group
following: gross upper extremity showed a difference (Z=-2.023,
Beekhuizen and Field-
movement, grip, and grip with rotation, p<0.05). No statistical differences were
Fote 2005; USA
pinch and pinch with rotation. Tasks in noted for the MP group.
PEDro=8
each block were performed for 25 min 4. Timed test scores between the 2
RCT
before moving to the next category. groups were also found to be
N=10
Outcome Measures: Maximal pinch grip statistically different (U=1.0, p<0.05).
force, Wolf motor function test timed task 5. Jebsen test scores: pre and posttest
scores, Jebson hand function test scores, scores were different for the MP+SS
stimulus intensity required to elicit motor group (Z=-2.023, p<0.05). The
threshold response in muscles, and motor MP+SS group showed greater
evoked potentials amplitude. improvement than the MP group
(U=3.0, p<0.05).
6. Cortical Excitability: No significant
differences were noted between the 2
groups.
Population: gender m=3, f=1, age 41- 1. No difference between patients when
54yrs, time since injury 1.25-8yrs, lesion looking at the assessments done after
level C5, ASIA-D baseline and after sham intervention.
Treatment: 5 days of sham repetitive 2. The level of intracortical inhibition was
transcranial magnetic stimulation (rTMS) reduced to 37.5 ± 8.0% of
followed by 5 days of therapeutic pretreatment levels during the week of
Belci et al. 2004; UK stimulation (rTMS) therapeutic treatment (p<0.05) and
Downs & Black score=13 Outcome Measures: electrophysiological, returned to 90.2 ± 15% of pretreatment
Prospective Controlled clinical - sensory + motor function (ASIA) & levels during the follow-up period.
Trail Functional - 9 Hole Peg Board 3. This was linked to improvements in
N=4 clinical measures of both motor and
pinprick of 4-10% during treatment
week. (p<0.05).
4. Subjects also improved perceptual
threshold to electrical stimulation of
the skin and peg board test scores
(p<0.05)
Discussion
Beekhuisen et al. (2005) suggested that massed practice or constraint-induced therapy

promotes cortical reorganization that may be an effective rehabilitative tool for improving
strength and function in individuals with cervical spinal cord injury. Improvement may be further
enhanced by the addition of somatosensory stimulation.
Belci et al. 2004 observed clinical changes consistent with the concept that reduced
corticospinal inhibition can facilitate functional recovery. Recovery involved increased ASIA
5-12
sensory and motor scores, improved response to cutaneous electrical stimulation over the
thenar muscles and possibly improved hand/finger function. This preliminary study
demonstrated rTMS treatment in patients with chronic stable incomplete spinal cord injury can
produce reductions in corticospinal inhibition detectable using electrophysiological techniques.
Additional research studies with appropriate controls are needed to confirm the overall
effectiveness of the intervention.
There is lack of studies evaluating the efficacy of restorative strategies. In order for these
therapies to be successful in everyday clinical practice, the therapy interventions need to be
associated with meaningful changes in functional motor performance and incorporate
techniques that are available in the clinic and at home (Beekhuizen et al. 2005).
Conclusion
There is level 1 evidence from one RCT that showed that massed practice (repetitive
activity) and somatosensory stimulation (median nerve stimulation) demonstrated
significant improvement in grip and pinch strength required for functional activity use.
There is level 2 evidence from a before/after study that showed that rTMs treatment in
individuals with chronic stable ISCI may produce reductions in corticospinal inhibition
that resulted in clinical and functional changes for several weeks after treatment.
Afferent inputs in the form of sensory stimulation associated with repetitive movement and
peripheral nerve stimulation may induce beneficial cortical neuroplasticity.
Restorative therapy interventions need to be associated with meaningful change in functional
motor performance and incorporate technology that is available in the clinic and at home.
5.5.2 Complimentary Alternative Therapies (CAM)
Acupuncture is an ancient Chinese therapy practiced for more than 2500 years to cure disease
and relieve pain (Lee et al. 1990). There are 361 identified acupoints that have been formed
into a network of 14 channels called the meridians. Acupuncture therapy has been shown to be
effective in improving functional outcomes in hemiplegic stroke patients and in paraplegic spinal
cord injured patients (Cheng et al. 1998). In electrical acupuncture therapy, electrical
stimulation is provided directly to the acupoint areas. It has been speculated that acupuncture
therapy through the correct acupoints and meridians in the acute spinal cord injury episode will
assist in the minimization of posttraumatic cord shrinkage and sparing of the ventral horn
neurons (Politis et al. 1990; Ran et al. 1992; Tsay 1974; Wu 1990).
Table 5.5 Complimentary Alternative Therapies (CAM)

Score Methods
Outcome
Research Design
Total Sample Size
Population: Age mean=35, gender m=80, 1. Acupuncture group - sensory, motor +
Wong et al. 2003; Taiwan f=20, ASIA A-B, tetraplegia FIM scores improved significantly day
PEDro=5 (37)/quadriplegia (63). Time since injury: of D/C + 1yr after injury (p<0.05).
RCT acute, admission to ER after injury Control group - only motor score
N=100 Treatment: Acupuncture was administered significant improvement at 1yr post
to the treatment group via 4 x 5 cm injury F/U p=0.023
5-13
Score Methods
Outcome
Research Design
Total Sample Size
adhesive surface electrodes at the 2. Comparison of ASIA + FIM scores of
acupoints of bilateral Hou Has (S13) and both groups not at admission; D/C +
Shen Mo (B62). Frequency was set at 75 1yr post significant improvement ASIA
hz with a pulse duration of 200 usec and + FIM in acupuncture vs. control
the magnitude of stimulation was set at 10 p<0.05
mV 3. More patients in acupuncture group
Outcome Measures: ASIA (sensory + improved to ASIA grade B + C or
motor), FIM, before + after therapy better at D/C + 1yr post p<0.05
Discussion
With acupuncture thin metal needles are inserted into specific body sites and slowly twisted
manually or stimulated electrically. The uncomfortable pain sensation or de qi, a prerequisite for
effective acupuncture therapy, is induced by needle manipulation (Wong et al. 2003).
The randomized control trial by Wong et al. (2003), studied the use of electrical acupuncture
therapy through adhesive surface electrodes and concomitant auricular acupuncture therapy in
improving the neurologic or functional recovery in acute traumatic spinal cord injury patients.
The study demonstrated that in the acupuncture group all sensory, motor and FIM scores
improved significantly when examined on the day of discharge from hospital and one year after
injury (p<0.05). The control group (auricular acupuncture) demonstrated only significant
improvement in motor score at one-year post injury follow up (p=0.023). At discharge and at
one year post injury follow up, the acupuncture group revealed significant improvement in all
ASIA and FIM scores when compared to the control group (p<0.05). An inherent bias may have
been introduced into this study as the reviewer who assessed the participants was not blinded
to the group assignment.
Conclusion
There is level 2 evidence from one RCT that showed that the use of concomitant
auricular and electrical acupuncture therapy may improve the neurological and
functional recovery of acutely injured spinal cord individuals.
The use of concomitant auricular and electrical acupuncture therapies when implemented early
in acute spinal cord injured persons may contribute to neurologic and functional recoveries in
spinal cord injured individuals with ASIA A and B.
5.5.3 Splinting of the Hand
Splinting of the hand in the management of tetraplegia is a well-accepted therapy intervention

and has been an accepted practice for many years in the management of SCI especially in the
acute phase of injury (Curtin1994; Krajnik and Bridle1992). The therapeutic goals of splinting
are immobilization, protection and support of the joints of the wrist and hand, prevention of joint
malalignment, prevention and reduction of soft tissue shortening and contractures, prevention of
soft tissue overstretch, counteracting hypertrophic scars, support of weak muscles,
improvement of function and pain relief (Paternostro-Sluga and Stieger 2004; Curtin1994;
Krajnik and Bridle 1992). There are four most common static hand splints for tetraplegic
5-14
patients; resting pan or paddle splints, wrist extension splints (Futuro-type splint, long opponens
splint and dorsal cock-up splint and spiral splint), short hand splints and tenodesis splints (Curtin
1994).
Table 5.6 Splinting of the Hand

Score
Methods Outcome
Level
Total Sample Size
Population: Age 18 to 42 yrs, gender 1. No significant differences were noted
m=12, f=1, time since injury 6–8wks between the 2 groups-all subjects
Treatment: EX gr. was given long or short demonstrated improvement in hand
orthosis to be worn at night (8hrs) as soon function and pinch strength.
as the subject could tolerate it. 2. At 8 weeks the 13 subjects showed
Outcome Measure: pinch strength and improvement in their performance on
functional activity use the checkers subtest (F=10.32, df=1,
DiPasquale-Lehnerz 11, p<0.01), simulated feeding subtest
1994; USA (F=7.58, df=1, 11, p<0.01), and the
Pedro=4 large light object subtest (F=5.49,
RCT df=1, 11, p<0.01).
Initial N=13; Final N=9 3. At the 12-week marker, improvement
could be seen on the card subtest
(F=3.94, df=2, 14, p<0.05).
4. An increase in pinch strength was
noted at 8 weeks for all subjects
(F=4.41, df=1,11, p<0.05) and at 12
weeks 9 remaining subjects (F=4.46,
df=2,14, p<0.05)
Discussion
Even though splinting and orthotic fabrication is an accepted practice, there is minimal research
data on the effectiveness of this intervention (DiPasquale-Lehnerz 1994; Krajnik and Bridle
1992), although there are numerous anecdotal descriptions of orthotic devices and rationales for
orthotic intervention (DiPasquale-Lehnerz 1994). Curtin (1994) and Krajnik and Bridle (1992)
also found formal assessments were often not done due to; a lack of time and staff shortages;
inconsistent documentation; absence of standardized tests available for spinal cord injured
patients; limited funding to purchase equipment; and/or patient declined to participate in formal
assessments due to boredom and frustration. Krajnik and Bridle (1992) noted that therapists
considered observation of the patient when involved in a functional activity as the most
informative assessment although this was not an objective means of documenting a patient’s
status and progress. There appears to be a variety of splints made for similar purposes
because there is little research as to what splint is best for the level and stage of SCI (Krajnik
and Bridle 1992).
In Paternostro-Sluga and Stieger’s (2004) review, the therapeutic aims of splinting and the
choice of splint depend on the disease and the individual functional problem resulting from the
impairment. These authors also concluded that there is insufficient evidence from clinical trials
on splinting strategies in CP or spinal cord injury patients. The studies also referred to research
looking at hand splints for clients with an acquired brain injury or stroke (Rose and Shah 1987;
McPherson et al. 1982).
In the only study which met criteria for our review, by DiPasquale-Lehnerz (1994) noted that
there was no significant improvement in hand function as it related to passive range of motion,
strength of prehension or coordination in subjects with C6 tetraplegia who wore a thumb
5-15
opponens orthoses during sleep as compared to those subjects with C6 tetraplegia who did not
wear such an orthosis. The study did show over time a significant improvement of hand
function especially pinch strength, and functional use (turning cards, picking up small objects,
simulated feeding and holding onto light cans) for those wearing the splint.
There are several published surveys that addressed the use of splints in the spinal cord
population with the majority of splints being functional use splints (i.e., feeding splint, writing
splint, typing splint or an application for an assistive device) (Krajnik and Bridle 1992; Garber
and Gregoria 1990). More research is needed in this area.
Conclusion
There is level 2 evidence based on one RCT that wearing a thumb opponens splint will
improve pinch strength and functional use of the hand.
There is clinical and intuitive support for the use of splinting for the prevention of joint problems
and promotion of function for the tetraplegic hand. However, there is very little research
evidence to validate its overall effectiveness.
5.6 Sub Acute Phase of Rehabilitation
5.6.1 Upper Limb Injuries
A spinal cord injured individual is forced to rely on their upper extremities for their weight
bearing activities such as transfers, mobility needs and activities of daily living (ADLs) using
limbs that were designed to place hands in space (Dalyan et al. 1999; Dyson-Hudson et al.
2004; Consortium of Spinal Cord Medicine, 2005). Repeated use of the upper limb for weight
bearing activities such as manual wheelchair propulsion, transfers, raised ischial pressure
reliefs (weight shifts) and reaching from a seated position in the wheelchair in environments
designed for nondisabled individuals places a great deal of stress on the bones, joints and soft
tissues of the shoulder complex. This places the structures of the upper limb at significant risk
for overuse and subsequent injury (Dyson-Hudson et al. 2004). Pain in the early post injury
period is typically due to increased demands on anatomically weakened muscles or muscle
weakness induced because of deconditioning.
Upper limb pain is known to interfere with a wide range of functional activities, transfers,
ambulation, pressure relief, self-care (Curtis et al. 1995, Dalyan et al. 1999); many individuals
report alternation/cessation of activities critical to functional independence (Pentland and
Twomey 1994; Sie et al. 1992). Shoulder pain may be functionally and economically equivalent
to a higher level of lesion (Salisbury et al. 2003). Dalyan et al. (1999) reported that of
individuals with upper limb pain, 26% needed additional help with functional activities and 28%
reported limitations of independence. Subbarao et al. (1994) and Gerhart et al. (1993) reported
that individuals with SCI reported that their dependence in personal care assistants fluctuated
with upper limb pain and was a major reason for functional decline. The Consortium of Spinal
Cord Medicine (2005) has written clinical practice guidelines “Preservation of Upper Limb
Function Following Spinal Cord Injury: A Clinical Practice Guideline for Health Care
Professionals,” as a way to address upper limb problems.
5-16
5.6.1.1 Shoulder Injuries
Upper limb pain and injury are highly prevalent in people with SCI and consequences are
significant. The Consortium of Spinal Cord Medicine (2005) and Dyson-Hudson and Kirshblum
(2004) reported through surveys and cross-sectional studies that shoulder pain in chronic spinal
cord injured persons are common in both paraplegia and tetraplegia at a prevalence of 30-73%.
In the acute phase after SCI, shoulder pain is reported in approximately 75% of patients
(Silfverskiold and Waters 1991; Waring and Maynard 1991), and 33% to 63% of patients in the
chronic phase (>6 months) experience shoulder pain (Nepomuceno et al. 1979; Sie et al. 1992;
Silfverskiold and Waters 1991). Curtis et al. (1995), Nichols et al. (1979) and Pentland and
Twomey (1991) reported in cross sectional studies that 60-100% of long-term wheelchair users
experience shoulder pain. Subbardo et al. (1994) and Sie et al. (1992) reported that there is a
high prevalence of shoulder pain during the first year after injury, and in individuals 15-20 years
post injury. Pain experienced above the injury level during the first 3-6 months after injury is
different than the pain experienced 1 year or more after injury (Apple 2001). Pain above the
level of injury in chronically injured person assumes the character of overuse syndromes (Apple
2001). Injury involving the shoulder, elbow, wrist and hand are seen at an earlier age in spinal
cord injured individuals than in the general population because of the stresses of weight bearing
and mobility that are added to the normal use of the upper limb (Pentland and Twomney 1996).
Individuals who are older at the time of injury may experience functional changes earlier than
people who are injured at a younger age (Thompson 1999).
It is also very difficult to determine whether shoulder pain is a function of duration of SCI or
simply a part of the normal aging process (Neer and Walsh 1977). The wide variability in these
numbers is most likely a reflection of the heterogeneity of participant populations between the
studies with respect to duration of injury, age, neurologic level and severity of injury, as well as
body mass index. Small sample size, selection bias and variations in participant populations
across the different studies with respect to duration of injury, age, gender and neurological level
and severity of injury make it difficult to assess the true prevalence of shoulder pain in
individuals with shoulder pain (Pentland and Twomey 1991). The incidence of shoulder pain in
acute tetraplegia (<6 months post injury) has been reported to range from 51% to 78%
(Salisbury et al. 2003).
Nichols et al. (1979) was one of the first groups to report an association between chronic SCI
and shoulder pain coining the term “wheelchair user’s shoulder. “ Due to the prevalence of
shoulder pain, Curtis et al. (1995) developed a Wheelchair Users’ Shoulder Pain Index (WUSPI)
that measures the severity of pain for 14 functional activities.
The following are the many identified risk factors for the development of injury and pain in the upper limb.
• The shoulder is the most common joint above the level of injury where pain complaints are reported with
persons with paralysis (tetraplegia or paraplegia) (Apple 2001).
• The shoulder is not well designed to handle the higher intra-articular pressures required for both weight
bearing and mobility (Apple 2001).
• Partial innervation and impaired balance of shoulder, scapular and thoracolumbar muscles place individuals
with tetraplegia at a higher risk for developing shoulder pain especially during weight-bearing upper limb
activities such as wheelchair propulsion, transfers, and pressure reliefs.
• Due to differences in trunk postural control, differences may also occur between individuals with high
paraplegia (T2-T7) and low paraplegia (T8-T12).
• Individuals with C1-C4 motor levels of injury are also at risk for shoulder pain
• SCI severity also may be associated with shoulder pain (Dyson-Hudson and Kirshblum 2004).
5-17
• Lack of use of immobilization of the shoulder girdle muscles can limit their active joint movement and lead to
muscle shortening and shoulder capsule tightness.
• The development of pain is associated with decreased shoulder ROM
• Weakness and paralysis in these muscles can lead to increased reliance on the trapezius, which can result
in overuse and pain in this muscle.
• Shoulder pain can occur from nerve root injury or radicular pain with dysesthesias or phantom sensations
• People of certain age groups, those with higher cervical lesions and those with shorter lengths of bed rest
may be at a greater risk
• Gender may be associated with shoulder pain in individuals with SCI (Pentland and Twomey 1991).
• Body mass index (BMI) also may play a role in shoulder injuries in manual wheelchair using individuals with
SCI because it directly relates to the amount of physical strain experienced during ADLs in these individuals
(Boninger et al. 2001; Jensen et al. 1996).
• Shoulder pain is more common in individuals with tetraplegia and complete injuries and in women and
duration of injury, older age, and higher BMI all may be risk factors for developing shoulder pain and/or
abnormalities in persons with SCI (Dyson-Hudson and Kirshblum 2004).
5.6.1.2 Elbow/Wrist and Hand Injuries
The prevalence of elbow pain and injury has been reported to be between 5-16% (Consortium
of Spinal Cord Medicine, 2005); Sie et al. (1992) found 15% and 16% rates of pain localized in
the elbow region in persons with tetraplegia and paraplegia. Dalyan et al. (1999) in their study
found 35% complained of elbow pain.
The prevalence of carpal tunnel syndrome is reported to be between 40-66% (Consortium of

Spinal Cord Medicine 2005). There are four studies done by Aljure et al. 1985; Gellman et al.
1988; Schroer et al. 1996, and Sie et al. 1992 that found an association between length of time
since injury and prevalence of carpal tunnel syndrome. Some studies also found median nerve
damage without clinical symptoms.
The most significant activities causing pain in the wrist and hand were propelling a wheelchair
and doing transfers (Subbarao et al. 1994).
Table 5.7 Shoulder Treatment Interventions

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=18, f=6, age: 28- 1. There was a significant effect of time
69yrs, time since injury: 5-33 yrs, SCI; for both treatments on performance
length of shoulder pain: 4mths-22yrs. corrected (PC)-WUSPI (Acupuncture
Treatment: Subjects received either p<0.001 and Trager p=0.001).
acupuncture treatments (sessions lasted 2. Overall a reduction of the PC-WUSPI
20 to 30 min) or Trager Psychophysical could be seen when looking at the
Dyson-Hudson et al.
Integration - sessions lasted approx 45 data from the beginning of treatment to
2001; USA
min. Consisted for both table work and the end for both groups (p<0.05)
PEDro=7
mentastic exercises. 3. There was a significant effect of time
RCT
Outcome Measures: Intake questionnaire for both acupuncture and Trager
N=21
(demographics and medical history), groups for average pain & most severe
Weekly log, Wheelchair users shoulder pain (p<0.01, p<0.001 respectively),
pain index (WUSPI), Numeric rating scale, for the least severe pain the
Verbal rating scale (VRS), Range of Motion acupuncture group showed a
(ROM). significant reduction (p<0.01)
compared to the Trager group.
5-18
Score
Methods Outcome
Research Design
Total Sample Size
4. Verbal response scores- there was a
statistically significant treatment effect
for both groups (p=0.001).
Population: age19-65 yrs; TSCI (C4-L1); 1. EX group reported less pain, stress
ASIA A-D; 1-24 yrs duration and depression after training + scored
Treatment: Experimental group higher than CON in indices of
participated in a progressive exercise satisfaction with physical function,
Hicks et al. 2003;
training twice weekly for 9 months-each level of perceived health + overall
Canada
session offered on alternative days lasing quality of life (p<0.05).
PEDro=6
90-120 minutes. 2. Following training, EX gr. had
RCT
Outcome Measures: Perceived stress significant increases in sub maximal
scale, muscle strength, depression, arm ergometry power output (81%;
physical self-concept pain, perceived p<0.05) and significant increases in
health and Q of L were assessed upper body muscle strength (19-34%;
p<0.05)
Population: Gender: m=35, f=7, age: 1. There were no significant differences
mean=35yrs, duration of wheelchair use: between control and experimental
mean=24yrs, Injury level: cervical to group in age, years of wheelchair use
lumbar, mixed etiology or activity levels.
Treatment: Both groups completed the 2. When looking at the effect of exercise
Wheelchair Users Shoulder Pain Index of intervention on performance
Curtis et al. 1999; USA
(WUSPI) q2mos x 6mos. The experimental corrected (PC) WUSPI, a 2 factor
PEDro=5
group attended a 60min educational repeated measures ANOVA showed a
RCT
session where they were instructed in 5 significant effect of time only
N=42
shoulder exercises. (p=0.048).
Outcome Measures: Self report
questionnaire (demographic and medical
info), Wheelchair User's Shoulder Pain
Index (WUSPI), and a visual analog scale
(VAS) used to rate intensity of pain.
Discussion
Management of established upper limb pain is very difficult and thus prevention is critical.
Evidence-based best practice standards have not been established for the medical,
rehabilitative or surgical treatment of upper limb injuries in people with spinal cord injury. In
addition, there is little consensus among health-care providers on the best treatment practices
for upper limb injuries in the general population. In general, musculoskeletal upper limb injuries
in the SCI population are managed in a similar fashion as the unimpaired population.
Outcome studies of surgical treatment in SCI also very limited. Two small studies report the
outcome of rotator cuff repair – one showing relatively poor results (Goldstein et al. 1997) and
another study showing relatively good outcomes (Robinson et al. 1993). Both studies
recommend non-surgical approaches prior to surgical intervention. One randomized control trial
found that supervised exercise produced results similar to arthroscopic surgery for patients with
impingement syndrome (Brox et al. 1993), however; this study was not on SCI patients.
Exercise has been shown to reduce pain in a randomized control trial in which subtypes of pain
were not reported (Hicks et al. 2003). Two studies found an association between restricted
ROM and pain, reduced activity and/or injury (Ballinger et al. 2000; Waring and Maynard 1991).
A study incorporating stretching into an exercise program for individuals who use manual
wheelchairs found stretching exercises were associated with decreased reported pain intensity
(Curtis et al. 1999).
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One study demonstrated that acupuncture was no more effective than Trager Treatment in the
treatment of shoulder pain (Dyson-Hudson et al. 2001). There are several studies that address
the use of complimentary or alternative medicine (CAM) with the spinal cord population, which is
used at similar rates to the general population. It was reported that the most common reason
CAM was used, was for dissatisfaction with conventional medicine for treatment of chronic pain
(Nayak et al. 2001). The only CAM technique evaluated in the SCI population is acupuncture
although studies do not provide conclusive evidence of effectiveness (Nayak et al. 2001; Dyson-
Hudson et al. 2001; Rapson et al. 2003).
Psychological interventions among non-SCI individuals with chronic pain are popular and it has
been suggested that selected approaches may be useful for those with SCI (Consortium of
Spinal Cord Medicine 2005). Cognitive-behavioural strategies have been found to produce
changes in pain experience, increase positive cognitive coping and appraisal skills and reduce
pain behaviours (Morley et al. 1999). There are mixed results for the use of relaxation training
for relief of chronic pain (Carroll and Seers1998), which may also have secondary beneficial
effects on muscle tension and emotional distress (Astin et al. 2002; Luebbert et al. 2001).
Cognitive-behavioral interventions have not been subjected to controlled trials as to their
effectiveness in the SCI population (Wegener et al. 2001).
As identified in the Consortium of Spinal Cord Medicine (2005) document, modification of task
performance based on ergonomic analysis has been proven to reduce the incidence of upper
limb pain and cumulative trauma disorders of the upper limb in various work settings (Carson
1994; Hoyt 1984; Chatterjee 1992; McKenzie et al. 1985). It is suggested that these same
interventions can be used to prevent pain and injury in SCI. Although the number of studies
linking activities of individual with SCI to injury may be small, the ergonomics literature provides
a strong basis for evidence-based practice.
The Consortium of Spinal Cord Medicine (2005) Clinical Practice Guideline Preservation of Upper Limb
Function published the following recommendations regarding the upper limb;
• Both the spinal cord injured person and the clinician need to be educated about the prevalence of
upper limb pain and injury and the potential impact of pain and possible means of prevention
• Routinely assess the patient’s function, ergonomics, equipment and level of pain as part of periodic
health review
• Assessment of risk factors, changes in medical status, new medical problems, changes in weight
• Reduce the number of non level transfers per day
• Assess work related activities
• Re-evaluate current exercise program (strengthening, stretching, conditioning)
Dyson-Hudson et al. (2001) in a randomized controlled trial compared acupuncture treatment

to Trager Psychosocial Integration performed by a certified Trager practitioner. The authors
noted that trager therapy is a form of bodywork and movement re-education to induce relaxation
and encourage the patient to identify and correct painful patterns. The theory is that chronically
contracted muscles reduced by stress led to pain (Dyson-Hudson et al. 2001). There was a
significant effect over time for both treatment groups in reducing shoulder pain, but there was no
difference between the two groups.
Curtis et al. (1999) in a randomized control trial and Hicks et al. (2003) studied the
effectiveness of a six-month exercise and stretching protocol on shoulder pain experienced by
wheelchair users. The data supported the effectiveness of this exercise and stretching protocol
5-20
in decreasing the intensity of shoulder pain that was interfering with functional activity of
wheelchair users.
Further Research
The Consortium of Spinal Cord Medicine (2005), Sipski and Richards (2006), Campbell and
Koris (1996), Dalyan et al. (1999), and Nichols et al. (1979), have identified the following as
important areas of further research in the upper limb:
• Research to validate and support the adoption of a standardized classification scheme with accompanying
diagnostic procedures and criteria.
• Research trials could include both primary prevention and treatment of acute and chronic pain.
• Determine the best methods to treat existing painful shoulder lesions and prevent others so that these
individuals are as pain free and independent as possible.
• Further study is needed to elucidate the mechanisms of pain in this group and to establish why some patients
who have pain early in rehabilitation continue to have pain at discharge and others do not.
• Multicentre RCT of intervention are also needed to reduce the severity and impact of different subtypes of SCI
pain.
• Possible links between pain during rehabilitation and pain in long-term SCI.
• Detailed investigation of the biomechanics of activities commonly performed by people with tetraplegia to
enhance understanding of the stresses placed on the shoulder and the mechanical causes of shoulder pain.
• Causes of shoulder pain in the acutely injured individual compared to the chronic spinal cord injured person.
• Implementation of upper limb pain prevention and management programs for persons with SCI- acute and
ongoing patient education about basic biomechanical principles on avoiding impingement and overuse
• Managing the early signs of strain and overuse and knowledge of several alternative techniques of ADL.
• Education and training in endurance and balanced strengthening of muscles acting around the shoulder and
optimizing posture to achieve a normal alignment of shoulder, head, and the spine are critical for avoidance of
injuries.
• Ergonomically designed environmental changes and wheelchair, home and work modifications
• Further clinical and biomechanical research to improve the preventative measures and treatment methods of
upper limb pain in SCI persons in order for them to maintain optimal functional status.
Conclusions
There is level 1 evidence based on two RCTs that a shoulder exercise and stretching
protocol reduces the intensity of shoulder pain post SCI.
There is level 2 evidence that general acupuncture is no more effective than Trager
therapy in reducing post-SCI upper limb pain.
Shoulder exercise and stretching protocol reduces post SCI shoulder pain intensity.
Acupuncture and Trager therapy may reduce post-SCI upper limb pain.
Prevention of upper limb injury and subsequent pain is critical.
5-21
5.7 Reconstructive Surgery
5.7.1 Hand
The loss of upper limb function especially the use of the hand is one of the most significant and
devastating losses an individual can experience. Tetraplegia is responsible for many problems
in daily living, mostly related to the recovery and/or preservation of independence for the
tetraplegic individual (Welraeds et al. 2003). In the study by Hanson and Franklin (1976)
showed recovery of hand function was preferred to that of the bladder, bowel or even sexual
function among tetraplegics. In a survey of tetraplegic patients, 75% responded that hand
function was very important for their independence in activities of daily living (ADL) and to
increase their quality of life (Snoek et al. 2004).
Reconstructive surgery is one option to attempt to improve the function of the hand and upper
limb in persons with tetraplegia. Functionally, the benefit of reconstructive surgery may be
evident as improved ability to write, complete catheterizations, dress, self-feed, drive, lift
objects, button, turn dials, propel their wheelchair, catch objects overhead, turn in bed and swim
are only some of the activities that become possible after surgery (Rabischong et al. 1993).
Surgery has been reported to improve quality of life for those people who had little or no upper
limb function (Freehafer et al. 1984). As aptly stated by Sterling Bunnell, one of the preeminent
surgeons when describing improvements of hand and upper limb function as a result of surgery,
“When you have nothing, a little is a lot.”
Despite the many reported studies, over 40 documented studies, hand reconstructive surgery is
not common practice in many spinal units and its importance in improving hand function still
remains controversial (Forner-Cordero et al. 2003). Guttmann (1976), McSweeney (1969) and
Bedbrook (1969) believed that only a small percentage of tetraplegics (5%) benefit from hand
surgery because they re-adjust the function of their arm and hands if properly rehabilitated,
while other authors like Moberg (1975) state that 75% of tetraplegics can obtain benefit from
hand surgery.
Reconstructive surgery and tendon transfers are generally performed following an identifiable
pattern based on the level of injury and results depend on the patient’s residual motor and
sensory function as identified in each group (Freehafer et al. 1984). In 1978, the International
Classification for Surgery of the Hand in Tetraplegia was developed at the International
Conference held in Edinburgh and modified in 1984. The classification takes into account the
residual motor strength below the elbow, considering that only the muscles graded 4 or 5
according to the Medical Research Council Scale (MRCS) are adequate for muscle transfer, as
well as the sensibility in thumb and index. The sensibility was evaluated by the two-point
discrimination test in the thumb and the index. If it is lower than 10mm the classification
belongs to the group Cutaneous (Cu-) and if it is higher than 10mm and the patient needs visual
help it is classified in the group Ocular (O-).
Table 8: Modified International Classification for Surgery of the Hand in Tetraplegia

Sensory
Motor O- Cu- Total
0 Weak or absent Brachioradialis (BR) ≤ grade 3 - - -
1 BR (≥ grade 4) 2 1 3
2 BR, ECRL - 1 1
3 BR, ECRL, ECRB 1 1 2
4 BR, ECRL, ECRB, PT 3 4 7
5 BR, ECRL, ECRB, PT, FCR - 4 4
5-22
Sensory
Motor O- Cu- Total
6 BR, ECRL, ECRB, PT, FCR, Finger Extensors - - -
7 BR, ECRL, ECRB, PT, FCR, Finger Extensors, Thumb Extensors - 1 1
BR, ECRL, ECRB, PT, FCR, Finger Extensors, Thumb Extensors,
8 1 - 1
Finger Flexors
9 Lacks intrinsics only - 1 1
Total 7 13 20
O-: Two-point discrimination in the thumb > 10mm.
Cu-: Two-point discrimination in the thumb < 10mm.
ECRL: Extensor Carpi Radialis Longus
ECRB: Extensor Carpi Radialis Brevis
PT: Pronator Teres
FCR: Flexor Carpi Radialis
The listing of a muscle means that it is functional (grade 4 or better).
(McDowell CL, Moberg EA, House JH. The Second International Conference on Surgical Rehabilitation of the Upper
Limb in Traumatic Quadriplegia. J Hand Surg 1986; 11A: 604-608.)
Candidates for reconstructive surgery are carefully selected and are followed by a rehabilitation
team that includes an orthopedic surgeon, rehabilitation physiatrist, and therapist over a
significant period of time. The identified criteria for selection are as follows:
• At least one year post injury

• Completed a comprehensive rehabilitation program
• Neurologically stable
• Psychologically adjusted to their injury
The measure of outcomes following reconstructive surgery continues to be debated in the

literature. Many of the reported studies on surgical outcomes are older, are case series
evaluations and lack the rigor of randomized control trials, and have subjective outcomes based
on reported client satisfaction. In addition, there is little consensus in the literature on the
assessment instruments and tools to be used in this population as their reliability, validity and
responsiveness have not been adequately proven. The methodology appears to be a major
failing of the various scales and the absence of clear conceptual models forming the basis of
their scales. Also, the scales or instruments have been deemed to be too insensitive to
document the small but meaningful functional gains made by tetraplegics after functional
surgery (Fattal 2004). Many authors state that comparing the post surgical condition is the best
way to evaluate results (Freehafer et al. 1984). There have been several articles published that
discuss the use of the ICF conceptual framework as a way to interpret hand function outcomes
following tendon transfer surgery for tetraplegia (Sinnott et al. 2004; Bryden et al. 2005).
The reconstructions of upper limb to obtain functions of pinch and grasp often require multiple
procedure and are also individualized to each person. The reconstructions performed are also
dependent on what motor muscles/tendons are present and strong enough for transfer. The
most commonly performed surgeries for reconstructive pinch are:
Key-Pinch Grip: Brachioradialis (BR) to Extensor Carpi Radialis Longus (ECRL), Flexor
Pollicis Longus (FPL) split tenodesis. The IP joint of the thumb may need to be stabilized to
prevent excessive IP flexion.
Key-Pinch Grip with or without Hook Grip: Brachioradialis (BR) to Flexor Pollicis Longus
(FPL) with or without Flexor Digitorum Profundus (FDP) tenodesis or Brachioradialis (BR) to
Extensor Carpi Radialis Longus (ECRL).
5-23
Key-Pinch Grip and Hook Grip: Brachioradialis (BR) or Pronator Teres (PT) to Flexor Pollicis
Longus (FPL) and BR or Extensor Carpi Radialis Longus (ECRL) to Flexor Digitorum Profundus
(FDP).
Additional procedures to increase thumb pinch and thumb opposition may also be completed.
Table 9: Reconstructive Surgery: Pinch Studies

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=13 , f=2; Age: 1. Release of the BR and suture to the
range 20-47 yrs; Injury to operation: range FPL. In 16/17 hands , fixation of the
8 months-18 yrs; Operation to follow-up: IP joint of the thumb was obtained with
range 8-48 months; a Moberg screw. 11/17 patients
Treatment: Surgery lacked active thumb extension had
Outcome Measures: Pinch strength; ADL tenodesis of the thumb extensors to
reports. the MCP to prevent excessive flexion
of the MCP joint.
2. EPL and EPB were secured to the
dorsum of the MC. 6/11 patients did
not require tenodesis had sufficient
strength in the EPL to extend the
thumb.
3. 2/6 EIP was transferred to EPL for
active extension.
4. Satisfactory finger flexion present 10
hands. In seven hands: intertendinous
suture of all FDP tendons 4 patients
who had active flexion in the ulnar
Waters et al. 1985; USA profundi of small and ring finger, but
Downs &Black score=12 could not flex index finger;
Case Series 5. Transfer of PT to all FDP tendons in 2
N=15 patients; transfer of ECRL to all FDP
tendons in 1 patient; transfer of FCU to
all FDP tendons one patient.
6. Preoperative lateral pinch ranged from
0- 0.15 lbs post operative lateral pinch
ranged from 2.2-4 (depending on
elbow and wrist position)
7. Residual motor function in triceps (fair
plus)(11 patients) and pinch strength;
lateral pinch 5.1 lbs, strength fair or
less (6patients) 2.0 lbs pinch.
8. 87% (13/15) reported significant
improvement; 4 patients wanted
stronger pinch;
9. 80% (12/15) could name 4 ADL
activities that they were able to
perform.
10. 13% (2/15) were dissatisfied.
11. 20% (3/15) reported discomfort tip of
thumb.
Population: Gender-m=14, f=4, level of (Follow-up 1-10yrs (average 3.5yrs)
injury-C5-C6, Age-16-29yrs, time to 1. All patients reported a significant
House et al. 1992; USA
surgery-16mths to 12/13 yrs increase in independent hand function
Treatment: Carpal-metacarpal fusion was in relation to ADL's, no patient
Case Series
performed; along with extensor pollicis reported hand function was worse
N=18
longus tenodesis and motor transfer to after surgery
flexor pollicis longus. 2. Technique provided a reliable and
5-24
Score
Methods Outcome
Research Design
Total Sample Size
Outcome measures: function of the hand, reproducible key pinch
subjective pain scale, & level of satisfaction 3. All patients had significant
with surgery and rehabilitation improvement in functional activities of
daily living and highly satisfied with
results of surgery
Population: Gender m=103, f=30, age 8- 1. All patients had preoperative grip
58yrs, tetraplegia, follow-up 3-24mths. strength of 0. At an average follow-up
Treatment: Extrinsic hand reconstruction period of 31 months, the average final
with intrinsic balancing procedures vs. grip strength was 69N (7kg) and the
extrinsic reconstructions without intrinsic ADL improvement score averaged
balancing procedures 35.5
Outcome Measures: Pre and post- 2. Patients who underwent an intrinsic
operative assessments of grip strength (on procedure had a statistically stronger
the second position of the Jamar grip (72N) than patients who did not
dynamometer) and a patient questionnaire undergo an intrinsic procedure
evaluating 31 activities of daily living (p=0.026).
3. OCU group 5 patients with an intrinsic
procedure had a statistically stronger
grip than patients without an intrinsic
procedure (p=0.028).
4. With the exception of OCU group 7 in
which 8 patients did not undergo an
intrinsic procedure due to their ability
McCarthy et al. 1997;
to balance tension between the
USA
extensors and flexors, all other OCU
groups with an intrinsic reconstruction
Pre-post
showed stronger grip than patients
N=135
without an intrinsic reconstruction.
5. ADL improvements scores were higher
but not statistically significant for those
with intrinsic rebalancing versus those
without rebalancing.
6. There was significant difference
between the hands treated by FDS
lasso and those treated by intrinsic
tenodesis when patients were stratified
by OCU level.
7. There was also no significant
difference in grip strength results
between the FDS lasso versus the
intrinsic tenodesis procedures when
stratified by both OCU level and type
of extrinsic reconstruction, both
surgical techniques were effective in
improving strength and ADL.
Summary Table 5.10 Pinch Studies

Author N Intervention Main Outcome(s)
15 patients BR to FPL (lateral pinch) with thumb IP +ve lateral pinch strength in all
(17 procedures) joint stabilization (16 hands) test positions
11 patients also had EPL tenodesis +ve ADL functions
Waters et al. 1985
and EPB to metacarpal joint; 2/17 +ve direct correlation between
patients EIP to EPL procedure pinch strength and amount of
residual triceps and wrist
extensor strength
18 patients CMC fusion +ve pinch strength
House et al. 1992
(21 procedures) EPL tenodesis +ve ADL and functional use
5-25
BR 0r ECRL or ECRI to FPL
As indicated: stabilization of thumb IP
joint and Zancolli Lasso procedure
135 patients Extrinsic reconstruction with Intrinsic +ve grip strength with intrinsic
McCarthy et al. (183 procedures) Balancing vs. without Intrinsic balancing
1997 Balancing = ADL and functional use
FDS Lasso vs. Intrinsic Tenodesis for = grip strength
Intrinsic Balancing = ADL and functional use
+ positive outcome, = no difference, - negative outcome
Pinch and Grasp (Key-Pinch and Hook Grip)

The most commonly performed surgeries to obtain key-pinch and hook grip are;
Wrist Extension: If the person does not have adequate wrist extension, Brachioradialis (BR) to
Extensor Carpi Radialis Brevis (ECRB) is performed prior to any surgery for pinch
reconstruction.
Key-Pinch and Hook Grip: Extensor Carpi Radialis Longus (ECRL) to Flexor Digitorum
Profundus (FDP). This is a synergistic transfer in which dorsiflexion of the wrist potentiates the
effects of the transfer. The amplitude of excursion provides strong flexion of the fingers into the
palm. Brachioradialis (BR) is also transferred to Flexor Pollicis Longus (FPL).
The aim of these transfers is to provide mass finger flexion for grasp and independent thumb
flexion for key-pinch against the side of the middle phalanx of the index finger. Adjustment of
tension in these transfers is also completed (Lamb and Chan 1983).
Table 5.11 Reconstructive Surgery: Pinch and Grip Studies

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender f=3, m=21, age 21- No statistical findings reported.
57yrs, time since injury 9-59months 1. Operative interventions on the
Meiners et al. 2002;
Methodology: Surgery tetraplegic hand brings gains in
Germany
Outcome Measures: ADL questionnaire, cylindrical and lateral grip and
Satisfaction Survey, Key grip and lateral improvement in ADL
Case Series
force grip 2. Subjective acceptance is high
3. Complication rate is high
4. Long duration of treatment
Population: Age: 19-60 yrs Age at injury: 1. 7 extremities had had post deltoid to
15-46 yrs; Injury to operation: 1-17 yrs; triceps transfer before
Follow-up post op: 1-17 yrs ; Gender: 17 opponensplasty; 24 patients, 11 (46%)
m, 7 f; Level of injury; 3 in group III, 11 in had bilateral opponensplasty.
group IV, 7 in group V, 4 in group VI. 2. 35 opponensplasties were done. 22
Intervention: surgery flexor tendon transfers were done for
Outcome Measures: Not specified voluntary grasp and then
Kelly et al. 1985; USA opponensplasty.
Downs & Black score=9 3. 14 patients (22 extremities) evaluated.
Case Series 4. Subjects reported that they would
N=24 have the operation again (95% of the
extremities) and had improved function
(91%).
5. One patient reported that function was
unchanged; 1 was dissatisfied.
Overall value of key pinch 35
extremities was 1.47 +/- 1.29 kg (mean
+/- SD).
5-26
Score
Methods Outcome
Research Design
Total Sample Size
6. Grasp measured in 20 extremities;
2.81 +/- 2.89 kg (mean +/-SD) (range
trace to 10kg).
7. Palmar pinch; 9 of 20 extremities
(45%) achieved palmar pinch (1.04 +/-
1.02 kg; mean +/- SD) (range 0.20-3.0
kg). Palmar pinch achieved in 17% of
the extremities in group III, 71% in
group IV, and 33% in group V.
Population: Age: mean=23.6yrs; age at No statistical results reported.
Rieser & Waters 1986;
time of surgery: mean=29.8yrs, time from 1. Self assessment questionnaire results
USA
injury to operation 6.2 yr, follow-up time of indicated: power decreased since
this study: 7.4 yrs surgery in all patients.
Case Series
Intervention: Surgery
N=23
Outcome Measures: Not specified
Population: at least 1 yr post injury, C5-6 No statistical results reported.
spared quadriplegia 1. All reported they would have surgery
Intervention: Surgery again.
Lo et al. 1998; CA Outcome Measures: not specified 2. Key pinch strength in non-op limbs
Downs & Black score=7 was 1.0 ± 1.3 kg, in surgically treated
Case Series arms it was 1.2 ± 1.1 kg.
N=9 3. Minnesota rate of manipulation: non-
operative limbs were 1 min 29 secs ±
15 secs, post operative limbs was 2
min 56 secs ± 1 min 56 secs.
Population: Age: 16-36yrs, time post No statistical results reported
injury: 4mths-18yrs 1. 6 of 8 subjects were evaluated.
Colyer & Kappelman
Intervention: Surgery Subjects indicated they were pleased
1981; USA
Outcome measures: Not specified with the surgery.
2. Hand function tests indicated an
Case Series
improvement (16-49% improvement).
N=8
5 of 6 subjects showed key grip
strength remained constant.
Population: age 9-58yrs, tetraplegia No statistical results reported-8 pts
Treatment: Surgery interviewed, 5 completed questionnaire.
Faillia et al. 1990; USA
Outcome Measures: key pinch, grip 1. Conclusion-transfer of brachioradialis
Downs & Black score =6
strength, function in ADL tendon provides key pinch and grip of
Case Reports
sufficient quality to improve the
N=8
activities of daily living in patients with
loss of flexion of the thumb and fingers
Population: age at first operation 20- 1. Strength: key-pinch strength average
62yrs, level of injury C4-C7, time from of 17.2 kPa (5-50 kPa); grasp strength
injury to operation 15-239 months. average 18.8 kPa (3-45 kPa).
Forner-Cordero et al. Treatment: Surgical reconstruction. 2. No relation found between the
2003; Spain Outcome Measures: Increased hand activities of daily living test and the
Downs & Black score=5 movement and strength; improvement in key=pinch strength (P=O.7976) or
Retrospective Follow-up ADL; patient's satisfaction, fulfillment of grasp strength (P=0.6948).
Initial N=15; Final N=14 patient's expectations, surgical 3. Modification of ADL questionnaire;
complications. excellent (3) 21.4%; good (7) 50.0%;
fair (2) 14.3 %; poor (2) 14.3%. Scores
ranged from 54-122 points.
Population: age at time of surgery 20-47 No statistical analysis reported
yrs. 1. Passive range of motion of the elbow
Gansel et al. 1990; USA
Intervention: Surgery. and wrist remained unchanged post
Outcome Measures: Not specified surgery. Functional active flexion of the
Case Series
fingers was gained in 10 of 11 subjects.
N=19
2. Improved performance of ADLs was
reported.
5-27
Summary Table 5.12 Pinch and Grip Studies
+ve lateral and cylindrical
grip
FCR to FDP
22 patients +ve satisfaction with
Meiners et al. 2002 ECRL to FDP
(23 hands) surgery
+ve ADL and functional
use
7/24 also had PD to
Triceps
Opponensplasty- FDS to
+ve satisfaction with
APB
surgery
24 patients Flexor tendon transfers:
Kelly et al. 1985 +ve ADL functional use
(57 procedures) BR (also used PT, FCR,
+ve key-pinch, palmar
ECRL, FCU, PL) to FDP
pinch and grip strength
22/35 Flexor tendon
transfer BR to FDP (also
used PT, FCR, ECRL)
Tenodesis of FPL, thumb
IP joint stabilization
6/9 MP joint tenodesis of -ve result, bowstringing of
9 patients extensor tendons of thumb FPL across MP joint
Reiser and Waters 1986
(10 procedures) 2/9 BR to wrist extensor -ve grasp and lateral pinch
7/9 tenodesis of EPL and strength
EPB
+ve satisfaction with

surgery
8 patients ERCL to FDP and BR to
Lo et al. 1998 +ve key-pinch and grip
(12 procedures) FPL
strength
+ve ADL functional use
+ve improved pinch
strength
Colyer and Kappleman 6 patients FPL tenodesis
-ve finger flexion
1981 (8 hands) 2 also had ECRL to FDP
+ve ADL and functional
use
+ve key-pinch and grip
BR to FDP or FPL
8 patients strength
Faillia et al. 1990 BR or ECRL to FPL
(9 hands) +ve ADL and functional
use
PD to Triceps
BR to ECRB
Tenodesis of FPL
APL to CMC joint or
+ve key-pinch strength
arthrodesis of CMC joint
+ve grip strength
15 patients BR or ECRL or PT to EDC
Forner-Cordero et al. 2003 = ADL and functional use
(20 limbs) and EPL or tenodesis of
+ve patient satisfaction
extensor tendons
-ve patient expectation
BR or ECRL or ECRB to
FPL
PT or ECRL or BR to FDP
Zancolli Lasso of FDS
11/11 PT to FDP +ve finger flexion
Gansel et al. 1990 11 patients 10/11 BR to FPL +ve key-pinch strength
1/11 BR to FDS +ve ADL functional use
5-28
5.7.2 Elbow Extension
The most commonly performed surgery for elbow extension is using the posterior third
of the deltoid (PD) to motor the triceps. This converts the transferred portion of the
deltoid into a two joint muscle but causes no functional loss at the shoulder (Moberg
1975).
Table 13: Reconstructive Surgery: Elbow Extension Studies (Posterior Deltoid to Triceps)
Score
Methods Outcome
Research Design
Total Sample Size
Population: age-mean 33.6yrs, level of 1. The muscle was tested at 6 different
lesion-C6, time since injury 28-173 months, lengths (130, 110, 90, 70, 45 and O
time prior to sugery-34.5yrs, time since degrees of elbow flexion) with the
surgery-46.1 months shoulder abducted at 90.
Treatment: The arm and forearm were 2. When compared, the absolute values
locked in position and a force transducer (dimension of torque) were
was used to assess the torque output significantly different between groups
Rabischong et al. 1993;
isometrically. The muscle was tested at 6 (0.00001<p<0.002.
France
different lengths with the shoulder 3. The expression of this relation (% of
abducted at 900 maximum values) revealed significant
Outcome Measures: Maximal torque and statistical differences (p<0.002) at 90
Trial
absolute values. and 70 degree of elbow flexion; peak
N=12
torque was at 130 degrees in
experimental group and 110 degrees
in control group with a plateau
between 110 and 70 degrees.
4. Length-tension relationship was fairly
similar among control group, but great
differences in experimental group.
Population: gender m=11, f=5, age mean 1. Straight Arm Raising-statistically
27yrs, ASIA score 16-20 significant decrease in maximal
Treatment: Surgery. Control group shoulder abduction (mean 57 SEM 12
members sat on a chair, while the before, 14 SEM 6 after surgery)
tetraplegics sat in a wheelchair. All were 2. Shoulder flexion increased after
asked to perform 2 movements; a straight deltoid-to-triceps transfer by 42%
arm lateral and maximal raising and return (mean 113 SEM 11), remained
Remy-Neris et al. 2003;
Outcome Measures: Straight Arm Raising significantly lower (121 SEM 12) than
France
& Hand-to-nape-of-neck movement control group (P<0.0001)
3. Hand-to-nape-of-neck-movement-no
Pre-post
significant improvements were noted
N=17
after surgery
4. Conclusion-peaks of shoulder and
elbow flexion speed are almost
normal, indicating the importance of
restoring elbow extension torque for
improving the whole kinematic picture
of the upper limb
Population: Age: 23-38yrs; Time since 1. FIM scores: both groups scored
injury: 5-16 yrs; Age at time of injury: 18-27 identically
Dunkerley 2000; UK
yrs. 2. Mobility: no significant differences
Treatment: Surgery. were noted (p=0.256, and p=0.432
Case-Control
Outcome Measures: Questionnaire; FIM; 3. Questionnaire: answered only by the
10 m push and the figure of 8 push treatment group-clients gave positive
response to the questions.
Lacey et al. 1986; USA Population: Level of injury: C6 or C7; time No statistical results reported: No
Downs & Black score=7 since injury: average 24 mths, time to statistically significant differences between
Case Series operation: approx 32 months pre and post operative stages.
N=10 Treatment: Surgery 1. Activities that were noted as improved
5-29
Score
Methods Outcome
Research Design
Total Sample Size
Outcome Measures: Not specified were: the overhead use of the arms,
use of arms while lying supine and
eating.
Population: Time since injury: average 10- No statistical analysis reported.
242 mths, 64.1 mths to surgery. 1. 15 of 18 reported function
Treatment: Surgery improvement after surgery, 13 felt they
Outcome Measures: ADLs, use of gained an increase in independence.
Raczka et al. 1984; USA
wheelchair 2. Functional improvements and
grooming was noted.
Case Series
3. Improvements were noted in subject’s
ability to relieve ischial pressure from
their wheelchair, writing improved, and
driving in a small percentage was
positively affected.
Summary Table 5.14 Elbow Extension (Posterior Deltoid to Triceps)

Gr 1- 8 pts/11
= initial tension pt transfer at time of
elbows
Rabischong et al. 1993 PD to triceps surgery is important for torque output
Gr 2-control 9 R
+ ve ADL and functional use
hand (female)
5 pts + ve straight arm raise
Remy-Neris et al. 2003 PD to triceps
17 limbs +ve speed of movement
= surgical/control gr: FIM (adapted) 13
items
5 elbows, 6 =surgical/control gr: W/C propulsion 8m&10
Dunkerley 2000 PD to triceps
controls m push
+ve elbow function indicated on
questionnaire
10 pts/16 +ve satisfaction with surgery
Lacey et al. 1986 PD to triceps
procedures +ve ADL and functional use
+ve elbow extension strength
Raczka et al. 1984 18pts/19transfers PD to triceps
+ve ADL and functional use
5.7.2.1 Elbow Extension (Biceps to Triceps)
A biceps to triceps transfer can be used to create elbow extension in patients who have active
supinator and brachialis muscles to provide for the lost functions of the transferred biceps (Kuz
et al. 1999).
Table 5.15 Reconstructive Surgery: Elbow Extension Studies (Biceps to Triceps Transfer)
Score
Methods Outcome
Research Design
Total Sample Size
Population: Tetraplegic No statistical results reported:
Treatment: Surgery 1. subjects indicated they were satisfied
Kuz et al. 1999; USA Outcome Measures: Not specifed with the surgery.
Downs & Black score=7 2. Activities that required precision hand
Case Series placement had improved.
N=3 3. Elimination of the need for some
adaptive aids was possible post
surgery.
5-30
Summary Table 5.16 Reconstructive Surgery: Elbow Extension Studies (Biceps to
Triceps Transfer)
+ve elbow extension
3 patients +ve functional improvements through ability
Kuz et al. 1999 Biceps to Triceps
4 elbows to place the hand in space
+ve satisfaction with surgery
5.7.3 Multiple Reconstructions
The following studies report results from multiple procedures to reconstruct the upper limb.
Table 5.17 Reconstructive Surgery: Multiple Reconstructions

Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: mean age 42.9 years; 1. Elbow Extension: bilateral surgery
Mean time since injury: 20.5 years; Mean 9/11 subjects; Hook Grip; 17 right
time since surgery: 15.1 years; 22/24 right hands (av. Grip 46.2 mm Hg in 1991;
handed; Level of Injury: 01: 6 hands; 02: 3 improved slightly, not statistical
hands; 03: 5 hands; 0Cu2: 2 hands; 0Cu3: significant (p=0.30)) Left hand: 15
6 hands; 0Cu4: 17 hands; 0Cu5: 8 hands; hands: significant increase (p=<0.001),
0Cu6: 1 hand; Tetraplegia av. 28.7 mmHg to 53.2 mmHg; no
Treatment: surgery statistical significance between right
Outcome Measures: Lamb and Chan and left hook grip as measured by
questionnaire with additional 10 Burwood SGM and DA in 2001 (p=0.93 and
questions; Swanson sphygmomanometer p=0.97).
(hook grip); Preston Pinch Meter (key 2. Key Pinch: av. key pinch 20 right
pinch); Quadriplegic index of Function thumbs in 1991 25.8 N and decreased
(QIF); Digital Analyzer (key and grip pinch) in time to av. 13.9 N (significant
decrease p=<0.001); average pinch
strength 18 left thumbs decreased
from 17.7 to 8.8 N (significant
decrease p=<0.001). Average pinch
strength measured by DA, increase in
Rothwell et al. 2003;
key pinch when compared to 1991,
New Zealand
significant for both right (p=0.01) and
left (p=0.01) thumbs.
Case Series
3. Active Transfer Vs. Tenodeses: hook
grip: active transfers 2x strength of
tenodeses in 1991 (p=0.05) and 2001
(p=0.03). Pinch grip: similar to 1991
data (p=<0.001), 2001 data does not
follow trend. 2001 DA data did not
reach significance (p=0.06);
4. Longitudinal Comparison: hook grip
strength 25 hands with active transfers
significant increase 42.1 to 60.2 mm
Hg (p=<0.001) and pinch grip increase
from 24.0 to 38.4 N in 31 thumbs that
had active transfers using 2001 DA
data (p=0.03). Hook strength obtained
from a tenodesis in 7 hands did not
weaken over time (p=0.05) but pinch
strength in 7 thumbs significantly
increased (p=<0.001) using 2001 DA
data.
5-31
Score
Methods Outcome
Research Design
Total Sample Size
5. Questionnaire results; Lamb and Chan
activity measure: showed perceived
improvement of functional activities
significantly lower in 2001 (p=<0.001).
QIF scores of current functional
independence was significantly better
(p=0.004). Additional Burwood
questionnaire showed levels of
satisfaction, perceived expectation,
gratification and opportunity
enhancement were maintained over
time (p=0.281).
Population: Age: 21-59 years (av. 29 1. Elbow Function: 10/16 elbows (10
years); Gender: 38 male; 3 female; patients): full extension; 2/16 elbows
Complete injuries. Av. Follow up after 20 degree flexion contracture; 4/16 15
operation: 6 months- 25 years; Tetraplegia degrees of extension lag. All 10
Treatment: Surgery patients considered the procedure
Outcome Measures: Elbow strength; beneficial.
Hand function (assessment checklist 2. Hand Function: 48 hands (assessed
developed); ADL (developed checklist) only 27 patients). 5 rated as excellent;
28 rated good; 11 rated as fair; 4
graded as poor. No patient had any
impairment of hand function after
Lamb & Chan 1983; UK operation.
Downs & Black score=14 3. ADL: 29 patients assessed. No one
Case Series considered their functional capability
N=41 deteriorated after operation. Most
significant improvement in basic
activities such as washing, eating and
using the toilet, hold glasses and cups,
wash limbs and brush hair, turn on
taps, improve bladder compression,
insertion of suppositories, change from
complete reliance on other for self-
care, more mobile, 7 able to drive a
car. Improvement in UL function
facilitated development of personal
interests.
Population: Age at time of injury-mean 1. No statistical analysis provided-
30yrs, age at time of operation-mean37yrs, gestural ability improved in more than
time between injury and surgery 7-356 80% of the patients and functional gain
Walreads et al. 2003;
months, injury level C5-C8 was important in more than half.
Belgium
Treatment: Upper limb surgery 2. 43 procedures; Atypical procedures (2)
Outcome measures: Functional testing. good: 2; Moberg procedures (18)
Case Series
good: 17; poor: 1; Deltoid/triceps (12)
N=25
good: 7; fair 3; poor 2; Additional
procedures (11) good: 7; fair: 3; poor:
1.
Population: Age: av. age at first operation 1. Subjective Assessment: obtained for
27 years (5-55 years); Gender: 51 males, 6 86% of the patients, av. Follow up of
females; Level of Injury: 00:4; 01: 6; 02: 4; 37 months (range 5-86 months); 70%
Mohammed et al. 1992
03: 6; 0X: 3; Cu3: 6; Cu 4: 24; Cu 5: 10; Cu reported good or excellent results;
New Zealand
6: 3; Cu X: 3; Tetraplegia 22% fair; 8% poor.
Treatment: Surgery 2. Simultaneous surgery for key-grip and
Case Series
Outcome Measures: Subject assessment hook grip strength 96% good or
N=57
of ADL by questionnaire; Objective excellent results.
assessment of key pinch (Preston Pinch 3. Objective Results: over 70% of
Meter); Hook-grip strength (modified patients, av. follow up of 32 months;
5-32
Score
Methods Outcome
Research Design
Total Sample Size
Sphygmomanometer); Elbow extension: Key Pinch 52/68 cases (76%); av.
MRC grading system strength was 2.1 kg. Hook grip
measured in 42/58 cases (72%),
thumb included av. strength was 42
mmHg; thumb excluded 29 mmHg.
4. Elbow extension measured in 71% of
patients, obtained grade 3 or 4
strength.
Population: age at time of surgery 15- 1. One hundred forty two transfers were
Freehafer et al. 1984;
61yrs, time since injury to surgery 1-17yrs, performed on 68 subjects.
USA
tetraplegics, 2. No upper limbs were made worse.
Treatment: Surgical reconstruction 3. Four remained unimproved, all others
Case Series
Outcome Measures: Comparison of the that had tendon transfers improved.
N=68
post surgical with the pre surgical condition
Population: Age: born between 1918- 1. Elbow Extension: 30 elbows in 23
1962; Gender: 7 female, 36 male; Level of patients; (23/30 with free tendon
Injury: 0:1 9 pts; 0:2 2 pts; 0Cu:1 4 pts; graft;7/30 Castro-Sierra and Lopez-
0Cu:2 13 pts; 0Cu:3 9 pts; 0Cu:4 5 pts; Pita method); 5/23 with free tendon
0Cu:6 1 pt. re-examined 1-14 yrs after the graft 1/23 full ext.; 8/23 lack ext.
last operation. against gravity of max. 60; 10/23 lack
Treatment: Surgery even more ext.; 6/7 ext. deficit greater
Outcome Measures: Questionnaire of 55 than 60.
ADL tasks; opinion of the effect of surgery 2. Key Grip: 50 hands/40 patients;
Ejeskar & Dahllof 1988; to perform these ADL tasks; elbow Strength 0-3.5 kg (av. 0.7 kg); 15 case
Sweden extension (evaluation of extension deficit or had minimum of 1.0 kg.
Downs & Black score=11 holding a sand bag in hand); key grip pinch 3. Finger Flexion: 14 hand/13 patients
Case Series (Preston Pinch Guage); finger flexion (ECRL to profundi II-V); grip 0-0.27 kP
N=43 (Martin Vigorimeter) (av. 0.13 kP); 5/14 minimum strength
1.0 kg.
4. 4 patients reported no improvement (1
severe spasticity, 2 BR muscle
transferred to wrist; 1 operation on
weaker hand); 4/43 could not state
how much they had improved, 35/43
average improved capacity to perform
23/55 ADL tasks; 3/43 patients a
functional deterioration.
Population: Neurological levels C5-C8. 1. Opponens transfers were done 180
Treatment: Surgical reconstruction. times; transfers for finger flexion-161
Freehafer 1998; USA Outcome Measures: Not specified times; posterior deltoid transfers-59
Downs & Black score=10 times; transfers for wrist extension-17
Case Series times.
N=285 2. 13 out of 285 stated that they were no
better, and no patient said they were
worse.
Population: level of injury OCu 1,2,3 No statistically significant findings reported
Treatment: Reconstruction of key grip and Subjective client reports.
active elbow extension.
Hentz et al. 1983; USA
Outcome Measures: interview and/or
questionnaire (self-care, communication,
Case Series
mobility), objective measurements - pre +
post op strength, ROM wrist + elbow
extension, strength of key pinch, range of
passive wrist flexion + functional testing
5-33
Summary Table 5.18 Multiple Reconstructions
BR to FPL or BR and
24 patients tenodesis FPL +ve key-pinch and hook grip
Rothwell et al. 2003
(48 reconstructions) ECRL to FDP +ve ADL and functional use
PD to Triceps
PD to Triceps
Biceps to Triceps
Hand Grip: ECRL to
FDP
+ve elbow extension and function
BR to FPL
-ve elbow extension (biceps to
41 patients Key-Pinch: FPL
Lamb and Chan 1983 triceps)
(57 reconstructions) tenodesis or FPL
+ve hook grip and key pinch and
tenodesis plus ECRL to
ADL and functional use
FDP
Other: EPB to ECU,
FCR to FDS, APB to
EDM
PD to Triceps +ve elbow extension
25 patients
Walreads et al. 2003 ECRL to FDS +ve key grip and grasp
(43 procedures)
BR to FDS +ve ADL and functional use
PD to Triceps
Key-Pinch: BR or PT to
57 patients ECRL; FPL tenodesis + hook grip strength
Mohammed et al. 1992
(97 transfers) and IP stabilization +ve ADL and functional use
Hook Grip: BR or ECRL
to FDP
+ve key-pinch and grip strength
68 patients Variation of all
Freehafer et al. 1984 +ve elbow extension
(142 transfers) procedures
PD to Triceps
-ve elbow extension
43 patients Tenodesis FPL, thumb
Ejeskar and Dahllof 1988 +ve key-grip and finger flexion
(94 transfers) IP joint stabilization
ECRL to Profundus iv
Opponens transfer: 180
times
Transfers to finger
285 patients Review of surgical procedures and
Freehafer 1998 flexors: 161 times
(417 transfers) recommendations.
PD to Triceps: 59 times
Transfers for wrist
extension: 17 times
PD to Triceps or Biceps
to Triceps
30 patients +ve satisfaction with surgery
Hentz et al. 1983 FPL tenodesis
(40 limbs) +ve pinch and grip strength
BR to ECRB
EPL and EPB tenodesis
Discussion
In reviewing the identified studies as a whole, the operative interventions on the tetraplegic hand
and upper limb bring definite gains in pinch force, cylindrical grasp, and the ability to reach
above shoulder height that result in an improvement in ADL function and quality of life for the
individual with tetraplegia. Despite the level of evidence (grade 4) the subjective acceptance
among patients who have had reconstructive surgery is high. One of the reported downsides of
surgery is the high complication rate (infection, torn attachments) and the extended period of
time post surgery for rehabilitation and increased need for personal care (Meiners et al. 2002).
5-34
Many Spinal Cord Injury Centres do not offer or have access to reconstructive surgery or
neuroprothesis interventions. It is also debated whether the overall cost of surgery or use of
neuroprostheses is more beneficial to the client, as the client has to relearn new movement
strategies in order to perform activities of daily living (ADL) (van Truijl et al. 2002).
Conclusion
There is level 4 evidence from multiple studies that support the use of reconstructive
surgery for the tetraplegic upper limb for the improvement of ADL and quality of life.
Reconstructive surgery appears to improve pinch, grip and elbow extension functions that
improve both ADL performance and quality of life in tetraplegia.
5.8 Neuroprostheses
A neuroprostheses for grasping is a device designed to improve or restore the grasping, holding
and reaching functions in individuals with stroke and SCI (Baker et al. (1993); Cornwall et al.
2004). The neuroprostheses applies functional electrical stimulation (FES) in which paralyzed
muscles are electrically stimulated to produce movement (Shimada et al. 1996A). The FES
uses bursts of short electrical pulses (pulse widths 0-250 mSec and pulse amplitude 0-150 mA)
to generate muscle contraction by stimulating motoneurons or reflex pathways. The key
element for achieving synergistic activity of muscles that results with reaching and grasping is
the appropriate sequencing of bursts of electrical pulses. For continuous contraction of the arm
and hand muscles (tetranization), a FES system has to deliver at least 16 stimulation pulses per
second to elicit action potentials (AP) in the motor nerve, causing the corresponding muscles to
contract. FES enables the patients with high spinal cord injury to reconstruct grasp movements
such as palmar and lateral grasps of the upper extremity (Shimada et al. 2003). The palmar
grasp is used to hold bigger and heavier objects such as cans and bottles and the lateral grasp
is used to hold smaller and thinner objects such as keys, paper and CDs (Popovic et al. 2002).
It has been reported to be useful in improving ADL functions (Shimada et al. 1996A; Popovic et
al. 2001). FES is also applied to generate elbow extension by stimulating the triceps brachii in
combination with voluntary biceps contraction used to augment reaching (Grill and Peckham
1998; Popovic et al. 1998). Elbow and shoulder FES systems have not been developed into
practical clinical devices.
The motor nerves can be stimulated using surface (transcutaneous), percutananeous or

implanted electrodes (Mortimer 1981). Transcutaneous stimulation is performed with self-
adhesive or non-adhesive electrodes that are placed on the subject’s skin in the vicinity of the
motor point of the muscle that needs to be stimulated (Baker et al. 1993; Mortimer et al. 1981).
Percutaneous and fully implanted electrodes are placed close to the entry point of the motor
nerve to the muscle which should be stimulated, either epimysial or intramuscular (Cameron et
al. 1997; Hoshimiya and Handa 1989).
Individuals with C5-C7 complete SCI and with no major degree of motoneuron or nerve root
damage of the stimulated muscles benefit the most from neuroprosthesis. The use of an
implanted FES system can only be applied once the patient reaches stable neurological status,
which usually occurs two or more years post SCI. The use of surface FES systems can be
introduced during the early rehabilitation period, as the patient does not have to be
neurologically stable.
5-35
Gorman et al. (1997) and Cornwall and Hausman (2004) have presented guidelines for patient
selection for consideration of for an implantable neuroprosthesis. They are as follows:
• Anatomic: Stable tetraplegia with C5 or C6 motor level with international classification
motor scores of 0, 1, 2 or an impairment scale level of A, B, C (ASIA)
• Physiologic: Presence of adequate ROM in joints of the shoulder, arm, forearm, wrist
and hand
• Medical: Free of overwhelming medical problems
• Psychosocial factors: Sufficient motivation to learn its use and use it
• Adequate caregiver and/or family support
• One year post injury, plateau of functional recovery.
• Need for sufficient vision to provide visual feedback during training and use sufficient
cognitive ability
Contraindications to neuroprothesis use include:

• Cardiac disease
• Arrhythmias
• Pace makers
• Chronic systemic infections
• Diabetes
• Immune disease
5.8.1 Types of Neuroprostheses
There are several existing neuroprostheses and these include implanted FES systems such as
the Freehand System and the NEC FESMate System and surface stimulation electrode systems
such as the Handmaster NMS-1, Bionic Glove, ETHZ-ParaCare Neuroprosthesis and systems
developed by Rebersek and Vodonik and Popovic et al.
5.8.1.1 Freehand System
The Freehand System from Cleveland, OH, USA is an implantable neuroprothesis intended to
restore hand function in C5 and C6 level tetraplegics. The Freehand system can stimulate eight
different muscles in order to produce a useful grip and key pinch in tetraplegic individuals. It is
the only FDA approved (1997) implantable upper extremity neuroprothesis. The system consists
of a surgically implanted receiver/stimulator unit and electrodes with an external controller and
power supply/microprocessor. It was first implanted in 1986 (Cornwall and Hausman 2004).
The NeuroControl Freehand System consists of an active receiver/stimulator that is placed in

the chest wall and has eight leads that come from the receiver/stimulator and pass under the
skin to a connector site in the upper arm. At this point they are joined to epimyseal electrode
leads that are passed under the skin from the forearm and hand. Power and control signals
from the unit are passed through the skin to the receiver/stimulator from a skin-mounted coil.
The patient controls the device by movement of the opposite shoulder that uses a skin surface
mounted position detector. The lateral grasp is generated by first flexing the fingers to provide
opposition, which is followed by thumb flexion. Palmar grasp is generated by first forming the
opposition between the thumb and palm, followed by simultaneous flexion of both the thumb
and fingers. Stimulating the flexor digitorum superficialis and profundus muscles performs
finger flexion and finger extension is obtained by stimulating the extensor communis digitorum.
Stimulation of the thumb thenar’s muscle or median nerve produces thumb flexion. Hand
opening and closure strength are proportional to the distance moved by the shoulder. Both
5-36
palmar and lateral grasps are possible by pressing a button on the shoulder controller. Taylor et
al. (2002) and Keith et al. (1996) reported that most clients with require several surgical
procedures are needed for each client for optimal use of the device. The most common
surgeries performed are brachioradialis to extensor carpi radialis for voluntary wrist extension
and posterior deltoid to triceps for elbow extension (Taylor et al. 2002; Keith et al. 1996). The
1st generation of the Freehand System is no longer available from NeuroControl Corporation.
There are devices still available on a selective basis in several centres (Cornwall et al. 2004).
Table 5.19 Freehand System

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender m=26, f=8; Age: 13- 1. General Satisfaction: 87% were
53 yrs; Age at implantation: 16-57yrs; positive agree or strongly agree, 97%
Tetraplegia; One year post survey, would recommend neuroprosthesis to
including 6 months of home use others, 90% were satisfied with
Treatment: Implemented with a hand neuroprosthesis, 90% stated
neuroprosthesis that provides grasp and neuroprosthesis was reliable, 87%
release would have surgery again, 80% felt the
Outcome Measures: Functional neuroprosthesis met their
Evaluations: standardized test of grasp and expectations, & 77% would pay for the
release, measurements of pinch strength neuroprosthesis if they had the money
and range of motion & satisfaction survey 2. Life Impact: 88% responses were
positive for life impact; 90% stated
neuroprosthesis improved their quality
of life; 87% positive impact on their life
(90% reported did not make a negative
impact); 83% provided a benefit ADL;
87% responses regarding changes in
ADL were positive; 93% participants
could perform ADL easier; 93% could
perform ADL such as painting and
shaving; 90% had increased
confidence when performing ADL;
Wuolle et al. 1999; USA
83% could perform ADL more
normally; 73% could perform ADL
Case Series
faster
3. Independence: 81% of responses
were positive; 87% reported they were
able to function more independently;
83% used less adaptive equipment;
87% required less assistance from
others; 67% felt more comfortable out
in the community alone
4. Occupation: 57% of responses to
occupation questions were positive
5. Appearance: 87% felt their hand
appearance was unchanged or
improved
6. Usage: used prosthesis median of 5.5
days/week - ranged from 15
participants (44%) who donned the
neuroprosthesis 7 days per week to 5
participants (15%) who used it less
than 1 day/week; 24/34 participants
(71%) used it 4 or more days/week;
range of usage C4/C5, C5/C5, C6/C6
levels was the same (0 to 7
days/week) C5/C6 group - used it
5-37
Score
Methods Outcome
Research Design
Total Sample Size
most regularly 4 to 7 days/week with
most participants 8/10 reporting daily
use
7. Activities: most frequently reported
activities included eating, drinking,
shaving, brushing teeth, brushing hair,
writing, operating a computer, playing
games
8. Quality of Life: 18/34 positive
comments; 1/34 responded neutrally;
1/34 responded negatively
9. Improvements: Additional stimulus
channels, an implanted command
source, smaller, lighter external control
unit - easier to don, improve hand and
arm function, make device operable if
user is confined to bed
Participants: gender m=42, f=9, age at 1. When the neuroprosthesis was
implant 16-57yrs, level of injury C5=C6, activated all participants increased
time from injury 4.6yrs (median), follow-up- their pinch force in lateral pinch
3-13.9yrs (p<0.001) and some increased their
Treatment: Participants were trained to pinch force in palmar grasp (p<0.001).
Peckham et al. 2001;
use the neuroprosthesis and to use it for 2. 98% of participants moved at least 1
USA/UK/Australia
functional activities. Once they were object with the neuroprosthesis
satisfied with their ability to perform daily (p<0.001) and 37 improved by moving
Cohort
activities or when they reached a plateau in at least 3 more objects (p<0.001).
proficiency then rehab was complete. 3. Disability was reduced in 49 of 50
Outcome Measures: Pinch strength, participants as measured by the ADL
active ROM, Grasp-Release Test, Activities abilities or ADL assessment tools.
of Daily Living (ADL) Abilities Test, ADL
Assessment Test, user satisfaction survey.
Population: Age: 31-48 No statistical results reported
Gender: m=7: f=1; Level: C4-6 1. Care-all users had come from outside
Time Since Injury: 43-430 months; Time agencies (mean 11.5 h a day, range 3-
Since Surgery: 8-53 months 24 hrs); 4 users had additional care
Treatment: Interviews- reviewing use of from family members (mean 3.4 h a
Neuro Control Freehand System day, range 2-5 hrs); no users claimed
Outcome Measures: Amount of Care & that care given by family members had
The System decreased
2. System-donning external components
5-10 min; most users reported no
significant problems fitting the external
Taylor et al. 2001; UK equipment; 2 users had problems
2001 locating the coil; 3 locating the
Downs & Black score=16 shoulder controller; 1 had persistent
Case Series problems maintaining the position
Initial N=9; Final N=8 through the day d/t the adhesive tape
used becoming detached (4 reported
this as an occasional problem); 4
users had problems with skin allergy to
the tape or double sided adhesive
rings; 2 users reported that the system
made transfers more difficult; 3 users
never stopped using the system d/t
system failure; some problems with
equipment reliability; no change in
paid caregiver time; 6 users felt more
5-38
Score
Methods Outcome
Research Design
Total Sample Size
confident when using the system; 7 felt
their quality of life had improved
Population: Level of injury C5-C6. 1. Variation in elbow moment across
Treatment: Epimysial or intramuscular subjects significantly greater than the
electrodes were implanted on the triceps. variance within subjects (ANOVA p<
Following surgery standard stimulation 0.001).
exercise regimens were followed. 2. 10/11 elbows tested elbow moment
Outcome Measures: elbow extension generated by triceps stimulation at
moments at different elbow positions, different elbow angles, elbow moment
performance in controllable workspace weakest with elbow in more extended
experiments, comparison to an alternative position (30 degrees flexion) and
method of providing elbow extension in peaked with elbow at 90 flexion,
these individuals (posterior deltoid to significant ANOVA p<0.001.
triceps tendon transfer) 3. Elbow moment generated by triceps
stimulation at 90 and 120 degrees
elbow flexion was significantly greater
Memberg et al. 2003; than elbow moment produced by
USA tendon transfer (ANOVA p<0.05), no
Downs & Black score=14 difference between elbow extension
Case Series methods at 30 degrees elbow flexion.
N=22 4. Triceps stimulation and posterior
deltoid together provided a greater
elbow moment than each method
separately, difference significant at
each elbow position p<0.05, except at
90 degrees.
5. Quantitative workspace assessment
done on 5 arms, more successful with
triceps stimulation, significant for each
subject, chi square p<.05).
6. Average acquisition time with triceps
stimulation less than without
stimulation 4/5 arms (3.2-6.4 seconds)
and significant in 3/5 arms (unpaired t-
test p<0.01) and not for one p=0.076.
Population: Tetraplegia; Age:16-55 1. 7/9 use Freehand System daily
Treatment: The patients, using an external 2. Provided an active grip of some
stimulator, built up the muscles strength in strength which allowed many
the hand and forearm, to ensure the functional activities
Hobby et al. 2001; UK
muscles were in good condition at the time 3. Increase in self confidence
of surgery 4. Over 80% of their selected ADL goals
Cohort
Outcome Measures: Grip Strength, ADL - user preferred to be independent with
N=9
their Freehand system than use
previous method or have activity
performed by caregiver
Population: Age: 28-57 years; Time from 1. Pinch force ranged from 8 to 25 N,
injury to insertion of implant: 2 years 2 with stimulation and greater than
months to 9 years; Clinically complete at tenodesis grasp alone; all
C5 or C6; Chronicity: 2 years 2 months to 9 demonstrated functional grasp
Kilgore et al. 1997; USA years patterns and were able to manipulate
Downs & Black score=13 Treatment: Implanted neuroprosthesis. at least 3 more objects with the
Case Series Outcome Measures: Grasp force; Grasp- neuroprosthesis; had increased
N=5 Release Test; Tests of ADL (functional independence and were able to use
independence); Usage Survey the neuroprosthesis at home on a
regular basis; the implanted stimulator
proved to be safe and reliable.
5-39
Score
Methods Outcome
Research Design
Total Sample Size
Population: age-16-18yrs, level CC6, >1yr 1. 40 electrodes implanted, 37 continued
post injury. to work, all implant stimulators have
Treatment: Surgery functioned without problems with
Mulcahey et al. 1997;
Outcome Measures: Grasp Release Test follow up ranging between 16 and 25
USA
& ADL Test before and after months
implementation of the implanted FES hand 2. Grasp Release Test-lateral pinch and
Pre-post
system palmar grasp forces - Wilcoxon test,
N=5
FES forces were significantly greater
than tenodesis forces for both grasps
(P=0.043)
Population: age-mean 38.4yrs, gender 1. Grasp release test results: increase in
m=7, f=1, level-C4-C6, time since injury- the types of tasks that subjects could
mean 10.1 yrs. perform (pre n=1.4) and post
Treatment: no-it was assessment of the implantation (n= 5.1 p=0.011).
Freehand System 2. One year post implantation the types
Outcome Measures: Grasp Release Test, of tasks performed was 5.5 p=0.027,
Taylor et al. 2002; UK
Grip Strength, Activities of Daily Living, without the system it was 1.2
Sensory ability (static 2 pt discrimination) (p=0.028).
Case Series
3. Number of repetitions increased post
N=9
implantation from 12.7 to 37.4
(p=0.028) and with out the implant
post-implantation (20.2, p=0.046).
4. At one year number of repetitions was
increase to 50.5, p=0.046 with the
system and without 24.3, p=0.28.
Population: age-13-19yrs, gender m=5, 1. No predicted difference between
level of injury C5-C6, # of mths in study 12- electrodes in intrinsic and extrinsic
38, time since injury 3-72mths muscles (P=0.93)
Treatment: Intramuscular electrodes were 2. Significant differences were predicted
implanted in the upper extremity muscles between exit sites (P=0.016) + across
Smith et al. 1994; USA Outcome measures: The Breslow Test - a muscle groups (P=0.047)
Downs & Black score=12 non-parametric linear rank test used to 3. Survival likelihoods poorer for
Case Series compare survival chances across electrodes exiting dorsally
N=5 subgroups 4. At 90 days after implant survivals
95% confidence limit used to reject the null probabilities of the finger + thumb
hypothesis extensors + thumb abductors (P=0.8)
were smaller than that of thumb
adductor + flexor muscle groups
(P>0.9)
Population: Age 23-48yrs, level of injury- No statistical analysis was complete.
C5-C6 1. Passive elbow extension was within
Treatment: Participants were implanted normal limits.
with an upper extremity neuroprothesis 2. With stimulated triceps subjects
including a triceps’ electrode to provide attained full elbow extension; without it
stimulated elbow extension. Participants full range was not met
Bryden et al. 2000; USA
exercised triceps 4-6 hr/session using a
Downs & Black socre=12
programmed electrical stimulation exercise
Case Series
regimen that includes breaks. Participants
N=4
exercised either nightly or every other
night-whatever was best for maintaining an
optimal amount of strength
Outcome Measures: 5 overhead reaching
tasks, amount of assistance required to
complete the task & survey of home use.
Smith et al. 1996; USA Population: age-13-19yrs, gender m=3, FNS vs. Tenodesis
Downs & Black score=11 f=2, level of injury C5, time since injury 3 – 1. With FNS and tenodesis each case of
Case Series 72mths. improved performance in later
N=5 Treatment: FNS vs. Tenodesis sessions was significantly better as
5-40
Score
Methods Outcome
Research Design
Total Sample Size
Outcome Measures: CWRU Hand System compared to the initial session.
(Case Western Reserve University), Grasp (p<0.05).
and Release Test 2. The average grasp forces with FNS
increased; the range was from 8.9N
(SD+5.2) to 22.5N (SD+8.6) and the
palmar grasp forces increases from
2.1N (SD+2.9) to 11.1N (SD+6.0).
Population: Age-13-16years, tetraplegia, 1. No statistical results are reported.
injury to surgery 4-16 weeks. 2. No perioperative complications
Treatment: The following muscles were reported.
implanted with intramuscular electrodes: 3. Subjects began Freehand System use
Extensor digitorum profundus, extensor between 2 = 5 days after implantation
pollicis longus, flexor pollicis longus, 4. Muscle Strength-no subject gained
adductor pollicis, and opponens pollicis for significant strength in any key muscle
each subject. on their freehand limb
Mulcahey et al. 2004; Outcome Measures: Muscle Strength- 5. Pinch Force-with Freehand System -
USA Pinch Force & Hand Function, each subject realized significant
Downs & Black score=6 Performance of ADL, Satisfaction with + improvement in pinch force
Case Series without the Freehand System (COPM), 6. Upper Extremity Capacity-first 11
N=4 Upper Extremity Capacity, Quadriplegic questions - no difference with or
Index of Function without Freehand-last set of questions
Freehand System improved scores
7. Quadriplegic Index of Function-all
subjects increased their level of
independence
8. Freehand System Open-ended
Questions-all subjects would repeat
implantation
SummaryTable5. 20 Implanted Neuroprostheses (Freehand System and CWRU)

+ve satisfaction (87%)
+ve life impact (90%)
+ve ADL (87%)
+ve independence (81%)
Implanted Freehand System and
Wuolle et al. 1999 34 +ve occupation (74%)
31 had adjunctive surgeries
+ve appearance
+ve usage (5.5 d/week median)
+ve activities
+ve QOL
+ve lateral pinch
+ve palmar grasp
51 implanted Implanted Neuroprosthesis and +ve Grasp Release Test
Peckham et al. 2001
(50 evaluated) adjunctive surgeries +ve satisfaction
= no change in ability and long
term stability and function
= no change in level of personal
care assistance
Taylor et al. 2001 8 Implantation of Freehand System
-ve system failure
5/11 Implanted Freehand System
6/11 CWRU
6/11 tendon transfer surgery for
+ve elbow extension
Memberg et al. 2003 10 elbow extension
+ve workspace assessment
4 arms triceps electrode
11 triceps electrodes/10 UL
5-41
+ve ADL and functional use (80%)
+ve lateral grasp
+ve palmar grasp
Implanted Freehand System and +ve 5 finger grasp
Hobby et al. 2001 9
adjunctive surgeries -ve several electrode failures;
stimulator failure; medical
complications
7/9 use device daily
+ve Grasp Release Test
Taylor et al. 2002 9 Implantation of Freehand System +ve Grip Strength
+ve ADL Assessment
+ve pinch force
Implanted Neuroprosthesis and +ve grasp strength
Kilgore et al. 1997 5
adjunctive surgeries +ve Grasp Release Test
Implanted Freehand System and +ve Grasp Release Test
Mulcahey et al. 1997 5
adjunctive surgeries +ve ADL and functional use
Smith et al. 1994 5 Implanted Neuroprosthesis -ve electrode failure
+ve elbow function (strength,
4 Implantation of Freehand System
Bryden et al. 2000 ROM)
(5 limbs) with electrode to triceps
+ve unilateral grasp and release
Smith et al. 1996 5 Implanted Neuroprosthesis
abilities with FNS
= UE strength
+ve ADL: QIF scores
Mulcahey et al. 2004 4 Implanted Freehand System +ve Satisfaction: COPM
+ve lateral and palmar pinch
= UE capacity: UEC
5.8.1.2 HandMaster-NMS-1
The Handmaster developed by Nathan et al., and produced by Neuromuscular Electrical

Stimulator Systems, Ra’anana, Israel. It has been FDA approved for use with stroke patients. It
is predominantly used as an exercise tool for stroke subjects and is commercially available in a
limited number of countries (Popovic et al. 2001). The Handmaster has three surface
stimulation channels used to generate grasping function in tetraplegic and stroke subjects. One
channel is used to stimulate extensor digitorum communis muscle at the volar side of the
forearm. The second channel stimulates the flexor digitorium superficialis and profundus
muscles. The third stimulation channel generates thumb opposition. The system is controlled
with a push button that triggers the hand opening and closing functions. The system is easy to
don and doff. However, it does have some limitations in its design. The system is limited by not
enough sufficient flexibility to vary the position of the electrodes for stimulation of the finger
flexors for grasp; it is a stiff orthosis that fixes the wrist joint angle and prevents full supination of
the forearm (Popovic et al. 2001).
Table 5. 21 Handmaster-NMS-1
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender m=7, level of injury No statistical results reported.
Alon & McBride 2003
C5-C6, 6mths post injury 1. All were 100% successful in using the
USA
Treatment: Subjects practiced with the handmaster in the studied ADL and
neuroprothesis daily to regain grasp, hold, grasp (hold and release) tasks.
Case Series
and release ability and to restore selected 2. Improvements were noted in strength
N=7
functions of 1 of the 2 paralyzed hands. (.57 ± 98N to 16.5 ± 4.4N, finger linear
5-42
Score
Methods Outcome
Research Design
Total Sample Size
Subjects were observed 2 to 3 times motion (0.0cm to 8.4 ± 3.2cm) and
weekly for 3 wee Fugi-Meyer scores (p<0.05)
Outcome Measures: Hand function was
evaluated by a series of upper limb
measures: 3 ADL tasks, 3 hand impairment
measures, 2 grasp and release tests.
Population: Gender: m=8, f=2; Age range: No statistical results were reported.
20 to 65; Level of injury: C4 to C6; 1. 6 people left the study for various
Snoek et al. 2000;
Classification: 3-Cu n=3, 1-O n=5, 2-O n=1, reasons (>50%). Over all the 4
Netherlands
0-O n=1; Fitted hand: Right n=6, Left n=4 remaining were able to perform
Treatment: Training for use of Handmaster several tasks with the Handmaster that
Case Series
Outcome Measures: not specified they were not able to without it ( e.g.:
3/4 were able to put the splint on
independently)
Summary Table 5. 22: Handmaster-NMS-1

+ve ADL use
+ve Grasp Release Test
Alon and McBride 2003 7 NESS Handmaster
+ve grip strength
= finger motion
10 patients -ve poor compliance, only 4 completed
Snoek et al. 2000 Handmaster
(7 at end) the training period
5.8.1.3 Bionic Glove
Developed by Prochazka and colleagues at the University of Alberta the Bionic Glove improves
hand function in people with SCI. This device uses three channels of electrical stimulation to
stimulate finger flexors, extensors and thumb flexors. The control signal comes from a wrist
position tranducer mounted in the garment. The actual functioning of the device can be
described as greatly augmenting tenodesis (Prochazka et al. 1997; Popovic et al. 2005).
The Bionic Glove is designed to enhance the tenodesis grasp in subjects that have a voluntary
control over the wrist (flexion and extension). Stimulates finger flexors and extensors during
tenodesis grasp, enhances strength of grasp. The Bionic Glove is available at the University of
Alberta, Alberta, Canada and used primarily for clinical evaluation. A modified version of this
device will be called Tetron (Popovic et al. 2002).
Overall acceptance rate for long-term use is reported in 30% of potential users. Functions of
power grasp and handling of big objects were significally improved (Popovic et al. 2002). There
have been several identified concerns with the device that include damage to the stimulator
located on the forearm that is frequently damaged through accidental contact during functional
activities and the transducer mechanism is delicate and has to be replaced frequently (Popovic
et al. 2001).
Table 5.23 Bionic Glove

Score
Methods Outcome
Level
Total Sample Size
Popovic et al. 1999; Population: 12 people with SCI at C5-7 1. QIF: mean was 19.0 +/- 6.5 at the
5-43
Score
Methods Outcome
Level
Total Sample Size
Yugoslavia who had used the device 6 months or more beginning; at the end 28.4 +/- 5.2,
Downs & Black score=13 Age: 26.5 +/- 8.3 years (18-38 yr) improvement of 49.5%.
Case Series 10 complete; 1 central cord; 1 Brown- 2. FIM: 63.8 +/- 10.4 at the beginning;
N=12 Sequard 79.0 +/- 8.9 after 6 months. When 3
Time post injury; 2+ years: 7; 1+ year: 3; 6 clients excluded who had 120 points
months+: 1; 3 months: 1 on FIM scores were beginning 44.4 +/-
Treatment: Taught how to use the device 13.5 and 64.8 +/- 16.6 after 6 months
Outcome Measures (increase of 20.4 points/46%).
Quadriplegia Index of Function; Functional 3. Functional task completion: 6 subjects
Independence Measure; Upper Extremity continued to use the device. Average
Function Test; Goniometric Measurements was .745 or 75% of the functions were
performed better after 6 months of
use. 6/12 (50%) did not continue to
use the device C6-C7 individuals may
find the device beneficial enough to
use it as an assistive device.
4. Technical improvements specifically
cosmetics, positioning of the
electrodes, donning/doffing.
5. Best candidates are individuals with
complete C6-C7 tetraplegia;
6. FIM score between 25-50 (up to 75),
QIF between 0-13 (up to 27), are
motivated to use it, can demonstrate
efficient grasp.
Population: Gender m=8, f=1, age-22- 1. Mean peak force of tenodesis grasp in
42yrs, level of injury-C6-C7, time post the nine subjects increased from 2.6 N
Prochazka et al. 1997; injury-16mths-22yrs. ± 3.8 N (passive) to 11.3 N ± 7.4 N
Canada Treatment: Use of bionic glove (glove active), significant than Fp (P=
Downs & Black score=12 Outcome Measures: Mean peak force of 0.0064, t-test), and significant at end
Case Series tenodesis grasp, qualitative ratings of of 5th grasp 6.8 N ± 4.2 N, P= 0.0064,
N=9 manual tasks. Mann-Whitney rank sum test.
2. Most manual tasks improved
significantly with the use of the glove
Summary Table 5.24 Bionic Glove

+ve QIF
Popovic et al. 1999 12 Bionic Glove +ve FIM
+ve UE Function Test
+ve grasp
Prochazka et al. 1997 9 Bionic Glove
+ve compliance (60%)
+ positive outcome,= no difference, - negative outcome
5.8.1.4 ETHZ-ParaCare System
The ETHZ-Para Care System was developed collaboratively between ParaCare, the University
Hospital Zurich, the Rehabilitation Engineering Group at Swiss Federal Institute of Technology
Zurich and Compex SA, Switzerland. The system was designed to improve grasping and
walking function in SCI and stroke patients. Surface stimulation FES system is programmable,
4 stimulation channels, can be interfaced with any sensor or sensory system. The system
provides both palmar and lateral grasps. The device has some reported disadvantage that
includes a lengthy time to don and doff the device (7-10 minutes) and it is not commercially
available. The next generation of the device will be called the Compex Motion (Popovic et al.
2001; Popovic et al. 2005). The Compex Motion device is currently available in clinical trials
5-44
with approximately 80 units available. The Compex Motion stimulator was designed to serve as
a hardware platform for the development of diverse FES systems that apply transcutaneous
(surface) stimulation technology. One of the main designs in this system is that it is easily
programmable (Popovic et al. 2005).
Table 5.25 ETHZ ParaCare and Compex Motion Systems

Score
Methods Outcome
Research Design
Total Sample Size
Population: gender m=9, f=2, age 15- No statistical results.
70yrs, level of injury C5-C7, ASIA A-D, Case Reports.
FES applied 1-67 mths post injury 1. Cervical SCI patients can benefit from
Treatment: FES was carried out with a transcutaneous FES of hand muscles
stationary stimulation system and 2 during rehabilitation with respect to
Mangold et al. 2005; portable systems (ETHZ-Paracare FES muscle strengthening, facilitation of
Switzerland system, and Complex Motion) voluntary muscle activity and
Downs & Black socre=10 Outcome Measures: videos of functional improvements of ADL functions
Case Series tasks: hand function tests, self-designed 2. Surface FES system is more flexible in
N=11 functional tests, f/u query-assessment of its application and does not need
muscle strength surgical procedures
3. High flexibility in electrode placement,
stimulation programmes, and FES
control devices is required in order to
adapt the system to individual needs
Summary Table 5.26: ETHZ ParaCare and Compex Motion Systems

+ve Training Programme
ETHZ-ParaCare FES System +ve Functional exercises in therapy
Mangold et al. 2005 11
and Compex Motion = ADL function in rehab centre
-ve ADL use at home
5.8.2 Other Surface or Percutaneous Neuroprosthesis Systems
5.8.2.1 NEC-FES System
The Sendai FES team in corporation with NEC Inc. 1994 developed the NEC-FES System. The
system is to restore both grasping and walking abilities. It is an implanted FES system with 16
stimulation channels. It is used almost exclusively for research purposes and is not available
outside Japan.
5.8.2.2 Neuroprosthesis developed by Rebersek and Vodovik (1973)
This is one of the first FES systems developed for grasping three decades ago. The device has
three stimulation channels (2 stimulation electrodes per channel) that are used to generate the
grasping function by stimulating finger flexors and extensors and thumb flexors. The user can
control the stimulation intensity via different sensory interfaces such as EMG sensor, sliding
resistor and pressure sensors. The main reported disadvantages of the system are the long
donning and doffing times and the selectivity of stimulation is low. This device is not
commercially available (Popovic et al. 2001).
5-45
5.8.2.3 Belgrade Grasping-Reaching System (BGS)
The BGS as proposed by Popovic et al. (1998) is a neuroprosthesis device designed for
grasping and it also provides a reaching function. The device has four stimulation channels
(three for generating grasping function and fourth to stimulate triceps brachii muscle for elbow
extension). The grasping function is controlled via a push button that triggers hand opening and
closing. The motion of grasp is performed in three phases; prehension that forms the correct
aperature of the hand, a relaxation phase that allows the hand to get into good contact with the
object and closure of the hand by opposing either the palm and the thumb or side of index finger
and thumb. The act of hand release is completed in two stages; opening of the hand and
resting. Measuring the subject’s shoulder velocity with a goniometer and then generating a
synergistic elbow motion by stimulation of the triceps brachii muscle achieves the reaching
function of the upper limb. It is reported that the BGS system requires more time to place
electrodes compared to Handmaster system, and it is not commercially available (Popovic et al.
2002).
5.8.3 Reported Benefits of Neuroprosthesis Use
There have been many documented and reported benefits of neuroprosthesis use with the
spinal cord injured person. The training required to use the device leads to short and long-term
changes within the central nervous system (Popovic et al. 2002). A neuroprosthesis can be
used as a neurorehabilitation system that promotes recovery and better hand function in
incomplete SCI and stroke subjects or as a permanent orthotic device for complete cervical
lesion SCI subjects to augment the grasp and manipulation functions required for typical ADLs.
5.8.4 Clinical Results of Neuroprosthesis Use
The following are the reported clinical results of neuroprosthesis use;

• Clinical trials show improvement in grasping functions in stroke and SCI subjects
• FES technology facilitates a comfortable and secure grasp that allows the individual to
hold and manipulate various objects
• All except the Bionic Glove were able to facilitate both palmar (power) grasp and lateral
(fine) grasp
• The Handmaster-NMS-1, the BGS system, and the ETHZ-ParaCare neuroprostheses
have been applied successfully as rehabilitation tools to restore grasping function in SCI
individuals instead of being used as permanent orthotic systems
• To control the neuroprosthesis, subjects are using either an on-off type of switch or have
to apply simple analog sensors to generate desired control commands
• There is a delay of 1-2 seconds from time command is issued and moment that grasp is
executed which restricts the speed that an individual can grasp and release objects
• Neuroprosthesis for grasping can only be used for slower grasping tasks
• The most widely used and accepted neuroprostheses for grasping are the Freehand
System and the Handmaster-NMS-1 and all of the other neuroprostheses mentioned are
mainly used in experimental trials for research purposes
5.8.5 Challenges in Neuroprosthesis Use
There are several reported challenges in neuroprosthesis use:

• There is a general perception within the clinical community that neuroprosthesis
technology is not fully matured and the application of its use is labour intensive
5-46
• Patients and families have over expectations from assistive systems as aspirations and
results do not match
• Acceptance of the device depends on the specific needs of the client
• Complicated by variety of age and lifestyle factors represented in patients with UE
paralysis
• Complacent (feel comfortable, safe and happy with home and workplace adaptation and
with attendant care)
• Waiting for cure (refuse any other intervention)
• Afraid of technology
• Degree of cognitive interaction they require – high levels of attention to their
neuroprosthesis may interfere with social interaction
• Impact in clinical applications is limited
• Reasons for poor acceptance is can be technical, cultural and psychological
• FES technology requires intensive maintenance and skilled technician
• Found to be effective in hospitals with strong engineering support
• Attempts to simplify neuroprosthesis systems and reduce the system’s donning and
doffing time resulted in less technical support needed but the devices then failed to
address the needs of a wider population
• Inadequate reliability of use (breakage of wires, electrode failure, accidental damage)
• The grasping functions are robotic quality of stimulated motions and in order to design a
more dexterous hand motion it would require a more complicated system
• Overall cosmetics of the device
• Implanted neuroprosthesis require additional surgery and it is recommended that tendon
transfers be performed to augment the system
• Extensive training is required to learn how to use the device, which is expensive in terms
of staffing and resources
• Efforts to increase reliability of system components, data on long-term reliability not yet
available
• Simple systems for powered tenodesis grip for individual with lesions at C6 or lower
have not been fully explored in deference to volitional tendon transfer surgery (Popovic
et al. 2002; Triolo et al. 1996)
Discussion
The use of neuroprosthesis whether implanted or surface electrodes appear to benefit persons
with C5-C7 level tetraplegia. The studies consistently demonstrate improvements in pinch
(lateral and palmar), grip strength, and ADL functioning and general satisfaction with the use of
the device, although the study subject numbers are relatively small. Ongoing compliancy and
use of the devices on a long-term basis continue to be problematic. Reasons for discontinuing
the use of the device are with length of time and the amount of assistance required to don and
doff the device, and if using the device can provide enough of a difference in overall level of
functioning. The studies also consistently report both mechanical/electrode failure and adverse
medical complications. Many of the devices are only available in specialized rehabilitation
centres where access to rehabilitation engineering is available. In addition, many of the devices
continue to be only available in clinical trials. The overall cost to use the device continues to be
great when factors such as cost of the device, the extensive training period required and staff to
support the programme.
5-47
Conclusion
There is level 4 evidence from multiple studies that support the use of neuroprostheses
for persons with C5-C6 complete tetraplegia in the improvement of pinch and grip
strength and ADL functioning. However, many devices are only available in clinical trials
in specialized rehabilitation centres and the overall cost of the device continues to be
expensive.
The use of neuroprostheses appears to have a positive impact on pinch and grip strength and
ADL functions in C5-C6 complete tetraplegia, however, access to the devices are limited and
continue to be expensive in use.
5.9 Summary
The treatment and management of the upper limb in persons with a spinal cord injury can be
rewarding yet very challenging. Secondary complications related to repetitive strain injury, pain
and hypertonicity in addition to aging presents numerous challenges for both the injured
individual and the clinician. In reviewing the critical evidence of treatment interventions it was
surprising that there was few studies on the effectiveness of traditional interventions such as
strengthening, exercise, splinting and management of hypertonicity. The majority of research
for the upper limb has been focused on reconstructive surgery and the use of neuroprosthesis.
Advancements in understanding the mechanisms related to spinal cord injury has led to
restorative treatment interventions especially in the management of the incomplete SCI person.
This chapter outlined the importance in the prevention of upper limb dysfunction and the impact
of an injury in one’s overall level of basic independence in the areas of self-care and mobility.
Further research and consensus is needed in how we assess and document upper limb function
especially hand function in an effort to establish objective, reliable and measurable outcomes.
Other areas for further research have been identified throughout the chapter.
There is level 1 evidence based on one RCT that physical capacity continues to improve
after 1- year post discharge.
There is level 2 evidence based on one pre/post study that neuromuscular stimulation-
assisted ergometry alone and in conjunction with voluntary arm crank exercise was an
effective strengthening intervention for chronically injured individuals.
There is level 2 evidence based on one study that muscle strength continues to improve
up to 15 months post hospital discharge for both tetraplegic and paraplegic individuals.
There is level 4 evidence based on one study that neuromuscular stimulation-assisted

exercise improves muscle strength over conventional therapy.
There is level 1 evidence (from 2 RCTs) that augmented feedback is not effective in
improving upper limb function in tetraplegia.
There is level 4 evidence that intrathecal baclofen may be an effective treatment for
upper extremity hypertonia of spinal cord origin.
5-48
There is level 1 evidence from one RCT that showed that massed practice (repetitive
activity) and somatosensory stimulation (median nerve stimulation) demonstrated
significant improvement in grip and pinch strength required for functional activity use.
There is level 2 evidence from a before/after study that showed that rTMs treatment in
individuals with chronic stable ISCI may produce reductions in corticospinal inhibition
that resulted in clinical and functional changes for several weeks after treatment.
There is level 2 evidence from one RCT that showed that the use of concomitant
auricular and electrical acupuncture therapy may improve the neurological and
functional recovery of acutely injured spinal cord individuals.
There is level 2 evidence based on one RCT that wearing a thumb opponens splint will
improve pinch strength and functional use of the hand.
There is level 1 evidence based on two RCTs that a shoulder exercise and stretching
protocol reduces the intensity of shoulder pain post SCI.
There is level 2 evidence that general acupuncture is no more effective than Trager
therapy in reducing post-SCI upper limb pain.
There is level 4 evidence from multiple studies that support the use of reconstructive
surgery for the tetraplegic upper limb for the improvement of ADL and quality of life.
There is level 4 evidence from multiple studies that support the use of neuroprostheses
for persons with C5-C6 complete tetraplegia in the improvement of pinch and grip
strength and ADL functioning. However, many devices are only available in clinical trials
in specialized rehabilitation centres and the overall cost of the device continues to be
expensive.
5-49
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Hand Surg 1994; 19A:209-218.
Yang JF, Stein RB, Jhamandas J, Goordon T. Motor unit numbers and contractile properties
after spinal cord injury. Ann Neurol 1990;28:496-502.
Zancolli E. Surgery of the quadriplegic hand with active strong wrist extension preserved: a
study of 97 cases. Clin Orthop 1975; 112: 101-113
5-58
CHAPTER SIX
Tania Lam, PhD, PT

Dalton L Wolfe, PhD
Jane TC Hsieh, MSc
Maura W Whittaker, PT
Janice J Eng, BSc (PT/OT), PhD
Key Points
Patterned Electrical Stimulation (PES) programs are beneficial in preventing and

restoring lower limb muscle atrophy as well as improving lower limb muscle strength
and endurance.
Functional Electrical Stimulation (FES)-assisted exercise programs are beneficial in

preventing and restoring lower limb muscle atrophy as well as improving lower limb
muscle strength and endurance.
For patients less than 6 months post-SCI, body weight supported treadmill training has
equivalent effects on gait outcomes to conventional rehabilitation consisting of
overground mobility practice.
Body weight-support gait training strategies can improve gait outcomes in chronic,
incomplete SCI, but no body weight-support strategy (overground, treadmill, with FES)
is more effective.
There is little evidence that any pharmacological agent is significantly beneficial in

directly improving ambulation in individuals with SCI.
FES-assisted walking can enable walking or enhance walking speed in incomplete SCI
or complete (T4-T11) SCI. Regular use of FES in gait training or activities of daily
living can lead to improvement in walking even when the stimulator is not in use.
There is limited evidence that bracing alone does not enable significant gains in
functional ambulation for people with complete SCI. The advantages of bracing
appear largely restricted to the general health and well-being benefits related to
practice of standing and the ability to ambulate short-distances in the home or indoor
settings. The benefits of bracing-alone on functional ambulation are primarily with
people with incomplete spinal lesions.
There is limited evidence that a combined approach of bracing and FES results in
additional benefit to functional ambulation in paraplegic patients with complete SCI.
Locomotor training programs are beneficial in improving lower limb muscle strength
although in acute SCI similar strength benefits can be obtained with conventional
rehabilitation. The real benefit of locomotor training on muscle strength may be
realized when it is combined with conventional therapy. This should be further
explored in acute, incomplete SCI where better functional outcomes may be realized
with the combination of therapies.
Table of Contents
6.1 Introduction ......................................................................................................................6-1
6.2 Electrical Stimulation to Enhance Lower Limb Muscle Function........................................6-2

6.2.1 Patterned Electrical Stimulation (PES) ...........................................................................6-2
6.2.2 Functional Electrical Stimulation .....................................................................................6-4
6.3 Gait Retraining to Achieve Functional Measures of Overground Ambulatory

Capacity ............................................................................................................................6-7
6.3.1 Body-weight supported treadmill training (BWSTT) ........................................................6-8
6.3.1.1 BWSTT in Acute/Sub-acute SCI ..................................................................................6-8
6.3.1.2 BWSTT in Chronic SCI ..............................................................................................6-10
6.3.2 Special Case Report: Spinal Cord Stimulation Combined with BWSTT .......................6-12
6.3.3 Pharmacological Interventions......................................................................................6-12
6.3.4 Functional Electrical Stimulation (FES).........................................................................6-15
6.3.5 Orthoses/Braces ...........................................................................................................6-18
6.3.5.1 Bracing alone in SCI ..................................................................................................6-18
6.3.5.2 Bracing Combined with FES in SCI ...........................................................................6-22
6.3.6 Enhancing Strength Following Locomotor Training ......................................................6-24
6.4 Summary...........................................................................................................................6-26
References..............................................................................................................................6-29
Lam T, Wolfe DL, Hsieh JTC, Whittaker M, Eng JJ (2006). Lower Limb Rehabilitation Following Spinal Cord Injury.
www.icord.org/scire
6.1 Introduction
The rehabilitation of lower extremity function after spinal cord injury has generally focused on
the recovery of mobility. In individuals with paraplegia, the recovery of trunk stability and walking
function are cited as the highest priorities after sexual and bladder/bowel function. Among
people with tetraplegia, the return of arm/hand function is by far the greatest concern, but trunk
stability and walking movement do appear among their priorities (Anderson 2004). Indeed, the
basic capacity to stand upright and interact with others at eye-level is an important ability that
many able-bodied individuals take for granted.
Improvements in emergency and acute medical care for spinal cord injury have translated into
improved survival rates in people who suffer such trauma (Frankel et al. 1998; O'Connor 2005).
Concomitant with this change is also the finding that there is a trend towards less severe
lesions, increasing the number of incomplete spinal cord injuries (Tator et al. 1993). The chance
that a person can be ambulatory following a spinal cord injury is greatly increased when the
severity of the spinal lesion is less (Burns et al. 1997; Curt & Dietz 1997). Thus, with the trend
towards increased survival rates and decreased lesion severity, there is an increasing need for
ambulatory rehabilitation treatments to maximize function and mobility for people with spinal
cord injury.
Conventional rehabilitation strategies for enhancing lower limb function after spinal cord injury
have focused on range of motion and stretching, active exercises, electrical stimulation to
strengthen functioning musculature, and functional training in daily mobility tasks (e.g.
transferring, bed mobility, sitting).
After SCI, it is well established that muscles experience deconditioning, especially those
denervated following complete SCI. The most visible effect of deconditioning is muscle atrophy,
characterized by a reduction in size of individual muscle fibers (Castro et al. 1999a; Castro et al.
1999b). Deconditioning is also associated with a complex cascade of biochemical events and
alterations over time in muscle composition such as changes to muscle fiber type (Stewart et al.
2004; Round et al. 1993). Functionally, these changes are manifest as loss of strength and
endurance of muscular contractions and have been targets for various interventions. Muscular
contractions have the added potential of improving the well known loss of bone density following
SCI. It should be noted that there might be additional benefits to enhancing muscle structure
and function in addition to the immediate functional consequences of enhancing strength and
endurance. For example, Anderson (2004) noted that future treatments developed for chronic
SCI may require the reversal of muscle atrophy in order for benefits of the treatment to be
detectable. Others have noted the potential health benefits (e.g., reduction in secondary
conditions) that may be associated with reducing muscle atrophy and enhancing muscular
strength and endurance (Shields & Dudley-Javoroski 2006). Various rehabilitation techniques
have been focused on reducing or reversing these detrimental changes to the muscles of the
lower limb following SCI.
Standing and overground ambulation training are also important components of conventional
rehabilitation using various bracing and assistive devices such as walkers (O'Sullivan & Schmitz
1994; Somers 1992). In the last several years, we have also seen exciting advances in
technology applications for facilitating or augmenting gait rehabilitation strategies, such as
6-1
robotic devices for treadmill gait retraining (Colombo et al. 2001; Hesse et al. 2004) and the
introduction of microstimulators for activating paralyzed muscles (Weber et al. 2004).
6.2 Electrical Stimulation to Enhance Lower Limb Muscle Function
A variety of electrical stimulation techniques have been employed to enhance lower limb muscle
structure and function in people with SCI. These typically involve delivering a series of electrical
pulse trains to the muscle (or nerve supplying the muscle) over time such that it simulates the
“normal” exercise experience. Specific stimulation parameters (i.e., pulse width, train duration,
between train interval, method of application) and other exercise-related variables (i.e.,
frequency, duration, intensity, program length) may each be varied to attain an optimal training
stimulus. Given the number and variety of these factors, it is not surprising that there is
considerable heterogeneity among the specific electrical stimulation interventions that have
been investigated to date. In the present review we focus on two strategies: patterned electrical
stimulation (PES) and functional electrical stimulation (FES). Whereas both methods typically
employ cyclical patterns of electrical stimulation that simulate natural muscular activity, FES is
directed towards the attainment of purposeful movement such as cycling or walking. PES, on
the other hand, is focused on producing muscle contractions that may be used to generate
muscle force such as in an isometric condition. In some applications, PES techniques have
been used as a training stimulus to prepare muscles for a subsequent FES training condition
(e.g., Kern et al. 2005; Hjeltnes & Lannem 1990). In situations where increased muscle torque
and endurance are primary goals to improve function, for example in the quadriceps in an
incomplete SCI, the outcomes of these experimental studies have direct clinical relevance.
6.2.1 Patterned Electrical Stimulation (PES)
Table 6.1 PES Studies Examining Muscle Function and Morphology

Score
Methods Outcome
Research Design
Total Sample Size
Population: 26 subjects within 15 weeks 1. Lean body mass increased with
SCI, traumatic, motor complete, thoracic or FES-cycling at all regions and
cervical SCI, mean ages from 25.0 to 28.2 declined for control and PES group.
years, 67.5-80% males. 2. With respect to total body lean
Baldi et al. 1998; USA Treatment: Random assignment to 3-6 mass, lower limb lean mass and
PEDro=5 months of 1. FES-assisted cycle ergometry gluteal lean mass, controls lost an
RCT (n=8), 30 min, 3X/week; 2. PES-assisted average of 6.1%, 10.1%, 12.4%
N=26 isometric exercise group (n=8) (same after 3 months and 9.5%, 21.4%,
muscle groups as FES group) for 1 hr, 26.8% after 6 months.
5X/week and 3. control group (n=9) with no
stimulation.
Outcome Measures: lean body mass
lower lim .
Population: 7 men with complete SCI Compared to the untrained side, stimulated
(ASIA class A), C5-T10, ≥ 6 weeks post- limb had:
injury, ages 21-43. 1. ↑ strength (↑ peak stimulated ankle
Treatment: PES exercise to unilateral torque and higher torque-time
Shields et al. 2006; USA ankle plantarflexion (untrained leg served integrals (p<0.05).
Downs & Black score=17 as a control). Four 4 min exercise bouts, 5 2. More resistant to fatigue (↑muscle
Prospective Controlled days/week for 1.87-3.05 years.
Trial fatigue indexes), (p<0.05).
Outcome Measures: Stimulated ankle
N=7 3. Increased twitch difference
torque and soleus twitch profiles at
(indicative of force generating
baseline and every 6 months up to 3 years.
capacity) (p<0.05), especially with
successive stimulation trains.
4. Greater trabecular bone mineral
6-2
Score
Methods Outcome
Research Design
Total Sample Size
density at some sites but not
others.
Population: 4 subjects with SCI; Frankel A 1. No group statistics done. At least 2

(3 chronic T7-T12; 1 with recent injury at subjects had ↑ knee extension
T5); age range 20-36; 3 females, 1 male; 3 torque, ↑ muscular endurance, ↑
months-5 years post-injury. thigh circumference, ↑ elevated CK
Hjeltnes & Lannem 1990;
Treatment: PES, 4 weeks, 2x/day, 5- (indicator of muscle injury) on
Norway
10mins, isokinetic resistance to quadriceps occasion. The more acute subject
muscles followed by 4 weeks, 30 min, stopped training due to muscle
Pre-post
2X/day, 4-5X/day of integrated training of spasms.
N=4
rising and standing. 2. One subject progressed to the
Outcome Measures: Knee extension planned stage of FNS-assisted
torque, thigh circumference, creatine ambulation training.
kinase collected monthly.
Population: 5 male patients, complete 1. No group statistical analysis
paraplegia (T5-L2), 19 to 68 years of age, performed, limited by heterogeneity
3-60 months post-injury. across subjects.
Kayaga et al. 1996; Treatment: Subcutaneous PES to various 2. All cross-sectional muscle areas
Japan lower limb nerves and muscles for 6 except gluteus maximus increased
Downs & Black score=9 months. Applied at 10 min, 3X/day and (p<0.05 to <0.001).
Pre-post gradually increased to 60 min, 3X/day at 10 3. Muscle torques generally increased
N=5 weeks. after PES.
Outcome Measures: Muscle cross- 4. Manual muscle tests generally
sectional area (CT scan), manual muscle increased (p<0.001) for muscles
test, stimulated muscle torque. initially assessed as poor-minus or
greater.
Discussion
In general, all studies reviewed involving PES produced beneficial results on muscle functions
such as strength and endurance or muscle structure such as increased muscle size (i.e.,
reduced muscle atrophy). The study with the strongest design was conducted by Shields and
Dudley-Javorski (2006), who employed an experimental non-RCT design to examine the effect
of long-term (up to 3 years) PES exercise to unilateral ankle plantarflexor muscles with the
untrained leg serving as a control. This study examined 7 ASIA class A males with relatively
recent injuries (~6 weeks post-injury). Peak stimulated ankle torque (i.e, non-voluntary) was
found to be significantly greater in the stimulated leg as compared to the untrained leg. Trained
limbs also generated significantly higher torque-time integrals than untrained limbs (p<0.05).
Pre-post study designs of PES-assisted exercise also found increased stimulated muscle forces
or torques following training although the subjects involved in these studies were generally more
chronic (Kagaya et al. 1996; Hjeltnes & Lannem 1990). In addition, Bajd et al. (1999) showed
increases in voluntary and stimulated isometric knee joint torques in 4 of 7 subjects with
incomplete SCI (2 months to 8 years post-injury) with a 5th subject showing an increase in the
stimulated response only.
In addition to enhancing muscle bulk, most interventions are focused on improving muscle
function, most notably strength and endurance, but also contractile speed and muscle fatigue.
PES-assisted exercise, in particular, has been studied and shown to benefit the property of
strength in the lower limb. All but one (i.e., Bajd et al. 1999) of the studies assessing outcome
measures associated with strength evaluated this in individuals with complete or motor
complete SCI (Shields & Dudley-Javoroski 2006; Kagaya et al. 1996; Hjeltnes & Lannem 1990).
6-3
Shields and Dudley-Javorski (2006), also demonstrated a beneficial effect with their protocol of
PES-assisted exercise to the plantarflexors in more recently injured individuals with ASIA A SCI.
Conclusion
There is level 2 evidence that a program of PES-assisted isometric exercise reduces the
degree of lower limb muscle atrophy in individuals with recent (~10 weeks post-injury)
motor complete SCI, but not to the same extent as a comparable program of FES-
assisted cycling exercise.
There is level 4 evidence that programs of PES-assisted exercise partially reverses the
lower limb muscle atrophy found in individuals with long-standing (>1 year post-injury)
motor complete SCI.
There is level 2 evidence that a program of PES-assisted exercise increases lower limb
strength and muscular endurance.
PES programs are beneficial in preventing and restoring lower limb muscle atrophy as well as
improving lower limb muscle strength and endurance.
6.2.2 Functional Electrical Stimulation
Table 6.2 FES Studies Examining Muscle function and Morphology

Score
Methods Outcome
Research Design
Total Sample Size
Population: 26 subjects within 15 weeks 1. Lean body mass increased with
SCI, traumatic, motor complete, thoracic or FES-cycling at all regions and
cervical SCI, mean ages from 25.0 to 28.2 declined for control and PES group.
years, 67.5-80% males. 2. Controls lost an average of 6.1%,
Baldi et al. 1998; USA Treatment: Random assignment to 3-6 10.1%, 12.4% after 3 months and
PEDro=5 months of 1. FES-assisted cycle ergometry 9.5%, 21.4%, 26.8% after 6 months
RCT (n=8), 30 min, 3X/week; 2. PES-assisted in total body lean mass, lower limb
N=26 isometric exercise group (n=8) (same lean mass and gluteal lean mass,
muscle groups as FES group) for 1 hr, respectively.
5X/week and 3. control group (n=9) with no
stimulation.
Outcome Measures: lower limb lean body
mass.
Population: 9 subjects (1 female, 8 1. Overall mean fiber diameter of
males), aged 20-49, complete traumatic trained group was increased vs
conus cauda equina lesions, at least .8 untrained group (p<0.001) and also
years post-injury. had similar values to normal
Kern et al. 2005; Austria Treatment: Progressive PES to FES sedentary adults.
Downs & Black score=14 program for quadriceps to FES-assisted 2. Proportion of total cross-sectional
Pre-post standing (n=4 trained ≥ 2.4 years); area covered by muscle fibers
N=9 untrained controls (n=5). increased with training whereas the
Outcome Measures: Muscle biopsy of area covered by adipocytes and
vastus lateralis (mean fiber diameter, % connective tissue significantly
area covered by muscle fibers, adipocytes, decreased.
connective tissue).
6-4
Score
Methods Outcome
Research Design
Total Sample Size
Population: 6 tetraplegic, 4 paraplegic, 1. Total collagen content (as indicated
complete, aged 27-45, 5 sedentary by hydroxyproline concentration)
controls, age 30-39. was increased with first training
Treatment: 18-month FES-assisted cycling period (p=0.05) and second training
Koskinen et al. 2000; ergometry (First training period: 30 min, period (p=0.05) and even more so
Finland 3X/week, 1 year; Second training compared to able-bodied controls.
Downs & Black score=14 period:1X/week, 6 months). No difference in Type IV collagen
Pre-post Outcome Measures: Muscle morphology content between groups.
N=15 and protein measurement (type IV 2. This result combined with the
collagen, total collagen, muscle proteins). changes seen with the other
muscle proteins suggest
accelerated type IV collagen
turnover in skeletal muscle.
Population: 7 male subjects with motor- 1. ↑ Work output as training
complete spinal lesions, aged 28-61, (5 progressed (p=0.019).
ASIA A, 2 ASIA B), C5-T8, from 1-27 years 2. More fatigue-resistant: ↓ force
post-injury. decrement during quadriceps
Gerrits et al. 2000; UK Treatment: FES leg cycle ergometry fatiguing stimulations (p=0.012).
Downs & Black score=16 training, 3 - 30 minutes sessions/week for 6 3. No change in contractile speed
Pre-post weeks. (using maximal rate of rise force),
N=7 Outcome Measures: Thigh girth, work ↓ mean ½ Rt (p=0.014) and the
output, contractile speed and fatigue degree of fusion diminished
resistance characteristics, including half (p=0.006).
relaxation time (½ Rt) and degree of fusion 4. ↓ Force responses at low
of electrically stimulated isometric stimulation frequencies.
contractions. 5. No change in thigh circumference.
Population: 13 males, ASIA class A, aged 1. ↑ cross-sectional area including:
24-46, C5-L1, 2-19 years post-injury. rectus femoris, sartorius, adductor
Treatment: A 3-phase, FES-assisted cycle magnus-hamstrings, vastus
ergometry exercise program leading to lateralis, vastus medialis-
FES-induced cycling for 30 minutes. intermedius (all p ≤ .025). No
Average program was 2.3X/week for 52.8 change in cross-sectional area of
Scremin et al. 1999; USA weeks. adductor longus and gracilis
Downs & Black score=16 Outcome Measures: CT-scan of legs to muscles.
Pre-post assess muscle cross-sectional area and 2. No correlations between total
N=13 proportion of muscle and adipose tissue number of sessions and magnitude
collected (pre-test, midpoint and post-test). of muscle hypertrophy.
3. There were significant increases in
the muscle/adipose tissue ratio
(p<0.05), muscle tissue in the thigh
and leg (p<0.05) but no changes in
the adipose tissue.
Population: 6 subjects with complete 1. Total work performed increased
paraplegia (T4-T12) at least 8 years post- (p<0.05) after training.
injury, 5 males, 1 female, age 28-43. 2. Paralysed vastus lateralis muscle
Treatment: FES leg cycle ergometry was altered with ↑ type IIA fibres, ↓
Crameri et al. 2002; training, 3 - 30 min/week for 10 weeks. type IIX fibres ↓ MHC IIx and ↑
Denmark Outcome Measures: Incremental exercise MHC IIA (p<0.05).
Downs & Black score=14 leg test to muscle fatigue (total work 3. Total mean fibre cross-sectional
Pre-post output), histological assessment, myosin area increase of 129%, ↑ cross-
N=6 heavy chain (contractile protein) (MHC), sectional area of type IIA and IIX
citrate synthase (a mitochondrial enzyme) fibres (p<0.05).
and hexokinase (enzyme needed to 4. ↑ Number of capillaries surrounding
produce muscle glycogen). each fibre (p<0.05).
5. ↑ Citrate synthase and hexokinase
activity (p<0.05).
6-5
Discussion
In general, all studies reviewed involving FES produced beneficial results on muscle functions
such as strength and endurance or muscle structure such as increased muscle size (i.e.,
reduced muscle atrophy). FES may have additional benefits over PES alone. In particular, the
study by Baldi et al. (1998) should be highlighted as it was the only randomized, controlled trial
(n=26) which compared FES (cycle ergometry exercise), PES (isometric exercise) and an
untrained control group. These investigators assessed lean body mass in 3 distinct body areas
(i.e., total body, lower limb, gluteal) as a marker of muscle atrophy in recently injured (˜10
weeks) individuals with motor complete SCI. Their results demonstrate that the FES-assisted
cycling program is effective in reducing atrophy and resulted in relative increases in lean body
mass in all areas after 3 and 6 months of participation. The PES-assisted isometric exercise
group also reduced muscle atrophy but had intermediate results between FES and no treatment
(their control group actually loss lean mass).
Reversal of muscle atrophy also appears feasible in more longstanding complete or motor-
complete SCI (i.e, > 2 years post-injury) SCI as shown by increases in muscle cross-sectional
area and the muscle/adipose tissue ratio using FES-cycling (Crameri et al. 2002; Scremin et al.
1999). However, controlled trials in chronic SCI are lacking.
Note that PES is often used to strengthen the atrophied muscles to some extent prior to FES
(Kern et al. 2005) and in some cases, FES is not possible unless PES is first used. Kern et al.
(2005) used a progressive PES - FES program for quadriceps building eventually leading to
FES-assisted standing in people with longstanding complete cauda equina injuries (>1.2 years
post-injury). These investigators demonstrated increases to the overall mean fiber diameter and
the proportion of total cross-sectional area covered by muscle fibers with training as compared
to an untrained group. However, the feasibility of providing life-long stimulation therapy to
subjects with denervation injuries is uncertain.
There was one null finding associated with muscle atrophy in that Gerrits et al. (2000) employed
a relatively shorter program of 6 weeks of FES-assisted cycling exercise in people with
longstanding motor complete SCI (> 1 year post-injury) and found no change in muscle size.
These non-significant results might be due to the measure of thigh circumference which may not
have been sufficiently sensitive to change, especially with the short intervention period and the
absence of a control group for comparison purposes.
In addition to improving muscle properties, FES-cycling can improve work output and endurance
(Crameri et al. 2002; Gerrits et al. 2000). For example, Gerrits et al. (2000) used a short (6
weeks) pre-post trial of FES-assisted cycling intervention in people with motor complete SCI
and found an increase resistance to fatigue in the quadriceps muscle and greater work output.
Some mechanistic investigations have been conducted which help to explain some of these
adaptations to muscle morphology and function with ongoing electrical stimulation exercise
programs. For example, using FES-assisted cycling, Koskinen et al. (2000) demonstrated an
increase in total collagen content as well as up- and down-regulation of proteins consistent with
muscle-building activity. Others have noted an adaptive response to FES-assisted cycling
exercise that serves to limit or alter the shift in the oxidative properties or fibre type composition
of muscles that typically occurs following SCI (Crameri et al. 2002)
6-6
Conclusion
There is level 2 evidence that a program of FES-assisted cycling exercise prevents and
reverses lower limb muscle atrophy in individuals with recent (~10 weeks post-injury)
motor complete SCI and to a greater extent than PES.
There is level 4 evidence that programs of FES partially reverses the lower limb muscle
atrophy found in individuals with long-standing (>1 year post-injury) motor complete SCI.
There is level 4 evidence that a program of FES-assisted cycle exercise increases lower
limb muscular endurance.
FES-assisted exercise programs are beneficial in preventing and restoring lower limb muscle
atrophy as well as improving lower limb muscle strength and endurance.
6.3 Gait Retraining to Achieve Functional Measures of Overground Ambulatory Capacity
There are several approaches to measure overground functional ambulation, as opposed to

neurophysiological or biomechanical measures of gait. These include objective measures of
walking speed or distance, or the use of qualitative functional scales or categories to describe
ambulatory capacity.
Walking speed is typically calculated from the time required for the subject to walk over 10 m
(10-m walk test, or 10MWT). Walking speed has also been calculated by measuring the total
distance traversed over a 2-minute period (Field-Fote 2001; Field-Fote et al. 2005).
Walking endurance is typically assessed by measuring the total distance traversed within 6
minutes (6-minute walk test, or 6MWT). This test was developed to assess fitness capacity in
patients with cardiopulmonary illnesses, but is now also often used to assess walking
endurance in patients with spinal cord injury e.g. (Hornby et al. 2005; Thomas & Gorassini 2005;
Wirz et al. 2005; Dobkin et al. 2006). Recently, both the 10MWT and the 6MWT have been
shown to be valid and reliable measures for assessing walking function in ambulatory
individuals with SCI (Van Hedel et al. 2005).
Ambulatory capacity may also be qualitatively described by the type of ambulatory aid used
during overground walking. The Walking Index for Spinal Cord Injury (WISCI) (Ditunno et al.
2000) and its current revision (the WISCI-II) (Dittuno & Dittuno 2001) is a 20-point scale that
measures the level of assistance and type of ambulatory aid required to walk 10-m. A score of 0
corresponds to an inability to stand or walk with assistance while the maximum score of 20 is
given when the subject can ambulate 10m without any personal or physical assistance (Dittuno
& Dittuno 2001). This measure has been shown to be a valid measure of ambulatory capacity in
patients with SCI (Ditunno et al. 2000).
There are other functional ambulatory scales in use by various investigators to describe walking
capacity in people with SCI. The Wernig Scale of Ambulatory Capacity (Wernig et al. 1995;
Wernig et al. 1998; Hicks et al. 2005; Effing et al. 2006) classifies people according to the
amount and type of assistance required to walk 5 steps, with classification levels ranging from
no walking capability to free walking for more than 5 steps. The Garrett Scale of Walking
classifies subjects according to their functional ambulatory status, ranging from a physiological
walker (hospital ambulation) to unlimited community ambulator (Scivoletto et al. 2000; Protas et
al. 2001).
6-7
6.3.1 Body-weight Supported Treadmill Training (BWSTT)
It has been more than a decade now since it was first demonstrated that body-weight supported
treadmill training (BWSTT) in animals can enhance locomotor activity after spinal cord
transection (Barbeau & Rossignol 1987; Edgerton et al. 1991). In this approach, partial body
weight support is provided by a harness suspended from the ceiling or a frame while limb
stepping movements are assisted by a moving treadmill belt. Since then, BWSTT strategies has
been introduced as a promising approach to improve ambulatory function in people with spinal
cord injury (Barbeau & Blunt 1991). This area of research has raised much excitement and
interest among rehabilitation specialists and neuroscientists.
In this review, we focus on the BWSTT intervention studies that report functional ambulation
outcome measures (such as walking speed). These studies tend to focus on individuals with
incomplete SCI lesions. There are a few studies reporting the effects of treadmill training on the
locomotor pattern in people with complete SCI lesions (Dietz et al. 1994; Dietz et al. 1995;
Wernig et al. 1995; Dietz et al. 1998; Wirz et al. 2001; Dietz & Muller 2004; Grasso et al. 2004).
While there is modulation of muscle (EMG) activity during body weight support treadmill-
assisted stepping in individuals with complete SCI lesions, there has not been any evidence for
functional ambulatory gains in this sub-population.
In people with incomplete SCI, much motor recovery already occurs within the first 2 months
post-injury; the rate of further recovery then decelerates over the next 3 to 6 months (Burns &
Ditunno 2001). However, it is possible for motor function to continue to improve up to 2 years
post-injury. For ease of interpretation, the studies reviewed in this section separate those that
investigated subjects <6 months post-injury (“acute/sub-acute”) from those that studied subjects
who were >6 months post-injury (“chronic”). In studies that used both types of subjects, the
results were divided by subject chronicity. In addition, only results from studies with more than 3
subjects of a given chronicity were included. Therefore, some studies that investigated both
chronic and acute SCI subjects may appear only in Table 6.4 because they had >3 chronic
subjects, but <3 acute subjects (e.g. Thomas & Gorassini 2005).
6.3.1.1 BWSTT in Acute/Sub-acute SCI
Table 6.3 Studies Using BWSTT in Acute/sub-acute SCI (<6 months post-injury)
Score
Methods Outcome
Research Design
Total Sample Size
Population: 117 men and women 1. No difference in Functional
(completed study), age 16-69 years, ASIA Independence Measure Locomotor
B-D; up to 8 weeks post-injury. Scale (ASIA B & C) or walking
Treatments: BWSTT (manual) vs. speed (ASIA C & D) between
conventional rehabilitation with overground groups.
mobility training. BWSTT group also 2. ASIA C & D subjects in both groups
Dobkin et al. 2006; USA practiced overground walking. Gait training improved walking function. No
PEDro=7 was 5X/week, 9-12 weeks, 30-45 improvement in walking function in
RCT min/session. Follow-up at 3 and 6 months the ASIA B subjects with either
N=117 post-training. intervention, except in subjects who
Outcome measures: primary: Locomotor improved to ASIA C within 8 weeks
Scale of the Functional Independence after injury.
Measure (ASIA B & C, n=108), walking
speed (ASIA C & D, n=72); secondary:

6MWT, WISCI.
Wernig et al. 1995; Population: Study 1: 0-4.5 months post 1. Study 1 (BWSTT): 7 initially non-
Germany injury. Study 2: 2-30 weeks post-injury. ambulatory tetraplegic subjects
6-8
Score
Methods Outcome
Research Design
Total Sample Size
Downs & Black score=9 Treatment: Study 1: BWSTT (manual, no progressed to walk with assistance
Case Control parameters presented) (n=12). Study 2: or with rollator. Five subjects
N=97 BWSTT (n=45), 2-22 weeks versus progressed from walking with aids
conventional rehab (n=40) (historical to walking independently.
controls). 2. Study 2: Of the non-ambulatory
Outcome measures: Wernig Scale of subjects, 33/36 progressed to
Ambulatory Capacity. walking with aids or independently
after BWSTT, but only 12/24
improved to functional walking with
conventional rehab.
Population: 41 subjects, incomplete, 3-16 1. 29/37 initially non-ambulatory
Wernig et al. 1998; weeks post-injury. subjects improved to walking with
Germany Treatment: BWSTT (manual). 30-60 min, aids.
Downs & Black score=12 5X/week, 3-22 weeks. 2. Follow-up (6 months to 6 years
Pre-post Outcome measures: Wernig Scale of post-training): 15 subjects showed
N=41 Ambulatory Capacity. continued improvement, 26 had no
change in ambulatory status
Discussion
For acute/sub-acute (< 6 months) incomplete SCI, there were 3 studies (n>3) reporting the
effects of locomotor training in subjects with using functional measures of ambulatory capacity
(Table 6.3). The general finding across these studies is that BWSTT with manual assistance
beginning during the acute/sub-acute post-injury period provides improvements in ambulatory
capacity in people with incomplete SCI. The studies of Wernig (Wernig et al. 1995; Wernig et al.
1998) showed that 87% (87/98) of their incomplete SCI subjects achieved improvements in
functional ambulation with BWSTT in the acute phases of injury. The lack of ambulatory change
in 13 subjects may be related to severe flaccid paralysis, high cervical lesion, or proprioceptive
disturbances (Wernig et al. 1995).
Although lower levels of study design (non-randomized, non-blinded) suggest that BWSTT in
acute/sub-acute SCI yields better outcomes than conventional rehabilitation (Wernig et al.
1995), there exists strong evidence from a single-blind RCT (Dobkin et al. 2006) (n=146) that
there are no differences in effects between BWSTT and overground mobility practice (standard
of care) in incomplete SCI during inpatient rehabilitation for walking speed or distance. In both
groups, improvements in walking function were particularly notable in subjects with ASIA C
(92%) or D (100%). Among the subjects who were initially classified as ASIA B, those who
improved to ASIA C within 8 weeks post-injury showed improved walking function. In addition,
subjects who entered the trial earlier (< 4 weeks post-injury) had faster walking speeds and
endurance post-training. This was particularly the case for subjects who improved in their ASIA
classification within 4 to 6 weeks post-injury.
The fact that both subjects in both treatment groups were provided with task-specific locomotor
training (on a treadmill or overground) may account for the lack of any difference in functional
outcomes observed (Dietz 2006). Both groups experienced similar durations of body loading
during therapy, either as a function of practicing standing or walking between parallel bars or
ambulatory aids overground, or practicing upright locomotion with body weight support and a
treadmill (Dobkin et al. 2006). In the older study that reported improved outcomes with BWSTT
compared to conventional rehabilitation (Wernig et al. 1995), the ‘conventional’ rehabilitation
was not well defined. The disparate results between these two sets of data may be accounted
for by the shift in recent years towards more intensive and task-specific rehabilitation therapy.
6-9
Conclusion
There is level 2 evidence using historical controls that BWSTT is effective in improving
ambulatory function. However, stronger evidence from one level 1RCT demonstrates
that BWSTT has equivalent effects to conventional rehabilitation consisting of
overground mobility practice for gait outcomes in acute/sub-acute SCI.
For patients less than 6 months post-SCI, body weight supported treadmill training has
equivalent effects on gait outcomes to conventional rehabilitation consisting of
overground mobility practice.
6.3.1.2 BWSTT in Chronic SCI
Table 6.4 Studies Using BWSTT in Chronic SCI (>1 year post-injury)
Score
Methods Outcome
Level
Total Sample Size
Population: 27 men and women, age 21- 1. No difference in outcome
64 years, incomplete, C3-T10. between groups, but a trend
Treatment: Randomized to 4 gait training towards better improvement in
strategies, 45-50 min, 5X/week, 12 weeks: groups who received FES (groups
Field-Fote et al. 2005;
1) BWSTT (manual leg movement) (n=7); 2 & 3).
USA
2) BWSTT+FES (common peroneal nerve) 2. Subjects with slower initial walking
PEDro=6
(n=7); 3) overground body weight support speed (< 0.1 m/s) had greater
RCT
walking+FES (n=7); 4) Lokomat (robotic percent increase in walking speed
N= 27
gait device with body weight support) compared to those with faster initial
(n=6). walking speeds.
Outcome measures: walking speed and
distance, step length, step symmetry.
Population: 44 subjects with para and 1. Study 1: 25/33 initially non-
tetraplegia. BWSTT (manual leg ambulatory could walk after
movement). BWSTT. At 6 months post-training,
Wernig et al. 1995;
Treatment: Study 1: 30-60 min, 5X/week, 18/21 ambulatory patients
Germany
3-20 weeks. Study 2: 29/44 subjects of maintained abilities.
study 1 compared with 24 chronic subjects 2. Study 2: 14/18 initially non-
Case Control
who underwent conventional rehab ambulatory subjects could walk
N=68
(historical controls). after BWSTT, compared with only
Outcome measures: Wernig Walking 1/14 in the conventional rehab
Capacity Scale. group.
Population: 14 men and women, age 20- 1. 6/14 subjects improved in walking
Hicks et al. 2005; 53 years, ASIA B (n=2) & C (n=12), C4-L1. capacity, but only 3 maintained
Canada Treatment: BWSTT (robotic). Up to 45 improvements at 8 months post-
Downs & Black score=18 min, 3X/week, 144 sessions (12 months). training.
Pre-post Outcome measures: Walking Capacity 2. 3/10 initially non-ambulatory
N=14 Scale (Wernig). subjects could walk (with
assistance) post-training.
Population: 20 men and women, age 16- 1. No statistical change in WISCI II.
Wirz et al. 2005; 64 years (mean 40, SD 14), ASIA C (n=9) 2. Among initially-ambulatory
Switzerland & D (n=11), C3-L1. subjects, there was an overall
Downs & Black score=17 Treatment: BWSTT (robotic). Up to 45 significant increase in 10MWT and
Pre-post min, 3-5X/week, 8 weeks. 6MWT.
N=20 Outcome measures: WISCI II, 10MWT,
6MWT.
Field-Fote 2001; USA Population: 19 men and women, mean 1. Significant increase in walking
Downs & Black score=15 age 31.7 (SD 9.4) years, ASIA C, para- speed (median: 77%).
Pre-post and tetraplegia.
6-10
Score
Methods Outcome
Level
Total Sample Size
N=19 Treatment: BWSTT + common peroneal
nerve FES. Up to 90 min, 3X/week, 12
weeks.
Outcome measures: gait speed.
Population: 14 men and women, age 18- 1. All subjects showed increase in
Field-Fote & Tepavac 50 years, ASIA C, C4-T7. walking speed (ranging from 0.01
2002; USA Treatment: BWSTT + common peroneal to 0.2 m/s increase).
Downs & Black score=13 nerve FES. Up to 90 min, 3X/week, 12 Subjects with slower walking
Pre-post weeks. speeds showed the greater %
N=14 Outcome measures: overground gait improvement.
speed.
Population: 6 men and women, age 29-78 1. Significant improvement in WISCI II
Thomas & Gorassini (mean 54.4, SD 14.8) years, ASIA C (n=4) score, 6MWT, and 10MWT and
2005; Canada & D (n=2), C5-L1. improvements correlated with the
Downs & Black score=12 Treatment: BWSTT (manual). Up to 60 increase in corticospinal
Pre-post min, 3-5X/week, 10-23 weeks. connectivity.
N=6 Outcome measures: 10MWT, 6MWT,
WISCI II.
Population: 35 men and women, age 19- 1. 20/25 initially non-ambulatory
70, C4-T12. improved to walking with aids.
Wernig et al. 1998; Treatment: BWSTT (manual). 30-60 min, 2. 2/10 ambulatory patients improved
Germany 5X/week, 8-20 weeks. functional class, but all improved
Downs & Black score=12 Outcome measures: Wernig Walking speed and endurance.
Pre-post Capacity Scale. 3. At follow-up (0.5-6.5 years later) all
N=35 ambulatory patients remained
ambulatory, with changes only in
functional class.
Discussion
Across 8 studies, there was a total of 158 chronic incomplete subjects (C3-L1) enrolled in some
form of body-weight supported gait retraining therapy. Gait retraining strategies were typically
performed with a treadmill and the assistance of therapists or the Lokomat, which is a robotic
gait device. The training protocols ranged from 30 to 90 minutes per day, occurred 3 to 5
times/week and lasted for 8 weeks to 12 months. All studies (and 82% of all subjects) reported
overall improvements in functional walking ability.
Subjects with initially-slower walking speeds (< 0.10 m/s walking speed) tend to make the most
improvements in locomotor function. Subjects with initially high walking capacity (> 0.10 m/s gait
speed) or severely impaired, initially non-ambulatory subjects tend to show little improvement
after gait retraining (Wernig et al. 1995; Wernig et al. 1998). Note that a large percent
improvement from an initially low walking speed can be a result of the mathematics. Of greater
clinical utility is an understanding of how gains in walking speed translate to everyday function.
For people with paraplegia, it has been suggested that an overground walking speed of at least
0.9 m/s is necessary for community ambulation (Cerny et al. 1980). None of the studies showed
attainment of walking speeds greater than 0.5 m/s. Nevertheless, even modest gains in walking
speed after treadmill training have been reported to translate into meaningful enhancements in
daily function (Field-Fote et al. 2005).
BWSTT with FES of the common peroneal nerve results in improvements in overground walking
speed in chronic incomplete SCI (Field-Fote 2001; Field-Fote & Tepavac 2002). However, there
is only a non-significant trend for better outcomes when electrical stimulation was combined with
6-11
treadmill or overground body weight support gait training in chronic SCI subjects compared with
locomotor training alone (Field-Fote et al. 2005).
Conclusion
There is Level 4 evidence from pre-test/post-test studies that BWSTT is effective for
improving ambulatory function in people with chronic, incomplete SCI. There is Level 1
evidence from 1 RCT that different strategies for implementing body weight support gait
retraining all yield similar ambulatory outcomes in people with chronic, incomplete SCI. It
is recommended that therapists may choose a body weight support gait retraining
strategy based on available resources (Field-Fote et al. 2005).
Body weight-support gait training strategies can improve gait outcomes in chronic, incomplete
SCI, but no body weight-support strategy (overground, treadmill, with FES) is more effective.
6.3.2 Special Case Report: Spinal Cord Stimulation Combined with BWSTT
There are 2 published reports (Herman et al. 2002; Carhart et al. 2004) describing the effects of
epidural spinal cord stimulation combined with gait training in a single subject (male with
incomplete tetraplegia, 43 years old, injury level C5-C6, ASIA C, 3.5 years post-injury). The
subject first underwent 12 weeks of BWSTT that resulted in some significant improvements in
treadmill gait parameters although overground ambulation remained limited. Subsequently, the
subject underwent surgical implantation of an epidural stimulation system placed over the T10-
T12 vertebral level. BWSTT and overground gait training in combination with epidural
stimulation commenced after surgical healing. The combination of epidural spinal cord
stimulation with gait training resulted in a substantial improvement in treadmill gait parameters
as well as in overground ambulation. The subject reported a decreased sense of effort, a
doubling in walking speed, and increased walking endurance when assisted by spinal cord
stimulation. This was associated with improved community and indoor functional ambulation.
Obviously, controlled trials of this specific intervention are required before spinal cord
stimulation combined with locomotor training can be recommended as a useful rehabilitation
strategy. Nevertheless, this special case report highlights one of the innovative and exciting
possibilities of technology.
6.3.3 Pharmacological Interventions
Drugs such as clonidine (a noradrenergic agonist), cyproheptadine (a serotonergic antagonist),

baclofen (GABA agonist), GM-1 ganglioside and 4-aminopyridine have been used in association
with attempts to improve ambulation in individuals with SCI. The results from animal studies
indicate that such drugs may act on the receptors in the spinal cord which facilitate interaction
with a locomotor central pattern generator (spinal circuits which produce coordinated locomotor
movement) (Barbeau et al. 1990; Chau et al. 1995; Rosssignol et al. 1996). Although not
conclusive, there is some evidence that similar “central pattern generator” circuits exist in
humans (Calancie et al. 1994; Illis 1995; Bussel et al. 1988; Bussel et al.1996a, 1996b) and
provide the rationale for clinical use of these drugs.
6-12
Table 6.5 Studies of Pharmacological Interventions for Enhancing Locomotion in SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI, chronic, ambulatory 1. Some positive effects for both
(ASIA D). placebo and 4-AP treatment when
Treatment: Double-blind, placebo- compared to baseline, but no
Deforge et al. 2004;
controlled, crossover design: 4- changes between groups were not
Canada
Aminopyridine (4-AP): 1 week of up- significant.
PEDro=10
titration prior to 2 weeks of 10 mg 4x/day
RCT
stable dosing of 4-AP (n=15) versus
N=29
Placebo (n=14) and then switch conditions.
Outcome measures: Isometric muscle
force, gait analysis.
Population: chronic, incomplete. 1. No significant differences were
Van der Bruggen et al. Treatment: Double-blind, placebo- found between groups, period,
2001; Netherlands controlled, crossover design: 4 weeks of cross over design, or treatment
PEDro=10 15-45 mg, immediate-release 4- effects.
RCT Aminopyridine capsules or Placebo. 2
N=20 week washout between conditions.
Outcome measure: walking speed.
Population: chronic paraplegia, complete 1. 1/3 ambulatory patients had
and incomplete. marked improvement in locomotor
Treatment: Double-blind, placebo- function resulting from Clonidine
controlled, crossover design: Two periods compared to Placebo.
of 4 weeks of medication (Clonidine or 2. Spasticity
Stewart et al. 1991; Placebo, randomly assigned) separated by (#Improvement/deterioration/no-
Canada a 2 week washout period. change resulting from Clonidine):
PEDro=8 Outcome measures: Kinematic measures Ankle reflexes 5/2/2, Knee reflexes
RCT during body weight support gait, spasticity, 5/0/2, spasticity visual analog scale
N=9 adverse effects. 6/1/2, Daily spasms 2/0/2, Daily
clonus 4/0/1.
3. Side effects of clonidine (8/9
patients): dry eyes and mouth,
lethargy, mild hypotension and
constipation.
Population: Chronic. 1. Irrespective of treatment order,
Treatment: Double-blind, placebo- GM-1 resulted in ↑motor scores,
Walker & Harris 1993;
controlled crossover study design: walking distance, ↑ walking
USA
Intravenous GM-1 ganglioside (Sygen®), 6 velocity.
PEDro=8
days per week. 6 month physical therapy
RCT
preceding 4 months of trial.
N=9
Outcome measures: Motor Score Walking
distance and velocity.
Population: spastic paraparesis of spinal 1. Descriptive results only.
origin, motor incomplete. 2. Compared to control,
Treatment: Randomized, double-blind Cyproheptadine resulted in 1) gait
Wainberg 1990; Canada cross-over design: Oral Cyproheptadine changes (↓ forward trunk flexion but
PEDro=7 (n=8) or placebo tablets (n=7) over 3 no change in EMG,↑ walking
RCT weeks (1 week each at 2mg, 4mg and 8mg speed, ↓ %stance time,↓ %double
N=15 5x/day) with a 1 week washout in between. support duration; 2) ↓ spasticity: all
Outcome measures: Kinematic and leg subjects reported a decrease in the
muscle activity (EMG) during gait, spasm severity and frequency of
severity, spasticity diary. involuntary movements.
Population: sub-acute to chronic (0.5-16 1. Only 5/8 ambulatory subjects could
Remy-Neris et al. 1999; years post injury). stand up and walk after 60 ug
France clonidine dose (2 showed
Treatment: Intrathecal Clonidine 60μg test
Downs & Black score=15 improvements).
dose (n=11) followed by 3 doses (15 to 90
Pre-post
μg) and a placebo injection (n=4). 2. One subject showed ↑ overground
N=11 speed (P>0.03), ↑ stride length
Outcome measures: Ashworth spasticity
6-13
Score
Methods Outcome
Research Design
Total Sample Size
scores, H-reflex, ambulation parameters, (P>0.0009) but not cycle duration
flexion reflexes. and higher doses impaired gait.
3. ↓ Ashworth score in all subjects. No
change seen in H-reflex. Flexion
reflex not enhanced with low doses.
Population: male, chronic, 6 tetraplegics, 1. Improvements in gait velocity (↑ by
3 paraplegics. 36% from 24.1 ± 16.5 m/min to
Treatment: 4-Aminopyridine (single 10mg 32.7 ± 22.9 m/min; (p ≤ 0.04); in
Segal & Brunneman;
immediate-release capsule). stride length (↑ from 0.9 ± 0.3
1998; USA
Comparison of means at baseline and at meters to 1.0 ± 0.3 meters, p≤
intervals over 24-hour follow-up. 0.02); ↑ cadence and gait cycle
Pre-post
Outcome measures: Ambulation duration, but not significant.
N=9
parameters. 2. Gait changes began 6 hours after
drug administered and persisted
the 24 hour follow-up.
Population: chronic, incomplete, 1. 7/12 subjects had evaluations of all
traumatic. 3 drugs; adverse effects for 4/5
Treatment: 3 different oral tablets in order subjects prevented completion of
of convenience: Clonidine (≤0.25 mg/day) all conditions. The greatest effects
or Cyproheptadine (≤24 mg/day) or in more severely disabled subjects.
Baclofen (≤80mg/day): each drug trial had 2. Cyprohyeptadine resulted in↓need
Norman et al. 1998; incremental increase to maximum dose for assistance, ↑ in maximum
Canada and stable dosing over 3 weeks followed treadmill speed and ↓ clonus.
Downs & Black score=13 by incremental decrease from maximum Clonidine resulted in ↑maximal
Pre-post dose and washout over 2 weeks. treadmill speed and a generally
N=12 Outcome measures: Surface EMG and more upright posture. Baclofen
kinematic gait analysis during treadmill resulted in minor changes in
walking. No statistical analysis. walking. Maximal treadmill speed
increases and other changes were
often retained following washout of
drugs.
Discussion
The interactions of these pharmacological interventions are complex and appear to affect
walking ability and spasticity to varying effects. The studies on clonidine (oral or intrathecal),
cyproheptadine and baclofen demonstrate improvements in various aspects of gait (i.e. walking
speed, posture, spasticity), but no improvements led to significant functional improvements in
walking. Norman et al. (1998) found the greatest improvements in more severely disabled
subjects and in many cases, the drug effects were retained following washout of drugs.
Bradycardia and hypotension, common side-effects of oral clonidine can be ameliorated with
intrathecal injection of clonidine (150-450µg) (Filos et. al. 1994). The combined effect of
different drugs has not been well explored. One very small study (not tabled due to its small
sample size of 2 subjects) (Fung et al. 1990) showed that a combination of Clonidine,
Cyproheptadine and treadmill training improved SCI locomotion in 2 subjects.
Conflicting evidence exists on the use of GM-1 ganglioside for neurologic recovery for walking in
SCI. The small RCT conducted by Walker and Harris in 1993 (N=9) concluded that the use of
GM-1 ganglioside improved motor scores, walking distance and walking speed in chronic SCI
subjects. A recent large scale multicenter RCT (n=760) (Geisler et al 2001) suggested that
although GM-1 treatment may have accelerated initial SCI recovery (at 8 weeks), it did not
improve the final extent of recovery (26 weeks). However, walking ability was not assessed
given the subjects who ranged from ASIA A to D.
6-14
The effects of immediate release, 4-aminopyridine capsules on ambulation are conflicting with 2
RCTs suggesting no benefit (vander Bruggen et al. 2001, n=20; Deforge et al. 2004, n=15).
However, the van der Bruggen et al. (2001) hypothesis was not directed solely at exploring the
effects on walking and therefore the heterogenous nature of the subject groups may have
confounded the ambulation results. Furthermore, differences in intervention (i.e. 10mg single
dose, 15-45mg/day over 4 weeks in the Deforge et al. study versus 10mg 4X/day for 8 days in
the Van der Bruggen et al study and the lack of consistent clinically relevant outcome measures
complicates the interpretation of the available evidence.
Conclusion
In summary, level 1 evidence describes limited and indirect improvements in aspects of

walking (i.e. spasticity, speed and posture) but do not translate into significant functional
walking gains as a result of clonidine and cyproheptadine. Limited and non-functional
improvements in walking as a result of baclofen are only supported by level 4 evidence.
Conflicting evidence provides little guidance with respect to the use of GM-1 and 4-
aminopyridine for the improvement of ambulation in spinal cord injury. Scientifically
robust studies with consistent clinically relevant outcome measures are needed for
pharmacological intervention studies of ambulation after spinal cord injury.
There is little evidence that any pharmacological agent is significantly beneficial in directly
improving ambulation in individuals with SCI.
6.3.4 Functional Electrical Stimulation (FES)
The idea of compensating for paralyzed function using electrical stimulation was introduced as
early as the 1960s (Liberson et al. 1961). Functional electrical stimulation of the common
peroneal nerve was found to be effective in assisting foot clearance during the swing phase
(Liberson et al. 1961). There has also been a report of attempts to stimulate the ankle
plantarflexor muscles to assist push-off at the end of stance and enhance the initiation of the
swing phase in subjects with incomplete SCI (Bajd et al. 1999). Approaches that focus on swing
phase activity are more suitable for less severely disabled individuals who have adequate
balance to support their stance leg during gait. There are also more complex systems that
involve several channels of stimulation that support proper extension as well as foot clearance
during swing (e.g. Sigmedics 2000). These are more suitable for patients who require
assistance in standing as well as gait, such as those with neurologically complete SCI. FES
systems such as the Parastep or ALT-2 provide stimulation of thigh extensor muscles
(quadriceps, gluteal muscles) to support extension and standing, as well as stimulation of the
common peroneal nerve to assist with swing phase movements. FES may also be combined
with bracing to counter trunk and hip instability (Solomonow et al. 1997a).
One of the limitations of surface FES is possible skin irritation, discomfort under the electrodes,
or difficulties with proper positioning of the electrodes. With improvements in electronics
technology, FES systems are becoming smaller and more amenable for everyday use. In
addition, some patients have opted for implanted FES systems that may be inserted without
surgery. These systems offer a more precise delivery of stimulation, enabling greater muscle
selectivity, and the ability to access deeper muscles, such as the hip flexors (Kobetic et al.
6-15
1997). Percutaneous electrodes, which are inserted through the skin with a hypodermic needle,
offer one possibility to circumvent complications with surface electrodes (Marsolais & Kobetic
1986; Kobetic et al. 1997). However, there may be complications due to infection or irritation at
the site of insertion, and electrode movement or breakage (Agarwal et al. 2003). More recently,
there was a case study reporting positive effects with a BION microstimulator in an incomplete
tetraplegic subject with drop-foot (Weber et al. 2004). Thus, preliminary reports of the use of
such innovative FES technology are promising, but further study is warranted to determine the
long-term stability and efficacy of such implanted systems.
Table 6.6 Studies Using Functional Electrical Stimulation to Improve Locomotor Function
Score
Methods Outcome
Research Design
Total Sample Size
Population: 15 men and women, age 16- 1. 13 subjects completed training. All
47 years, T3-T11, Frankel A, B (n=1), and could ambulate independently with
C (n=1), 6-240 months post-injury (some the Parastep system after ~14
Brissot et al. 2000; same subjects as Gallien et al. (1995). sessions.
France Treatment: Surface FES: Parastep® 6 2. The mean walking distance without
Downs & Black score=17 channels (bilateral common peroneal a rest was 52.8 m (SD 69 m; range:
Post-test nerve, quadriceps, glutei/lumbar muscles), 1-350 m). The mean speed was
N=15 mean of 20 sessions. 0.15 m/s (SD 0.14 m/s; range:
Outcome measures: ambulatory status, 0.03-0.4 m/s). 5/10 patients with a
walking distance and speed (with FES). 3 year follow-up continued to use
the system at home.
Population: 14 (but only 10 subjects 1. Mean increase of 0.10 m/s in
analyzed), age 25-49 years, C3-L1, walking speed (over the first year of
incomplete, 1.8-19.1 years post-injury. FES-use (measured with and
Ladouceur & Barbeau;
Treatment: Surface FES: bilateral or without FES).
2000a; Canada
unilateral common peroneal nerve, home
use as much as possible ~1 year (26 and
Pre-post
56 weeks), 2 subjects also had bilateral
N=14
quadriceps.
Outcome measures: temporal gait
measures.
Population: 16 men and women, mean 1. Most subjects improved endurance
age 28.4 (SD 6.6) years, T4-T11, and gait speed. Longest distance
complete, 0.7-9.0 years post-injury. walked with FES was between 12
Klose et al. 1997; USA Treatment: Surface FES: Parastep®I: 6 to 1707 m (mean: 334 m; SD 402
Downs & Black score=15 channels (bilateral common peroneal m).
Pre-post nerve, quadriceps, glutei). 3X/week, 32
N=16 sessions (once subjects had sufficient
strength to stand).
Outcome measures: walking distance and
speed (with FES).
Population: 6 men and women, age 20-40 1. Significant mean increase in stride
years, C3-L1, Frankel C & D, 2 to 18 years length, but not speed or cadence.
post-injury. 2. 3 to 4 subjects had significant
Granat et al. 1993;
Treatment: Surface FES: quadriceps, hip individual increases in gait speed,
Scotland
abductors, hamstrings, erector spinae, stride length and cadence.
common peroneal nerve,
Pre-post
home program >30 min, 5X/week, 3
N=6
months.
Outcome measures: walking speed, stride
length, cadence.
6-16
Score
Methods Outcome
Research Design
Total Sample Size
Population: 14 (but only 10 subjects 1. All subjects showed an
analyzed), age 25-49 years, C3-L1, improvement in functional mobility.
incomplete, 1.8-19.1 years post-injury 7/14 subjects showed improvement
(same subjects as in Ladouceur & Barbeau based on type of ambulatory
Ladouceur & Barbeau
2000a). device.
2000b; Canada
Treatment: Surface FES: bilateral or 2. When walking with FES, 13/14
unilateral common peroneal nerve, 2 subjects improved gait speed.
Pre-post
subjects also had bilateral quadriceps, Ambulatory improvements were still
N=14
home use as much as possible ~1 year. evident when the FES was turned
Outcome measures: temporal gait off during walking in12/14 subjects,
measures. suggesting a training, or carryover,
effect with long-term FES-use.
Population: 31, mean age 36 (SD 2) 1. Overall improvement in gait speed
years, injury level above lumbar levels, which persisted even when
incomplete, mean 6 (SD 1) years post- subjects walked without FES.
Wieler et al. 1999; injury, 4 centres. 2. Mean increase in speed was 0.14
Canada Treatment: Surface FES: common m/s (SE: 0.03 m/s) (although mixed
Downs & Black score=13 peroneal nerve; some subjects also stroke and SCI results). Greatest %
Pre-post received FES to hamstrings, quadriceps, improvements particularly for the
N=31 gluteus medius, duration of FES ranged initially slow walkers.
from 3 months to over 3 years.
Outcome measures: walking speed, stride
length, cycle time.
Population: 13 men and women, age 17- 1. Independent ambulatory distances
42 years, T4-T10, complete, 5-240 months 2 to 350m (mean 73.25 m, SD 102
Gallien et al. 1995;
post-injury. m) and speed 0.2 to 0.6 m/s (mean:
France
Treatment: Surface FES: Parastep®: 6 0.2 m/s, SD 0.1 m/s).
channels (bilateral common peroneal 2. Poorer performances were
Post-test
nerve, quadriceps, glutei). observed in more chronic subjects.
N=13
Outcome measures: walking distance and
speed (with FES).
Population: age 20-44 years, C2-T10, 1. All subjects improved gait speed
incomplete, 2.5-10 years post-injury. when FES was on (mean change
Stein et al. 1993; Canada Treatment: Surface, percutaneous, or was 4 m/min), particularly
Downs & Black score=6 implanted FES of common peroneal nerve, significant for more disabled
Pre-post and sometimes quadriceps, glutei, and subjects.
N=10 psoas.
Outcome measures: speed, gait
parameters
Discussion
To date, there are no randomized controlled or blinded assessments of the efficacy of any form
of FES to improve mobility after SCI. Results from the experimental pre-test/post-test studies
reviewed here show that almost all the participants showed improvements in gait parameters
(walking speed or distance) when FES was used. This is not surprising, given that the FES
could compensate for weakened or paralyzed muscle function during gait. Of greater interest is
the finding of carryover effects after FES training. After completion of an FES-training program,
improvements in gait function persisted even when the stimulator was turned off (Wieler et al.
1999; Ladouceur & Barbeau 2000; Johnston et al. 2003). This suggests that neuroplastic
changes may have taken place in response to regular use of FES during walking. Indeed, it has
been shown in non-disabled human subjects that the combination of treadmill walking and FES
led to an acute increase in corticospinal excitability that persists even after the cessation of FES
6-17
(Kido Thompson & Stein 2004). Improved muscle strength and conditioning after regular use of
FES could also contribute to carryover effects in walking function (Granat et al. 1993).
Although laboratory studies advocate the efficacy of FES systems for improving ambulatory
function in patients with SCI, the effectiveness of any technology is only as good as its
acceptance by the intended users. Wieler et al (Wieler et al. 1999) reported that the majority of
their subjects found they could use the FES device easily on a regular basis and that they
walked better with the FES. Those who reported difficulties reported problems with finding the
proper stimulation site or technical difficulties with the leads, switches, or electrodes. There
have also been reports of musculoskeletal complications such as ankle sprain, calcaneum
fracture, back pain, or falls with FES use (Gallien et al. 1995; Brissot et al. 2000). Some of these
complications may have been associated with commencement of upright exercise (gait) after a
period of being non-ambulatory. Anecdotal reports found in several studies suggest that most
subjects mainly use FES indoors or at home, for short distance walking, to prevent
complications due to prolonged immobilization, and to enhance physical fitness rather than
functional community ambulation (Gallien et al. 1995; Klose et al. 1997; Brissot et al. 2000).
Subjects who do use FES outdoors for community ambulation tend to be the less severely
impaired (Granat et al. 1993; Brissot et al. 2000).
The functional benefits derived from FES are also quite variable. For instance, Stein et al. (Stein
et al. 1993) report that most subjects showed a modest improvement in gait speed (average: 4
m/min), which was more significant for the more severely disabled subjects. Higher-functioning
subjects felt that this small benefit in gait speed did not warrant the daily use of FES. In contrast,
(Ladouceur & Barbeau 2000) reported that there was a tendency for the subjects with initially
faster gait speed to have greater absolute improvements. Thus, outcomes from FES-use also
seem to be quite variable in terms of walking speed (Stein et al. 1993; Ladouceur & Barbeau
2000) or distance (Klose et al. 1997).
Conclusion
There is Level 4 evidence that FES-assisted walking can enhance walking speed and
distance in complete and incomplete SCI. There is also Level 4 evidence from 3
independent laboratories that regular use of FES in gait training or activities of daily
living leads to persistent improvement in walking function that is observed even when
the stimulator is not in use.
FES-assisted walking can enable walking or enhance walking speed in incomplete SCI or
complete (T4-T11) SCI. Regular use of FES in gait training or activities of daily living can lead
to improvement in walking even when the stimulator is not in use.
6.3.5 Orthoses/Braces
6.3.5.1 Bracing alone in SCI
There are several available devices used for bracing the legs in order to support standing and
walking function, particularly for people with complete SCI. These range from single-joint
bracing (e.g. ankle-foot orthosis), usually for individuals with low, incomplete spinal lesions, to
whole-leg/long-leg braces that extend from the lower back to the ankle. Among the most
common long-leg braces studied in the literature are the purely mechanical Parawalker (Rose
6-18
1979) or the Reciprocating Gait Orthosis (RGO) (Douglas et al. 1983). These devices may also
be combined with FES to augment gait function and efficiency (Nene and Patrick 1990; Yang et
al. 1996; Marsolais et al. 2000). These devices must be used with a walking aid (e.g. crutches
or walker) for functional ambulation.
Table 6.7 Studies of Bracing Interventions in SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: 10 men and women, mean 1. No differences between orthoses
age 37 years (SD 8.4), T9-T12, motor re: donning/doffing (“independent”),
complete, 4-19 years post-injury. stairs and curbs (“stand-by” or
1
Treatment: Walkabout Orthosis (WO ) vs. “minimal”), or level gait
Isocentric Reciprocal Gait Orthosis (“independent” or “stand-by”).
(IRGO2): training with first orthosis 2-3 2. Tendency for better performance
hours, 2-3X/week for 6-8 weeks, followed with IRGO for flat walking, ramp
Harvey et al. 1997; by 3-month home trial period. 2-month walking, and stairs. Faster gait with
Australia wash-out period (no orthosis) followed by IRGO on flat (mean IRGO=0.34
Downs & Black score=17 other orthosis. m/s ± 0.18, mean WO=0.14 m/s ±
Post-test Outcome measures: functional skills (e.g., 0.12; p=.002) and on inclined
N=10 curbs, stairs, donning/doffing, sit-stand), surfaces. IRGO allowed more
Functional Independence Measure, gait independent gait; WO easier to go
speed over flat and inclined surfaces. from sit-stand and stand-sit.
3. Neither orthosis enabled subjects
to be fully independent in the key
skills necessary for functional
ambulation after 8 weeks of
training.
Population: 3 men, age 22 to 28 years, T8 1. The orthosis enabled all subjects to
-T12, complete (ASIA A), 8-12 months independently ambulate with
Nakazawa et al. 2004;
post-injury. canes.
Japan
Treatment: Weight bearing control orthosis 2. All 3 subjects increased gait speed
(WCBO), a long-brace reciprocating gait from 0.13, 0.22, 0.37 m/s to 0.20,
Pre-post
orthosis: training occurred 1 hour, 5X/week 0.35, 0.43 m/s, respectively.
N=3
for 12 weeks.
Outcome measures: walking speed.
Population: 24 men and women, mean 1. 11/24 patients had stopped using
age 33.6 years (SD 3.2), T1-T12, complete RGO at 1-year follow-up, but there
(ASIA A), mean 5.3 years (SD 2.1) post- was no difference between the
injury. RGO-users and RGO-non-users in
Treatment: RGO: training provided and terms of gait speed, stair climbing,
then subjects given braces for home-use or use of ambulatory aid. However,
Scivoletto et al. 2000; for 1 year. the RGO-users achieved a higher
Italy Outcome measures: gait speed, going up functional ambulatory capacity
Downs & Black score=14 and down stairs, use of walker or crutches, (Garrett Scale) than non-users.
Post-test Garrett Score (out of 6; 6 = community 2. RGO-users achieved home
N=24 ambulation with no limitations; 1=hospital ambulation with limitations or home
ambulation). ambulation (Level 2-3) while non-
users achieved hospital ambulation
or home ambulation with limitations
(Level 1-2).
3. No one reached community
ambulation levels.
1
Similar model to the MSH-KAFO
2
Successor model to the RGO (uses a central pivot bar and tie rod arrangement instead of crossed-cable to couple
hip flexion/extension). The IRGO is thought to be less fatiguing for subjects compared to RGO Winchester et al.
(1993).
6-19
Score
Methods Outcome
Research Design
Total Sample Size
Population: 5 men, age 26-36 years, T5- 1. 4 of 5 were able to stand without
L1, 4 complete (Frankel A) and 1 crutches with MSH-KAFO (1
incomplete (Frankel C), 8.4-70 months subject needed parallel bars).
post-injury. 2. 3/5 could climb stairs with crutches
Saitoh et al. 1996; Japan Treatment: Medially-placed Single-axis and rail. Donning and doffing brace
Downs & Black score=10 Hip joint with long-leg hip-Knee-Ankle-Foot took only 3-4 minutes.
Pre-post Orthosis (MSH-KAFO). Patients were 3. After 3-10 months of therapy, gait
N=5 trained to stand and walk using device speed improved from 0.05-0.2 m/s
daily for 2 weeks, followed by an exercise to 0.17-0.63 m/s) and walking
program 1-2 times/week. distance ranged from 300 to 4000
Outcome measures: walking speed and m.
distance.
Population: multicentre, 74 men and 1. At discharge, 28 patients could
women, mean age 27 years, T1-T12, climb stairs (13 with crutches, 15
complete (Frankel A & B), mean 37 years with a walker).
post-injury. 2. The ability to climb stairs or Garret
Treatment: Orthoses: RGO (n=53), score at discharge was associated
Franceschini et al. 1997;
Advanced RGO (RGO with links between with continued orthosis-use. 31
Italy
mechanical hip joints and hip and knee patients achieved functional gait
joints) (n=17), and Hip Guidance Orthosis (Garrett = 2-5) and 9 achieved
Post-test
(HGO) (n=4). Individual treatment included community ambulation (Garrett=4-
N=74
practice at don/doff device and functional 5). 19 used orthosis only for
mobility. Follow-up at hospital discharge exercise (Garrett=1).
and 6 months later.
Outcome measures: Garrett Score, ability
to climb up and down 12 steps.
Population: 22 men and women, age 21 1. No significant differences between
to 44 years, T3-T12. the orthoses in terms of gait speed,
Treatment: Hip Guidance Orthosis (HGO), cadence, and stride length.
also known as Parawalker combined with 2. Mean walking speed with either
crutches vs. Reciprocating Gait Orthosis orthosis was 0.24 m/s.
(RGO) combined with rollator walker. 3. The HGO was much quicker to put
Groups matched for age and level of injury. on and to take off. The RGO was
Whittle et al. 1991; UK Practice period followed by 4 month home quicker on most of the other
Downs & Black score=12 use before being switched to the second ergonomic tests, but this was
Post-test orthosis. significant only for standing up and
N=22 Outcome measures: walking speed, climbing up a curb.
cadence, stride length. 4. At the end of the trial 12 subjects
chose to keep the RGO, 4 the
HGO, and 6 kept neither. The
rollator prescribed for use with the
RGO may have influenced
subjects’ preference to keep the
RGO system.
Discussion
The level 4 (primarily pre-test/post-test studies) reviewed here indicate that these devices
facilitate the ability of people with sub-acute (as low as 4 months post-injury) or chronic
complete paraplegia to rise from sitting to standing independently and to achieve some modest
gains in ambulation (Thoumie et al. 1995; Saitoh et al. 1996; Harvey et al. 1997; Scivoletto et al.
2000). In general, however, the use of any of the braces investigated in these studies did not
greatly enhance the ability of complete paraplegic subjects to be fully independent for functional
community ambulation (Hong et al. 1990; Harvey et al. 1997; Scivoletto et al. 2000), although
community ambulation was reported in some subjects in one study (Franceschini et al. 1997).
6-20
Maximum walking speeds achieved with orthosis-use range from 0.14 to 0.63 m/s, which is 13
to 57% of the optimal speed (1.1 m/s) required for successful community ambulation (Robinett &
Vondran 1988). In a few studies, some subjects demonstrated the ability to climb up and down
stairs with the assistance of crutches or walker (Whittle et al. 1991; Franceschini et al. 1997;
Harvey et al. 1997). Thus, the greatest benefit derived from orthosis/brace-use is from
enhanced home or indoor mobility, for general exercise and health benefits, and psychological
benefits from attaining upright posture and standing (Mikelberg & Reid 1981; Hong et al. 1990;
Sykes et al. 1996).
The successful use of orthoses/braces is also dependent on other more individual and practical
factors. It has been recommended that orthoses or braces are best for people who are well-
motivated, with complete SCI at T9 or below or incomplete SCI at any level, with good postural
control and good level of fitness (Hong et al. 1990; Thoumie et al. 1995; Franceschini et al.
1997). Medical problems such as limited thoraco-lumbar mobility or mechanical back pain, or
any musculoskeletal problems that make standing upright uncomfortable tend to interfere with
successful use of these orthoses/braces (Harvey et al. 1997; Middleton et al. 1997).
The ability for a patient to don/doff the orthosis without difficulty and relatively quickly (e.g. <5
minutes) also appears to enhance the probability of their acceptance (Mikelberg & Reid 1981;
Hong et al. 1990; Thoumie et al. 1995; Saitoh et al. 1996; Franceschini et al. 1997; Harvey et al.
1997; Scivoletto et al. 2000). Frequent reports of technical problems (e.g. mechanical
breakdown at the hinges, improper fitting) across many studies (Mikelberg & Reid 1981; Whittle
et al. 1991; Thoumie et al. 1995; Harvey et al. 1997; Scivoletto et al. 2000) suggest that
appropriate technical support of these mechanical devices is necessary to enhance ongoing use
of these braces (Whittle et al. 1991).
Overall, it appears that most subjects feel that the difficulties and inconvenience encountered
with orthoses/braces and the modest increase in function do not warrant their acceptance for
regular, daily use in functional activities (Mikelberg & Reid 1981; Hong et al. 1990; Sykes et al.
1996; Harvey et al. 1997). It has been suggested that the therapeutic benefits of orthosis-use
(e.g. health benefits from standing practice) should be stressed to patients rather than setting
forth an expectation that they will enhance functional ambulation and be a replacement for
wheelchair-use (Franceschini et al. 1997). However, it must be noted that for people with
incomplete SCI, bracing (AFO-use) alone during walking can enhance gait speed and
endurance compared to walking without an AFO (Kim et al. 2004).
Conclusion
None of the studies investigating the efficacy of brace/orthotic devices for upright
support and mobility are randomized or blinded, but that is in part due to the ethical
dilemma of providing safe and appropriate bracing and the fact that participants will be
able to distinguish which device they received. There is weak evidence from post-test
studies that bracing alone results in significant gains in functional ambulation for people
with complete SCI. Only 2 studies reported pre-test/post-test results (total n = 8) that the
use of long-leg braces could enhance gait speed and endurance in people with complete
SCI.
6-21
There is limited evidence that bracing alone does not enable significant gains in functional
ambulation for people with complete SCI. The advantages of bracing appear largely restricted
to the general health and well-being benefits related to practice of standing and the ability
to ambulate short-distances in the home or indoor settings. The benefits of bracing-alone
on functional ambulation are primarily with people with incomplete spinal lesions.
6.3.5.2 Bracing Combined with FES in SCI
Energy expenditure of walking facilitated by bracing alone in spinal cord injury is extremely high
and contributes to its low use. Hybrid systems combine conventional bracing with FES to
activate large lower extremity muscles in the hopes of improving the gait pattern and reduce
upper extremity exertion. The additional FES is used to improve trunk and hip stability and to
facilitate forward progression.
Table 6.8 Studies of Bracing Interventions combined with FES in SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: 26 men and women, age 20- 1. 21/26 completed the training
53 years, C8-T11, complete, 9-144 months program, 19 were able to stand up
post-injury. alone. Following program, walking
Treatment: RGO-II orthosis: long-leg distance ranged from 200-1400 m
brace with reciprocal hip joint combined with hybrid orthosis, 150-400 m
with FES to the quadriceps and with RGO II.
Thoumie et al. 1995;
hamstrings. 4-6 weeks of gait training with 2. Maximal walking speed with the
France
orthosis alone followed by RGO-II+FES hybrid orthosis (mean 0.32 m/s; SD
(hybrid) program (total program time: 2-5 0.02; range 0.21-0.45 m/s) was not
Pre-post
months inpatients, 3-14 months significantly different from that with
N=26
outpatients). orthosis alone (mean 0.29 m/s; SD
Outcome measures: walking distance and 0.03; range 0.22-0.41 m/s).
speed with RGO and with RGO+FES. 3. A two-month follow-up study
revealed that, out of 15 patients
using the hybrid orthosis, 11 were
home users.
Population: 70 men and women, age 16 1. After training, 57 patients could
to 50+, C6-T12, 1-10+ years post-injury. walk at least 180 m (19 could walk
Treatment: RGO +/- FES. Orthosis-use >450 m). 77% of patients could
Solomonow et al. 1997b;
and gait training of 1-3 hours, 3X/week for walk independently on different
USA
6 weeks. In patients with injury level above surfaces (grass, ramps, curbs).
T10, FES was added (bilateral quadriceps
Post-test
and hamstrings) with up to 6 more weeks
N=70
of gait training.
Outcome measures: walking ability, 180m
walk.
Population: 6 men and women, age 22-50 1. Subjects who were unable to use
years, C7-T12, severity not reported, 2.5- RGO alone could ambulate with
20.6 years post-injury. hybrid system. 3 subjects (all
Marsolais et al. 2000; Treatment: Case-Western Reserve paraplegics) who were previously
USA University Hybrid Gait Orthosis: IRGO ambulatory with either RGO or FES
Downs & Black score=11 combined with FES to various muscles alone showed improvement in
Pre-post (combination of 8-16 muscles). walking distance with the hybrid
N=6 Outcome measures: walking speed and system (from 3-90 m to 200-350
distance. m).
6-22
Score
Methods Outcome
Research Design
Total Sample Size
2. 2 of the subjects were capable of
stair-climbing with the hybrid
system.
Population: 3 subjects, age 28-42 years, 1. Use of the RGO with FES was
C6 -T8 (tetraplegic incomplete, paraplegics associated with modest (non-
complete), 3-15 years post-injury. significant) increase in walking
Yang et al. 1996; UK Treatment: RGO ± FES. RGO with and speed and stride length compared
Downs & Black score=11 without FES to common peroneal nerve with RGO with no FES.
Pre-post stimulation. 2. When subjects walked with the
N=3 Outcome measures: walking speed, stride RGO+FES, average walking speed
length.
3. was 13% faster and stride length
was 5% longer.
Population: 5 subjects, age 24-37 years, 1. Number of steps taken per week
C2 -T6 (2 tetraplegics ASIA A & C, 3 varied between 306 and 1879 steps
paraplegics ASIA A & B), 8-14 years post- (=99-845 m/week).
injury. 2. Use of the RGO was low and no
Sykes et al. 1996; UK Treatment: RGO and FES. 20-40 weeks of increase in use or function after
Downs & Black score=13 RGO use at home followed by hybrid hybrid system supplied.
Observational system (RGO combined with FES. 3. 1 subject (ASIA C) was already a
N=5 bilaterally to quadriceps and hamstrings). community ambulator and showed
Outcome measures: RGO pedometer most frequent use of RGO but
measured number of steps over 18 across all subjects, RGO-use was
months. variable, intermittent and generally
poor.
Discussion
There does not seem to be much further benefit of combining FES with orthosis-use in terms of
maximal walking speed (Thoumie et al. 1995; Sykes et al. 1996; Yang et al. 1996), although
greater walking distance may be achieved (Thoumie et al. 1995; Marsolais et al. 2000).
Biomechanical studies (not included in the summary tables if they did not have a training period)
provide some insight into the relative benefits of FES versus bracing. One study that has
compared FES-alone with bracing-alone found that FES provides a particular advantage in
facilitating sit-to-stand movements and donning the system in young (<18 years old) patients
with chronic motor complete SCI (Bonaroti et al. 1999). However, mobility (e.g. walking, stairs)
once standing was achieved was not found to be different between FES and bracing. In
incomplete SCI, FES-use was found to result in greater benefits in terms of walking speed while
bracing alone (with an AFO) was found to be particularly advantageous for improving walking
distance (Kim et al. 2004). However, the combination of AFO with FES provided improved gait
benefits than either device used alone (Kim et al. 2004).
Conclusion
There is Level 4 evidence that a combined approach of bracing and FES results in
However, in subjects who are achieve little benefit from bracing alone, the addition of
FES appears to help improve standing or short-distance walking function (Marsolais et
al. 2000). In incomplete SCI, however, there is some indication that a combination of
bracing and FES provides greater ambulatory function than either approach alone (Kim
et al. 2004).
6-23
There is limited evidence that a combined approach of bracing and FES results in additional
benefit to functional ambulation in paraplegic patients with complete SCI.
6.3.6 Enhancing Strength Following Locomotor Training
Much research is focused on the development of effective therapies directed at enhancing

locomotion. Typically, as noted earlier in this chapter, the majority of these investigations focus
on individuals with incomplete SCI and also predominately employ ambulation-related outcome
measures. However, some investigators have also examined the effect of locomotor training on
enhancing lower limb strength as a secondary measure, or in other cases have examined the
relationship between changes in lower limb strength and walking ability. For the most part, these
therapies include a form of body-weight supported treadmill training (also termed Laufband
Therapy). In these therapies, the patient’s limb movements may also be assisted by any (or a
combination) of the following: therapist, appropriately timed stimulation (i.e., FES) or a
robotically controlled servo-mechanism (Wernig et al. 1995; Wernig et al. 1998; Field-Fote 2001;
Hornby et al. 2005; Wirz et al. 2005). In other locomotor studies involving strength measures,
locomotor training consisted of overground walking assisted by FES (Johnston et al. 2003;
Granat et al. 1993) or a combination of this with treadmill and biofeedback training (Petrofsky
2001). In the present section, the outcomes associated with the strength benefits of these
studies will be presented.
Table 6.9 Locomotor Training Studies Examining strength Measures

Score
Methods Outcome
Level
Total Sample Size
Population: 10 male patients with 1. Gains in strength (in quadriceps,
incomplete SCI, paraplegia T3-T12, aged gluteus medius and hamstring)
22-30, asymmetrical impairment with were seen for both groups but were
Trendelenburg gait; could walk without an greater for the experimental group
assistive device. than controls (p<0.05).
Petrofsky 2001; USA Treatment: The control group (n=5) had 2- 2. After 2 months of therapy the
Downs & Black score=12 hour daily conventional physical therapy, reduction in Trendelenburg gait
Prospective Controlled including 30 min biofeedback of more was greater for the experimental
Trial affected gluteus medius for 2 months. group than for the control group
N=10 Experimental treatment (n=5) had same (p<0.01) and the experimental
program and used a portable home group showed almost normal gait.
biofeedback device.
Outcome Measures: Muscle strength
(isometric strain gauge transducer) and
gait analysis.
Population: 153 patients overall, 89 (44 1. 6 /20 chronic individuals initially
chronic, 45 acute) locomotor training, 64 “nearly paralysed” gained bilateral
(24 chronic, 40 acute) control. muscle strength (↑ manual muscle
Treatment: Body-weight supported testing)
Wernig et al. 1995;
treadmill locomotor training (BWSTT) 2. For acute patients, no differences
Germany
(Laufband therapy) vs conventional in strength gains between BWSTT
rehabilitation. Specific parameters for each and conventional rehab.
Case Control
were not described or appeared to vary 3. Authors noted that locomotor gains
N=153
within and between groups. had little correlation with strength
Outcome Measures: Manual muscle gains.
testing, walking function and neurological
examination pre and post training.
6-24
Score
Methods Outcome
Level
Total Sample Size
Population: 19 subjects, 13 men and 6 1. LEMS had median increases of 3
men, mean age 31.7 (ASIA class C), > 1 points in both the FES-assisted leg
year post-injury, asymmetrical lower and the non-stimulated leg
Field-Fote 2001; USA extremity function. (p<.005).
Downs & Black score=15 Treatment: Body weight-supported 2. ↑ASIA lower limb motor scores in
Pre-post treadmill walking with peroneal nerve FES 15 of 19 incomplete SCI (ASIA C)
of the weaker limb for 1.5 hours, 3X/week, (p<.005).
N=19
3 months.
Outcome Measures: Lower extremity
motor score (LEMS), Gait outcomes.
Population: 6 incomplete SCI (3 males, 3 1. ↑ strength (↑ hip flexors and knee

females), aged 20-40, 2-18 years post extensor manual muscle test,
injury, C4 to L1, 3 Frankel C, 3 Frankel D. p<0.05).
Treatment: FES-assisted locomotor 2. ↑ strength as indicated by
Granat et al. 1993; UK training to quadriceps, hip abductors, increased quadriceps torque with
Downs & Black score=14 hamstrings, erector spinae, common MVC (p<0.05).
Pre-post peroneal nerve, minimum 30 min, 5
N=6 days/week.
Outcome Measures: Manual muscle tests,
maximum voluntary contraction (MVC),
upright motor control, spasticity, balance
and gait outcomes.
Population: 3 adolescents (age 12-17), 1. No group statistics.
incomplete SCI, 1-3 years post-injury, 1 2. ↑ Voluntary strength for all subjects
Johnston et al. 2003; male, 2 females, all ASIA C, C6, C7 and L2 in 12/13 stimulated muscles by ~1
USA injury levels. manual muscle grade. The greatest
Downs & Black score=14 Treatment: 1 year percutaneaous gains were in hip extension and hip
Pre-post intramuscular FES system preceded by 4 abduction.
N=3 week stimulated exercise and FES gait
training period.
Outcome Measures: Manual muscle test
scores, gait outcomes.
Population: 2 males, 1 female, ASIA C, 5 1. No group statistics
weeks/ 6 weeks/ 18 months post-injury. 2. ↑ ASIA lower limb motor scores in
Hornby et al. 2005; USA Treatment: Therapist and Robotic- 2/3 subjects in acute phase (5 & 6
Downs & Black score=12 assisted, body-weight-supported treadmill weeks) which cannot be separated
Pre-post training (parameters varied between from natural recovery. No changes
N=3 subjects). seen in 3rd person initiated at 18
Outcome Measures: Lower extremity months.
motor scores (LEMS), functional mobility
outcomes.
Population: 76 SCI patients (35 chronic, 1. No group statistics. All subjects
41 acute), strength data reported for 25 showed increases in cumulative
Wernig et al. 1998; chronic only who returned to clinic for muscle scores (i.e., 8 muscles
Germany follow-up. summed) indicative of increased
Downs & Black score=12 Treatment: Body-weight supported strength.
Pre-post treadmill locomotor training (Laufband
N=76 therapy). 1-2X/day for 30 minutes, 5
days/week for 8-20 weeks.
Outcome Measures: Voluntary muscle
scores and walking function.
Discussion
Measures of strength were employed as a secondary outcome measure to the primary outcome
of ambulation. In general, investigators have noted significant increases of lower limb strength
6-25
following locomotor training – despite variations between training protocols and specific
methods employed. Outcome measures have included manual muscle testing of individual
lower limb muscles in incomplete SCI or summated scores of several muscles (Granat et al.
1993; Wernig et al. 1995; Wernig et al. 1998; Field-Fote 2001; Johnston et al. 2003; Hornby et
al. 2005; Wirz et al. 2005). Most recent studies have adhered to ASIA international guidelines
for the manual muscle testing (Field-Fote 2001; Hornby et al. 2005; Wirz et al. 2005). Others
have employed muscle torque measurements by employing strain gauge transducers (Granat et
al. 1993; Petrofsky 2001;).
All investigators have reported increases in lower limb muscle strength in individuals with
chronic SCI. However, several investigators have noted that enhanced walking capability did not
necessarily demonstrate parallel increases in strength (Wernig et al. 1995; Wernig et al. 1998;
Field-Fote 2001; Wirz et al. 2005). Furthermore, the clinical relevance of the small strength
gains following locomotor training is questionable when considering the duration and complexity
of the intervention (Field-Fote 2001). However, there is weak evidence (from 1 study, n = 3) that
significant improvements in muscle strength may be realized when locomotor training is
combined with conventional therapy (Hornby et al. 2005).
Detecting group differences in strength gains during the acute phase may be more challenging
given the natural recovery. Wernig et al. (1995) found no differences between those provided
locomotor training versus those treated conventionally in muscle strength gains. However,
specific subject characteristics were inadequately described other than stating that body-weight
supported treadmill training was initiated within a few weeks (i.e., 2-20 weeks, median 7 weeks)
following injury. There was also a lack of standardized assessment, further confounding the
findings.
Conclusion
There is level 4 evidence that most forms of locomotor training (i.e., including body
weight supported treadmill training with various assists and FES-assisted overland
training) increase lower limb muscle strength in chronic SCI as indicated by overall
increases in total lower extremity motor scores.
There is level 3 evidence that body weight supported treadmill training is not
significantly different than conventional rehabilitation therapy in enhancing lower limb
muscle strength in acute SCI, although these studies are confounded by the natural
recovery that may take place in the acute period.
Locomotor training programs are beneficial in improving lower limb muscle strength although
in acute SCI similar strength benefits can be obtained with conventional rehabilitation. The
real benefit of locomotor training on muscle strength may be realized when it is combined
with conventional therapy. This should be further explored in acute, incomplete SCI where
better functional outcomes may be realized with the combination of therapies.
6.4 Summary
There is level 2 evidence that a program of PES-assisted isometric exercise reduces the
degree of lower limb muscle atrophy in individuals with recent (~10 weeks post-injury)
6-26
motor complete SCI, but not to the same extent as a comparable program of FES-
assisted cycling exercise.
There is level 4 evidence that programs of PES-assisted exercise partially reverses the
lower limb muscle atrophy found in individuals with long-standing (>1 year post-injury)
motor complete SCI.
There is level 2 evidence that a program of PES-assisted exercise increases lower limb
strength and muscular endurance.
There is level 2 evidence that a program of FES-assisted cycling exercise prevents and
reverses lower limb muscle atrophy in individuals with recent (~10 weeks post-injury)
motor complete SCI and to a greater extent than PES.
There is level 4 evidence that programs of FES partially reverses the lower limb muscle
atrophy found in individuals with long-standing (>1 year post-injury) motor complete SCI.
There is level 4 evidence that a program of FES-assisted cycle exercise increases lower
limb muscular endurance.
There is level 2 evidence using historical controls that BWSTT is effective in improving
ambulatory function. However, stronger evidence from one level 1RCT demonstrates
that BWSTT has equivalent effects to conventional rehabilitation consisting of
overground mobility practice for gait outcomes in acute/sub-acute SCI.
There is Level 4 evidence from pre-test/post-test studies that BWSTT is effective for
improving ambulatory function in people with chronic, incomplete SCI. There is Level 1
evidence from 1 RCT that different strategies for implementing body weight support gait
retraining all yield similar ambulatory outcomes in people with chronic, incomplete SCI. It
is recommended that therapists may choose a body weight support gait retraining
strategy based on available resources (Field-Fote et al. 2005).
In summary, level 1 evidence describes limited and indirect improvements in aspects of
walking (i.e. spasticity, speed and posture) but do not translate into significant functional
walking gains as a result of clonidine and cyproheptadine. Limited and non-functional
improvements in walking as a result of baclofen are only supported by level 4 evidence.
Conflicting evidence provides little guidance with respect to the use of GM-1 and 4-
aminopyridine for the improvement of ambulation in spinal cord injury. Scientifically
robust studies with consistent clinically relevant outcome measures are needed for
pharmacological intervention studies of ambulation after spinal cord injury.
There is Level 4 evidence that FES-assisted walking can enhance walking speed and
distance in complete and incomplete SCI. There is also Level 4 evidence from 3
independent laboratories that regular use of FES in gait training or activities of daily
living leads to persistent improvement in walking function that is observed even when
the stimulator is not in use.
None of the studies investigating the efficacy of brace/orthotic devices for upright
support and mobility are randomized or blinded, but that is in part due to the ethical
dilemma of providing safe and appropriate bracing and the fact that participants will be
able to distinguish which device they received. There is weak evidence from post-test
studies that bracing alone results in significant gains in functional ambulation for people
with complete SCI. Only 2 studies reported pre-test/post-test results (total n = 8) that the
use of long-leg braces could enhance gait speed and endurance in people with complete
SCI.
6-27
There is Level 4 evidence that a combined approach of bracing and FES results in
However, in subjects who are achieve little benefit from bracing alone, the addition of
FES appears to help improve standing or short-distance walking function (Marsolais et
al. 2000). In incomplete SCI, however, there is some indication that a combination of
bracing and FES provides greater ambulatory function than either approach alone (Kim
et al. 2004).
There is level 4 evidence that most forms of locomotor training (i.e., including body
weight supported treadmill training with various assists and FES-assisted overland
training) increase lower limb muscle strength in chronic SCI as indicated by overall
increases in total lower extremity motor scores.
There is level 3 evidence that body weight supported treadmill training is not
significantly different than conventional rehabilitation therapy in enhancing lower limb
muscle strength in acute SCI, although these studies are confounded by the natural
recovery that may take place in the acute period.
6-28
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CHAPTER SEVEN

Darren ER Warburton, PhD

Shannon Sproule, PT
Andrei Krassioukov, MD, PhD
Janice J Eng, BSc (OT/PT), PhD
Key Points
There is limited evidence that BWSTT can improve indicators of cardiovascular health
in individuals with complete and incomplete SCI.
Tetraplegics and paraplegics can improve their cardiovascular fitness and physical
work capacity through aerobic exercise training which are of moderate intensity,
performed 20-60 min day, at least three times per week for a minimum of six to eight
weeks. Resistance training at a moderate intensity at least two days per week also
appears to be appropriate for the rehabilitation of persons with SCI. It remains to be
determined the optimal exercise intervention for improving cardiovascular fitness.
Interventions that involve FES training a minimum of 3 days per week for 2 months
can improve muscular endurance, oxidative metabolism, exercise tolerance, and
cardiovascular fitness.
Aerobic and FES exercise training may lead to clinically significant improvements in
glucose homeostasis in persons with SCI. Preliminary evidence indicates that a
minimum of 30 min of moderate intensity training on 3 days per week is required to
achieve and/or maintain the benefits from exercise training.
Aerobic and FES exercise training may lead to improvements in lipid lipoprotein
profile that are clinically relevant for the at risk SCI population. The optimal training
program for changes in lipid lipoprotein profile remains to be determined. However, a
minimal aerobic exercise intensity of 70% of heart rate reserve on most days of the
week appears to be a good general recommendation for improving lipid lipoprotein
profile in persons with SCI.
Table of Contents
7.1 Introduction ......................................................................................................................7-1
7.2 The Risk for Cardiovascular Disease in Persons with SCI ..........................................7-2
7.3 Physical Inactivity and the Risk for Cardiovascular Disease in Persons with SCI....7-3
7.4 Exercise Rehabilitation and Cardiovascular Fitness ...................................................7-3

7.4.1 Treadmill Training ...........................................................................................................7-4
7.4.2 Arm, Mixed Arm and Wheelchair Ergometry...................................................................7-6
7.5 Functional Electrical Stimulation (FES).........................................................................7-9

7.5.1 FES Leg Cycle Ergometry ..............................................................................................7-9
7.5.2 Hybrid FES (Combined Leg and Arm Ergometry).........................................................7-11
7.5.3 Other Electrically-Assisted Training Programs .............................................................7-12
7.6 Glucose Homeostasis ...................................................................................................7-14
7.7 Lipid Lipoprotein Profiles .............................................................................................7-17
7.8 Summary.........................................................................................................................7-19
References..............................................................................................................................7-23
Warburton DER, Sproule S, Krassioukov A, Eng JJ (2006). Cardiovascular Health and Exercise Following Spinal Cord
Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors.
www.icord.org/scire
7.1 Introduction
Persons with SCI currently have an increased life expectancy owing to improvements in medical
treatment (Bauman et al. 1992a). The majority of all SCI (80%) occur in individuals who are
under 30 years of age (ICORD 2003). Therefore, persons with SCI will be susceptible to the
same chronic conditions across the lifespan as able-bodied persons. In fact, cardiovascular
disease (CVD) is the leading cause of death in both able-bodied individuals (Health Canada
1999) and persons with SCI (Bauman et al. 1992a, Whiteneck et al. 1992). In the general
population, it is estimated that approximately one in four Canadians has some form of CVD.
However, there appears to be an earlier onset of CVD and/or and increased prevalence of CVD
in individuals with SCI in comparison to the general population (Yekutiel et al. 1989, Whiteneck
et al. 1992, DeVivo et al. 1993, Bauman et al. 1999b). The prevalence of asymptomatic CVD
has been shown to be between 60-70% in persons with SCI (Bauman et al. 1993, Bauman et al.
1994). This is an alarming statistic, which places a significant burden upon the patient, his/her
family and society as a whole.
Physical inactivity is a major independent risk factor for CVD and premature mortality (Blair &
Brodney 1999, Booth et al. 2000, Katzmarzyk et al. 2000). As reviewed later, persons with SCI
are commonly inactive and exhibit low levels of cardiovascular fitness (Hoffman 1986). Also, it
appears that the ordinary activities of daily living are not adequate to maintain cardiovascular
fitness in persons with SCI (Hoffman 1986). Extremely low levels of physical activity and fitness
(as a result of wheelchair dependency) may explain directly the increased risk for CVD in
individuals with SCI. Moreover, a reduction in cardiovascular fitness may also lead to a vicious
cycle of further decline, which results in a reduction in functional capacity and the ability to live
an independent lifestyle.
The current chapter summarizes briefly the literature regarding the risk for CVD in persons with
SCI. This chapter also evaluates critically the level of evidence regarding the effectiveness of
varied forms of exercise rehabilitation in increasing cardiovascular fitness and attenuating the
risk for CVD in persons with SCI. Table 7.1 contains a definition of the commonly used terms
and/or abbreviations in this chapter (Warburton et al. 2006a).
Table 7.1 Description of Commonly Used Terms

Term Definition
Spinal Cord Injury (SCI) • Refers to persons who have sustained a spinal cord injury.
• Refers to diseases affecting the circulatory system (i.e., heart and/or blood vessels)
Cardiovascular Disease including acute myocardial infarction, coronary artery disease, arteriosclerosis, heart
(CVD) valve disease, heart failure, high blood pressure, peripheral vascular dysfunction,
congenital heart disease, stroke, and arrhythmias.
• Refers to all leisure and non-leisure body movements resulting in an increased energy
Physical Activity
output from the resting condition.
• Refers to structured and repetitive physical activity designed to maintain or improve
Exercise
physical fitness.
• Refers to an exercise program that incorporates activities that are rhythmic in nature,
Aerobic Training
using large muscle groups at moderate intensities for 3 to 5 days per week.
Heart Rate Reserve • Refers to the difference between maximal heart rate (HRmax; predicted or determined
7-1
Term Definition
(HRR) directly) and resting HR. The %HRR formula takes into account resting and maximal
HR to provide an appropriate target HR (or range) for training.
• Training Heart Rate = [(HRmax – HRrest) x 40-85%] + HRrest
• Refers to an estimate of resting metabolic rate while sitting quietly.
MET
• 1 MET = 3.5 mL·kg-1·min-1 or 1 kcal·kg-1·h-1
Moderate Intensity • Exercise performed at relative intensities of 40-59% HRR, approximately 4-6 METs, or
Exercise 55-69% of HRmax.
Current General • Moderate intensity exercise for 20-60 min day on most days of the week.
Exercise
Recommendation
Activities of Daily Living • Refers to the activities in which one engages during daily life.
(ADLs)
• Refers to the ability to transport and utilize oxygen during prolonged, strenuous
Cardiovascular
exercise or work. It reflects the combined efficiency of the lungs, heart, vascular
(Aerobic) Fitness
system and exercising muscles in the transport and utilization of oxygen.
Maximal Aerobic Power • The maximum amount of oxygen that can be transported and utilized by the working
(VO2max) muscles. Also, known as maximal oxygen consumption.
Health-related • Involves the components of physical fitness that are related to health status including
Physical Fitness cardiovascular fitness, musculoskeletal fitness, body composition and metabolism.
• Refers to an overall satisfaction and happiness with life, and includes the facets of
Quality of Life
physiological, emotional, functional and spiritual well-being.
7.2 The Risk for Cardiovascular Disease in Persons with SCI
The majority of CVD events are the result of atherosclerosis (i.e., narrowing and hardening of
the arteries) (Grey et al. 2003). Persons with SCI appear to be particularly susceptible to the
development of atherosclerotic disease (Bravo et al. 2004). Researchers have revealed that
persons with SCI exhibit a series of risk factors for atherosclerotic disease and thus CVD (as
shown in Table 7.2).
A healthy endothelium (interior lining of blood vessels) is essential for the protection against
atherosclerosis (Anderson 2003). Relatively limited data exists regarding the vascular health of
individuals with SCI (de Groot et al. 2005). However, the majority (if not all) of the risk factors for
CVD in persons with SCI will have a significant negative impact upon endothelial function. As
such, it would appear that vascular dysfunction is also a central step in the development of CVD
in persons with SCI.
Table 7.2 Risk Factors for Cardiovascular Disease in Persons with SCI
Risk Factor Literature Support
• Abnormal lipoprotein profiles Brenes et al. 1986, Dearwater et al. 1986, Bauman et al.
1992b, Krum et al. 1992, Maki et al. 1995, Dallmeijer et al.
1997, Bauman et al. 1998, Bauman et al. 1999a, Bauman
et al. 1999b
• Abnormal glucose homeostasis Myllynen et al. 1987, Bauman & Spungen 2001
• Increased relative adiposity, elevated body fat
Bauman et al. 1999c, Spungen et al. 2003
and/or reduced lean body mass
• Reduced peripheral vascular function and/or
Wecht et al. 2000, Wecht et al. 2003, de Groot et al. 2005
endothelial dysfunction
• Increased risk for deep vein thrombosis Miranda & Hassouna 2000
• Abnormal haemostatic and inflammatory Vaidyanathan et al. 1998, Kahn 1999, Roussi et al. 1999,
markers Kahn et al. 2001, Frost et al. 2005, Lee et al. 2005
• Excessive homocysteine Bauman et al. 2001
• Depressed endogenous anabolic hormone
Claus-Walker & Halstead 1982b, Bauman & Spungen
levels (e.g. serum testosterone and growth
2000
hormone)
7-2
Risk Factor Literature Support
• Increased activation of the renin-angiotensin-
Claus-Walker & Halstead 1982a
aldosterone system
• Hypertension Lee et al. 2006
• Reduced aerobic fitness Hoffman 1986
7.3 Physical Inactivity and the Risk for Cardiovascular Disease in Persons with SCI
The separation of the autonomic nervous system from the superior brain centres after injury
results in a series of changes that markedly affect the cardiovascular health of persons with SCI
(Bravo et al. 2004). Adrenergic dysfunction, poor diet, and physical inactivity are thought to play
key roles in the elevated risk for CVD in SCI.
Physical inactivity is prevalent amongst persons with SCI. In fact, persons with SCI often lead
relatively sedentary lives leading to marked deconditioning (Jacobs & Nash 2004). In the
general population, deconditioning has been associated with a pronounced reduction in
cardiovascular fitness (Warburton et al. 2006a) and an increase in the risk for CVD and
premature mortality (Warburton & Mathur 2004).
Not only is physical inactivity a major independent risk factor for CVD and premature mortality
(Warburton et al. 2006a), it also plays a key role in the development of the majority of the other
commonly observed risk factors for CVD in persons with SCI. For instance, cross-sectional
investigations have shown that the extreme inactivity (associated with SCI) is related to lower
HDL cholesterol levels (Brenes et al. 1986, Dearwater et al. 1986, Shetty et al. 1992, Schmid et
al. 2000, Manns et al. 2005), elevated LDL cholesterol (Schmid et al. 2000), triglyceride (Schmid
et al. 2000, Manns et al. 2005), and total cholesterol levels (Schmid et al. 2000), abnormal
glucose homeostasis (Myllynen et al. 1987, Elder et al. 2004, Manns et al. 2005), increased
adiposity (Elder et al. 2004, Manns et al. 2005), and excessive reductions in aerobic fitness
(Eriksson et al. 1988, Schmid et al. 2000, Manns et al. 2005). It is important to note, that SCI
presents additional risk for CVD above that seen in able-bodied individuals owing to the marked
decrease in physical activity and injury-related changes in metabolic function (Bravo et al.
2004).
The major abnormalities observed in SCI are reduced physical activity/fitness, abnormal
glucose homeostasis, and deteriorated lipid lipoprotein profiles. Based on the available
literature, it is clear that effective exercise interventions are required to slow the progression of
multiple risk factors for CVD and other chronic diseases (e.g. obesity, type 2 diabetes) in
persons with SCI.
7.4 Exercise Rehabilitation and Cardiovascular Fitness
Exercise rehabilitation has been shown to be an effective means of attenuating or reversing

chronic disease in persons with SCI. Similar to the general able-bodied population (Warburton
et al. 2006a), habitual physical activity (beyond activities of daily living) can lead to numerous
health benefits that significantly reduce the risk for multiple chronic conditions (in particular
CVD) and premature mortality in persons with SCI. Although research is increasingly evaluating
the health benefits of physical activity in persons with SCI, this body of information is relatively
low in comparison to the general population and other clinical conditions (such as chronic heart
failure) (Warburton et al. 2006a).
7-3
The research conducted within the field of SCI has examined predominantly the effects of
aerobic exercise and/or functional electrical stimulation (FES) training. In the following sections
we will review the literature regarding to the effects of varied exercise interventions on the risk
for CVD in persons with SCI. Particular attention will be given to the changes in cardiovascular
fitness, glucose metabolism, and lipid lipoprotein profiles that occur after training interventions in
persons with SCI.
Aerobic fitness is a strong predictor of multiple chronic diseases, the capacity for activities of
daily living, and premature mortality in the general population (Warburton et al. 2006a).
Moreover, exercise training commonly results in significant improvements in aerobic fitness (i.e.,
VO2max) in the general population (Warburton et al. 2006a, 2006b). There is increasing
evidence illustrating the important association between the risk for chronic disease (in particular
CVD) and cardiovascular fitness in persons with SCI. Recent work has also revealed the
importance of maintaining high levels of health-related physical fitness for the capacity of
performing activities of daily living in able-bodied and disabled populations (including persons
with SCI) (Sloan et al. 1994, Warburton et al. 2006a). Moreover, aerobic fitness (and other
components of health-related physical fitness) have been positively associated with the gainful
employment of paraplegics (Noreau & Shephard 1992). Both tetraplegic and paraplegic
persons appear to benefit from regimented exercise interventions that improve health-related
physical fitness.
We found at total of 41 studies in our search of the literature for investigations evaluating
cardiovascular fitness before and after an exercise intervention. This included investigations
related to treadmill training (2 studies; n = 14), arm exercise (20 studies; n = 278), and FES (18
studies; n = 233) training.
7.4.1 Treadmill Training
Body-weight supported treadmill training (BWSTT) is an exercise protocol that has been used to
potentially affect a number of domains, including motor recovery, bone density, cardiovascular
fitness, respiratory function as well as quality of life. Traditional BWSTT requires participants to
step on a treadmill while supporting some of their body weight on two parallel bars. Significant
resources are often required with BWSTT as the majority of individuals will require one or two
assistants to manually move the limbs forward. Limited data exists regarding the changes in
cardiovascular fitness and health that occur with BWSTT (Table 7.3).
Table 7.3 Effects of Bdy-weight Sported Treadmill Training on Cardiovascular Fitness

and Health
Score
Methods Outcome
Research Design
Total Sample Size
Population: 6 participants (4 male, 2 1. No changes in femoral or carotid
female), ASIA A and B, C4-T12, mean age artery cross sectional area, blood
37.7 yrs, mean 6.7 years post-injury, motor flow, or resistance post-training
Ditor et al. 2005a; complete. 2. An improvement in femoral artery
Canada Treatment: Body weight supported compliance.
Downs & Black score=14 treadmill training, 15 min/day (3 bouts of 5 3. No change in resting BP, mean
Pre-post min), 3 days/week for 4 months. arterial blood pressure, resting HR or
N=6 Outcome Measures: BP, HR, HR HR and blood pressure variability
variability, BP variability, arterial diameters after training.
and mean blood velocities, and arterial 4. 3/6 patients had changes in HR and
blood flow. blood pressure variability reflective of
increased vagal predominance.
7-4
Score
Methods Outcome
Research Design
Total Sample Size
Population : 8 participants (6 males, 2 1. Significant decrease in resting HR
females), ASIA B-C, C4-C5, incomplete, (10.0%) after training.
mean age 27.6 yrs, mean 9.6 years post- 2. No changes in resting systolic,
injury. diastolic, or mean arterial BP after
Ditor et al. 2005b;
Treatment: Progressive, body weight- training.
Canada
supported treadmill training, 3 day/week for 3. Significant reduction in the resting
6 months. LF/HF ratio after training.
Pre-post
Outcome Measures: HR and BP 4. There were no significant effects of
N=8
variability, LF/HR ratio (low to high training on HR and/or blood pressure
frequency heart spectrum and is indicative variability during an orthostatic
of balanced sympathetic/parasympathetic challenge (60° head up tilt).
tone and reduced risk for cardiovascular-
related mortality).
Discussion
The two level 4 papers are by the same Canadian research group (Ditor et al. 2005a, Ditor et al.
2005b). They reported that BWSTT did not have substantial group effects on HR and blood
pressure in motor complete subjects, but did reveal a significant reduction in resting HR in the
study with incomplete tetraplegics. There is also evidence that improvements in HR and blood
pressure variability may occur after BWSTT in incomplete SCI and a subset of participants with
complete SCI. These changes reflected an increased predominance of the parasympathetic
nervous system control of HR and blood pressure. The changes in HR variability are indicative
that beneficial changes in cardiac autonomic balance can occur in SCI. This research group
also revealed the potential for improvements in vascular health (e.g. arterial compliance) after
BWSTT in individuals with motor-complete SCI. There was no indication of the effects of
BWSTT on VO2peak.
In both papers, two trainers assisted the participants with the gait cycle, while a third trainer
assisted with weight shifting, balance and overall safety. The mechanisms responsible for the
improvement in markers of cardiovascular health and regulation in individuals with incomplete
SCI remain to be determined. Both weight-bearing and the passive movement of the limbs may
contribute to the improvement in cardiovascular health in these studies.
Conclusion
There is Level 4 evidence that BWSTT can reduce resting heart rate in individuals with
incomplete, but not complete SCI injuries.
There is Level 4 evidence that BWSTT can result in improvements in cardiac autonomic
balance in persons with incomplete tetraplegia.
balance in a subset of individuals with motor-complete SCI who respond to ambulation
with moderate to large increases in heart rate.
There is Level 4 evidence that BWSTT can improve arterial compliance in individuals with
motor-complete SCI.
There is limited evidence that BWSTT can improve indicators of cardiovascular health in
individuals with complete and incomplete SCI.
7-5
7.4.2 Arm, Mixed Arm and Wheelchair Ergometry
Given the motor loss of the lower limbs, upper extremity exercise is a logical choice. Improving
cardiovascular fitness can be challenging using the smaller mass of the arms especially when
muscle fatigue can often occur before endurance training targets are met. From our search, we
found one level 1, five level 2, and fourteen level 4 studies. Given the large number of studies
which have looked at upper extremity exercise, we have tabled only those studies which
included an SCI control group.
Table 7.4 Effects of Arm, Mixed Arm, and Wheelchair Ergometry Training on
Cardiovascular Fitness and Health
Score
Methods Outcome
Research Design
Total Sample Size
Arm Ergometry
Population: 4 male, 2 female, C5-L1, 1. Training resulted in a significant
ASIA A (n=1), B (n=1), C (n=4), mean age improvement in VO2peak and peak
36 yrs. power output in the entire group.
de Groot et al. 2003; Treatment: Interval training (3 min 2. The changes in VO2peak were
Netherlands exercise of arm cranking, boxing, push ups significantly greater in the high
PEDro=7 and ball throwing followed by 2 minutes intensity (59%) versus low intensity
RCT rest for 1 hour), 1h/day, 3 days/wk for 8 group (17%).
N=6 weeks. Randomized to low intensity (50-
60% HRR) or high intensity (70-80% HRR)
group.
Outcome Measures: VO2peak, maximal
power output.
Population: 24 men with spinal lesions: 8 1. Training increased VO2peak in the 3
spina bifida, 16 traumatic, ages 17-42 yrs. arm ergometry groups (about 21%).
Treatment: Random assignment to 1) 2. Significant increases in submaximal
control or 1 of 3 arm ergometry programs 2 stroke volume and cardiac output
Davis et al. 1991;
days/week for 24 weeks: 1) high-intensity with training in the high intensity long
Canada
long duration (40 min at 70% of VO2peak) and the low intensity long training
PEDro=4
exercise training, 2) high-intensity short groups.
RCT
duration (20 min at 70% of VO2peak) 3. In contrast, the low intensity short
N=24
exercise training, and 3) low-intensity short duration training and control groups
duration (20 min at 50% of VO2peak) exhibited small, but non-significant
training. decrements in SV.
Outcome Measures: cardiac output, HR,
VO2peak, power output, stroke volume.
Participants: 14 sedentary, disabled 1. Training was associated with a
males (n=9 exercise group, n=5 control significant improvement in VO2peak
Davis et al. 1987; group), ages 20-39. (31%) and HR (-9.5%)
Canada Treatment: 16 week arm ergometry 2. During isometric handgrip exercise,
PEDro=4 aerobic training at 50-70% of VO2peak for ↓rate pressure product (20%),
RCT 20-40 min/day, 3 days/week. ↑stroke volume (12-16%)
N=14 Outcome Measures: BP, HR, power 3. No changes in echocardiographic
output, VO2peak, resting left ventricular responses at rest or during isometric
dimensions, cardiac function. handgrip exercise.
7-6
Score
Methods Outcome
Research Design
Total Sample Size
Population: 27 participants: Exercise 1. Peak workload increased (45%)
group: 10 tetraplegia, C6-8, 7 ASIA A & 3 significantly, while VO2peak did not
Hjeltnes & Wallberg-
ASIA B, 99 days post-injury; Control: 10 change in the tetraplegics after
Henriksson 1998;
paraplegia, T7-11, all ASIA A. training.
Norway
Treatment: Exercise group: standard 2. Peak workload (45.5%) and
rehabilitation + Arm ergometry, 30 min/day, VO2peak (27.7) increased
3 day/week for a 12-16 week period; significantly in the paraplegics after
Trial
Control: standard rehabilitation. standard rehabilitation.
N=27
Outcome Measures: power output, 3. No change in peak HR, systolic BP,
cardiac function, HR, VO2, systolic blood submaximal exercise stroke volume
pressure, lactate levels, muscular strength, or cardiac output in either SCI group.
ability to perform activities of daily living.
Mixed Arm and Other Exercise
Population: 34 participants (18 tetraplegic 1. Power output increased by 118%
and 16 paraplegic), ASIA A-D, C4-L1, ages and 45% after training in the
19-65 yrs. tetraplegic and paraplegic groups,
Treatment: The exercise group: 90-120 respectively.
Hicks et al. 2003; min/day, 2 days/wk for 9 months of aerobic 2. There were progressive increases in
Canada (arm ergometry, 15-30 mins, at ~70% strength over the 9 months of
PEDro=5 VO2max) and whole-body, circuit training (ranging from 19-34%).
RCT resistance exercise (wall pulley, free and 3. There was a significant decline in the
N=23 machine weights) components. Control HR to power output ratio (an
group: bimonthly education session on indicator of improved aerobic fitness)
topics including exercise physiology, after training.
osteoporosis, and relaxation.
Outcome Measures: muscular strength,
power output, HR, quality of life ratings.
Wheelchair Ergometry
Population: low-intensity group n=6, C5- 1. Neither group had changes in
T7, moderate-intensity group n=5, C5-T9. maximal HR, maximal power output,
Treatment: Wheelchair ergometry 20 maximal blood lactate, or VO2max.
min/day, 3 days/week for 8 weeks. The The mean change in VO2max was
Hooker & Wells 1989;
low-intensity group trained at 50-60% max 10 and 24%, respectively, for the
USA
HR reserve (HRR); Moderate intensity low-intensity and high-intensity
group trained at 70-80% max HRR. training groups.
Outcome Measures: HR, power output, 2. The moderate-intensity group had
Trial
blood lactate, VO2max, Rating of Perceived significantly lower post-training
N=8
Exertion (RPE), lipid profiles. submaximal HR, lactate, and RPE
but no changes in oxygen
consumption.
3. 70% maximal HRR appears to be
the beneficial training threshold.
Discussion
The reported improvements in aerobic capacity after aerobic arm training in SCI are
approximately 20-30%; however, it is not uncommon for improvements in excess of 50%. For
instance, researchers (DiCarlo 1988) revealed a 99% improvement in VO2max after aerobic arm
cycle training.
The majority of aerobic training investigations have evaluated the effectiveness of moderate
(40-59% HRR or 55-69% of maximum HR) to vigorous (60-84% HRR or 70-89% of maximum
HR) intensity exercise. These studies have used arm ergometry, wheelchair ergometry, and
swimming based interventions (Jacobs & Nash 2004). Based on the current level of literature, it
appears that moderate intensity exercise performed 20-60 min per day, at least 3 days per week
7-7
for a minimum of 6 weeks is effective for improving cardiovascular fitness in persons with SCI.
Therefore, the general recommendations provided by Health Canada, the Canadian Society for
Exercise Physiology, and the American College of Sports Medicine are appropriate for
improving the cardiovascular fitness of persons with SCI. It is important to note that an exercise
intensity threshold of 70% maximal HRR has been advocated for the attainment of training
benefits when a minimal training duration (20 min) is the standard (Hooker& Wells 1989, Tordi
et al. 2001, Bizzarini et al. 2005). It is also important to note that improvements in exercise
capacity and functional status may occur after training without significant improvements in
VO2peak, particularly in tetraplegic patients (Hjeltnes & Wallberg-Henriksson 1998).
Questions remain regarding the primary mechanisms of importance for improvements in aerobic
fitness after training. It is unclear whether central (heart and lung) or peripheral (skeletal muscle)
adaptations are of key importance. Improvements have been observed in peripheral muscle
function. For instance, investigators have shown intrinsic cellular adaptations that facilitate
oxidative metabolism (level 4) (Stewart et al. 2004). Only limited investigations, however, have
shown an improvement in cardiac function after aerobic exercise training. It could therefore be
argued that peripheral adaptations are of primary importance to the improvement in aerobic
capacity after aerobic exercise interventions. However, this statement is somewhat misleading
as the majority of investigations have not directly evaluated cardiac output during maximal/peak
exercise. This is owing to the fact that the assessment of maximal cardiac output during
exercise is one of the most difficult and expensive procedures in clinical exercise physiology
(Warburton et al. 1999a, 1999b). When exercise measures of cardiac function have been taken,
improvements in central function have been observed (Davis et al. 1987). Further research
examining the primary mechanism(s) of importance for the improved cardiovascular fitness and
exercise capacity seen in SCI after aerobic exercise training is warranted.
Less is known about the effects of resistance training on cardiovascular fitness. However, as
reviewed by Jacobs and Nash (2004) the incorporation of resistance training into the treatment
of persons with SCI appears to be essential. In fact, muscle weakness and dysfunction are key
determinants of pain and functional status in persons with SCI. Investigators have evaluated the
effects of resistance training on cardiovascular fitness in persons with SCI. For instance,
hydraulic resistance training has also been shown to lead to significant improvements in
VO2max (Cooney & Walker 1986). Furthermore, circuit resistance training has resulted in
increases in VO2peak, time to fatigue, peak power output, and musculoskeletal fitness (Jacobs
et al. 2001). The general health guidelines for resistance training appear to be appropriate for
the rehabilitation of persons with SCI. This includes 1-2 sets of 8-10 different resistance
exercises with large muscle groups for 8-12 repetitions (moderate intensity), on 2-4 days per
week (Warburton et al. 2006b). Circuit weight training is also likely appropriate as it provides a
significant stress to the cardiovascular and musculoskeletal systems.
Conclusion
There is Level 1 evidence that arm exercise at a moderate to vigorous intensity (50-80%
HRR), 3 days/week for at least 2 months improves cardiovascular fitness.
There is Level 1 evidence that high intensity (70-80% HRR) exercise leads to greater
improvements in peak power and VO2peak than low intensity (50-60% HRR) exercise.
There is Level 1 evidence that aerobic exercise training is effective in improving exercise
capacity/tolerance in persons with SCI.
7-8
It is uncertain whether aerobic training can improve cardiac function in persons with SCI.
Based on the changes observed in VO2max and findings from able-bodied individuals, a
consensus was derived stating that aerobic training may be effective in improving the
ability to extract oxygen at the periphery in persons with SCI.
Tetraplegics and paraplegics can improve their cardiovascular fitness and physical work
capacity through aerobic exercise training which are of moderate intensity, performed 20-60
min day, at least three times per week for a minimum of six to eight weeks. Resistance
training at a moderate intensity at least two days per week also appears to be appropriate for
the rehabilitation of persons with SCI. It remains to be determined the optimal exercise
intervention for improving cardiovascular fitness.
7.5 Functional Electrical Stimulation (FES)
Computer-assisted FES during leg cycling has been shown to be an important and practical
means of exercising a relatively large muscle mass in persons with SCI (Hooker et al. 1992).
These devices also permit the activation of the skeletal muscle pump during leg cycling. For
these reasons, FES training has been widely advocated as an effective treatment strategy for
SCI. It is important to note, that the physiological responses to FES training appear to be distinct
from arm ergometry training. For instance, arm exercise has been shown to lead to faster VO2
kinetics (at a constant workload), greater changes in HR, and lower post-exercise blood lactates
than FES leg cycling (Barstow et al. 2000).
7.5.1 FES Leg Cycle Ergometry
Table 7.5 Effects of Functional Electrical Stimulation on Cardiovascular Fitness

Score
Methods Outcome
Research Design
Total Sample Size
Population: 6 tetraplegia at C6, 4 1. 4 fold increase in total work output
paraplegia at T4, all complete, ages 27- and 12% increase in thigh muscle
45 yrs, 3-23 yrs post-injury. mass over the training program.
Mohr et al. 1997; Treatment: One-year exercise training 2. VO2max increased 17.5% (6 months)
Denmark using an FES cycle ergometer (30 min/day, and 19.2% (12 months).
Downs & Black score=14 3 days/week). 3. Shift towards more fatigue resistant
Pre-post Outcome Measures: VO2max, total contractile proteins, which was
N=10 work output, blood lactate, muscle accompanied by a doubling of citric
properties. synthase activity.
Population : 16 male, 3 females (7 1. Most participants showed an increase

paraplegics T4-T10, 12 tetraplegics C4- in strength and endurance. The
C7), ages 19-47 yrs, 2-17yrs post-injury. average resistance increased by
Ragnarsson et al. 1988; Treatment: Phase I: quadriceps 50.4%.
USA stimulation with dynamic knee extensions 2. VO2peak increased non-significantly
Downs & Black score=14 against increasing resistance, 3 days/week (14.9%) after training.
Pre-post for 4 weeks. Phase II: leg-cycle FES, 15-30
N=19 mins/day, 3 days/week for 12 weeks.
Outcome Measures: HR, work, BP,
and VO2peak.
Hooker et al. 1992; USA Population: 17 males, 1 female, 10 1. Increase in power output (45%),
Downs & Black score=13 tetraplegia (C5-C7), 8 paraplegia (T4-T11), VO2peak (23%), cardiac output (13%),
Pre-post 7 incomplete, mean age 30.6 yrs, mean HR (11%), and a reduction in total
7-9
Score
Methods Outcome
Research Design
Total Sample Size
N=18 6.1yrs post-injury. peripheral resistance (-14%) during
Treatment: FES leg cycle training 10-30 peak FES leg cycle.
min/day, 2-3 days/week for 12-16 weeks. 2. No changes in stroke volume (6%),
Outcome Measures: VO2peak, power mean arterial BP (-5%), or
output, cardiac output, stroke volume, arteriovenous oxygen difference
total peripheral resistance, and HR. (+10%).
3. No differences during peak arm
cranking exercise for any of the
cardiovascular variables – therefore no
carry-over effect from leg training.
Population: all paraplegic, complete, C6- 1. The isometric-trained leg showed
T7, ages 26-54yrs, 3-21yrs post-injury. significantly larger mean increases
Treatment: FES training 45 min/day, 3 in force, increase in type 1 fibres,
days/week, for 10 weeks. One leg: fibre cross-sectional area, capillary-
Crameri et al. 2004;
dynamic cycle ergometry involved bilateral to-fibre ratio, citrate synthase
Denmark
quadriceps and hamstring stimulation; activity and relative oxygenation
Contralateral leg: isometric contractions. after static training in comparison to
Pre-post
Outcome Measures: muscle biopsies, baseline and the dynamically
N=6
capillary-to-fibre ratio, muscle proteins, and trained leg.
oxygenation. 2. These changes reflect the
importance of load in the amount of
adaptation to FES.
Population: 5 males, complete chronic 1. VO2peak increased (70%) during
lesions, 2 C5, 2 C6, 1 C7; 4 ASIA A, 1 FES leg cycling, but not during arm
Hjeltnes et al. 1997;
ASIA A/B, mean age 35yrs, mean cycling.
Norway
10.2yrs post-injury. 2. Increase in lean body mass (3.0%)
Treatment: 8 weeks of FES leg cycling, and a decrease in body fat (6.4%).
Pre-post
7X/week. 3. Increase in muscle cross-sectional
N=5
Outcome Measures: DXA (Body area (21.3%).
composition), VO2peak.
Population: 9 males, 2 tetraplegia, 7 1. Training significantly increased
paraplegia, all ASIA A, mean age 34.4yrs, VO2peak (10.9%), peak work rate
Barstow et al. 1996; USA
mean 10.1yrs post-injury. (46.5%), and peak oxygen pulse
Treatment: FES leg cycle exercise, 30 min (12.6%).
Pre-post
(minimum of 24 sessions, 3X/week). 2. HR was unaffected both at rest or
N=9
Outcome Measures: work rate, peak exercise.
VO2peak, oxygen pulse.
Population: 6 paraplegics (5 complete), 7 1. ↑resting HR and systolic blood pressure
tetraplegics (all incomplete), C4-C7 and in the tetraplegics, while ↓systolic,
T4-T10, mean age 30.5yrs, mean 8yrs diastolic and mean arterial BP in the
post-injury. paraplegics after training.
Faghri et al. 1992a; USA Treatment: FES leg cycle, 3X/week for 2. ↓exercise power output after training in
Downs & Black score=12 about 12 weeks. both groups.
Pre-post Outcome Measures: BP, power output, 3. In both groups, ↓submaximal exercise
N=13 HR, VO2peak, stroke volume, and HR and blood pressure and ↑ stroke
cardiac output. volume after training.
4. After training, submaximal cardiac
output increased significantly in the
paraplegic group.
Population: C4-C6 and T4-T8, ASIA A (5), 1. ↑work output (300%) over training.
Gerrits et al. 2001; B (3) and C (1), ages 26-61yrs, 1-27yrs 2. No change HR and systolic BP.
Netherlands post-injury. 3. ↑common femoral artery diameter
Downs & Black score=11 Treatment: FES leg cycle ergometry, (8%), no change common carotid
Pre-post 30min/day, 3day/wk for 6 weeks. artery diameter.
N=9 Outcome Measures: BP, end-diastolic Blood flow to the paralyzed limbs was
velocity, HR. increased.
7-10
7.5.2 Hybrid FES (Combined Leg and Arm Ergometry)
Table 7.6 Effects of Hybrid FES Training on Cardiovascular Fitness and Health
Score
Methods Outcome
Research Design
Total Sample Size
Population: 9 males, 1 female, T1-T12, 1. Training resulted in increased thigh
9 complete, mean age 39.2yrs, 1-20yrs resting (43.5%) and peak blood flow
post-injury. (17.1%), decreased thigh resting
Treatment: simultaneous FES cycle vascular resistance (31.8%), and
Thijssen et al. 2005;
ergometry and voluntary arm ergometry, 30 increased common femoral artery
Netherlands
mins/day, 2-3 days/wk for 4 weeks. diameter in the stimulated thigh tissue.
Outcome Measures: VO2peak, blood 2. Forearm and calf arterial parameters
Pre-post
flow and vascular resistance, and echo and FMD, in both superficial femoral
N=10
Doppler (diameter and flow-mediated and brachial artery, did not change.
dilation (FMD) after 13 min of ischemia). 3. After training, there was an increase in
maximal workload (6.8%), VO2peak
(6.1%), and resistance to fatigue.
Population: all male, C4-T10, 4 1. ↑VO2peak (81.7%) and workload
paraplegia, 2 tetraplegia, ages 23-41yrs, with FES leg cycle.
5-24yrs post-injury. 2. 8 week detraining period, peak
Gurney et al. 1998; USA Treatment: Phase I: FES leg cycle, 3 workload returned to baseline
Downs & Black score=12 days/week for 6 weeks. Phase II: FES leg levels; however VO2peak was still
Pre-post cycle with simultaneous, voluntary arm higher than baseline.
N=6 ergometry, 3 days/week for 6 weeks.
Phase III: 8 weeks of detraining inactivity.
Outcome Measures: VO2peak,
submaximal and maximal HR.
Population: all male, complete ASIA A, 1. In response to FES-LCE training both
C5-6 to T12-L1, mean 35.6yrs, mean VO2peak and peak work rate during
9.7yrs post-injury. graded FES leg exercise (but not
Treatment: 3 phases of exercise training graded arm ergometry) testing
(FES-Leg cycle ergometry): Phase I improved with training.
Mutton et al. 1997; USA progressive FES-Leg Cycle Exercise (FES- 2. As a result of the hybrid exercise
Downs & Black score=12 LCE) to 30 min of exercise; Phase II training, VO2peak (13%) and peak
Pre-post approximately 35 sessions of FES-LCE, power output (28%) were significantly
N=11 and Phase III approximately 41 sessions increased during graded hybrid testing,
(30 min each) of combined FES-LCE and but not during graded arm or graded
arm ergometry. FES leg testing alone.
Outcome Measures: VO2peak and
submaximal physiological parameters
(VO2, HR, blood lactate).
Population: 7male, 1 female, 7 1. After Phase 1, ↑arm ergometer
paraplegia, 1 tetraplegia, mean age VO2peak (21.9%) and FES leg
32yrs, mean 13yrs post-injury. ergometer VO2peak (62.7%).
Krauss et al. 1993; USA Treatment: 2 phase program. Phase I: 2. After Phase 2, the hybrid exercise
Downs & Black score=12 FES leg cycle for 6 weeks, 3 days/week. VO2peak increased 13.7%.
Pre-post Phase II: FES leg cycle plus simultaneous, 3. Peak HR only increased with training
N=8 voluntary arm ergometry for a 6 week in FES leg ergometry.
period. 4. There were no significant changes in
Outcome Measures: VO2peak, HR, peak lactate with training.
workload, peak lactate.
Population: 7 male and 4 female, C4-C6 1. Resting measures of VO2, HR, and
and T2-T6, complete motor lesions, ages oxygen pulse did not significantly
Pollack et al. 1989; USA 18-54yrs, 6-132 months post-injury. change with training.
Downs & Black score=11 Treatment: 3 phase program over 13-28 2. There were significant increases in
Pre-post weeks. Phase I: quadriceps stimulation for endurance time (288%), VO2peak
N=11 knee extension. Phase II: FES leg cycle (95.9%) and HR (16.8%), and
with 0-1 kp resistance. Phase III: loaded decreases in diastolic blood pressure
FES leg cycle, 3 days/week for 3 weeks. (31.5%) with training.
7-11
Score
Methods Outcome
Research Design
Total Sample Size
Outcome Measures: BP, HR, oxygen 3. There was a non-significant increase
consumption. (59.7%) in oxygen pulse with training.
7.5.3 Other Electrically-Assisted Training Programs
Table 7.7 Effects of Other Electrically Assisted Training Programs on Cardiovascular

Fitness and Health
Score
Methods Outcome
Research Design
Total Sample Size
Population: C7-T12, 5 ASIA A, 1 ASIA 1. Training resulted in significant
C, mean age, 42.5yrs, mean 13.8yrs increases in rowing distance (25%),
Wheeler et al. 2002;
post-injury. VO2peak (11.2%), and peak
Canada
Treatment: FES (quadriceps) with arm oxygen pulse (11.4%).
rowing 30 min/day, 3 days/week, for 12
Pre-post
weeks at 70-75% of VO2peak.
N=6
Outcome Measures: VO2peak, rowing
distance, and peak oxygen pulse.
Population: all male, complete ASIA A, 1. Training resulted in significant
C5-T10, mean age 35.6yrs, mean increases in weight lifted and muscle
13.4yrs post-injury. mass, and a decrease in muscle
Treatment: Home-based electrical fatigue (-60%).
Sabatier et al. 2006; USA stimulation (4 sets of 10 dynamic knee 2. There was no change in femoral artery
Downs & Black score=15 extensions with 3 mins rest between, diameter with training.
Pre-post increasing resistance with weight), 3. Resting, reactive hyperaemia, and
N=5 2X/week for 18 weeks. exercise blood flow did not change
Outcome Measures: Doppler echo significantly with training.
ultrasound (blood velocity and flow,
femoral artery diameter), muscle
fatigue, and muscle mass.
Population: all paraplegia, no other details 1. There was a non-significant increase in
Solomonow et al. 1997; given. cardiac output (7.1%) and stroke
USA Treatment: 3 hours per week for 14 weeks volume (5.0%) after training.
Downs & Black score=13 with the Reciprocating Gait Orthosis. 2. There was a significant increase in knee
Pre-post Outcome Measures: muscle extensor torque (78.2%).
N=70 hypertrophy, cholesterol, LDL, cardiac
output, and stroke volume.
Population: SCI: 3 male, 3 female, T4- 1. There was an increase in arterial
L2, all complete ASIA A/B, mean age 43 compliance and a decrease in the
yrs, mean 14.5yrs post-injury; Controls: flow-mediated dilation response in the
8 able-bodied individuals (4 male, 4 femoral artery of the trained leg, with
female), mean age 41yrs. no changes in these vascular
Treatment: Unilateral surface stimulation parameters in the femoral artery of the
de Groot et al. 2005; of the quadricep, tibial anterior and untrained leg, the carotid artery, and
Netherlands gastrocnemius muscles, 30 min/day, daily the brachial artery.
Downs & Black score=10 for 4 weeks (isometric training, as the leg 2. There were no significant training-
Pre-post was fixed in a sitting position with a knee related changes in resting vessel
N=6 angle of ~90°) diameter, blood flow or shear rate in
Outcome Measures: leg circumference, the femoral, carotid, and brachial
total limb volume, resting mean red blood arteries.
cell velocity and vessel diameter and blood 3.
pressure. 4. No significant training-related changes
occurred in blood pressure or leg
volumes.
7-12
Discussion
There is a growing body of literature indicating that FES exercise training is effective in
improving cardiovascular health, peak power output, and exercise tolerance/capacity in persons
with SCI (Table 7.5). This research generally employs a cycling motion, although rowing and
bipedal ambulation have also been evaluated. It appears that moderate-to-vigorous intensity
FES training (relative to baseline capacity) is effective to improve cardiovascular fitness in
persons with SCI. The majority of the investigations are pre-post designs (level 4) with
investigations reporting marked changes in VO2max or VO2peak after FES training. Similar to
aerobic training, 20-40% changes in aerobic capacity are often observed after FES training.
However, it is not uncommon for improvements in excess of 70% (Table 7.5). For instance,
researchers (Faghri et al. 1992) found a 260% increase in VO2peak after FES training.
Investigations with FES training have also shown an improvement in musculoskeletal fitness
and health. Similar to arm exercise training, limited investigations have shown an improvement
in cardiac function after FES training. A recent investigation has also revealed that the degree of
muscular adaptation that can be achieved via FES exercise is dependent upon the load that is
applied to the paralyzed muscle (Crameri et al. 2004).
Researchers have also revealed that hybrid exercise training (FES-leg cycling combined with
arm ergometry) may elicit greater changes in peak work rates and VO2max/VO2peak than FES-
leg cycling exercise alone (Krauss et al. 1993, Mutton et al. 1997). Moreover, it appears that the
physiological adaptations to combined FES-leg cycling and arm ergometry training are
maintained partially following 8 weeks of detraining (Gurney et al. 1998). Furthermore, other
interventions (Table 7.7) that make use of FES training have also been shown to improve the
exercise capacity and cardiovascular health status of persons with SCI.
A series of intrinsic muscle adaptations can also occur after FES training that enhance the
ability for oxidative metabolism at the cellular level, which in turn facilitate improved endurance,
exercise tolerance and functional capacity. Key intrinsic muscle adaptations that have been
observed include an increase in the proportion of type 1 fibres, an enhancement in cross-
sectional fibre area, an increase in capillary-to-fibre ratio, a shift towards more fatigue resistant
contractile proteins, and an increase in citrate synthase activity. Given the recently established
importance of musculoskeletal fitness for health and functional status (Warburton et al. 2001a,
2001b, Warburton et al. 2006b), further research is clearly warranted with persons with SCI.
Randomized, controlled exercise interventions (both arm and/or FES training) that evaluate
concurrent changes in musculoskeletal fitness and health status are particularly needed.
Conclusion
There is Level 4 evidence FES training for a minimum of 3 days per week for 2 months
There is Level 4 evidence that FES training is effective in improving exercise cardiac
function in persons with SCI.
Based on the changes observed in VO2max and findings from able-bodied individuals a
consensus (Level 5; Expert Opinion) was derived stating that aerobic training is effective
in improving the ability to extract oxygen at the periphery in persons with SCI.
7-13
Interventions that involve FES training a minimum of 3 days per week for 2 months can improve
muscular endurance, oxidative metabolism, exercise tolerance, and cardiovascular fitness.
7.6 Glucose Homeostasis
Glucose intolerance and decreased insulin sensitivity are independent risk factors for CVD
(Hurley & Hagberg 1998). Abnormal glucose homeostasis is associated with deteriorated lipid-
lipoprotein profiles and an increased risk for the development of hypertension and type 2
diabetes (Hurley & Hagberg 1998, Warburton et al. 2001a, 2001b). It is well-established that
habitual physical activity is an effective primary preventative strategy against insulin resistance
and Type 2 diabetes in the general population (Warburton et al. 2006a). Although comparatively
less information is available for SCI, it appears that exercise training programs are effective in
improving glucose homeostasis (Hjeltnes et al. 1998, Chilibeck et al. 1999, de Groot et al. 2003,
Phillips et al. 2004, Mahoney et al. 2005).
Table 7.8 Glucose Homeostasis

• Involves the ingestion of glucose and the subsequent serial
blood analysis of glucose levels to determine the rate of
Oral Glucose Tolerance Test (OGTT)
blood glucose removal. Common test used in the diagnosis
of diabetes.
• Refers to the sensitivity of target cells (muscle, hepatic cells
Insulin Sensitivity
and adipose) to insulin.
• Refers to blood levels of glucose (a simple sugar,
Blood Glucose carbohydrate). High fasting blood glucose levels reflects
pre-diabetic or diabetic conditions.
• Refers to blood levels of insulin (a hormone that regulates
Blood Insulin
carbohydrate metabolism).
• Glucose transporters are important membrane proteins that
Glucose Transporters facilitate the transport of glucose through the cellular
(GLUT-4) membrane. GLUT4 is an insulin-regulated glucose
transporter located in adipose and muscle tissues.
Glycogen Synthase • Enzyme involved in the synthesis of glycogen from glucose.
• An enzyme that acts during carbohydrate metabolism. In
the first step of glycolysis, hexokinase phosphorylates
Hexokinase
(transfers phosphate from ATP) glucose to prepare it for
subsequent breakdown for use in energy production.
• Citrate synthase is an important enzyme in the Citric Acid
Citrate Synthase
Cycle (Krebs cycle).
• Phosphofructokinase (PFK) is an important regulatory
Phosphofructokinase
enzyme of glycolysis.
Table 7.9 Effects of Exercise Training on Glucose Metabolism in Persons with SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: 4 male, 2 female, C5-L1, 1. There was a significant difference in
de Groot et al. 2003;
ASIA A (n=1), B (n=1), and C (n=4), mean insulin sensitivity between groups,
Netherlands
age 36yrs, mean 116 days post-injury. with a non-significant decline in the
PEDro=7
Treatment: Randomized to low intensity high intensity group and a significant
RCT
(50-60% HRR) or high intensity (70-80% improvement in the low intensity
N=6
HRR) arm ergometry. 20 min/day, 3 group with training.
days/week for 8 weeks. 2. A significant positive correlation
Outcome Measures: VO2peak, insulin between VO2peak and insulin
7-14
Score
Methods Outcome
Research Design
Total Sample Size
sensitivity, blood glucose. sensitivity (r=0.68, p=0.02) was
found for the group as a whole.
Population: 5 males, complete SCI, C5- 1. Quadriceps femoris muscle cross-
T10, ASIA grade A, mean age 35.6yrs, sectional area increased in both
mean 13.4yrs post-injury. thighs (~37%) after training.
Treatment: Home-based neuromuscular 2. All participants had normal fasting
Mahoney et al. 2005; electric stimulation-induced resistance glucose levels before and after
USA exercise training, 2 days/week for 12 training.
Downs & Black score=17 weeks. 3. There were no significant changes
Pre-post Outcome Measures: quadriceps femoris in blood glucose or insulin with
N=5 muscle cross-sectional area, plasma training. However, there was a trend
glucose, insulin. towards reduced plasma glucose
levels (p=0.074).
4. There was a progressive increase in
muscular strength over the 12 week
program.
Population: 5 males, C5-C7, all complete 1. After training, insulin-mediated
ASIA A, mean age 35yrs, mean 10yrs post- glucose disposal was increased by
injury. 33%. There was an associated 2.1
Treatment: Electrically stimulated leg fold increase in insulin-stimulated
cycling exercise, 7 days/week for 8 weeks. glucose transport activity.
Outcome Measures: peripheral insulin 2. Training led to marked increases in
Hjeltnes et al. 1998; sensitivity, whole body glucose utilization, protein expression of GLUT4
Sweden glucose transport, phosphofructokinase, (glucose transporter) (378%),
Downs & Black score=13 citrate synthase, hexokinase, glycogen glycogen synthase (526%), and
Pre-post synthase, blood glucose, plasma insulin. hexokinase II (204%) in the vastus
N=5 lateralis muscle.
3. Hexokinase II activity increased
25% after training.
4. A small increase in percentage type
I muscle fibres and signs of
transformation from type IIb to IIa
muscle fibres were noted in 4/5
participants.
Population : 8 male, 1 female, incomplete 1. Decrease in the external supported
ASIA C, C4-T12, mean 8.1yrs post-injury. proportion of body weight and
Treatment: Body-weight supported increase in session length and
treadmill walking, 3 days/week for 6 walking velocity.
months. 2. Reduction in the area under the
Phillips et al. 2004; Outcome Measures: whole-body dual- curve for glucose (-15%) and insulin
Canada energy X-ray absorptiometry, GLUT4 (-33%).
Downs & Black score=12 protein abundance, hexokinase activity, 3. The oxidation of exogenous
Pre-post oral glucose tolerance tests, glucose (ingested) glucose and endogenous
N=9 oxidation, CO2 breath analysis. (liver) glucose increased (68% and
36.8%, respectively) after training.
4. Training resulted in increased
muscle glycogen, GLUT-4 content
(glucose transporter) (126%), and
hexokinase II enzyme activity
(49%).
Population: 5 male, 2 female, motor 1. There were significantly lower
Jeon et al. 2002; Canada complete, C5-T10, ages 30-53yrs, 3-40yrs (14.3%) 2h OGTT glucose levels
Downs & Black score=11 post-injury. after 8 weeks of training.
Pre-post Treatment: FES leg cycle training, 30 2. Glucose utilization was higher for all
N=7 min/day, 3 day/week for 8 weeks. 3 participants and insulin sensitivity
Outcome Measures: oral glucose was higher for 2 of the 3 participants
tolerance test (OGTT), glucose and insulin during post-training 2h clamp test.
7-15
Score
Methods Outcome
Research Design
Total Sample Size
levels, glucose utilization, insulin sensitivity
and levels.
Population : 8 male, 2 female, 6 1. Insulin-stimulated glucose uptake
tetraplegia, 4 paraplegia, C6-T4, mean age rates increased after intensive
35yrs, mean 12yrs post-injury. training.
Treatment: FES cycling, 30 min/day, 3 2. With the reduction in training, insulin
day/wk for 12 months. 7 participants sensitivity decreased to a similar
Mohr et al. 2001;
completed an additional 6 months (at 1 level as before training. GLUT 4
Denmark
day/week). increased by 105% after intense
Outcome Measures: insulin-stimulated training and decreased again with
Pre-post
glucose uptake, oral glucose tolerance test the training reduction. The
N=10
(OGTT), GLUT 4 glucose transporter participants had impaired glucose
protein. tolerance before and after training,
and neither glucose tolerance nor
insulin responses to OGTT were
significantly altered by training.
Population: 4 male, 1 female, motor 1. Training resulted in increases in
complete C5-T8, ages 31-50yrs, 3-25yrs GLUT-1 (52%) and GLUT-4 (72%).
Chilibeck et al. 1999; post-injury. 2. There was a training-induced
Canada Treatment: FES leg cycle ergometry increase in citrate synthase activity
Downs & Black score=10 training, 30 min/day, 3 day/week for 8 (56%) and an improvement in the
Pre-post weeks. insulin sensitivity index as
N=5 Outcome Measures: glucose transporters determined from oral glucose
(GLUT-4, GLUT-1), oral glucose tolerance tolerance test.
test, citrate synthase.
Discussion
The majority of the data is from experimental non-randomized controlled trials. A search of the
literature revealed 7 investigations (n = 47). This included 1 randomized controlled trial (RCT)
and 6 experimental non-randomized controlled trials. The RCT involved the randomization to
two different forms of exercise, and as such an exercise condition served as the control. The
majority (5) of these trials examined the effectiveness of FES training in comparison to aerobic
training (2 investigations).
Similar to other studies in the field of SCI research, this area of investigation is limited by the
lack of quality RCT. Moreover, the majority of the research relates to the effects of FES training.
Limited work has been conducted using aerobic and/or resistance exercise training. As a whole,
however, these studies are consistent and reveal several important findings. For instance, the
improvements in glucose homeostasis may be the result of increased lean body mass (which
leads to enhancd insulin sensitivity), and increased expression of GLUT4, glycogen synthase,
and hexokinase in exercised muscle.
Consistent with findings in able-bodied individuals (Warburton et al. 2001a, 2001b), the
improvement in glucose homeostasis after exercise interventions (such as aerobic training or
FES) does not appear to be solely related to decreases in body adiposity and/or increases in
VO2max. This is due to the fact that significant improvements in glucose homeostasis can occur
with minor changes in body composition and/or aerobic fitness.
It is also important to note that there appears to be a minimal volume of exercise required for
improvements in glucose homeostasis. For instance, Mohr et al. (2001) revealed that a
reduction of FES training was not sufficient to maintain the beneficial changes in insulin
sensitivity and GLUT4 protein observed during a 3 day/week FES training program.
7-16
Conclusion
There is Level 4 evidence that aerobic exercise training programs (performed 30 min/day,
3 day per week for 6 weeks or more) are effective in improving glucose homeostasis in
persons with SCI.
There is Level 4 evidence that FES training programs (performed 30 min/day, 3 day per
week for 6 weeks or more) are effective in improving glucose homeostasis in persons
with SCI.
There is Level 4 evidence that the changes in glucose homeostasis after aerobic or FES
training are clinically significant for the prevention and/or treatment of type 2 diabetes.
Aerobic and FES exercise training may lead to clinically significant improvements in glucose
homeostasis in persons with SCI. Preliminary evidence indicates that a minimum of 30 min of
moderate intensity training on 3 days per week is required to achieve and/or maintain the
benefits from exercise training.
7.7 Lipid Lipoprotein Profiles
Abnormal lipid-lipoprotein profiles have been associated with an increased risk for CVD (Hurley
& Hagberg 1998, Warburton et al. 2001a, 2001b, Warburton et al. 2006a, 2006b). Routine
physical activity has been shown to enhance lipid lipoprotein profiles, e.g., reduced triglycerides
(TG), greater levels of high-density lipoprotein (HDL) cholesterol and lower low/high density
lipoprotein ratios (LDL/HDL) (Brenes et al. 1986, Tell & Vellar 1988, DuRant et al. 1993,
Taimela et al. 1994, O'Connor et al. 1995, Halle et al. 1996, Berg et al. 1997, Warburton et al.
2001a, 2001b) in the general population (Warburton et al. 2006a). Although limited, similar
findings have been observed in persons with SCI (Table 7.9).
The following table describe the common measurements of lipid profiles.
Table 7.10 Lipid Lipoprotein Profiles

• Lipid protein complex that transports cholesterol from the liver to other
Low-density lipoprotein (LDL) tissues within the body. LDL is often referred to as the “bad” cholesterol.
LDL levels above 160 mg/dL (4.1 mmol/L) are considered to be high.
• Lipid protein complex that transports cholesterol from the tissues to the
liver for excretion and re-utilization. HDL is often referred to as the “good”
High-density lipoprotein (HDL)
cholesterol. HDL levels of <40 mg/dL (<1.03 mmol/L) are associated with
an increased risk for CVD.
Total cholesterol (TC) • Total amount of all cholesterol in the blood (↑TC related to ↑risk for CVD)
Triglycerides (TG) • High energy fatty acids which form much of the fat stored by the body
Table 7.11 Effects of Exercise Training on Lipid Lipoprotein Profiles in Persons with SCI
Score
Methods Outcome
Research Design
Total Sample Size
de Groot et al. 2003; Population: 4 male, 2 female, C5-L1, 1. The TC/HDL and triglycerides
Netherlands ASIA A (n=1), B (n=1), and C (n=4), mean decreased significantly more in the
PEDro=7 age 36yrs, mean 116 days post-injury. high intensity versus the low
RCT Treatment: Randomized to low intensity intensity group.
N=6 (50-60% HRR) or high intensity (70-80%
7-17
Score
Methods Outcome
Research Design
Total Sample Size
HRR) arm ergometry. 20 min/day, 3
days/week for 8 weeks.
Outcome Measures: lipid profiles
including total cholesterol (TC), HDL, LDL,
triglycerides (TG).
Population: 5 SCI: lesion below T10, 1. There was a significant increase in
mean age 32 years; 7 AB controls: mean peak workload (10.1%) and
El-Sayed et al. 2005; UK
age 31 years. VO2peak (8.6%).
Treatment: Arm ergometry, 30 min/day (at 2. Training did not alter TC or
Pre-post
60-65% VO2peak), 3 day/week for 12 wks. triglycerides.
N=12
Outcome Measures: VO2peak, peak HR, 3. Training improved HDL.
peak workload, TC, triglycerides, HDL.
Population: all paraplegia, no other details 1. There were significant reductions in total
given. cholesterol, LDL, LDL/HDL, and TC/HDL
Solomonow et al. 1997;
Treatment: 3 hours per week for 14 weeks in 8 patients with initially high total
USA
with the Reciprocating Gait Orthosis. cholesterol levels (>200 mg/dL).
Outcome Measures: cholesterol, LDL, 2. 20 patients with initially normal
Pre-post
HDL cholesterol levels did not exhibit a
statistically significant change in total
cholesterol, HDL, or LDL levels.
Population: 5 males, complete lesions T6- 1. There were significant increases in
L1, mean age 37.8yrs, mean 4.8yrs post- VO2peak, time to fatigue and peak
Nash et al. 2001; USA injury. power output after training.
Downs & Black score=11 Treatment: Circuit resistance training, 3 2. There were significant decreases in
Pre-post days/week for 12 weeks, with resistive load LDL, LDL/HDL and TC/HDL after
N=5 of 50-60% 1RM. training.
Outcome Measures: VO2peak, time to
fatigue, TC, triglycerides, HDL, LDL.
Population: 8 male, 1 female, incomplete 1. Treadmill velocity and session
lesions ASIA C, C4-T12, mean 8.1yrs post- length increased by 135% and 55%,
Stewart et al. 2004; injury. respectively, while amount of
Canada Treatment: Body weight-supported externally supported weight
Downs & Black score=10 treadmill training, 3 day/week for 6 months. decreased as the result of training.
Pre-post Outcome Measures: ambulatory capacity 2. Functional locomotor capacity
N=9 (Wernig Walking Scale), cholesterol, HDL, improved in 4 subjects.
LDL, triglycerides 3. There were significant reductions in
TC (-11.2%), LDL (-12.9%) and total
cholesterol/HDL (-19.8%).
Population: low-intensity group: n=6, 3 1. Blood lipid levels remained
male, 3 female, C5-T10, ages 26-36yrs, unaltered in the low-intensity group,
3months-19yrs post-injury; moderate- while the moderate-intensity group
Hooker & Wells 1989;
intensity group: n=5, 3 male, 2 female, C5- exhibited significant increases in
USA
T9, ages 23-30yrs, 2-19yrs post-injury. HDL and decreases in triglycerides,
Treatment: Two SCI groups performed LDL, and the TC/HDL ratio.
wheelchair ergometry 20 min/day, 3 2. It appears that 70% maximal HRR
Trial
days/week for 8 weeks. The low-intensity was the threshold intensity needed
N=8
group trained at 50-60% max HRR and the to elicit training benefits in SCI
moderate intensity group trained at 70-80% persons.
max HRR.
Outcome Measures: total cholesterol
(TC), triglycerides, HDL, LDL.
Discussion
The information regarding the effects of exercise training on lipid lipoprotein profile is derived
from one level 1 study, 1 level 2 and several level 4 studies (N = 105). The majority (6) of the
investigations examined a form of aerobic training (either arm ergometry or assisted-treadmill
7-18
walking). The other investigation examined the effects of reciprocating gait orthosis powered
with electrical muscle stimulation.
These findings generally support the importance of exercise in the reduction of atherogenic lipid
lipoprotein profiles and the reduction of the risk for CVD in persons with SCI. It appears that a
minimal threshold of training exists for changes in lipoprotein profile. For instance, a few authors
reported that 70% of maximal HRR is the threshold necessary to achieve significant
improvements in lipid lipoprotein profiles. Future research is warranted, however, to quantify the
effects of varying forms of exercise (including aerobic exercise, resistance exercise, and FES)
on lipid lipoprotein profiles in persons with SCI.
Conclusion
There is Level 4 evidence to suggest that aerobic exercise training programs (performed
at a moderate to vigorous intensity 20-30 min/day, 3 days per week for 8 weeks) are
effective in improving the lipid lipoprotein profiles of persons with SCI.
Preliminary evidence (Level 4) also indicates that FES training (3 hours/week, for 14
weeks) may improve lipid lipoprotein profiles in SCI.
Aerobic and FES exercise training may lead to improvements in lipid lipoprotein profile that
are clinically relevant for the at risk SCI population. The optimal training program for changes
in lipid lipoprotein profile remains to be determined. However, a minimal aerobic exercise
intensity of 70% of heart rate reserve on most days of the week appears to be a good
general recommendation for improving lipid lipoprotein profile in persons with SCI.
7.8 Summary
There is a growing body of evidence to suggest that persons with SCI are at an increased
risk for CVD. The evidence is summarized for the management of the risk of
cardiovascular disease with aerobic exercise training (Table 7.12) and with FES (Table
7.13).
Table 7.12 Management of the Risk for Cardiovascular Disease in Persons with SCI
through Aerobic Exercise Training Interventions
Strength
Risk Factor of Literature Support
Evidence
Gass et al. 1980, DiCarlo et
al. 1983, DiCarlo 1988,
Cardiovascular Hjeltnes & Wallberg-
• Increased exercise tolerance Level 1
Fitness Henriksson 1998, Jacobs et
al. 2002, Sutbeyaz et al.
2005
Gass et al. 1980, DiCarlo et
al. 1983, Cooney & Walker
1986, DiCarlo 1988, Jacobs
• Increased VO2max Level 1
et al. 2002, de Groot et al.
2003, El-Sayed et al. 2004,
Sutbeyaz et al. 2005.
Davis et al. 1987, Davis et al.
• Increased cardiac output Level 4
1991
7-19
Strength
Evidence
• Reduced submaximal exercise heart rate Level 4 DiCarlo 1988
• Increased maximal heart rate Level 4 Sutbeyaz et al. 2005
• Increased stroke volume Level 4
1991
• Decreased total peripheral resistance Level 4
1991
Cooney & Walker 1986,
DiCarlo 1988, Hjeltnes &
Wallberg-Henriksson 1998,
• Increased power output Level 1
Jacobs et al. 2002, de Groot
et al. 2003, Hicks et al. 2003,
Sutbeyaz et al. 2005
• Intrinsic cellular adaptations that facilitate
Level 4 Stewart et al. 2004
oxidative metabolism
Hooker & Wells 1989, Nash
• Increased HDL cholesterol Level 4 et al. 2001, El-Sayed &
Younesian 2005
Hooker & Wells 1989, Nash
Lipid
• Reduced LDL cholesterol Level 4 et al. 2001, de Groot et al.
Lipoprotein
2003, Stewart et al. 2004
Profile
• Reduced triglycerides Level 4 de Groot et al. 2003
Hooker & Wells 1989, de
• Reduced total cholesterol Level 4 Groot et al. 2003, Stewart et
al. 2004
Glucose • Increased insulin sensitivity, decreased insulin
Level 4 de Groot et al. 2003
Homeostasis resistance, and/or improved glucose tolerance.
Table 7.13 Management of the Risk for Cardiovascular Disease in Persons with SCI
through Functional Electrical Stimulation Training Interventions
Strength
Evidence
Pollack et al. 1989, Hooker et
al. 1992, Barstow et al. 1996,
• Increased exercise tolerance Level 4
Mohr et al. 1997, Wheeler et
al. 2002, Thijssen et al. 2005
Pollack et al. 1989, Hooker et
al. 1992, Barstow et al. 1996,
• Increased VO2max Level 4 Hjeltnes et al. 1997, Mohr et
al. 1997, Wheeler et al. 2002,
Thijssen et al. 2005
Cardiovascular • Increased cardiac output Level 4 Hooker et al. 1992
Fitness
• Reduced submaximal exercise heart rate Level 4 Faghri et al. 1992
• Increased stroke volume Level 4 Faghri et al. 1992
• Decreased total peripheral/vascular
Level 4 Faghri et al. 1992
resistance
Faghri et al. 1992, Hooker et
• Increased power output Level 4
al. 1992, Thijssen et al. 2005
Andersen et al. 1996, Mohr et
• Intrinsic cellular adaptations that facilitate
Level 4 al. 1997, Crameri et al. 2002,
oxidative metabolism
Crameri et al. 2004
Lipid Lipoprotein • Reduced LDL cholesterol Level 4 Solomonow et al. 1997
Profile • Reduced total cholesterol Level 4 Solomonow et al. 1997
• Increased insulin sensitivity, decreased
Glucose
insulin resistance, and/or improved glucose Level 4 Jeon et al. 2002
Homeostasis
tolerance.
7-20
Marked physical inactivity appears to play a central role in this increased risk.
Accordingly, exercise interventions are effective in leading to significant reductions in
the risk for CVD and multiple comorbidities (such as type 2 diabetes, hypertension,
obesity). Both exercise and FES training are effective in attenuating and/or reversing
abnormalities in glucose homeostasis, lipid lipoprotein profiles, and cardiovascular
fitness in persons with SCI. Future well-designed randomized controlled trials are
required to firmly establish the primary mechanisms by which exercise interventions
elicit these beneficial changes in health status.
There is Level 4 evidence that BWSTT can reduce resting heart rate in individuals with
incomplete, but not complete SCI injuries.
balance in persons with incomplete tetraplegia.
balance in a subset of individuals with motor-complete SCI who respond to ambulation
with moderate to large increases in heart rate.
There is Level 4 evidence that BWSTT can improve arterial compliance in individuals with
motor-complete SCI.
There is Level 1 evidence that arm exercise at a moderate to vigorous intensity (50-80%
HRR), 3 days/week for at least 2 months improves cardiovascular fitness.
There is Level 1 evidence that high intensity (70-80% HRR) exercise leads to greater
improvements in peak power and VO2peak than low intensity (50-60% HRR) exercise.
There is Level 1 evidence that aerobic exercise training is effective in improving exercise
capacity/tolerance in persons with SCI.
It is uncertain whether aerobic training can improve cardiac function in persons with SCI.
Based on the changes observed in VO2max and findings from able-bodied individuals, a
consensus was derived stating that aerobic training may be effective in improving the
ability to extract oxygen at the periphery in persons with SCI.
There is Level 4 evidence FES training for a minimum of 3 days per week for 2 months
There is Level 4 evidence that FES training is effective in improving exercise cardiac
function in persons with SCI.
Based on the changes observed in VO2max and findings from able-bodied individuals a
consensus (Level 5; Expert Opinion) was derived stating that aerobic training is effective
in improving the ability to extract oxygen at the periphery in persons with SCI.
There is Level 4 evidence that aerobic exercise training programs (performed 30 min/day,
3 day per week for 6 weeks or more) are effective in improving glucose homeostasis in
persons with SCI.
7-21
There is Level 4 evidence that FES training programs (performed 30 min/day, 3 day per
week for 6 weeks or more) are effective in improving glucose homeostasis in persons
with SCI.
There is Level 4 evidence that the changes in glucose homeostasis after aerobic or FES
training are clinically significant for the prevention and/or treatment of type 2 diabetes.
There is Level 4 evidence to suggest that aerobic exercise training programs (performed
at a moderate to vigorous intensity 20-30 min/day, 3 days per week for 8 weeks) are
effective in improving the lipid lipoprotein profiles of persons with SCI.
Preliminary evidence (Level 4) also indicates that FES training (3 hours/week, for 14
weeks) may improve lipid lipoprotein profiles in SCI.
7-22
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Whiteneck GG, Charlifue SW, Frankel HL, Fraser MH, Gardner BP, Gerhart KA, et al. Mortality,
morbidity, and psychosocial outcomes of persons spinal cord injured more than 20 years
ago. Paraplegia 1992;30(9):617-30.
Yekutiel M, Brooks ME, Ohry A, Yarom J, Carel R. The prevalence of hypertension, ischaemic
heart disease and diabetes in traumatic spinal cord injured patients and amputees.
Paraplegia 1989;27(1):58-62.
7-28
CHAPTER EIGHT
A William Sheel, PhD

W Darlene Reid, BMR (PT), PhD
Andrea F Townson, MD FRCPC
Najib Ayas, MD FRCPC, MPH
Key Points
For exercise training to improve respiratory function the training intensity must be
relatively high (70-80% of maximum heart rate) performed three times per week for six
weeks Ideal training regimes have not been identified.
There is limited evidence that inspiratory muscle training improves respiratory muscle
strength or endurance in people with SCI.
The use of bronchodilators should be considered in subjects with tetraplegia who
demonstrate an element of obstructive airway impairment.
The effects of other medications commonly used in the management of SCI such as
baclofen and oxybutynin should be considered when reviewing airway hyperreactivity
in subjects with tetraplegia
The short-term use of oxandrolone should be considered to improve pulmonary
function in subjects with tetraplegia.
Progressive ventilator free breathing protocol should be considered for ventilator
dependent subjects with tetraplegia who are appropriate for ventilator weaning.
Resistance and endurance training should be considered in subjects who are
candidates for ventilator weaning.
Case by case consideration should be given to tracheostomy decannulation in
subjects with SCI. The indications and criteria for tracheostomy decannulation
have not been established in SCI.
Abdominal binding can be used to achieve immediate improvements in respiratory
function, but long term effects have not been established.
Chest wall vibration may improve pulmonary function while the vibration is applied,
but carry-over effects when the vibration is not in use has not been evaluated.
There is limited evidence that immersion to shoulder-deep 33-34° Celsius water may
improve pulmonary function, but carry-over effects following immersion has not been
evaluated.
Patients with SCI have a high prevalence of obstructive sleep apnea, and therapy may
improve quality of life and other outcomes. Therefore, we recommend vigilance for
suggestive signs and symptoms (e.g., snoring, obesity, witnessed apneas, daytime
sleepiness) and further testing in patients with suggestive symptoms/signs (with
overnight oximetry or polysomnography).
There is limited evidence that suggests that improving inspiratory and expiratory
muscle force is important to maximize expiratory flow during cough.
Cough effectiveness can be enhanced by a variety of methods including manual
assistance by a caregiver and/or electrical stimulation triggered by the person with
SCI.
Hand-held expiratory pressure devices may enhance secretion removal in people with
SCI.
Table of Contents
8.1 Introduction ......................................................................................................................8-1
8.2 Exercise Training .............................................................................................................8-3
8.3 Inspiratory Muscle Training ............................................................................................8-6
8.4 Pharmaceutical Interventions.......................................................................................8-10

8.4.1 Airway Hyperresponsiveness and Bronchodilators.......................................................8-10
8.4.2 Anabolic Agents ............................................................................................................8-14
8.4.3 Other pharmaceuticals..................................................................................................8-15
8.5 Assistive Devices...........................................................................................................8-15

8.5.1 Mechanical Ventilation and Weaning Protocols............................................................8-15
8.5.2 Other methods of ventilation .........................................................................................8-17
8.5.3 Tracheostomy Decannulation .......................................................................................8-17
8.5.4 Girdle/abdominal Binder ...............................................................................................8-18
8.5.5 Vibration........................................................................................................................8-19
8.5.6 Immersion .....................................................................................................................8-20
8.6 Obstructive Sleep Apnea in SCI ...................................................................................8-21

8.6.1 Prevalence and Risk Factors ........................................................................................8-22
8.7 Secretion Removal.........................................................................................................8-23
8.8 Summary.........................................................................................................................8-25
Reference................................................................................................................................8-27
Sheel AW, Reid WD, Townson AF, Ayas N (2006). Respiratory Management Following Spinal Cord Injury. In: Eng JJ,
www.icord.org/scire
8.1 Introduction
The respiratory system, including the lung, respiratory muscles, and neural control system, is a
complex integrated physiological system that is not yet fully understood. The respiratory system
is unique in that it must operate in a cyclical and highly coordinated fashion for 24 hours per day
in order to sustain life. Respiratory complications continue to be one of the leading causes of
morbidity and mortality in people with spinal cord injury (SCI), especially among cervical and
higher thoracic injuries. This continues to be the case despite recent advances in SCI patient
care where acute and long-term mortality rates have been significantly reduced (DeVivo et al.
1993; 1999). Respiratory system complications can be exacerbated by pre-existing medical
conditions, history of smoking, advanced age and by therapeutic measures to manage the
resuscitation phase of the injured patient.
Respiratory dysfunction resulting from cervical SCI depends on the level of injury and the extent
of innervation. The higher level lesions result in denervation of progressively more of the
expiratory and inspiratory muscles as illustrated in Figure.8.1. Although the primary
consequence of SCI is dennervation of the respiratory pump, secondary consequences occur
within the lungs because of the inability to effectively distend and inflate the lung to its full
capacity. As a consequence, the compliance of the lungs diminishes with increasing time after
SCI.
Figure 8.1 Innervation of the respiratory muscles
Accessory Muscles of
Primary Muscles Inspiration & Muscles of
of Inspiration Expiration
Sternomastoid
Diaphragm C3-C5
Accessory Nerve & C2-C3
Scalenes C2-C7
Intercostals T1-T11
Abdominal Muscles
especially Transversus
Abdominus T7-L1
Complete paralysis of all muscles involved with respiration occurs when the lesion is above C3;
this type of injury requires immediate and permanent ventilatory support in order to sustain life.
The primary goal of ventilatory support is to ensure arterial blood gas homeostasis. When the
8-1
injury is between C3 to C5 (innervation of the diaphragm), respiratory insufficiency occurs via
respiratory muscle dysfunction. Although primary and some accessory muscles of inspiration
are fully innervated with injuries below cervical lesions, the ability to ventilate at higher levels is
still compromised because the intercostals and other chest wall muscles do not provide the
integrated expansion of the upper chest wall as the diaphragm descends during inspiration.
Furthermore, ventilation during exercise can be greatly compromised. The expiratory muscles
actively contract in healthy people whereas partial or fully denervated expiratory muscles in
those with SCI will diminish exercise ventilation and ventilatory reserve.
Lung volumes reflect these diminished capacities for full inspiration and forced expiration in
people with SCI. These pulmonary function measures are derived by having the person breathe
normally followed by full inspiration and full expiration in and out of an apparatus that measures
lung volumes (Figure 8.2). As expected lung volumes like the inspiratory capacity (IC) and
expiratory reserve volume (ERV), are progressively smaller in higher cervical lesions versus
lower thoracic and lumbar lesions (Baydur et al. 2001).
Figure 8.2 Measurement of lung volume
Lung Capacities Lung Volumes
Inspiratory capacity (IC): maximal volume of air Tidal volume (VT but also known as TV): volume
that can be inhaled (sum of VT and IRV). of air inhaled or exhaled during breathing (at rest or
Functional residual capacity (FRC): volume of air during exercise).
remaining in the lungs at the end of an ordinary Inspiratory reserve volume (IRV): maximum
expiration, i.e. at the resting level or end-expiratory volume of air that can be inhaled to total lung
level. capacity over and above the tidal volume.
Vital Capacity (VC): maximum volume of air that Expiratory reserve volume (ERV): maximum
can be expelled after a maximum inspiration, i.e. volume of air that can be exhaled from the end-
from total lung capacity (TLC) to residual volume. expiratory level or from functional residual capacity
Total Lung Capacity (TLC): total amount of air in (FRC) to residual volume.
the lungs after a maximal inspiration. TLC= RV + Residual volume (RV): volume of air remaining in
ERV + VT (TV) + IRV. the lungs after a maximal expiration.
The forced expiratory volume in one second (volume of air that can be exhaled in the first
second = FEV1) and forced vital capacity (maximum volume of air that can be exhaled = FVC)
are usually measured in apparently healthy people to detect airways obstruction. Due to
reduced inspiratory muscle force, these measures are diminished in people after SCI with
higher lesions and especially in people with tetraplegia (Linn et al. 2000; Baydur et al. 2001) and
demonstrate moderate correlation with injury level (Baydur et al. 2001). Longer duration of
injury and smoking are two factors associated with greater loss while incomplete lesions
8-2
(compared to complete lesions) have less loss of forced expiratory measures of FEV1 and FVC
(Linn et al. 2000).
People with SCI at most levels affect innervation of the abdominal muscles (Figure 8.1), which
severely compromises the ability to generate cough and clear respiratory secretions. Cough
generation is accomplished primarily by the expiratory intercostals muscles (thoracic roots) and
the abdominal muscles (T4-L1). Cough is important as a defense mechanism to prevent
respiratory tract infections and atelectasis. The respiratory system has other important roles
such as speaking and posture-related activities which can also be negatively impacted by the
SCI, especially with higher lesions.
In summary, the respiratory consequences of SCI are readily apparent and are largely
dependent on the level of injury. Additional large-scale cross sectional and longitudinal studies
are required to fully characterize pulmonary function in SCI. Secondary respiratory
complications related to other respiratory pathologies (i.e., chronic obstructive pulmonary
disease, asthma) are not well described. In particular, the consequences of aging on pulmonary
function are not well defined in SCI. With healthy aging there is a decline in lung function,
primarily because of a loss of elastic recoil. Moreover, additional age-related changes that are
known to negatively affect gas exchange are decreased surface area of the lung, decreased
pulmonary capillary blood volume, increased dead space ventilation and decreased distensibility
of the pulmonary arterial vasculature. A greater understanding of the interactions between SCI,
aging and the respiratory system are necessary for comprehensive patient management.
While it is clear that the respiratory system can be compromised with SCI, the salient question
is: what intervention strategies are known to be effective in patient management? The
subsequent sections are divided into commonly used respiratory-related interventions used for
the respiratory management of the patient with SCI.
The following commonly used respiratory abbreviations are used:
IMT inspiratory muscle training PaCO2 partial pressure of arterial carbon dioxide
MVV maximal voluntary ventilation PaO2 partial pressure of arterial oxygen
SIP sustained inspiratory pressure RV residual volume
FEV1 forced expiratory volume in the first second MIP maximal inspiratory pressure
FVC forced vital capacity MEP maximal expiratory pressure
TLC total lung capacity VE minute ventilation
IC inspiratory capacity VT tidal volume
ERV expiratory reserve volume (TV) frequency of breathing
PEFR peak expiratory flow rate fb inspiratory duty cycle; inspiratory
Ti/Ttot time/total time for one breath
8.2 Exercise Training
As with able-bodied individuals, there is strong evidence in support for the use of exercise
training for improving cardiovascular health among people this SCI (see Chapter 7). This is
important because there is a high incidence of physical inactivity in individuals with SCI and as
such they are at increased risk of secondary conditions such as cardiovascular disease,
diabetes, osteoporosis and obesity. There is clear evidence that the cardiovascular and skeletal
muscle systems adapt positively to exercise training in both able-bodied and SCI people.
However, the lungs and airways do not change appreciably in response to exercise training. It
is likely that exercise is not sufficiently stressful to warrant an adaptive response. This may be
even more so when considering the small muscle mass used in wheelchair propulsion or arm
8-3
cranking exercise. On the other hand, respiratory muscles are both metabolically and
structurally plastic and they respond to exercise training. This statement is based largely on
direct evidence from animal models and indirect evidence from able bodied humans.
Exercise training may influence the control of breathing and respiratory sensations (i.e.,
dyspnea). It is generally accepted that exercise training results in a lower minute ventilation at
any given absolute oxygen consumption or power output. This is likely due to a reduction in one
or more of the mechanisms (neural and/or humoral) purported to cause the hyperpnea
(increased respiratory rate) associated with exercise. As such, the positive effects of exercise
training in SCI may reside in an increase in respiratory muscle strength and endurance as well
as a reduced ventilatory demand during exercise. A lower ventilation and/or sensation of
dyspnea during exercise would lower the work of breathing and prevent early termination of
exercise respectively.
Table 8.1 Exercise training

Score
Methods Outcome
Research Design
Total Sample Size
Population: 24 subjects (12 paraplegics, 1.After aerobic training, SCI subjects
12 able-bodied individuals), median age showed significant ↑ in FVC
SCI: 31 yrs (range 22-54), control: 30 (P<0.05) and the ventilatory muscle
(range 22-52), T1-T12, all ASIA A, >3 yrs endurance (P<0.001), so that max
Silva et al. 1998; Brazil
after injury. voluntary venilitation at 70% time
Treatment: Arm cranking aerobic training: values post-training were not
Pre-post
30 mins, 3x/wk x 6 wks. different from the initial values of
N=24
Outcome measures: Spirometry. able bodied individuals.
2. Severely limited ventilatory muscle
endurance in people with paraplegia
can be improved by arm cranking.
Population: 20 people with SCI (12 men, 8 1. After training, FVC, FEV1, and VC,
women), 14 complete, 6 incomplete (T6- were significantly higher than the
T12), 3.8±5.8 yrs, Mean age 31.31±8.17 baseline values
Sutbeyaz et al. 2005; years. 2. Exercise testing showed increased
Turkey Treatment: Ventilatory and upper extremity peak VE and peak workload and a
Downs & Black score=15 muscle exercise: 1h, 3x/wk x 6 wks; reduction in the ratio of physiological
Pre-post Diaphragmatic, pursed lip breathing for dead space to tidal volume
N=20 15min; Air shifting for 5min; voluntary compared to baseline values.
isocapneic hypernea 10min; arm-crank
exercise.
Outcome measures: Spirometry.
Population: 6 subjects (5 male, 1 female), 1. At maximal exercise, peak VE
T6- & T11/12, age 29±14 years (range:18- (75%), peak fb (-13.4%), peak VT
54), Mean time since injury: 94 days (+28.9%), and the ventilatory
(range:73-137 days). reserve (12.9%) improved after
Treatment: Wheelchair Interval-training 1training. The oxygen cost of VE ↓
Program – 30 min (6 x 5 min bouts: 4 min significantly decreased (-20%) after
Le Foll-de-Moro et al.
moderate intensity and 1 min of high training.
2005; France
intensity) 3x/wk for 6 wks; Progressed 2. For the wheelchair test, at the same
throughout training program to achieve 50% workload after training, VE and fb ↓
Pre-post
and 80% of heart rate. and VT ↑ consistent with improved
N=6
Outcome measures: Spirometry. ventilatory efficiency and greater
reliance on aerobic capacity after
training.
3. Spirometric values and lung
volumes showed small trend
towards improvement after training.
8-4
Score
Methods Outcome
Research Design
Total Sample Size
Population: 8 SCI (4 males, 4 females), 1. After training, no changes to
Low intensity group: C5-T7 (age range 26- maximal oxygen uptake or peak
36yrs), power.
Moderate Intensity group: C5-T9 (age range 2. No detectable changes during
Hooker & Wells 1989; 23-36yrs) submaximal or maximal exercise
USA Treatment: Aerobic training: WC ergometry were detected.
Downs & Black score=12 20 min 3 x/wk for 8 wk 3. Training intensity was insufficient,
Pre-post Low Intensity exercised at a power output = subjects did not comply with the
N=8 50-60% of maximal heart rate. Moderate program, or study was
Intensity exercised at a power output = 70- underpowered due to small sample
80% maximal heart rate. size and heterogeneity of subject
Outcome measures: maximal oxygen responses.
uptake, peak power.
Discussion
Evidence for exercise training for the respiratory management of the SCI person includes four
experimental, non-randomized control trials. Studies describing the acute responses to
exercise in people with SCI were not included nor were those studies concerned with
competitive athletes with SCI. Of the studies included, they were difficult to interpret because of
woefully small sample sizes, differences in exercise modality (wheelchair vs. arm crank
exercise) as well as inconsistency in the frequency, intensity and duration of exercise training.
Although one study included a control group (Silva et al. 1998), the control group consisted of
able-bodied subjects which was used for the normative values, but cannot be considered a true
control group for SCI subjects.
There is insufficient evidence to strongly support exercise training as a means to improve

pulmonary function or ventilatory responses to exercise in SCI people. There is some evidence
(Le Foll-de-Moro et al. 2005) to demonstrate that following exercise training that peak VE, VT
and ventilatory reserve improve. However, the training intensity needs to be relatively high (70-
80% of maximum heart rate at a minimum of 3X/week for 6 weeks) as lower intensities have not
been shown to be effective (Hooker & Wells 1989). Additional well-designed randomized
controlled trials are necessary to elucidate if exercise training is an effective means by which to
improve pulmonary function at rest and during exercise. Nonetheless, from the limited SCI data
and the well-known able bodied response to upper limb training it appears that changes to
exercise ventilation and ventilatory efficiency can be positively changed.
Conclusion
There is Level 4 evidence to support exercise training as an intervention that might

improve resting and exercising respiratory function in people with SCI.
For exercise training to improve respiratory function the training intensity must be relatively
high (70-80% of maximum heart rate) performed three times per week for six weeks.
Ideal training regimes have not been identified.
8-5
8.3 Inspiratory Muscle Training
As expected, the loss of inspiratory muscle function is related to the level of injury as illustrated
in Figure 8.1. Dyspnea, defined as a subjective report of breathlessness or shortness of breath,
is common in people with SCI and is greatest in people with tetraplegia (Ayas et al. 1999).
Approximately two-thirds of the prevalence of dyspnea in this group is attributed to the
inspiratory muscle loss (Spungen et al. 1997). Improved inspiratory muscle strength and
endurance could potentially improve cough and maximal exercise ventilation in addition to
decreasing dyspnea. The inspiratory muscles can be trained similar to the limb muscles with
inexpensive devices that increase the resistive or threshold inspiratory load on the inspiratory
muscles (Reid et al. 2004). Table 8.2 outlines common measures that are indicative of
respiratory muscle strength and endurance. In neuromuscular disorders like SCI, maximal lung
volumes that measure inspiratory capacity also can reflect increased inspiratory muscle
strength.
Table 8.2 Measures of respiratory muscle strength and endurance

Term Abbreviation Definition
Estimate of inspiratory muscle force as reflected by the maximal
Maximal Inspiratory Pressure MIP or PImax pressure exerted by the inspiratory muscles measured at the
mouth.
Estimate of expiratory muscle force as reflected by the maximal
Maximal Expiratory Pressure MEP or PEmax pressure exerted by the expiratory muscles measured at the
mouth.
Maximum ventilation in 15 seconds, which reflects the “sprint”
capacity of the respiratory muscles. The maximum ventilation
Maximum voluntary ventilation MVV can be measured over several minutes - between 4 and 15
minutes – which is more reflective of the endurance of the
respiratory muscles.
Maximum mouth pressure sustained during a 10 minute period
Maximal sustainable mouth
SIP of threshold loading which is usually lower than the MIP. This is
pressure
an estimate of the endurance of the inspiratory muscles.
Endurance time sustained on The endurance time while breathing on a resistive or threshold
Tlim
training load trainer at a defined level of the MIP
The maximal load (usually defined as an inspiratory mouth
Maximal incremental
TLmax pressure) attained on an incremental threshold loading test
threshold load
whereby the load is progressively increased every 2-3 minutes.
Commercially available hand-held devices can be used for inspiratory muscle training. The two
main types of devices are the resistive and threshold trainers (Figure8.3). Both of these devices
have a one-way valve that closes during inspiration so that the subject must breathe through a
small diameter hole for the resistive trainer or against a spring loaded valve for the threshold
trainer. The one-way valve opens during expiration such that no load is imposed during the
expiratory phase of respiration. Evidence showing decreased dyspnea and improved strength
and endurance after IMT is well documented in people with other health conditions like chronic
obstructive pulmonary disease (COPD) (Reid et al. 2004; Geddes et al. 2005).
Two main types of commercially available trainers are used to improve the strength and
endurance of the inspiratory muscles. Both trainers have a one way valve that opens during
expiration such that no load is imposed during the expiratory phase of respiration.
8-6
Figure 8.3 Inspiratory muscle trainers
Threshold trainer (top) has an adjustable
spring-loaded valve that imposes the inspiratory
load. The inspiratory load can be increased by
winding the spring more tightly. Advantage of
this trainer is that the same load is imposed on
the inspiratory muscles regardless of breathing
pattern.
Resistive trainer (bottom) has holes of different
diameters. The inspiratory load can be
increased by setting the dial to holes of lesser
diameter. Disadvantage of this trainer is that the
subject can reduce the inspiratory load by
breathing more slowly. If this device is used for
training, a target must be used. Various targets
have been designed that set a breathing rate
(flow and/or inspiratory pressure) for the subject.
Threshold® and P-Flex ® trainers available from

Respironics HealthScan Inc., 41 Canfield Rd.,
Cedar Grove, NJ7, 0009-1201. 1-800-962-1266.
Table 8.3 Inspiratory Muscle Training

Score
Methods Outcome
Research Design
Total Sample Size
Population: 12 subjects with complete 1. ↑ MIP and Maximal sustainable
motor loss below C6-C7 (n=6 control, n=6 mouth pressure (SIP) in both the
training) >1yr post injury, Age IMT:31±4.1 control group (30%±19% and
yrs, Controls: 35±12 yrs. 31%±18% respectively), and IMT
Treatment: Resistive IMT without target at group (42% + 24% and 78%±49%
Loveridge et al. 1989; 85% SIP for 15 minutes twice daily, 5 days
Canada respectively) but no difference in
per wk × 8 wks. post-training improvements between
PEDro=5 Outcome measures: Spiropmetry.
RCT groups.
N=12 2. The increased MIP and SIP resulted
in a slower and deeper breathing
pattern and a significantly shorter
inspiratory time:total time of
respiratory cycle in both trainers and
control subjects.
Population: 30 men & women with SCI 1. Pre-post % change of vital capacity
(C4-C7, 30-134 post-injury); 20 subjects (VC) and total lung capacity (TLC) in
completed (13 control,17 IMT group), IMT group was greater compared to
Liaw et al. 2000; Taiwan
8M:2F in each group, age change in control values.
Pedro=4
RIMT:30.9+11.6yrs; control:36.5+11.5yrs 2. MIP improved in both groups which
RCT
Treatment: Target resistive IMT or control; might be due to natural progression
N=30
15-20min 2x/day × 6wks; other rehab of improvement from SCI, learning
activities continued. to do the maneuver, and/or
Outcome measures: Spiropmetry, MIP.. insufficient length of training.
Population: 40 subjects met admission 1. Significant improvements within both
criteria; 11 subjects completed (9 males, 2 groups in forced vital capacity
Derrickson et al. 1992; females), neurologically complete, C4-C7; (FVC), maximal voluntary ventilation
USA 2-74 days post-injury, studied at >24hrs (MVV), peak expiratory flow rate
PEDro=3 after spontaneous breathing, Age:28.5±5.6 (PEFR) and Maximal Inspiratory
RCT yrs. Pressure (MIP) (p<0.001 to 0.05)
N=40 Treatment: Resistive IMT without target between week 1 and week 7.
(n=6) and (n=5) breathing with abdominal 2. No significant differences between
weights, 5 days per wk × 7 wks. treatment groups for any of the
8-7
Score
Methods Outcome
Research Design
Total Sample Size
Outcome Measures: Spiropmetry. improvements in pulmonary
variables; however, mean changes
between week 1 and 7 tended to be
larger for the IMT group.
Population: 10 men and women began, 1. TLmax, a measure of inspiratory
M:F= 8:2; 9 subjects completed (8 males, 1 muscle endurance increased after
female), all tetraplegic C3-C7, 2-27yrs both sham training and IMT (p<0.05
Uijl et al. 1999; post-injury; ASIA A (n=3), B (n=3), C and D and p=0.01, respectively).
Netherlands (n=3); Age: mean 34.4 yrs (range 20-49 2. No significant improvement in MIP
Downs & Black score=14 yrs) for either group or differences in
Prospective Controlled Treatment: No resistance sham training (6 post-training change between
Trial weeks) then Target flow IMT (6 weeks). 15 groups.
N=10 min twice daily for each phase of 6 wks. 3. Significant ↑ in peak power, VT and
Outcome measures:.Spirometry, MIP, oxygen consumption during maximal
Maximal incremental threshold load exercise test at 6-12wks of IMT
(TLmax). (p<0.05).
Gross et al. 1980; Population: 4 males:2 females; age 1. During training, progressive and
Canada range:18-41 yrs; >1 yr post injury significant increases in MIP and the
Downs & Black score=12 Treatment: Resistive IMT without target critical mouth pressure that resulted
Pre-post 30 min per day, 6 days per wk × 16 wks. in EMG signs of diaphragm fatigue.
N=6 Outcome measures: MIP
Population: 20 (2F:18M) in acute post- 1. Four months after IMT began, 10
traumatic phase; 10 tested at 4 months, 10 subjects showed improvement in
Hornstein & Ledsome others were discharged, non-compliant or MIP from 45+4.1 mmHg to 59+6.8
1986; Canada had medical complications. mm Hg but no statistics were
Downs & Black score=11 Treatment: Resistive IMT without target performed on data.
Case Series 15min 2x/day ×6wks. 2. Two case reports showed
N=20 Outcome measures: MIP. improvement in MIP and decreased
dyspnea.
Population: 9 people after SCI C4-C7, > 1. Significant ↑ in MIP and lung
1 yr since injury; Age: 24-65 yrs with mean volumes after IMT
36 yrs Treatment: Resistive IMT without 2. At 6 months, 4 months after training
Rutchik et al. 1998; USA target 15 min twice daily × 8 wks. stopped, trends towards baseline
Downs &Black score=10 Outcome measures: MIP, spirometry. and repeat measures in 7 of 8
Pre-post subjects showed no difference
N=9 between baseline and 6 months
outcomes.
3. Compliance ranged between 48 and
100% of IMT sessions.
Population: 26 yr old male,C3-C4 1. Number of respiratory infections
Treatment: Threshold IMT and Positive decreased from 3 to 2
Ehrlich et al. 1999; expiratory pressure value (Peripep) for 2. Number of respiratory infections
Canada one year. requiring acute care hospitalization
Downs & Black score=7 Outcome measures: MIP, infection decreased from 2 to 0.
Case Series number. 3. MIP ↑ from 10 to 42 cm H2O.
N=1 4. Daily suctioning 10x daily ↓ to
intermittent suctioning not required
daily.
Discussion
There is insufficient evidence to strongly support IMT for people with SCI. Most studies are not
comparable and could not be combined in a meta-analysis (Brooks et al. 2005) because of
research design, heterogeneity of subject characteristics or differences in training techniques.
None of the studies that used an RCT design incorporated an optimal IMT protocol. In
8-8
particular, several used an inspiratory resistive device with no target to control for decreasing
resistance with slower flows so the training methods may have induced an alteration in
breathing pattern towards slower inspiratory flows rather than a training response against higher
inspiratory pressures. The few studies that utilized a RCT design also showed improvement in
both control (or sham) and training groups. Comparable improvement in measures of
inspiratory muscle and lung function in the control and IMT groups may reflect learning of
testing maneuvers, benefit from other rehabilitation or lifestyle activities, and/or natural
progression of improvement after SCI.
Some of the pre-post design studies showed improvement in inspiratory strength and
endurance measures, however, this type of design can show an exaggerated treatment effect.
The single subject report by Ehrlich et al. (1999), utilized the threshold trainer, which imposes a
constant inspiratory load regardless of breathing pattern. Given that threshold IMT has
consistently shown improvements in inspiratory muscle strength and endurance in people with
chronic obstructive pulmonary disease, this technique warrants a larger RCT to determine its
benefit for people after SCI.
Future research to determine a potential treatment effect of IMT after SCI, should utilize: 1)
larger samples; 2) a research design that controls for the influence of learning or recovery from
SCI on IMT outcome measures of inspiratory muscle strength and endurance, and dyspnea; 3)
optimal training techniques of threshold loading, targeted resistive devices, or isocapnic
hyperpnea, (see Reid et al. 2004 for details of these training techniques); 4) outcomes of
inspiratory muscle strength and endurance; dyspnea; quality of life; daily function; 5) a
comparison of the effectiveness of IMT relative to or as an adjunct to other rehabilitation
interventions.
Until more solid research is performed to further delineate the most effective IMT protocols and
criteria for responders and non-responders, prescription of IMT should be approached
cautiously. Other types of exercise training and rehabilitation interventions may provide more
benefit. Of equal importance, overly aggressive prescription of IMT has the potential to fatigue
and injure the inspiratory muscles, which can increase the person’s predisposition to respiratory
compromise. The article by Reid et al. (2004) provides a table that outlines parameters to
monitor during IMT in order to avoid untoward responses such as muscle fatigue and
hypercapnia.
For inspiratory muscle training to improve ventilation, decrease dyspnea, and to improve daily
function after SCI, parameters to optimize IMT are only available for people with other
respiratory conditions. For people with chronic obstructive pulmonary disease, the optimal IMT
protocol should utilize threshold or targeted resistive trainers, at an intensity of 30-70% of MIP,
for a duration up to 30 minutes per session, performed continuously or in intervals, 4-6
days/week and be continued indefinitely (Geddes et al. 2006). Progression of intensity (MIP)
should not exceed 5% per week.
Conclusion
There is Level 4 evidence to support IMT as an intervention that might decrease dyspnea
and improve inspiratory muscle function in some people with SCI
8-9
T
There is limited evidence that inspiratory muscle training improves respiratory muscle strength
or endurance in people with SCI.
8.4 Pharmaceutical Interventions
8.4.1 Airway Hyperresponsiveness and Bronchodilators
Subjects with spinal cord injuries have a restrictive ventilatory impairment that is dependent
upon the level and completeness of injury. However, there is also a body of evidence that
patients with cervical spinal cord injuries have a component of obstructive ventilatory
impairment.
Subjects with tetraplegia demonstrate bronchial hyperresponsiveness to multiple agents

including methacholine, histamine and distilled water (Dicpinigaitis 1994a; Singas 1996; Fein
1998; Grimm 1999; Singas 1999). There are several potential mechanisms for
hyperresponsiveness in tetraplegia including loss of sympathetic autonomic input with relatively
unopposed parasympathetic input, (Dicpinigaitis 1994a; Grimm 1997; Singas 1999), altered
mechanical lung properties with decreased deep breathing and “stretching” of airways (Singas
1999) and nonspecific airway hyperresponsiveness similar to subjects with asthma (Grimm
1997).
Despite evidence regarding the presence of airway hyperresponsiveness in tetraplegia, the use
of anticholinergic bronchodilators such as ipratropium and beta 2 selective agonists such as
metaproterenol in SCI has not been well studied. The use of bronchodilators is routinely
recommended as add-on therapy in other conditions with airway hyperreactivity such as chronic
obstructive pulmonary disease (COPD) and asthma, but it is not clear if these recommendations
can be generalized to the SCI population.
For mechanically ventilated subjects, bronchodilators are routinely administered to relieve

dyspnea and reverse bronchoconstriction. They can be administered by metered-dose inhaler
(MDI) or by nebulizer. Again, the long-term use of bronchodilators and the best route of
administration in mechanically ventilated subjects with SCI have not been studied.
The measurement of airway responsiveness with inhaled bronchoconstrictor stimuli such as

methacholine or histamine involves the patient inhaling increasing doses or concentrations of a
stimulus until a given level of bronchoconstriction is achieved, typically a 20% fall in forced
expired volume in one second (FEV1). Airway responsiveness is then expressed as the dose or
concentration of the stimulus required to achieve this degree of bronchoconstriction (PD20 and
PC20, respectively).
Table 8.4 Bronchodilators

Score
Methods Outcome
Research Design
Total Sample Size
Schilero et al. 2004; USA Population: 5 tetraplegia (C4-C7), 2 1. In subjects with tetraplegia, inhaled
Downs & Black score=13 complete, 3 incomplete, age:45±16 yrs, metaproterenol resulted in
Pre-post 17±8 yrs post-injury; 5 paraplegia (below significant increase in specific
N=10 T5), 2 complete, 3 incomplete, age:40±9 airway conductance and significant
yrs, 19±10 yrs post-injury. increases in FEV1 and forced
8-10
Score
Methods Outcome
Research Design
Total Sample Size
Treatment: Inhalation of 0.3 mL of 5% expiratory flow 25-75%.
solution of metaproterenol sulfate via 2. In subjects with paraplegia, inhaled
nebulizer metaproterenol resulted in
Outcome Measures: Spirometry and significant increase in specifc airway
specific airway conductance as measured conductance although the increase
by body plethysmography pre- and post- was considerably less than that
bronchodilator. seen in tetraplegia. There was no
significant change in FVC, FEV1 and
forced expiratory flow 25-75%.
Population: tetraplegia (C4-C7); all male, 1. 8 out of 8 control subjects showed
age range 23-57 years, 6 on chronic oral significant bronchoconstrictor response
baclofen and 8 controls to methacholine (mean PC20= 1.42±1.6)
Dicpinigaitis et al. 1994b;
Treatment: Administration of increasing 2. 2 out of 6 baclofen subjects had
USA
concentrations of nebulized methacholine. borderline to mild bronchoconstrictor
Outcome Measures: Spirometry, PC20. response to methacholine. 4/6 baclofen
subjects did not respond to
Trial
methacholine (mean PC20= 15.0±9.1 for
N=14
baclofen group). There was no
correlation between PC20 and dosage
or duration of baclofen.
Population: 25 tetraplegia: 6 complete,19 1. 48% of subjects had a positive
incomplete, all male, age: 43±3yrs, 11±2 bronchodilator response (6/10 smokers
Almenoff et al. 1995; yrs post-injury. and 6/15 non-smokers).
USA Treatment: Administration of 72 mcg 2. There were no significant correlation
Downs & Black score=11 ipratropium bromide by inhaler with spacer between the response to ipratropium
Pre-post Outcome Measures: Spirometry pre- and and dyspnea at rest, smoking
N=25 post-bronchodilator (improvement in FVC history, or sensory completeness of
or FEV1>=12%) cord lesion.
Population: 15 tetraplegia (C4-C7): 5 1. 12/15 subjects had a significant
complete and 10 incomplete, all male, age bronchoconstrictor response to
range:24-64yrs, time since injury range:3- aerosolized histamine (geometric
31 yrs mean PC20 1.27 mg/mL).
Treatment: Increasing inhaled 2. There were no significant
Fein et al. 1998; USA
concentrations of aerosolized histamine differences in FVC and FEV1 values
diphosphate. Responders to histamine between responders and non-
Pre-post
were retested on a separate day after pre- responders.
N=15
treatment with ipratropium bromide 72 3. All 12 subjects initially responsive to
mcg. histamine were again
Outcome Measures: Spirometry, PC20. hyperresponsive at the time of
rechallenge following ipratropium
(geometric mean PC20 1.50 mg/mL).
Population: 25 tetraplegia (C4-C7): 10 1. All 13 control subjects (methacholine
complete & 15 incomplete, all males, age and histamine) and all 6 oxybutynin-
range:23-63yrs, 1-40yrs post-injury, 12 histamine subjects had a significant
maintained on oral oxybutynin & 13 age- bronchoconstrictor response
Singas et al. 1999; USA matched controls. (PC20<8 mg/mL).
Downs & Black score=9 Treatment: 6/12 oxybutynin subjects were 2. The oxybutynin-methacholine
Prospective Controlled challenged with methacholine, & 6/12 with subjects had a normal response to
Trial histamine; 7/13 control subjects were methacholine. (PC20>=25 mg/mL).
N=25 challenged with methacholine & 6/13 with
histamine. Increasing concentrations of
aerosolized histamine or methacholine
were administered.
Outcome Measures: Spirometry, PC20.
8-11
Score
Methods Outcome
Research Design
Total Sample Size
Population: 9 tetraplegia (C4-C7) and 6 1. 8/9 tetraplegic subjects (known
paraplegia (T9-L1), 4 complete & 11 histamine response positive) had a
incomplete, all male, age:25-61yrs, 4-32yrs significant bronchoconstrictor
post-injury response to UNDW (PD20 7.76 +/-
Treatment: Increasing duration of 7.67 mL).
Grimm et al. 1999; USA
exposure time to ultrasonically nebulized 2. 0/6 paraplegic subjects (known
distilled water (UNDW). 5 subjects histamine response negative)
Pre-post
responding to UNDW returned on a demonstrated a response to UNDW
N=15
separate day for UNDW challenge (PD20 24 mL).
following the inhalation of aerosolized 3. 5/5 tetraplegic responders to UNDW
ipratropium bromide. no longer responded after
Outcome Measures: Spirometry, PD20 pretreatment with ipratropium
bromide.
Population: tetraplegia: 34 males, all 1. 41% of subjects demonstrated a
motor complete, non-smokers’ mean significant response in FEV1 to inhaled
age:40±5 yrs, smokers’ mean age:48±3 metaproterenol (5/12 non-smokers and
yrs, 11.8±1.6 yrs since injury 9/22 smokers).
Spungen et al. 1993; Treatment: Inhalation of 2.5 ml 2. In the non-smokers, the correlation of
USA metaproterenol sulfate inhalation solution. FVC and FEV1 with level of lesion was
Downs & Black score=9 Outcome Measures: Spirometry pre- and positive and significant prior to
Pre-post post-bronchodilator (improvement in administration of bronchodilator and
N=34 FEV1>=12% became more significant post-
bronchodilator.
3. In the smokers, FVC and FEV1 failed to
significantly correlate with level of
lesion.
Population: tetraplegia (C4-C7), all male, 1. 11/14 subjects on baclofen and 8/10
age range:23-65, time since injury range:2- control subjects had significant
29 yrs, 14 on chronic oral baclofen and 10 bronchoconstrictor response to
age-matched controls histamine.
Treatment: Administration of histamine by 2. There was no significant difference
Grimm et al. 1997; USA inhaler in 14 baclofen subjects and 10 in mean PC20 between the baclofen
Downs & Black score=9 controls. Administration of methacholine in and control groups (mean PC20=
Prospective Controlled 4 baclofen subjects and 5 controls. 2.91±2.3 and PC20 =2.18±1.9,
Trial Outcome Measures: Spirometry, PC20 respectively).
N=24 3. The methacholine and histamine
PC20 were almost identical in
controls. ¾ balcofen subjects had
significantly different responses to
methacholine and histamine.
Discussion
Both ipratropium and metaproterenol have been studied in SCI. Both drugs have shown a
positive effect with improvements in FEV1 in subjects with tetraplegia.
Almenoff et al. (1995) showed that 48% of tetraplegic subjects given inhaled ipratropium
bromide responded with greater or equal to 12% improvement in FEV1 and/or FVC. In a study
looking at the effects of metaproterenol in tetraplegia, 41% of tetraplegic subjects responded to
metaproterenol with a greater or equal to 12% improvement in FEV1 (Spungen et al. 1993).
Schilero et al. (2004) also found a significant improvement in FEV1 in tetraplegic subjects
treated with metaproterenol. In the short-term, both ipratropium and metaproterenol appeared to
be effective in improving pulmonary function. There are concerns that ipratropium’s
anticholinergic effects could cause thickening of secretions and block release of surfactant
8-12
which could compromise its ultimate effects on respiratory function (Consortium for Spinal Cord
Medicine 2005).
Although these studies only provide level 4 evidence for the use of bronchodilators in SCI, they
cannot be considered in isolation of the large body of literature regarding bronchodilators in
other conditions. The recommendations for the use of bronchodilators in asthma and chronic
obstructive pulmonary disease are well supported by the literature and there is a strong
likelihood that SCI shares some clinical and pathophysiologic similarities to those conditions.
Nevertheless, it is important to recognize that literature in SCI remains lacking.
In addition to traditional bronchodilators, there is evidence that airway hyperresponsiveness in

tetraplegia can be modulated by medications used for other conditions in SCI, such as baclofen
and oxybutynin. Baclofen, a GABA agonist, is commonly used to treat spasticity. GABA
receptors have been found in peripheral tissue, including lung, raising the possibility that
baclofen may have the potential to affect airway hyperreactivity. Oxybutynin, a medication used
to treat bladder spasms, has the potential to affect airway hyperreactivity through its
anticholinergic properties. The effects of both baclofen and oxybutynin have been studied in
small controlled trials in tetraplegia. In each study, the study group was a group of subjects who
were already maintained on the medications for the usual indications. The studies did not look
at the bronchodilator effects of the medications, but focused on their ability to block
bronchoconstrictor challenges to methacholine and histamine.
Pre-treating tetraplegic subjects with inhaled ipratropium bromide blocked hyperresponsiveness

to methacholine (Dicpinigaitis 1994a). Baclofen and oxybutynin also decreased
hyperresponsiveness to methacholine (Dicpinigaitis 1994b; Grimm 1997; Singas 1999). In
contrast to the findings with methacholine, pre-treating tetraplegic subjects with inhaled
ipratropium bromide did not block hyperresponsiveness to histamine (Fein 1998). Similarly,
oxybutynin and chronic oral baclofen did not block hyperresponsiveness to histamine in
tetraplegia (Grimm 1997; Singas 1999). Although these results are intriguing, the results of
these small studies cannot necessarily be extrapolated to the clinical situation where a
bronchodilator effect is required.
There are no long-term studies on the use of bronchodilators in SCI. Further studies on the
selection of bronchodilators, route of administration and role in long-term mechanical ventilation
in SCI should be undertaken. Studies looking at the clinical effects of other commonly used SCI
medications with potential bronchodilator effects such as baclofen and oxybutynin are
warranted.
Conclusion
There is level 4 evidence that ipratropium and metaproterenol have a positive effect on
pulmonary function in subjects with tetraplegia.
There is level 2 evidence that chronic oral baclofen and chronic oxybutynin and level 4
evidence that ipratropium bromide decrease or block hyperresponsiveness to
methacholine, but not histamine in tetraplegia.
8-13
The use of bronchodilators should be considered in subjects with tetraplegia who demonstrate
an element of obstructive airway impairment.
The effects of other medications commonly used in the management of SCI such as baclofen
and oxybutynin should be considered when reviewing airway hyperreactivity
in subjects with tetraplegia.
8.4.2 Anabolic Agents
Anabolic steroids are derivatives of testosterone. Their exact physiologic effects on the
respiratory system are unclear, but they have been studied as a possible treatment in chronic
obstructive pulmonary disease, especially for their role in potentially increasing muscle mass.
Anabolic steroids have potentially serious side effects, including effects on liver function, lipid
profile and the reproductive system. The long-term safety of anabolic steroids such as
oxandrolone in SCI has not been established.
Table 8.5 Anabolic steroids

Score
Methods Outcome
Research Design
Total Sample Size
Population: 10 tetraplegia (C4-5), motor 1. On average, subjects gained
complete, all male, mean age: 41±9 yrs, 1.4±1.5 kg (2±2% ↑ p=0.01).
16±8 yrs post-injury 2. A significant improvement was
Spungen et al. 1999; Treatment: Administration of oxandrolone seen in combined measures of
USA 20 mg/day for 1 month. spirometry (9±2% p<0.005).
Downs & Black score=16 Outcome Measures: Weight gain, 3. A significant improvement was
Pre-post spirometry, MIP, MEP, resting self-rate of seen in MIP (10±7% p<0.001. The
N=10 dyspnea (Borg scale), serum lipid profiles improvement in MEP was not
and liver function tests. significant (9±13%).
4. Borg scale ↓ an average of 37±28%
p<0.01.
Discussion
There is one study in the literature on the effects of anabolic steroids on pulmonary function in
SCI. Spungen et al. (1999) treated 10 male subjects with motor complete C4-C5 tetraplegia with
a one month course of oxandrolone, an oral anabolic steroid. Following oxandrolone, significant
improvements were seen in weight gain, forced vital capacity, FEV1 and forced inspiratory vital
capacity. There was a significant increase in maximal inspiratory pressure (PI max) from
baseline and a non-significant increase in maximal expiratory pressure (PE max). Subjects
experienced a significant decrease in subjective dyspnea. There was no long-term follow-up of
subjects to see if any of the improvements were permanent.
Conclusion
There is level 4 evidence that the short-term use of oxandrolone improves pulmonary
function in subjects with tetraplegia.
8-14
The short-term use of oxandrolone should be considered to improve pulmonary function
in subjects with tetraplegia.
8.4.3 Other pharmaceuticals
There are many other medications with potential benefit for the treatment of pulmonary function
in SCI. The use of anticoagulants for the prevention of deep vein thrombosis and pulmonary
emboli is covered in Chapter 15. Other medications used in the treatment of asthma and/or
chronic obstructive pulmonary disease such as cromolyn sodium, methylxanthines and inhaled
corticosteroids have not been studied in SCI.
8.5 Assistive Devices
8.5.1 Mechanical Ventilation and Weaning Protocols
The indications for mechanical ventilation and the acute management of respiratory issues in
SCI are outside the scope of this review which focuses on rehabilitation. However, the long-
term complications associated with chronic ventilator dependency need to be mentioned in
order to highlight their importance. The overall life expectancy for individuals with SCI who are
ventilator dependent has been increasing, especially for those individuals who survive the first
year following injury. (DeVivo 1995) Despite advances, mortality for individuals with ventilator
dependency remains high. (DeVivo 1995).
In general, subjects with complete neurologic injuries at C2 and above have no

diaphragmatic function and are ventilator dependent. Subjects with complete neurologic
injuries at C3 or C4 have variable diaphragmatic function. Although they may have the
potential for ventilator weaning, it is difficult to predict whether they will ultimately be
successfully weaned. Subjects with complete injuries at C5 and below have intact
diaphragmatic function. They may require ventilatory support initially post-injury, but are
usually able to wean from the ventilator.
The approach to ventilator weaning in SCI remains an important and somewhat neglected
issue. The PVA Consortium for Spinal Cord Medicine—Respiratory management following
spinal cord injury: a clinical practice guideline for health-care professionals (2005) suggest
the consideration of “ …progressive ventilator free breathing over synchronized intermittent
mandatory ventilation”.
Table 8.6 Weaning protocols

Score
Methods Outcome
Research Design
Total Sample Size
Population: tetraplegia (C3-C4), ventilator 1. 26/82 weaning attempts used IMV,
dependent 34/82 used PVFB and 22/82 used a
Peterson et al. 1994; Treatment: Retrospective review of 82 combination of various techniques.
USA ventilator weaning attempts in 52 subjects 2. PVFB weaning success rate was
Downs & Black score=16 using intermittent mandatory 67.6 % (23/34) and IMV was 34.6%
Case Series ventilation(IMV), progressive ventilator free (9/26) (p=0.02) and other techniques
N=52 breathing (PVFB) or a combination of other was 11/22.
ventilator weaning techniques 3. Overall 43/52 (83%) of subjects
Outcome Measures: Successful ventilator were successfully weaned. 6/52
8-15
Score
Methods Outcome
Research Design
Total Sample Size
weaning. were partially weaned. 2/52 subjects
died.
Population: 7 tetraplegia: C2(n=2), C4- 1. Subjects with low tetraplegia
C7(n=5), incomplete, all male, age range: achieved significant gains in
45-68 years, time on ventilator: 4-36 inspiratory & and expiratory muscle
months strength, VC, mean on-ventilator
Treatment: Implementation of an endurance & off-ventilator
Gutierrez et al. 2003; evidence-based resistance endurance endurance.
USA protocol (REP) designed to help 2. Subjects with high tetraplegia had
Downs & Black score=14 discontinue mechanical ventilation by non-significant improvements in
Pre-post improving ventilatory muscle strength and inspiratory & expiratory muscle
N=7 endurance strength and VC and were able to
Outcome Measures: Pulmonary function discontinue mechanical ventilation.
tests; on-ventilator endurance and off- 3. 4/5 low tetraplegic subjects with low
ventilator endurance. tetraplegia were weaned from the
ventilator. 1/5 low tetraplegic
subjects died.
Discussion
Peterson et al. (1994) retrospectively compared weaning methods in 52 subjects with C3 and
C4 SCI. Overall 83% of subjects were successfully weaned with progressive ventilator free
breathing (PVFB, also known as T-piece weaning) being the most successful technique.
However, most of the PVFB trials occurred at a single institution and in subjects who were
longer post-injury whereas most of the intermittent mandatory ventilation trials (IMV) occurred
in a variety of institutions in subjects who were earlier post-injury.
Gutierrez et al. (2003) developed an evidence based resistance and endurance protocol to
improve ventilatory muscle strength and endurance in subjects with ventilator-dependent
cervical SCI. The evidence was based on SCI literature where possible, but was also derived
from the general respiratory literature where required. The protocol included 4 daily phases with
rests in between each phase: pre-training optimization (Trendelenberg positioning, trachea
suctioning, bronchodilator use, and lung hyperinflation); inspiratory/expiratory resistance
training; on-ventilator endurance training; and off-ventilator endurance training. Although the
pilot study only included 7 subjects, it did show promising results with respect to increasing
inspiratory pressure, expiratory pressure and vital capacity and ultimately ventilator weaning,
especially in subjects with low tetraplegia (C4-C7) (Gutierrez et al. 2003).
Prospective studies on weaning protocols are required to determine the best way to assess,
treat and wean subjects requiring mechanical ventilation following SCI.
Conclusion
There is level 4 evidence that progressive ventilator free breathing (PFVB) protocol is
more successful for weaning subjects with C3 and C4 spinal cord injuries than
intermittent mandatory ventilation (IMV).
There is level 4 evidence that a resistance and endurance protocol increases
inspiratory pressure, expiratory pressure and vital capacity especially in low
tetraplegia (C4-C7).
8-16
Progressive ventilator free breathing protocol should be considered for ventilator dependent
subjects with tetraplegia who are appropriate for ventilator weaning. Resistance and
endurance training should be considered in subjects who are candidates
for ventilator weaning.
8.5.2 Other methods of ventilation
Non-invasive ventilation (Bach 1990), phrenic nerve stimulation (Glenn et al. 1972) and
diaphragmatic stimulation (Onders 2004, Di Marco 2006) are all potential alternatives to
traditional mechanical ventilation following SCI. Complication rates, cost and quality of life are
among the many important factors to consider in all forms of assisted ventilation. The
evidence for various methods of assisted ventilation will be addressed in a future edition. The
evidence for traditional mechanical ventilation, non-invasive ventilation, phrenic nerve
stimulation and diaphragmatic stimulation will be addressed in a future edition.
8.5.3 Tracheostomy Decannulation

Subjects with SCI often undergo tracheostomy if it is anticipated that they are going to require
ventilatory support for longer than 3 weeks. Evidence for the decannulation of subjects with SCI
is lacking. Subjects may not meet the traditional criteria for decannulation and should be
assessed on an individualized basis (Bach 1990; Ross & White 2003).
Table 8.7 Tracheostomy decannulation

Score
Methods Outcome
Research Design
Total Sample Size
Population: tetraplegia (n=3) and 1. 4 subjects who had evidence of
Ross & White 2003; paraplegia (n=1), level:C5-T9, ASIA A aspiration were successfully
Australia (n=3) & B(n=1), age: 20-71 yrs decannulated after assessment by a
Downs & Black score=15 Treatment: Interdisciplinary evaluation and multidisciplinary team.
Case Series assessment 2. None experienced respiratory
N=4 Outcome Measures: Successful deterioration.
decannulation.
Discussion
Ross and White (2003) describe a case series of 4 subjects with SCI who were successfully
decannulated despite the presence of traditional contraindications for decannulation such as
evidence of aspiration. These 4 subjects were carefully selected by a multidisciplinary team
who opted for decannulation after assessing the overall risks of decannulation versus the risks
of prolonged tracheostomy. Further studies examining the criteria for decannulation of subjects
with SCI are required.
Conclusions
There is level 4 evidence that decannulation can be successful in subjects with

evidence of aspiration.
8-17
Case by case consideration should be given to tracheostomy decannulation in subjects
with SCI. The indications and criteria for tracheostomy decannulation
have not been established in SCI.
8.5.4 Girdle/abdominal Binder
Abdominal binders are used to prevent the abdominal contents from falling forward in upright
subjects with SCI. Abdominal binders are most commonly used in subjects with loss of
abdominal wall strength (generally lesions above T6). Some early work (primarily level 4
studies) looking at the effects of abdominal binders on respiratory function in SCI was done prior
to 1980 but was not included in this review. Studies on the effects of abdominal binders need to
include positioning information as position greatly influences lung volumes in tetraplegia.
In addition to being used as a respiratory intervention, abdominal binders are used as an

intervention in subjects with postural hypotension (see chapter 16).
Table 8.8 Abdominal binding

Score
Methods Outcome
Research Design
Total Sample Size
Population: 7 tetraplegia, 3 paraplegia, Abdominal binding resulted in:
mean age: 35.8 yrs, age range:18-56 yrs, 1. decrease in respiratory effort
3-27 months post-injury, post-traumatic measured by Borg scale (4.3±1.8 to
SCI levels: C5-T6, ASIA A, 2.3±1.8; p=0.02).
Treatment: Custom girdle, designed to 2. increase in inspiratory capacity and
Hart et al. 2005; France provide truncal stability and abdominal forced vital capacity,
Downs & Black score=16 support 3. decrease in functional residual
Pre-post Outcome measures: Spirometry capacity ;
N=10 4. increase in diaphragm pressure-
time product - a measure of
diaphragm work;
5. increases in twitch and maximal
transdiaphragmatic pressure –
measures of diaphragm force.
Population: 13 tetraplegia (C4-C7), 9 Abdominal binding in SCI resulted in:
able-bodied controls, all male, 1. increase inspiratory capacity in all
McCool et al. 1986; USA
age:29.9±11.4 yrs positions, and total lung capacity in
Treatment: 3 Body Positions: supine, the tilted and sitting positions
head-up tilted (37o) and seated – w/ & w/o 2. decrease in functional residual
Trial
abdominal binders capacity in all positions
N=13
Outcome measures: Spirometry 3. an increase in rib cage dimensions
at TLC.
Population: 8 subjects with SCI; Age Strapping the abdomen in SCI resulted
range: 21-41 years; level of injury C5-C8; in:
length of injury: 6-200 months 1. Increase in vital capacity;
Estenne et al. 1998; USA
Treatment: Abdominal strapping 2. Decrease in FRC and residual
Downs & Black Score=10
Outcome measures: Spirometry volume.
Pre-post
3. Small but inconsistent increases in
N=8
maximal esophageal pressure and
expiratory flow rate that might not
improve cough.
8-18
Discussion
Well-designed studies demonstrate that abdominal binders in tetraplegia significantly increase

inspiratory capacity or vital capacity, and decrease FRC in all positions (McCool et al. 1986;
Estenne et al. 1998; Hart et al. 2005). One study examining a small sample (n=10) showed that
a custom girdle reduces the sensation of respiratory effort as measured by the Borg Rating of
Perceived Exertion (Hart et al. 2005). Abdominal binding does not appear to consistently
improve expiratory flow rates to enhance cough (Estenne et al. 1998). Worthy of further study,
the diaphragmatic pressure-time product increases after abdominal binding which may
represent enhanced diaphragmatic force production but does not provide information about
enhanced efficiency of breathing.
All studies on abdominal binding examined short-term response of measures that relate to lung
volumes, expiratory flow rates, and/or inspiratory muscle force. No studies have examined the
long-term effects of abdominal binding over several hours or intermittent use over several days.
Appreciation of the long-term effects of abdominal binding is essential in order to provide
evidence-based clinical guidelines. Important outcomes to evaluate are comfort of intervention,
sensation of breathlessness, inspiratory muscle efficiency, inspiratory muscle fatigue, and
overall fatigue after several hours of abdominal binding. Some of these outcomes may adapt or
show deleterious effects over several days or weeks of daily sessions of abdominal binding;
such knowledge about repetitive use of the binder will also guide clinical practice.
Interventions to increase abdominal pressure and decrease the laxity of abdominal chest wall,
which in turn affects diaphragm length and position, have been used in other patient groups.
The acute impact on lung volumes and inspiratory muscle force has been documented in small
samples of people with SCI. Abdominal binding for people with SCI should be introduced
cautiously and be rigorously assessed because of the potential for alteration of diaphragm
length to result in mechanical inefficiency, increased dyspnea, and inspiratory muscle fatigue.
There is a lack of literature and only anecodotal evidence on the intermediate or long-term
effects of abdominal binding on people with SCI above T6. Positioning and using other
interventions that increase abdominal pressure in other chronic respiratory conditions improve
diaphragm force production but also can induce diaphragm fatigue and have variable influence
on dyspnea reduction. The clinical outcomes of abdominal binding should be carefully evaluated
for each individual. Abdominal binding could potentially have positive or deleterious effects on
inspiratory muscle efficiency and dyspnea in different people after SCI.
Conclusions:
There is level 2 evidence that abdominal binding in tetraplegic individuals has immediate
improvement in respiratory function, but longer term effects have not been studied.
Abdominal binding can be used to achieve immediate improvements in respiratory

function, but long term effects have not been established.
8.5.5 Vibration
Vibration of the muscle tendon to enhance muscle contractile force has been studied in healthy
people and in people after SCI. This modality may have the potential to decrease disuse
8-19
atrophy in some people after SCI who have partial voluntary control of muscle and is described
as being more comfortable than electrical stimulation (Ribot-Ciscar et al. 2003). Alternatively,
vibration also has been considered as an intervention to diminish involuntary muscle contraction
after SCI (Butler et al. 2006). The literature on the use of vibration to improve inspiratory and
expiratory muscle contraction or to control unwanted spasm of these muscles after spinal cord
injury is almost non-existent. One early report examining the physiologic response to this
modality in people with spinal cord injury is outlined in the following table.
Table 8.9 Vibration

Score
Methods Outcome
Research Design
Total Sample Size
Population: 13 people after SCI (11 1. Inspiratory, expiratory and
males, 2 females), ages:17-49 yrs, C4-T1 combined in-phase vibrations
lesions, 1 incomplete, 12 complete); 19-49 increased VT and VE while
months post-injury decreasing fb.
Homma et al. 1981; USA
Treatment: Application of vibratory 2. The combined-alternating in-phase
stimulus to the 1) parasternal intercostal vibration increased VT more than
Pre-post
spaces; 2) 7th -10th intercostal spaces inspiratory or expiratory in-phase
N=13
anterior to midaxillary lines; 3) Inspiratory vibration alone.
and expiratory vibrations were combined to
produce alternating in phase vibration.
Outcome measures: Spirometry.
Discussion
One report has shown that alternating in-phase vibration applied during inspiration (over the
parasternal intercostals) or during expiration (applied over the 7th-10th intercostal spaces)
significantly increased tidal volume (VT) and minute ventilation (VE) with an even greater effect
on these two variables when in-phase vibration was applied during inspiration and expiration.
Further study is required to examine the long-term utility and compliance of this modality to
enhance ventilation in people with SCI. Further, the specific parameters of vibration that
enhance versus diminish muscle excitation and contraction needs to be explored in people with
different levels and types of SCI.
Conclusion
There is level 4 evidence that the use of chest wall vibration increases tidal volume and
minute ventilation in subjects with tetraplegia.
Chest wall vibration may improve pulmonary function while the vibration is applied, but carry-
over effects when the vibration is not in use has not been evaluated.
8.5.6 Immersion
The effects of immersion in shoulder-deep water on spirometry in SCI have been studied. While
immersion in water does not represent a treatment modality for pulmonary function, the effects
of immersion are important to note from a clinical perspective because many subjects with SCI
undergo pool-based therapy that exposes them to shoulder-deep immersion in water.
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Table 8.10 Immersion
Score
Methods Outcome
Research Design
Total Sample Size
Population: 34 men: 23 complete (C4-C8) 1. Immersion increased the FVC and
tetraplegia & 11 healthy controls. median FEV1 of tetraplegic subjects. FVC
age:25yrs (treatment) & 27yrs (control), 2- and FEV1 decreased in control
89 months post-injury, ASIA A-B subjects.
Thomaz et al. 2005; Treatment: Spirometry immediately before 2. Among the subjects with
Brazil and 5-15min following immersion to tetraplegia, the lower the pre-
Downs & Black socre=10 shoulder level in water (33.5ºC-34.5ºC) and immersion vital capacity (VC), the
Pre-post 5-10min after withdrawal from the water. All greater the percentage of
N=34 subjects were studied in upright, seated improvement following immersion.
posture, in & out of the water. 3. No relationship was found between
Outcome Measures: Spirometric the time elapsed since cervical cord
measurements. injury or its level and the degree of
improvement.
Immersion in shoulder-deep water results in changes in lung function tests in tetraplegic

subjects. Bosch and Wells (1991) showed that in comparison to able-bodied and paraplegic
subjects, tetraplegic subjects have a significant decrease in residual volume with immersion. In
a pre-post trial involving 23 motor complete tetraplegic subjects and 11 healthy controls,
Thomaz et al. (2005) concluded that overall, immersion in water appeared to improve breathing
mechanics in subjects with tetraplegia.
Conclusion:
There is level 4 evidence that the use of immersion to shoulder-deep 33-34° Celsius water
improves pulmonary function in tetraplegia.
There is limited evidence that immersion to shoulder-deep 33-34° Celsius water may improve
pulmonary function, but carry-over effects following immersion has not been evaluated.
8.6 Obstructive Sleep Apnea in SCI
Obstructive sleep apnea is a disease characterized by recurrent collapse of the upper airway
during sleep leading to nocturnal hypoxemia and sleep fragmentation. Characteristic symptoms
include loud snoring, excessive daytime sleepiness, and nocturnal choking. Risk factors for
disease include alcohol use, sedatives, obesity, increased age, and male gender. Because of
activation of systemic inflammation and the sympathetic nervous system, sleep apnea may be
an independent risk factor for the development of cardiovascular disease. In the able-bodied,
sleep apnea is relatively common and under-diagnosed.
Treatment of obstructive sleep apnea includes lifestyle counseling (i.e., weight loss, avoidance
of alcohol). For patients with substantial disease, continuous positive airway pressure (CPAP)
therapy is considered to be first-line therapy. This consists of a mask placed on the face
attached to an air compressor via plastic tubing. CPAP devices establish a positive pressure in
the upper airway preventing its collapse during sleep. Studies of CPAP in people without SCI
demonstrate significant benefits in terms of reducing sleepiness and preventing motor vehicle
crashes. Other therapies that have been used to treat obstructive sleep apnea include
mandibular advancement devices (dental splints) and upper airway surgery.
8-21
8.6.1 Prevalence and Risk Factors
Breathing disorders including sleep apnea appear to have a higher prevalence in people after
SCI than those without. In general, the studies that examined the prevalence of obstructive
sleep apnea were limited by small sample sizes and by an experimental design that lacked an
able-bodied control group that could be directly compared to the SCI patients. Both overnight
oximetry and full polysomnography were used to diagnose disease. The prevalence rate ranged
from 9.1-83% (Short et al. 1992; Burns et al. 2000; Burns et al. 2001; Stockhammer et al. 2002;
Berlowitz et al. 2005). Obesity was identified as a risk factor for sleep apnea in most studies.
The use of muscle relaxants was identified as a potential risk factor for sleep disordered
breathing in some but not all studies (Short et al. 1992; Ayas et al. 2001; Burns et al. 2001
Berlowitz et al. 2005).
Table 8.11 Treatment of obstructive sleep apnea

Score
Methods Outcome
Research Design
Total Sample Size
Population: 50 people with SCI lesion 1. 31 out of the 50 tetraplegic patients
levels between C3 and C8; M:F – 40:10; had a respiratory disturbance index
Age: 48.6±14.0, range from 20-81 years; (RDI) of 15 or more (mean 30.5)
Stockhammer et al. Mean 11.4 years post injury (range from defined as sleep disordered
2002; Switzerland 0.5 to 37 years) breathing (SDB).
Downs & Black score=15 Treatment: CPAP 2. 16 patients accepted a trial of
Pre-post CPAP; of these, 11 continued to
N=50 use CPAP after a few weeks. Of
these 11 patients, 10 patients
reported an improvement of
symptoms after using long term
CPAP therapy.
Population: 40 men after SCI (37 1. CPAP continually used by 63% of
tetraplegics) the participants out of 32 (80%) of
2
BMI: 29.2±6.6 kg/m ; most of whom were participants who tried it.
Burns et al. 2005; USA
diagnosed with sleep apnea . 2. Main reasons for not using CPAP
Treatment: Survey requesting information were inability to fall sleep, mask
Case Series
about long-term treatment outcomes and discomfort & claustrophobia.
N=40
side effects of sleep apnea treatment in 3. Most common side effects were
persons with SCI. nasal congestion in 12 and mask
discomfort in 8.
Population: 3 people after SCI, ages: 47, 1. In two patients, CPAP treatment
Biering-Sørensen et al. 54, 56 yrs, C6 incomplete, T2 complete/; decreased daytime sleepiness,
1995; England Duration of injury: 19, 6, 37 years. All 3 improved sleep and oxygen
Downs & Black score=8 patients reported severe daytime saturation.
Case Series sleepiness and sleep complaints 2. One patient improved after losing 33
N=3 Treatment: Continuous positive airway kg, and reducing alcohol intake and
pressure (CPAP) via a nasal mask smoking
Discussion
Obstructive sleep apnea is very common in patients with SCI; obesity appears to be a
consistent risk factor. There are few studies that have assessed the impact of sleep apnea
therapy in patients with SCI. In a three person case series, Biering-Sorensen demonstrated
successful therapy with CPAP in two patients, and with weight loss in the third. No randomized
controlled trials of CPAP have been reported. One study (Burns et al. 2000) demonstrated a low
acceptance rate of CPAP (2 of 8 patients) given a trial of therapy. However, two larger studies
demonstrated greater rates; Burns et al. (2005) demonstrated a long-term acceptance rate of
CPAP of 63% (20/32) in patients offered CPAP therapy, and another (Stockhammer et al. 2002)
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a long-term rate of 69% (11/16 who accepted a trial). Patients who continued to use CPAP in
general reported beneficial effects. No reports concerning the treatment of SCI patients with
sleep apnea with a dental appliance or upper airway surgery were identified. There is a paucity
of studies that have examined the impact of therapy on health and quality of life outcomes; this
should be a focus of future investigations.
Conclusion
There is level 4 evidence to support therapies to treat obstructive sleep apnea in people
with SCI.
Patients with SCI have a high prevalence of obstructive sleep apnea, and therapy may improve
quality of life and other outcomes. Therefore, we recommend vigilance for suggestive signs and
symptoms (e.g., snoring, obesity, witnessed apneas, daytime sleepiness) and further testing in
patients with suggestive symptoms/signs (with overnight oximetry or polysomnography).
8.7 Secretion Removal
People with spinal cord injury are at risk for retention of secretions because of an increased
prevalence of pneumonia compounded by lower expiratory flows during cough. Increased
prevalence of respiratory infections, although decreased during the rehabilitation phase of
recovery, is still higher in people with SCI compared to age-matched healthy people. Reduction
in expiratory flows during cough is related to the higher levels of SCI. Of considerable surprise,
several devices that have been shown to be effective in people with other chronic respiratory
conditions have not been evaluated in people with spinal cord injury.
Table 8.12 Secretion Removal

Score
Methods Outcome
Research Design
Total Sample Size
Population: 40 traumatic CSCI 1. MIP more so than MEP showed
Treatment: Compared four types of cough stronger relationships with peak
Kang et al. 2006; Korea 1. unassisted peak cough flow exp flow during cough maneuvers.
Downs & Black score=17 2. inspiratory assist cough flow 2. All three assisted techniques (2,3,
Prospective Controlled 3. abdominal thrust cough flow & 4) showed higher peak expiratory
Trial 4. inspiratory assist & abdominal thrust flows. The combined assist (4)
N=40 cough flow. showed significantly higher values
Outcome Measures: Spirometry, than the inspiratory or abdominal
Maximum Inspiratory Pressure (MIP), thrust assist.
Maximum Expiratory Pressure (MEP).
Population: 11 people with complete SCI 1. (Group 1) MEP generated from
(C4 & below), Age group 1: 38±11.4 yrs, spontaneous coughing, manual
group 2: 36.7±7.2 yrs, average time since assist and FES was 27.3±6.4,
injury: 12.3 (grp.1), 18yrs (grp.2) 83±18.7 and 60±22.8 cm H2O,
Linder 1993; USA
Treatment: Assisted coughing by: 1. respectively.
manual assist or 2. functional electrical 2. (Group 1) In all patients in the study,
stimulation (FES) the MEP ↑ w/ abdominal muscle
Trial
Outcome Measures: Maximum Expiratory FES as well as w/ manually assisted
N=11
Pressure (MEP). cough.
3. (Group 2) Portable FES compared
to spontaneous cough ↑ the mean
MEP from 32.3 to 58 cm H2O.
8-23
Score
Methods Outcome
Research Design
Total Sample Size
Population: 18 SCI patients (C1-T3), 88% 1. MI-E was less irritating, less painful,
were C5 or higher less tiring, less uncomfortable
Methods: Surveyed preference for: (p<0.01 or p<0.001). All were
Garstang et al. 2000; suctioning or maximal inexsufflation (MI-E). clinically significant changes
USA Outcome measure: Not Specified. (except less tiring).
Downs & Black score=11 2. 16 of 18 patients preferred MI-E
Pre-post and one preferred suctioning; 1
N=18 patient had no preference.
3. When surveyed, average time from
MI-E was 146 days and from
suctioning was 253 days (p<0.001)
Population: 26 yr old M C3-C4 1. Number of respiratory infections
Treatment: Threshold IMT and Positive decreased from 3 to 2.
expiratory pressure value (Peripep®) for 2. Number of respiratory infections
Ehrlich et al. 1999;
one year requiring acute care hospitalization
Canada
Outcome Measures: Frequency of decreased from 2 to 0.
suction, Maximum Inspiratory Pressure 3. MIP increased from -10 to -42 cm
Case Series
(MIP), number of respiratory infection. H2O.
N=1
4. Daily suctioning 10x daily
decreased to intermittent suctioning
not required daily
Population: 52 y/o male, incomplete C5- 1. Airway pressure was 90, 82, and
C6, 7 yrs ago; ASIA C 132 cm H2O during stimulation of
DiMarco et al. 2006; USA
Treatment: Electrical stimulation via electrodes stimulated at T9, L1, or
epidural electrodes in T9, T11 and L1 combined, respectively.
Pre-post
spinal cord regions 2. Stimulation causes trunk motion but
N=1
Outcome Measures: Airway pressure this was tolerated without pain or
discomfort.
Population: 16 subjects: (8 SCI, 8 1. Maximal stimulation ↑ gastric
matched controls), complete tetraplegia, pressure to 76.0±11.7 in controls
C4-C7, mean age SCI: 39±3.1yrs; controls: and 29.9±3.7 cmH2O in SCI
Estenne et al. 2000; 38±1.8yrs subjects (p=0.002).
Belgium Treatment: Magnetic stimulation of 2. The cumulative thickness of the
Downs & Black score=5 abdominal muscles. four abdominal muscles was 34%
Pre-post Outcome Measures: Gastric pressure.
N=16 smaller in the people with SCI than
in control subjects and correlated
positively with changes in gastric
pressure induced by stimulation.
Discussion
Very few studies have examined the effectiveness of secretion removal techniques in people
with SCI even though respiratory complications are a primary cause of morbidity and mortality in
this population. Studies performed to date are limited by a survey (Garstang et al. 2000) or
case study design (Ehrlich et al. 1999) or lack of documentation of valid measurement
technique of standard pulmonary function (Kang et al. 2006). Limited evidence supports the
postulate that improving inspiratory muscle strength (Ehrlich et al. 1999; Kang et al. 2006) in
addition to expiratory muscle force (Estenne et al. 2000) are important to maximize expiratory
flows during cough. Inspiratory muscle training (Ehrlich et al. 1999) and electrical stimulation of
the expiratory muscles (Linder 1993; Estenne et al. 2000; DiMarco et al. 2006) are two potential
therapies that can maximize the force produced by the inspiratory and expiratory muscles,
respectively, in order to increase expiratory flows during cough. RCTs examining the
effectiveness of these techniques in people after SCI have not yet been performed.
Other issues that require further study in SCI is to examine the effectiveness of hand-held
8-24
devices that facilitate airway clearance, such as those that apply continuous (Peripep®) or
oscillating positive expiratory pressure (Flutter®). Of equal concern is to evaluate the comfort
and preference of airway clearance techniques that are readily adhered to and performed by
people with SCI. Some evidence supports the effectiveness of these positive expiratory
pressure devices and other secretion removal techniques such as autogenic drainage in people
with cystic fibrosis and other chronic respiratory diseases; however, the evidence to date is
somewhat equivocal (Hess 2001; Reid & Chung 2004).
Conclusion
Secretion removal techniques are common practice in people with spinal cord injury and
yet only level 4 evidence supports the use of some airway clearance techniques to
facilitate secretion removal in this population.
No evidence supports the selective use of the best airway clearance technique nor are
criteria available to indicate when to implement the various airway clearance techniques.
Urgent evaluation is required to determine the most efficient and effective techniques
that are comfortable and readily adhered to for people with SCI in order facilitate airway
clearance, to improve their quality of life, and decrease health care costs.
There is limited evidence that suggests that improving inspiratory and expiratory muscle force is
important to maximize expiratory flow during cough.
Cough effectiveness can be enhanced by a variety of methods including manual assistance by
a caregiver and/or electrical stimulation triggered by the person with SCI.
Hand-held expiratory pressure devices may enhance secretion removal in people with SCI.
8.8 Summary
Pulmonary function alteration and respiratory complications continue to be a major cause

of morbidity and mortality in patients with SCI. There are currently no widely accepted
clinical practice guidelines for the long term respiratory management of the SCI patient.
Much of the SCI-respiratory literature focuses on the acute care of the SCI patient.
However, given that long-term survival rates following SCI injury have increased in recent
years a greater understanding of the effects of chronic SCI on the respiratory system is
necessary. Moreover, identifying interventions that can improve (or minimize the decline
in) pulmonary function and reduce respiratory complications are of great importance.
Despite this need there are also no widely accepted clinical practice guidelines available
for the respiratory management of the SCI patient following hospital discharge. This is
largely due to the fact that there have been relatively few well designed studies that point
to effective management strategies. Interpretation of the available literature is difficult
because many studies have a least one, and more often multiple methodological or
research design concerns. Specific major concerns include an overall lack of RCTs;
patient sample sizes are often small with little or no consideration for statistical power;
lack of appropriate control or placebo groups; and inadequate characterization of the SCI.
In addition, most studies do not take into account gender, time since injury, smoking
history and other respiratory complications. As such, the amount and quality of the
literature can be considered modest at best and the ability to generalize is limited.
8-25
Despite the above caveats and research design shortcomings, some conclusions can be
cautiously drawn regarding commonly used respiratory intervention strategies.
(i) Exercise Training. The evidence that the respiratory system is positively influenced by
exercise training is not strong. There is some evidence that rigorous training can improve
respiratory muscle strength, endurance and efficiency in SCI. There have been no reports of
negative consequences of exercise training. Exercise training should be encouraged for
maintenance of general cardio-respiratory health in people with SCI.
(ii) Respiratory Muscle Training. Specific training of the respiratory muscles in SCI is not well
supported by the available research. Well designed studies are lacking but there is some
evidence to show that respiratory muscle training can improve respiratory muscle strength and
endurance. From the available literature on other subject groups (healthy, lung disease) it
appears that training of the respiratory muscle may improve ventilation, decrease dyspnea and
improve daily respiratory function. Consistent improvement in respiratory function following
respiratory muscle training has not been demonstrated in people with SCI.
(iii) Pharmaceutical Interventions. Restrictive ventilatory impairment is common in SCI and is

dependent on lesion level and degree of completeness. Obstructive ventilatory impairment is
present with cervical injury. There is some evidence to show that use of bronchodilators can elicit
a positive response in pulmonary function. Bronchodilators can be recommended for short-
term use in patients with obstructive impairment. The long-term effects are unknown.
There is limited evidence to support the use of anabolic steroids for improvement in
pulmonary function.
(iv) Assistive Devices. Ventilatory weaning in SCI is important but there is no consensus on the
ideal weaning protocol. There is some evidence that progressive ventilator free breathing is
more effective than intermittent mandatory ventilation in cervical SCI. There is insufficient
research to advocate the long-term use of abdominal binding or vibration to improve
indices of pulmonary function.
(v) Obstructive Sleep Apnea. There is a higher prevalence of sleep apnea in SCI relative to
able-bodied individuals. Treatment options include CPAP and weight loss but there is
limited research evidence to suggest positive long-term benefits. Anecdotal and patient
reports suggest that therapy for sleep apnea is beneficial.
(vi) Secretion Removal. Retention of secretions is common in SCI because of a diminished

capacity for cough generation. Elimination of secretions is commonplace in clinical practice and is
generally considered an integral part of maintaining respiratory health in SCI. There are several
commonly used secretion removal techniques but there is no consensus on their
effectiveness.
8-26
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pulmonary symptoms in subjects with spinal cord injury. Spinal Cord. 1997;35:652-657,
Spungen AM, Grimm DR, Strakhan M, Pizzolato PM, Bauman WA. Treatment with an anabolic
agent is associated with improvement in respiratory function in persons with tetraplegia: a
pilot study. Mt Sinai J Med. 1999;66:201-5.
Stockhammer E, Tobon A, Michel F, Eser P, Scheuler W, Bauer W, Baumberger M, Muller W,
Kakebeeke TH, Knecht H, Zach GA. Characteristics of sleep apnea syndrome in tetraplegic
patients. Spinal Cord. 2002 Jun;40(6):286-94.
Sutbeyaz ST, Koseoglu BF, Gokkay NKO. The combined effects of controlled breathing
techniques and ventilatory and upper extremity muscle exercise on cardiopulmonary
responses in patients with spinal cord injury. Int. J. Rehabil. Res. 2005;28:273-276.
8-29
Thomaz S, Beraldo P, Mateus S, Horan T, Leal JC. Effects of partial isothermic immersion on
the spirometry parameters of tetraplegic patients. Chest. 2005;128:184-9.
Uijl SG, Houtman S, Folgering HT, Hopman MT. Training of the respiratory muscles in
individuals with tetraplegia. Spinal Cord. 1999;37:575-9.
8-30
CHAPTER NINE
Bone Health
Maureen C Ashe, PhD, PT

B Cathy Craven, MD FRCPC
Key Points
Fragility fractures, especially around the knee, are very common in people with SCI.
Ideally, bone loss intervention should be introduced early following SCI as a large
portion of bone is loss during the first year.
Oral Tiludronate and Clodronate prevent a decrease in BMD of the hip and knee region
with no adverse effects on bone mineralization in men with paraplegia.
Oral Etidronate prevents a decrease in BMD of the hip and knee region in people with
incomplete paraplegia or tetraplegia.
Pamidronate 30 mg IV or 60 mg IV 4x/year is not effective for the prevention of BMD

loss at the hip and knee region early after SCI people with motor complete paraplegia
or tetraplegia.
Alendronate 10 mg daily and Calcium 500 mg orally 3x/day is effective for the
maintenance of BMD of the wrist, hip and knee region for men with paraplegia.
Short term (6 weeks) therapeutic ultrasound is not effective for preventing bone loss
after a SCI.
FES-cycling does not improve or maintain bone at the tibial midshaft in the acute
phase.
Electrical stimulation can maintain or increase BMD over the stimulated areas.
Six months of FES cycle ergometry may increase lower extremity BMD over areas
stimulated.
There is inconclusive evidence for Reciprocating Gait Orthosis (RGO), long leg braces,
passive standing or self-reported physical activity as a treatment for low bone mass.
Early assessment and monitoring of bone mass after SCI are essential to identify low
bone mass and risk for fragility fractures. Prevention with oral bisphosphonates
(Tiludronate, Clodronate and Etidronate) may slow the loss of BMD early after SCI, but
there is limited evidence that treatment with oral bisphosphonates maintains bone
mass late after SCI. There is a lack of definitive evidence supporting non-
pharmacological interventions for either prevention or treatment of bone loss after a
SCI.
Table of Contents
9.1 Introduction ........................................................................................................................9-1
9.2 Fracture risk following a SCI ............................................................................................9-1
9.3 Bone Outcome Measures..................................................................................................9-2
9.4 Pharmacologic Therapy: Bisphosphonates....................................................................9-3

9.4.1 Pharmacologic Therapy: Prevention (within 12 months of injury).......................................9-3
9.4.2 Pharmacologic Therapy: Treatment..................................................................................9-5
9.5 Non-Pharmacologic Therapy: Rehabilitation Modalities ...............................................9-6

9.5.1 Non-Pharmacologic Therapy: Prevention (within 12 months of injury) .............................9-7
9.5.2 Non-Pharmacologic Therapy: Treatment..........................................................................9-8
9.5.2.1 Electrical stimulation ......................................................................................................9-9
9.5.2.2 FES Cycle Ergometry ..................................................................................................9-10
9.5.2.3 Standing.........................................................................................................................9-11
9.6 General Discussion ...........................................................................................................9-12
References................................................................................................................................9-16
Ashe MC, Craven C, Krassioukov A, Eng JJ (2006). Bone Health Following Spinal Cord Injury. In: Eng JJ, Teasell RW,
Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury
Rehabilitation Evidence. Vancouver, p 9.1-9.18.
www.icord.org/scire
Bone Health Following Spinal Cord Injury
9.1 Introduction
Preserving and maintaining bone mass after a spinal cord injury (SCI) is crucial to decrease the
risk of fragility fractures that results from bone loss. The pathophysiology of this loss is such that
within the first few days following a spinal cord injury there is an increase in excreted calcium
(known as hypercalciuria) that is 2-4 times that of individuals who are confined to prolonged
bedrest but without a SCI (Bauman & Spungen 2001) and reflects excessive bone resorption.
Longitudinal studies also highlight a higher rate of hypercalcemia (excessive calcium in the
blood) for people after a SCI that leads to rapid bone mineral loss in the first 4-6 months that
slows for the remaining first year post injury (Hancock et al. 1980; Frey-Rindova et al. 2000).
Early studies also suggest that bone mineral density (BMD) stabilizes by 1-2 years after SCI
(Griffiths et al. 1976; Hancock et al. 1980; Garland et al.1992) at 25-50% below that of able-
bodied peers in the hip and knee region. More recent investigations support a continual loss of
bone mass with time since injury (Demirel et al. 1998; Bauman et al. 1999) and suggest that a
steady-state of lower extremity bone mineral homeostasis is not reached.
The immediate and excessive loss of bone mass post SCI is believed to result mostly from a
decrease in mechanical loading as a result of reduced or complete loss of muscle function and/or
weight-bearing activities. Neural, vascular, hormonal and nutritional changes may also
negatively impact bone but the relative contributions of these factors is not known. Aging and
inactivity accentuate bone loss resulting in site-specific decrease in bone mineral content
(trabecular>cortical bone). Specifically, the decreased systemic calcium and vitamin D (with
subsequent increase in parathyroid hormone) that results from SCI can be accentuated by
inadequate dietary calcium intake, decreased sunlight exposure and the potential for
hyperparathyroidism (Bauman et al. 1995). Further evidence suggests that women with a
complete SCI experience bone loss around the hip and knee during menopause that is greater
than age-matched able-bodied women (Garland et al. 2001). These factors all contribute to the
increased risk for low-trauma or fragility fractures in people who sustain a SCI.
9.2 Fracture Risk following a SCI
There is overwhelming evidence that supports the importance of addressing bone health issues
early after a SCI. A high incidence of lower extremity fragility fractures (1-46%) exist in people
who sustain a SCI (Table 9.1); the majority of fragility fractures occur following transfers or
activities that involve minimal or no trauma (Ragnarsson & Sell, 1981). The distal femur and
proximal tibia are most at risk, consistent with site-specific decreases in bone mineral density
around the knee such that fractures of the distal femur are referred to as ‘the paraplegic fracture’
(Comarr et al. 1962).
There are many notable risk factors for fragility fracture after SCI. There is a greater risk for
women compared with men (Vestergaard et al. 1998; Garland et al. 2004), also with increasing
age and longer time since injury. Further, paraplegics have more fractures compared with
tetraplegics and those with complete injuries have greater bone loss compared with incomplete
injuries (Garland et al. 2004). In the general population, individuals with a prior history of fragility
fracture or a maternal history of fracture have a greater risk for future fracture, and these risk
factors should also be considered in people with SCI.
9-1
Table 9.1 Fracture Incidence and risk factors for Fragility fractures after SCI
Time to 1st Fracture
First Author /Year N Age Risk Factors
Fracture incidence
A complete injury > risk than incomplete
Comarr et al. 1962 1,363 6%
injury.
Ragnarsson & Sell 1981 578 17-77 4%
Freehafer 1995 133 12-62 >10 months
20-79 33% ↑ Age
20-39 15%
Frisbie 1997 120 21±12 yrs
40-59 31%
60-79 46%
Vestergaard et al. 1998 Women >Men; Family history of
438 10-80 > 1 yr 21%
fractures; Time since SCI > 3 years
1-39
McKinley et al. 1999 40-59 <1.1% 2%
>60 9%
Women >Men; Family history of
Lazo et al. 2001 41 27-83 1-54 yrs 34%
fractures
Nelson et al. 2003 45 Women >Men; Time since injury
0.4-30 yrs 2%/yr Time since injury; ↓ tibia BMD
<1 yr 1%/yr
Zehnder et al. 2004 100 1-9 yrs 1%/yr
10-19 yrs 3%/yr
20-29 yrs 5%/yr
Fracture BMD threshold < 0.86 gm/cm2;
Garland et al. 2004 breakpoint BMD at 0.49 gm/cm2;
28 26-52 2-43 yrs
Women >Men ↑ Age; low BMI;
Completeness of injury post SCI
Fragility fractures, especially around the knee, are very common in people with SCI.
9.3 Bone Outcome Measures
Evaluation of bone occurs in many ways depending on the tools used for investigation. Common
methods of bone evaluation include urine and blood (serum) analyses yielding biochemical
markers to quantify rates of bone turnover. The most commonly used biochemical markers of
bone turnover include osteocalcin, n-telopeptide and hydroxyproline.
Areal bone mineral density is quantified non-invasively with imaging technologies such as dual
energy X-ray absorptiometry (DXA) and previously with dual energy photon absorptiometry
(DPA). Dual energy X-ray absorptiometry is considered by the World Health Organisation as the
“gold or criterion standard” to diagnose osteoporosis and is the most widely used assessment
technique for osteoporosis. DXA can measure BMD for the spine, hip or the limbs at relatively
low cost and minimal risks to the patient. Volumetric bone mineral density is assessed using
peripheral quantitative computed tomography (pQCT). Peripheral quantitative computed
tomography (pQCT) is a safe and precise technique to differentiate cortical from trabecular bone
and assess both bone geometry and volumetric density.
Histomorphometry are measurements from bone biopsies and analyzed at the tissue and cellular
level to provide an in-depth understanding of bone. There are two types of bone
histomorphometry, dynamic and static. Dynamic histomorphometry involves using substances
9-2
such as tetracycline to measure tissue growth. Static histomorphometry involves determining the
size and types of cells; measurements include length, area or cell counts. Static
histomorphometry involves embedding bone in a resin then sanding the specimen down until it is
very thin (<150 microns) and the images are viewed under microscope at various magnifications.
Although bone histomorphometry is considered an important tool, it is not always feasible
because it requires taking surgically removed bone specimens from willing participants.
In this section, prevention and treatment interventions for bone health after a SCI are discussed.
As bone loss is greatest immediately following a SCI, pharmacological and non-pharmacological
interventions are classified as either prevention (the participants are less than 1 year post SCI) or
treatment (study involved participants who are > 1 year after the injury). The intent is to address
two distinct clinical questions: 1.What is the best way to prevent acute regional declines in bone
mineral density?; and 2. What are the best treatments for low bone mass of the hip and knee
region for people with longstanding SCI?
9.4 Pharmacologic Therapy: Bisphosphonates
Within weeks after SCI, there is a marked increase in bone resorption (taking bone away) with a
decrease in bone formation (adding new bone) and this is responsible for the significant loss in
BMD. Bisphosphonates are a group of medications that are used to prevent declines in bone
mass or treat low BMD; they act to slow down excessive bone resorption. Etidronate (Didrocal),
Alendronate (Fosamax) and Risedronate (Actonel) are oral bisphosphonates, which are currently
approved for the treatment of postmenopausal osteoporosis in Canada (Brown et al. 2002).
Clodronate (Benefos or Ostac) is available intravenously (IV) and orally for the treatment of
osteoporosis. Tiludronate (Skelid) is available in oral form in the United States. Giving calcium
and vitamin D at the same time as bisphosphonate therapy has the potential for greater efficacy
for bisphosphonates. Concurrent supplementation with calcium and vitamin D have been
important additions to bisphosphonate therapy for other medical conditions (such as post-
menopausal osteoporosis) (Brown et al. 2002).
9.4.1 Pharmacologic Therapy: Prevention (within 12 months of injury)
Table 9.2 Prevention Studies using Pharmacology for Bone Health after a Spinal Cord Injury.
Score
Methods Outcome
Research Design
Total Sample Size
Population: 14 men and women, ages 21- 1. There was no significant between
61, motor complete para/ tetraplegia. group differences in BMD decline at 1
Treatment: Pamidronate for 12 months. year.
Bauman et al. 2005; USA
Participants randomized to 1. 60mg IV or 2. The treatment group had significantly
PEDro=10
placebo(saline) at 1, 2, 3, 6, 9, 12-mos. lower 24-hr urinary calcium at 1month
RCT
post SCI (N=6). 2. Placebo (N=5). vs. placebo group (P<0.05) and there
N=14
Outcome measures: BMD by DXA, bone were no significant changes in
turnover markers. markers of bone formation over the 12
month study.
Population: 21 men and women, ages 15- 1. No reported adverse effects on
54 years, complete paraplegia. bone mineralization with
Minaire et al. 1981; Treatment: Clodronate for 3.5 months. intervention.
France Participants randomized to 1. 400mg per 2. ↑ in serum and urine markers in the
PEDro=10 day (N=7); 2.1,600 per day (N=7); or 3. Placebo group (↑ bone turnover).
RCT Placebo (N=7). 3. Effective for acute prevention of
N=21 Outcome measures: BMD dual photon declining bone mass and a
absorptiometry (DPA), histomorphometry maintenance of BMC of the femur
and tibia in the treatment groups.
9-3
Score
Methods Outcome
Research Design
Total Sample Size
Population: 20 men and women, ages 16- 1. There was an ↑ in total bone volume in
Chappard et al. 1995; 50, injuries between C5-T12. the treatment group 1(400mg/day) vs.
France Treatment: Tiludronate for 3 months. treatment group 2 (200mg/day) and
PEDro=9 Participants randomized to 1. 400 mg/day placebo groups.
RCT (N=7); 2. 200 mg/day (N=7); or 3. Placebo 2. ↑ bone resorption indicators in the
N=20 (N=6). placebo group vs. the treatment
Outcome measures: histomorphometry. groups.
Population: 13 men and women, ages 22- 1. BMD loss at the distal femur was 26%
57, injuries between C5-T12, ASIA: A or D. and 22% at the proximal tibia. The rate
Pearson et al. 1997; Treatment: Etidronate for 30 weeks. of decline in BMD was greatest
Canada Participants randomized to 1.800mg daily amongst the ASIA A patients. BMD of
PEDro=8 (N=6) or 2. Conventional rehab and lower extremity for the Etidronate
RCT calcium 1000mg/day (N=7). treated ASIA D patients were
N=13 Outcome measures: DXA and adverse preserved.
event rate. 2. Oral Etidronate was safe and well
tolerated by participants.
Population: 21 men and women, ages 15- 1. There was a greater ↑ in bone removal
54, complete paraplegia. markers in Placebo group (48%),
Minaire et al. 1987; Treatment: Clodronate for 100 days. . compared with treatment groups (17-
France Participants randomized to 1.400mg per 27%).
PEDro=7 day (N=7); 2. 1,600 per day (N=7); or 3. 2. BMD was maintained in treatment
RCT Placebo (N=7). groups with a ↓ in placebo group.
N=21 Outcome measures: DXA, 3. Lower bone turnover markers in
histomorphometry, biochemical bone treatment groups.
turnover markers.
Population: 24 men and women, ages 25- 1. There was a lower % decline in BMD
57, injuries between C5-T12, ASIA: A-D. in treatment vs. control group. The
Nance et al. 1999; Treatment: Pamidronate for 6 months. mean overall bone loss was 8.7% in
Canada Participants randomized to 1. 30mg IV the placebo group but only 2.7% in the
PEDro=4 every 4wks x 6doses (total treatment group (p=0.02). The average
RCT 180mg/participant) (N=14) or 2. loss of BMD was 3.1% in the ASIA D
N=24 conventional rehab (N=10). group and 7.7% in the ASIA A group.
Outcome measures: BMD by DXA, urine
biochemical bone markers.
Discussion
Evidence for pharmacological prevention of SCI bone loss includes 6 randomized controlled trials
(RCT) (n=113 participants) (Table 2). These studies were difficult to interpret as a group due to
the variability in selection of the primary outcome measure, relatively short durations of follow-up,
small sample sizes, and the lack of stratification based on impairment level. Preventing bone
loss immediately following SCI is challenging given the rapid bone resorption especially in ASIA
A patients. The majority of studies found bisphosphonates resulted in a reduction of bone loss
compared to a control group. The two studies which report that first generation bisphosphonates
(Clodronate) can maintain bone were short in duration (3 month intervention) and participants
had less severe injury (paraplegia, incomplete SCI) (Minaire et al. 1981, 1987). In two studies
(Pearson 1997; Nance 1999), both groups continued to lose bone, except ASIA D participants
who had bone density preservation in the lower extremity with bisphosphonates while participants
with ASIA A had the greatest decline in both studies. A recent study which used a second-
generation version of the bisphosphonate, Pamidronate and a longer intervention period found no
significant differences between groups for bone loss after 1 year (Baumann 2005).
9-4
Conclusion
There is Level 1 evidence that oral Tiludronate and Clodronate prevent a decrease in BMD
of the hip and knee region with no adverse effects on bone mineralization in men with
paraplegia.
There is Level 1 evidence that oral Etidronate prevents a decrease in BMD of the hip and
knee region in people with incomplete paraplegia or tetraplegia (ASIA D impairment) who
return to walking within 3 months of the SCI.
There is Level 1 evidence that Pamidronate 30 mg IV or 60mg IV four times per year is not
effective for the prevention of BMD loss at the hip and knee region early after SCI in men
and women who have motor complete paraplegia or tetraplegia.
Ideally, bone loss intervention should be introduced early following SCI as a large portion
of bone is loss during the first year.
Oral Tiludronate and Clodronate prevent a decrease in BMD of the hip and knee region with no
adverse effects on bone mineralization in men with paraplegia.
Oral Etidronate prevents a decrease in BMD of the hip and knee region in people
with incomplete paraplegia or tetraplegia.
Pamidronate 30 mg IV or 60 mg IV 4x/year is not effective for the prevention of BMD loss at the
hip and knee region early after SCI people with motor complete paraplegia or tetraplegia.
9.4.2 Pharmacologic Therapy: Treatment
Table 9.3 Treatment Studies Using Pharmacology for Bone Health after a Spinal Cord
Injury
Score
Methods Outcome
Research Design
Total Sample Size
Population: 65 men, ages 18-60, 1. ↓ BMD of the tibia in calcium group but
complete injuries between T1-L3, ASIA: remained stable in the Treatment group
A, B. (group difference, p = 0.017). There
Treatment: Alendronate for 6 months. was no change in wrist BMD and a
Zehnder et al. 2004;
1.10mg per day plus 500mg calcium per significant ↑ in lumbar spine BMD in
Switzerland
day (N=33) or 2. calcium alone (500mg both groups. BMD of the mid-shaft tibia
PEDro=7
per day) (N=32). and hip were maintained in the
RCT
Outcome measures: BMD by DXA and Treatment group and ↓ in the calcium
N=65
bone turnover markers. group.
2. Biochemical markers of bone absorption
were significantly ↓ from baseline in the
Treatment group.
Population: 19 men (< 50 yrs) and 1. There was a mean ↑ in upper extremity
Moran de Brioto et al. women (< 35 yrs), para/tetraplegia, BMD that was greater in Treatment vs.
2005; Brazil ASIA: A, B, or C calcium group. There were no group
PEDro=6 Treatment: Alendronate for 6 months. differences for BMD of the lumbar
RCT 1. 10mg and calcium 500mg bid (N=10) spine, lower extremity or whole body
N=19 and 2. calcium (500mg bid) (N=9). BMD and lower extremity T-score.
Outcome measures: BMD by DXA
9-5
Discussion
Evidence for pharmacological treatment of SCI bone loss includes 2 RCTs (n=84 participants).
In both studies, the treatment group experienced improvement in bone health at various sites.
However, the extent of improvement was greater in the study by Zehnder et al. (2004) who found
an increase in BMD at the spine with maintenance of BMD at the tibia and hip. In contrast,
Moran de Brioto et al. (2005) only found an increase in BMD at the wrist. The difference in
outcomes could be a result of the younger participants with less severe injuries in the work by
Zehnder and coworkers. This review has provided strong support for second generation
bisphosphonates for treatment for low bone mass.
This review has provided strong support for using first and second generation oral
bisphosphonates for prevention and treatment for low bone mass. Despite the benefits of these
medications, they are not without their complications. Oral bisphosphonates must be ingested on
an empty stomach, with 4-8oz of water, followed by sitting up for one-hour post ingestion prior to
taking any other food or medication. Only 1% of the ingested oral bisphosphonate is absorbed in
the upper intestine, yet it remains in the body in an inactive form for several months or years
thereafter. Oral bisphosphonate therapy can cause side effects; joint pain and stomach upset
being the most frequently reported adverse effects. Intravenous formulations of bisphosphonates
are available in daily, monthly and quarterly preparations, and have a greater relative potency.
Although their common short-term side effects include fever, low serum calcium and transient
decrease in white blood cells, IV preparations are attractive due to the flexibility in dosing
regimens, assured compliance and the reduced relative risk of an adverse upper gastrointestinal
event. Bisphosphonates should be used with caution in pre-menopausal women due to the
unknown effects of these medications on the fetus during pregnancy. Patients taking
acetylsalicylic acid (ASA), corticosteroids or NSAIDS may require preventative measures
because using these medications with bisphosphonates increases the relative risk of upper
gastrointestinal side effects.
Conclusion
There is Level 1 evidence that Alendronate 10 mg daily and Calcium 500mg orally 3x/day
is effective for the maintenance of BMD of the wrist, hip and knee region for men with
paraplegia.
Alendronate 10 mg daily and Calcium 500 mg orally 3x/day is effective for the maintenance of
BMD of the wrist, hip and knee region for men with paraplegia.
9.5 Non-Pharmacologic Therapy: Rehabilitation Modalities
Rehabilitation options after a SCI for bone health focus on stimulating muscles and encouraging
weight-bearing. Functional electrical stimulation (FES) is an important option to stimulate muscle
with the goal of increasing regional BMD and involves the use of surface or implanted electrodes
to stimulate standing, ambulation or bicycling (cycle ergometry). The FES-cycle ergometer uses a
series of electrodes placed over the hamstrings, quadriceps and gluteal muscles of the legs to
simulate a cycling pattern. Weight-bearing activities are also used for bone health after a SCI;
these modalities include either passive (tilt-table or standing frame) or active weight-bearing
activities with or without assistance from FES. Many FES studies have enrolled participants with
both acute and chronic injuries and are therefore difficult to classify as pure prevention or
9-6
treatment interventions. For the purpose of this review, studies that enrolled participants that
ranged from the acute phase to > 1 year were included with the treatment literature as the
majority of their participants were in the chronic phase.
9.5.1 Non-Pharmacologic Therapy: Prevention (within 12 months of injury)
Table 9.4 Prevention Studies Using Rehabilitation Modalities for Bone Health after SCI
Score
Methods Outcome
Research Design
Total Sample Size
FES-cycle ergometer
Population: 38 men and women, mean 1. Both groups had a 0-10% ↓ in tibial
age = 33, complete injuries between C5- cortical BMD. There was no difference
T12, (19 participants, 19 controls). between groups for BMD after the
Eser et al. 2003;
Treatment: FES-cycle ergometer. intervention.
Switzerland
Progressive training sessions until able to
cycle for 30 mins. Then 3x/wk for 6 mos.
from this baseline. On the remaining 2days
Trial
of the week there was passive standing.
N=38
Control group performed 30 mins. of
passive standing 5 days/week.
Outcome measures: CT
Standing/Walking
Population: 19 men, ages 19-59, injuries 1. Marked ↓ in trabecular BMD at the left
between C4-T12, ASIA: A-D tibia for the immobilized group but
Treatment: Standing/Walking. Group 1 had minimal ↓ in trabecular BMD in Group
de Bruin et al. 1999;
0-5 hrs per week loading exercises with 2 and 3.
Switzerland
standing frame. Group 2 had 5+hrs of
PEDro=6
standing exercises per week (standing).
RCT
Group 3 had 5+hrs of standing and treadmill
N=19
(walking). Interventions lasted 25 wks.
Outcome Measures: vBMD by pQCT
Treadmill training
Population: 2 men and 3 women, ages 1. ↓ in BMD for all participants at almost
19-40, injuries between C3-C8, ASIA: B all lower limb sites after training,
and C. no controls. ranging from -1.2 to -26.7%.
Giangregorio et al. 2005; Treatment: Body-weight supported 2. Lumbar spine BMD changes ranged
Canada treadmill training. Initial session started at from 0.2 to -7.4%.
Downs & Black score=13 5mins and was ↑ gradually to 10-15mins in 3. No consistent changes in bone
Pre-post all but 1 participant during 48 sessions of geometry at distal femur and proximal
N=5 2x/wk-training over a period of 6-8 months. tibia. Did not alter the expected pattern
Outcome measures: BMD by DXA and of change in bone biochemical
CT. markers over time.
Ultrasound
Population: 15 men, ages 17-40, injuries 1. For specified dose, no significant
between C5-T10, ASIA: A-B, (within group effect of QUS for any skeletal
design) measurement parameter (p>0.05).
Treatment: Pulsed therapeutic ultrasound.
Warden et al. 2001; Applied to both calcanei for each
Australia participant for 20 min/day, 5x/wk over a
PEDro=11 consecutive 6-wk period. Right and left
RCT calcaneus within each participant was
N=15 randomized.
Outcome measures: BMD by DXA and
quantitative ultrasound (QUS).
9-7
Discussion
Evidence for non-pharmacological prevention of SCI bone loss includes 4 investigations (n=77
participants). This includes 2 RCTs (34 participants), 1 non-randomized controlled trial (38
participants) and 1 pre-post studies (5 participants) (Table 4). As with pharmacology prevention
studies, there were difficulties with interpretation because of low numbers of participants and
variability with the primary outcome measures. For each of the four different modalities there is
only one study available and there was variability for the primary outcome of interest. Only the
therapeutic ultrasound study by Warden and coworkers found no significant improvement in bone
health after a 6 week intervention. Although prospective observational data (Frey-Rindova et al.
2000) highlight the loss of bone in the early phase (first 6-months post SCI), there was no
significant influence of self-reported physical activity level. Overall, the evidence suggests that
rehab modalities were not successful in reducing bone loss in the acute phase after SCI.
Conclusion
For NON-PHARMACOLOGICAL PREVENTION of bone loss after a SCI:
There is Level 1 evidence from one RCT that short-term (6 weeks) ultrasound is not
effective for treating bone loss after a SCI.
There is Level 2 evidence that FES-cycling did not improve or maintain bone at the tibial
midshaft in the acute phase.
There is Level 4 evidence that walking and standing in the acute phase did not differ from
immobilization for bone loss at the tibia.
Short term (6 weeks) therapeutic ultrasound is not effective for preventing bone loss after a SCI.
FES-cycling does not improve or maintain bone at the tibial midshaft in the acute phase.
9.5.2 Non-Pharmacologic Therapy: Treatment
In this section, non-pharmacological rehabilitation treatment modalities are divided into 4 sub-
sections: Patterned electrical stimulation (PES), functional electrical stimulation (FES) cycle
ergometry, standing and walking (Tables 5-7). Both PES and FES use cyclical patterns of
electrical stimulation that simulate muscular activity. However, FES is directed towards the
attainment of purposeful tasks such as cycling or walking. PES, on the other hand, is focused on
producing muscle contractions (isometric, isotonic). In some applications, PES techniques are
used as a training stimulus to prepare muscles for a subsequent FES training condition.
9-8
9.5.2.1 Electrical Stimulation
Table 9.5 Treatment Studies Using Electrical Stimulation for Bone Health after SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: 14 men and women, ages 23- 1. At baseline BMD from the
42, complete and incomplete injuries experimental group was lower at the
between C5-T6, 14 able-bodied controls. distal femur, proximal tibia and mid-
Bélanger et al. 2000;
Treatment: PES. Quadriceps training was tibia (↓ range: 25.8% to 44.4%) than
Canada
conducted 5 days/wk for 24 wks. able-bodied controls.
PEDro=11
Participants trained for 1hr/day or until 2. ↑ BMD with training (p<0.05) for both
fatigue. Right quadriceps were stimulated sides of SCI participants, but the type
Trial
with no resistance (but against gravity) of training had no effect (resistance vs.
N=28
while the left quadriceps were stimulated no resistance). There was a significant
against a resistance. ↑ in the BMD of the distal femur and
Outcome measures: BMD by DXA proximal tibia, but not in the mid-tibia.
Population: 12 men and women, ages 19- 1. Tibial BMD was not significantly
63, para/tetraplegia, complete/incomplete, changed after PES protocol (p>0.05),
Rodgers et al. 1991; no controls (only 9 participants had BMD) but BMD was better than predicted
USA Treatment: PES. Each participant trained values.
Downs & Black score=10 for a total of 36 sessions (3x/wk for 12wks)
Pre-post using a progressive intensity protocol for
N=12 PES stimulated knee extension. This
progression was continued to a maximum
15 kg load.
Population: 10 men and women, ages 27- 1. After 12 mos. of training, there was a
45, injuries either C6 or T2, no controls significant 10%↑ in proximal tibia BMD
Treatment: PES. Stimulated the legs for (p< 0.05) but no change at the lumbar
Mohr et al. 1997;
30 min, 3x/wk for 12 mos. followed by spine or femoral neck.
Denmark
1x/wk for 6 mos. 2. After 6 mos. of reduced training, BMD
Downs & Black score= 9
Outcome measures: BMD by DXA, for the proximal tibia returned to
Pre-post
biochemical markers. baseline.
N=10
3. Blood and urine markers were within
normal limits at baseline and there
was no significant change with PES.
Discussion
Although there were no randomized controlled trials that assessed the effect of patterned
electrical stimulation, Bélanger et al. (2000) produced impressive results with a level 2, non-
randomized trial which used 1 limb as the treatment and the other as the control limb. Following
training, the BMD recovered 30% of bone loss compared with able-bodied values. Stimulation
effects only occur over the areas of stimulation and return to baseline within months once
stimulation is stopped (Mohr et al. 1997).
Conclusion
There is Level 2 evidence that electrical stimulation either increased or maintained BMD
over the stimulated areas.
Electrical stimulation can maintain or increase BMD over the stimulated areas.
9-9
9.5.2.2 FES Cycle Ergometry
Table 9.6 Treatment Studies Using FES Cycle Ergometry for Bone Health after SCI
Score
Research Design
Methods Outcome
Total Sample Size
Population: 15 men, ages 23-37, 1. At baseline, participants’ BMD at the
complete, C6-T8. 15 able-bodied controls femoral neck, distal femur and
Treatment: FES-cycle ergometer. proximal tibia was lower than controls.
Participants performed FES-cycling 2. After 6 months, BMD of the distal
Chen et al. 2005; exercises with minimal resistance for 30 femur and proximal tibia ↑ significantly
Taiwan minutes/day, 5 days/week for 6 months. (p<0.05) and BMD of the calcaneus
Downs & Black score= 9 Follow-up 6 months after intervention. (p>0.05) showed a trend toward
Pre-post Outcome measures: BMD by DXA increasing. BMD in the distal femur,
N=30 proximal tibia, and heel ↓ significantly
after 6 mos. without intervention
(p<0.05). The BMD of the femoral
neck ↓ progressively throughout the
treatment (p>0.05).
Population: 6 men, ages 18-27, 1. The BMD of the proximal femurs were
tetraplegia, no controls. below normal before commencing
Treatment: FES+ FES-cycle ergometer. 1- exercise intervention (compared with
Leeds et al. 1989; USA
month quads strengthening exercise, matched able-bodied individuals).
followed by 6-mos cycle ergometry (CE). 2. After 7 months of exercise training
Pre-post
Knee extension sessions were 45 lifts/leg there was no significant difference in
N=6
3x/week for 1month. CE sessions were BMD for any of the sites of the
3X/wk up to 30 mins for 6 mos. proximal femurs compared to normal
Outcome measures: BMD by DXA values.
Population: 12 men, ages 23-46, 1. At baseline, SCI participants were not
complete injuries between C5-T12, no significantly different from aged-
controls. matched able-bodied ambulatory men
Treatment: FES+ FES-cycle ergometer. for lumbar-spine BMD. However, BMD
Participants participated in a 3-phase was significantly lower for participants
BeDell et al. 1996; USA training program of FES-CE. Phase 1: at the hip (p<0.025) for bilat
Downs & Black score=10 quads strengthening. Phase 2: FES-CE trochanters, Wards triangles, and
Pre-post progression until 30 min continuously. femoral necks.
N=12 Phase 3a: 24x 30-mins continuous 2. Only the L2-L4 values demonstrated
exercise sessions performed 3x/wk. Phase any positive training effects (p=0.056).
3b: An extra 24x 30-min sessions adding Further training (Phase 3b) did not
simultaneous arm ergometry (8 demonstrate further increase in BMD
participants only). at any site.
Outcome measure: BMD by DXA
Population: 4 men, ages 20-35, paraplegia, 1. No significant change in lumbar spine
no controls and femoral shaft and/or distal tibia
Treatment: FES+ FES-cycle ergometer. trabecular BMD after the intervention.
Pacy et al. 1988; UK
Part 1 was quads strengthening with ↑ load
ranging from 1.4-11.4 kg bilateral for 15
Pre-post
mins for 5x/wk (10 wks). Part 2 was CE at
N=4
50 rpm with resistance (0-18.75 W).
Performed for 15 mins, 5x/wk (32 wks).
Population: 15 men and women, ages 17- 1. Participants in the exercise groups
46, complete and incomplete injury continued to lose bone at the distal
Hangartner et al. 1994; between C5-T10, no controls. and proximal end of the tibia, but it
USA Treatment: FES+ FES-cycle ergometer. was less than expected from the
Downs & Black score= 9 Either 1. FES knee extension exercises regression lines.
Pre-post (n=3) or 2. FES cycling (n=9) or 3. both
N=15 (n=3). Sessions were 3x/week for 12 wks
except Group 3 had 24 weeks.
Outcome measures: CT
9-10
Discussion
For FES-Cycling there are mixed results for bone parameters. One study found an 11-13%
increase in BMD at the proximal tibia or distal femur while there was no significant within-
participant BMD change in 3 pre-post studies. The FES-cycling study which reported a positive
effect on bone parameters used a protocol that was 3 sessions/week for at least 6 months in
duration, increased bone parameters were over areas directly affected by stimulated muscles
(e.g. quads, distal femur and proximal tibia), and FES-cycling intervention needed to be
maintained or bone gains were lost. FES shows promise as an effective treatment; however the
limited availability of cycle ergometry for home or longitudinal use may limit its generalizibility if
the therapy cannot be sustained outside a clinical trial scenario.
Conclusion
There is Level 4 evidence that 6 months of FES cycle ergometry increased regional lower
extremity BMD over areas stimulated amongst paraplegics.
Six months of FES cycle ergometry may increase lower extremity BMD over areas stimulated.
9.5.2.3 Standing
Table 9.7 Treatment Studies Using Standing or Walking for Bone Health after SCI
Score
Methods Outcome
Research Design
Total Sample Size
Standing (n=4 studies)
Population: 6 men, ages 36-65, complete 1. There was no significant change in
and incomplete, C5-T12, no controls. fracture risk as measured with BMD
Treatment: Passive standing frame. for femoral neck or lumbar spine with
Kunkel et al. 1993; USA
Increased gradually until able to "stand" 30 "standing".
mins 3x/day. Progressed to 45 mins 2x/day
Pre-post
then participants completed 45 mins of
N=6
standing 2x/day for 5 mos.
Outcome measures: BMD and fracture
risk by DPA
Population: 16 men and women, mean 1. There were no significant changes in
Needham-Shropshire et age=29, complete injuries, T4-T11, no BMD in the femoral neck, Ward's
al. 1997; USA controls. triangle, or the trochanter.
Downs & Black score=10 Treatment: Standing and ambulation. 32
Pre-post sessions then participants continued
N=16 ambulation for 8 more weeks.
Outcome measures: BMD by DPA
Population: 8 men and women, ages 19- 1. Significant improvement (p<0.01) in
56, incomplete tetraplegia, no controls. calcium excretion, urinary calcium,
Treatment: Tilt-table weight-bearing and and calcium balance for the early
strengthening exercises. Each tilt table group.
Kaplan et al. 1981; USA
session lasted at least 20mins 1x/day, and 2. The late group had a significant
Downs & Black score= 8 0
the tilt table angle attained was ≥45 . Two improvement for urinary calcium, and
Pre-post
groups: 1) early (within 6 mos of SCI) and calcium balance.
N=8
2) late group (12-18 mos post SCI).
Outcome Measures: urinary calcium
excretion
9-11
Score
Methods Outcome
Research Design
Total Sample Size
Walking (n=2 studies)
Population: Bone assessment with 2 men 1. Three of 4 participants increased or
and 2 women, ages 16-42, paraplegia. no maintained femoral neck BMD but no
controls. change in lumbar spine.
Ogilvie et al. 1993; Treatment: Reciprocal gait orthosis. No
England protocol provided. Quantitative computed
Downs & Black score= 8 tomography repeated every 6 mos from the
Pre-post 1st referral, orthotic fitting and training, to
N=4 independent and regulator ambulation
(mean=5 mo). The RGO was used daily on
average for 3 hrs.
Outcome measures: BMD by QCT
Population: For bone assessment there 1. At baseline, participants (compared
were 6 men and 1 woman, ages 26-33, with age-matched Z-score) had no
Thoumie et al. 1995; injuries between T2-T10. no controls. significant change in L-spine BMD but
France Treatment: RGO-II hybrid orthosis. a ↓ in femoral neck BMD.
Downs & Black score= 8 Completed the protocol within 3-14 mos (2- 2. After the training program (16 mos),
Pre-post hr sessions 2x/wk). no consistent changes at the femoral
N=7 Outcome measures: BMD by DPA neck BMD among participants (4
participants ↓ BMD, 1 participant ↑
BMD and no change in 2 participants).
Discussion
There is inconclusive evidence for Reciprocating Gait Orthosis (RGO), long leg braces or passive
standing as a treatment for bone loss. One cross-sectional study (Goemaere et al. 1994) used a
self-report physical activity measure to highlight the potential for standing to reduce bone loss at
the femoral shaft; patients with long leg braces had a significantly higher trochanter and total
BMD compared with standing frame or standing wheelchair. In contrast, another cross-sectional
investigation of bone outcomes and self-report physical activity measures found no effect of
activity on lower extremity bone parameters (Jones et al. 2002).
Conclusion
9.6 General Discussion
The risk for fragility fractures after a SCI has been established and low bone mass is an
important factor to be considered. In 2002, the Canadian Medical Association published clinical
practice guidelines for prevention and treatment of bone health (Brown et al. 2002). Currently,
these guidelines do not specifically address persons with spinal cord injury, but they do provide a
resource for osteoporosis diagnosis, prevention and treatment. Hopefully future guidelines will
provide recommendations for people who have paralysis such as after a stroke, SCI, multiple
9-12
sclerosis or other neurological impairments that lead to reduced weight-bearing, muscle activity
and physical activity levels.
In the past 40 years there have been a number of interventions (both medications and
rehabilitation modalities) aimed to maintain or retard bone loss after SCI yet, consistent
methodological oversights have emerged including: small sample sizes and broad inclusion
criteria that do not always account for gender, time since injury or impairment differences
between participants. The pharmacological interventions (either prevention or treatment
interventions) discussed here report stronger methodologies— all were RCTs with PEDro scores
ranging from 6-10 indicating moderate to high quality. In contrast, the studies employing rehab
modalities had low numbers of participants and only 2 of the 17 studies were RCTs. These
factors contribute to difficulties drawing generalisible conclusions regarding the impact of rehab
interventions on bone parameters. Nonetheless, despite the lack of evidence to establish the
effectiveness of these rehab modalities on bone parameters, it does not negate these treatments
as beneficial to other body systems. For example, FES-cycling may have small effects on bone,
but this modality has been shown to have large effects on cardiovascular health (Jacobs & Nash
2004).
There are a few key points to consider when interpreting the results from interventions designed
to maintain and/or improve bone parameters after a SCI. These include biological differences in
bone development and maintenance between men and women, the natural loss of bone with
aging and the type of primary outcome measure used. Age-related changes affect both women
and men but the pattern of change is different because estrogen plays such a dominant role in
bone remodeling. Consequently in women, the loss of estrogen at the menopause initiates a
rapid loss of bone that eventually slows but continues throughout life. Men do not experience the
rapid phase of bone loss with aging rather, only the slower phase of bone loss is observed.
Therefore, keeping in mind that bone is lost over time, a study that reports no significant
difference in BMD between two time periods 6 months apart may be interpreted as positive
because of the expected loss.
Due to the nature of different primary outcomes (BMD by DPA, DXA or pQCT, urine or blood
markers) it can be difficult to determine the level of evidence. When measuring parameters such
as urine or blood biomarkers, studies of short duration may yield significant results. However,
using imaging, cortical bone remodeling can take at least 6 months in order to observe changes
within participants over time. Consequently, investigations that did not maintain an intervention
for at least 6-months may not show changes, but, the results cannot be interpreted as negative.
Importantly all primary outcomes for bone health after a SCI are surrogate measures, that is,
there has yet to be a study published in this area that investigates the effect of an intervention
(either pharmacological or non-pharmacological) on reducing fractures. Generally, these types of
studies are too costly due to the large number of participants that would need to be enrolled and
followed for a long time period. Consequently, the clinical significance of the interventions based
on fractures for this population remains to be determined.
Conclusion
There is a significant risk for lower extremity fragility fractures after a SCI; the risk
increases with gender, type and time since injury. Early assessment and ongoing
monitoring of bone health is an essential element of SCI care. There is Level 1 evidence
for the prevention and treatment of bone loss using medications, however, non-
pharmacological evidence for preventing bone loss and treating bone health is limited by
small studies, different treatment protocols, participant groups that are too
heterogeneous, relatively short treatment sessions given the time required to detect
9-13
improvements in bone parameters and variability with imaging technologies and
measured regions of interest.
Early assessment and monitoring of bone mass after SCI are essential to identify low bone
mass and risk for fragility fractures. Prevention with oral bisphosphonates (Tiludronate,
Clodronate and Etidronate) may slow the loss of BMD early after SCI, but there is limited
evidence that treatment with oral bisphosphonates maintains bone mass late after SCI.
There is a lack of definitive evidence supporting non-pharmacological interventions for either
prevention or treatment of bone loss after a SCI.
9.7 Summary
There is Level 1 evidence that oral Tiludronate and Clodronate prevent a decrease in BMD
of the hip and knee region with no adverse effects on bone mineralization in men with
paraplegia.
There is Level 1 evidence that oral Etidronate prevents a decrease in BMD of the hip and
knee region in people with incomplete paraplegia or tetraplegia (ASIA D impairment) who
return to walking within 3 months of the SCI.
There is Level 1 evidence that Pamidronate 30 mg IV or 60mg IV four times per year is not
effective for the prevention of BMD loss at the hip and knee region early after SCI in men
and women who have motor complete paraplegia or tetraplegia.
There is Level 1 evidence that Alendronate 10 mg daily and Calcium 500mg orally 3x/day
is effective for the maintenance of BMD of the wrist, hip and knee region for men with
paraplegia.
For NON-PHARMACOLOGICAL PREVENTION of bone loss after a SCI:
There is Level 1 evidence from one RCT that short-term (6 weeks) ultrasound is not
effective for treating bone loss after a SCI.
There is Level 2 evidence that FES-cycling did not improve or maintain bone at the tibial
midshaft in the acute phase.
There is Level 4 evidence that walking and standing in the acute phase did not differ from
immobilization for bone loss at the tibia.
There is Level 2 evidence that electrical stimulation either increased or maintained BMD
over the stimulated areas.
There is Level 4 evidence that 6 months of FES cycle ergometry increased regional lower
extremity BMD over areas stimulated amongst paraplegics.
9-14
There is a significant risk for lower extremity fragility fractures after a SCI; the risk
increases with gender, type and time since injury. Early assessment and ongoing
monitoring of bone health is an essential element of SCI care. There is Level 1 evidence
for the prevention and treatment of bone loss using medications, however, non-
pharmacological evidence for preventing bone loss and treating bone health is limited by
small studies, different treatment protocols, participant groups that are too
heterogeneous, relatively short treatment sessions given the time required to detect
improvements in bone parameters and variability with imaging technologies and
measured regions of interest.
9-15
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9-18
CHAPTER TEN
Depression Following Spinal Cord Injury
Steven Orenczuk, PsyD

Jim Slivinski, MA
Robert W Teasell, MD FRCPC
Key Points
Depression is a common consequence of SCI.
Despite methodological challenges, our understanding of post-SCI depression,

treatment, and associated psychological conditions is growing.
Cognitive behavioural interventions provided in a group setting appear helpful in

reducing post-SCI depression and related difficulties.
The benefits of drug treatment for post-SCI depression are largely extrapolated from
studies in non-SCI populations.
Programs to encourage regular exercise, reduce stress, and improve or maintain

health appear to have benefits in reducing reports of depressive symptoms in persons
with SCI.
Table of Contents
10.1 Introduction ..................................................................................................................10-1
10.2 Prevalence of Depression Post-SCI ...........................................................................10-2
10.3 Interventions for Treatment of Depression following SCI........................................10-4

10.3.1 Cognitive Behavioural Therapy...................................................................................10-4
10.4 Pharmacotherapy for Treatment of Depression in SCI ..........................................10-10
10.5 Other Treatments for Depression following SCI .....................................................10-11
10.6 Summary.....................................................................................................................10-16
References............................................................................................................................10-17
Orenczuk S, Slivinski J, Teasell RW (2006). Depression Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller
WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation
Evidence. Vancouver, p 10.1-10.19.
www.icord.org/scire
Depression Following Spinal Cord Injury
10.1 Introduction
Practitioners providing clinical rehabilitation services to individuals who have suffered

catastrophic injuries and illnesses focus much interest on the issue of psychological adjustment.
This chapter summarizes evidence garnered from SCI research that investigates the treatment
of post-SCI depression and other psychosocial factors potentially affecting successful recovery.
Though as yet quite limited, these findings can assist in developing a foundation for evidence-
based practice, and hopefully lead to improved and more consistent care. It should be
emphasized however that evidence-based practice constitutes more than the routine use of
treatments supported by the best research evidence available. Such practice also necessitates
that the practitioner employ his or her clinical judgment in determining the applicability of such
research conclusions to the treatment provided each patient (APA 2005).
Concerns regarding “depression” are commonly reported by SCI survivors, staff, or their
families. Indeed, Elliott and Umlauf (1995) report that depression is the most frequently
researched psychological issue in individuals who have sustained a SCI. Given the
innumerable modifications necessitated following a SCI, an individual will likely encounter
repeated strains upon their available coping resources. The occurrence of depression is not a
surprising outcome of such challenges (Kemp et al. 2004) and some early investigators have
described it as an “inevitable” outcome (e.g. Hohmann 1975). Of added concern, rates of
suicide average approximately 3 to 5 times that reported in the general population (e.g. DeVivo
et al. 1989; Charlifue & Gerhart 1991; Hartkopp et al. 1998) and stand in contrast to the
reductions achieved in other preventable causes of death following SCI (e.g. septicemia,
respiratory illness, diseases of the urinary system) (Soden et al. 2000).
The term “depressed mood” refers to a state of dysphoria that occurs routinely and is a normal
process (Elliott & Frank 1996). In contrast, a diagnosable “depressive syndrome” refers to a
constellation of observable affective, cognitive and neurovegetative symptoms of sufficient
frequency and severity to negatively impact upon an individual’s functioning. The Diagnostic
and Statistical Manual of Mental Disorders (DSM-IV-TR 2000) is a frequently cited classification
system for establishing diagnoses of various depressive and other mental disorders. For
example, a diagnosis of Major Depressive Disorder in an adult requires at least a two-week
period of five or more symptoms, with at least one either depressed mood or a loss of interest or
pleasure in almost all activities. Further, symptoms may include weight changes, changes in
sleep, psychomotor agitation or retardation, fatigue, feelings of worthlessness or guilt,
indecisiveness or decreased concentration, and/or thoughts of death or suicide. Symptoms
together must result in an impairment in functioning (social, occupational or other) and are not
due to the direct physiological effects of a substance or medical condition.
Identifying depression is often more difficult than might be anticipated. Even rehabilitation staff
have been shown to overestimate it in inpatient populations (Cushman & Dijkers 1990) while
underestimating patients’ reported coping ability and mental health (Siosteen et al. 2005).
Similarly, the life satisfaction and well-being of persons in the community with complete
tetraplegic injuries (including those who required ventilator support) was also shown to be
underestimated by health care professionals (Bach & Tilton 1994).
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Various methodological issues have “served to constrain” the study of depression in the SCI
population (Elliott & Frank 1996). The use of ambiguous definitions and the unclear or
inconsistent use of diagnostic criteria are two of many such challenges. Others issues include a
lack of theoretical models, selection biases, and limited longitudinal studies.
How best should the occurrence of depression be viewed in the process of adjustment to SCI?
Anecdotal models of adjustment have incorporated the “clinical lore” that depression was to be
universally anticipated soon after injury (Elliott & Kennedy 2004), and demonstrating the
individual’s rational acceptance of the permanence of the injury and associated losses (Frank et
al. 1985). Taken further, those individuals who do not evidence depression were often
considered to be in “denial” and potentially vulnerable to a more precarious adjustment (e.g.
Siller 1969). Accordingly, it had been also proposed that depression be induced to encourage
appropriate grieving (Nemiah 1957). Indeed both the universality and the benefits of depression
in the adjustment process have since come into question by investigative findings (e.g. Howell
et al. 1981; Judd et al. 1986). Given the many negative outcomes associated with depression
post injury (e.g. longer hospitalization, decreased longevity, increased rates of suicide, reduced
health, daily functioning, limited community participation) it is likely best viewed as a secondary
complication or sequelae rather than an adaptive process facilitating overall emotional
adjustment (Consortium for Spinal Cord Medicine 1998).
Contrary to expectations, Kemp et al. (2004) note that depression is not simply a necessary
consequence of sustaining a spinal cord injury – not all who sustain a spinal cord injury become
depressed. Tirch et al. (1999) used several self-report depression scales in a study of 11 pairs
of monozygotic twins where one of the pair had sustained a SCI. The SCI and non-SCI co-
twins did not differ significantly in their self-reports, lending additional support to the view that
SCI does not inevitably lead to increased depression. Further, there is little relationship
between depression and the level of SCI or the completeness of the lesion (Kemp et al. 2004).
As an example, Hall et al. (1999) sampled 82 individuals with C1-4 quadriplegia between 14 and
24 years post injury, and these individuals reported their self-esteem and quality of life to be
high – with 95% feeling they were “glad to be alive”.
In reality, it appears more likely that depression post-SCI is a function of difficulties coping with
the multiple environmental, social and health related problems that follow. If depression is not
inevitable following SCI, then it is noteworthy that depression is related to modifiable factors that
play a role in its development and maintenance (Kemp et al. 2004). Elliott and Shewchuk (2000)
note that an individual’s primary concerns soon after injury (i.e. restorative and curative
therapies) tend to change over time, with those with SCI becoming increasingly interested in
addressing social and interpersonal barriers as well as age-related health issues.
In a summary of the extant adjustment literature, Elliott and Rivera (2002) review a model
determining psychological well being and physical health post-SCI. The components include
demographics, injury characteristics, preinjury behaviours and psychopathology, personality
factors, social/environmental factors and styles of appraisals. The authors highlight how the
consequences of physical disability exist within a larger context and that changes in public and
health policies can dramatically impact post-injury quality of life.
10.2 Prevalence of Depression Post-SCI
Estimates of the prevalence of depression are affected by the nature of the measures used,
how depression is defined, and when symptoms are assessed post injury. The common
research practice of employing self-report measures is both convenient and cost-effective.
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However, the resulting prevalence rates may reflect subjective anxiety and overall distress
rather than symptoms specific to depression, per se. In clinical practice, self-report measures
may serve to alert the clinician to the need for additional evaluation.
Depression rates post-SCI range from 16-30%, with up to 25% of men and 47% of women
(Consortium for SCI Practice Guideline 1998). Krause et al. (2000) suggest a rate of
depression of 42% overall with a 21% probable rate of major depression – indicative of a 4-fold
increase of depressive disorders among individuals with SCI compared with samples of non-
disabled individuals. In an Italian sample averaging 6 years post-SCI, Scivoletto et al. (1997)
found 16% reported significant symptoms of depression and 13% of anxiety.
In a 6-year follow-up study of 233 Albertans with SCI, 28.9% were treated for depression
following their traumatic spinal cord injuries, with approximately 59% of these individuals
beginning treatment during their initial hospitalization (both acute and rehabilitation admissions).
An additional 10% of people were treated during the remainder of the first year. This exceeded
depression treatment rates reported in able-bodied controls (approximately 11%) (Dryden et al.
2004), with those at highest risk reporting permanent neurological deficit, a preinjury history of
depression, or substance abuse (Dryden et al. 2005). Kennedy and Rogers (2000) reported
that anxiety, depression and hopelessness gradually increased beginning at week 30 post injury
and continued until discharge from rehabilitation (week 48). At that point 60% of SCI clients
scored above a clinical cut-off for depression (i.e. Beck Depression Inventory).
It has been questioned whether, despite its reported prevalence, efforts to improve the detection
and treatment of depression in individuals with SCI have improved (Bombardier et al. 2004). In
an editorial comment, Faber (2005) expressed concern that given possible underestimates,
about half of all persons hospitalized for traumatic SCI may benefit from treatment for
depression. Similarly, while a substantial percentage of their SCI clinic sample reported
symptoms suggestive of major depression, Kemp and Krause (1999) found that none were
receiving treatment (psychotherapy or medications).
Bombardier et al. (2004) surveyed over 800 SCI survivors at one-year post injury. Using the
Patient Health Questionnaire – 9, a self-report screening measure, 11.4% met criteria for DSM-
IV major depressive disorder. Interestingly, the results supported an “inclusive” approach to
diagnose MDD, one that suggests somatic symptoms such as appetite changes, sleep
disturbance, and poor energy should be included in identifying MDD in those with SCI.
As noted, concerns regarding depression post-SCI are frequently cited in the literature. Data
obtained in earlier studies has also suggested that in newly injured persons who met a criteria
for major and minor depression, many may remit within 3 months of onset (Kishi et al. 1994)
and that the frequency of reported problems decreases over the first year (Richards 1986).
Conclusion
While not universal, for many persons with spinal cord injury, depression can be a
complication that poses a significant impediment to their functioning and adaptation.
Identifying depression can be difficult, but is most likely to develop during the initial year
post injury. Self-report measures should be viewed as screening tools to alert the
clinician to arrange a more thorough evaluation.
Depression is a common consequence of SCI.
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10.3 Interventions for Treatment of Depression following SCI
The American Psychological Association (APA 2005) states that evidence-based practice
involves the integration of the best of existing research with clinical expertise and the reality of
the patient’s needs and wishes. However both the exigencies of the SCI population and
practical concerns limit the nature of SCI research topics and designs. Specific to the issue of
depression, Elliott and Kennedy (2004) have questioned whether the current “glaring lack of
intervention data” reflects a lack of interest by consumers, researchers and funding agencies to
examine the effects of various interventions for depression in those with SCI.
Difficulties inherent in conducting intervention studies are numerous (King & Kennedy, 1999).
The SCI population can be varied. Most sites do not have access to a large number of patients,
thus obtaining treatment and appropriate control groups becomes difficult and would likely
require the participation of multiple sites. Also, ethical concerns over providing the best possible
care to all SCI patients are obvious, so that withholding aspects of treatment in order to
establish control conditions is not acceptable. Current research strategies frequently use self-
report screening measures (e.g. Beck Depression Inventory, Zung Depression Inventory,
Patient Health Questionnaire-9, Center for Epidemiological Studies – Depression Scale), and
while they offer many benefits (e.g. low cost, quick, easy to complete), they require further
evaluation to support a diagnosis of depression. Typical SCI interventions to encourage
adjustment are often multi-faceted, thereby posing difficulties in identifying which combination of
components can offer optimal care for any particular patient. Further, psychosocial
interventions cannot be independent of other aspects of care (e.g. medical, rehabilitation). In
addition, many pre-morbid psychological and historical influences are very difficult to determine.
As many SCI studies lack one or several aspects of “gold standard” research, the
generalizability of the findings may be limited. Despite these challenges, researchers have
made invaluable clinical contributions using smaller groups, non-randomized control groups, or
controls chosen from historical data. In summarizing the limited research currently available
however, Elliott and Kennedy (2004) suggest “we have many untested assumptions regarding
the available treatments for depression among persons with SCI”.
Conclusion
Despite methodological challenges, our understanding of post-SCI depression, treatment,

and associated psychological conditions is growing.
10.3.1 Cognitive Behavioural Therapy
In the SCI population, the application of cognitive behavioural therapy (CBT) approaches to aid
in the management of anxiety and depression is described as a prudent choice given its
demonstrated effectiveness in a wide range of disorders (Craig et al. 1997). CBT strategies can
include addressing “irrational” or negative thoughts, increasing opportunities for participating in
rewarding activities, and instruction in relaxation, among others. Within this context, issues of
assertiveness, social skills and discussions of sexuality have also at times been included to
address the unique concerns of SCI individuals. Employing a group setting to provide CBT can
also be a cost effective opportunity for peer support, practice of social skills and the opportunity
for gaining additional viewpoints. Several authors have described the effects of group CBT
10-4
interventions for individuals following SCI to reduce psychological distress and/or provide
“immunization” against future difficulties.
Table 10.1 CBT Group Interventions

Score Methods
Outcome
Research Design
Total Sample Size
Population: 27 treatment gr, 31 controls. 1. No significant differences were noted
Intervention: 10 week program. Small across time for anxiety but there were
groups (4-5 per group), for 1.5 hours per significant differences noted for
week. depression overall, (p<0.05).
Major aim was to provide cognitive and 2. Both the treatment and the control
behavioural skills to cope with the groups appeared to be less depressed
psychological and social difficulties 1 and 2 yrs after injury.
encountered upon entering the community. 3. For individuals who scored high on the
Cognitive behavioural therapy included depression scale before therapy, (9
Craig et al. 1998a; muscle relaxation, visualization techniques, from each group) there were
Australia self-hypnosis and cognitive restructuring, significant differences after treatment.
Downs & Black score=21 social skills and assertiveness training, and (p<.01) with the control group reporting
Prospective Controlled sexuality sessions. higher levels of depressive mood.
Trial Outcome Measures: State-Trait Anxiety 4. Depressive mood scores showed
(Continuation of Scale (STAIC); Beck Depression Inventory significant differences across time
Craig et al. 1997) (BDI) scale. (p<0.01) with scores 1 and 2 years
Initial N=69; Final N=58 post injury were significantly lower
than pretreatment scores (p<0.01).
5. Those that scored high on the anxiety
scale (n=19 in total), there were
significant differences in scores overall
across time (p<0.1) with anxiety
scores decreasing over time.
Population: Ages:16 –65; new injured Pre-intervention comparisons of

Intervention: Consisted of 60-75 minute groups:
session run twice a week in small groups of 1. On the coping scale two items (religion
6 to 9 people. Sessions included a mixture and humor) showed significant
of didactic presentations, practical differences, Religion (intervention
exercises and time allocated for open group mean score was higher,
group discussions. Following components p<0.05).
made up the program: appraisal training, 2. Humor (control group mean higher,
King & Kennedy 1999; cognitive behavioural coping skills training, p<0.05). There were no pre-
UK and strategies for choosing an adaptive intervention differences between the
Downs & Black score=20 match between appraisal and coping skills, groups on range of injury, social
Pre-post and obtaining and maintaining social support, FIM scores, coping,
Initial N=38; Final N=38 support. depression or anxiety.
Outcome Measures: Functional Post-intervention comparison of
Independence Measure, Social Support groups:
Questionnaire, Beck Depression Inventory, 1. Depression and Anxiety: Across time
State Anxiety Inventory, COPE (for there were significant decrease in the
coping). depression scores (p<0.05) but not for
anxiety (p=ns).
2. Coping: No significant differences
between the groups or across time.
Population: Ages 16-65 years, newly Pre-intervention comparisons of
Kennedy et al. 2003; UK injured traumatic SCI. groups:
Downs & Black score=19 Intervention: consisted of 7, 60-75 1. Intervention group was older more
Pre-post minutes sessions that ran twice a week in likely to have a complete injury and to
Initial N=85; Final N=85 small groups of 6-9 participants. Session have been injured longer than the
topics were: normalizing stress, appraisal control group (p<0.01).
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Score Methods
Outcome
Research Design
Total Sample Size
skills, problem solving, examination of 2. Intervention group tended to use
thoughts feeling and behavior, awareness active and religious coping strategies
of negative assumptions, and choosing (p<0.05).
appropriate ways both to cope and to 3. Intervention group tended to use
increase social supports. drugs/alcohol less frequently (adjusted
Outcome Measures: State Anxiety for unequal variance p<0.05).
Inventory, Beck Depression Inventory, Post-intervention comparison of
Coping Strategies Scale, Self Perception groups:
Scale, and Functional Independence 1. Overall the intervention was
Measure. successful in decreasing both
Measures were taken before and depression and anxiety.
immediately after the intervention, and at a 2. Mood: depression scores decreased
6wk follow-up with the intervention group, for the intervention group following the
and every 6 weeks with the historic control intervention (p=0.001).
group. 3. Anxiety: decreased for the intervention
group following the intervention
(p=0.001).
4. Coping: alcohol use was significantly
lower for the intervention group,
(p=0.003).
5. Self perception scale: intervention
group only-ideal self scores had
significantly greater scores than either
how they would see themselves
without injury (p<0.05) or “as I am” on
all items (p<0.001).
Population: Gender: m=57, f=12, age: 16- Percentages are reported for each area
73yrs, SCI (new injured), 68%-71% measured.
complete injury. 1. Re-admission: More control were
Intervention: 10 weeks in small groups. readmitted following discharge
Each session lasted from 1.5 to 2 hours (X²=3.93, P<0.05).
replacing normal rehab therapy. Patients 2. Drug usage: Controls were found to
Craig et al. 1999; underwent cognitive behaviour therapy have higher self-reported drug usage
Australia (CBT) attempts to change behaviour and than the treatment group (cases)
Downs & Black score=18 feeling associated with the problem and (X²=4.12, P<0.05).
Case Control considered maladaptive. Main aim of the 3. Relationships and Social
(Continuation of program was to provide cognitive and discrimination: No significant
Craig et al. 1997) behavioural skills to cope with the differences were noted between the
Initial N=58; Final N=58 psychological and social difficulties two groups in relation to the types of
encountered upon entering the community relationship each person developed.
(as described above). 4. Self-reports of adjustment:
Outcome measures: Re-admissions, drug Treatment groups said they had a
usage, relationships, social discrimination, higher number of persons who felt
self-reports of adjustment they had adjusted well compared to
the controls. (X²=12.0, P<0.01).
Population: Gender: m=57, f=12, age: 16- 1. No pre-treatment differences between
73yrs, SCI (new injured), 68%-71% the treatment and the control groups
complete injury. on LCB (t=0.686).
Craig et al. 1998b;
Intervention: 10 week program. 2. No significant differences were found
Australia
Small groups (4-5 per group), for 1.5 hours between groups overall for locus of
per week. control as a result of treatment (F1.67
Major aim was to provide cognitive and = 0.928).
Trial (longitudinal)
behavioural skills to cope with the 3. No significant differences occurred
(Continuation of
psychological and social difficulties across time for LCB (F3.201 = 2.07).
Craig et al. 1997)
encountered upon entering the community. 4. No significant interactions present
Cognitive behavioural therapy included between group and time (F3.201 =
muscle relaxation, visualization techniques, 0.199).
self-hypnosis and cognitive restructuring, 5. A repeated measure MANOVA was
10-6
Score Methods
Outcome
Research Design
Total Sample Size
social skills and assertiveness training, and completed on participants (n=26) who
sexuality sessions. scored higher than 33 on the LCB.
Outcome Measures: Locus of Control of 6. Significant differences were noted
Behaviour Scale (LCB), and the Beck between the two groups (F1.23 = 4.94,
Depression Inventory (BDI) scale. p<0.05).
7. Across time there was a significant
reduction in LCB scores across time.
(F1.69 = 7.33, p<0.05).
8. Post hoc Scheffe tests indicated post-
treatment scores to be lower than pre-
treatment scores (p<0.01).
9. A significant association was found
between depressive mood and locus
of control post-therapy, 1 year later
and 2 years later.
10. For the control group locus of control
was mildly associated with depressive
mood and for the treatment groups
locus of control was not significantly
associated with depressive mood at
anytime.
Population: Gender: m=57, f=12; age: 16- 1. Significantly greater self-esteem for
73yrs; SCI (new injured); 68%-71% treatment group (t=3.18, df=67,
complete injury. p<0.01). Taking this into account, no
Intervention: 10 week program. Small significant differences between the
groups (4-5 per group), for 1.5 hours per groups were found immediately after
week Provided cognitive and behavioural injury or 1 year later.
skills to cope with the psychological and 2. No significant initial differences were
social difficulties encountered upon found between the groups on anxiety
entering the community. Cognitive F(1,67) =.47) and depression
behavioural therapy included muscle F(1,67)=.24 when comparing pre, post
relaxation, visualization techniques, self- and 1-year scores.
hypnosis and cognitive restructuring, social 3. BDI scores were significantly lower for
Craig et al. 1997;
skills and assertiveness training, and both conditions one year after injury F
Australia
sexuality sessions. (2,124) = 4.34, p=0.014.
Outcome Measures: State-Trait anxiety 4. Neither anxiety nor self-esteem scores
Inventory (STAIC); Beck Depression improved significantly over the year.
Trial
Inventory (BDI) scale, Rosenberg Self- 5. Those who scored higher than 14 on
N=69
Esteem scale. the depressive mood scale were
analyzed using repeated measures
ANOVA. 22 persons (from both
groups) were looked at. Significant
differences were noted between the
groups (F1, 20) =7.41, p<0.01).
6. Significant differences were also noted
across time for the BDI scores. F (2,
40) =7.1, p<.01. Post hoc tests
showed that the treatment group had
significantly greater levels of
improvement across time (p<0.05).
Discussion
In Australia, Craig et al. reported several investigations (1997, 1998a, 1998b, 1999) employing a
10 week CBT based group treatment format involving newly injured SCI rehabilitation inpatients
with permanent injuries. They developed a CBT based treatment protocol implemented by a
10-7
psychologist and an occupational therapist. Treatment groups consisted of 4-5 individuals and
sessions approximated 1.5 to 2 hours weekly. A matched control group of SCI patients received
traditional rehabilitation services. Measures of depression, anxiety and self-esteem were
completed when individuals were no longer immobilized in bed, after conclusion of therapy (3
months post-injury) and at one year post injury. Prior to treatment, the treatment group reported
greater self-esteem than did controls, but did not differ on other outcome measures. Anxiety did
not change over time. Both treatment and control groups reported fewer symptoms of
depression at 12 months post injury. Taking into account pretreatment group differences in self-
esteem, there was no significant improvement over time for either group. Given that neither
group had high levels of depressive mood before treatment, a further analysis of those with
elevated scores on depression revealed that the mean score for the treatment group (n= 10)
showed improvement after treatment and further gains one year later. Controls (n = 12) who
were moderately to severely depressed initially remained at these levels over the year. Patients
with initially high levels of anxiety (in either condition) showed symptom decreases over the
year, with a trend for those in the treatment group to improve more so than did those in the
control group. CBT did not significantly impact upon self-esteem in individuals with recent onset
SCI. The authors conclude that clinicians servicing SCI rehabilitation wards should evaluate
individuals soon after admission to identify those with high levels of depression and/or anxiety
and then recommend CBT. Further, not all persons with SCI are depressed, anxious or low in
self-esteem, and may not require intervention.
In a follow-up report, Craig et al. (1998a) surveyed a subset of the SCI CBT treatment group
participants and SCI controls (noted above) at 24 months post injury. Group differences were
not significant for measures of depression and anxiety. At 1 and 2 years post injury, subjects
were less depressed but levels of anxiety were essentially unchanged. For those subjects with
elevated depressive symptoms prior to treatment, levels of depression over the long term were
lower for the treatment than the control group. Differences over time were also noted, with the
short-term improvements in the depressive symptoms of the treatment group maintained over
the two-year period. In contrast, controls did not show improvement in the short term and were
only slightly improved after 1 to 2 years. Interestingly, the authors report that none of the
treatment group had sought further treatment for depression between the 12 and 24-month
period. Both groups became less anxious over time. The small number of subjects precluded
identification of significance, but an inspection of the data revealed that the treatment group
lowered their elevated anxiety scores to within the normal range at two years, while the control
subjects’ scores averaged approximately one standard deviation above general population
norms. The authors conclude that not all individuals with recent onset SCI require specialized
psychological intervention. For those with elevated levels of reported depression and anxiety,
these symptoms hypothetically could return to normal levels in the absence of intervention.
However, such improvements could require a protracted period and result in both increased
health costs and a diminished quality of life. This study further suggests the merits of screening
and ongoing benefits of an intervention program.
In a related study, Craig et al. (1998b) used the Locus of Control Behaviour Scale (LCB) to
assess subjects’ perceptions that circumstances were within or beyond their control. No
treatment differences were found when comparing SCI CBT group participants and controls
over a two-year post injury period. Both groups averaged scores in the range suggestive of a
more internal rather than external orientation. When subjects with scores suggestive of an
external locus of control scores were identified (9 treatment subjects and 16 controls), the
treatment group showed a significant reduction in externality over time while controls did not.
The finding supports the conclusion that CBT was effective for those in the treatment group who
perceived living with a SCI (and related concerns) to be out of their control. Associations of
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locus of control scores and depressive mood (Beck Depression Inventory) almost all reached
significance for the control group when assessed pre treatment, post treatment, and at one and
two year intervals. In contrast, no associations were evident between LCB scores and reports
of depressive symptoms in SCI treatment subjects, even for those who were external in their
perceptions prior to participation in the CBT group. The authors speculated that CBT “positively
interfered in the determination of depressive mood”. While there may be a substantial group at
risk for developing psychological difficulties following spinal cord injury, the majority did not
show problematic levels of externality and helplessness. As such, the authors concluded that
CBT for all SCI survivors is costly and unnecessary.
Craig et al. (1999) continued a long term (2 years post injury) assessment of persons with SCI
who previously participated in a non-randomized longitudinal controlled trial of CBT during their
inpatient admission to a rehabilitation ward (1991-1992). These responses were compared with
those of control subjects who received only traditional rehabilitation services during their
hospital stay. Treatment subjects indicated 15% fewer hospital readmissions, 25% less drug
use and much more often reported a positive adjustment than did controls. Of concern,
approximately 40% of controls frequently used drugs. Forty three percent of controls reported
that they had not adjusted well, while only one treatment subject held a similar view. Neither
group reported the occurrence of suicide over the two years. Self-reports of adjustment were
negatively correlated with Beck Depression Scale scores. The groups did not differ in the
frequency of relationship breakups, with the majority of those married at the time of injury
remaining so at two years. Further, about half who were unmarried had formed new
relationships. The findings again are seen as suggesting benefits of CBT group treatment in
encouraging positive adjustment following SCI.
Two studies conducted at the National Spinal Cord Injuries Centre (NSCIC) in the UK
investigated group Coping Effectiveness Training (CET). CET includes CBT, didactic, and
practical elements. The first (King & Kennedy 1999) was a pilot study of CET, and the second
(Kennedy et al. 2003) continued the work with additional subjects and measures. Both studies
used matched historic controls from the NSCIC database, although there did remain some
significant pre-intervention differences between groups. Results suggest that their intervention
package produced a number of positive changes, including less depression and anxiety, less
use of alcohol, and more positive self-perception. Participants said that they found the sharing
of views and experiences and reviews of “real life” scenarios to be most valuable aspects of the
group.
In summary, this series of studies has demonstrated the long term benefits of CBT group
programming on various aspects of adjustment. Receiving CBT during the initial rehabilitation
phase has been reported to reduce depressive mood, helplessness, anxiety, and is associated
with fewer hospital readmissions, less drug use and greater self-reported adjustment.
Conclusion
A variety of logistical and ethical factors limit the study of depression in SCI samples.
Attempts to treat depressive symptoms using multifaceted packages that incorporate
cognitive behavioural skills appear encouraging in reducing the incidence of depression,
anxiety and encourage positive adjustment post-SCI, particularly for individuals who
exhibit substantial emotional distress in the acute phase of rehabilitation. The use of a
group format appears to offer a cost-effective method of intervention.
10-9
There is level 2 evidence from 6 non-RCT studies to support the use of small group CBT
based treatment packages to decrease depression symptoms following SCI. (Note that 4
of these studies were based on the same groups and intervention.)
Cognitive behavioural interventions provided in a group setting appear helpful in

reducing post-SCI depression and related difficulties.
10.4 Pharmacotherapy for Treatment of Depression in SCI
Several case series studies have reported positive results using pharmacotherapy for
depression in SCI individuals (e.g. Kim et al. 1977 (amitriptyline); Fullerton et al. 1981; Judd et
al. 1986 (mianserin and nomifensine); Judd et al. 1989 (tetracyclic and tricyclic)). Overall,
support for pharmacological treatment of depression in individuals with SCI is largely an
extrapolation from the extant literature concerning use in the general population and
comparative trials of medications and cognitive behavioural interventions are “sorely needed”
(Elliott & Kennedy 2004).
Table 10.2 Combined Individual Psychotherapy and Pharmacotherapy for Treatment of

Depression in SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m = 32; f = 11, Age: 1. Depression Outcomes: A decrease
20-74 yrs, time since injury: 5-37 years, 28 was observed in depression scores
treated for depression, 15 acted as quasi- from 0-24wks in the treatment group
controls. (F (2,26)=51.2, p<0.001).
Intervention: 6 months of individual 2. Paired t-tests indicated a 24% decline
treatment. 2 components-psychotherapy in depression scores from 0-8wks
and medication were offered to all. (time 1=15.7, time 2=11.9, t(27)=6.77,
Therapy began once a week for the first 2 p<0.001) and from 8-24wks (6.7)
months then was reduced to twice a (t(27)=5.26, p<0.001).
month. All were prescribed an 3. 8 subjects continued to score in the
antidepressant based upon their needs and range for major depression. If cases
physician’s decision. with variable treatment adherence
Treatment fidelity: average number of were eliminated 100% of participants
therapy session completed was 14 out of treated no longer had scores in the
Kemp et al. 2004; USA 17 (range from 6 to 17). range of major depression.
Downs & Black score=20 Outcome Measures: Health and mood 4. Community activities: There was a
Pre-post questionnaire (OAHMQ) significant increase in community
Initial N=43; Final N=28 Hamilton Depression rating scale activities from 0-24wks of treatment (F
Community activities checklist (2, 26) = 15.7, p<0.001).
Life satisfaction scale (11 item Likert scale 5. T-tests showed a 40% increase in
looking at satisfaction with family life, activities from 0-8wks (time 1=11.1,
health, economics, and community safety). time 2=15.5, t (27) =3.73, p<0.001).
6. A further increase was noted between
8 and 24 weeks (time 2=15.5, time
3=22.3, t (27)=4.55, p<0.001). The
correlation between the change in # of
depressive symptoms and the change
in the # of community activities was
high (-0.81, p<0.001).
7. Life satisfaction: While a significant
overall effect was observed for life
satisfaction scores (F(2,26)=14.0,
10-10
Score
Methods Outcome
Research Design
Total Sample Size
p<0.001), significant differences in life
satisfaction were noted only between 8
and 24 weeks (time 2=23.5, time
3=28.4, t(27)=5.20, p<0.001).
8. Non-treatment group: Scores on the
depression measure did not change
significantly over time.
Discussion
Kemp et al. (2004) used a pre-post treatment design to assure access to services and avoid
ethical concerns that might arise in a randomized trial. A total of 43 community living adult SCI
survivors were identified as depressed using the Older Adult Health and Mood Questionnaire
and confirmed by clinical interview. Citing distance problems, 15 subjects subsequently
declined participation but served as a “quasi-control” group. The 28 remaining subjects began a
combined 6-month trial of antidepressant medications and individual cognitive behavioural
psychotherapy. The participants were somewhat older but did not differ from non-participants in
terms of level of injury, gender, or race/ethnicity. Medications employed included SSRI and
tricyclic antidepressants. Psychotherapy included education regarding the signs, symptoms and
consequences of depression, cognitive restructuring and encouraging greater community
involvement (average of 14 sessions). During the treatment trial, four subjects discontinued
their medications, one discontinued psychotherapy and three developed medical complications.
After eliminating these eight results, all of the remaining 20 subjects improved, no longer
meeting criteria scores for major depression (12 appeared mildly depressed and eight appeared
non-depressed). Their participation in community activities doubled over the 24 weeks, while
life satisfaction showed improvement, primarily during the final 16 weeks of the program. The
average depression score for non-treated subjects did not change significantly over a 24-month
follow-up period and suggests that untreated depression can become a chronic disorder.
Conclusion
Evidence of the benefits of pharmacotherapy alone and in combination with individual

psychotherapy in the treatment of depression in individuals with SCI is encouraging,
although support is largely from investigations in other populations.
There is level 4 evidence from a single non-RCT study indicating the effectiveness of
psychotherapy combined with pharmacotherapy for treatment of depression in SCI.
The benefits of drug treatment for post-SCI depression are largely extrapolated from studies in
non-SCI populations.
10.5 Other Treatments for Depression following SCI
Strategies to encourage health, reduce secondary complications and consequently support

positive emotional adjustment following SCI have emerged as a source of increasing research
interest. As examples, the following studies review the impact of access to medical care,
10-11
wellness education, regular exercise and massage upon various measures of physical health
and emotional well-being.
Table 10.3 Other Treatments for Depression following SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: both, Age: 19-65yrs, 1. Quality of life components: Exercisers
Time since injury: 1-24yrs. reported less stress, fewer depressive
Treatment: Experimental group symptoms, and greater satisfaction
participated in a progressive exercise with their physical functioning than the
training program twice weekly for 9 mths controls. (p=0.06). Exercisers
on alternative days 90-120 mins starting reported less pain (p<0.01) and a
with warm up, upper extremity stretching, better Q of L (p<0.05).
and 15 to 30 min of aerobic training. As the 2. Performance on the 3-stage arm crank
rate of perceived exertion decreased, protocol was different paraplegics and
workload was increased. Some resistance tetraplegics. (p<0.05).
training took place. 3. No changes in HR and BP between
Outcome Measures: Changes in groups or after 9 months of training.
Hicks et al. 2003; cardiovascular function, muscle strength & 4. Arm crank protocol was different
Canada quality of life. between tetraplegia and paraplegia.
PEDro=8 Training induced increases occurred in
RCT all subjects in the experimental group.
Initial N=43; Final N=32 5. No significant differences in heart rate
response over the 9 mths.
6. Significant group x lesion x time
interactions were found in stages 2
(F(3.48)=4.64), p=0.006 and stage 3
(F(3.48)=3.55, p=0.02), indicating the
tetraplegics had the greatest decrease
in heart rate.
7. Changes in muscle strength:
Experimental group showed changes
in muscle strength over the 9 mth
period. The control group did not
show any significant changes.
Population: Gender: m = 15, F= 5, Age: 1. Interaction effect on STAI scores F(1,
average 39 years, Tetraplegia, Time since 18) = 14.51, p<.01.
injury: minimum 1 year. 2. Massage group had significantly lower
Treatment/Controls: One group received anxiety scores immediately after
a 40 min massage 2 x per week for 5 treatment on the first (t[9] = 5.05,
weeks by a massage therapist while the p<.01) and the last (t[9] = 4.93, p<.01)
Diego et al. 2002; USA other was taught an exercise routine that sessions.
PEDro=8 they performed 2 x per week for 5 wks on 3. CES-D scores obtained on first day vs.
RCT their own. last day assessment by group.
N=20 Outcome Measures: State Anxiety Repeated measures ANOVA showed
Inventory (STAI), Center for a group by day interaction effect F(1,
Epidemiological Studies – Depression 18) = 5.05, p<.05).
Scale (CES-D), Manual muscle test, 4. t-tests revealed greater decrease in
Modified Barthel Index, range of motion. CES-D depression scores for the
massage therapy group (t[9] = 2.30,
p<.05).
Population: Gender m = 5, f = 16; Age: 1. Path A (treatment-exercise to
19-65 years, Years post injury 1-24yrs. outcome) (ΔR2=0.19, p<0.05), and
Latimer et al. 2004;
Treatment/Controls: A nine-month path B (exercise and perceived pain)
Canada
program of twice-weekly small group (ΔR2=0.28, p<0.01) and stress
PEDro=6
exercise sessions of 60-90 minutes (ΔR2=0.23, p<0.01) were significant.
RCT
duration incorporating stretching, arm 2. Path C (mediator-outcome) revealed
ergometry, and resistance exercise under that depression was predicted by
the supervision of volunteers at a university stress (β=0.49, p=0.02) but not by
10-12
Score
Methods Outcome
Research Design
Total Sample Size
health promotion centre. Control subjects perceived pain (β=0.29, p=2.25).
were instructed to continue with their
normal activities and were requested to
refrain from starting a regular exercise
routine during the length of the study.
Monthly health information sessions were
discontinued due to poor attendance.
Outcome Measures: Pain perception (two
items from the Short Form 36-Item Health
Survey - SF-36 scale); Perceived stress
scale (14 items-Likert scale), CES-D scale
(score out of 60).
Population: Gender: m = 23; f = 11; 1. Changes in potential mediators:
complete/incomplete; Age: average 38.6 Stress and Pain--ANCOVA showed
yrs; tiem since injury: average 10.4 yrs that after 3 mths of training the exp
Intervention: Those in the exercise group group showed less stress than
participated in 5 min of stretching, 15 to 30 controls (F(1,27)=6.98,p=0.01) and
min of aerobic arm ergometry exercise and less pain (F(1,27)=4.99, p=0.03).
45 to 60 min of resistance exercise. These 2. Changes in QofL, Physical self
subjects trained twice weekly in small concept and depression: After 3
groups. Participants in the nonexercise months differences appeared between
group were asked to continue their usual the 2 groups for QofL (F(1,27)=8.47,
activities but they were asked not to p=0.007); satisfaction with physical
exercise regularly. function (F(1,27)=20.17, p<0.01);
Outcome Measures: Pain perception (two satisfaction with physical appearance
Ginis et al. 2003; Canada items from the Short Form 36-Item Health (F(1,27)=8.47, p=0.007); depression
PEDro=6 Survey - SF-36 scale); Symptom self (F(1,27)=6.16, p=0.02).
RCT efficacy and perceived control (2 core 3. Stress and pain (mediators of
Initial N=34; Final N=34 items from the Beliefs Scale a modified QofL): Once baseline pain and stress
version of the Arthritis Beliefs Scale); values were controlled for, the 3 month
Perceived Stress Scale (14 items-Likert scores for pain was (R2=.15, p<0.01)
scale). and for stress was (R2=0.12,p<0.01).
These were significant predictors of
baseline adjusted 3 month QofL.
4. Stress and pain as mediators of
depression: Changes in pain but not
stress explained significant variance in
baseline adjusted depression scores
(R2=0.19 & 0.04). Adjusted pain
scores showed variance in the
adjusted 3 month depression scores
(R2=0.19, <0.01).
Population: 43 SCI, M=30 F = 13, mean 1. The intervention group showed
age 47 range 22-80, 28% single, 23% statistically significant improvement
married, 8% divorced, average 14 years after intervention in several areas as
post injury, range 1-49 years, 42% compared to the control group:
paraplegia, 39% tetraplegia, 3% Abilities for Health Practices (SAHP):
ambulatory. Participants recruited from an (p<0.05). Health Promoting Lifestyle
Zemper et al. 2003; USA outpatient clinic or Center for Independent (HPLP-II): (p<0.001). Nutrition (HPLP-
PEDro=4 living. Intervention group was more II subscale): improvement in nutritional
RCT educated and had fewer retirees despite awareness and behaviour (p <0.05)
Initial N=67; Final N=43 random assignment. Stress (HPLP-II subscale): Increased
Intervention: A series of six 4 hr use of stress management techniques
workshop sessions held over a 3 month and decreases in perceived stress
period, promoting health and wellness. (p =.001).
Sessions included lifestyle management, 2. Secondary Conditions (SCS): fewer
physical activity, nutrition, preventing and less serious secondary conditions
secondary conditions, individual coaching (p<0.001) Depression was less though
10-13
Score
Methods Outcome
Research Design
Total Sample Size
sessions, follow-up phone calls during the did not reach significance.
4 months following the workshops. 3. Physical Activity – (self-reported on
Controls participated in pre/post various scales of the HPLP-II):
assessment but received no intervention Increased reported physical activity
Outcome Measures: Health Promoting and improved physical fitness (p =
Lifestyle Profile II, Secondary Conditions 0.001).
Scale, Self-rated Abilities for Health 4. However there was no improvement in
Practices scale (SAHP), Perceived Stress either measured Physical Activity
Scale, Physical activities with disabilities (PADS) or physical fitness measures.
(PADS), Arm crank ergometer testing,
neurologic exam, Body Mass Index (BMI).
Population: Gender: mixed group-with 1. An overall difference between the two
more males, time since injury: mean groups was found (F3,343 = 6.211;
18.44yrs. p=0.0004).
Intervention: Follow-up after initial 2. Medical Follow-up group reported a
rehabilitation was completed addressing significantly higher subjective rating
the secondary conditions post-SCI as well than did the No-F/U group on 3
Dunn et al. 2000; USA as the primary effects of their spinal cord variables: Health (p=0.0068),
Downs & Black score=17 injury. The focus is wellness, health Independence (p=0.005), Absence of
Non-RCT promotion, and illness prevention through a depression (p<0.0001). (Fisher’s
Initial N=371; continuum of coordinated care. protected least significant diff. test).
Final N=371 Outcome Measures: The Secondary 3. A MANOVA showed a main effect on
Surveillance Instrument (SCSI) and the education on health, independence
Check Your Health Questionnaire (CHY) and absence of depression (F15,900
(rating the “absence” of depression. =2.063, p=0.0098). Further analysis
showed that as education increased
subjects reported greater health, and
independence and lower depression.
Discussion
Dunn et al. (2000) reported that veterans approaching 20 years post-SCI with access to medical
follow-up through a specialty comprehensive outpatient program reported better health,
independence, and less depression than a demographically similar (civilian) group without
access to follow-up care. Neither group reported “depression” with sufficient frequency to earn
it a top ten ranking from a list of 40 possible complications. However, those without access to
medical follow-up who did endorse depression considered it of sufficient intensity to rank it
among the ten most severe problems. While the types of secondary complications were similar,
these were less frequent and less severe in those receiving health care. Noting a variety of
methodological concerns that limit conclusions and generalizability, the authors reported that
their findings were consistent with those in other studies (involving SCI and other patient
groups).
Zemper et al. (2003) examined a holistic wellness program for SCI patients. The intervention in
this RCT study involved six group workshop sessions focused upon lifestyle management
(including sexual health and stress management), physical activity, nutrition, and preventing
secondary complications. It also included individual coaching sessions and follow-up phone
calls. Assessments were completed at three times: prior to the series, two weeks following
completion and four months later. Results of this study pointed to improvements in awareness
and behavior in areas of health practices, nutrition, and stress. Also secondary conditions were
fewer and less serious. Reports of depression intensity decreased but did not reach
10-14
significance. Self-reports indicated improvements in physical activity, while more objective tests
showed no improvement in physical fitness.
In a series of Canadian studies, Ginis et al. (2003), Hicks et al. (2003) and Latimer et al. (2004)
reported RCT investigations of sedentary community dwelling SCI adult volunteers who
participated in 3, and later 9 month trials of twice weekly, 60-90 minute sessions of stretching,
aerobic arm ergometry and resistance exercises or a “wait” control condition who were asked to
continue usual activities and refrain from beginning an exercise program. Among other findings,
Exercisers reported less stress, fewer depressive symptoms and greater satisfaction with
physical functioning than did controls. While the average frequency of depressive symptoms in
the intervention group did not vary substantively over the 9 months (and remained below
clinically significant levels), depressive symptoms in the control group increased and the
average exceeded levels considered “at risk” for clinical depression. The authors suggested the
benefits of exercise as offering a prophylactic or stabilizing effect on pain – perhaps reducing
the propensity for flare-ups, and the potential benefits of targeting sources of recurrent pain (i.e.
shoulder pain). Consistent with the Chronic Pain Process Model, a series of regression
analyses the nine-month data revealed that changes in perceived pain mediated changes in
stress, and the change in stress mediated a change in reported depression. It was
recommended that clinicians prescribe exercise as a therapeutic modality for improving and
maintaining well-being among people with SCI.
With a university clinic group of 20 outpatients with quadriplegic injuries, Diego et al. (2002)
compared the effects of a 5-week massage therapy program to those of an independently
performed exercise routine conducted over a similar period. Subjects were stratified according
to range of motion and then assigned to either of the two treatment groups. While both groups
averaged pretreatment depression scores approaching the clinically depressed range, only the
massage therapy group showed a decrease in reported post treatment depression symptoms.
The massage therapy group also reported lower anxiety immediately after treatment on the first
and last days of the protocol. The authors suggested that the significant gains in upper limb
muscle strength and wrist range of motion demonstrated by the massage therapy group may
have contributed to their reported reduction in subjective distress.
Conclusion
Access to medical follow-up for individuals with SCI can lead to reports of better health,
independence, less depression and fewer secondary complications. Wellness education
can assist in encouraging improved health practices and reducing the frequency and
seriousness of secondary conditions, including reported depression. Regular physical
exercise may contribute to a reduction of pain, stress, and depression as well as
potentially offering a prophylactic effect on sources of recurrent pain and in preventing a
decline in quality of life following SCI. Massage may aid in decreasing depression and
anxiety in SCI individuals, with gains in physical strength potentially contributing to a
reported decrease in distress.
There is level 2 evidence from 1 RCT and 1 non-RCT that a wellness and health
promotion program can decrease depression symptoms.
There is level 1 evidence from 3 RCTs that exercise based programs can contribute to
reduced depression symptoms.
There is level 1 evidence that massage therapy can reduce depression symptoms.
10-15
Programs to encourage regular exercise, reduce stress, and improve or maintain health appear
to have benefits in reducing reports of depressive symptoms in persons with SCI.
10.6 Summary
This chapter has summarized research highlighting several promising approaches to the
management of post-SCI depression. The research has also provided some evidence for these
approaches being effective for related therapeutic targets such as anxiety and self-esteem.
When leavened with clinical judgment, this research offers preliminary empirical support to
guide the practitioner in employing evidenced-based therapeutic strategies. Future
investigations, particularly those employing more stringent research designs, will continue to
expand the options and confidence of clinical efforts to assist those individuals who have
sustained spinal cord injuries.
The reader is encouraged to also consider the following topic reviews of depression and SCI
(Consortium for Spinal Cord Medicine 1998; Elliott & Frank 1996; Elliott & Kennedy 2004) and
also, more generally, a recent state of the science review of SCI rehabilitation (Sipski &
Richards 2006).
There is level 2 evidence from 6 non-RCT studies to support the use of small group CBT
based treatment packages to decrease depression symptoms following SCI.
There is level 4 evidence from a single non-RCT study indicating the effectiveness of
psychotherapy combined with pharmacotherapy for treatment of depression in SCI.
There is level 2 evidence from 1 RCT and 1 non-RCT that a wellness and health
promotion program can decrease depression symptoms.
There is level 1 evidence from 3 RCTs that exercise based programs can contribute to
reduced depression symptoms.
There is level 1 evidence that massage therapy can reduce depression symptoms.
10-16
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10-19
CHAPTER ELEVEN
Sexual Health Following Spinal Cord Injury
Stacy Elliott, MD
Kate McBride, RN, BSN, CRRN
Sally Breen, RN, BSN, CRRN
Key Points
Phosphodiesterase Type 5 Inhibitors (PDE5i) can be used safely and effectively for
treatment of erection dysfunction (ED) in men with SCI and are recommended as first
line treatment for ED after SCI.
Intracavernosal (penile injectable) medications (ICI) are very effective for the treatment
of ED in men with SCI and may be used with some precautions.
Topical agents are not effective for treatment of erection dysfunction in men with SCI.
Intraurethral preparations are not effective for treatment of erection dysfunction in

men with SCI.
Vacuum devices and penile rings may be used for treatment of erection dysfunction in
men with SCI.
Penile prostheses, while the last resort, are effective for treatment of erection
dysfunction in men with SCI.
The use of PDE5i for treatment of ED in men with SCI is effective, safe and popular,
followed by the more invasive but highly effective method of intracavernosal injection.
The use of mechanical devices is effective but less popular, and surgical options
should be reserved for cases where other ED treatments fail.
The least invasive sperm retrieval method should be tried first (i.e. vibrostimulation in
the clinic setting to monitor for autonomic dysreflexia) followed with the more
invasive electroejaculation (in clinic or operating room settings). Vibrostimulation is
most successful in men with SCI above T10.
Vibratory stimulus may result in better sperm quality. Antegrade samples appear to
have better sperm motility than that found in retrograde samples.
Bladder management with clean intermittent catheterization may improve semen

quality over indwelling catheterization, reflex voiding or straining.
SCI sperm quality may be improved by processing in able-bodied seminal plasma.
Men with SCI can have realistic expectations of becoming a biological father.
Depending on semen quality and female factors, a progression from intravaginal
insemination to assisted techniques such as intrauterine insemination, in vitro
fertilization (IVF) to IVF plus intracytoplasmic sperm injection (ICSI) is recommended.
Sildenafil may partially reverse subjective sexual arousal difficulties in women with
SCI; however, larger scale studies are required to solidify this conclusion.
Continent urinary diversion in women with tetraplegia results in improved self-image,

quality of life, and enables greater sexual satisfaction.
No conclusive evidence exists to suggest that a comprehensive gynecologic service

improves women’s health behaviors.
Table of Contents
11.1 Introduction ..................................................................................................................11-1
11.2 Sexual Functioning in Men after Spinal Cord Injury.................................................11-1

11.2.1 Male Erectile Response and Enhancement................................................................11-1
11.2.1.1 Phosphodiesterase Type 5 Inhibitors (PDE5i) and Other Oral Agents ....................11-2
11.2.1.2 Intracavernosal (penile injectable) Medications or ICI .............................................11-5
11.2.1.3 Topical Agents .........................................................................................................11-7
11.2.1.4 Intraurethral Preparations ........................................................................................11-8
11.2.1.5 Mechanical Methods - Vacuum Devices and Penile Rings......................................11-8
11.2.1.6 Surgical Penile Implants ........................................................................................11-10
11.2.1.7 Behavioral Management ........................................................................................11-11
11.2.1.8 Summary: Treatment for ED ..................................................................................11-11
11.3 Ejaculation and Orgasm............................................................................................11-12
11.4 Male Fertility ...............................................................................................................11-13

11.4.1 Sperm Retrieval ........................................................................................................11-13
11.4.2 Sperm Quality ...........................................................................................................11-19
11.4.3 Pregnancy.................................................................................................................11-23
11.5 Sexual and Reproductive Health in Women with Spinal Cord Injury....................11-26
11.5.1 Sexual Response......................................................................................................11-26
11.5.2 Gynecological Health ................................................................................................11-26
11.5.3 Fertility/Contraception ...............................................................................................11-27
11.5.4 Obstetrical Health .....................................................................................................11-27
11.5.5 Menopause ...............................................................................................................11-27
11.6 Sexual Adjustment.....................................................................................................11-29

11.6.1 Sexual Behaviour......................................................................................................11-29
11.6.2 Sexual Satisfaction ...................................................................................................11-30
11.7 Summary.....................................................................................................................11-32
References............................................................................................................................11-34
Elliott S, McBride K, Breen S, Abramson C (2006). Sexual Health Following Spinal Cord Injury. In: Eng JJ, Teasell
RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury
Rehabilitation Evidence. Vancouver, p 11.1-11.40.
www.icord.org/scire
Sexual Health Following Spinal Cord Injury
11.1 Introduction
Spinal Cord Injury (SCI) significantly changes motor, sensory and autonomic function affecting
many areas of a person’s life including sexual functioning. Sexuality is an integral part of being
human. While changes to sexual function usually refer to changes in arousal (erection in men,
vaginal lubrication and accommodation in women), ejaculation in men, and orgasm in men and
women, sexuality is also inclusive of the psychological and physiological effects of loss of motor
and sensory function, bladder and bowel control and alterations to body image and sexual self
esteem. Furthermore, in men with SCI, fertility is affected not only by altered erection and
ejaculatory function, but also by changes to semen quality. The impact of an SCI on sexual
functioning depends on the location and severity of the injury.
In 2004, Anderson surveyed 681 participants (approximately 25% were female) asking what
“gain of function” was most important to their quality of life. For the majority of paraplegics,
regaining sexual function was rated the highest priority. Quadriplegics identified regaining
sexual function as the second highest priority preceded only by regaining hand and arm
function.
In contrast to the priority given to sexuality by people with SCI, the medical and research
community has not done a body of sufficient research that would result in evidence-based
information to guide clinical sexual health practice (Biering-Sorensen & Sonksen 2001; Deforge
et al. 2005). Several authors have highlighted the lack of attention given to this area and the
resulting dissatisfaction within the SCI community (Tepper 1992; Tepper et al. 2001; Anderson
2004; Kennedy 2006). Current sexual health clinical practice has limitations since it is primarily
based on results from case reports and observational studies with some areas (such as erection
dysfunction in men with SCI) having a larger body of evidence.
This review attempts to summarize the literature and to provide some recommendations for
sexual and reproductive clinical practice based on the evidenced-based literature. In areas
where evidence is lacking, recommendations based on case reports, opinions and observational
studies are also indicated. The clinician can therefore weigh the recommendations separately.
11.2 Sexual Functioning in Men after Spinal Cord Injury
11.2.1 Male Erectile Response and Enhancement
In general, the majority of men can attain an erection after SCI either though the psychogenic
(via T11 – L2 pathways) or reflexogenic pathways (S2- S4 reflex), depending on the level and
completeness of injury. However, these erections are often not reliable or adequate for sexual
intercourse since there may be difficulties with maintenance of the erection (Alexander et al.
1993; Courtois et al. 1993). Treatments in the area of erectile dysfunction (ED) for men with SCI
have advanced in the last several years with the ability to take phosphodiesterase type 5
inhibitors (PDE5i) in the form of a pill. However, other methods are still being utilized when the
pill is not effective or affordable. There is stronger evidence for treatment of erectile dysfunction
than other areas of sexuality and SCI, primarily due to the advent of the PDE5i and their
effectiveness in this population.
11-1
Therapies for erectile dysfunction (ED) include:
1. Oral medications which indirectly relax the penile smooth muscle and enhance an
erection attained from sexual stimulation, such as the oral phosphodiesterase V
inhibitors [PDE5i] Viagra®, Levitra® and Cialis®
2. Injectable medications which directly relax the penile smooth muscle creating an
erection (prostaglandin E1 penile injections [compounded or Caverject®] and other
injectable combinations of papaverine and phentolamine)
3. Topical agents for penile smooth muscle relaxation (prostaglandin, minoxidil and
nitroglycerine)
4. Intraurethral preparation of prostaglandin E1 (MUSE®)
5. Mechanical methods such as vacuum devices and penile rings
6. Surgical penile implants
7. Behavioral methods (perineal muscle training).
All methods except penile implants are clinically reversible. The use of implantable sacral
stimulators to assist an erection via stimulation of S2 and S3 anterior roots has not been well
explored due to its limited use in those with complete injuries (Brindley et al. 1989).
11.2.1.1 Phosphodiesterase Type 5 Inhibitors (PDE5i) and Other Oral Agents
Erection is initiated by smooth muscle relaxation of the corpora cavernosa (erectile bodies) of
the penis, which is dependant on the nitric oxide- cyclic quanosine monophoshpate [cGMP]
pathway. The PDE5i are selective inhibitors of type 5 (cGMP specific) phosphodiesterase,
which in turn allows for cGMP to not be broken down as quickly, prolonging and enhancing the
erectile response. Apomorphine is a dopamine-receptor agonist important in the control of
sexual functioning whereas 4 –aminopyridine is a K+ channel blocking agent noted for
increasing neurotransmitter release at neuroneuronal sites.
Table 11.1 Effects of Phosphodiesterase Type 5 Inhibitors (PDE5i) and Other Oral Agents
Score
Methods Outcome
Research Design
Total Sample Size
Population: 418 men, treatment n= 207, 1. EF domain scores in the vardenafil
placebo n=211, age range: 18-80 yrs. group improved (22.0 from 11.6)
Treatment: Randomized to 12 wks of compared to the placebo group
vardenafil (10mg for the first 4 wks) or (13.5 from 12.1) (p<0.001).
placebo. 1 tablet 1 hr before each attempt 2. Over 12 weeks of treatment, mean
Giuliano et al. 2006; USA
at intercourse, not more than 1/day. At wks per-patient penetration (76% vs
PEDro=9
4 and 8, dose maintained or titrated ↑ or ↓ 41%), maintenance (55% vs 22%),
RCT
1step (to 5 or 20 mg). and ejaculation success rates (19%
N=418
Outcome Measures: efficacy and vs 10%) on vardenafil were
tolerability of vardenafil, Erectile Function significantly greater vs the placebo
Domain Scores (from International Index of group (p<0.001 for all measures).
Erectile Function), Sexual Encounter
Profile.
Population: 27 men, treatment n=12, 1. 75% on sildenafil & 7% on placebo
placebo n=14, mean age: 32-34 yr, injury reported that treatment improved
Derry et al. 1998; UK
level: T6-L5, ASIA: A-D but must have erections (p=0.0043).
PEDro=9
partial reflexogenic erection to 2. Significant satisfaction
RCT
vibrostimulation. improvement with sex life reported
Initial N=27
Treatment: Randomized to receive 50mg by sildenafil group (p=0.012).
Final N=26
of sildenafil or placebo not more than 3. Mean # of grade 3-4 erections was
1/day, approx 1 hr before sexual activity. 1.8/wk for sildenafil group, 0.4/wk
11-2
Score
Methods Outcome
Research Design
Total Sample Size
Outcome Measures: efficacy and safety of for placebo patients (p=0.0761).
sildenafil, sexual function questionnaire.
Population: age range 21-49yrs, ASIA A: 1. Part I: 65% had erections (defined as
14, B: 3, C: 5, D: 5, level of injury: T6-L5. >60% rigidity) on sildenafil, 8% with
Treatment: Single dose sildenafil 50mg or placebo.
Maytom et al. 1999; UK matching placebo (part I) in random order 2. Part II: 75% on sildenafil & 7% on
PEDro=8 followed by at least a 3 day washout period placebo reported improved erections
RCT before cross-over treatment (part II) for 28 (p<0.005).
N=27 days. 3. Sexual Satisfaction: the sildenafil
Outcome Measures: efficacy and safety of group were more satisfied with their
sildenafil, duration & rigidity of erections, sex lives (p=.001).
self-report diary data.
Population: 30 men, age range: 21-60 yrs, 1. Tadalafil allowed normal sexual
6-12 months post-injury. functioning up to 24hr post dosing
Treatment: Randomized to sildenafil (4 compared to sildenafil (p<0.01).
Del Popolo et al. 2004;
doses 50mg) or tadalafil (4 doses 10 mg).
Italy
To attempt intercourse on 4 separate
PEDro=7
occasions: within 4h of 1st tablet, 12h of
RCT
2nd tablet, 24h of 3rd and 24-36h after 4th
N=30
tablet. Cross-over after 2 wk wash-out.
Outcome Measures: safety, time/duration
effectiveness, Sexual Encounter Profile.
Population: 178 men, average age: 38 1. IIEF: 83% reported improved erections
yrs, 53% complete SCI. with sildenafil vs. 12% on placebo
Treatment: 25, 50, or 100mg of sildenafil (p<0.0001).
Giuliano et al. 1999; UK or placebo 1hr pre-sexual activity for 6 2. Ability to achieve & maintain erection,
PEDro=7 weeks followed by a 2-week washout satisfaction of sexual intercourse, &
RCT before cross-over. satisfaction of sexual relationship with
(cross-over) Outcome Measures: efficacy and safety of partner significantly improved with
N=178 oral sildenafil, International Index of sildenafil over placebo (p<0.0001).
Erectile Function (IIEF), event log data. 3. Ejaculation and orgasm frequency
improved in sildenafil group over
placebo (p=0.0012).
Population: 26 men, incomplete SCI, 19 1. No significant results related to
tetratplegic, 10 paraplegic, mean age: 40.6 sexual function.
yrs, level: C4-T12. 2. 5 fampridine-SR patients reported
Potter et al. 1998; USA
Treatment: Fampridine-SR or placebo erection improvement; however 4
PEDro=7
12.5mg for first week, 17.5 mg for 7 days, 1 placebo patients also reported
RCT
week washout before cross-over. erection improvement.
Initial N=29
Outcome Measures: safety and efficacy of
Final N=26
oral Fampridine-SR, patient satisfaction,
quality of life, sensory & motor scores,
Ashworth.
Population: 178 men, SCI, age range: 19- 1. ↑ in overall satisfaction with sex life
63 yrs, mean age: 38 years. (49% over baseline).
Treatment: Sildenafil upward and 2. Sexual relationship with partner (↑’d
downward titration with variable dose of 34% over baseline) with Viagra.
Hultling et al. 2000;
25mg 1hr pre-sexual activity to a maximum 3. “Impact of erectile problems”
Australia
of 100mg. Doses adjusted by 25mg/wk assessing emotional distress
PEDro=6
during 6-wk period. Randomized to 6-wk improved 23% above baseline.
RCT
flexible dosing, 2 wk washout, then 6-wk
(cross-over)
placebo or vice versa.
N=178
Outcome Measures: efficacy of Sildenafil
citrate, IIEF (Q13,14), Medical Outcomes
Survey, SF-12, Psychological General
Well-Being Index .
11-3
Discussion
Just under 1000 men have been investigated in seven RCTs and two non-RCT studies with the
use of oral agents for ED in men with SCI. The evidence supports the use of PDE5i as the first
line of treatment in men with ED secondary to SCI. Random effects pooled estimate of efficacy
of Viagra® was 79%, with the ranges appearing to be anywhere from 75% - 85% (Sanchez
Ramos et al. 2001; DeForge et al. 2004a, 2004b). In addition, significant increases in
satisfaction with sexual life (49% over baseline) and sexual relationship with partner (34%) is
noted with the use of sildenafil (Hultling 2000). The one study on vardenafil that has been done
(Guiliano et al. 2006) was a large placebo – controlled randomized multi-centered trial of men
with SCI (n=418) showed 76% ( vs. 41% with placebo) had erections firm enough for
penetration, and 59% felt these erections lasted for satisfactory intercourse (vs. 22% with
placebo). One small comparative study of sildenafil and tadalafil use (Del Popolo et al. 2004) in
men with SCI was found that tadalafil allowed the majority of men to achieve normal sexual
functioning up to 24 hours post dosing compared to sildenafil. Of interest, two patients with low
motor neuron incomplete lesions, did not respond to sildenafil but did respond to tadalafil, but
other than that, the advantage of tadalafil over sildenafil in terms of duration of action was not
influenced by degree or level of lesions in SCI men.
Headache (10% - 15%) and flushing (6 – 10%) were noted to be the most common side effect
for men with SCI using the PDE5i, followed by dyspepsia, nasal congestion, dizziness and
visual disturbances.
Two non-RCT studies trialed other oral medications for men with SCI are mentioned here to
point out their relative ineffectiveness as compared to the PDE5i. Apomorphine, relatively
successful in men without SCI, was used for 22 men with SCI and was noted to have an overall
low rate of response for erectile dysfunction; several side effects (headache, nausea, tiredness)
were noted in 41% (Strebel et al. 2004). Potter et al. (1998) looked at 26 men with incomplete
SCI in an exploratory trial of fampridine-SR. Although the Global Assessment of Patient
Satisfaction statistically improved, only five patients (19%) on fampridine-SR had stronger, more
frequent and more sustainable penile erections, however, four patients on placebo also reported
improved erections.
Conclusion
There is level 1 evidence (from 7 RCTs) that supports the use of PDE5i as a safe and
effective treatment for erection dysfunction in men with SCI.
Phosphodiesterase Type 5 Inhibitors (PDE5i) can be used safely and effectively

for treatment of erection dysfunction (ED) in men with SCI and are recommended as
first line treatment for ED after SCI.
11-4
11.2.1.2 Intracavernosal (Penile Injectable) Medications or ICI
Table 11.2 Effects of Intracavernosal (Penile Injectable) Medications or ICI

Score
Methods Outcome
Research Design
Total Sample Size
Population: 28 men, age range: 16-60 yrs. 1. Erectile index of papaverine
Treatment: Randomized to transdermal significantly higher than that of
Renganathan et al. 1997; nitro-glycerine or Intracavernous injection nitroglycerine.
India of papaverine, two week washout, cross- 2. 93% who received papaverine had
PEDro=4 over. a complete response vs. 61% who
RCT Outcome Measures: effectiveness of received nitroglycerine (P=0.004).
N=28 transdermal nitroglycerin vs. 3. 32% of patients had complications
intracavernous injection of papaverine. with papaverine vs 21% with
nitorglycerine.
Population: 101 men, SCI, 65 paraplegia, 1. Satisfactory erection sufficient for
36 tetraplegia, age range: 20- 51 yrs, penetration was possible in 98
lesion level: C4-L4. patients.
Kapoor et al. 1993; India Treatment: intracavernosal injection (ICI) 2. 78 subjects had good erection
Downs & Black score=17 of papavarine hydrochloride. within 10 minutes, 13 within 20
Post-test Outcome Measures: erectile rigidity, minutes, 7 within 30 minutes.
N=101 duration of erection. 3. Older patients required higher
dose.
4. Erections lasted from< 1 hour to >4
hours.
Population: 37 men, mean age: 43.7 1. 28 patients (76%) responded to
years, age range: 24-72, level: C3-L4. injection.
Treatment: intracavernosal injection (ICI) 2. 21% ejaculated during >50 % of
of papaverine & prostaglandin E1 (PGE1). sexual encounters.
Dosage was titrated until satisfactory 3. At 3 months: 77% were moderately
Zaslau et al. 1999; USA
erection obtained. or extremely satisfied with therapy;
Downs & Black score: 15
Outcome Measures: safety & efficacy of 4. 85% rated their intracavernosal
Pre-post
intracavernosal injection therapy, injection -produced erections as
N=37
satisfaction. good or excellent.
5. 60% on intracavernosal injection
reported almost always or always
being able to have successful
intercourse.
Population: 40 SCI (116 vascular based 1. SCI patients required lower doses,
impotence), mean age: 34.7 yrs, complete: used injections less frequently, had
Lloyd & Richards 1989; 26, incomplete: 14. longer lasting, better quality
USA Treatment: injection of intracavernous erections than patients with
Downs & Black score=12 phentolamine and papaverine. vascular based impotence.
Pre-post Outcome Measures: complications, 2. Minor complications occurred
N=40 dosage, quality of erection. frequently in both groups.
Population: 58 men, age range: 19-68yrs, 1. Rigid erections in 45 patients

44 complete, 14 incomplete, 19 cervical, 32 (90%).
thoracic, 17 lumbar, (53%) dropped out. 2. 53% of participants dropped out of
Bodner et al. 1992; USA
Treatment: 7.5mg papaverine, titrated to program, usually after 1stinjection
dosage that produced adequate erection, or during titration period.
Post-test
evaluated every week during titration 3. Main complication was prolonged
N=58
period, then every 2 months. erection necessitating aspiration
Outcome Measures: erectile rigidity, and epinephrine injection.
complications.
11-5
Score
Methods Outcome
Research Design
Total Sample Size
Population: 66 males, age range: 18-61. 1. 52 patients had functional
Treatment: intracavernsoa injection of erections.
Sidi et al. 1987; USA papaverine hydrochloride & phentolamine 2. In response to plain papaverine
Downs & Black score=11 mesylate (n=22), papaverine hydrochloride 20/30 responded with functional
Post-test alone (n=44). erections.
N=66 Outcome Measures: erection quality. 3. 4 patients had sustained erections
that had to be drained.
4. 71% continued to use method.
Population: 22 men, age range: 18-52. 1. 20/22 were able to achieve an erection
Treatment: 20-30mg papaverine. with complete rigidity with a mean
Beretta et al. 1986; Italy Outcome Measures: effectiveness of duration of 4.1 hrs.
Downs & Black score=7 papaverine. 2. 20 patients who were successful at
Post-test intercourse were offered training in self
N=22 injection, but only 10 accepted.
3. 7/22 lasting >5 hrs controlled with
ethilefrine and aspiration of corpus.
Discussion
There is only one RCT study (Renaganathan et al. 1997) in this area and it is a comparative one
looking at two forms of administration, intracavernosal papaverine and transdermal
nitroglycerine. Patients who received papaverine were statistically more likely to have a
complete response (erection) than those patients who received nitroglycerine.
There are other non-RCTs of clinical importance since they underscore that intracavernosal
(penile injectable) medications (ICI) are more efficacious and provide a firmer erection than
PDE5i and that there is a dose response to the efficacy of ICI. The most common side effects of
ICI are transient, such as pain and swelling at the injection site. The more serious side effect of
priapism (or prolonged erection) can be treated with irrigation (blood removal) of cavernosal
bodies with alpha-adrenergic drugs (Sidi et al. 1987).
One series of 58 patients using papaverine or papaverine/phentolamine combinations

demonstrated 90% rigidity (Bodner et al. 1992). Sustained erections were treated with aspiration
and injection of a dilute epinephrine solution. Lowered frequency of injections and lowered
doses of medications reduced the risk of subtle plaque development, a complication of scarring
of the tunica albuginia. In general, lower doses of ICI were required in neurogenic patients, but a
combination of SCI and another comorbidity (diabetes, hypertension) decreased the efficacy of
injections (Sidi et al. 1987; Zaslau et al. 1999). Complication rates of ICI have been reported in
the 15-31% range (Lloyd & Richards 1989; Dietzen & Lloyd 1992) with the caveat that
accumulated experience of clinicians and dosage adjustments reduce this substantially. Prior to
the availability of PDE5i, ICI had a high acceptance rate (70%) in the SCI population (Sidi et al.
1987; Watanabe et al. 1996).
Conclusion
There is level 2 evidence that supports the use of ICI as treatment for erection
Intracavernosal (penile injectable) medications (ICI) are very effective for the treatment of ED
in men with SCI and may be used with some precautions.
11-6
11.2.1.3 Topical Agents
Table 11.3 Effects of Topical Agents

Score
Methods Outcome
Research Design
Total Sample Size
Population: 13 SCI, 7 non-SCI, age range: For SCI patients (n=12)
19-73 yrs, range of duration ED: 0.6-27 yrs. 1. 3 patients with papaverine gel had
Kim et al. 1995; USA Treatment: papaverine gel or placebo gel, full erections, but full erections also
Downs & Black score=15 dose range: 133-500mg. occurred with placebo gel.
Prospective Controlled Outcome Measures: safety and efficacy of
Trial topical papaverine gel.
N=20
Population: 18 males, age range: 19-65 1. Papaverine injections ↑ median

yrs, level: C7-L3, 15 thoracic. rigidity 77% (range 30-100%).
Treatment: minoxidil spray, papaverine Rigidity was significantly less with
injection, or vacuum constriction device minoxidil (p<0.05).
(VCD). 2. Vacuum constriction device
Outcome Measures: erectile response. changed rigidity a median of 57%
Chancellor et al. 1994;
(range 30-80%).
USA
3. No difference between vacuum
constriction device and papaverine.
Post-test
4. Patient subjective rating scale was
N=18
significantly lower for minoxidil than
vacuum constriction device or
papaverine (p<0.05).
5. Physicians subjective ratings were
other treatments (p<0.05).
Population: 15 men, age range: 20-38 yrs, 1. 4 patients had complete responses, 5
Level: T2-L5. had partial, 6 had no response.
Beretta et al. 1993; Italy Treatment: Prostaglandin E1 and 2% 2. 9 patients with complete/partial
Downs & Black score=10 Minoxidil solution. response continued to use minoxidil at
Post-test Outcome Measures: erectile response. home for 1 month.
N=15 3. 26.6% obtained an erectile response
sufficient for vaginal penetration.
Population: 17 men, age range: 19-51 yrs, 1. 5 patients had complete responses
level: C2-L4, 13 complete, 4 incomplete. (full rigidity), 7 had partial
Treatment: Transiderm-Nitro plaster responses (some rigidity &/or
Sonksen et al. 1992;
(10mg/24hrs), which contains 50mg increase in penile circumference),
Denmark
glyceryli nitras. & 5 had no response (no noticeable
Outcome Measures: erectile response. erection).
Post-test
2. Erection duration (complete
N=17
response): 20-45 min.
4. 5 (29%) had erections sufficient for
vaginal penetration.
Discussion
There are no RCT studies in this area. Topical agents such as minoxidil, PGE1, papaverine and
nitroglycerin, although generally safe and act as vasodilators, were not found to be effective
beyond 25 – 40%, most likely due to their inability to be absorbed well through the tunica
albuginia. One study found topical minoxidil spray to have no effect. The move to use of topical
agents does not seem to be progressive in the SCI population likely due to the efficacy of PDE5i
and ICI.
11-7
Conclusion
There is level 2 evidence that shows that the use of topical agents is not effective as
treatment for erection dysfunction in men with SCI.
Topical agents are not effective for treatment of erection dysfunction in men with SCI.
11.2.1.4 Intraurethral Preparations

Table 11.4 Effects Intraurethral Preparations
Score
Methods Outcome
Research Design
Total Sample Size
Population: 15 men age range: 30-70 yrs, 1. 12 achieved grade 1-3 erections, 3
7 tetraplegia, 8 paraplegia. achieved grade 4 erections.
Bodner et al. 1999; USA Treatment: intraurethral alprostadil (125- 2. All could achieve grade 5 erections
Downs & Black score=12 1000µg); MUSE (application system for with intracavernosal injections
Post-test medicated transurethral system for delivery therapy. The three that achieved
N=15 of alprostadil to the male urethra). gr.4 erections all tried MUSE at
Outcome Measures: efficacy of home and were dissatisfied.
intraurethral prostaglandin E1.
Discussion
There are no RCT studies in this area. In a series of 15 SCI, Bodner et al. (1999) found that the
use of intraurethral alprostadil (PGE1) was ineffective in sustaining adequate erections and
without the penile ring to sustain any increases in penile circumference (tumescence), patients
experienced hypotension from the medication. Based on the evidence to date, such studies do
not seem worth pursuing.
Conclusion
There is level 4 evidence that suggests that the use of intraurethral preparations is not
effective as treatment for erection dysfunction in men with SCI.
Intraurethral preparations are not effective for the treatment of erection dysfunction
in men with SCI.
11.2.1.5 Mechanical Methods - Vacuum Devices and Penile Rings
Table 11.5 Effects of Vacuum Devices and Penile Rings

Score
Methods Outcome
Research Design
Total Sample Size
Population: 30 men, 10 paraplegia, 7 1. 17 (57%) of 30 patients bought
paraparesis, 7 hemiplegia, 2 quadriplegia, vacuum tumescence constriction
Heller et al. 1992; Israel 2 multiple sclerosis, 2 autonomic therapy device.
Downs & Black score=14 neuropathy. 2. 83% very satisfied at follow-up.
Pre-post Treatment: pilot trial of vacuum 3. 53% using device at follow-up.
N=30 tumescence constriction therapy (VTCT).
Outcome Measures: device usage,
11-8
Score
Methods Outcome
Research Design
Total Sample Size
frequency of coitus.
Population: 20 SCI males age range: 21- 1. Snap gauge assessment correlated
65 yrs, level: C4-L2. with subjective reports of erectile
Zasler & Katz 1989; USA
Intervention: each patient was custom capability (r=0.92, p<0.001).
fitted for the synergist erection system. 2. n=15 men and n=14 women rated
Post-test
Outcome Measures: efficacy of the the quality of coitus as very good to
N=20
synergist erection system. excellent compared to previous
best since injury (r=0.78 p<0.001).
Population: 20 men, SCI, age range: 20- 1. At 3 months, 93% of the men and
50 yrs, 13 complete, 7 incomplete. 83% of the women reported rigidity
Treatment: use vacuum erection device sufficient for vaginal penetration.
(VED). 2. At 6 months, 14 couples were
Denil et al. 1996; USA
Outcome Measures: safety and efficacy of regularly using device at least 1/wk.
vacuum erection device, patient & partner 3. At 6 months, 41% of the men and
Post-test
satisfaction. 45% of the women were satisfied
N=20
with the device.
4. 60% of men and 42% of women
indicated an improvement of the
sexual relationship.
Population: 18 males, age range: 19-65 1. Vacuum constriction device
yrs, level: C7-L3, 15 thoracic. changed rigidity a median range of
Treatment: minoxidil spray, papaverine 57% range (30-80%).
injection, or vacuum constriction device 2. No difference between vacuum
(VCD). constriction device and papaverine.
USA
Outcome Measures: erectile response. 3. Patient subjective rating scale was
Post-test
vacuum constriction device or
N=18
papaverine (p<0.05).
4. Physicians subjective ratings were
other treatments (p<0.05).
Discussion
There are no RCT studies in this area, but level 4 pre-post studies noted that the vacuum device
is an acceptable alternative for ED therapy in men with SCI who may not tolerate other methods
and whose hand function can warrant its use (unless a partner applies it). Premature loss of
rigidity, petechiae and penile skin edema were unwanted side effects. The maximum vacuum
pressure should not exceed 250 mmHg (to prevent petechiae and ecchymosis) and the penile
ring placed at the base of the penis to trap blood does not remain for more than 30 – 45
minutes. An alternative vacuum device (Synergist) is a vacuum device within a silicone sheath
that remains on the penis that can be used for longer periods of time due to the absence of
constricting bands and a much lower vacuum pressure (8 – 20 mmHg), and which the majority
of patients found satisfying. Denil et al. (1996) reported on 20 couples where 93% of men with
SCI and 83% of their female partners reported sufficient penile rigidity for intercourse obtained
by the use of a vacuum device after 3 months, but by 6 months less than half the couples were
satisfied with the device. Most side effects were temporary and minor.
Conclusion
There is level 4 evidence that supports the use of vacuum devices and penile rings as
11-9
Vacuum devices and penile rings may be used for treatment of erection dysfunction
in men with SCI.
11.2.1.6 Surgical Penile Implants
Table 11.6 Effects of Surgical Penile Implants

Score
Methods Outcome
Research Design
Total Sample Size
Population: 63 men, SCI. 1. 53 patients with a semi-rigid
Treatment: penile implantation of semi- implant, 44 currently have
rigid device or Mentor inflatable prosthesis. functional prosthesis (83% overall
Outcome Measures: penile implantation success rate).
Collins & Hackler 1988;
functionality. 2. 10 patients received inflatable
USA
penile prostheses: 4 were lost, 2
had successful reimplantation.
Post-test
3. Overall complication rate in the 63
N=63
patients=33% (lost prosthesis).
4. After reimplantation, 52/63 patients
had functional device, resulting in
82% ultimate success rate.
Green & Sloan 1986; Population: 40 men, age range: 21-60 yrs, 1. 31 patients have intercourse
USA ASIA A: 31, B-D: 9. regularly and pleased with decision
Downs & Black score=10 Treatment: penile prosthesis. to have device.
Observational Outcome Measures: sexual 2. 4 patients dissatisfied, all had semi-
N=40 questionnaire. rigid implant.
Discussion
There are no RCT studies in this area. In a systematic review of male erectile dysfunction
following SCI, Deforge et al. (2006) examined 5 case-series reports on the use of penile
prosthesis in men with SCI and found that there was a high level of satisfaction amongst the
users and that they were helpful for condom drainage placement. The negatives were that those
men who were explanted were no longer candidates for other treatment options due to the
extent of the penile damage. Penile implantation is reserved now only for failure of the
reversible ED therapies or for those men who find reversible alternatives unacceptable.
However, implantable devices have improved in design and a reduced infection rate has been
noted over the last 5 – 10 years.
Conclusion
There is level 4 evidence that suggests that penile prostheses should not be used as
treatment for erection dysfunction (ED) in men with SCI unless there is a failure of all
other ED treatments.
Penile prostheses, while the last resort, are effective for treatment of erection dysfunction
in men with SCI.
11-10
11.2.1.7 Behavioral Management
Table 11.7 Effects of Behavioral Management

Score
Methods Outcome
Research Design
Total Sample Size
Population: 10 men, age range: 25-52 yrs. 1. Perineal training resulted in
Courtois et al. 2001; Treatment: Perineal training combined significant differences in
Canada with biofeedback and home exercises. tumescence.
Downs & Black score=10 Outcome Measures: tumescence (penile 2. After treatments were stopped
Pre-post circumference) there was a ↓ in penile
N=10/8 circumference that was statistically
significant from the treatment ↑.
This study (n=10) is worth mentioning since it focuses on the relatively successful use of
perineal muscle training exercises to improve penile rigidity in those men with some capacity for
voluntary pelvic floor contraction. The approach of maximizing the physiological potential before
introducing pharmacological or mechanical intervention is an approach often forgotten in
rehabilitation (Elliott 2003).
Conclusion
There is level 4 evidence that suggests that perineal training may result in improvement
in erectile function in men with SCI who have some voluntary pelvic floor muscle
contraction.
Perineal training may enhance erectile function in men with SCI who have some voluntary
pelvic floor muscle contraction.
11.2.1.8 Summary: Treatment for ED
There is a wide discrepancy and little standardization, except in the area of PDE5i, between
various research designs and how outcome measures are attained in the area of treatment of
ED in men with SCI. Little in the way of RCT studies have been done, mainly due to the lack of
financial incentive to do large trials in this population on ED therapies that will not have a large
market (except PDE5i use). That said, to the individual with SCI, the differences between the
efficacy, practicality and safety of each method is very relevant.
In summary, the effectiveness of all 3 of the PDE5i in the SCI population is generally excellent
(about 80% success). The longer acting tadalafil may be advantageous in those men where
Viagra failed or for those wishing for more spontaneous activity (longer action of up to 24–36
hours versus 1-4 with Viagra and Levitra). In general, PDE5i works best on those with upper
motor neuron lesions (UMN) versus those with lower motor neuron lesions (LMN) whose nitric
oxide release at the nerve end terminal may not be as consistent. Effectiveness of sildenafil in
men with LMN is about 50% (Del Popolo et al. 2004). Short term side effects are approximately
the same as with able–bodied (headache and flushing between 10 – 15%, dyspepsia about 5%
and visual disturbances noted in higher doses), but caution should be used in differentiating the
side effects of the PDE5i with those seen with autonomic dysreflexia (AD) - especially the
presence of headache so as not to ignore the symptoms of AD. The use of PDE5i is
contraindicated in men taking nitrates, and should be used with a caution in men with
11-11
symptomatic hypotension due to its mildly hypotensive effect. Long term side effects have not
been evaluated in the SCI population. At the present time, there is not enough evidence to
suggest either sublingual Apomorphine or oral fampridine-SR are useful in the SCI population
for the treatment of ED. Injectable medications have better efficacy (90%) than PDE5i, but are
more invasive, and have a higher risk of short term side effects, especially prolonged erection in
the SCI population (Deforge et al. 2004a). Careful teaching and titration dosing can virtually
eliminate this problem. PGE1, papaverine and phentolamine all require refrigeration; PGE1 is
the least stable at room temperature (Deforge et al. 2004b). Prolonged use of papaverine is
more likely to cause cavernosal fibrosis due to its low ph of 3-4, and therefore is more
commonly used in conjunction with other medications (commonly papaverine, phentolamine or
atropine). All injection medications can cause subcutaneous hematomas, cavernosal or tunica
fibrosis (usually small and reversible with time) or mild edema. The use of intraurethral
prostaglandin (MUSE®) and topical preparations have not been that successful and are rarely
used. Penile implant surgery is reserved now for those men with failed or unacceptable
reversible methods (ICI, Oral therapy or vacuum device), although some men with difficulties
with external drainage devices may find penile implants helpful.
Conclusion
Oral PDE5i are the first line treatment for ED in men with SCI, with the more invasive but
successful use of ICI being used most often in men who do not respond to the oral
medications. Mechanical devices such as vacuum devices and rings are effective but not
as popular. Surgical prostheses are reserved for refractory cases.
The use of PDE5i for treatment of ED in men with SCI is effective, safe and popular, followed
by the more invasive but highly effective method of intracavernosal injection. The use of
mechanical devices is effective but less popular, and surgical options should be reserved for
cases where other ED treatments fail.
11.3 Ejaculation and Orgasm
Very little has been written about ejaculation and orgasmic sexual satisfaction outside of the
fertility literature. There is one recent study that has explored the responses of men with SCI
and their partners to these changes (Sipski et al. 2006).
There are no RCT studies in this area, as expected. All reports of ejaculation and orgasm in the
non-fertility literature are self-reports from surveys, with only one recent study (Sipski et al.
2006) performing laboratory evaluation. However, orgasm is not defined and only self described
by subjects as either similar or different compared to their pre-injury experience.
Neurophysiologically, orgasm is not defined. Orgasm may be cerebrally, body or genitally
generated, and is an area of much needed research.
A study by Phelps et al. (1983) reported orgasmic self-report of 42% in 50 male SCI veterans
with various levels and completeness of SCI. Alexander et al. (1993) showed in their series that
the majority of 38 men with SCI could not ejaculate, with the exception of incomplete
paraplegics of whom 75% could ejaculate in some fashion. They reported that 50% of the
quadriplegics and 25% of paraplegics with complete injuries reported they could have some sort
of orgasm, and of those that could, 38% of quadriplegics and 67% of paraplegics reported it was
not accompanied by ejaculation. For the men with incomplete injuries, 66% of the quadriplegics
11-12
said they could have orgasm (of which 50% said it was accompanied by ejaculation) and 75% of
the paraplegics reported they could have some kind of orgasm that was always accompanied by
ejaculation. There was a significant correlation between the ability to have an orgasm and
ejaculation, as was the ability to ejaculate and having an erection firm enough for penetration.
Similarly, a recent laboratory study of 45 men with SCI and 6 able-bodied controls (Sipski et al.
2006) demonstrated that 78.9% of the men with incomplete injuries and 28.0% of those with
complete injuries achieved orgasm in the laboratory setting (historically, these men reported
post-injury orgasmic ability to be 84.2% and 50% respectively). Independent significant
predictors of orgasm in the laboratory were completeness of injury and prior history of orgasm
post-injury. Those men with lower motor neuron lesions affecting the sacral segments (n=4) had
no historic or laboratory experience with orgasm. They also reported that although orgasm and
ejaculation were likely to occur together there was a disconnect between the presence of
orgasm and the presence of ejaculation.
11.4 Male Fertility
Male fertility after SCI is affected by the functional difficulties of erection and ejaculation. Few
men with SCI are able to ejaculate and require medical assistance to obtain sperm. This sperm
is then used for intravaginal, intrauterine or other assisted reproductive technology (ART).
Although most of the male fertility studies describe issues of retrieval, sperm quality,
reproductive technology, pregnancy and live births within a single study, the tabled studies have
been sorted into the topics of sperm retrieval, sperm quality and pregnancy based on the
primary focus of the paper, although overlap does occur.
11.4.1 Sperm Retrieval
The two methods of sperm retrieval most commonly used are vibrostimulation (VS) and
electroejaculation (EE). VS is a specialized vibrator placed on the penis to induce reflex
ejaculation, whereas EE uses a rectal probe to deliver electrical current to the periprostatic
nerves, eliciting seminal emission. Semen can only be attained by EE in the first months after
injury since spinal shock renders VS ineffectual.
Table 11.8 Sperm Retrieval

Score
Methods Outcome
Research Design
Total Sample Size
Population: 34 couples (males were SCI), 1. Electroejaculation was successful in
21-37 yrs (females), 28-46 yrs (males), 32 of 34 cases. The rate of normal
paraplegia, tetraplegia, C6-L1. sperm morphology was not different
Treatment: The male partner was between groups.
randomly assigned to single transrectal 2. The mean sperm concentration and
Giulini et al. 2004; Italy
electroejaculation or multiple (baseline, 1- rate of total sperm motility increased at
PEDro=5
month, 3- month) transrectal 1- and 3-month in multi-transrectal
RCT
electroejaculation before intracytoplasmic electroejaculation group.
N=34
sperm injection (ICSI). 3. A fertilization rate of 63.6% was
Outcome Measures: sperm concentration, observed and the pregnancy rate
morphology, and motility. per patient was significantly higher
(p<0.001) in multi-transrectal
electroejaculation group.
11-13
Score
Methods Outcome
Research Design
Total Sample Size
Population: 24-44 yrs, n=9, C4-C9, n=10, 1. 14/19 achieved at least 1 pregnancy
T4-T12/L1, 1-24 yrs post-injury, 12 2. Methods used: Intrauterine
complete and 7 incomplete. insemination 12% (11/92), gamete
Treatment: sperm was extracted through Intrafallopian transfer 38.9% (8/18),
vibrator application or electroejaculation intracytoplasmic sperm injection
Taylor et al. 1999;
followed by assisted reproductive 19.2% (5/21).
Australia
treatments (intrauterine insemination, 3. In patients with incomplete lesions
gamete intrafallopian transfer, in vitro vibratory stimulation was more
Post-test
fertilization and embryo transfer, commonly useful (4/7) 53%.
N=19
intracytoplasmic sperm injection). 4. Complete lesions required more
Outcome Measures: seminal parameters, advanced procedures to achieve
pregnancy rates (intrauterine insemination, pregnancy, (7/12) 58% required
gamete intrafallopian transfer, electroejaculation.
intracytoplasmic sperm injection).
Population: mean age=28.5 yrs, age 1. 30/39 patients produced an
range=19-49 yrs, 8 complete, 9 incomplete, ejaculation.
17 tetraplegic, C4-L2, 22 paraplegic, T1- 2. Greater success rate with tetraplegic
Le Chapelain et al. 1998;
L2. (96%), then T1-T10 (73%), then T11-
France
Treatment: Retrospective analysis of L2 (42%).
vibratory stimulation, electroejaculation or 3. Vibratory stimulation had better sperm
Case Series
subcutaneous physostigmine (at least 2 quality collected.
N=44
sessions). 4. Among 10 couples who wanted
Outcome Measures: conception, sperm children, 3 pregnancies resulted & 2
count, motility births of healthy children.
Population: SCI males with erectile 1. Similar ejaculation responses when
dysfunction, age range=18-44 yrs, 0.6-39 using frequencies of 80-100Hz and an
Sonksen et al. 1994; yrs post-injury, C2-L1. amplitude of 1mm.
Denmark Treatment: Vibrator (multicept ApS) and 2. At 100Hz and a 2.5mm amplitude
Downs & Black score=13 Relax (Nordic Light) vibrators. Different there were higher ejaculation rates
Post-test amplitudes were tested. (p<0.0001) than an amplitude of 1mm.
N=66 Outcome Measures: ejaculation 3. Ejaculation occurred in 58/66 men
responses. (88%).
Population: n=33 couples, age range=23- 1. Vibratory stimulation achieved
44 yrs, 37 cervical, 41 thoracic. ejaculation in 20/37 cervical patients,
Treatment: Retrospective review of 14/26 at or above T10 and 0/15 below
electrical stimulation followed by cervical T10.
self-insemination, intrauterine insemination, 2. Pregnancy rates: 17/27 achieved
Nehra et al. 1996; USA in vitro fertilization, or gamete intrafallopian pregnancy (10 with vibratory stim, 7
Downs & Black score=12 transfer. with electroejaculation).
Case Series Outcome Measures: sperm quality, 3. 5/8 achieved self-home insemination
N=78 pregnancy rates. with PVS.
4. 17/27 couples were successful at
conception (5 self-insemination, 5
intrauterine insemination and 7
assisted reproductive techniques).
5. 20 live births in 14 couples.
Population: 7 SCI, 1 primary anorgasmia, 1. Post-implant, all patients achieved
age range=27-37 yrs, C5-T9, 5 complete, external emission of semen, volume
2-15 yrs post-injury. between 1-5ml in 4 patients, only a
Brindley et al. 1989; UK
Treatment: Implantation of radio-linked drop or two drops in 3 patients (but
hypogastric plexus stimulator device. good quantities obtained later).
Post-test
Outcome Measures: seminal emission 2. 5 pregnancies (2 live births) in the
N=8
and erection (with use of implant). partners of 4 patients. Implants
functioned for years without
deterioration in performance.
11-14
Score
Methods Outcome
Research Design
Total Sample Size
Population: age range=23-38 yrs, C5-C6, 1. Anterograde ejaculation occurred in 9
n=4, T3-T12, n=7, L1, n=1, 8 para, 4 quad, patients with improvement in % motility
Halstead et al. 1987; 0.5-18 yrs post-injury, ASIA A, n=7, B, n=1, and total live sperm count on repeated
USA C, n=3, D, n=1. stimulations in 5 patients.
Downs & Black score=12 Treatment: rectal probe electroejaculation 2. Significant retrograde ejaculation
Post-test on 38 occasions. occurred in 1 patient.
N=12 Outcome Measures: ejaculation response 3. Sperm acceptable for artificial
and sperm quality. insemination from 4 patients.
Population: mean age=36.2 yrs, > 2 yrs 1. For anterograde ejaculation,
post-injury, C4-T11. interrupted current produced greater
Treatment: Electroejaculation was semen volume (2 vs .9 ml), total sperm
performed with the Seager Model 14 count (130 vs 79 million) and # motile
electroejaculation unit. A total of 99 sperm (34 vs 25 million) compared to
Brackett et al. 2002; USA
electroejaculation trials were administered continuous current delivery.
4-8 weeks apart according to a random 2. In retrograde fractions, total sperm
Post-test
schedule. Each trial consisted of count was higher for continuous (113.6
N=12
continuous or interrupted current delivery. million) than for interrupted delivery
Outcome Measures: semen quality. (29 million).
3. Retrograde sperm motility was lower
than anterograde sperm motility
regardless of the method used.
Population: mean age=31yrs, age 1. > 10 million sperm obtained in 71% of
range=20-53 yrs, cervical=15, thoracic=29, subjects (n=34).
lumbar=4, 4mo-34 yrs post-injury, 56% 2. Age and interval since injury had no
complete, 44% incomplete. effect on outcome.
Treatment: rectal probe electroejaculation 3. Higher success in thoracic paraplegics
Ohl et al. 1989; USA (EE). (90% ejaculated successfully) and in
Downs & Black score=11 Outcome Measures: sperm quality. those using intermittent catheterization
Post-test for bladder management compared to
N=48 cervical or lumbar patients (successful
ejaculation in 60% and 50%,
respectively).
4. Indwelling urethral catheters and high
pressure reflex voiding had a negative
impact on EE results.
Population: T6-L4, >6months post-injury, 1. Initial PSC application successful in
paraplegia. 5/20 patients. 3 patients successful in
Treatment: physostigmine (PSC) followed subsequent tests. 12 not successful.
Chapelle et al. 1983;
by intraspinal injection of neostigmine (ISN) 2. Only successful if T12-L2 myelomeres
France
(0.25-0.5mg) or PSC (2mg physostigmine intact.
sulfate injected 30min after 40mg N-
Post-test
buthylhyocine) several weeks later.
N=20
Outcome Measures: ejaculation.
Population: all male, C1-C5 to L1-L2, 1. Fertility rates: of 35 males seeking

n=35 female partners, age range=21-42 pregnancy, 29 could produce viable
yrs. sperm.
Dahlberg et al. 1995;
Treatment: Sperm was extracted through 2. Live births: n=24 children from 18/35
Finland
vibrator application, drug application couples). Miscarriages: n=4.
(Nifidepine 10-30mg), electroejaculation or
Post-test
sperm aspiration from the vas deferens.
N=63
Sperm was then introduced by
insemination or IVF.
Outcome Measures: live births.
11-15
Score
Methods Outcome
Research Design
Total Sample Size
Population: 10 couples, N=10 SCI men, 1. 7 clinical pregnancies achieved, 2 of
age range=27-37 yrs, C6-T12, 9 which ended with spontaneous
incomplete & 1 complete, 9 paraplegics & 1 abortion. 1 couple accomplished
tetraplegics, 4-20 years post-injury. pregnancy by ICSI with cryopreserved
Treatment: If semen sample from sperm from vasal aspiration.
Shieh et al. 2003; Taiwan
electroejaculation (EE) was of fair quality, 2. The fertilization and pregnancy rates
then 3 cycles of intrauterine insemination of ICSI cycles using sperm from men
Post-test
(IUI) prior to intracytoplasmic sperm with SCI were comparable to men
N=10
injection treatment (ICSI). If semen without SCI.
samples were poor, ICSI was suggested. If 3. One couple attained pregnancy by
no sperm from EE, surgical retrieval of using donor sperm.
sperm was performed. 4. The cumulative successful pregnancy
Outcome Measures: pregnancy rates. rate per couple was 80%.
Population: 28 couples, 28 males, age 1. 28/28 men were able to ejaculate, 22
range=24-43 yrs, 1-22 yrs post-injury, C2- by vibratory stimulation (all with lesion
L4; 28 females, mean age=29 yrs, age above T10), 6 by electroejaculation.
range=19-39 yrs. 2. 4/16 achieved pregnancy and had
Treatment: Males with SCI: vibratory healthy babies. This was achieved by
Sonksen et al. 1997;
stimulation or electroejaculation. Female home vibratory stimulation and self
Denmark
partners: assisted reproductive techniques insemination within two years.
(vaginal self-insemination at home, 3. All couples who had children had
Case Series
intrauterine insemination, in vitro significantly higher median motile
N=28
fertilization with or without intracytoplasmic sperm per ejaculate (105 million vs. 10
sperm injection). million, p=0.01)
Outcome Measures: ejaculation rates, 4. Overall 9/28 couples (32%) achieved
seminal parameters, pregnancy rates. 10 pregnancies with a delivery of 9
healthy babies.
Population: n=12 SCI, n=2 non-SCI 1. Seminal parameters: volume obtained:
(diabetes), mean age=34.6 yrs, age a few drops to 5.5ml, % of progressive
range=25-46 yrs, C5-T10. motility: 0-60%, and sperm
Lucas et al. 1991; UK
Treatment: electrical stimulator (up to concentration: 0-260 million/ml.
35V, 900mA, 50Hz). 2. 1 pregnancy recorded (father:T10
Post-test
Outcome Measures: fertility rates, seminal paraplegia, 8 yrs post-injury,
N=14
parameters, pregnancy rates. 54million/ml, 30% motility) resulted in
a singleton with no genetic
abnormalities.
Population: m=27, n=9 couples, 1. Ejaculation rates: 43/112 were
10 Cervical, 16 Thoracic, 1 Lumbar. antegrade ejaculations (38%), 24/112
Treatment: electrical stimulation (12-18V, were retrograde ejaculations, 45/112
Kolettis et al. 2002; USA 400-600mA for 30 second bursts) followed were both antegrade and retrograde
Downs & Black score=8 by intrauterine insemination or IVF. ejaculations (40%) and 2/112 were not
Post-test Outcome Measures: seminal parameters, able to ejaculate (2%)
N=27 ejaculation rates, cycle function, pregnancy 2. Pregnancy rate: 3/9 couples achieved
rates. pregnancy, 2 or which resulted in live
births and both were twins.
Population: mean age=29.5 yrs, age 1. 54% of cases resulted in antegrade

range=19-61years, cervical=15 (9 ejaculation.
complete, 6 incomplete) & thoracic=22 (20 2. 46 samples showed mean normal
complete, 2 incomplete), 3mo-23yrs post- count but low motility rate (28%).
Leduc et al. 1992;
injury. 3. Fresh unwashed sperm artificial
Canada
Treatment: 10mg nifedipine for autonomic insemination performed in 6 couples
dysreflexia, 40mg butylbromure hyoscine with 3 successful pregnancies.
Post-test
subcutaneously, 2-4mg physostigmine
N=37
subcutaneously 30 mins later and
masturbation by female partner.
Outcome Measures: ejaculation
responses, pregnancies.
11-16
Score
Methods Outcome
Research Design
Total Sample Size
Population: 102 men, mean age: 25.6 yrs, 1. Penile vibrators triggered ejaculation in
cervical-sacral lesions, >T11 (n=58), 72 patients (70.5%).
thoracolumbar lesions (n=36), sacral (n=8), 2. 11 other patients showed 'weak'
mean 6.1yrs post-injury. ejaculation with poor contractions of
Beretta et al. 1989; Italy
Treatment: simple vibrator applied to the perineal muscles.
penis for ejaculatory response. 15 patients 3. Stimulation ranged from 30sec-20min.
Post-test
who wanted to conceive a child received Of 15 'home-use' patients, ↑ in sperm
N=102
instruction in home use of vibrator. concentration and steep ↓ in abnormal
Outcome Measures: ejaculation spermatozoa over 3 months.
frequency, sperm quality. 4. 6 couples had homologous artificial
insemination, 3 pregnancies resulted.
Population: N=81 males with SCI, mostly 1. Required duration <20min (usually
complete. <3min) in 48/81 SCI men.
Treatment: application of a vibrator of 80 2. It failed in 19/81 who lacked reflex hip
Hz and 2.5mm amplitude to the lower flexion on scratching soles of feet and
Brindley 1984; England
surface of the glans penis, in 14 others. It failed in 11/12 men with
electroejaculation (EE). injuries <6 months duration.
Post-test
Outcome Measures: semen retrieval. 3. From 21/34 men for whom the vibrator
N=81
failed, semen cold be obtained by
electroejaculation (EE).
4. 11 pregnancies reported. 9 healthy
children born.
Population: 121 couples (87 involved an 1. 52/121 became pregnant, 39 by IUI
SCI patient). alone.
Treatment: electroejaculation followed by 2. All patients undergoing IVF had higher
Ohl et al. 2001; USA intrauterine insemination (IUI) was the cycle fecundity than did those
Downs & Black score=7 route of sperm delivery. If not successful undergoing IUI (p<0.001).
Post-test after 3-6 cycles of IUI, GIFT (gamete 3. The rates of spontaneous abortion and
N=121 intrafallopian transfer) or IVF procedures multiple gestations were 23% and
were recommended. 12%, respectively.
Outcome Measures: pregnancy success
and pregnancy outcomes.
Population: all male, 51 tetraplegics & 161 1. Vibrostimulation in supranuclear
paraplegics, mean 11.9 yrs post-injury. lesions was successful in 133 patients,
Treatment: supranuclear patients were and in 5 more after physostigmine
treated by vibrostimulation. When this injection.
Lochner-Ernst et al. failed, further treatment was applied: 2. EE was successful in all 7 infranuclear
1997; Germany physostigmine medication and lesions and in 4 supranuclear patients
Downs & Black score=7 vibrostimulation, electroejaculation, failing with vibrostimulation. 8 more
Post-test physostigmine with electroejaculation (EE), supranuclear patients responded to
N=219 surgical approaches. Infranuclear patients EE and physostigmine.
were treated by EE. 3. Surgical retrieval was applied in 27
Outcome Measures: semen retrieval and patients.
pregnancy success. 4. In 109 patients who wanted children,
73 pregnancies in 46 couples, leading
to 54 births and 16 abortions.
Population: C4-L5. 1. Semen obtained from 21 of 24 men
Rawicki & Hill 1991; Treatment: electroejaculation (EE), with a lesion at T8 or above, and from
Australia vibration ejaculation (VE), and 4 of 11 men with lesions below T10.
Downs & Black score=4 subcutaneous physostigmine (SP). 2. 8 pregnancies from 6 couples.
Post-test Outcome Measures: conception, seminal
N=39 emission, pregnancies.
11-17
Discussion
Most studies included in this section were not comparative for differences in sperm retrieval
technique (surgical and non surgical), but rather focused on cumulative ejaculatory and/or
pregnancy success (Dahlberg et al. 1995; Nehra et al. 1996; Brinsden et al. 1997; Chung et al.
1997; Lochner-Ernst et al. 1997; Le-Chapelain et al. 1998). The evidence was often from
retrospective chart reviews and prospective clinical trials were rare. The application of a
specialized vibrator, with settings of approximately 70–100 Hz with 2.5- 3.5 mm amplitude
(Brindley 1984; Sonsken et al. 1994; Ohl et al. 1997) on the penis (usually frenulum) produces
antegrade, retrograde, and some mixed semen samples. Vibrostimulation worked most reliably
in those men with lesions above T10, those men with SCI who had a reflex hip flexion with
scratching the soles of the feet and with injuries over 6 months (Brindley 1984; Sonsken et al.
1994; Lochner-Ernst et al. 1997; Sonsken et al. 1997) or in patients with incomplete lesions
(Taylor et al. 1999). Vibrostimulation application for 30 sec – 20 minutes (most occurring in less
than 3 min) resulted in ejaculation between 60 – 100% (Beretta et al. 1989; Rawicki & Hill 1991;
Sonksen et al. 1994; Rutkowski et al. 1995; Chung et al. 1997; Sonksen et al. 1997). Those that
failed vibrostimulation could usually have semen obtained by electroejaculation (Taylor et al.
1999), a method successful in lower lesions (Ohl et al. 2001). Since ejaculate was almost
always attainable by vibrostimulation or electroejaculation, the need for surgical aspiration was
rare but reported (Dahlberg et al. 1995; Lochner–Ernst et al. 1997; Shieh et al. 2003).
Controlling severity of autonomic dysreflexia with nifedipine allowed for better sperm retrieval
technique (VerVoort et al. 1988; Lucas et al. 1991; Brackett et al. 2002; Elliott & Krassioukov
2006). Electroejaculation is considered more invasive and painful than penile vibratory
stimulation for men with SCI, and patients prefer penile vibratory stimulation if sperm quality was
equal between the two techniques (Ohl et al. 1997). The use of physostigmine injections alone
or in conjunction with both vibrostimulation and electroejaculation has largely dropped out of use
since the mid–1990’s (Chapelle et al. 1983; Leduc et al. 1992). An implantable hypogastric
nerve stimulator (radio-controlled) was also successful in yielding semen with sperm (not
necessary all motile), but has not been further developed (Brindley et al.1989).
Conclusion
There is level 4 evidence that semen retrieval can be assisted by vibrostimulation in men
with lesions above T10.
There is level 4 evidence that semen retrieval can be assisted by electroejaculation in

men who failed vibrostimulation.
There is level 4 evidence that surgical aspiration can be used to retrieve sperm if
vibrostimulation and electroejaculation are not successful.
The least invasive sperm retrieval method should be tried first (i.e. vibrostimulation in
the clinic setting to monitor for autonomic dysreflexia) followed with the
more invasive electroejaculation (in clinic or operating room settings).
Vibrostimulation is most successful in men with SCI above T10.
11-18
11.4.2 Sperm Quality
Unfortunately after SCI, semen quality also declines. The literature supports what Deforge et al.
(2005) wrote about semen quality after SCI. Semen obtained by EEP in the first 2 – 3 days after
injury was scant, but had normal quality by 6 – 10 days post –injury (Mallidis et al. 1994). After
approximately 2 weeks semen quality deteriorates to levels reaching those observed in males
with chronic SCI. After 6 months to 1 year there is no relationship between duration of injury and
sperm quality (Sarkarati et al. 1987). Semen quality in men with chronic SCI is reported to have
decreased motility and viability, although total numbers of sperm tend to remain high (Brackett
et al. 1997b). The following studies investigate the sperm quality under a number of conditions
including: repeated ejaculations, different bladder management, antegrade versus retrograde
ejaculation, vibratory stimulation versus electroejaculation, heat and varying seminal plasma.
Table 11.9 Sperm Quality

Score
Methods Outcome
Research Design
Total Sample Size
Population: 77 males, 45% cervical, 51% 1. ↑ motile sperm with vibratory
Brackett et al. 1997a; thoracic, 4% lumbar. stimulation compared to
USA Treatment: 1) vibration (n=23), 2) electroejaculation.
Downs & Black score=17 electroejaculation (n=44) or 3) underwent 2. No difference in total sperm count.
Prospective Controlled both procedures (n=10).
Trial Outcome Measures: sperm quality.
N=77
Population: all males. 1. No difference in antegrade sperm

Treatment: n=5 FertiCare Clinic Vibrator count, but penile vibratory stimulation
(2.5 mm, 100Hz, for 3 min) or specimens had greater motility,
Ohl et al. 1997; USA electroejaculation (Seager model 11). viability and motile sperm count
Downs & Black score=14 Outcome Measures: sperm quality. compared to EE.
Prospective Controlled 2. No difference in sperm functional
Trial assessment (mucus or sperm
N=11 penetration assay).
3. Electroejaculation was more painful
and less preferred than penile
vibratory stimulation.
Population: all male, mean age=30 yrs, 1. Neurological level (p<0.0072) and
age range=19-59 yrs, n=36, C1-C8, n=19, method of bladder management
T1-T9,n=15, T10-L2, mean 6 yrs post- (p<0.0115) were found to be
injury. significant variables that influenced
Rutkowski et al. 1995; Treatment: Vibroejaculation at 10-50Hz, 3 70% of the patients’ sperm sample
Australia cycles for 45seconds (n=36) or quality.
Downs & Black score=14 electroejaculation (n=34). 2. As neurological level became more
Case Series Outcome Measures: seminal parameters, caudal, motile sperm decreased. Use
N=70 type of catheterization, method of of a catheter greatly increased the
ejaculation. number of motile sperm.
3. Intermittent self catheterization was
superior to suprapubic catheter or no
catheter.
Population: 7 SCI, 5 fertile age matched 1. The majority of sperm (65%) exhibited
donors, age range=27-54 yrs, 5 to 31 yrs degenerative changes and significant
Monga et al. 2001; USA post-injury, C4-C7, 5 incomplete, 2 axonemal defects.
Downs & Black score=13 complete. 2. A significant percentage of sperm
Prospective Controlled Treatment: electrovibratory stimulation. (65%) demonstrated disappearance of
Trial Outcome Measures: semen quality. fiber doublets.
N=12 3. Incubation of normal sperm with
seminal fluid of subjects with SCI
11-19
Score
Methods Outcome
Research Design
Total Sample Size
induced a significant (p<0.05) 43%
decrease in motility within 15 min.
Population: all male, age range=25-41 1. Antegrade specimens collected in 51
yrs, 8 cervical, 6 thoracic, Frankel A (n=8), trials (84%) and retrograde specimens
B (n=4), and C (n=2). Hip flexion reflex in obtained in all 61 trials (100%).
13 (93%) and spasticity in 12 (86%). 2. Non-statistically significant trend
Chen et al. 1999; USA Treatment: antegrade sample obtained toward higher sperm counts in the
Downs & Black score=13 using Ling vibrator. Bladder catheterized antegrade samples (mean=74.1
Post-test for collection of any retrograde ejaculate. million) than in retrograde (40 million).
N=14 Vibratory stimulation at clinic every 2-4 wk. 3. No difference in sperm motility and
Outcome Measures: sperm quality. morphology between antegrade and
retrograde specimens.
4. Fructose and zinc were present in all
antegrade and retrograde specimens.
Population: age range=19-43 yrs, C5-T12 1. 21/25 retrograde, 12/21 antegrade
all complete. ejaculations.
Treatment: Pharmacologic: meperidine 2. Poor sperm mobility in most cases, no
and diazepam; Device: Electroejaculation motile Spermatozoa in 6/21.
Wang et al. 1992; Taiwan
using Seger model 12 (max 60 3. No correlation in sperm quality and
stimulations). Bladder was emptied and quantity with method of bladder
Post-test
then 20ml of Hams F-10 solution was management, age, level of injury or
N=25
instilled. time after injury.
Outcome Measures: seminal parameters, 4. Sperm quality declines after
sperm motility, sperm quality and quantity, stimulations are repeated more than
ejaculation rate. once a week.
Population: all males, age range=18-40 1. Initial stimulation yielded semen in 29
yrs, C4-L1, 5 incomplete, 27 complete, 23 men (91%; 22 had antegrade and 7
tetraplegics, 9 paraplegics. retrograde ejaculation).
Treatment: vibrator stimulation (29/32 2. 16 with antegrade ejaculation started
subjects with hip flexion reflex) or 4-6 months of home stimulation which
Siosteen et al. 1990;
electrostimulation (3 subjects), 4-6 months resulted in a rise of semen volume and
Sweden
of 'at-home' treatment, 1X/week fructose and acid phosphatase levels
stimulation. in seminal plasma (improved function
Post-test
Outcome Measures: semen quality. of the seminal vesicles and prostate).
N=32
3. % motile sperm was low (before and
after treatment period).
4. 11 men (69%) showed normal or
nearly normal penetration tests after
the period of regular stimulation.
Population: 12 males, age range=29-40 1. Sperm was obtained from 9/12 SCI
yrs, C4-L1, mean 14.6 yrs post-injury, 14 patients and 12/14 non-SCI patients
able-bodies controls, all had vasectomy having a vasectomy.
Brackett et al. 2000; USA and biological children. 2. SCI aspirated sperm had greater
Downs & Black score=12 Treatment: 1) sperm retrieved by electrical motility (54.4%) and viability (74.1%)
Prospective Controlled stimulator or vibratory stimulation for SCI compared to ejaculated sperm (14.1%)
Trial patients, 2) sperm retrieval before motility and viability (26.1%)
N=26 exposure to the seminal and prostatic fluids (p<0.0001).
during vasectomy surgery in controls and 3. Controls showed no difference
vas aspiration surgery in SCI. between aspirated and ejaculated
Outcome Measures: sperm quality. sperm.
Population: 12 SCI, age range=18-42 yrs, 1. At 5 minutes, seminal plasma from
3-28 yrs post-injury, thoracic injuries, n=14 SCI males reduced motility of sperm
Brackett et al. 1996; USA
age matched controls. from control.
Treatment: vibratory stimulation (SCI) or 2. Seminal plasma from controls
masturbation (controls). Effect of SCI improved motility of sperm from SCI
Trial
seminal plasma was tested on control males.
N=26
sperm and vice versa. 3. At 60 minutes the values were not
different from each other.
11-20
Score
Methods Outcome
Research Design
Total Sample Size
Outcomes Measures: seminal
parameters.
Population: 135 complete SCI subjects, 1. 75/135 patients ejaculated after
Chapelle et al. 1988; n=13 age matched controls, age range 18- pharmacologic intervention.
France 47 yrs. 2. Only 3/75 who could ejaculate had
Downs & Black score=12 Treatment: 0.2mg physostigmine. lesions T12-L2 lesions (p<0.001) and
Prospective Controlled Outcome Measures: ejaculation rates and testicle volume was significantly lower
Trial procreation, level of injured metamers, in patients with injured T12 segments.
N=148 testical volume.
Population: age range=23-38 yrs, C5-C6, 1. Anterograde ejaculation occurred in 9

n=4, T3-T12, n=7, L1, n=1, 8 para, 4 quad, patients with improvement in % motility
Halstead et al. 1987; 0.5-18 yrs post-injury, ASIA A, n=7, B, n=1, and total live sperm count on repeated
USA C, n=3, D, n=1. stimulations in 5 patients.
Downs & Black score=12 Treatment: rectal probe electroejaculation 2. Significant retrograde ejaculation
Post-test on 38 occasions. occurred in 1 patient.
N=12 Outcome Measures: ejaculation response 3. Sperm acceptable for artificial
and sperm quality. insemination from 4 patients.
Population: all male, age range=16-36 1. Semen obtained during first 6 months
yrs, 14 cervical (3 complete, 11 after injury was not of a quality
Sarkarati et al. 1987; incomplete), 13 thoracic T1-T9 (all consistent with successful fertilization,
USA complete), 7 T10-L3 (3 complete, 4 owing to poor motility.
Downs & Black score=12 incomplete). 2. Semen quality and motility were better
Post-test Treatment: vibratory stimulation and/or in patients who had been injured for
N=34 electrostimulation. more than 6 months.
Outcome Measures: ejaculation 3. Repeated electro-ejaculation did not
response. improve the quality of semen.
Population: all male, mean age=28 yrs, 1. Mean sperm motility increased 23% on
age range=22-36 yrs. days 2 and 3; however, sperm
Mallidis et al. 2000; Treatment: electroejaculation using CGS concentration and volume decreased.
Australia/USA Electroejaculator with progressively 2. In 3 of 7 patients sperm motility still
Downs & Black score=11 increasing sine wave current at 20 Hz over remained low.
Post-test 4 consecutive days. 3. Major gains in sperm motility and
N=9 Outcome Measures: semen quality. viability were achieved by day 2 with
some improvements in day 3 for three
patients.
Population: 10 SCI males, mean 1. Heat did not affect rate of degradation
age=33.1 yrs, 11.4 yrs post-injury, C4-C5, in motility in control specimens, but
Brackett et al. 1997b; n=5, T5-T6, n=4, T12, n=1, 9 age matched body temperature reduced sperm
USA non-SCI males. motility in SCI specimens compared to
Downs & Black score=10 Treatment: electroejaculator (Seager room temperature.
Prospective Controlled model 14, 1-10Volts) or laboratory
Trial stimulation. Specimens stored at room
N=19 temperature (23°C) or body temperature
(37°C).
Outcome Measures: fertility rates.
Population: n=18 SCI, n=22 non-SCI, 2 1. Motile sperm were obtained in 95% of
cervical, 15 thoracic, 1 lumbar, 33 of 40 men. Semen quality improved with
were in a relationship with a female. subsequent rectal probe ejaculation in
Matthews et al. 1996; Treatment: Retrospective review of 23/35 men.
USA electrical stimulator with rectal stimulation 2. Antegrade ejaculations produced
Downs & Black score=10 followed by intrauterine insemination (126 greater percentage sperm motility in
Case Control cycles in n=33) or in vitro fertilization (n=7 59% of procedures in which both types
N=40 total 14 cycles). of ejaculation were obtained in a
Outcome Measures: fertility rates, seminal patient.
parameters, ejaculatory rates, cycle 3. However, total motile sperm in
function, pregnancy rates. retrograde samples exceeded
11-21
Score
Methods Outcome
Research Design
Total Sample Size
antegrade in 57% of the cases.
4. Pregnancy rate: 15/33 couples
achieved pregnancy (45%), of which,
10/15 were achieved through
intrauterine insemination.
5. Pregnancies leading to live birth were
recorded in 5/7 couples undergoing
IVF.
Discussion
Results varied, however, in general, sperm parameters found in antegrade and retrograde
samples were approximately the same except for decreased motility in non-alkalinized
retrograde samples and one study which showed antegrade samples were better in motility and
viability than retrograde samples (Ohl et al. 1997). There is some evidence to suggest that
vibratory stimulus seems to produce more viable samples than electroejaculation in terms of
motility and volume (Ohl et al. 1997; Le Chapelain et al. 1998). Semen quality appeared to
improve with repeated ejaculations in some series (Matthews et al. 1996; Giulini et al. 2004),
and not in others (Sarkarati et al. 1987). It has been suggested that parameters improve with
consecutive days of electroejaculation (Mallidis et al. 2000). Once weekly vibrator stimulation
resulted in an increase of semen volume and of fructose and acid phosphatase levels in the
seminal plasma (suggesting improved function of the seminal vesicles and prostate) (Siosteen
et al. 1990), whereas other investigators found that too frequent ejaculation caused semen
quality to deteriorate (Wang et al. 1992). The chance of improved semen parameters came with
consistency of ejaculations over a regulated time period. Poor sperm motility may be due in part
to the seminal plasma secondary to disturbed nervous systems and anejaculation (Brackett et
al. 2000), and there may be testicular functional or anatomical anomalies (Chapelle et al. 1988;
Elliott et al. 2000; Monga et al. 2001). Once ejaculated, sperm motility in men with SCI declines
rapidly, and storing at body temperature (in a 37°C incubator) may exacerbate this (Brackett et
al. 1997b). Bladder management also seems to affect sperm quality, with clean intermittent
catheterization improving semen quality over indwelling catheterization, reflex voiding or
straining (Ohl et al. 1989; Rutkowski et al. 1995).
Conclusion
There is level 4 evidence that vibratory stimulus appear to result in better sperm motility
than electrostimulation.
There is level 4 evidence that sperm obtained by antegrade samples appear to have
better motility than retrograde samples.
There is level 4 evidence that bladder management with clean intermittent catheterization
may improve semen quality over indwelling catheterization, reflex voiding or straining.
There is level 4 evidence that SCI sperm quality can be improved by placing sperm from
SCI in able-bodied seminal plasma, and that aspirated sperm from the vas deferens had
better motility than that ejaculated, demonstrating the etiology of poor semen quality
may lie within the seminal constitutes in men with SCI. These techniques have not been
studied clinically with respect to pregnancy rates.
11-22
Vibratory stimulus may result in better sperm quality.
Antegrade samples appear to have better sperm motility than that found in retrograde samples.
Bladder management with clean intermittent catheterization may improve semen quality over
indwelling catheterization, reflex voiding or straining.
SCI sperm quality may be improved by processing in able-bodied seminal plasma.
11.4.3 Pregnancy
Unfortunately, after SCI, semen quality declines necessitating assistive reproductive

technologies to compensate for the alterations (Elliott 2003). Pregnancy rates are lower than
the general population but have been much improved since the advent of in vitro fertilization
(IVF) and intracytoplasmic injection (ICSI).
Table 11.10 Pregnancy

Score
Methods Outcome
Research Design
Total Sample Size
Population: 84 SCI, 49 couples, age 1. Ejaculation occurred in 98.6% of
range=19-45 yrs, cervical (34.5%), thoracic patients, with sperm in 88% of patients
(59.5%), lumbar (5.9%), ASIA level: n=63 and enough viable sperm in 54.8%.
A, n=15 B n=5 C, n=1 D, 4 mos-34yrs post- 2. Antegrade semen parameters had
injury. better sperm count, morphology and
Treatment: electroejaculation followed by motility than retrograde samples
Heruti et al. 2001; Israel
intrauterine insemination for 3 trials (p>0.001).
(10million sperm/cc). If this did not result in 3. No significant improvements were
Post-test
fertilization, intracytoplasmic sperm seen in seminal parameters after
N=84
injection and IVF. repeated ejaculations.
Outcome Measures: volume, sperm 4. 69.2% overall pregnancy rate/couple.
count, motility, morphology, total motile 33% (5/15) after intrauterine
sperm count, conception. insemination, 70% (14/20) after IVF
5. 26 live births (n=12 singletons, n=5
twins, n=1 triplets) and 4 abortions.
Population: all male, tetraplegic SCI with 1. No pregnancies with protocol 1 or 2.
partners. 6/10 patients became pregnant with
Treatment: electrical stimulation or protocol 3, which has the longest delay
vibratory stimulation followed by 1) between drug administration and
Pryor et al. 2001; USA
intrauterine insemination of partner 24 hour insemination.
after Luteinizing Hormone surge (n=5), 2)
50 mg clomiphene citrate & hCG, followed
Trial
by insemination after 32-34 hours (n=5), or
N=11
3) same as #2, except 38-40 hour delay
(n=10).
Outcome Measures: fertility rates, seminal
parameters.
Population: all male with female partners, 1. Pregnancy rates: 18 total (14 were
age range=24-47 yrs, female: age fresh embryo transfers, 4 were frozen
range=21-43 yrs, C5-L1, 1-27 yrs post- embryo transfers).
Brinsden et al. 1997; UK
injury. 2. Pregnancy rate per treatment cycle
Treatment: trans-rectal electroejaculation was 21.2% (18/35).
Post-test
with in-vitro fertilization. 71 IVF cycles were 3. Overall clinical pregnancy rate per
N=35
used. stimulated IVF treatment was
Outcome Measures: pregnancies, 25.4% (18/71).
fertilization rate, motile sperm count.
11-23
Score
Methods Outcome
Research Design
Total Sample Size
Population: all male, 24 with SCI, n=3 with 1. 7 pregnancies in 13 couples with a
retroperitoneal dissection, age range=24- total of 56 IUI, 2 spontaneous
Chung et al. 1997; USA 48 yrs, 3-25 yrs post-injury. abortions, 4 live births, 1 ongoing twin
Downs & Black score=14 Treatment: electrostimulation and pregnancy.
Post-test nifidepine (10mg) for prophylaxis of
N=27 autonomic dysreflexia.
Outcome Measures: ejaculation rates,
pregnancy rates, seminal parameters.
Population: mean age=38.9 yrs, 10 SCI, 7 1. ICSI resulted in a median fertilization
non-SCI related anejaculation. of 60%, 15% pregnancies per cycle
Schatte et al. 2000; USA Treatment: electroejaculation and and 29% pregnancies per couple.
Downs & Black score=13 intracytoplasmic sperm injection and 2. Pregnancy rates were lower for the
Post-test results compared to 620 ICSI cycles for anejaculation group compared to the
N=17 non-SCI severe male factor infertility with severe male factor group.
normal ejaculation.
Outcome Measures: pregnancy rate.
Population: 12 couples, 12 male SCI, 12 1. Pregnancy rates: 7 pregnancies in 6
female partners, age range= 27-38 yrs, C4- couples, 3 spontaneous abortions, 2
Hultling et al. 1994; L3, 4-33 yrs post-injury. live births, 2 ongoing pregnancies.
Sweden Treatment: vibratory stimulation and, if
Downs & Black score=13 necessary, physostigmine and/or
Post-test electroejaculation followed by IVF.
N=12 Outcome Measures: seminal parameters,
pregnancy rates.
Population: age range=30-35 yrs, C4-C7, 1. Pregnancies occurred in 5/6 of the
6-18 yrs post-injury, 6 tetraplegics. partners. 2 partners delivered healthy
Pryor et al. 1995; USA Treatment: vibratory stimulation (using boys, 1 partner miscarried at 9 wks.
Downs & Black score=11 4,200rpm for 5-45min, with 5 min breaks 2. One couple has completed second
Post-test every 5 min) followed by intrauterine vibratory stimulation without
N=6 inseminations. conception and will try again.
Outcome Measures: pregnancy rates.
Population: age range=22-43 yrs, C5-T12, 1. After fertility testing, 6/18 men
12 complete, 6 incomplete, 2-22 yrs post- proceeded to use RPE in effort to
injury, ASIA A, n=12, ASIA B-D, n=6. conceive. Sperm obtained in 16/18
Treatment: rectal probe electroejaculation cases.
(RPE). 2. Ejaculate total sperm count=306
Buch & Zorn 1993; USA Outcome Measures: sperm quality. million (good), but motility (22%) was
Downs & Black score=11 poor.
Post-test 3. Adequate sperm retrieval after
N=18 processing yielded normal sperm
penetration assay in 4/16 (25%) cases
in which sperm was obtained.
4. Live births in 2/6 couples attempting
conception.
Population: all male SCI with female 1. Pregnancy rate: 16/25 pregnancies
partner, males: mean age=25-51 yrs, occurred leading to 11 deliveries.
female partners: mean age=21-38 yrs, C2- 2. n=9 singletons, n=2 sets of twins. n=4
Hultling et al. 1997; L3, 3-33 yrs post-injury. miscarriages during the first or second
Sweden Treatment: vibratory or electrical trimester (1 case of intrauterine death
Downs & Black score=10 stimulation followed by IVF. in week 31 of gestation).
Post-test Outcome Measures: conception. 3. Pregnancy occurred in all groups of
N=25 patients in the ASIA scale A-D from
injuries from C2-L2.
11-24
Score
Methods Outcome
Research Design
Total Sample Size
4. Clinical pregnancy rate was 31% and
the cumulative pregnancy rates up to
four cycles were 56%.
Discussion
Pregnancy rates were dependant on obtaining motile sperm and were improved consistently
with higher levels of reproductive assisted technology. The following order indicates
progressively improved fertility rates as assisted reproductive technology (ART) advanced:
• at home (intercourse or vaginal insemination)

• intrauterine insemination
• in vitro fertilization (IVF)
• IVF + intracytoplasmic sperm injection (ICSI).
Reports varied in their description of pregnancy rates, using either pregnancy rate per couple or
pregnancy rate per insemination method. In general, reported as per couple, there was
considerable improvement in rates over the last 20 years due to better technology (Brinsden et
al. 1997; Schatte et al. 2000). In assessing many authors, there appeared to be an average 30 -
50% pregnancy rate and a 40% live birth rate (Beretta et al. 1989; Hultling et al. 1994; Dahlberg
et al. 1995; Chung et al. 1997; Hultling et al. 1997; Heruti et al. 2001; Sheih et al. 2003; Giulini
et al. 2004). Cumulative pregnancy rates could go as high as 80% (Sheih et al. 2003). The
number of attempts varied greatly, with pregnancy unlikely to occur after 5 attempts of any
method (recognizing that some couples advanced on the continuum of increasing ART). Cycle
fecundity rate (chance of pregnancy per cycle) for intrauterine insemination is <15%, whereas
for IVF/ICSI it is between 25 – 40%. In one study it was felt that delayed timing of intrauterine
insemination resulted in significantly improved pregnancy rates in female partners of
quadriplegic men (Pryor et al. 2001). While fresh semen samples were preferred, cryopreserved
semen samples were used successfully for IVF technology. Cryopreservation of embryos to be
replaced at a later date is also useful (Buch & Zorn 1993). Multiple gestations were more
frequent with IVF/ICSI. Testicular aspiration is rarely used since it commits the man and his
partner to IVF /ICSI procedures.
Substantial heterogeneity of the data has provided estimates of the feasibility of and effort
required to pursue biological fatherhood after SCI. This cumulative evidence and substantial
clinical experience suggest starting with proper assessment of the physical health and risk
factors for the man (i.e. autonomic dysreflexia), as well as fertility history and blood work for the
female partner. Assessment of sperm retrieval methods follows with evaluation of the resultant
semen samples retrieved. Female intervention is determined by her fertility factors and by the
quality of semen available. The least invasive and least expensive insemination options are
pursued after weighing invasiveness and risk of sperm retrieval and semen quality. Men with
SCI stand a good chance (>50%) of becoming biological fathers with access to specialized
clinics and care.
11-25
Conclusion
There is level 4 evidence that men with SCI have a good chance (>50%) of becoming
biological fathers with access to specialized care utilizing reproductive assisted
technology.
Men with SCI can have realistic expectations of becoming a biological father. Depending on
semen quality and female factors, a progression from intravaginal insemination to assisted
techniques such as intrauterine insemination, in vitro fertilization (IVF) to IVF plus
intracytoplasmic sperm injection (ICSI) is recommended.
11.5 Sexual and Reproductive Health in Women with Spinal Cord Injury
For many years the sexual and reproductive health of women with SCI was not studied.
Although few intervention trials exist on this topic, there are observational studies of clinical
importance, as they provide information as well as serve to highlight the major sexual and
reproductive health issues that exist for women with SCI.
11.5.1 Sexual Response
While it is true that women with SCI have clinically significant impairment in arousal and
orgasm, women with complete SCI have been self-reporting orgasm that seemed
physiologically impossible (Richards et al. 1997). Recent laboratory work using functional
magnetic resonance imaging has documented the presence of vaginal-cervical perceptual
awareness and orgasm in women with complete SCI (Whipple & Komisaruk 2002; Komisaruk et
al. 2004). The vagus nerves are thought to be a spinal cord bypass pathway that facilitates
those responses (Komisaruk et al. 2004). Preservation of T11 – L2 sensory dermatomes is
associated with psychogenically mediated genital vasocongestion and lubrication (Sipski et al.
1997; Sipski et al. 2001). Furthermore, women with LMN injuries affecting S2 – S5 were less
likely to achieve orgasm compared with women who had other levels and degrees of SCI
(Sipski et al. 2001). Women with SCI are less likely to achieve orgasm than able-bodied women,
and time to orgasm is significantly increased compared to able-bodied controls (Sipski et al.
2001). Some studies found similar cardiovascular responses in women with SCI compared to
able-bodied controls (Sipski et al. 1995; Sipski et al. 1996), while a different study found a
greater increase in heart rate and BP for the control group (Whipple et al. 1996) during orgasmic
responses.
11.5.2 Gynecological Health
There are conflicting reports on the occurrence of dysmenorrhea post-injury. Jackson and
Wadley (1999) and Comarr (1966) found a decrease and absence, respectively, whereas Axel
(1982) found the majority of women had no change in menstrual discomfort. Other
gynecological problems reported by women with SCI include increase incidence of urinary tract
infections and vaginal yeast infections (Jackson & Wadley 1999). One qualitative study found a
common pattern of diarrhea frequently occurring in conjunction with menstruation, leading to
bowel accidents during transfers, and in turn to bladder and vaginal infections (Pentland et al.
2002). In terms of health promotion behaviour of women with SCI, women were found to be less
likely to have routine mammograms and annual Papanicolaou smears (Nosek 1996; Jackson &
11-26
Wadley 1999) than women without disabilities; however, they had a similar practice of breast
self-exam (Jackson & Wadley 1999).
11.5.3 Fertility/Contraception
Amenorrhea may occur immediately following injury, lasting 4-5 months on average (Jackson &
Wadley 1999; Axel 1982). It is commonly believed that despite this initial delay in menstruation
following traumatic SCI, fertility in women is unaffected. However, as DeForge et al. (2005) point
out, there are no controlled studies comparing fertility rates with non-SCI cohorts and thus, there
may be unknown effects of SCI on the rate of miscarriages and live births in couples trying to
conceive. Jackson and Wadley (1999) found 70.3% of sexually active women use some form of
contraception after injury and that fewer women used the birth control pill compared to before
the injury.
11.5.4 Obstetrical Health
Women with SCI are able to conceive, carry and deliver a baby; however, there is an increased
frequency of complications during pregnancy, labour and delivery (Baker & Cardenas 1996;
Jackson & Wadley 1999). Bladder problems, spasticity, pressure sores, autonomic dysreflexia,
and problems with mobility can pose a threat to the pregnant woman with SCI (Baker et al.
1992; Jackson & Wadley 1999). Obstetric outcomes include higher rates of Caesarian-sections
and increased incidence of low birth-weight babies (Jackson & Wadley 1999). Fewer women
practice breastfeeding post-SCI (Jackson & Wadley 1999). Breastfeeding was thought to be
compromised in women with SCI above T7; however, a recent report of 3 cases of women with
tetraplegia suggests that, with psychogenic and pharmacologic induction of the let-down reflex,
long-term breastfeeding may be possible (Cowley 2005).
11.5.5 Menopause
Little has been published on women’s experience of menopause post-SCI. In their observational
study, Dannels and Charlifue (2004) report presence of typical perimenopausal symptoms in
women with SCI but at a lower rate compared to the general population. The authors surmise
several explanations for this difference, including the possibility of the symptoms mimicking
those related to SCI, or a lack of communication about perimenopause between providers and
women with SCI (Dannels & Charlifue 2004). Jackson and Wadley (1999) also found a lower
frequency of menopausal symptoms post-injury, but higher than those women who had
undergone menopause pre-injury.
The aforementioned studies illuminate the unique experiences of women after SCI in terms of
their sexual and reproductive health. Numerous clinical questions remain unanswered however,
leaving women with SCI frustrated and angry about the lack of information and support for the
particular needs of women with SCI and gynecological health (Pentland et al. 2002). This lack of
information combined with the fact that obtaining access to gynecological and obstetric care is a
challenge for many women with SCI (Nosek et al. 1996) raises the question of whether women
with SCI are receiving adequate sexual and reproductive health care (Jackson & Wadley 1999).
The following two studies evaluate interventions in the field of sexual and reproductive health for
women with SCI.
11-27
Table 11.11 Sexual and Reproductive Health in Women with Spinal Cord Injury
Score
Methods Outcome
Research Design
Total Sample Size
Population: age range: 25-45 yrs, 19 1. Significant increases in subjective
females, 13 complete, 6 incomplete, length arousal were observed with both drug
of injury range=15-457mos. (p<0.01) and sexual stimulation
Treatment: random assignment to conditions (p<0.001).
sildenafil (50mg) or placebo on day 1 and 2. Borderline significant (p<0.07) effect of
the alternate medication on day 2. One drug administration on vaginal pulse
Sipski et al. 2000; USA
hour after drug, subjects underwent two amplitude, an objective measure of
PEDro=9
12-minute periods of audiovisual vaginal arousal, was noted.
RCT
stimulation, followed by two 12-minute 3. Findings suggest that sildenafil may
N=19
periods of audiovisual plus manual clitoral partially reverse sex dysfunction in
stimulation, each separated by 6-minute women with SCI.
baseline periods. The identical protocol
was administered on the subsequent day
with the alternate medication.
Outcome Measures: subjective arousal,
vaginal pulse amplitude.
Discussion
Sipski et al. (2000) evaluated the use of sildenafil (Viagra) 50 mg in women with SCI and
reported promising increases in subjective arousal especially when combined with manual and
visual stimulation. The results of this study support the need for larger scale studies of sildenafil
to augment sexual arousal in women with SCI.
Table 15.12 Sexual and Reproductive Health in Women with Spinal Cord Injury
Score
Methods Outcome
Research Design
Total Sample Size
Population: age range=17-59 yrs. 1. Trend towards increased frequency of
Schopp et al. 2002; USA Treatment: attended a women’s health BSE 3 months after initial participation
Downs & Black score=13 clinic, completed pre and post surveys at in the clinic (p=0.11).
Pre-post baseline, 3 months and 12 months. 2. Increased willingness to receive a
N=28 Outcome Measures: survey, breast self mammogram between baseline and
exam (BSE), willingness to receive a 12 months (p=0.125).
mammogram.
Discussion
Schopp et al. (2002) investigated the effect of comprehensive gynecologic services on the
health behaviour of women with SCI. The authors note a trend towards desired behavioural
improvement in one outcome measured, namely, increased willingness to receive a
mammogram. The other outcome measure (adoption of health–promoting behaviours) was not
shown to change.
Conclusion
There is level 1 evidence (from 1 RCT) that supports the use of sildenafil in women with
SCI to partially reverse subjective sexual arousal difficulties.
11-28
There is level 4 evidence that suggests that comprehensive gynecologic services may
not affect women’s health behaviours.
Sildenafil may partially reverse subjective sexual arousal difficulties in women with SCI;
however, larger scale studies are required to solidify this conclusion.
Limited evidence exists that participation in a specialized women’s health clinic may lead to an
increase in preventative gynecologic health care behaviours.
11.6 Sexual Adjustment

There is a growing body of SCI literature on aspects of sexuality beyond genital sexual
functioning and fertility. A large scale (350 respondents over 4 European countries) cross-
sectional questionnaire identified sexual activity as the area of greatest unmet need for persons
with SCI (Kennedy 2006). This is even more disconcerting given the importance placed on
sexuality by men and women with SCI (Anderson 2004). Sexual rehabilitation is recognized as
an important component of the overall rehabilitation program for patients with SCI; however,
retrospective studies identify a gap between services desired by patients and the services
actually provided (White et al. 1993; McAlonan 1996; Tepper 1999). As far back as 1982,
Schuler compared five sexual rehab programs for persons with SCI, and urged clinicians to
evaluate the sexual rehab services provided (Schuler 1982)
Few intervention trials exist in this area, but a number of observational studies offer insight into
post-injury sexual adjustment in terms of sexual behaviour and sexual satisfaction, as to what
factors are perceived as contributing to or hindering sexual satisfaction. A summary of these
findings follows.
11.6.1 Sexual Behaviour

• Frequency of sexual activity and desire for sexual activity decrease after injury in both
men and women (Alexander 1993; White et al. 1993; Jackson & Wadley 1999; Fisher et
al. 2002).
• Fisher et al. (2002) showed a significant increase in sexual activity between inpatient
rehab discharge and their 6 month survey.
• For women, longer duration of injury and lower level of injury (not extent of injury) were
significant positive predictors of sexual intercourse (Jackson & Wadley 1999).
• For men, level and extent of injury have not been found to affect frequency of sexual
activity (Alexander 1993).
• The preferred type of sexual activity for men and women changes after injury. Preferred
activities for women are kissing, hugging and touching, instead of penis-vagina
intercourse (Sipski & Alexander 1993) and for men, oral sex, kissing and hugging
(Alexander et al. 1993).
• Males reported engaging in masturbation significantly more often than females whereas
females indicated being involved in intimate touching more often than males (Mona et al.
2000).
• Males used condoms during penile-vaginal intercourse more often than females and
more females used condoms during oral sex compared to males (Mona et al. 2000).
• Both women and men remain interested in sexual activity after SCI but level of desire
decreases (Charlifue et al. 1992; Alexander et al. 1993)
11-29
11.6.2 Sexual Satisfaction
• Sexual satisfaction is reportedly lower in both men and women after SCI (Alexander et
al. 1993; Fisher et al. 2002; Reitz et al. 2004; Kennedy et al. 2006; Sharma et al. 2006).
• In an exploratory study of comparing African-American men and women with SCI,
authors found that the women reported greater satisfaction with their sex lives than the
men (Krause et al. 2004).
• A comparison study of women with and without SCI, found that married women with SCI
are as sexually satisfied as their able-bodied counterparts (Black et al. 1998).
• In a study involving women with SCI of East Indian culture, the women reported lack of
sexual satisfaction more often than the men (Sharma et al. 2006).
Table 11.13 Sexual Satisfaction

Issues perceived to affect sexual Positive or
Reported in
satisfaction and/or Negative Studies supporting
men/women or both
sexual adjustment Impact
Kreuter et al. 1994; Westgren et
Age (<18 years or >30 years old) (−) women al. 1997; Ferreiro-Velasco et al.
2005
Black et al. 1998; Tepper et al.
Time since injury (+)
2001
Severity of injury (−) Both Mona et al. 2000
White et al. 1993; Richards et al.
Bladder management problems 1997; Jackson & Wadley 1999;
(−) Women
(incontinence/UTI’s) Benevento & Sipski 2002; Blok
& Holstege 1999
Spasticity (−) women Jackson & Wadley 1999
Charlifue et al. 1992; White et al.
Fecal incontinence (−) women
1993; Richards et al. 1997
Charlifue et al. 1992; Jackson &
Autonomic dysreflexia (−) women
Wadley 1999
Sexual self esteem (+) Both Mona et al. 2000
Richards et al. 1997; Elkland &
Altered body image (−) Both, women
Lawrie 2004; Reitz et al. 2004
Altered genital sensation (−) Women Richards et al. 1997
Phelps et al. 2001; Reitz et al.
Sexual desire (+) Both, men
2004
Lack of a partner (−) Women Jackson & Wadley, 1999
Quality of intimate Jackson & Wadley 1999; Phelps
(+) Both/men
relationship/relationship satisfaction et al. 2001; Reitz et al. 2004
Richards et al. 1997; Phelps et
Repertoire of sexual behaviour (+) Men, women
al. 2001
Kreuter et al. 1996; Black et al.
Partner as caregiver (−) women
1998; Pentland et al. 2002
Phelps et al. 2001; Ekland &
Perceived partner satisfaction (+) Men, women
Lawrie 2004
Partner’s understanding of his
(+) Kreuter et al. 1996
partner’s sexual needs
Level of social and vocational
activity; outgoing personality; (+) Kreuter 2000
acceptance of the disability**
Charlifue et al. 1992; Jackson &
Inadequate vaginal lubrication (−) women
Wadley 1999
Ability to move (+) both Reitz et al. 2004
Mental well-being (+) both Reitz et al. 2004
White et al. 1993; Westgren et
Sexual education and counseling (+) women
al. 1997
Peer support (+) Women, both Richards et al. 1997; Fisher et
11-30
Issues perceived to affect sexual Positive or
Reported in
satisfaction and/or Negative Studies supporting
men/women or both
sexual adjustment Impact
al. 2002; Pentland et al. 2002;
Ekland & Lawrie 2004
**correlates positively with partner availability thereby indirectly related to sexual satisfaction
Despite the importance of sexual adjustment to overall quality of life, there have been few
studies addressing this topic and few investigating the effectiveness of interventions on sexual
satisfaction and adjustment to SCI. Studies do support the need for health care providers to
address the area of sexuality during the inpatient rehabilitation period and beyond (Fisher et al.
2002). For women with SCI, qualitative studies reveal a desire for sexuality information to be
received from their peers with SCI (Richards et al. 1997; Fisher et al. 2002; Pentland et al.
2002; Ekland & Lawrie 2004).
The following studies included evaluation of specific interventions on the sexual satisfaction and
adjustment of women with SCI.
Table 11.14 Sexual Parameters Outcome of Continent Urinary Diversion with a

Catheterizable mbilical Stoma in Women with Tetraplegia
Score
Methods Outcome
Research Design
Total Sample Size
Population: 3 females, SCI, age 1. Both sexually active women report a
range=32-33 yrs, level of injury: C5-C7, subjective improvement in the quality
length of injury: 5-15 yrs. and enjoyment of their sexuality.
Moreno et al. 1995; USA
Treatment: catheterizable umbilical stoma. 2. Body image an overall satisfaction
Outcome Measures: pelvic pain, urinary with urologic management improved
Pre-post
tract infections, frequency of sexual in all three patients.
N=3
intercourse, body image. 3. All three women were able to empty
their neo-bladder using a 14F clear
plastic catheter.
Moreno et al. (1995) included sexual parameters in their report of outcome of continent urinary
diversion with a catheterizable umbilical stoma in women with tetraplegia (n=3). They found that
sexual satisfaction improved in the 2 women who were sexually active and body image
improved in all 3 women.
Table 11.15 Common Points from Discussions with Women with SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: ~70 females, SCI. 1. Majority admitted that sex and sexual
Treatment: informal discussion of pre- rehabilitation was not a primary
decided topics surrounding sexual concern during initial rehabilitation.
rehabilitation. 2. All expressed dissatisfaction with
Forsythe & Horsewell
Outcome Measures: qualitative reports amount and quality of the information
2006; UK
based on sexual rehabilitation. received during initial rehabilitation.
Downs & Black score= 5
3. Patients expect clinicians to initiate
Observational
discussion about sex and sexuality.
N=~70
4. Women recounted difficulties in
adjusting to their "new" bodies and
most felt that they had become less
attractive since suffering SCI.
5. The vast majority felt that they first
11-31
Score
Methods Outcome
Research Design
Total Sample Size
became aware of their sexual
problems when they returned home
so post-rehabilitation counseling
would be helpful.
6. The opportunity to talk to other
women who had learned to cope with
living with SCI was regarded by all as
being extremely useful.
7. There was an anxiety about the lack
of knowledge and information about
the effects of SCI on other aspects of
their physiology.
Forsythe and Horsewell (2006) identified common points from their discussions with women
with SCI (all of whom were expected to attend a course dealing with topics of sexuality and
fertility). Women desired more information during the initial rehabilitation phase and continued
opportunity for sexual counseling post-rehabilitation. They indicated sexual counseling should
be initiated by the personnel of the clinic – not by the individual patient. They also regarded peer
counseling as extremely useful in their sexual adjustment. Women expressed anxiety about the
lack of information about gynecological and obstetric issues.
Conclusion
There is level 4 evidence to suggest that a catheterizable umbilical stoma in women with
tetraplegia may improve sexual satisfaction and body image.
There is level 5 evidence to suggest that a comprehensive gynecologic service may

improve women’s health behaviours.
Continent urinary diversion in women with tetraplegia may result in improved self-image, quality
of life, and enables greater sexual satisfaction.
There is level 5 evidence to suggest that a comprehensive gynecologic service may improve
women’s health behaviors.
11.7 Summary
There is level 1 evidence (from 7 RCTs) that supports the use of PDE5i as a safe and
effective treatment for erection dysfunction in men with SCI.
There is level 2 evidence that supports the use of ICI as treatment for erection
There is no evidence to support the use of topical agents as treatment for erection
11-32
There is no evidence that supports the use of intraurethral preparations as treatment for
erection dysfunction in men with SCI.
There is level 4 evidence that supports the use of vacuum devices and penile rings as
There is no evidence to support the use of penile prostheses as treatment for erection
dysfunction (ED) in men with SCI unless there is a failure of all other ED treatments.
Oral PDE5i are the first line treatment for ED in men with SCI, with the more invasive but
successful use of ICI being used most often in men who do not respond to the oral
medications. Mechanical devices such as vacuum devices and rings are effective but not
as popular. Surgical prostheses are reserved for refractory cases.
There is level 4 evidence that semen retrieval can be assisted by vibrostimulation in men
with lesions above T10.
There is level 4 evidence that semen retrieval can be assisted by electroejaculation in

men who failed vibrostimulation
There is level 4 evidence that surgical aspiration can be used to retrieve sperm if
vibrostimulation and electroejaculation are not successful.
There is level 4 evidence that vibratory stimulus appear to result in better sperm motility
than electrostimulation.
There is level 4 evidence that sperm obtained by antegrade samples appear to have
better motility than retrograde samples.
There is level 4 evidence that bladder management with clean intermittent catheterization
improving semen quality over indwelling catheterization, reflex voiding or straining.
There is level 4 evidence that SCI sperm quality can be improved by placing sperm from
SCI in able-bodied seminal plasma, and that aspirated sperm from the vas deferens had
better motility than that ejaculated, demonstrating the etiology of poor semen quality
may lie within the seminal constitutes in men with SCI. These techniques have not been
studied clinically with respect to pregnancy rates.
There is level 4 evidence that men with SCI have a good chance (> 50%) of becoming
biological fathers with access to specialized care utilizing reproductive assisted
technology.
There is level 1 evidence (from 1 RCT) that supports the use of sildenafil in women with
SCI to partially reverse subjective sexual arousal difficulties.
There is level 4 evidence that suggests that comprehensive gynecologic services may
not affect women’s health behaviours.
There is early evidence to suggest that a catheterizable umbilical stoma in women with
tetraplegia may improve sexual satisfaction and body image.
There is no conclusive evidence to suggest that a comprehensive gynecologic service

improves women’s health behaviour.
11-33
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11-40
CHAPTER TWELVE
Neurogenic Bowel Following Spinal Cord Injury
Geri Claxton, RN
Key Points
There is limited evidence that supports a multifaceted program for managing a

neurogenic bowel.
Electrical stimulation of the abdominal wall muscles can improve bowel management
for individuals with tetraplegia.
Functional magnetic stimulation may reduce colonic transit time in individuals with
SCI.
Pulsed water irrigation may remove stool in individuals with SCI. Often more than one
procedure is necessary for individuals that are unable to develop an effective bowel
routine.
There is a need for further research to examine the optimal level of dietary intake in
spinal cord injured patients.
Cisapride, prucalopride, and metoclopramide may be used for the treatment of chronic
constipation in persons with SCI.
There is sufficient evidence to support including polyethylene glycol-based (PGB)

suppositories (10 mg. bisacodyl) in bowel management programs, especially for
persons with an upper motor neuron SCI.
Colostomy is a safe and effective treatment for severe, chronic gastrointestinal

problems and perianal pressure ulcers in persons with SCI, and greatly improves their
quality of life.
Table of Contents
12.1 Introduction ..................................................................................................................12-1
12.2 Function........................................................................................................................12-2
12.2.1 Bowel Function ...........................................................................................................12-2
12.2.2 Anorectal function .......................................................................................................12-2
12.3 Management .................................................................................................................12-3

12.3.1 Multifaceted Programs ................................................................................................12-3
12.3.2 Stimulation ..................................................................................................................12-4
12.3.3 Pulsed water irrigation ................................................................................................12-6
12.3.4 Dietary Fibre ...............................................................................................................12-7
12.3.5 Use of Pharmacological Agents..................................................................................12-8
12.3.6 Use of Suppositories.................................................................................................12-11
12.3.7 Colostomy .................................................................................................................12-12
12.4 Summary.....................................................................................................................12-14
References............................................................................................................................12-16
Claxton G, Abramson C (2006). Neurogenic Bowel Following Spinal Cord Injury. In: Eng JJ, Teasell RW,
Miller WC, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 12.1-12.17.
www.icord.org/scire
Neurogenic Bowel Following Spinal Cord Injury
12.1 Introduction
Neurogenic bowel is defined as a bowel that does not function normally after a spinal cord
injury, as messages to and from the spinal cord are interrupted. It has the potential to disrupt
almost every aspect of life. The effects of neurogenic bowel on quality of life of spinal cord injury
patients are significant. One report found that 27 – 41 % of patients with neurogenic bowel
report chronic gastrointestinal problems that alter lifestyle and may require treatment (Correa &
Rotter 2000). Fear of bowel accidents is a frequent event for people with SCI that causes
individuals to not participate in social and other outside activities (Correa & Rotter 2000). Severe
constipation often follows spinal cord injury. Chronic constipation in patients with spinal cord
injury has a significant impact on quality of life (Longo et al. 1995). The prevalence of chronic
gastrointestinal (GI) symptoms increases with time after injury, suggesting that these problems
are acquired and potentially preventable (Rajendran et al.1992). Clinical experience indicates
that an effective and successful bowel program consists of the predictable, regular and thorough
evacuation of the bowels without the occurrence of incontinence and prevention of
complications. It takes into consideration diet and nutritional factors, use of medications when
necessary and a well-developed, appropriate program that is consistent with the neurologic
condition and needs of the patient with SCI. It is important to emphasize that each person with
SCI is unique and that individual bowel programs need to be client specific. Clinical experience
indicates that the procedures used and the need for medications will depend greatly on the level
of neurologic injury, the extent of impairment and subsequent effect of the injury on bowel
function. The effectiveness of a bowel program should be reevaluated and modified as needed.
Figure 12.1 Gastrointestinal System
Those with an incomplete injury may retain the sensation of rectal fullness and ability to
evacuate bowels so no specific bowel program may be required. A lower lumbar-sacral injury
presents with a “spastic” bowel, also known as an “areflexic” or “lower motor neuron” bowel
characterized by no reflex activity in the rectum. In these individuals manual removal of the
stool from the rectum is required. A higher injury (cervical and thoracic) usually presents with a
“reflexic” bowel, also known as a “spastic” or “upper motor neuron” bowel. It is characterized by
12-1
reflex activity in the rectum. Stool evacuation occurs by means of reflex activity caused by a
stimulus introduced into the rectum such as an irritant suppository or digital stimulation.
Improvement in rehabilitation and medical care has led to increased life span in persons with
SCI. As a result of increased life expectancy, chronic problems are becoming more prevalent in
this population (Rosito et al. 2002). Colostomy is an option when the extent of bowel dysfunction
is severe and other non-surgical methods have failed to produce a desired result. Colostomy is
a safe, effective and well-accepted treatment for severe, chronic gastrointestinal problems, and
perianal pressure ulcers in persons with SCI, and it greatly improves their quality of life (Stone
et al. 1990).
12.2 Function
12.2.1 Bowel Function
Bowel function is a major physical and psychological problem for persons with spinal cord injury.
Following a spinal cord injury, changes in bowel motility, sphincter control and gross motor
dexterity interact to make bowel management a major life-limiting problem. In 2000, Lynch et al.
surveyed 1200 persons with SCI and 1200 age and gender-matched controls to describe bowel
function. For persons with SCI, their mean Fecal Incontinence Score (FIS) was significantly
higher than controls. It was also noted that for persons with complete SCI, their mean FIS was
significantly higher than those persons with incomplete SCI. Quality of life was affected by
incontinence in 62% of SCI respondents compared with 8% of controls. Fecal urgency and time
spent at the toilet were also significantly higher for persons with SCI. A significantly higher
percentage (39%) of SCI respondents use laxatives compared to 4% of controls. The decreased
ability to discriminate gas and liquid for complete SCI patients also makes the chance for fecal
incontinence more likely.
12.2.2 Anorectal function
Difficulties with bowel emptying are of concern to most persons with spinal cord injury. For the
quadriplegic patient, loss of control over visceral function may be seen as more important than
the ability to walk (Frost et al. 1993). Urinary problems in patients with SCI have been
extensively studied, and with the advent of intermittent self-catheterization, electrical stimulation
of the bladder and advances in diagnostic techniques, considerable improvements have been
made in managing lower urinary tract and renal function. In contrast, the management of bowel
disorders, and in particular, the intractable constipation that is so common in these patients, has
remained essentially unchanged over the past two decades (MacDonagh et al. 1990).
Various researchers have shown that electrical stimulation of the somatic nervous system can
bring about an alteration in visceral function in humans. Riedy et al. (2000) showed that the
impact of short periods of electrical stimulation with perianal electrodes, increased anal
pressures. Bowel reflex centres within the sacral spinal cord may be released from descending
inhibition after SCI and may be altered with somatic input (Frost et al. 1993). Electrical sacral
root stimulation induces defacation in SCI patients and is currently under examination as a new
therapy for fecal incontinence. In contrast to electrical stimulation, magnetic stimulation may
produce similar results and is noninvasive (Morren et al. 2001). Morren et al. (2001) studied the
effects of magnetic sacral root stimulation on anorectal pressure and volume in both fecal
incontinence and SCI patients. Sun et al. (1995) investigated the role of spinal reflexes in
anorectal function. Their subjects underwent anorectal manometry and electromyography,
before and after having a sacral posterior rhizotomy performed by the same neurosurgeon.
They found that all subjects lost conscious control of the external anal sphincter, response to
intra-abdominal pressure and response to rectal distention. While the use of sacral root
12-2
stimulation, either electrical or magnetic, seems to be producing positive results, further
research is required.
12.3 Management
Few SCI patients feel normal desire to defecate and most use laxatives, enemas, suppositories
or digital stimulation of the rectum and anal canal to initiate defecation. SCI results in severely
prolonged colonic transit times both in the acute and chronic phase. However, the type of
colorectal dysfunction depends on the level of SCI (Krogh et al. 2000). Colorectal problems
often restrict their social activities and influence their quality of life. Colorectal function is not
completely understood (Krogh et al. 2000). Krogh et al. (2000) and Nino-Murcia et al. (1990)
measured colonic transit time in individuals using ingested radiopaque markers, and abdominal
radiographs taken at 24 hour intervals. They found that the mean transit time through the entire
colon in SCI patients was significantly longer than normal adults. They also note that better
information about colonic transit times and anorectal dynamics could aid in the approach to
management of SCI patients with bowel dysfunction. Difficulty with evacuation has been
attributed to prolongation of the colonic transit time in individuals with SCI.
The Consortium for Spinal Cord Medicine developed guidelines for neurogenic bowel
management (Consortium for Spinal Cord Medicine, 1998). The recommendations include: a
comprehensive evaluation of bowel function, impairment, and possible problems (completed at
the onset of SCI and at least once annually) including a patient history, physical exam,
assessment of function (ability of individual/caregiver to perform procedures safely and
effectively), bowel program design, assistive techniques/devices, and nutrition.
The management of neurogenic bowel complications is reliant on the physician to recognize the
common complications and their clinical presentation (Consortium for Spinal Cord Medicine,
1998). Common complications include constipation, fecal impaction and hemorrhoids. The
management protocols recommended for constipation are: establishment of a balanced diet,
adequate fluid and fibre intake, increased daily activity, and if possible reduction or elimination
of medication contributing to constipation. If these recommendations fail, prokinetic medication
may be used to promote transit through the gastrointestinal tract. The management protocols
recommended for fecal impaction are (in order): manual evacuation, oral stimulants, and oil
retention enemas. To minimize the development of hemorrhoids, oral agents (to maintain soft-
formed stool), less straining, and minimal physical trauma during anal stimulation are
recommended. Once hemorrhoids have developed, topical anti-inflammatory creams or
suppositories are suggested as early treatment. Overall the Consortium for Spinal Cord
Medicine recommends further research in all bowel management areas (Consortium for Spinal
Cord Medicine, 1998).
12.3.1 Multifaceted Programs
There are several factors that may influence bowel function including nutrition, fluid
consumption, and routine bowel evacuations. Multifaceted programs incorporate more than one
of the factors in an attempt to reduce colonic transit time as well as decrease the incidences of
difficult evacuations.
12-3
Table 12.1 Multifaceted Programs after a spinal cord injury
Score
Total Sample Size
Population: age range=19-71yrs 21 1. Post SCI DIE was increased (from
complete, 10 incomplete, and 7 medullary 2.6% to 26.3%) from pre SCI DIE
cone syndrome and cauda equina; 2/21 (recall from memory)
Correa & Rotter 2000; tetraplegic and 19/21 paraplegic (complete 2. The most frequent GI symptom was
Chile lesions); length of injury range=5 months- abdominal distention.
Downs & Black score=13 16yrs 3. With the intestinal program, the
Pre-post Treatment: Intestinal program incidence of DIE was reduced to
N=38 administration and 6-month follow-up. 8.8% and manual extraction was
Outcome Measures: Difficulty in intestinal reduced from 53% to 37%.
evacuation (DIE); colonic transit time;
anorectal manometry; recto-colonoscopy;
gastrointestinal (GI) symptoms
Population: Gender: m=5, f=5; Age: range
20 to 60, mean 33yrs; Level of injury: C3 to 1. Bowel frequency was reported to
L4 have increased at the end of
Badiali et al. 1997; Italy Treatment: multifaceted intervention training.
Downs & Black score=13 including diet, water intake, and evacuation 2. By the end of the study period the
Pre-post schedule gastrointestinal transit time (TGITT)
N=10 Outcome Measures: 3 variables were was reduced.
assessed: bowel movement frequency,
bowel habit, total and segmental large-
bowel transit time.
Discussion
The two different multifaceted bowel management programs above reduced both the
gastrointestinal transit time (Badiali et al. 1997) and the incidences of difficulty in intestinal
evacuation (Correa & Rotter 2000). As both studies incorporated several factors into the bowel
management programs including diet, fluid consumption, and routine bowel practice it is not
possible to determine the key factor.
Conclusion
There is level 4 evidence (from two pre-post studies) that multifaceted bowel
management programs reduce gastrointestinal transit time and incidences of difficult
evacuations.
There is limited evidence that supports a multifaceted program for

managing a neurogenic bowel.
12.3.2 Stimulation
The Consortium of Spinal Cord Medicine (1998) acknowledges the use of electrical stimulation
as a potential treatment modality but recommends further research.
Different types of stimulation that have been tested are functional magnetic stimulation (FMS),
abdominal belt with embedded electrodes for electrical stimulation, and a Brindley implanted
stimulator. Magnetic stimulation applies Faraday's law which generates magnetic field changes
to induce an electric field. This induced electric field can generate sufficient current to stimulate
12-4
nerves. Magnetic stimulation is relatively new compared to standard electrical current
stimulation applied by electrodes. Anterior nerve root stimulation (e.g., Brindley implanted
stimulator) was originally developed for bladder control but has been also used to treat bowel
function.
Table 12.2 Electrical stimulation for neurogenic bowel after a spinal cord injury
Score
Total Sample Size
Population: Age range=23-67 years (SCI 1. Activation of the abdominal belt
part A subjects), mean=48 years (part B resulted in a significant reduction in
SCI subjects); 9 tetraplegics, 7 paraplegics; time to first stool and time for total
mean length of injury=13 yrs bowel care independent of the level of
Treatment: An abdominal belt with injury.
embedded electrodes was wrapped around 2. The time to first stool and time for total
Korsten et al. 2004; USA
at the umbilicus level. Device activation bowel care were significantly
PEDro=6
was random, subjects did not know shortened in the 6 subjects with
RCT
whether the device was activated. Subjects tetraplegia, but not in the 2 subjects
N=16
used belt for six bowel care sessions over with paraplegia.
2 weeks (the belt was activated for three
sessions and deactivated for three
sessions).
Outcome Measures: time to first stool,
time for total bowel care.
Population: 13 SCI, 2 controls, level of 1. Rectal pressures increased with
injury range=C3-L1; length of injury sacrolumbar stimulation, and with
range=11-35 years (protocol 2 only); ASIA transabdominal stimulation.
classes=7 A, 3 B, 1 C. 2. With stimulation, the mean colonic
Treatment: Protocol 1: measured the transit times decreased from 105.2 to
effects of functional magnetic stimulation 89.4 hours.
Lin et al. 2001; USA (FMS) on rectal pressure by placing the
Downs & Black score=12 magnetic coil on the transabdominal and
Pre-post lumbosacral regions. Protocol 2: consisted
N=15 of a 5-week stimulation period to
investigate the effects of functional
magnetic stimulation on total and
segmental colonic transit times.
Outcome Measures: rectal pressure and
total and segmental transit times
Population: 4 SCI, 5 controls, mean age: 1. The gastric emptying time of post-
42+/-5.8 years; level of injury: C3-C7; stimulation was significantly shorter
ASIA: 3 B, 1 D than the baseline.
Treatment: Each subject participated in a 2. The percentage of gastric emptying
3-day protocol. On the first day subjects at baseline and with FMS was
received a baseline gastric emptying study. significantly different over the time
Lin et al. 2002; USA
On day 2 there was no change in the course of the measurements.
eating pattern and the subject did not
Pre-post
undergo any intervention. On day 3
N=9
subjects received functional magnetic
stimulation (FMS) while undergoing a
second gastric emptying study.
Outcome Measures: Rate of gastric
emptying
MacDonagh et al. 1990; Population: 12 Patients with complete 1. 6 patients achieved full defecation with
UK supraconal spinal cord lesions, > 2 years implant and manual help no longer
Downs & Black score=10 post-injury required.
Pre-post Treatment: Implanted Brindley-Finetech 2. time taken to complete defecation was
12-5
Score
Total Sample Size
N=12 intradural sacral anterior root stimulator reduced
Outcome Measures: full defecation 3. 3.all were free from constipation
Population: 2 groups: 7 SCI with 1. There was no significant difference
implanted stimulator; 10 SCI without between the oro-caecal times for the
implant, Age range=20-50 years; C3-T10; controls and the SCI group or between
time since injury range=1-21 years the controls and the Brindley
Binnie et al. 1991; UK
Treatment: comparing individuals with SCI stimulator group (p>0.05).
with a Brindley anterior sacral root 2. Paraplegics in stimulator group had a
stimulator implant to individuals with SCI significant increase in defecation
Trial
without the implant frequency compared to the SCI group.
N=27 Outcome Measures: Oro-caecal and oro- 3. There was a non-significant trend
anal transit time, fecal water content, and towards a more rapid CTT in the
frequency of defecation stimulator group compared to the SCI
group.
Discussion
Stimulation has been tested to determine whether or not it affects colonic transit time in
individuals with SCI. The use of functional magnetic stimulation decreased the mean colonic
transit time (Lin et al. 2002; Lin et al. 2001), as did an overnight abdominal belt (with implanted
electrodes) for tetraplegic subjects (Korsten et al. 2004). However, an implanted Brindley
stimulator did not reduce oro-caecal time for individuals with SCI (Binnie et al. 1991).
Conclusions
There is level 1 evidence (from 1 RCT) that electrical stimulation of the abdominal wall
muscles can improve bowel management for individuals with tetraplegia.
There is level 4 evidence that supports the use of functional magnetic stimulation as a
method to reduce colonic transit time in individuals with SCI.
There is level 2 evidence that supports the use of sacral anterior root stimulation to
reduce severe constipation in complete injuries.
Electrical stimulation of the abdominal wall muscles can improve bowel

management for individuals with tetraplegia.
Functional magnetic stimulation may reduce colonic transit time in individuals with SCI.
12.3.3 Pulsed water irrigation
Persons with spinal cord injury require assistance with the regular emptying of their bowels, and
this may include the use of medications, suppositories, digital stimulation and/or mini enemas
(Consortium of Spinal Cord Medicine, 1998). Clinical experience shows that in spite of their best
effort, some persons with SCI, especially with a lower injury, are unable to achieve an effective,
productive, regular bowel routine, and must look to other methods to assist in this process.
Pulse water irrigation (intermittent rapid pulses of warm water) into the rectum, to break up stool
impactions and stimulate peristalsis, is one such technique (Puet et al. 1997).
12-6
Table 12.3 Pulsed water irrigation for neurogenic bowel after spinal cord injury
Score
Total Sample Size
Population: 31 SCI 1. Successful in removing stool in all
Treatment: Pulsed irrigation evaluation but three patients.
was used in SCI patients. It consists of 2. 11 patients had multiple procedures.
Puet et al. 1997; USA
intermittent, rapid pulses of warm water to 3. 162 procedures were performed on
break up stool impactions and stimulate 4 outpatients on a regular basis
Case Series
peristalsis. because they could not develop an
N=31
Outcome Measures: Efficacy of effective bowel routine with the
technique, outpatient use standard digital stimulation,
suppositories, or mini enemas.
Discussion
Pulsed irrigation evacuation is a safe and effective method for individuals with SCI (Puet et al.
1997) who develop impactions or do not have an effective bowel routine.
Conclusion
There is level 4 evidence (from 1 case series study) that supports using pulsed water
irrigation (intermittent rapid pulses) to remove stool in individuals with SCI.
Pulsed water irrigation may remove stool in individuals with SCI. Often more than one
procedure is necessary for individuals that are unable to develop an effective bowel routine.
12.3.4 Dietary Fibre
It is well known that fibre is an important part of any diet. There are different types of fibre, which
are beneficial in different ways. Soluble fibres mix with water in the intestine to form a gel-like
substance, which acts as a trap to collect certain body wastes and move them out of the body.
Insoluble fibres absorb and hold water. They provide ‘bulk” that pushes food through the
digestive system quickly. Insoluble fibres promote regularity and treat constipation.
The Consortium for Spinal Cord Medicine (1998) recommends an initial diet with no less than 15
grams of fibre daily. They do not recommend placing individuals with SCI on high fibre diets
(Consortium for Spinal Cord Medicine, 1998). The most common source of dietary fibre is bran.
Clinical experience shows that too much fibre can cause problems, such as constipation, for
people with spinal cord injuries. Finding the right balance is essential.
12-7
Table 12.4 Dietary fibre for managing neurogenic bowel after a spinal cord injury
Score
Total Sample Size
Population: Age range: 19-53yrs, SCI: C4- 1. Following the addition of bran, dietary
T12; 1 incomplete and 10 complete; 7 fibre intake significantly increased from
tetraplegics and 4 paraplegics 25g/d to 31g/d.
Cameron et al. 1996; Treatment: In phase 1, subjects ate a 2. Mean colonic transit time increased
Australia normal hospital diet and maintained their from 28.2 hours to 42.2 hours (p<.05)
Downs & Black score=10 bowel routine. In phase 2, fibre intake was
Case Series increased with the addition of 40g Kellogg’s
N=11 All Bran.
Outcome Measures: stool weight, total
and segmental transit time, bowel
evacuation time and dietary intake
Discussion
Results of this study suggest that increasing dietary fibre in SCI patients does not have the
same effect on bowel function as has been previously demonstrated in individuals with normally
functioning bowels. The effect may actually be the opposite of the desired result (Cameron et al.
1996). Therefore, adding more fibre alone does not increase bowel function.
Conclusion
There is level 4 evidence that indicates high fibre diets may increase colonic transit time.
There is a need for further research to examine the optimal level of dietary intake in spinal
cord injured patients.
12.3.5 Use of Pharmacological Agents
Prokinetic agents are presumed to promote transit through the gastrointestinal tract, thereby
decreasing the length of time for stool to pass through the intestines, and increase frequency of
stool available for evacuation. Cisapride (the most common), prucalopride and metoclopramide,
are three examples used in the following research. The presence of constipation with slow
transit in patients with SCI has been well documented (Geders et al. 1995). Often medication is
a last resort, when modification of the bowel program by altering diet or increasing fluids does
not achieve the required result – a decrease in constipation. Its use is often reserved for
persons with SCI with severe constipation and where modification of the bowel program has
failed. Chronic constipation is a common problem after spinal cord injury affecting up to 80% of
such patients (Krogh et al. 2002).
12-8
Table 12.5 Treatment studies using pharmacology for neurogenic bowel after SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: mean age range: SCI - 58.8 1. Mean total colonic transit time
years, controls - 63.4 years, 2 paraplegics, (CTT) was significantly longer in
7 quadriplegics SCI patients than controls.
Treatment: Cisapride or placebo 2. Subjects with a normal CTT
Geders et al. 1995; USA administered in oral doses. Pts received demonstrated no benefit to the
PEDro=8 cisapride or placebo 3 days before administration of cisapride.
RCT ingestion of the radiopque markers. 3. 5 quadriplegic subjects with initial
N=9 Outcome Measures: total and segmental abnormal total CTT improved their
colonic transit time (CTT), questionnaire on left CTT following treatment
type, frequency, and severity of clinical 4. No adverse side effects of
symptoms before and after cisapride or cisapride administration were
placebo administration noted.
Population: Age range: 19-71yrs, SCI: C4- 1. No delay or improvement in gastric
L2; 7 tetraplegics and 7 paraplegics; length emptying was observed after the
of injury range=7months-33yrs administration of cisapride.
Treatment: Subjects were administered 2. Mean MCTT in quadriplegic subjects
Rajendran et al. 1992; cisapride orally (10mg four times a day) for was significantly longer than normal
USA 4d. Gastric emptying or mouth-to-cecum subjects; cisapride resulted in
PEDro=8 transit time (MCTT) was measured either normalization of the quadriplegic
RCT on the 4th or 5th day after the subjects’ MCTT
N=14 administration of cisapride or placebo. The
control subjects were tested without
medication or placebo.
Outcome Measures: mouth-to-cecum
transit time; gastric emptying
Population: mean age: 34.7±2.49 yrs 1. Compared with baseline, mean
(placebo), 36.5±3.91 yrs (1mg group), changes in constipation severity
44.3±3.05 yrs (2mg group) increased with placebo, but decreased
Treatment: Pts randomized to double-blind with prucalopride.
Krogh et al. 2002;
treatment with prucalopride 1mg or 3. Diary data showed an improvement in
Denmark
placebo, taken 1/day for 4 wks. A 2nd group average weekly frequency of all bowel
PEDro=7
of pts was randomized to double-blind movements over 4wks within the 2mg
RCT
treatment with prucalopride 2mg or placebo group
N=22
for 4wks. 4. 4 patients (2mg group) reported
Outcome measures: constipation; urinary moderate/severe abdominal pain.
habit; constipation severity and symptoms;
colonic transit times
Population: mean age: 34.1yrs, 9 males, 1 1. The colonic transit time (CTT) was
female, age range 20-45yrs; level of injury: reduced from 185 to 123 hours.
C4-T10, all complete; length of injury:
Binnie et al. 1988; UK
mean 8.1yrs, range 1-20 yrs
Treatment: Intravenous injection of 10 mg
Case Series
cisapride. After an interval of at least 48
N=10
hours the subject was commenced on oral
cisapride.
Outcome measures: Oro-caecal transit
time
Population: Age range was from 20 to 55 1. The mean gastric emptying (GE)
years, complete SCI, 11 quadriplegic, 9 half time for a liquid meal decreased
paraplegic, 8 controls in the quadriplegic subjects from
Segal et al. 1987; USA
Treatment: subjects ingested a liquid 104.8 min to 18.8 min after
Downs & Black score=9 nd
meal, then within 2 weeks, ingested 2 treatment with metoclopramide.
liquid meal while metoclopramide was 2. In the paraplegic subjects, a
Trial
administered intravenously; gastric pretreatment mean GE of 111.5 min
N=20, Control N=8
emptying (GE) was evaluated after each decreased to 29.1min.
liquid meal
Outcome Measures:
12-9
Score
Methods Outcome
Research Design
Total Sample Size
half time of gastric emptying, gastric
emptying patterns in the early (alpha) and
later (beta) phases
Population: Gender: male; SCI: 12 1. All patients had three months or more
tetraplegics and 3 paraplegics, length of of treatment with cisapride.
injury=3-356 months 2. 6/12 reported that symptoms of
Treatment: After establishing baseline constipation improved.
studies, patients with constipation, received 3. 9/12 patients reported that the amount
Longo et al. 1995; USA
one oral cisapride 20mg tablet three times of time needed to accomplish a bowel
Downs & Black score =9
each day for one month. Pts offered drug movement decreased.
Case Series
for two additional months, all 4. No patient reported a worsening of
N=15
measurements were repeated. constipation.
Outcome Measures: colonic transit study;
anorectal manometry; bowel movement per
day or week; intestinal transit and pelvic
floor studies
Discussion
In persons with SCI with chronic constipation, cisapride appears to produce subjective
improvement in both colonic and anorectal function with alleviation of symptoms (Longo et al.
1995). Their study also found that there an increase in stool frequency and less use of laxatives,
as well as an increase in the ease of defecation. A significant reduction in colonic transit time
(CTT), from 7.7 days to 5.1 days, was reported (Binnie et al. 1988). Geders et al. (1995) and
Rajendran et al. (1992) found that in quadriplegic subjects with initial abnormal transit times,
cisapride improved transit times. In conjunction with newer and more sophisticated techniques
of CTT measurement, further investigations of cisapride in those with SCI and symptomatic
bowel dysfunction is warranted (Geders et al. 1995). Segal et al. (1987) investigated the use of
metoclopramide in enhancing gastric emptying in the SCI. They found that impaired gastric
emptying is a characteristic of SCI and is correlated with decreased drug absorption. Since
constipation in patients with both acute and chronic SCI is considered primarily a consequence
of prolonged colonic transit time, stimulating intestinal motility would appear to be a reasonable
therapeutic approach. Prucalopride is a novel, highly selective, specific serotonin receptor
agonist with enterokinetic properties and facilitates cholinergic and excitatory non-adrenergic
non-cholinergic neurotransmission (Krogh et al. 2002).
Conclusion
Cisapride: There is level 1 evidence (from 2 RCTs) that cisapride significantly reduces
the colonic transit time for chronic constipation.
Prucalopride: There is level 1 evidence (from 1 RCT) that prucalopride increases stool
frequency, improves stool consistency and decreases gastrointestinal transit time.
Metoclopramide: There is level 2 evidence (from 1 prospective controlled trial) that

intravenous administration of metoclopramide corrects impairments in gastric emptying.
Cisapride, prucalopride, and metoclopramide may be used for the treatment of chronic
constipation in persons with SCI.
12-10
12.3.6 Use of Suppositories
More than 20% of persons with SCI report difficulty with evacuation of their bowels (House et al.
1997). The use of chemical rectal agents (suppositories) is a common, often necessary part, of
a successful bowel management program, for a person with spinal cord injury. Bisacodyl
(dulcolax) and glycerin are the most common active ingredients in these suppositories. The
glycerin suppository is a mild local stimulus and lubricating agent. Bisacodyl (dulcolax) is an
irritant that acts directly on the colonic mucosa producing peristalsis throughout the colon. The
bisacodyl may also have a vegetable oil, or polyethylene glycol base. The most commonly used
laxative suppositories contain 10mg. Bisacodyl powder distributed within a hydrogenated
vegetable-oil base (HVB) (House et al. 1997).
Table 12.6 Treatment studies using suppositories for neurogenic bowel after SCI
Score
Total Sample Size
Population: Age range=26-61, 9 cervical, Time to Flatus
6 thoracic, 11 complete, 4 incomplete, 1. PGB sig. less time than HVB
length of injury: 3 months to 45 years Flatus to stool flow
Treatment: At each regularly scheduled 2. No sig. differences
House & Stiens 1997; bowel care session, either a 10 mg Defecation Period
USA hydrogenated vegetable-oil base (HVB) or 3. PGB sig. less time than HVB
PEDro=7 10 mg polyethylene glycol base (PBG) Overall
RCT suppository was inserted. 4. PGB suppositories significantly
N=15 Outcome Measures: time to flatus, flatus decreased bowel care time
to stool flow, defecation period, wait until
transfer cystometrogram, intracolonic
pressure, colonic motor and myoelectrical
activity
Population: age range=27-67yrs, C5-L1, 5 1. For group A the mean evacuation
tetraplegics, 9 paraplegics, length of injury time was significantly reduced with
range=2-38yrs Theravac SB compared to the mean
Treatment: pts used bisacodyl times with the bisacodyl
suppositories for five bowel programs for interventions.
Dunn & Galka 1994; baseline data, used Theravac SB for the 2. There was a significant reduction in
USA next five bowel programs, then used mean evacuation time with the
Downs & Black score=12 bisacodyl for five more bowel programs all Theravac SB intervention compared
Case Series while recording similar information in a to the mean time with both of the
N=14 diary log. bisacodyl interventions.
Outcome Measures: time of insertion of 3. There was not significant difference
the rectal medication; time of first in evacuation time between the first
evacuation; time required to complete the and second bisacodyl interventions.
first evacuation; other interventions used;
bowel problems between bowel programs
Population: Age range=21-76yrs, C4-T12, 1. The total CTT was significantly
6 tetraplegics, 1 paraplegic, length of injury reduced with docusate sodium mini-
range=2-25yrs enemas.
Treatment: Each subject was studied after 2. There was no significant difference
receiving one week of therapy with one of in total CTT between docusate
Amir et al. 1998; USA the following four modalities: 1) two sodium and mineral oil enema, and
Downs & Black score=9 bisacodyl suppositories, 2) two glycerin both produced significantly shorter
Cohort suppositories, 3) one mineral oil enema transit times compared to bisacodyl
N=7 and 4) one docusate sodium mini enema or glycerin suppositories.
(Theravac SB) daily. 3. Bowel evacuation time was least for
Outcome Measures: total colonic and docusate sodium mini-enemas.
segmental colonic transit times 4. In terms of difficulty with evacuation,
docusate sodium scored best in
symptom reduction followed by, in
12-11
Score
Total Sample Size
descending order of efficacy,
mineral oil enema, bisacodyl
suppositories and glycerin
suppositories.
Discussion
The effectiveness of the hydrogenated vegetable oil-based (HVB) bisacodyl suppositories

compared to the polyethylene glycol-based (PGB) suppositories has often been examined. The
total bowel care time with the polyethylene glycol-based suppository is often significantly less
(Dunn & Galka 1994). House and Stiens (1997) compared the effectiveness of hydrogenated
vegetable-based, polyethylene glycol-based and docusate glycerin (mini-enema) in subjects
with upper motor neuron (UMN) lesions. Results showed a significant decrease in bowel care
time using the PGB suppository and the mini-enema as compared with the HVB suppositories.
Chemical rectal agents (suppositories) are used commonly by persons with SCI to maintain or
enhance a successful bowel management program.
Conclusion
There is level 1 evidence (from 1 RCT) to support polyethylene glycol-based (PGB)

suppositories for bowel management. There is a clinically significant decrease in the
amount of nursing time for persons requiring assistance and less time performing bowel
care for the independent individual.
There is sufficient evidence to support including polyethylene glycol-based (PGB) suppositories

(10 mg. bisacodyl) in bowel management programs, especially for persons with
an upper motor neuron SCI.
12.3.7 Colostomy
Bowel dysfunction is perceived as one of the most important disabilities, causing great anxiety
and a source of emotional upset. Of all the medical problems experienced by persons with SCI,
many rate the loss or change in bowel habit, to be one of the most significant factors affecting
their quality of life. A colostomy is the surgical formation of an artificial anus by connecting the
colon to an opening in the abdominal wall. SCI patients, who receive elective colostomy, have
usually exhausted medical treatments available to them for bowel management. Colostomy is
an option when the extent of bowel dysfunction becomes severe and other non-surgical
methods have failed to produce a desired result. Colostomy is also frequently advocated as an
adjunct in the treatment of perineal pressure ulcers, in SCI patients. However, colostomy
following SCI is not routinely used, and is seen by many as failure of rehabilitation services.
There is no general consensus as to when colostomy should be performed in SCI patients
because there has been no way to capture the vague gastrointestinal problems that often
necessitate colostomy. Colostomy significantly improved the quality of life (QOL) index in
patients with SCI (Rosito et al, 2002).
Table 12.7 Colostomy after a spinal cord injury
12-12
Score
Total Sample Size
Population: 26 pts w/ colostomy: age: 22- 1. No significant difference (p>0.05) in
87 yr, 10 pts w/ cervical SCI, 16 w/ the 2 groups of pts in regard to their
Randell et al. 2001; lumbar/lower thoracic SCI, 26 SCI without general well being, emotional, social
New Zealand colostomy or work functioning.
Downs & Black score=17 Treatment: Burwood Quality of Life
Case Control Outcome Measures: Burwood Quality of
N=52 Life Questionnaire: 5 areas: systemic
symptoms, and emotional, social, work and
bowel function
Population: Age at injury: average 28.9 1. The average time spent on bowel
yrs; level of injury: 10 cervical, 18 thoracic, care per week decreased from 10.3
3 lumbar; length of injury: mean 17.1 years hours to 1.9 hours (p<.0001).
Branagan et al. 2003; UK
Treatment: Medical records were 2. 18/31 patients felt the colostomy
reviewed for patients who had a colostomy. gave them greater independence.
Case Series
Outcome Measures: Results of surgery 3. 25 patients wished they had been
N=32
offered a stoma earlier.
4. No patients wanted a stoma
reversal.
Population: Mean age 51.6 years, level of 1. All seven patients who had
injury C4-T10; length of injury mean 15.7 colostomy performed as an adjunct
Stone et al. 1990; USA
years to the treatment of perianal
Treatment: Medical records were pressure ulcers successfully healed
Retrospective Case
reviewed for patients who had undergone a their ulcers.
Series
colostomy 2. The amount of time spent on bowel
N=7
Outcome Measures: Efficacy of care decreased dramatically in the
colostomy. patients with prolonged bowel care.
Population: mean age=62.9 years; 26 1. quality of life (QOL) improved
males, 1 female, level of injury range=C4- significantly (p<0.0001) after
L3; 17 complete and 10 incomplete colostomy.
injuries; mean length of injury=25.8 years 2. all 27 patients were satisfied, 16 very
Intervention: completed questionnaire satisfied
Outcome Measures: Quality of Life 3. Colostomy reduced the number of
Rosito et al. 2002; USA questionnaire with 5 domains: physical hospitalizations caused by chronic
Downs & Black score=8 health, psychosocial adjustment, body bowel dysfunction by 70.4%.
Case Series image, self-efficacy, and recreation/leisure 4. After colostomy, the average amount
N=27 of time spent on bowel care was
reduced from 117.0 min/day to 12.8
min/day (p<0.0001).
5. Significance improvements were
recorded in the areas of physical
health, psychosocial adjustment, and
self-efficacy.
Discussion
Colostomy is a safe, effective and well-accepted treatment for severe, chronic gastrointestinal
problems and perianal pressure ulcers in persons with SCI. As the research shows, colostomy
reliably reduces the number of hours spent on bowel care, greatly simplifies bowel care routine,
reduces the number of hospitalizations caused by gastrointestinal problems and improves
quality of life (Stone et al. 1990). Colostomy increases independence, ability to travel, elevates
the feelings of self-efficacy, and does not negatively affect body image. Colostomy was well
received by the patients and either met or exceeded their expectations. It appears that most
patients would have preferred to have the colostomy done earlier. The evolution of health care
will require physicians to evaluate more critically the impact of surgical interventions, e.g.
colostomy, on the patient’s well-being.
12-13
Conclusions
There is level 4 evidence (one level 4 study) that colostomy reduces the number of hours
spent on bowel care, greatly simplifies bowel care routines, and reduces the number of
hospitalizations caused by gastrointestinal problems.
There is level 4 evidence (one level 4 study) that colostomy improves the physical health,
psychosocial adjustment and self-efficacy areas within quality of life.
Colostomy is a safe and effective treatment for severe, chronic gastrointestinal problems and
perianal pressure ulcers in persons with SCI, and greatly improves their quality of life.
12.4 Summary
Gastrointestinal (GI) complications are frequent following a SCI and their daily challenges can
severely affect the quality of life of an individual. In addition, GI complications can lead to visits
to physicians, re-hospitalizations and even death. The evidence suggests that a multi-faceted
approach to bowel management is effective and includes consideration of diet, medications,
fluid intake, and evacuation schedules. When severe constipation persists and a bowel
program cannot be attained, surgical options such as a colostomy or implanted stimulator may
be considered.
There is level 4 evidence (from two pre-post studies) that multifaceted bowel
management programs reduce gastrointestinal transit time and incidences of difficult
evacuations.
There is level 1 evidence (from 1 RCT) that electrical stimulation of the abdominal wall
muscles can improve bowel management for individuals with tetraplegia.
There is level 4 evidence that supports the use of functional magnetic stimulation as a
method to reduce colonic transit time in individuals with SCI.
There is level 2 evidence that supports the use of sacral anterior root stimulation to
reduce severe constipation in complete injuries.
There is level 4 evidence (from 1 case series study) that supports using pulsed water
irrigation (intermittent rapid pulses) to remove stool in individuals with SCI.
There is level 4 evidence that indicates high fibre diets may increase colonic transit time.
Cisapride: There is level 1 evidence (from 2 RCTs) that cisapride significantly reduces
the colonic transit time for chronic constipation.
Prucalopride: There is level 1 evidence (from 1 RCT) that prucalopride increases stool
frequency, improves stool consistency and decreases gastrointestinal transit time.
Metoclopramide: There is level 2 evidence (from 1 prospective controlled trial) that

intravenous administration of metoclopramide corrects impairments in gastric emptying.
12-14
There is level 1 evidence (from 1 RCT) to support polyethylene glycol-based (PGB)
suppositories for bowel management. There is a clinically significant decrease in the
amount of nursing time for persons requiring assistance and less time performing bowel
care for the independent individual.
There is level 4 evidence (one level 4 study) that colostomy reduces the number of hours
spent on bowel care, greatly simplifies bowel care routines, and reduces the number of
hospitalizations caused by gastrointestinal problems.
There is level 4 evidence (one level 4 study) that colostomy improves the physical health,
psychosocial adjustment and self-efficacy areas within quality of life.
12-15
References
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comparison of four approaches. J Spinal Cord Med 1998;21:21-24.
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treatment of chronic constipation in paraplegic subjects. Spinal Cord 1997;35:116-120.
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injury. In Clinical practice guidelines. Paralyzed Veterans of America; 1998.
Correa GI, Rotter KP. Clinical evaluation and management of neurogenic bowel after spinal
cord injury. Spinal Cord 2000;38:301-308.
Dunn KL, Galka ML. A comparison of the effectiveness of Therevac SB and bisacodyl
suppositories in SCI patients' bowel programs. Rehabil.Nurs 1994;19:334-338.
Frost F, Hartwig D, Jaeger R, Leffler E, Wu Y. Electrical stimulation of the sacral dermatomes in
spinal cord injury: effect on rectal manometry and bowel emptying. Arch Phys Med Rehabil
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Geders JM, Gaing A, Bauman WA, Korsten MA. The effect of cisapride on segmental colonic
transit time in patients with spinal cord injury. Am.J.Gastroenterol 1995;90:285-289.
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in patients with thoracic spinal cord injury. Gastroenterology 1984;86:287-294.
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effectiveness of three agents. Arch Phys Med Rehabil 1997;78:1062-1065.
Keshavarzian A, Barnes WE, Bruninga K, Nemchausky B, Mermall H, Bushnell D. Delayed
colonic transit in spinal cord-injured patients measured by indium-111 Amberlite
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Korsten MA, Fajardo NR, Rosman AS, Creasey GH, Spungen AM, Bauman WA. Difficulty with
evacuation after spinal cord injury: Colonic motility during sleep and effects of abdominal
wall stimulation. JRRD 2004;41:95-99.
Krogh K, Jensen MB, Gandrup P, Laurberg S, Nilsson J, Kerstens R, De Pauw M. Efficacy and
tolerability of prucalopride in patients with constipation due to spinal cord injury. Scand J
Gastroenterol 2002;37:431-436.
Krogh K, Mosdal C, Laurberg S. Gastrointestinal and segmental colonic transit times in patients
with acute and chronic spinal cord lesions. Spinal Cord 2000;38:615-621.
Lin VW, Kim KH, Hsiao I, Brown W. Functional magnetic stimulation facilitates gastric
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Lin VW, Nino-Murcia M, Frost F, Wolfe V, Hsiao I, Perkash I. Functional magnetic stimulation of
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Longo WE, Woolsey RM, Vernava AM, Virgo KS, McKirgan L, Johnson FE. Cisapride for
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12-17
CHAPTER THIRTEEN
Bladder Health And Function

Jane TC Hsieh, MSc

Dalton L Wolfe, PhD
Key Points
Those able to use intermittent catheterization will likely have fewer short- and long-
term urological and renal complications and become catheter free faster but will not
necessarily have a greater chance of becoming catheter-free as compared to other
methods of bladder management.
Early electroacupuncture therapy as adjunctive therapy with other bladder

management methods may result in decreased time to achieve desired outcomes.
Although both pre-lubricated and hydrophilic catheters have been associated with
reduced incidence of UTIs as compared to conventional Poly Vinyl Chloride catheters,
less urethral microtrauma with their use may only be seen with pre-lubricated
catheters.
Oxybutynin administered along with intermittent catheterization may reduce

incontinence.
Valsalva or Crede maneuver may assist some individuals to void spontaneously but
also may produce high intra-vesical pressure, increasing the risk for long-term
complications.
Penile implants may allow easier use of condom catheters and reduce incontinence.
With diligent care and ongoing medical follow-up indwelling suprapubic

catheterization may be an effective and satisfactory bladder management choice for
some people.
Sacral anterior root stimulation (accompanied in most cases by posterior sacral

rhizotomy) enhances bladder function and is an effective bladder management
technique for some people.
Dorsal penile nerve stimulation and direct bladder stimulation may be effective in
enhancing bladder function but requires further study.
Epidural dorsal spinal cord stimulation and functional electrical stimulation of the
lower limbs are not effective in enhancing bladder function.
Surgical and prosthetic approaches (with a sphincterotomy and stent respectively) to

allow bladder emptying from a previously dysfunctional external sphincter both seem
equally effective resulting in enhanced bladder function.
Transurethral balloon dilation of the external sphincter may be associated with

enhanced bladder function but requires further study.
Cutaneous ileal conduit diversion may increase the likelihood of achieving continence
but may also be associated with a high incidence of various long-term complications.
Propiverine, oxybutynin, tolterodine and trospium chloride are efficacious

anticholinergic agents for the treatment of SCI neurogenic bladder.
Oxybutynin co-treatment with Verapamil may enhance the standard formulation of
oxybutynin in the treatment of SCI detrussor hyperreflexia.
Tolterodine likely results in less dry mouth but is similar in efficacy to oxybutynin in
terms of improving neurogenic detrusor overactivity.
Tamsulosin is likely to improve urine flow in SCI individuals with bladder neck
dysfunction.
Mosixylyte is likely able to decrease maximum urethral closure pressure at a dose of

0.75mg/kg in individuals with SCI.
Terazosin may be an alternative treatment for bladder neck dysfunction in individuals

with SCI. but side effects and drug tolerance should be monitored.
Phenoxybenzamine may be useful as an adjunct therapy for reducing residual urine

volume in SCI neuropathic bladders maintained by crede or tapping.
Six months of alpha 1-blocker therapy in male SCI patients may improve upper tract
stasis.
Intra-thecal clonidine may be beneficial as an adjunct treatment to detrussor

hyperreflexia in SCI.
Intrathecal Baclofen may be a beneficial adjunct treatment for bladder dysfunction in

SCI.
Botox A injections into the detrusor muscle or external sphincter may provide
targeted treatment for bladder dysfunction in SCI.
Cisapride should not be used for treatment of SCI bladder dysfunction due to lack of
efficacy and risk of serious cardiac arrhythmias.
Vanillanoid compounds (CAP or RTX) improve function of neurogenic detrusor

overactivity of spinal origin.
Capsaicin may not be linked to common bladder cancers within 5 years of use, when
instilled in the bladders of individuals with SCI .
N/OFG is effective for the treatment of neurogenic bladder in SCI.
Intranasal DDVAP may decrease the frequency of voids or catheterizations in SCI

neurogenic bladder otherwise unresponsive to conventional therapy.
UTI educational intervention improves bladder health and a patient’s perception of the
control that they have of their own health behaviours.
Out-patient, nursing-mediated, re-education may be cost-effective in reducing the

number of UTIs in SCI individuals identified as high risk for UTI.
Adjunct tapping and compression may help to maintain acceptable residual urine
volumes in SCI bladder management.
The use of portable ultrasound devices is accepted by patients and the number of
intermittent catheterizations per day are reduced in patients using these devices.
Quadriplegic patients can be successful with clean intermittent catheterizations for

many years post-discharge.
Quadriplegic patients taught clean intermittent catheterizations may continue to use

this technique successfully for many years after discharge.
Urostomy as a alternative to insufficient common bladder management methods may

lead to long-term renal impairment.
External chlorohexidine application or methenamine mandelate with hemiacidrin

bladder instillant are separate techniques that are likely to reduce the incidence of UTI.
Sterile vs clean catheterization technique is more effective at reducing rate of UTI but
is much more costly to maintain.
The prevalence of gram-negative bacteriuria is not affect by continual use or night-

time discontinuation of condom drainage.
Oral methenamine mandelate in combination with hemiacidrin bladder instillant likely

lowers the rate of UTI.
Sterile intermittent catheterization is likely to provide successful bladder management

with a lower rate of UTI and complications with a maintained continence level after
discharge.
There is no difference between incidence of bacteriuria in catheterized patients

instilled with Kanamycin-Colistin versus Trisdine.
Both limited and full microbial investigation result in adequate clinical response to UTI
treatment with antibiotics.
Urinalysis and urine culture results of SCI patients are not affected by sample
refrigeration (up to 24 hours).
Norfloxacin may be a reasonable treatment choice for UTI in SCI but subsequent
resistance must be monitored.
Weekly oral cyclic antibiotic (WOCA) may be beneficial in preventing UTI in SCI
patients.
Improved clinical and microbiological SCI UTI treatment outcome is achieved after 14
(vs 3) days of treatment with Ciprofloxin.
Aminoglycosides have a low success rate in the treatment of SCI UTI.

Ofloxacin, after a 3 day treatment regimen resulted in significant UTI cure rate and
bladder cell biofilm eradication rate.
Successfully SCI UTI prophylaxis without appreciable side effects is possible with
low-dose, long-term ciprofloxacin but not TMP-SMX.
Bladder irrigation is ineffective to treat neurogenic bladder bacteriuria.
Intermittent neomycin/polymyxin bladder irrigation may be effective in altering the

resistance of the offending bladder organism(s) to allow for appropriate antibiotic
treatment.
Conflicting evidence exists for the effectiveness of cranberry juice or extracts used in
the treatment of UTI.
Use of cranberry, phosphate or ascorbic acid supplementation is not efficacious in

acidifying the urine in SCI.
Mandatory post-discharge urological management may improve quality of life in

patients with neurogenic bladder secondary to SCI.
Higher functioning and work-productive individuals seem to have fewer UTIs per year
and this is likely associated with higher global satisfaction.
Urostomy may not be a good long-term bladder management method although it may
improve quality of life when other methods fail.
Table of Contents
13.1 Introduction ...................................................................................................................13-1
13.2 Bladder Function in SCI - Abbreviations and Definitions .........................................13-2
13.4 Enhancing Bladder Function By Non-pharmacological Means................................13-2

13.4.1 Comparative Studies of Various Methods of Bladder Management ............................13-3
13.4.2 Intermittent Catheterization..........................................................................................13-8
13.4.3 Triggering-Type or Expression Voiding Methods of Bladder Management................13-11
13.4.4 Condom Catheterization ............................................................................................13-13
13.4.5 Indwelling Suprapubic Catheterization for Bladder Management ..............................13-14
13.4.6 Electrical Stimulation to Enhance Bladder Function ..................................................13-16
13.4.7 Surgical and Related Techniques ..............................................................................13-21
13.5 Enhancing Bladder Use with Pharmacological Interventions ................................13-26

13.5.1 Pharmacological Interventions to Treat SCI Bladder Dysfunction .............................13-26
13.5.1.1 Anticholinergics.......................................................................................................13-27
13.5.1.2 Alpha Adrenergic Blockers......................................................................................13-29
13.5.1.3 Alpha Adrenergic Agonists......................................................................................13-32
13.5.1.4 Antispasmodics (Muscle Relaxants) .......................................................................13-33
13.5.1.5 Botulinum Toxin for the Treatment of Bladder Dysfunction in SCI..........................13-34
13.5.1.6 Other Pharmacologic agents ..................................................................................13-36
13.6 Non-pharmacological Interventions for Preventing and Treating UTIs .................13-40

13.6.1 Educational interventions...........................................................................................13-41
13.6.2 Managing Possible Sources of Contaminants ...........................................................13-46
13.6.3 Bladder Management Techniques .............................................................................13-49
13.7 Pharmacological Interventions for Preventing and Treating UTIs .........................13-52

13.7.1 Preventative Pharmacological Interventions..............................................................13-52
13.7.2 Antibiotic Interventions for Treating UTIs ...................................................................13-54
13.7.3 Dietary supplementation Based Interventions for Preventing UTIs ...........................13-60
13.8 Bladder Function and Quality of Life ........................................................................13-62
13.9 Overall Comment ........................................................................................................13-65
13.10 Summary....................................................................................................................13-65
References............................................................................................................................13-71
Hsieh JTC, Wolfe DL, Teasell RW (2006). Bladder Health and Function Following Spinal Cord Injury.
In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly
S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 13.1-13.77.
www.icord.org/scire
Bladder Health And Function
13.1 Introduction
Bladder dysfunction, secondary to spinal cord injury (SCI), is not only disabling medically and
physically but also socially (Liguori et al 1997). Normally, a full bladder provides the brain the
signal to initiate bladder muscle and sphincter contraction when a person is ready to void.
However, disruption of these signals through SCI causes too little, too much and/or un-
coordinated contraction and prevents normal voluntary voiding without assistance. In the case
of a flaccid bladder, loss of detrusor muscle tone prevents bladder emptying and leads to
bladder wall damage from over-filling, urine reflux and/or an increase in infection risk. In the
case of a spastic bladder, lack of or insufficient voluntary detrusor muscle and/or bladder
sphincter control leads to accidental voiding or incomplete emptying. Alternatively, dysnergia of
the sphincter muscles leads to un-coordination of urine outflow which can result in reflux and
infection in the kidneys, ureters or bladder.
A healthy bladder is possible through a bladder training program, medication and/or surgery. As
well, many tests are available to help assess the bladder dysfunction (i.e. cystogram or
intravenous pyelogram (IVP), cystometrogram, cystoscopy, renal ultrasound, etc.) and maintain
a healthy urinary system (i.e. urinalysis, urine culture and sensitivity, BUN and creatinine, etc.).
The most common problem resulting from a dysfunctional bladder, secondary to SCI, is a
urinary tract infection (UTI). Bacteria carried in from a catheter or growing in residual urine is
the usual cause of an UTI. Prevention, through sterile catheter technique and a complete
bladder emptying routine, is the best method to combat UTI’s. However, once a UTI has begun,
antibiotic treatment is commonly required to remove the offending bacteria.
Regardless of type of bladder management, early and accurate detection of UTI is an important
aspect of bladder health in individuals with SCI. Many patients become very astute at
recognizing early UTI symptoms such as increased voiding urge, blood in the urine, cloudy or
smelly urine, increased spasticity in the lower extremities, fevers, chills and possibly painful
urination or discomfort in the lower mid-region of the body. However, these symptoms can also
be associated to medical problems other than UTI. For objective UTI confirmation, microbial
investigation is often required.
In the present chapter, the literature has been classified into sections pertaining either to
interventions focusing on maintaining or enhancing bladder function or those aimed at
preventing or treating UTIs. Within these sections the literature is further classified by non-
pharmacological vs. pharmacological interventions. It should be noted that this distinction is
somewhat arbitrary in that it is generally recognized that prevention of UTIs is best
accomplished by optimizing bladder function including the most appropriate bladder
management method.
13-1
13.2 Bladder Function in SCI - Abbreviations and Definitions
(some modified from Regional SCI Center of Delaware Valley, 2001)
Blood Urea Nitrogen (BUN) and Creatinine - Blood tests for urea nitrogen and creatinine.
These provide information about kidney function.
Cystoscopy - A procedure that provides a view of the inside of the bladder and urethra in great
detail using a specialized endoscope (a tube with a small camera) called a cystoscope.
This allows the detection of bladder stones or tumours. Alternative name:
Cystourethroscopy
Intermittent Catheterization (IC) – A bladder management program in which the bladder is

drained by inserting a catheter into the bladder at certain, typically routine times. Variants
of this procedure include Sterile Intermittent Catheterization (SIC) and Clean Intermittent
Catheterization (CIC).
Intravenous Pyelogram (IVP) – A measure of urinary function involving a contrast (iodine) dye
in combination with x-rays to obtain an idea of the size, shape, functioning and
abnormalities of the kidneys, ureters and bladder.
Urinalysis – Urine test that provides information about kidney function. Tells if there are any
white blood cells, protein, sugar, blood or bacteria in the urine that are not there usually.
Also determines Ph.
Urine Culture and Sensitivity – Urine test which assesses the amount and type of bacterial
growth that occurs with an infection. The sensitivity refers to the antibiotic(s) for which the
bacteria species may be susceptible.
Urodynamics (Cystometrogram) – Functional series of tests of the bladder that measures the
way the bladder contracts when it fills and empties. Fluid or a gas is inserted slowly
through a catheter into the bladder allowing a variety of procedures including among
others monitoring the amount of bladder emptying (called post-void urine residual) and the
pressure of the sphincters in the bladder neck (called the UPP or Urethral Pressure
Profile), bladder storage pressures and whether or not the sphincter pressure creates the
problem called bladder-sphincter dyssynergia.
Urinary Tract Infection (UTI) – An infection in the bladder or ureter. A more detailed and
rigorous definition is found in 13.6.
13.4 Enhancing Bladder Function By Non-pharmacological Means
In this section, the evidence for treating and maintaining healthy bladder function via non-
pharmacological means will be reviewed. First and foremost, a healthy bladder involves careful
selection of the most appropriate bladder management technique, with a preference for more
conservative approaches that serve to minimize potential long-term complications while
maintaining optimal function in a manner most suited to an individual’s ability and lifestyle (Weld
and Dmochowski, 2000). Often, individuals are fitted initially in the acute phase with an
indwelling catheter or managed with a form of IC depending on the practice of the specific SCI
unit providing care (Jamil, 2001). After the resolution of spinal shock, careful consideration of
the most appropriate method takes place, ideally guided by clinical investigation involving
urodynamic assessment (Jamil, 2001) in addition to the factors noted above. During
rehabilitation, a complete bladder management program focuses on practice of the selected
method and education highlighting the importance of regular and complete bladder emptying.
13-2
The primary purpose of a bladder management program is to ensure that the patient takes
control of their voiding process and works towards emptying the bladder with a minimum of
“accidents” (Regional SCI Center of Delaware Valley, 2001). A successful bladder management
program will involve a method(s) that allows maximum independence while continuing to be
effective at avoiding residual urine in the bladder and infections.
The most common approaches to bladder management include intermittent catheterization (IC),
reflexive bladder techniques (i.e., manually “triggering” the bladder reflex to assist emptying),
bladder expression (e.g., Valsalva or Crede maneuvers), condom catheterization and indwelling
(i.e., urethral or suprapubic) catheterization (Regional SCI Center of Delaware Valley, 2001;
Wyndaele et al., 2001; Weld and Dmochowski, 2000). If these methods alone or in combination
do not prove adequate, other therapeutic modalities (e.g., acupuncture), assistive devices,
electrical stimulation techniques or surgical augmentations may also be employed to assist or
replace the bladder management method chosen. In the present section, the literature
examining each of these approaches will be grouped by individual treatment. However, in some
cases specific treatments may be combined with one another and reported within the
subsection deemed as the primary method of bladder management. In other cases treatments
are grouped because they are associated with the same anatomical or functional entity (e.g.,
literature pertaining to surgical sphincterotomy is combined with that relating to use of sphincter
stents).
13.4.1 Comparative Studies of Various Methods of Bladder Management
As noted above, the most appropiate bladder management method is selected and practiced as
part of inpatient rehabilitation. The bladder management techniques presented during
rehabilitation will depend on the type of bladder dysfunction (i.e. flaccid, spastic/reflex or
sphincter dysnergia), an individual’s susceptibility to infection and are best based on
urodynamic evaluation (Wyndaele et al., 2001). Prior to discharge, an individual’s activities of
daily living, psychological factors and potential caregiving needs will further impact the optimum
bladder management program. Typically, conservative methods are attempted first including the
following: IC, indwelling urethral catheterization or condom catheterization (males only). A
slightly less conservative option involves suprapubic catheterization especially in the acute
stage, which has some advantages initially in that there is no disturbance to the urethra and
may also be favoured in the case of obesity, lower extremity spasticity, lack of hand function or
inceased ability to engage in sexual relations (Weld and Dmochowski, 2000; Peatfield et al.,
1983). If bladder function permits, spontaneous “triggered” or expression voiding without the
need for an external drainage system may also be an option, although the disadvantages with
these approaches have been outlined in a recent review (Wyndaele et al., 2001). This involves
tapping on the abdomen or raising the bladder pressure through maneuvers such as Crede or
Valsalva to assist voiding. Valsalva is defined as increasing the abdominal pressure by using
the diaphragm and/or abdominal musculature, while Crede involves the manual application of
suprapubic pressure over the bladder (Greenstein et al., 1992). Often, these approaches are
attempted in combination with each other and in particular, these latter maneuvers are
sometimes employed to initiate voiding, no matter what the primary method. In this way, these
maneuvers act as “triggering” mechanisms to initiate voiding (Regional SCI Center of Delaware
Valley, 2001). For the most part, these approaches are considered in advance of other options
involving surgery or stimulator implantation and there are several authors that have compared
the relative effectiveness of these various methods of bladder management.
13-3
Table 13.1 Individual Studies Comparing Bladder Management Methods to Optimize
Bladder Function
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI; Acupuncture vs Control 1. ↓ time to achieve bladder balancing for

Group; Gender (M/F): 24/8 vs 23/5; Mean those with upper motor lesions -
Age: 39.4±12.1 vs 34.3±11.6 years; 34 acupuncture vs control, 57.1±22.5 vs
above T11, 26 below T11; 25 Frankel A, 35 85.2±27.4 days (p<0.005).
Frankel B; Post-injury time: 23.7±12.8 vs 2. Similar for lower motor neuron lesions,
26.1±12.1 days. 55.4± 22.6 vs 83.4 ±26.1 days
Cheng et al. 1998; Treatment: Electroacupuncture to 4 points (p<0.01).
Taiwan (CV3,CV4,UB32 bilateral) + conventional 3. If it was started within 3 weeks of SCI,
PEDro=4 bladder training (n=32) vs control group of bladder balancing was achieved
RCT conventional bladder training only (n=28). sooner, 46.6±13.2 vs 65.8±15.4 days
N=60 Outcome measures: Time from SCI- (p<0.005).
bladder balanced, urodynamic assessment 4. No significant changes seen in
in n=20 of acupuncture group. urodynamic assessment associated
with 1st acupuncture session but ↑ in
bladder capacity and ↓ voiding
pressure seen by time bladder was
balanced.
Population: SCI with > 6 months follow- 1. Both forms of indwelling
up; 88% males; Mean Age: 29-40 years for catheterization had an increased risk
various groups; Average injury level: T3 – of getting bladder stones and requiring
T9 for various groups; complete, hospitalization for bladder stones over
incomplete; Median follow-up: 48 – 107 IC and condom drainage with or
months for various groups. without sphincterotomy.
Treatment: Assessment of various bladder 2. Relative to IC, hazard ratio was 10.5
management methods (i.e., for suprapubic catheters and 12.8 for
Ord et al. 2003; England sphincterotomy, condom, IC, indwelling indwelling urethral catheters.
Downs & Black score=15 urethral catheter, suprapubic catheter, + 3. Incidence density ratio (like odds ratio)
Case Series combinations of each). was 40.7 for developing bladder
N=457 Outcome measures: Bladder stone stones for indwelling catheters relative
formation rate. to IC. Condom incidence density ratio
was 7.5 relative to IC.
4. % Annual risk for stone formation:
Condom & Sphincterotomy 0%; IC
0.2%; Expression voiding with or
without condom 0.5%; Indwelling
catheter 4% (first stone), 16%
(subsequent stone).
Population: SCI; 313 males, 3 females; 1. Complication rates for those managed
Mean Age: 33.9-41.0 years for various by IC, voiding spontaneously,
groups; 269 suprasacral, 47 sacral; 45 suprapubic and urethral catheterization
complete, 271 incomplete; Mean follow-up: were 27.2%, 32.4%, 44.4% and 53.5%
17.8-19.3 years for various groups. respectively.
Weld & Dmochowski Treatment: Assessment of various bladder 2. Frequency of those managed by IC,
2000; USA management methods (i.e., IC, voiding voiding spontaneously, suprapubic and
Downs & Black score=15 spontaneously, indwelling urethral urethral catheterization was 92, 74, 36
Case Series catheter, suprapubic catheter). and 114 respectively.
N=316 Outcome measures: Urological 3. Urethral catheter users had the highest
complication rate (epididymitis, rates for epididymitis, pyelonephritis,
pyelonephritis, upper tract stone, bladder upper tract stone, bladder stone,
stone, urethral strictures, periurethral urethral strictures and periurethral
abscess, vesicoureteral reflux, abnormal abscess.
upper tracts). 4. Suprapubic catheter users had the
13-4
Score
Methods Outcome
Research Design
Total Sample Size
highest rates for vesicoureteral reflux

and abnormal upper tracts.
Population: SCI; 36 males, 14 females ; 1. At admission 86% used indwelling

Age: 38±15 (18 to 58) yrs; ASIA: A-D; 7 catheter and by discharge IC was
tetraplegia, 43 paraplegia; time since used by 74%.
injury: 124±80 (10-210) days; 2. At follow-up, of 38 people using IC,
Rehabilitation LoS: 130±50 (40 to 190) 52% reverted back to indwelling
days; Follow-up: 24±8 (5 to 40) months;. catheter by 24 months, 42% continued
Treatment: Follow-up of those with various with IC.
bladder management methods. 3. Tetraplegics had lower compliance
Outcome measures: Bladder with IC than paraplegics (p<0.05) -
Yavuzer et al. 2000;
management method, compliance. majority of tetraplegics (80%) reverted
Turkey
to indwelling catheter vs only 40% of
paraplegics.
Case Series
4. More females (60% vs 50%) reverted
N=50
to indwelling catheters but this was not
significant.
5. More with complete injuries reverted to
indwelling catheters (68% vs 31%,
p<0.01).
6. Main reasons for changing method =
dependence on care givers, severe
spasticity, incontinence and
inconvenience (females).
Population: Traumatic and non-traumatic 1. No difference between the methods in

SCI; 92 males, 23 females; Mean age=34 proportion of people catheter free.
(males), 42 (females); Paraplegia, 2. Of those becoming catheter free,
Wyndaele et al. 1985; Tetraplegia. those using IC became catheter free
Belgium Treatment: Voiding by subrapubic significantly faster (p<0.01).
Downs & Black score=7 catheter, indwelling Foley catheter, IC or 3. Most urological complications
Case Series indwelling Foley and IC combined during (including UTIs) were most frequent
N=115 spinal shock. with use of indwelling Foley catheters.
Outcome measures: % patients being
catheter-free, UTIs and various urological
complications.
Population: SCI; all above T11; time since 1. Renal complication rate is greater after
injury> 5 years. 8 years of suprapubic cystostomy
Treatment: Assessment of urological/renal (SPC) than for those with 20 years use
complication rate associated with of condom or to a lesser extent Foley
Hackler 1982; USA suprapubic cystostomy drainage of >=5 catheter drainage.
Downs & Black score=7 year vs condom or Foley catheter 2. Percentages reported for various
Case Series drainage. complications: Normal - 39% with
N=31 Outcome measures: Intravenous suprapubic vs 51% Foley and 66%
urography (IVU) and cystourethrogram condom; Caliectasis (calculi) - 50%
(CUG) evaluated at >= 5 years post-injury. with SPC vs 24% Foley and 23%
condom; Hydronephrosis - 10% with
SPC vs 19% Foley and 10% condom.
Discussion
Several authors have examined the frequency of a variety of urological and renal complications
associated with various forms of chronic bladder management (Ord et al., 2003; Weld and
13-5
Dmochowski, 2000; Hackler, 1982). These authors have all employed retrospective chart
reviews to examine complication rates associated with long-term follow-up data. In general,
these authors concur that the greatest number of complication occur with long-term use of
indwelling suprapubic and urethral catheters. In particular, of these investigations, Weld and
Dmochowski (2000) employed a large sample (N=357) and examined the greatest range of
complications. These authors noted that long-term urethral catheterization was associated with
the largest overall number of complications, with long-term suprapubic cathetrization ranked
next. Depending on the specific complication, one of these two methods was associated with
the highest incidence. Urethral catheter users had the highest rates for epididymitis,
pyelonephritis, upper tract stones, bladder stones, urethral strictures and periurethral abscess.
Suprapubic catheter users had the highest rates for vesicoureteral reflux and abnormal upper
tracts. It should be noted that these authors did not account for changing bladder management
methods, preferring to simplify the analysis by classifying the results by the most predominate
bladder management method.
Ord et al. (2003), on the other hand, also examined a relatively large dataset (n=467) but
examined all the combinations of changing methods. However, these authors limited their
analysis to the effect of various bladder management techniques on the risk of bladder stone
formation. Similar to Weld and Dmochowski (2000), these authors also found a slightly greater
incidence of bladder stones for indwelling urethral catheters as compared to suprapubic
catheters with each much greater than for IC. Ord et al. (2003) reported, hazard ratios relative to
IC of 10.5 for suprapubic catheters and 12.8 for indwelling urethral catheters. In contrast,
Hackler (1982) reported comparisons between long-term complication rates among those with
condom (Texas), urethral (Foley) and suprapubic catheterization and found markedly higher
rates for those managed with suprapubic catheters even though the follow-up period for these
patients was only 5 years as compared to 20 years for those managed with the other 2
methods. However, these findings reflected a much smaller series of patients (N=31) and the
comparisons were made from patients from different time periods reflecting different
“generations” of care.
As opposed to later and chronic use, Wyndaele et al., (1985) employed a retrospective case
series design to examine the effect that various bladder management approaches used during
the period of spinal shock had on outcomes as assessed at 8 months. They evaluated those
individuals using IC, indwelling urethral (Foley) catheter, combination of indwelling urethral
(Foley) with IC and subrapubic catheter alone or with IC in a case series of 115 patients. Only 6
individuals used a suprapubic catheter alone or with IC so this was likely too small a number
from which to draw meaningful conclusions. As with investigations of long-term usage, those
individuals able to use IC as their primary method during earlier acute and post-acute care (i.e.,
prior to the resolution of spinal shock) had the in fewest complications number of complications
as assessed at 8 months. In addition, Wyndaele et al. (1985) noted that those using IC became
catheter-free faster although there were no differences in the proportion of those becoming
catheter-free in comparison to those using the other bladder management methods.
It should be noted that even though there are differences in rates between bladder approaches
supportive of the clinical preference of intermittent catheterization or use of triggered
spontaneous voiding, it is not always possible to use these methods. Spontaneous voiding may
not be possible given the state of bladder function and intermittent catheterization is limited in
those with impaired hand function. Yavuzer et al., (2000) employed a case series (N=50) and
reported the compliance of those employing various bladder methods at discharge from
inpatient rehabilitation. At admission 86% of their patients used indwelling catheters and by
discharge intermittent catheterization was used by 74%. However, at follow-up (mean time = 24
13-6
months) 52% of those individuals employing intermittent catheterization at discharge had
reverted back to indwelling catheters with only 42% continuing with intermittent catheterization.
The majority of those with tetraplegia (80%) reverted to indwelling catheters as compared to
only 40% of those with paraplegia, presumably due to limitations with hand function. In addition,
having a complete injury and being female also was associated with a greater likelihood of
reverting to indwelling catheters. The primary reasons indicated for changing methods were a
greater dependence on care-givers than originally thought, presence of severe spasticity,
incontinence and inconvenience with intermittent catheterization (females only).
It should be noted that some assistive devices that may enhance compliance with intermittent
catheterization for those with impaired hand function do exist, although these are likely not in
widespread use. For example, Adler and Kirshblum (2002) reported a series of 9 individuals
with C5-C7 SCI, originally unable to perform intermittent catheterization, having success and
expressing satisfaction with a device to help performance of intermittent catheterization.
Other trials have been conducted which examine approaches that may prove effective as
adjunctive therapies. For example, Cheng et al. (1998) conducted a RCT (N=60) investigating
the effectiveness of electroacupuncture administered in combination with the bladder
management of choice as compared to those not receiving electroacupuncture. Their primary
outcome measure was the time to achieve bladder balancing which was defined as the time
when 1) the patient could easily pass adequate urine at low pressure, 2) residual urine of
approximately 100 ml or less and 3) absent UTIs. Although employing a randomized, controlled
design, some limitations of the design (i.e., lack of blinding, concealed allocation or intent to
treat) constrained the level of evidence assigned to this trial (i.e., Level 2). Regardless, those
receiving electroacupuncture had a reduced time to achieve bladder balancing for both those
with upper motor lesions (p<0.005) and lower motor neuron lesions (p<0.01). In addition, if
electroacupuncture was started within 3 weeks of SCI, bladder balancing was achieved sooner
than those in which started after 3 weeks (p<0.005).
Conclusion
There is Level 4 evidence that indwelling urethral catheterization, employed acutely, has
abated is associated with a higher rate of acute urological complications than
intermittent catheterization.
There is Level 4 evidence that prolonged indwelling catheterization, whether suprapubic

or urethral, may result in a higher long-term rate of urological and renal complications
than IC, condom catheterization or triggered spontaneous voiding.
There is Level 4 evidence that intermittent catheterization, whether performed acutely or

chronically, has the lowest complication rate. Chronic use of a spontaneous triggered
voiding method has comparable long-term complication rates to intermittent
catheterization.
There is Level 4 evidence that acute use of intermittent catheterization is associated with
reduced time to become catheter-free in comparison with indwelling urethral or
suprapubic catheterization. There is likely no difference among these methods for the
likelihood with which one will become catheter-free.
13-7
There is Level 4 evidence that those who use intermittent catheterization at discharge
from rehabilitation may have difficulty continuing with particular difficulty for those with
tetraplegia and complete injuries. To a lesser degree females also have more difficulty
than males in maintaining compliance with IC procedures.
There is Level 2 evidence that early treatment with electroacupuncture may shorten the
time that it takes for urine to pass at low pressure with minimal residual volume, no
matter the primary method of bladder management.
Those able to use intermittent catheterization will likely have fewer short- and long-term
urological and renal complications and become catheter free faster but will not necessarily
have a greater chance of becoming catheter-free as compared to
other methods of bladder management.
Early electroacupuncture therapy as adjunctive therapy with other bladder management
methods may result in decreased time to achieve desired outcomes.
13.4.2 Intermittent Catheterization
As noted above, intermittent catheterization is a preferred method of bladder management

which if able to be performed, is associated with a reduced number of complications and faster
time to achieve spontaneous voiding (if this becomes possible). The present section outlines
those studies focusing on specific aspects of intermittent catheterization, providing information
about catheter selection (Waller et al.,1997; De Ridder et al.,2005; Giannantoni et al.,2001) and
potential adjunctive therapies (Vaidyananthan et al.,1998) as well as a study examining bladder-
related quality of life of those using IC vs able-bodied controls (Oh et al.,2005).
Table 13.2 Individual Studies Examining Use of Intermittent Catheterization to Enhance

Bladder Function
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI; Mean Age: 38.2±16.4 1. Lower incidence of UTIs (p=0.03) and
years; C5-Cauda Equina; AIS A-D; Post- asymptomatic bacteriuria (p=0.0244)
injury time: 18-60 days. of those using pre-lubricated catheters
Treatment: Assessment of “Instacath®” vs PVC.
nonhydrophilic pre-lubricated catheter vs 2. More epithelial cells found on
conventional uncoated PVC Nelaton conventional vs pre-lubricated catheter
Giannantoni et al. 2001; catheter for IC (crossover design). (p=0.01) indicative of possible
Italy Outcome measures: symptomatic UTI, microtrauma.
PEDro=9 incidence of urethral complications 3. 2 people had urethral bleeding with
RCT (ultrasound, CUG), urinalysis, visual conventional catheter, 0 with pre-
N=18 analog scale of patient satisfaction. lubricated.
Collected at the start and end of 7 week 4. Pre-lubricated catheters had
study period. significantly higher satisfaction scores
for 4 of 5 items on the scale.
5. 3 subjects requiring assistance with
the conventional catheter became
independent with the pre-lubricated
13-8
Score
Methods Outcome
Research Design
Total Sample Size
catheter (order effect unreported)

6. No subject had impaired renal function
of upper & lower tract abnormalities
with either catheter.
Population: SCI treated at SCI Unit; 1. Lo-Fric® catheter had significantly

Median Age: 30 (22-62) years; 5 reduced friction (55%) as compared to
paraplegia, 8 tetraplegia; 8 complete, 6 Easicath® (p<0.001).
incomplete; Post-injury time: 5 days – 5 2. Nurses reported fewer # of times
months. catheters had “stickings” with Lo-Fric®
Waller et al. 1997;
Treatment: Assessment of “Lo-Fric®” vs catheter as compared to Easicath® (3
Sweden
“EasiCath®” hydrophilic catheters for IC. vs 42).
PEDro=7
Outcome measures: Friction force on 3. There was no significant difference in
RCT
removal, # of times catheter ”stuck”, UTIs, the incidence of UTIs with either
N=14
osmolality. catheter (2 vs 3).
4. Mean catheterization time was similar
for both catheters.
5. Lo-Fric® catheter had >10x higher
osmolality as compared to Easicath®
Population: SCI using hydrophilic vs PVC 1. Lower incidence of UTIs of those
catheter; Mean Age: 37.5±14.6 vs using SpeediCath hydrophilic vs PVC
36.7±14.6 years; AIS A-D. (p=0.02).
Treatment: “SpeediCath®” hydrophilic 2. No difference in number of bleeding
catheters vs conventional uncoated PVC episodes or occurrence of hematuria,
catheter for IC. leukocyturia and bacteriuria between 2
De Ridder et al. 2005; Outcome measures: Occurrence of catheters.
Belgium, Spain symptomatic UTIs, hematuria, strictures, 3. More individuals expressed greater
PEDro=5 convenience of use, satisfaction with satisfaction with various aspects of the
RCT catheter collected over a 12 month period. hydrophilic catheter, although these
N=123 differences were not significant.
4. 54% dropout rate (slightly moreso in
hydrophilic group) partially due to the
fact that many subjects no longer
needed to catheterize when bladder
function was retained within the 1 year
period.
Population: SCI vs healthy controls; 81 1. All scores for the non-SCI subjects
males, 51 females ; Age: 41.8±1.4 yrs; were significantly higher than those
81.8% tetraplegia, 18.2% paraplegia; time with SCI, indicative of ⁭ QoL.
since injury: 67.8±8.6 months. 2. Within the SCI group, older patients
Treatment: Assessment of health-related (>50) had significantly lower scores for
Oh et al. 2005; South quality of life of those using IC vs matched energy and vitality (p=0.003).
Korea healthy controls. 3. Those with non-cervical injury had
Downs & Black score=18 Outcome measures: SF-36, higher physical functioning scores
Post Trial with Control demographics collected at outpatient than those with cervical injury
(Inadequate Control) appointment or post-rehabilitation hospital (p<0.001). Those able to perform self-
N=282 visit. catheterization had higher physical
functioning scores than those unable
(p<0.0001).
4. There were no differences due to
gender, education level or income
within the SCI group.
Vaidyananthan et al. Population: SCI; Age=22-69; Level=C6- No group results reported.

1998; England T12; Time post-injury=6-38 years. 1. All subjects showed ⁭ continence with
13-9
Score
Methods Outcome
Research Design
Total Sample Size
Downs & Black score=10 Treatment: IC 5-6 times a day alone first IC and much moreso with oxybutynin
Pre-post then with intra-vesical instillation of added.
N=7 oxybutynin (5 mg in 30 ml) 1-3 times a day 2. 6/7 subjects reported ⁭ sexuality with IC
for 14 to 30 months in individuals originally and all subjects had even much higher
managed by condom catheterization. ratings with oxybutynin added.
Outcome measures: Customized scales 3. Mixed results with quality of life with IC
of urinary continence, sexuality, quality of but consistently ⁭ quality of life when
life and monitoring of side effects. added oxybutynin.
4. ↓ UTIs with IC and oxybutynin.
Discussion
There are several trials which have investigated the effects of varying the properties of catheters
used for intermittent catheterization (De Ridder et al., 2005; Giannantoni et al., 2001; Waller et
al., 1997). For example, Giannantoni et al. (2001) employed a double-blind, crossover RCT
design (N=18) to examine the difference between a pre-lubricated nonhydrophillic Instantcath
catheter as compared to a conventional polyvinyl chloride (PVC) silicon-coated Nelaton catheter
with respect to the occurrence of UTIs and urethral trauma. The subjects were randomized to 1
of 2 groups which tried each catheter for a period of 7 weeks in an A-B, B-A design. Both
incidence of UTIs and presence of asymptomatic bacteriuria was reduced for the pre-lubricated
catheter vs the conventional PVC catheter. Perhaps most interesting, 3 subjects requiring
assistance with the conventional catheter became independent with the pre-lubricated catheter,
although it was not reported if these individuals were in the group using the conventional
catheter initially or lastly. The existence of an order effect (or not) for any of the measures was
not reported. In terms of general satisfaction with use, subjects rated the pre-lubricated catheter
significantly higher than the conventional catheter with respect to comfort, ease of inserting and
extracting, and handling.
A similar finding of reduced incidence of UTIs was reported by De Ridder et al. (2005), but in
this case the comparison was between a hydrophilic catheter as compared to the conventional
PVC catheter, with the hydrophilic catheter associated with fewer infections. This multi-centre
investigation also employed a RCT design (N=123) but had several methodological problems
that likely constrained the potential utility of the results. Most significant was a high drop-out rate
(54%) with slightly more individuals not completing the study from the hydrophilic catheter
group. A probable cause for many of these drop-outs was the lengthy treatment period of 1 year
during which many individuals were likely to improve bladder function such that intermittent
catheterization was no longer required. There were no other significant differences noted
between the two groups including the number of bleeding episodes or occurrence of hematuria,
leukocyturia and bacteriuria. More individuals expressed greater satisfaction with various
aspects of the hydrophilic catheter, although these differences were also not significant.
A third investigation examining catheter properties was designed to examine the effect of
osmolality on two different hydrophilic catheters. Waller et al. (1997) demonstrated significantly
reduced friction with one catheter vs the other and nurses also reported significantly fewer times
this catheter had “stickings”. These differences did not translate into clinically significant results,
however, as there was no significant difference in the incidence of UTIs with either catheter.
However, the friction difference was explained by the authors as consistent with a greater than
10-fold higher osmolality for the catheter with lower friction.
13-10
Another investigation employed a different method to enhance bladder function by an adjunctive
therapy to intermittent catheterization. Vaidyananthan et al. (1998) reported a pre-post trial
(N=7) for which individuals originally managed by condom catheterization were switched to
intermittent catheterization for a period of time, followed by another period when an intra-vesical
instillation of oxybutynin was administered as well. Although no group statistical results were
reported, all subjects showed improved continence with intermittent catheterization and even
moreso when oxybutynin was added. Quality of life scores were mixed with intermittent
catheterization alone but showed a definite improvement when oxybutynin was added. This may
have been partly due to a reduced incidence of UTIs with the combination of intermittent
catheterization and intra-vesical oxybutynin.
Quality of life assessments associated with intermittent catheterization were also reported by Oh
et al. (2005). These authors conducted interviews with the SF-36 in 132 individuals with SCI
who performed clean intermittent catheterization and compared the results with 150 able-bodied
controls of similar gender and age distribution. Generally, all scores for the non-SCI subjects
were significantly higher than those with SCI indicative of reduced health-related quality of life
for those with SCI. Within the SCI group, those able to perform self-catheterization had higher
physical functioning scores than those unable (p<0.0001). These results are not surprising and
the role of intermittent catheterization in these differences is likely relatively minor given the
potential for other physical limitations within the SCI group.
Conclusion
There is Level 1 evidence based on 1 RCT that pre-lubricated hydrophilic catheters are
associated with fewer UTIs and reduced incidence of urethral bleeding and microtrauma
as compared to conventional Poly Vinyl Chloride catheters.
There is Level 2 evidence based on 1 RCT that fewer UTIs, but not necessarily urethral
bleeding may result with the use of hydrophilic catheters as compared to conventional
PVC catheters.
There is Level 4 evidence that those with neurogenic bladder due to SCI and managed
with IC may have a lower health-related quality of life on most domains assessed by the
SF-36.
There is Level 4 evidence that incontinence may be reduced with intermittent

catheterization and even moreso when oxybutynin is administered as well.
Although both pre-lubricated and hydrophilic catheters have been associated with reduced
incidence of UTIs as compared to conventional Poly Vinyl Chloride
catheters, less urethral microtrauma with their use may only be
seen with pre-lubricated catheters.
Oxybutynin administered along with intermittent catheterization
may reduce incontinence.
13.4.3 Triggering-Type or Expression Voiding Methods of Bladder Management
Individuals with SCI undergoing inpatient rehabilitation are taught various maneuvers in order to
initiate or attempt spontaneous voiding, termed “expression voiding” as well as to provide a
13-11
“trigger” to initiate voiding via catheters (Regional SCI Center of Delaware Valley, 2001;
Wyndaele et al., 2001). As noted previously, these involve methods to increase intra-abdominal
pressure so as to facilitate voiding. The recent literature addressing these techniques is sparse
and only 1 study is included in the present review.
Table 13.3 Individual Studies Describing Triggering-Type Bladder Management Methods

Author Year; Country Methods Outcome
Score
Research Design
Total Sample Size
Population: SCI; 5 males; Age: 29-58yrs; No group results reported.

Paraplegic; Incomplete, Complete; Time 1. The Valsalva procedure enabled
since injury=2.5-34yrs. bladder emptying in 4 and the Crede
Treatment: Voiding by Valsalva or Crede procedure in 1 people.
maneuver. 2. 1 of 5 people using these methods
Greenstein et al. 1992;
Outcome measures: Bladder pressure long-term developed a significant
USA
(urodynamics), bladder and renal complication (increasing difficulty
complications. voiding, several UTIs with bilateral
Case Series
hydronephrosis) associated with
N=5
bilateral grade 3 reflux.
3. 1 other had grade 2 vesicoureteral
reflux.
4. 3 had symptomatic UTIs and 1 had an
asymptomatic UTI.
Discussion
Greenstein et al. (1992) documented the use of Valsalva and Crede maneuvers to initiate
spontaneous voiding in a small case series of 5 males with paraplegia. This study was intended
to examine the potential for long-term complications in those who employed these techniques
over an extended period of time. It was noted via urodynamic studies that a bladder pressure
during voiding ranged from 95 to 160 cm of H2O. In 2 individuals vesicoureteral reflux was
demonstrated, with one of these more serious (Grade 3) and this individual had impaired renal
function and hydronephrosis. The authors suggested that long-term monitoring for these
individuals is advisable and intermittent catheterization should replace these methods in the
event of urological complications.
Conclusion
There is Level 4 evidence that triggering mechanisms such as the Valsalva or Crede
maneuvers may assist some individuals with neurogenic bladder to void spontaneously
but these are also associated with high intra-vesical pressures which could conceivably
lead to renal complications.
Valsalva or Crede maneuver may assist some individuals to void spontaneously but also may
produce high intra-vesical pressure, increasing the risk for long-term complications.
13-12
13.4.4 Condom Catheterization
A viable option for bladder management in males is condom catheterization. As noted above,
condom catheterization is associated with relatively fewer complications than indwelling
methods but more than IC (Ord et al., 2003; Hackler, 1982). One issue with condom
catheterization is the difficulty by which they may be applied, especially in the event of impaired
hand function. Also, slippage of the condom can result in leaks. The paper reviewed below
describes the use of penile implants, in part as a means to circumvent these issues.
Table 13.4 Individual Studies Describing Issues Associated with Condom Catheterization
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI; Mean age: 41.9 (20-74) 1. Penile implants in place mean of 7.08
years; 38 tetraplegia, 37 paraplegia, 4 years.
cauda equina; all above T11; 61 complete, 2. Overall failure rate was 8% with an
18 incomplete; Mean time since injury: infection complication rate of < 2%.
8.24 (1-21) years. 3. Prior to implant, 77% of people lost
Treatment: Follow-up of individuals condoms and had accidents with urine
Perkash 1992; USA
implanted with a penile implant allowing leakage > 2 x week, while only 19%
condom placement or sexual penetration. reported this after.
Case Series
Outcome measures: Failures, 4. Prior to implant, 18% of people had
N=79
complications, Quality of Life Satisfaction indwelling catheters, while none had
survey. indwelling catheters after.
5. 68% of patients expressed satisfaction
with sexual intercourse.
6. All felt it was easier to keep
themselves clean and dry.
Discussion
Perkash et al. (1992) conducted a retrospective analysis of 79 male patients with penile
implants in place over a mean time of 7.08 years. A primary reason for obtaining a penile
implant in these patients, among others, was to provide a stable penile shaft to hold a condom
for external urinary drainage. Prior to implant, 77% of these individuals reported having lost a
condom or having an accident with urine leakage greater than twice per week. After implant,
these issues were greatly improved with only 19% reporting these problems. In addition, penile
implantation allowed some to switch to a more effective and safer bladder management method.
Prior to implant, 18% of people had indwelling catheters, while none had indwelling catheters
after. All reported improved continence, feeling it was easier to keep themselves clean and dry.
Conclusion
There is Level 4 evidence that penile implants may allow easier use of condom catheters,
thereby reducing incontinence.
Penile implants may allow easier use of condom catheters and reduce incontinence.
13-13
13.4.5 Indwelling Suprapubic Catheterization for Bladder Management
Suprapubic catheterization, first described in SCI by Cook and Smith (1976), is a preferred
choice for effective bladder management in some circumstances. Although typically IC is the
first choice in the acute setting during spinal shock, suprapubic catheterization is considered if
there is a special concern over the potential for urethral damage with IC or indwelling urethral
catheterization, the former being especially time-consuming for medical staff. Later, in chronic
situations, suprapubic catheterization may also be favoured by individuals with SCI in the case
of obesity, lower extremity spasticity, lack of hand function or because of perceived inceased
ability to engage in sexual relations (Weld and Dmochowski, 2000; Peatfield et al., 1983).
However, several have reported a high incidence of complication rates with long-term use,
typically due to the inevitable incidence of accompanying bacteriuria (Jamil, 2001; Hackler,
1982). Others have noted that for the right individual and with special care and proper
monitoring, suprapubic catheterization is an effective and well-tolerated method of management
(Sheriff et al., 1998; MacDiarmid et al., 1995).
Table 13.5 Individual Studies Describing Outcomes Associated with Suprapubic

Catheterization
Score
Methods Outcome
Research Design
Total Sample Size
Population: Traumatic SCI with indwelling 1. Percentages reported for various

suprapubic catheter for > 1 year; 31 males, complications:0% renal deterioration,
13 females ; Age: 36 (13 – 79) years; 0% vesicoureteral reflux, 0% bladder
MacDiarmid et al. 1995; paraplegia, tetraplegia; complete, cancer, 11% incontinence, 100%
USA incomplete; time since injury: 69 (15 – 151) asymptomatic bacteriuria, UTIs with
Downs & Black score=15 months. +ive cultures 43% uncomplicated and
Case Series Treatment: Assessment of urological/renal 9% complicated, 5% hematuria, 7%
N=44 complication rate associated with renal calcul, 41% bladder calculi, 36%
suprapubic cystostomy drainage. blocked cystostomy tubes.
Outcome measures: Urological and renal
complication rate.
Population: SCI; 80 male , 77 female; 1. Primary indications for insertion
Age: 17-71 years; Time post-procedure: 24 included failed IC due to poor hand
(3-68 months). function, persistent incontinence,
Treatment: Long-term follow-up of those recurrent UTIs or bulbar strictures.
managed by subrapubic catheter. 2. In patients using suprapubic catheter
Outcome measures: Indication, stable for > 2 years - no apparent decline in
Sheriff et al. 1998;
serum creatine levels, ultrasonography and renal function.
England
satisfaction survey 3. Overall complaint rate -30%. Most
common was recurrent catheter block
Observational
(18%), persistent urinary leakage (8%)
N=185
and a recurrent symptomatic UTI rate
of 4%.
4. 48% of patients had bladder calculi
requiring intervention.
5. Satisfaction survey indicated that for a
variety of questions (e.g., impact on
life, pleasure with the switch, would
you do it again, etc.) 70-90% of those
responding answered favourably.
Peatfield et al. 1983; Population: SCI; 15 Paraplegia, 25 1. 15/41 had died, 2 due to renal causes;
England Tetraplegia. 10 year survival rate 68%, 15 year
13-14
Score
Methods Outcome
Research Design
Total Sample Size
Downs & Black score=11 Treatment: Long-term follow-up (minimum 63%.

Case Series of 8 years) of those managed originally by 2. 22 of 23 surviving, evaluable patients
N=41 subrapubic catheter as reported in 1976. had normal blood urea levels.
Outcome measures: Mortality, renal 3. IVP Results: 15 Normal, 3 bilateral
function. pelvic/ureter dilation, 2 kidney stones,
3 non-functioning kidneys (all with
indwelling urethral catheters).
4. Current drainage system in Para (P)
vs Tetra (T) as follows: Dead - 9 T, 6
P; Condom - 2 T, 12 P; Catheter - 3 T,
6P; Ileal conduit - 1 T, 1 P
Discussion
The specific concerns regarding suprapubic catheter use centre on the potential for urological
complications with long-term use. Several investigators have attempted to address these
concerns by performing retrospective reviews of the patients within their practice (Sheriff et al.,
1998; MacDiarmid et al., 1995). In particular, Sheriff et al. (1998) and MacDiarmid et al. (1995)
conducted reviews focused on evaluation of long-term suprapubic catheter users. MacDiarmid
et al. (1995) conducted a case series investigation of the 44 patients treated with a suprapubic
catheter for at least 1 year out of the total of 688 patients seen by their spinal unit during the
study period. They reported relatively low incidences for various complications (i.e., 0% renal
deterioration, 0% vesicoureteral reflux, 0% bladder cancer, 11% incontinence, 100%
asymptomatic bacteriuria, UTIs with +ive cultures 43% uncomplicated and 9% complicated, 5%
hematuria, 7% renal calcul, 41% bladder calculi, 36% blocked cystostomy tubes) which they
ascribed to strict adherence to the catheter protocol with regular follow-up and close
surveillance with a dedicated medical and nursing team and informed primary care practitioners.
Similarly, Sheriff et al. (1998) reported their experience with 185 patients having undergone
long-term use of suprapubic catheterization, representing 23% of all new patients referred to
their unit. Primary indications for insertion included failed IC due to poor hand function,
persistent incontinence, recurrent UTIs or bulbar strictures. In addition, suprapubic catheters
were placed to replace urethral catheters or by patient request. In all patients using suprapubic
catheter for > 2 years there was no apparent decline in renal function as indicated by stable
serum creatine levels and ultrasonography. There was a significant incidence of complaints
associated with suprapubic catheterization (i.e., 30%). Most common was recurrent catheter
block (18%), persistent urinary leakage (8%) and a recurrent symptomatic UTI rate of 4%. 48%
of patients had bladder calculi requiring intervention. In spite of this, and perhaps more
importantly, a satisfaction survey indicated that for a variety of questions indicating satisfaction
with the catheter (e.g., impact on life, pleasure with the switch, would you do it again, etc.) 70-
90% of those responding answered favourably.
In contrast, Peatfield et al. (1983) also conducted a long-term follow-up investigation (minimum
of 8 years), however these authors examined the long-term outcomes of those managed soon
after injury by subrapubic catheter as reported initially in a prior study (Smith et al., 1976). They
focused on mortality and assessing renal function. In their original series of 41 patients 15 had
died, 2 due to renal causes; resulting in a 10 year survival rate of 68% and a 15 year survival
rate of 63%. Of 23 surviving patients, 22 were evaluable and had normal blood urea levels. IVP
13-15
results demonstrated low morbidity with the majority having normal kidney function and those
with current kidney or urological problems (i.e., stones, non-functioning, dilation of pelvis or
ureter) being currently managed with indwelling urethral catheterization. Although no control
data was provided, the authors purported that these rates represented low mortality and
morbidity rates indicating successful early intervention with suprapubic catheterization, stating “it
may even well become the treatment of choice in all spinal injury units” (Peatfield et al., 1983).
However, there were so many intervening variables unaccounted for in such an analysis and
little information is provided about other potential treatments used by the subjects that such a
conclusion is somewhat tenuous as has been borne out by more recent practice (Wyndaele et
al., 2001).
Conclusion
There is Level 4 evidence that despite a significant incidence of urological and renal
complications associated with acute and chronic indwelling suprapubic catheterization,
this is still a reasonable choice for bladder management for some people.
With diligent care and ongoing medical follow-up indwelling suprapubic catheterization may be
an effective and satisfactory bladder management choice for some people.
13.4.6 Electrical Stimulation to Enhance Bladder Function
Although electrostimulation to induce voiding has been studied since the 1950’s it was not until
the development of the Brindley anterior sacral nerve root stimulator, and subsequent
implantation of the first device in a human in1978 that widespread clinical applications have
been available (Egon et al., 1998; Brindley et al., 1982). Although there are several
configuarations, Creasey et al. (2001) described a system as consisting of an implanted internal
stimulator-receiver which is controlled and powered via telemetered radio transmission by an
external controller-transmitter. Cables and electrodes are also implanted which are held in
contact with sacral nerves (i.e., often S2-S4). This system allows programmable stimulation
patterns and permits control of both bowel and bladder function. Often dorsal sacral rhizotomy is
performed at the same time as stimulator implantation (Vastenholt et al., 2003; Creasey et al.,
2001; Egon et al., 1998). Various investigators have examined other forms of stimulation (e.g.,
direct bladder stimulation) employing stimulators intended for other purposes such as enhancing
muscle functions for improving movement, spasticity or muscle strength. In addition, multi-
functional stimulators may be configured so as to provide similar stimulation patterns to similar
targets as the bladder-specific stimulators. For example, Johnston et al. (2005) reported a case
series (n=3) of the results associated with a multi-functional stimulator serving functions of
enhancing standing and stepping ability and bowel and bladder management. This article was
not included in the review outlined below as the stimulator function was only configured for
bladder function in 2 of the subjects and only fully explored in 1 of these, thereby falling short of
the criteria of n≥3.
13-16
Table 13.6 Individual Studies Describing Use of Bladder Stimulation to Enhance Bladder
Function
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI; 14 males; C6 – L1; 1. Both continuous and conditional

Complete, incomplete; > 1 year post-injury. stimulation increased bladder
Treatment: Different patterns of dorsal capacity.
penile nerve stimulation (continuous or 2. Continuous stimulation increased
conditional which was a one minute burst bladder compliance.
Kirkham et al. 2001;
triggered by a rise in detrusor pressure of 3. Of 6 subjects in which both stimulation
England
10 cm H2O) assessed during urodynamic methods were tested, 4 showed ↑
evaluation. bladder capacity with the conditional
Pre-post
Outcome measures: Urodynamic vs continuous method but the
N=14
parameters (bladder capacity, bladder difference was not significant.
compliance). Collected prior and 4. The authors suggest the conditional
during/following stimulation. neuromodulation method would be
effective for use in an implanted
device.
Population: Complete, suprasacral (C4- 1. At 3 months, 19/21 were successful in

T12) SCI; 16 males, 7 females; Median voiding more than 200 ml of urine on
Age: 40 (14-67) years; Median time since demand, while 17/21 achieved
injury: 7 (3-26) years. residual volumes of less than 50 ml.
Treatment: Implantation of externally These results were maintained at 12
controlled neuroprosthesis for stimulating months and were compared to 4/23
the sacral nerves and posterior sacral and 3/23 respectively prior to
rhizotomy. implantation (p<0.001).
Outcome measures: Voided and residual 2. Median voided volume ⁭ (p<0.001) and
volumes, catheter use, UTIs, residual volume ↓ (p<0.001as
anticholinergic use, autonomic dysreflexia, compared to baseline.
Creasey et al. 2002; USA incontinence, satisfaction. Collected at 3. By 12 months 18/23 people used the
Downs & Black score=14 baseline, 3 months and 12 months post- system as their primary bladder
Pre-post implantation. management method.
N=23 4. ↓ median # of UTIs/person/year from 3
to 2 at 12 months.
5. ↓ # of people using anticholinergics
(17 Æ 2 at 12 months).
6. ↓ # of people experiencing autonomic
dysreflexia (8 Æ 2 at 12 months).
7. Most people were satisfied with
device.
8. Also helped with bowel management.
15 of 17 ↓ time spend on bowel
management. Median time was halved
(p<0.001).
Population: SCI; 68 males, 28 females; 1. Bladder capacity ↑ from 242 ± 120 (40
Mean Age: 34.3 (males) 31.4 (females) to 600) to 567 ± 51 (300 to 600) ml for
years; 41 tetraplegia, 55 paraplegia; Time males and from 118 ± 80 (50 to 600)
post-injury to implantation: 6.9 (males) & to 560 ± 43 (400 to 600) ml for
Egon et al. 1998; France 6.1 (females) years; Time implantation to females.
Downs & Black score=11 follow-up: 5.4 (males) & 5.8 (females) 2. 56 of 65 surviving males and 26 of 28
Case Series years. females were all continent. All but 1
N=96 Treatment: ≥6 month follow-up of those female was incontinent prior. 5
implanted with Finetech-Brindley sacral patients required an anticholinergic for
anterior root stimulator and in most cases continence.
posterior sacral rhizotomy. 3. 58 males and 25 females used the
Outcome measures: Urodynamic stimulator for bladder emptying with a
13-17
Score
Methods Outcome
Research Design
Total Sample Size
assessment prior and at follow-up as noted residual volume of < 50 ml.

above. 4. UTIs ↓. 4 reported at least 1 UTI after,
35 prior.
5. Some reported ↑ spasticity which was
transitory, pre-existing autonomic
dysreflexia in 22 with bladder filling
ceased.
6. 2 stimulators became infected, 5
stimulators failed, 3 had cable failures.
Population: SCI; 31 males, 2 females; 1. For the most part, 17 of 23 evaluable

Mean Age: 40 (24-66) years; 21 patients had no change in urodynamic
tetraplegia, 12 paraplegia (C4-T10); 11 values and mean urodynamic
motor incomplete; Mean time since injury: parameters showed no change
Katz et al. 1991; USA 83.6 (7-378) months. (p>0.05).
Downs & Black score=11 Treatment: Implantation of epidural dorsal 2. 6 of these subjects had changes in
Case Series spinal cord stimulator at T1 (tetraplegia) or lower urinary tract function but these
N=33 T11-T12 (paraplegia) intended primarily for changes were not systematic.
spasticity relief.
Outcome measures: Urodynamic
parameters. Collected prior and 3 months
to 1 year post-implantation.
Population: SCI; 32 males, 5 females; 1. 32 of 37 still use the stimulator -
Mean Age: 43 (23-63) years; 14 complete continence for 57% during
tetraplegia, 23 paraplegia; Time post-injury day and 70% at night. 73% reported
to implantation: 87 (11-471) months; Time an improvement in continence.
implantation to follow-up: 86 (16-159) 2. UTIs decreased with stimulator with
months. majority saying they had >3/year
Treatment: Long-term follow-up of those before and 0-2/year after.
implanted with sacral anterior root 3. Overall, patient expectations for
stimulator. micturition were met in 62% and
Vastenholt et al. 2003; Outcome measures: Qualiveen partially met in 32%.
Netherlands questionnaire for Quality of Life and impact 4. Top 3 advantages – ↑ UTI 68%, ↑
Downs & Black score=7 of urinary problems, plus questions about social life 54%, ↑ continence 54%.
Case Series effectiveness, side effects, advantages. 5. 30% noted no disadvantage.
N=37 6. Impact of urinary problems on quality
of life ↓ with the stimulator.
7. ↑ quality of life as compared to a
reference group reported previously
with various methods of management.
8. External technical failures = 1/17
years for cable breaks and 1/38 years
for transmitter defects.
9. Internal technical failures = 1/66 user-
years.
Population: SCI; 20 males, 2 females; No group results reported.
Mean Age: 30 (20-46) years; 7 tetraplegia, 1. 16/22 using implant (11 continent, 5
Robinson et al. 1988; 15 paraplegia; “generally” complete; > 1 incontinent).
England year post-injury. 2. Of 5 incontinent, 4 had hyperreflexia
Downs & Black score=5 Treatment: Implantation of Brindley and these were unable to use
Pre-post anterior sacral root stimulator. stimulator with sufficient frequency.
N=22 Outcome measures: Urodynamics, 3. 2 had hydronephrosis, both eventually
intravenous urography, continence. undergoing sphincterotomy.
Collected prior and following implantation. 4. 6 were able to sustain an erection.
13-18
Score
Methods Outcome
Research Design
Total Sample Size
5. Dyssynergia was noted as the main

complication (n=6).
Population: SCI; 15 males; Mean Age: 47 No group results reported.

(22-70) years; C5-T12; incomplete, 1. In general, slightly more individuals
complete; Time post-injury: 4 months – 16 had enhanced bladder function with
years. treatment than those with no change
Treatment: 4 to 8 weeks of quadriceps or reduced bladder function.
muscle reconditioning by surface electrical 2. 7 people had ↑ bladder capacity with
Wheeler et al. 1986; USA
stimulation (FES) bilaterally intended for pressure that ↓ or stayed the same.
strength and spasticity. 3. 6 people had ↓ bladder capacity with
Pre-post
Outcome measures: Urodynamic pressure that ↑ or stayed the same,
N=15
assessment, strength (force transducer), however 2 of these results were
spasticity (pendulum test). Collected prior confounded by resolution of spinal
and following stimulation program. shock.
4. Changes in bladder function were
correlated with changes in strength
and spasticity.
Population: SCI; 26 males, 3 females; No group results reported.
Mean Age: 18-60 years; C5-S1; 1. 17 of 29 became continent, 10 others
incomplete; Mean time post-injury to became socially dry without need for
stimulation: 3 months (14 days to 8 pads and urinals.
Madersbacher et al. months). 2. 26 gained perfect bladder sensation.
1982; Austria Treatment: Impulses packages applied to 25 achieved satisfactory bladder
Downs & Black score=5 a saline filled bladder. Minimum of ~ 50 contractions.
Case Series stimulations for up to 90 minutes daily until 3. 28 had residual urine below 50 cc.
N=29 maximal improvement is attained. 4. At one year, patients reported ↓ effect.
Outcome measures: Urodynamic
assessment, incontinence assessed with
urilos-meter. Collected prior and at un-
specified follow-up time.
Discussion
Sacral anterior root stimulation is the most well studied method of producing bladdar voiding via
electrical stimulation techniques. Vastenholt et al. (2003), Creasey et al. (2001), Egon et al.
(1998) and Robinson et al. (1988) all employed Level 4 type studies consisting of case series,
pre-post or post-test study designs of externally controlled sacral anterior root stimulators. Most
importantly, in each of these studies the vast majority of subjects became continent and were
able to successfully void with these devices, whereas this was typically not the case for most
participants with whatever bladder management method was used prior to implantation. These
findings appear to persist with perhaps a slight drop-off in success in that both Vastenholt et al.
(2003) and Egon et al. (1998) reported continence rates of 73% and 88% for those using the
stimulators an average of 7 and ~5.5 years respectively. Several of these investigators reported
a significant decrease in UTIs (Vastenholt et al., 2003; Creasey et al., 2001; Egon et al., 1998)
and autonomic dysreflexia (Creasey et al., 2001; Egon et al., 1998) among participants, even
after long-term use. Several investigators performed satisfaction surveys and reported that most
participants remained satisfied with the device, even after many years. In particular, Vastenholt
et al. (2003) conducted a Qualiveen questionnaire for assessing the bladder health-related
quality of life and impact of urinary problems. Overall, the top 3 advantages noted by stiulator
users was a reduction in UTIs (68% reporting), improved social life (54%) and improved
13-19
continence (54%). It was also noted that the impact of urinary problems on quality of life
decreased with the stimulator. There was an increased quality of life with stimulation users as
compared to a reference group which had been reported previously consisting of those with SCI
using various other methods of bladder management. These investigators also reported the
incidence of external technical failures as 1 per 17 years for cable breaks and 1 per 38 years for
transmitter defects. Internal technical failures were reported as 1 per 66 user-years.
Other investigators have employed various other forms of stimulation in an effort to elicit similar
benefits to the neurogenic bladder as those seen with anterior sacral root stimulation. For
example, Kirkham et al. (2001) delivered two patterns of dorsal penile nerve stimulation (i.e.,
continuous vs one minute bursts triggered by a rise in detrusor pressure of 10 cm H2O) for this
purpose. They assessed the effects of these forms of stimulation in14 individuals with SCI
urodynamic evaluation before and after stimulation sessions. Both continuous and conditional
stimulation increased bladder capacity whereas only continuous stimulation increased bladder
compliance. Of 6 subjects in which both stimulation methods were tested, 4 showed increased
bladder capacity with the conditional method vs the continuous method but the difference was
not significant. Given these findings, the authors suggested that the conditional
neuromodulation method would be effective for ongoing use in an implanted device which
stimulates this nerve.
A novel approach, which differs from the others reported here involving ongoing stimulation,
was reported by Madersbacher et al. (1982). In this study, the stimulation, in the form of impulse
packages applied to a saline filled bladder, was not delivered each time the subject wished to
void. Rather, there was a defined treatment period (although variable for each subject)
afterwhich the treatment effect persisted although by one year most subjects had reported a
definite waning of the benefits. The treatment involved a minimum of 50 stimulations for up to 90
minutes daily until maximal improvement was attained. Unlike other studies presented here, this
was conducted on those more relatively recently injured with mean time post-injury to
stimulation being 3 months (range 14 days to 8 months). With this approach17 of 29 became
continent and 10 others became socially dry without need for pads and urinals. In addition, 28
had post-void residual urine levels below 50 cc. This study involved a case series design but
would have been much more powerful with the inclusion of a control group, given the potential
for natural bladder recovery in individuals with more recent injuries.
All of the approaches noted thus far have involved stimulation of neurons or other structures
with direct connections to the urinary system. Other investigators have attempted stimulation of
systems with less direct connection to the urinary system. For example, Katz et al. (1991) tested
the effect of epidural dorsal spinal cord stimulation at T1 (for those with tetraplegia) or T11-T12
(for those with paraplegia) intended primarily for spasticity relief and Wheeler et al. (1986)
investigated the effect of 4 to 8 weeks of quadriceps muscle reconditioning by surface electrical
stimulation (FES) bilaterally intended primarily for strength and spasticity. In each case, these
techniques had marginal effects on bladder function at best, however, in the latter experiment it
was noted that some subjects did achieve beneficial changes in bladder function and that these
tended to be most noticeable in the same subjects that showed positive improvements in
strength and spasticity.
Conclusion
There is Level 4 evidence that ongoing use of sacral anterior root stimulation
(accompanied in most cases by posterior sacral rhizotomy) results in reduced
13-20
incontinence for the majority of those implanted. This is associated with increased
bladder capacity and reduced post-void residual volume.
There is Level 4 evidence that sacral anterior root stimulation (accompanied in most
cases by posterior sacral rhizotomy) may be associated with reducing UTIs and
autonomic dysreflexia.
There is Level 4 evidence that other forms of neuroanatomically-related stimulation (e.g.,

dorsal penile nerve stimulation or direct bladder stimulation) may have similar effects to
sacral stimulation but require further study.
There is Level 4 evidence that epidural dorsal spinal cord stimulation originally intended
for reducing muscle spasticity may have little effect on bladder function.
There is Level 4 evidence that a program of functional electrical stimulation exercise

involving the quadriceps muscle originally intended for enhancing muscle function and
reducing muscle spasticity has only marginal (if any) effects on bladder function.
Sacral anterior root stimulation (accompanied in most cases by posterior sacral rhizotomy)
enhances bladder function and is an effective bladder management technique for some people.
Dorsal penile nerve stimulation and direct bladder stimulation may be effective in enhancing
bladder function but requires further study.
Epidural dorsal spinal cord stimulation and functional electrical stimulation of the lower limbs
are not effective in enhancing bladder function.
13.4.7 Surgical and Related Techniques
There are several surgical options available for enhancing bladder function with most authors
suggesting that conservative approaches should be exhausted first (Pazooki et al., 2006; Kato
et al., 2002; Juma et al., 1995). Most common are those approaches associated with the
external sphincter. Transtherurethral sphincterotomy and related procedures such as insertion
of sphinteric stents or balloon dilation of the external urinary sphincter provide a means to
overcome persistent dysynergia (Chancellor et al., 1999; Juma et al., 1995; Chancellor et al.,
1993b; Chancellor et al., 1993c). Often these are performed when IC is not an option because
of lack of manual dexterity or other reasons (Chancellor et al., 1999; Juma et al., 1995). Ileal
conduit diversion, another surgical approach more commonly performed in females, is often
performed for these same reasons of lack of manual dexterity or ease of care and convenience
(Pazooki et al., 2006; Chartier-Kastler et al., 2002). This technique aims to establish low-
pressure urinary drainage by diverting urine prior to entering the bladder and connecting the
ureters to an external urinary collection system via a catheter passed through the ileal
lumen.This procedure is sometimes conducted along with removal of the bladder as well
(Chartier-Kastler et al., 2002; Kato et al., 2002). Another approach has been reported by
Chancellor et al. (1993) involving bladder augmentation using the stomach in SCI patients with
impaired renal function. This particular article did not meet the criteria for inclusion in the
present review as it involved a case series of N<3.
13-21
Table 13.7 Individual Studies Describing Surgical Methods to Enhance Bladder Function
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI; 26 sphincterotomy vs 31 1. Significant ↓ in detrusor pressure

stent; 57 males; Mean Age: 34.5±9.9 vs (p<0.05) relative to baseline with both
39.1±11.8 years; 70% cervical, 30% treatments and no difference between
thoracic; Mean time post-injury: 8.7±6.6 vs sphincterotomy and stent at any time.
8.0±5.3 years. 2. No significant change in bladder
Treatment: Sphincterotomy vs placement capacity with either treatment at any
of a sphincteric stent (UroLume time.
prosthesis). 3. Significant ↓ in post-void residual
Outcome measures: Urodynamic volume (p<0.05) at some time points
parameters (maximum detrusor pressure, but not others – no difference between
bladder capacity, post-void residual urine treatments.
USA
volume), length of hospitalization. 4. The need for catheterization, initially
PEDro=5
Collected pre-operatively and 3, 6, 12 and required in 50% of the sphincterotomy
RCT
24 months post-op. group and 71% of the stent group, was
N=57
reduced to just 3, 4, 1, & 1 and 1, 0, 1
& 2 individuals respectively at each
follow-up period.
5. There was little difference in subjective
assessment of impact of bladder
function on quality of life or in the
incidence of complications between
the treatment groups.
6. Those in the stent group spent less
time in the hospital for the procedure.
Population: SCI; 25 males; Mean Age: 1. Significant ↓ in voiding pressure
32.8 (19-50) years; 23 tetraplegia, 2 (p<0.001) relative to baseline at all
paraplegia; Mean time post-injury: 7.2 (2- follow-up times.
15) years. 2. No significant change in bladder
Treatment: Insertion of a sphincteric stent capacity (p=0.57) at any follow-up
(UroLome prosthesis). time.
Outcome measures: Urodynamic 3. Significant ↓ in post-void residual
Chancellor et al. 1993c;
parameters (voiding pressure, bladder volume (p<0.01) at all follow-up times.
USA
capacity, post-void residual urine volume) 4. Positive urine cultures (i.e., UTI)
and various complications. Collected pre- occurred in 22 of 25 patients prior to
Pre-post
operatively and 3, 6, 12 months post-op. surgery but only in 9, 11 and 4 of the
N=25
patients at 3, 6 and 12 months
respectively.
5. Subjective autonomic dysreflexia
improved in all 19 who had previously
complained of this.
6. Pre-existing hydronephrosis in 5
patients resolved in 4.
Population: 16 SCI, 1 MS; 17 males; 1. Of all 17 patients previously managed

Mean Age: 34.7 (20-58) years; 13 by indwelling Foley catheter, 15 now
tetraplegia, 4 paraplegia; Mean time post- used condom catheters and 2 voided
Chancellor et al. 1993b; injury: 13 (3-20) years. on their own.
USA Treatment: Transurethral balloon dilation 2. Significant ↓ in voiding pressure
Downs & Black score=15 of external urinary sphincter. (p=0.008) relative to baseline at all
Pre-post Outcome measures: Urodynamic follow-up times.
N=17 parameters (voiding pressure, bladder 3. No change in bladder capacity
capacity, post-void residual urine volume), (p=0.30) at any follow-up time.
cystoscopy, UTIs, autonomic dysreflexia 4. Significant ↓ in post-void residual
and monitoring of renal and erectile volume (p<0.05) at all follow-up times.
13-22
Score
Methods Outcome
Research Design
Total Sample Size
function. Collected prior and 3, 6, 12 5. +ive urine cultures (i.e., UTI) in 15/17
months post procedure. prior to surgery but only in 5, 8 and 4
of the patients at 3, 6 and 12 months
respectively.
6. Subjective autonomic dysreflexia
improved in all 9 who had previously
complained of this.
7. Pre-existing hydronephrosis in 2
resolved.
8. 3 had subjectively improved erectile
function.
9. Post-procedural complications
included bleeding (1), development of
new obstructions (2), stricture (1).
Population: SCI; Mean Age: 53 (23-76) No statistical comparisons reported
years; 32 cervical, 25 thoracic, 6 lumbar; 1. 25/63 had upper tract pathology (12
32 complete, 32 incomplete; Mean time renal calculi, 11 renal scarring, 1
since injury: 27 (3-50) years; Mean follow- atrophic kidney, 1 renal cyst). 19 of
up since last sphincterotomy: 11 (2-30) these were deemed significant.
years; Mean # of sphincterotomies: 1.74 2. Risk of significant upper tract
(1-4). complications in presence or absence
Treatment: Follow-up evaluation of those of bacteria was 38% and 13%
having sphincterotomy. respectively.
Juma et al. 1995; USA
Outcome measures: Complicatons since 3. 30/63 had lower tract complications (5
sphincterotomy as determined by following: bladder calculi, 10 recurrent UTI, 3
Case Series
urinalysis, urine culture (UTI), urea, urethral diverticula, 6 urethral stricture
N=63
creatine levels, IVP, renal ultrasound, or bladder neck stenosis and 6
urodynamics, cystoscopy and voiding recurrent epididymitis).
cystorethrogram (as indicated). Collected 4. Risk for lower tract complications ↑
at follow-up at mean of 11 (2-30) years with ↑ in leak point pressure; 50% for
since last sphincterotomy. those with leak point pressure of > 70
cm H2O; reduced to 25% when leak
point pressure of < 30 cm H2O.
5. Mean post-void residual remained
high (496 ml).
Population: SCI (21), MS (4), CP (3), No statistical comparisons reported

Myelitis (3), Other (2); 14 males, 19 1. Initial surgery was successful. All
females; Mean Age: 40.6±15.2 years; 32 patients became continent after
cervical, 25 thoracic, 14 C1-T10, 6 T11-L1, initially being incontinent prior to
1 below L2; complete, incomplete; Mean surgery.
follow-up: 48 (12-240) months. 2. Of 17 with pre-op hydronephrenosis,
Chartier-Kastler et al.
Treatment: Follow-up evaluation of those 10 showed a ↓ or disappearance.
2002; France
having cutaneous ileal conduit (ileo- 3. 12 patients developed one or more
ureterostomy) diversion. complications during follow-up. 4 early
Case Series
Outcome measures: IVU, serum complications and 13 late
N=33
creatinine, cystoscopy, urine cultures and complications.
UTIs, visual analog patient satisfaction. 4. Most prevalent long-term
Collected at follow-up as indicated above. complications were pyocystitis (4),
pyelonephritis (4) and urethral leak (2).
5. Satisfaction survey indicated none
regretted surgery (9.1±2.8 out of 10).
Kato et al. 2002; Japan Population: SCI; 13 males, 3 females; No statistical comparisons reported
Downs & Black score=11 Mean Age: 46±15.2 (19-70) years; 1. 3 subjects died (constrictive ileus,
13-23
Score
Methods Outcome
Research Design
Total Sample Size
Case Series tetraplegia; Mean follow-up: 8.7 (2-17) unknown, septicemia associated with
N=16 years. UTIs) during the follow-up period.
Treatment: Follow-up evaluation of those 2. 7/16 patients had calculus formation in
having ileal conduit formation. the upper urinary tract.
Outcome measures: IVU, serum 3. 8 subjects of 13 in whom a bladder
creatinine, cystoscopy, urine cultures and was initially preserved sustained a
UTIs, visual analog patient satisfaction. procyst.
Collected at follow-up as indicated above. 4. 5 experienced calculus formation in
the upper urinary tract, 3 of these
having severe UTIs as a result.
5. Most patients were more satisfied with
procedure than previous management
method upon survey a few months
after operation (no long-term follow-up
on this issue).
Discussion
A common surgical method of treating bladder outlet obstruction or detrusor-sphincter

dyssynergia is transurethral sphincterotomy. Juma et al. (1995) reported a case series of N=63
individuals who had received 1 or more sphincterotomies with a mean follow-up time of 11
(range 2-30) years. This study was directed at describing the risk for long-term complications
following this procedure. Although more than half of these individuals had normal upper tract
imaging studies a significant proportion had complications - with 25/63 having some upper tract
pathology (i.e., 12 renal calculi, 11 renal scarring, 1 atrophic kidney, 1 renal cyst). Nineteen of
these were deemed significant. Risk of significant upper tract complications in presence or
absence of bacteria was 38% and 13% respectively. 30/63 had lower tract complications (5
bladder calculi, 10 recurrent UTI, 3 urethral diverticula, 6 urethral stricture or bladder neck
stenosis and 6 recurrent epididymitis). The authors noted that the most reliable urodynamic
measure for predicting potential complications following sphincterotomy appeared to be an
increase in leak point pressure. Complication rates of 50% were noted for those with leak point
pressure of > 70 cm H2O, whereas rates were reduced to 25% when leak point pressure was <
30 cm H2O.
One alternative to sphinterotomy is placement of a stent passing through the external sphincter
thereby ensuring an open passage. Chancellor and colleagues have conducted several studies
examining this approach (Chancellor et al., 1999, 1993c). In an initial study these investigators
conducted a pre-post trial of 25 individuals focusing on urodynamic parameters as outcome
measures collected pre-operatively and 3, 6 and 12 months post-operatively (Chancellor et al.,
1993c). Significant reductions in voiding pressure (p<0.001) relative to baseline at all follow-up
times were noted wheras no significant changes were seen in bladder capacity (p=0.57) at any
follow-up time. In addition, significant decreases were seen in post-void residual urine volumes
(p<0.01) at all follow-up times. Positive urine cultures (i.e., UTI) occurred in 22 of 25 patients
prior to surgery but only in 9, 11 and 4 of the patients at 3, 6 and 12 months respectively.
Subjective autonomic dysreflexia improved in all 19 who had previously complained of this.
Subsequently, this research group conducted a RCT (N=57) comparing the outcomes
associated with sphincterotomy as compared to placement of the stent prosthesis (Chancellor et
13-24
al., 1999). This study was deemed a low quality RCT, largely because blinding and concealed
allocation was not possible given the nature of the intervention. Similar measurement
procedures and overall findings were noted as reported for the study above (i.e., Chancellor et
al., 1993c) with significant decreases in detrusor pressure (p<0.05) relative to baseline with both
treatments and no difference between sphincterotomy and stent at any time. In this study, the
same time periods of baseline, 3, 6 and 12 months were recorded as well as a urodynamic
assessment conducted at 24 months. There were no significant changes reported for bladder
capacity with either treatment and significant reductions were seen in post-void residual urine
volumes (p<0.05) at some time points but not others – no difference between treatments.The
need for catheterization, initially required in 50% of the sphincterotomy group (N=26) and 71%
of the stent group (N=31), was reduced to just 3, 4, 1, & 1 and 1, 0, 1 & 2 individuals
respectively at 3, 6, 12 and 24 months respectively. There was little difference in subjective
assessment of impact of bladder function on quality of life or in the incidence of complications
between the treatment groups although those in the stent group spent less time in the hospital
for the procedure.
Chancellor et al. (1993b) also have examined a third procedure with similar rationale as that
associated with sphinterotomy. This investigation involved a pre-post trial design (N=17) of
transurethral balloon dilation of the external urinary sphincter. Again, similar methods were
employed as the studies noted above and findings were also similar. Of all 17 patients
previously managed by indwelling Foley catheter, 15 now used condom catheters and 2 voided
on their own. Significant decreases were noted in voiding pressure (p=0.008) relative to
baseline at all follow-up times (i.e., 3, 6 and 12 months). No changes were seen in bladder
capacity (p=0.30) and significant reductions in post-void residual urine volumes (p<0.05) were
seen at all follow-up times. Positive urine cultures (i.e., UTI) were noted in 15/17 prior to surgery
but only in 5, 8 and 4 of the patients at 3, 6 and 12 months respectively. Subjective autonomic
dysreflexia improved in all 9 individuals who had previously complained of this.
Ileal conduit diversion is another surgical procedure noted with some frequency in the literature.
Chartier-Kastler et al. (2002) and Kato et al. (2002) have reported separate case series (N=33
and N=16 respectively) examining this approach. Some success was reported with the
procedure in that Chartier-Kastler et al. (2002) reported all patients became continent after
initially being incontinent prior to surgery and Kato et al. (2002) reported most patients were
more satisfied with the procedure than their previous management method upon survey a few
months after the operation. Both authors also reported several long-term complications.
However, it is uncertain if these high complication rates noted (as also indicated for
sphinterotomy by Juma et al. (1995)) would be comparable in the event individuals had
continued with their previous form of bladder management as often surgical procedures are
performed only if other more conservative methods are unsuccessful. Some form of controlled
trial is required to address this issue.
Conclusion
There is Level 2 evidence based on 1 RCT comparative study that both sphincterotomy
and implantation of a sphincteric stent resulted in enhanced bladder function, with little
need for subsequent catheterization. The only significant difference in these 2 treatments
was the reduced initial hospitalization associated with the stent, given the lesser degree
of invasiveness.
13-25
There is Level 2 evidence that both sphincterotomy and implantation of a sphincteric
stent are associated with reduced detrusor pressure and reduced post-void residual
volume but not changes in bladder capacity.
There is Level 4 evidence that implantation of a sphincteric stent may result in reduced
incidence of UTIs and bladder-related autonomic dysreflexia.
There is Level 4 evidence from long-term follow-up of those having a previous

sphincterotomy that the incidence of various upper and lower tract urological
complications is quite high.
There is Level 4 evidence that transurethral balloon dilation of the external sphincter may
be associated with enhanced bladder function, notably reduced detrusor pressure and
reduced post-void residual volume but not changes in bladder capacity. Most individuals
undergoing the procedure were able to discontinue use of indwelling catheters in favour
of condom catheterization.
There is Level 4 evidence that most individuals undergoing cutaneous ileal conduit (ileo-
ureterostomy) diversion became newly continent and were more satisfied than with their
previous bladder management method. Long-term follow-up demonstrated the presence
of a high incidence of urological or renal complications.
Surgical and prosthetic approaches (with a sphincterotomy and stent respectively) to allow
bladder emptying from a previously dysfunctional external sphincter both seem equally effective
resulting in enhanced bladder function.
Transurethral balloon dilation of the external sphincter may be associated with enhanced
bladder function but requires further study.
Cutaneous ileal conduit diversion may increase the likelihood of achieving continence but may
also be associated with a high incidence of various long-term complications.
13.5 Enhancing Bladder Use with Pharmacological Interventions
The disruption of information transmittal between the brain and the bladder resulting from spinal
cord injury causes bladder dysfunctions such as abnormal detrusor muscle tone, urine reflux,
accidental voiding or incomplete emptying. There are two general categories of bladder
dysfunction: 1) spastic or reflex bladder and flaccid or non-reflex bladder. The former causes
involuntary voiding while the latter results in overfilling of the bladder. Dyssynergia occurs when
the bladder contracts but the sphincter does not open. The nature of the problem can be
assessed with tests such as cystograms or intravenous pyelograms (IVP), cystometrograms,
cystoscopy, renal ultrasound, and/or routine laboratory analysis such as urinalysis, urine culture
and sensitivity, BUN and creatinine, etc. Pharmacological management is often used to
augment one or more non-pharmacological bladder management methods.
13.5.1 Pharmacological Interventions to Treat SCI Bladder Dysfunction
As with many organ systems, the genitourinary system is modulated by both the voluntary
(somatic) and involuntary (autonomic) nervous system. The striated muscles of the external
sphincter are under control of the somatic nervous system while the smooth muscles of the
13-26
detrusor and the internal sphincter are in large part under control of the autonomic nervous
system. To complicate matters further, the autonomic nervous system is comprised of both the
sympathetic and parasympathetic nervous systems whose actions can be oppositional
depending on emotional states. Injuries to the spinal cord can result in damage to
parasympathetic nerve supply to the detrusor smooth muscles, the sympathetic nerve supply to
the bladder neck smooth muscle and/or somatic nerve supply to the striated muscle of the
external urethral sphincter. As a result of heterogenous innervations to the urinary system,
alternative treatments are widely varied. Commonly chosen pharmacological agents for the
treatment of bladder dysfunction include anticholinergics, alpha adrenergic blockers, alpha
adrenergic stimulants, muscle relaxants, botulinum toxin and others.
13.5.1.1 Anticholinergics
Of the two general categories of bladder dysfunction, spastic or reflex bladder causes
involuntary voiding that can be treated with smooth muscle relaxants that are called
anticholinergics. The muscarinic receptros in the detrusor muscle are blocked by
anticholinergics to decrease inappropriate bladder contraction. Overactive bladder secondary
to a variety of indications is commonly treated with marketed drugs such as Ditropan, Detrol,
Levsinex.
Table 13.8 Summary Table of Anticholinergics

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=69, f=44; Age: Significant treatment increases:

mean 29-30 yrs 1. Bladder capacity (p=0.006).
Treatment: 15mg of propiverine or placebo 2. Maximal cystometric bladder capacity
Stohrer et al. 1999;
were given 3 times a day for 14 days (p<0.0001).
Germany
Outcome Measures: Urodynamic 3. Residual urine i (p=0.01).
PEDro=9
parameters, patients clinical symptoms, Significant treatment decreases:
RCT
physicians assessment of efficacy, adverse 4. Maximal detrusor contractions
Initial N=124;
events and laboratory parameters (p<0.001).
Final N=113
(haematology, bleeding times, clinical 5. Detrusor contraction duration (p<0.03).
chemistry etc) Improved clinical symptoms: Treatment
=63.3%; placebo =22.6%.
Population: SCI, MS; Mean Age: 40.5 No significant difference between T vs P
years; 9 male, 1 female; Mean Post-injury groups in:
time: 13.7 years. 1. mean cystometric capacity
Treatment: Neurogenic detrusor 2. degree of mouth dryness
overactivity tx. Double-blind design with T vs P significantly improved:
Ethans et al. 2004;
tolterodine (T) 2mg twice daily vs placebo 3. mean catheterization volume (263 mL
Canada
(P). Open label: tolterodine self-selected vs 188 mL, p<0.001)
PEDro=6
dose (TSSD) vs oxybutynin SSD (OSSD) 4. # incontinence episodes/day (1 vs 2.8,
RCT (Tolterodine vs
Outcome measures: Cystometric p<0.005)
placebo)
capacity, catheterization volumes, number No sig. diff. btwn TSSD vs OSSD in :
Cohort (Oxybutynin vs
of episodes of urinary incontinence per 1. mean cystometric capacity
tolterodine)
day, degree of mouth dryness per day 2. catheterization volume
N=14
using visual analog scale (VAS).
3. # incontinence episodes/day
TSSD <OSSD for dry mouth (VAS 2.6 vs
4.4, p<0.05).
Stohrer et al. 1991; Population: SCI with detrusor Statistical improvements (p<0.001) in the
Australia hyperreflexia treatment group vs placebo:
PEDro=6 Treatment: trospium chloride (20mg bid, 1. increased MCC
13-27
Score
Methods Outcome
Research Design
Total Sample Size
RCT 3wks) vs placebo 2. decreased MDP

N=61 Outcome Measures: Pre-/post-treatment No effect in either group on:
max cystometric capacity (MCC); max 1. max flow rate
detrusor pressure (MDP), urinary flow rate 2. residual urine volume
and residual urine volumes, adverse Side effects low and no difference between
events. groups.
Population: m=2, f=; Age 35-77; SCI, 1. Urodynamic bladder capacity: mean
ASIA:A-D; omplete/incomplete. cystometric bladder capacity volume
Treatment: Initial 10 mg of oxybutynin XL significantly increased (p=0.008).
daily; increased by 5mg daily until 2. Mean number of voids / 24 hr period
O’Leary et al. 2003; USA
symptoms were controlled or until a max decreased (p=0.003).
dosage of 30 mg per day. 3. Residual urine increased (p=0.02).
Pre-post
Outcome Measures: Micturation 4. Nocturia decreased but not significant.
N=10
frequency diaries and urodynamics were 5. Incontinence episodes / week:
completed at baseline and repeated at decreased (p=0.03)
week 12. Tolerability info was also
collected.
Population: m=10, f=4; age 19-55yrs, SCI, No statistical results reported: 13 of the 14
Bodner et al. 1999; USA time since injury: 5mths-27yrs improved clinically on oxybutynin and
Downs & Black score=7 Treatment: Oxybutynin chloride alone or verapmil over oxybutynin alone.
Case Series combined with verapamil. A few subjects
N=14 were treated with Verapamil alone
Discussion
Propiverine is anticholinergic or antimuscarinic muscle relaxant that works by relaxing the

involuntary smooth muscle that is found in the wall of the bladder and was tested specifically in
the SCI population. In a double-blind, placebo-controlled, randomized, multicentre (N=124 with
113 completers) study, 15mg tid administration of propiverine over 2 weeks yielded significant
improvement of SCI detrusor hyperreflexia represented by increased maximal cystometric
bladder capacity (Stohrer et al, 1999). A subsequent increase in residual urine volume was
considered by the authors to be acceptable with concurrent intermittent catheterization and
side effects (primarily dry mouth) considered tolerable.
Oxybutynin is another anticholinergic agent used to treat overactive bladder in a variety of

indications. O’Leary et al 2003, in a small (N=10), before and after trial showed that controlled-
release oxybutynin was efficacious for SCI individuals with detrusor hyperreflexia as reflected
by significantly increased bladder volume with decreased mean number of voids per 24 hours.
However, post-void residual volumes, nocturia and weekly incontinence episodes did not
change significantly. Bodner et al 1999, used standard oxybutynin in combination with
verapamil (a calcium channel blocker) to treat detrusor hyperreflexia in SCI individuals and
found that 13 of 14 subjects showed clinical signs of improvement with oxybutynin plus
varapamil over oxybutynin alone.
Although oxybutynin is commonly chosen to treat overactive bladder, it is accompanied by

annoying side effects such as dry mouth. A new anticholinergic, tolterodine, that causes less
dry mouth has also been shown to be efficacious for the treatment of neurogenic bladder
dysfunction. In a RCT (Ethans et al., 2004) tolterodine was significantly better at increasing
intermittent catheterization (IC) volumes (p<0.0005) and reducing incontinence (p<0.001) but
13-28
was similar in its effects on cystometric bladder capacity when compared to placebo. As an
eligibility criteria, subjects were using oxybutynin and IC prior to a 4-day washout prior to
randomization to the tolterodine vs placebo study. This design allowed for an efficacy
comparison between oxybutynin and tolterodine where the two drugs were found to be
equivocal with respect to IC volumes, degree of incontinence and bladder capacity.
Although available in Europe for many years, trospium chloride (an anticholinergic
antispasmodic, antimuscarinic medication) was approved in 2004 for use in overactive bladder
causing symptoms of frequency, urgency, or urge incontinence. The efficacy of trospium
chloride (20mg bid) in SCI with detrusor hyperreflexia was confirmed in a RCT. Specifically,
highly significant (p<0.001) responses were recorded in favour of trospium chloride vs placebo
for increased bladder capacity and compliance, and decreased bladder pressure with low side
effects and no effect on flow rate and residual urine volumes.
Conclusion
Level 1 evidence supports the use of propiverine to treat detrusor hyperreflexia by

significantly improving bladder capacity.
Early experience in the form of level 4 evidence (1 before/after trial with N=10 and 1 N=14,
case series study) exists to support the potential benefits of controlled-release
oxybutynin. Standard oxybutynin may be enhanced by co-verapamil administration, in
the treatment of detrusor hyperreflexia in individuals with SCI.
Level 1 evidence supports the use of tolterodine vs placebo to significantly increase

intermittent catheterization volumes and decrease incontinence in neurogenic detrusor
overactivity.
There is level 2 evidence that for neurogenic detrusor overactivity, efficacy of tolterodine
and oxybutynin is equivocal except that tolterodine results in less dry mouth as
confirmed by level 2 evidence.
Level 1 evidence supports the use of trospium chloride to increase bladder capacity and
compliance, and decrease bladder pressure with very few side effects in SCI individuals
with neurogenic bladder.
Propiverine, oxybutynin, tolterodine and trospium chloride are efficacious anticholinergic

agents for the treatment of SCI neurogenic bladder.
Oxybutynin co-treatment with Verapamil may enhance the standard formulation
of oxybutynin in the treatment of SCI detrussor hyperreflexia.
Tolterodine likely results in less dry mouth but is similar in efficacy to oxybutynin
in terms of improving neurogenic detrusor overactivity.
13.5.1.2 Alpha Adrenergic Blockers
Alpha adrenergic blockers in general have been used to treat SCI bladder dysfunction. Alpha
adrenoreceptor blocker subtypes may also be used to specifically target bladder neck
dysfunction, increased bladder outlet resistance, detrusor-sphincter dyssynergia, autonomic
hyperreflexia or upper tract stasis.
13-29
Table 13.9 Summary Table of Alpha Adrenergic Blockers
Score
Methods Outcome
Research Design
Total Sample Size
Population: Age:>18yrs; SCI, Time since

injury: 85-103 mths. 1. No significant change-maximal urethal
Treatment: Subjects were randomized to closure pressure.
Abrams et al. 2003; UK
one of three groups; the 0.4 mg 2. Significant patient micturition diary
PEDro=8
tamsulosin, the 0.8mg tamsulosin or the change – 1) incontinence episode
RCT
placebo group. Medication or placebo frequency and pad change freq: 0.04
Study 1 Initial N=263
were given once daily (after breakfast). mg (p=0.009); 2) mean void volume :
Study 1 Final N=244
Assessment for the groups was 2 and 4 0.08mg (p=0.003); 3) some QoL,
weeks after treatment bladder storage /emptying symptoms
Study 2 Final N=134
Outcome measures: Not specified of autonomic dysrelfexia
3. 71% Improved (44% slightly; 27%
much improved)
Population: male; age 18-60 yrs; SCI, 1. No side effects reported.
complete/incomplete; length of injury: 2. Treatment effects at 10 mins.
4mths-7yrs. (p=0.0106)
Treatment: .25, .50, .75 or placebo on 3. Decrease in diastolic blood pressure of
different days separated by 4 to 7 days. 17.8%, 14%, 5.2% after .75 mg, .50
according to the balance incomplete block mg, .25 mg.
Costa et al. 1993; France
design (3 treatments/patient). Significant heart rate increases at 5, 10*,
PEDro=8
Outcome Measures: Maximum urethral 15, 20, 30, 60 minutes (p= 0.0016*)
RCT
closure pressure (trapezoidal rule used on *=max
N=20
tracings); pre/post arterial blood pressure For .50 & .75 mg/kg, significant difference
and heart rate; pharmacodynamic analysis. at 20 min (p<0.02) but not at 15 min
(p=0.0598).
4. Urethral closure pressure dose related
– max of 47.6% reduction at 10 min
after .75mg/kg
Population: Age: 20-74; SCI; Frankel: A, 1. Improved voiding-no difference.
Perkash 1995; USA C-D. 2. Occasional autonomic dysreflexia in
Downs & Black score=10 Treatment: Terazosin to voiding 39% of patients
Pre-post Outcome Measures: subjective 3. Decreased voiding pressure in 42%,
N=28 assessment and voiding pressure no change in37%, increased pressure
(urodynamics) in 21% .
Population: m=15; age: 18-45yrs; SCI 1. No significant differences in DESD
Treatment: Once Detrusor External voiding pressure after 4-12 weeks
Sphincter Dyssynergia (DESD) without initial terazosin treatment (p=.48)
obstruction of the bladder neck or prostate 2. Voiding pressure was reduced
was documented, therapy with terazosin (p<0.001) after subsquent external
Chancellor et al. 1993; (5mg daily) was initiated. sphincterotomy or sphinceter sting
USA Outcome Measures: Not specified placement.
Downs & Black score=12 Out of 9 subjects who experienced
Case Series persistent voiding symptoms after
Study 1:n=15 sphincterotomy following initial
Study 2: n=9 terazosin treatment, subsequent
terazosin treatment improved voiding
in patients with only bladder neck
obstruction while the other 4 who did
not improve had obstruction only at the
external sphincter.
Population: Age: 13-49yrs; SCI, No statistically significant results reported.
Al-Ali et al. 1999; Iraq complete/incomplete 1. Improved max urethral closure
Downs & Black score=12 Treatment: Phenoxybenzamine 10mg pressure in 19 patients with reflex
Case Series daily increased to 10 mg/twice daily and bladders.
Initial N=46; Final N=41 then 10 mg/3 x daily for 3 wks to 6 mos. 2. Non-responders=22 (9=areflexive
Outcome measures: Not specified bladders; 13=reflex bladders)
13-30
Score
Methods Outcome
Research Design
Total Sample Size
Population: Study 1: gender m=10; age: 1. Pre-treatment: 6 subjects taking

mean=28yrs; SCI; ASIA A&B. Study 2: prazosin, 4 taking terazosin.
gender m=7 2. Three month treatment with alpha
Treatment: Study 1: impact of alpha blockers resolves upper tract stasis
Linsenmeyer et al. 2002;
blockers on upper tract stasis. Study 2: the (p<0.0003).
USA
impact of alpha blockers on urodynamic 3. Study 2: Uninhibited bladder
parameters in those with and without contraction duration decreased with
Case Series
resolution of stasis. alpha-blocker usage (p<0.001).
Study 1: n=10
Outcome Measures: Urodynamic 4. Mean arterial pressure during
Study 2: n=7
paramters: mean changes in opening uninhibited contraction significantly
pressure, maximum detruor voiding decreased during alpha-blocker
pressure and duration uninhibited treatment (p<0.01).
contraction.
Discussion
An alpha1 adrenoreceptor antagonist that has been used to treat SCI bladder neck dysfunction
is Tamsulosin. Tamsulosin was found to cause smooth muscles in the bladder neck to relax
and improve urine flow rate. A large scale (N=263) RCT conducted by Abrams et al., (2003),
provides evidence for increased micturition frequency and improvement in urinary leakage
parameters for individuals with SCI.
Moxisylyte is an alpha adrenoreceptor blocker used commonly in the treatment of Raynaud’s

disease where narrowing of the blood vessels in the hands causes numbness and pain in the
fingers. Costa et al., (1993) in an N=20 RCT investigated the off-label use of moxisylyte in the
treatment of SCI bladder neck dysfunction. With its smooth muscle relaxant property, the
decrease in urethral closure pressure was found to be dose related and significant when
compared to placebo, with the maximum reduction of 47.6% occurring at 10 minutes after
0.75mg/kg in individuals with SCI.
Terazosin is often used to treat hypertension. However, this alpha-adrenergic blocker is also
useful in treating bladder neck dysfunction by relaxing the bladder neck muscles and easing the
urination process. Perkash (1995) reported that although 82% of patients (N=28), with absent
detrusor sphincter dyssynergia, perceived improvement in voiding, only 42% registered
meaningful objective decreases in maximum urodynamic voiding pressure. Side effects,
tolerance and required subsequent urodynamic monitoring may be deterrents to the wide-spread
adoption of Terazosin as a alternative treatment for bladder neck dysfunction in SCI individuals.
The specificity of Terazosin action on the bladder neck, exclusive of the external sphincter, was
demonstrated by Chancellor et al. (1994) in a subgroup of SCI patients who had persistent
voiding difficulty after previous sphinterotomy subsequent to failed initial terazosin treatment.
In contrast to the alpha adrenoreceptor blockers discussed above, phenoxybenzamine is one

that is not efficacious for bladder neck dysfunction. Phenoxybenzamine is an antihypertensive
usually chosen to treat autonomic symptoms of pheochromocytomas, such as high blood
pressure or excess sweating. Al-Ali et al. (1999) undertook to utilize the autonomic effects of
phenoxybenzamine to treat bladder dysfunction which is in part under autonomic control.
Treatment with phenoxybenzamine (N=46 with 41 completers), resulted in a reduction of bladder
outlet resistance, detrusor-sphincter dyssynergia or autonomic hyperreflexia in some subjects
while no benefits were recorded for areflexive bladders. Phenoxybenzamine can be beneficial as
13-31
an adjunct treatment for neuropathic bladder following SCI, when tapping or crede is unable to
achieve satisfactory residual urine volumes of < 100 mL. The lack of efficacy in those with
bladder neck dysfunction was specifically noted in this study. Since statistically significant results
were not reported in this study, further appropriately sized RCTs would be helpful in providing
sufficient evidence for the use of phenoxybenzamine in the treatment of SCI neuropathic bladder.
The pyeloureteral smooth muscle responsible for ureteral peristalsis and movement of the urine
from the kidneys to the bladder via the ureters is also a potential site of action for certain alpha 1-
receptor antagonist therapy. Linsenmeyer et al. (2002), in a small (N=10) retrospective chart
review found that in men with upper tract (i.e. kidneys and ureters) stasis secondary to SCI at or
above T6, 6 months of alpha1-blocker therapy provided improvement in upper tract stasis in 80%
of subjects, who used reflex voiding to manage their bladder as measured by significant
decreases of the duration of uninhibited contractions. Firm conclusions about effectiveness and
the optimum duration of treatment can only be validated with further RCT trials.
Conclusion
Level 1 evidence supports the use of Tamsulosin to improve bladder neck relaxation and
subsequent urine flow in SCI individuals.
Level 1 evidence suggests that moxisylyte decreases maximum urethral closure

pressure by 47.6% at 10 minutes after an optimum dose of 0.75mg/kg in individuals with
SCI.
Level 4 evidence (two non-RCT, N=28 & 9), supports Terazosin as an alternative
treatment for bladder neck dysfunction in SCI individuals provided that side effects and
drug tolerance are monitored.
Level 4 evidence derived from a single, case series study involving 46 subjects (41
completers) indicates a potential for phenoxybenzamine as an adjunct treatment for
neuropathic bladder following SCI, when tapping or crede is insufficient to achieve
residual urine volume of <100mL.
Level 4 evidence from 1 small retrospective chart review suggests that 6 months of alpha
1-blocker therapy may improve upper tract stasis secondary to SCI in men by decreasing
the duration of involuntary contractions.
Tamsulosin is likely to improve urine flow in SCI individuals with bladder neck dysfunction.
Mosixylyte is likely able to decrease maximum urethral closure pressure at
a dose of 0.75mg/kg in individuals with SCI.
Terazosin may be an alternative treatment for bladder neck dysfunction in individuals with SCI.
but side effects and drug tolerance should be monitored.
Phenoxybenzamine may be useful as an adjunct therapy for reducing residual
urine volume in SCI neuropathic bladders maintained by crede or tapping.
Six months of alpha 1-blocker therapy in male SCI patients may improve upper tract stasis.
13.5.1.3 Alpha Adrenergic Agonists
Alpha-adrenergic agonists are thought to be of benefit bladder dysfunction by increasing
bladder neck and urethral pressure to prevent accidental voiding. One drug in this class,
13-32
clonidine has already been shown to be efficacious in treating general spasticity secondary to
SCI (Donovan et al., 1988, Nance et al., 1989, Nance, 1994).
Table 13.10 Summary Table of Alpha Adrenergic Agonists

Score
Methods Outcome
Research Design
Total Sample Size
Chartier-Kastler et al, Population: m=6, f=3; Paraplegia; No statistical results reported.

2000; France complete/incomplete 1. Six of 9 subjects elected to have
Downs & Black score=7 Treatment: All underwent surgery to have permanent pump implantation for the
Case Series a catheter implanted allowing intrathecal treatment of severe detrussor
N=9 injections of Clonidine. hyperreflexia
Outcome measures: not specified 2. No complication or infections reported.
Discussion
Chartier-Kastler et al. (2000) specifically used test bolus intrathecal injections of Clonidine (ITC)
to investigate its effects over SCI detrussor hyperreflexia that was otherwise resistant to a
combination of oral treatment and self-clean intermittent catheterization (SCIC). After the test
bolus injection, 6 of 9 subjects elected to have permanent pump implantation for the treatment
of severe detrussor hyperreflexia. Further confirmatory study of this proposed alternative
treatment is needed as the sample size was small and no objective outcome measures were
used.
Conclusion
Level 4 evidence is available from a single, small (N=9), case series study for the use of
intra-thecal clonidine to improve detrussor hyperreflexia in individuals with SCI when a
combination of oral treatment and sterile intermittent catheterization are insufficient.
Intra-thecal clonidine may be beneficial as an adjunct treatment

to detrussor hyperreflexia in SCI.
13.5.1.4 Antispasmodics (Muscle Relaxants)
Baclofen, a derivative of gamma aminobutyric acid (GABA), is used as the pharmacological

treatment of choice for spasticity in SCI (Taricco et al., 2006; Kirshblum, 1999) by enhancing
inhibitory influences on the spinal stretch reflex via increasing presynaptic inhibition (Kirshblum,
1999).
Table 13.11 Summary Table of Antispasmodics

Score
Methods Outcome
Research Design
Total Sample Size
Steers et al. 1992; USA Population: m=7, f=3 Post bolus intrathecal
PEDro=8 Age range 24-61yrs: SCI; Time since 1. Increase in bladder volume at first
RCT injury: 1 to 12 years sensation and bladder compliance at 2
13-33
Score
Methods Outcome
Research Design
Total Sample Size
Initial N=10; Final N=9 Treatment: Intrathecal bolus of baclofen or hrs (p<0.05).
saline at L3 to L4. 2. Ashworth decrease >2.
Outcome measures: Reduction in Pre-post continuous intrathecal baclofen:
spasticity, urodynamics. 1. Increased volume, volume at first
sensation, compliance, residual
volume: p<0.05
2. Decreased maximum urethral
pressure, voiding pressure: p<0.05.
3. Change in bladder symptoms reported
at or after 48 hours.
4. Dosages ranged from 94-372 ug
(mean 220 ug) and followup ranged
from 12-23 months (mean 18).
Discussion
Steers et al. (1992), investigated the use of intrathecal baclofen (ITB) specifically for the
treatment of genitourinary function in 10 SCI patients with severe spasticity. Compared with
placebo, involuntary bladder contraction induced incontinence was eliminated and 1 patient
was able to convert from indwelling urethral catheterization to intermittent self-catheterization.
Bladder capacity was increased by a mean of 72% while detrusor-sphincter dyssynergia was
eliminated in 50% of patients. These authors recommend the use of ITB for SCI genitourinary
dysfunction when oral pharmacological interventions are insufficient to improve bladder
function.
Conclusion
There is Level 1 evidence that Intrathecal Baclofen may be beneficial for bladder function
improvement in individuals with SCI when oral pharmacological interventions are
insufficient.
Intrathecal Baclofen may be a beneficial adjunct treatment for bladder dysfunction in SCI.
13.5.1.5 Botulinum Toxin for the Treatment of Bladder Dysfunction in SCI
Botulinum toxin (Botox), the most toxic naturally occurring substance, used in minute doses
was approved for therapeutic use on eye and facial muscle overactivity in 1989 (i.e. BTX-A).
Although the more publicized use of Botox is in the area of cosmetic dermatology, it’s use in
the treatment of spasticity and muscle pain is gaining popularity. As such, BTX-A has been
tested for targeted bladder dysfunction treatment in individuals with SCI. The advantage over
systemic drug administration is the treatment of discreet portions of the dysfunctional voiding
process.
13-34
Table 13.12 Individual Studies of Botulinum Toxin for the Treating of Bladder Dysfunction
in SCI
Score
Methods Results
Level
Total Sample Size
Wheeler et al, Population: males; Age: 26-37 yrs; SCI; No systematic or group effects noted; 1
1998; USA Chronic. patient no response, 2 had improved
Downs & Black=8 Treatment: Transperineal botulinum toxin voiding with IC although only one of these
Level 4 Case Series injections continued using this method and eventually
N=3 Outcome Measures: bladder function as had a sphincterotomy.
assessed with urodynamics
Schurch et al, Population: m=14, f=7; Age: 15-59yrs, 1. Significant increase in reflux volume,
2000; Switzerland SCI maximum cystometric bladder capacity
Downs & Black=20 Treatment: Outpatient botulinum-A toxin (p<0.016).
Level 4 Before and After injection under cystoscopic control 2. Increase in post void residual urine
Initial N=21; Final N=19 Outcome Measures: Continence level volume.
achieved, dose of anticholinergic 3. Non-significant voiding pressure
medication, reflex volume, max detrusor change.
pressure during voiding, detrusor 4. At the 6-wk followup complete
compliance, max cystometric bladder continence was restored in 17 of 19
capacity and patient satisfaction. cases in which anticholinergic
medication was markedly decreased
or withdrawn
5. Eleven patients at 16 & 36 wks follow-
up continued to show bladder function
improvement .
Phelan et al, Population: gender: m=8, f=13; age 34- No statistics provided.
2000; USA 74yrs 1. 19/21 subjects voiding without
Downs & Black score=9 Treatment: Botuliumn A toxin (80-100 catheterization after injection.
Level 4 Case Series units) injected via cystoscipic collagen 2. 14 (67%) reported significant
N=21 needle/cytoscope into the external subjective improvement in voiding
sphincter at 3, 6, 9 and 12 o’clock. patterns
Outcome Measures: Able to void without 3. Postoperative post void residual
catheterization. decreased by 71%.
Discussion
Schurch and colleagues (2000) undertook to evaluate the efficacy of Botox A injections into the
detrusor muscle in men with spinal cord injury to reduce incontinence and increase bladder
capacity. Pre-operatively, the subjects had detrusor hyperreflexia and urge incontinence
resistant to high-dose oral anticholinergic treatment and emptied their bladders by intermittent
self-catheterization. Ninety percent of subjects were catheter free in conjunction with markedly
decreased or withdrawn anticholinergic drug administration by the 6-week post-operative
follow-up. Although mean post-void residual urine volume significantly increased post-
operatively, autonomic dysreflexic (AD) hypertensive crisis’ were abolished in the 3 patients
with a history of AD, and significant increases in cystometric bladder capacity as well as
decreases in maximum detrusor voiding pressure were additional reported findings. This group
reported that a dose of 300 units of Botox A was required for successful treatment of detrusor
overactivity lasting at least 9 months per injection. Wheeler et al, in a 1998 case series of 3
patients, showed preliminary results confirmed by Schurch and colleagues 2 years later.
Phelan et al. (2000), undertook to expand the use of botox to include those with voiding
dysfunction as a result of neurogenic detrusor-sphincter dyssynergia, pelvic floor spasticity, or
acontractile detrusor. After injection into the external sphincter, 95% (18/19) of patients who
13-35
pre-operatively required catheterization were catheter free, and post-void residuals and voiding
pressures decreased on average by 71% and 38%, respectively. Sixty-seven percent of
subjects reported subjective improvement in voiding patterns.
Conclusion
Level 4 evidence based on 3 studies supports the use of Botox A injections into the
detrusor muscle to provide targeted treatment for detrusor hyperreflexia and urge
incontinence resistant to high-dose oral anticholinergic treatments with intermittent self-
catheterization in SCI.
Additional level 4 evidence supports Botox A injected into the external sphincter to
assist with SCI related voiding dysfunctions including neurogenic detrusor-sphincter
dyssynergia, pelvic floor spasticity, or acontractile detrusor.
Botox A injections into the detrusor muscle or external sphincter may provide
targeted treatment for bladder dysfunction in SCI.
13.5.1.6 Other Pharmacologic agents
Pharmacologic manipulation can also be applied to other parts of the urinary system such as
somatic innervation of the lower urinary tract (i.e. pudenal nerve), receptors within the kidney
and at the level of neurotransmitter release.
Table 13.13 Individual Studies Describing Use of Other Pharmacological Interventions to

Treat Bladder Function
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender m=14, f=4; Age:17- No significant pre/post differences between

59yrs, SCI groups.
Wyndaele & Van
Treatment: Cisapride or placebo/4 wks.
Kerrebroeck
Outcome Measures: Max cystometric
1995; Belgium
capacity, first filling sensation volume, void
PEDro=7
sensation volume, max detrusor pressure,
RCT
compliance, first involuntary detrusor
N=21
contraction bladder capacity, and residual
urine.
Population: SCI neurogenic detrusor RTX (over Placebo) significantly:
overactivity; Age: 38y; 15M, 13F. 1. increased FDC (143±95mL to
Treatment: intravesical resiniferatoxin 184±93mL; p=0.03)
(RTX) vs placebo 2. increased MCC(115±61mL to
Silva et al. 2005;
Outcome measures: max cystometric 204±92mL;p=0.02)
Portugal
capacity (MCC) and volume of first 3. decreased urinary frequency (=0.01)
PEDro=10
involuntary detrusor contraction (FDC), 4. decreased incontinence (p=0.03)
RCT
discomfort Visual analog scale (VAS). 1mo Similar side effects (VAS) as compared to
N=28
& 1wk pre-tx and 1&3mo post-tx placebo.
cystometries. 3d micturation diary pre-
cystometry.
13-36
Score
Methods Outcome
Research Design
Total Sample Size
Population: 18 SCI; 21 MS; m=17, f=22; 1. No significant difference between

21-64y (mean 47y); 14/4 SCI para/tetra, groups: both resulted in clinical and
AIS A & B; bladder management method: urodynamical improvement at day 30
IC/23, reflex or voluntary voiding/8, 2. CAP attained statistical significance for
suprapubic percussion/2, spontaneous increase in security delay (p<0.01)
voiding/14. 3. Trend to greater increase in MCC in
Treatment: 100ml 100nMol/l CAP group
resiniferatoxin (RTX) in 10% ethanol or 4. No difference in DP.
deSeze et al. 2004; 1mmol/l capsaicin (CAP) diluted in glucidic 5. Persistent clinical improvement 94%
France solvent vs 60% in favour of RTX but not
PEDro=10 Outcome Measures: Clinical: daily significant.
RCT voids/catheterization, leakage episodes 6. MCC improvement maintained at 90
N=39 with urgency/ leakage delay. Urodynamic: days with 86% vs 68% in favour of
max cystometric capacity [MCC]; max CAP but not statistically significant.
detrusor pressure [DPmax]. Day 7. Duration of efficacy similar.
30&60=general tolerability; Cystoscopy on 8. Side effects similar between groups
day 60. except clinically tolerable/brief
suprapubic pain sig higher in CAP
group (P<0.04).
9. No cystocopic pathological changes
on day 60.
Population: MS 12, SCI 8; m=11, f=9; 30 days after instillation, results favoured
Age 20-66; Duration of illness 1-27y; capsaicin over placebo:
deSeze et al. 1998; compl/incompl 6/14; para/tetra 17/3. 1. Decrease in 24h voiding freq
France Treatment: 30mg capsaicin in 100ml 30% (p=0.016);
PEDro=10 ethanol or 100ml 30% ethanol alone 2. Decrease in 24h leakages (p=0.0008).
RCT Outcome Measures: Clinical: voiding 3. Increase in MCC (p=0.01)
N=20 diary. Urodynamic: max cystometric 4. Decrease in MDP (p=0.07; not
capacity [MCC]; max detrusor pressure significant).
[DPmax]. 5. Similar side effects in each group.
Population: SCI subjects with neurogenic N/OFQ resulted in sig increase in:
detrusor overactivity; Mean Age: 43.7 ± 8.3 1. capacity (p<0.001; 139 ± 48mL to 240
years (treatment) and 41.4 ± 11.9 years ± 61mL)
(placebo); Gender: 6M, 8F (ratio 3:4 per 2. DO volume threshold (p<0.01 84 ±
group); Level of Injury: T4-L2; 10 32mL to 201 ± 68mL).
Traumatic, 4 Non-traumatic (ratio 5:2 per N/OFQ resulted in non-sig decrease:
group); Post-injury time: 8.7 ± 3.4 years 3. in max bladder pressure: 81 ± 25cm
Lazzeri et al. 2003; Italy
(treatment) and 7.0 ± 3.5 years (placebo) H20 to 66 ± 12cm H20.
PEDro=10
Treatment: Evaluate the neuropeptide No diff btwn N/OFG and Placebo in:
RCT
nociceptin/orphanin FQ (N/OFQ) vs 4. no phasic contractions or autonomic
N=14
placebo (randomized placebo-controlled, dysreflexia
double-blind study). 5. Incomplete patients - no suprapubic or
Outcome measures: bladder capacity, urethral sensation
volume threshold for the appearance of 6. vital signs unchanged.
detrusor overactivity (DO), and maximal N/OFQ (but not placebo) elicits robust
bladder pressure during involuntary acute inhibitory effect on micturition reflex
bladder contractions. in patients with neurogenic bladder.
Population: SCI=20, MS=7, Other=9 with 1. VAPS: min. to mild discomfort with
detrusor hyperreflexia (DH) and intractable values of 2.85 and 2.28 for the 0.5-
UTIs despite previous anticholinergic drug microM and 1.0-microM RTX
Kim et al. 2003; USA
use; m=22, f=14; treatment groups.
PEDro=8
Treatment: Double-blind dose escalation 2. No statistically significant changes in
RCT
of single instillation of 100 mL intravesical MCC or incontinence at lower doses.
N=36
resineferatoxin (RTX 0.005, 0.025, 0.05, 3. MCC increased by 53% & 48% for the
0.10, 0.2, 0.5, or 1.0 microM of RTX; 0.5-microM & 1.0-microM RTX at 3
n=4/group) or placebo (n = 8 ). wks.
13-37
Score
Methods Outcome
Research Design
Total Sample Size
Outcome measures: A visual analog pain 4. Incontinence decreased by 51.9% &

scale (VAPS), bladder diary, mean 52.7% for the 0.5-microM & 1.0-
cystometric bladder capacity (MCC) at wks microM RTX.
1, 3, 6 & 12 posttreatment, adverse events 5. No long-term complications.
including autonomic dysreflexia (AD) Intravesical RTX is well-tolerated for DH
but monitoring for AD required.
Das et al. 1996; USA Population: Age: 23-52; Mixed group 1. Symptomatic improvement: 3/5
Downs & Black score=11 Treatment: Intravesical capsaicin completers - Mean urodynamic
Case Series treatment: 100uM, 500uM, 1mM, 2 mM bladder capacity increased (p<0.05)
Initial N=7; Final N=5 Outcome Measures: Not specified
Population: m=9, f=11; Age: 40-70; SCI & 1. All biopsies were benign. Some
MS. reflected chronic inflammation
Dasgupta et al. 1998; UK
Treatment: Intravesical capsaicin (cystoscopy: 2 males with TM -
Outcome Measures: Histopathological transient inflammatory reaction to
Post Test
examination of bladder biopsies, treatment).
N=20
urodynamics to assess bladder capacity, Bladder capacity improvement at 6 weeks.
cystoscopy in 2 patients
Population: m=3, f=4; Age:22-52; SCI No statistical results reported.
Chancellor et al. 1994; Treatment: 10ug/day intranasal DDAVP 1. Decreased nocturia for 4 patients
USA after urodynamic evaluation. treated at night (Nocturnal enuresis
Downs & Black score=6 Outcome Measures: Not specified eliminated in 2 patients)
Case Series 2. Increased duration between
N=7 catheterizations for 3 patients treated
during the day.
Discussion
The neurotransmitter 5-hydroxytryptamine (5-HT; Serotonin) is known to affect the pudenal

nerve which in turn causes the contraction of external urinary sphincter to prevent accidental
voiding. Cisapride was previously indicated for use to assist with increasing movements or
contractions in the stomach and intestines by interacting as a 5-hydroxytryptamine(4) receptor
agonist. These 5-HT4 receptors have also been identified in in vitro preparations of the human
urinary bladder (Tonini et al., 1994) and therefore there was a possibility that the dysfunctional
bladder may also have been susceptible to the prokinetic actions of cisapride. Wyndaele &
Van Kerrebroeck (1995), conducted a RCT to test the effects of 4 weeks of Cisapride or
Placebo on the cystometric paramers in SCI patients and found no difference between groups.
This type of robust evidence along with a FDA warning regarding the risk of serious cardiac
arrhythmias should be sufficient to dissuade use of cisapride for the treatment of SCI bladder
dysfunction. Since May 1, 2000, Cisapride is only available through an investigational limited
access program.
DDVAP, otherwise known as desmopressin, is a synthetic analogue of antidiuretic hormone

(ADH) most commonly administered by intravenous infusion for treatment of bleeding disorders.
It can also be taken in the form of a pill of intranasal spray and also has been used treat bed-
wetting, frequent urination and extreme thirst in diabetes, blood coagulation disorders and
amnesia and memory loss. Chancellor et al., (1994) investigated the use of intranasal DDVAP
as an alternative therapy for neurogenic bladder dysfunction that is unresponsive to
conventional therapy. DDAVP is thought to bind to V2 receptors in renal collecting ducts to
increase water resorption. After one month of DDAVP treatment, two patients had only one
episode of nocturia per night and in the other two patients, nocturnal enuresis was completely
13-38
eliminated. Three patients used daytime DDAVP administration at work and were able to
achieve an additional 3.5 hours between catheterizations. These improvements persisted for a
mean of 12 months. This small scale (N=7), case series study provides only preliminary
evidence and encourages further study in order to recommend intranasal DDVAP for the
treatment of SCI neurogenic bladder.
The use of Capsaicin as a topical temporary analgesic is not uncommon as evidenced by over-
the-counter ointments available for purchase in local pharmacies. Localized and reversible
antinociception by capsaicin is a result of induced C-fibre conduction and subsequent
neuropeptide release inactivation (Dray, 1992). Although C-fibers are not involved in normal
voiding, neuroplastic changes to C-fiber bladder afferent growth account for injury emergent C-
fiber mediated voiding reflex (i.e. spinal detrusor hyperreflexia; deGroat, (1995)). By chemically
decreasing C-fiber bladder afferent influence with intravesical vanilloids (i.e. capsaicin,
resiniferatoxin) bladder contractility is decreased and bladder capacity is increased (Evans
2005). deSeze et al 1998 has provided level 1 evidence in support of capsaicin’s ability to
improve bladder function (decrease frequency and leakages) by increasing bladder capacity.
This corroborates other small, non-RCT studies that also reported significant capsaicin
induced increases in bladder capacity (Das et al., 1996; Dasgupta et al., 1998). Although the
Dasgupta group confirmed that metaplasia, dysplasia, flat carcinoma in situ, papillary or solid
invasive cancer have not been detected after 5 years of follow-up, further surveillance is
required up to 10 years when chemical carcinogenic morphologies are typically apparent.
deSeze et al. (2004) later established that another vanilloid, resiniferatoxin (RTX) was similarily
effective in increasing bladder capacity when compared to capsaicin (CAP). CAP was
significantly more effective at increasing urgency delay (p<0.01) but there was only a trend to
greater maximum bladder capacity in favour of CAP. There was also a statistically significant
increase in the side effect, suprapubic pain, that was clinically tolerable and brief (p<0.04). The
increase in persistent clinical improvements due to RTX over CAP at 90 days follow-up was not
statistically significant. The efficacy of RTX vs placebo was confirmed an RCT conducted by
Silva et al. (2005) where they found that RTX was responsible for significantly increased
volume of first involuntary detrusor contraction (FDC; p=0.03)) and maximum cystometric
capacity (MCC, p=0.02), and decreased urinary frequency (=0.01) and incontinence (p=0.03)
with similar side effects as compared to placebo. Kim et al. (2003) confirmed the
improvements in SCI bladder function and further investigated the effect of dose (single100ml
instillation of 0.005, 0.025, 0.05, 0.10, 0.2, 0.5, 1.0 microM RTX or placebo). Despite the small
sample size in each dose category, MCC increased by 53% and 48% for the two highest
dosages by 3 weeks post-treatment. Similarly, incontinence episodes decreased by 51.9% and
52.7%. As with all bladder instillilations, autonomic dysreflexia remains a potential problem
with RTX treatment.
A heptadecapeptide (Meunier et al., 1995; Reinscheid et al., 1995), N/OFG

(nociception/orphanin phenylalanine glutamine) that acts on sensory innvervation of the lower
urinary tract in a similar fashion to CAP and RTX has been shown to be effective in inhibiting
the micturition reflex in the rat (Lecci et al., 2000). Following a successful preliminary study,
Lazzeri et al. (2003) confirmed that N/OFG versus placebo is responsible for a significant
increase in the bladder capacity (p<0.001) and threshold volume of detrusor overactivity
(p<0.001), and a non-significant decrease of maximum bladder pressure of the dysfunctional
neurogenic bladder. The authors conclude that this inhibition of the micturition reflex supports
nociceptin orphan peptide receptor agonists as a new treatment for neurogenic bladders of SCI
patients.
13-39
Conclusion
Level 1 evidence for lack of efficacy, in combination with a FDA warning for risk of
serious cardiac arrhythmias, supports not using Cisapride for treatment of SCI bladder
dysfunction.
Level 1 evidence supports the use of vanillanoid compounds such as capsaicin or

resiniferatoxin to increase maximum bladder capacity and decrease urinary frequency
and leakages in neurogenic detrusor overactivity of spinal origin.
Level 4 evidence exists to suggest that intravesical capsaicin installation in bladders of

SCI individuals does not increase the rate of common bladder cancers after 5 years of
use.
Level 1 evidence supports the use of N/OFG, a nociceptin orphan peptide receptor
agonist for the treatment of neurogenic bladder in SCI.
Level 4 evidence from one small, case series study, suggests that intranasal DDVAP may
increase the time between the need to void or catheterization in SCI with neurogenic
bladder that is unresponsive to conventional therapy.
Cisapride should not be used for treatment of SCI bladder dysfunction due to lack of efficacy
and risk of serious cardiac arrhythmias.
Vanillanoid compounds (CAP or RTX) improve function of neurogenic
detrusor overactivity of spinal origin.
Capsaicin may not be linked to common bladder cancers within 5 years of use,
when instilled in the bladders of individuals with SCI .
N/OFG is effective for the treatment of neurogenic bladder in SCI.
Intranasal DDVAP may decrease the frequency of voids or catheterizations in SCI
neurogenic bladder otherwise unresponsive to conventional therapy
13.6 Non-pharmacological Interventions for Preventing and Treating UTIs
Bladder dysfunction secondary to SCI leads to urinary tract infection (UTI). UTI and its
complications continue to be a leading cause of secondary health problems and death after
spinal cord injury (Stover et al., 1989; DeVivo & Stover, 1995; DeVivo et al., 1999).
Clinicians often diagnose UTI based on their clinical experience and knowledge of each
patients’ history. However, to objectively assess the use of clean, intermittent catheterization
following SCI, Maynard and Diokno (1984) clearly defined urinary tract infections as potential
infections that met 5 criteria: 1) purulent urethral discharge with positive urethral culture; 2)
pyuria/foul smelling urine with positive urine culture and white blood cells more than 25/HPF
(laboratory infection); 3) fever of more than 100°F/chills/flank pain, with laboratory infection; 4)
positive C-reactive protein with positive urine culture. Although the Maynard and Diokno
definition can be useful, the National Institute on Disability and Rehabilitation Research (NIDRR)
developed a statement on UTI that was derived by expert consensus.
13-40
In January 1992, the NIDRR defined UTI as “bacteriuria (102 bacteria/ml of urine) with tissue
invasion and resultant tissue response with signs and/or symptoms. Asymptomatic bacteriuria
represents colonization of the urinary tract without symptoms or signs.” They further defined
risk factors to include: “over-distention of bladder, vesicoureteral reflux, high pressure voiding,
large post-void residuals, presence of stones in urinary tract, and outlet obstruction. Possible
physiologic/structural, behavioral, and demographic risk factors were identified also, Indwelling
catheterization, including suprapubic, and urinary diversion and the drainage methods most
likely to lead to persistent bacteriuria.”
The Centers for Disease Control and Prevention (CDC) have further defined asymptomatic
bacteriuria (ASB) and other infections of the urinary tract (OUTI) as well as symptomatic urinary
tract infections (SUTI) that apply to SCI and the general population. For a diagnosis of ASB, 5
criteria must be met provided that urine cultures are acquired using appropriate technique, such
as clean catch collection or catheterization and the positive culture of a urinary catheter tip is not
used. OUTIs include infections of the kidney, ureter, bladder, urethra, or tissues surrounding
the retroperitoneal or perinephric spasces. A diagnosis for SUTI or OUTI must include at least 1
of 4 major criteria that include several subcriteria. Some examples of criteria include fever >
38°, urgency, frequency, dysuria, or suprapubic tenderness; and 1) ≥105 microorganisms/cm3 of
urine with no more than two species; 2) positive dipstick for leukocyte esterase and/or nitrate; 3)
pyuria (urine specimen with ≥10 WBC/mm3), etc. Detailed definitions and criteria can be
obtained from Horan & Gaynes (2004) or downloaded from www.cdc.gov.
With a documented and widely accepted consensus on UTI, initial SCI rehabilitation should be
able to include quality bladder management education that can provide a common consistent
goal to reduce the incidence of UTI in SCI. Educational efforts can initially cover at least one of
the following methods to empty the neuropathic bladder: intermittent, indwelling or external
condom (males only) catheterization and/or manual forms of voiding encouragement (anal or
rectal stretch, crede, tapping, valsalva).
Bacteria is the source of UTI and the source of bacteria is usually introduced from the skin and
urethra via catheters. Alternatively, normally occurring bladder bacteria have the opportunity to
grow when the bladder is not completely emptied of urine. Therefore the best prevention of UTI
is to prevent the introduction and growth of bacteria. Prevention can be encouraged by properly
educating the patients on the following: 1) keeping urinary care supplies clean, 2) keeping skin
clean, 3) proper bladder emptying technique 4) regular and sufficient scheduling of bladder
emptying and 5) knowing the early signs of UTI.
13.6.1 Educational interventions
All SCI patients with neurogenic bladder are educated to healthy bladder function while in initial
and some continue to receive ongoing education as situational changes occur post discharge.
Table 13.14 Individual Studies of Educational Interventions for Preventing and Treating
UTIs
Score
Methods Outcome
Research Design
Total Sample Size
Anton et al. 1998; Population: Gender: m=30, f=8; age 19- 1. A total of 19 participants (in both
Canada 69; SCI groups) dropped out of the study.
PEDro=7 Treatment: PUD; recording frequency of 2. PUD group - fewer catheters p=0.026.
13-41
Score
Methods Outcome
Research Design
Total Sample Size
RCT catheterizations, catheter volumes, 3. No significant difference for mean over

Initial N=57; Final N=38 episodes of UTI distention per subject (p=0.61).
Outcome Measures: The frequency of
overdistension of the bladder, the
frequency of catheterization and patient
satisfaction were measured
Population: m=42, f=14; age: 20-77; level Significant changes in favour of treatment:
of injury: C1-S4/5; ASIA A-D; Bladder 1. Fewer Urinary Colony Counts
Management IC n=33, Condom Catheter (p=0.009).
n=11, Indwelling catheter n=11, 2. Fewer symptom reports (p=0.097).
spontaneous management n=1; Time since 3. Fewer episodes treated with antibiotics
injury: .5 to 48 yrs (p=0.232).
Cardenas et al. 2002;
Treatment: specialized educational 4. No significant difference between the
USA
program for the prevention of UTIs vs no groups for NIDRR defined UTI.
PEDro=5
program 5. Increase in the perception of the
RCT
Outcome Measures: episodes of severity of the UTI (p=0.042).
symptomatic UTI, white blood cell count, 6. Higher locus of control (p=0.066).
bacterial colony counts, # antibiotic Lower self-efficacy (p=0.033).
treatments for UTI, UTI related symptoms,
health belief questionnaire,
multidimensional health locus of control,
self efficacy.
Population: Not specified Treatment vs Control following education:
Treatment: Urinary tract care education 1. No impairment: 71 vs 32%.
Anderson et al. 1983;
program (patient and staff training), 5 2. Symptomatic: 24 vs 57%
USA
classes + manual 3. No time lost: 71 vs 50%
Outcome Measures: Functional 4. Lost various times: 5 vs 23%
Impairment Scale for Bacteriuria, UTIs, UTI 5. Recognition of symptoms: no
Trial
symptoms, time lost due to UTI difference
N=75
6. No p values - between group stats
tests conducted.
Population: Not specified 7. 11/17 responders
Treatment:Patients with no risk factors for 1. 8/11 required multiple counseling
UTI received intensive counseling with sessions.
Barber et al. 1999; USA
respect to proper CIC technique, daily 2. 4/17 were placed on prophylactic
external condom catheter application and methenamine mandelate and ascorbic
Case Series
care. If subjects had 2 or more UTIs in acid with various treatment periods.
N=17
6mths either nitrofuratoin or methenamine 3. 3/17 were placed on prophylactic
mandelate with ascorbic acid was initiated. nitrofurantion for 1 to 2 3/4 yrs.
Outcome Measures: Not specified.
Population: m=45, f=10; Age: 15-75yrs At discharge
Menon & Tan 1991; Tetra/paraplegia/paresis; SCI 1. 45 (82%) successfully bladder trained,
Singapore Treatment: Suprapubic tapping every 4 2. 8 (15%) used clean intermittent self-
Downs & Black score=4 hours with or without compression followed catheterization,
Case Series by catheterization (residual volume goal < 3. 2 had indwelling catheter.
N=55 100 ml). No statistical results reported
Outcome Measures: not specified
Population: m=11, f=1; Age: 17-72; 3- Hyper vs hypoactive bladder changes
Jensen et al. 1995;
7mths since injury; complete/incomplete 1. Max scored retention p=.06
Norway
Treatment: Intermittent catheterization 2. Mean residual volumes p=.21
Outcome Measures: Residual urine 3. UTI p=.49
Case Series
volume as measured by utrasonography; 4. Mean & Max residual volumes/UTI
N=12
urinary tract infections correlations: r=.19 & .16 (p=.52 & .63)
Sutton et al. 2002; Population: m=35, f=1; age: 1. 81% continued to use CISC at 5 years
Australia mean=31.5yrs, level of injury: C5-C8; post-discharge.
Downs & Black score=16 complete=16/incomplete=20. 2. 24/29: independent CISC
13-42
Score
Methods Outcome
Research Design
Total Sample Size
Observational Treatment: No treatment-survey mailed to 3. 16/18 patients who were screened by

N=36 participants urinalysis had sterile urine.
Outcome Measures: bladder 4. Higher CISC success with earlier
management method, degree of CISC education
satisfaction, independence, ADLs with this 5. Pre-/post-discharge ADL scores did
method, reasons for CISC cessation, not correlate with CISC success.
number and reason for hospitalizations, Very little statistical analysis reported.
frequency of contact with local medical
office and SI unit, current use of adaptive
equipment, and modified barthel index.
Population: SCI patients with ileostomy or Although 27 charts reviewed only 18
urostomy patients located to complete the
Treatment: No treatment – chart review questionnaire:
Craven & Etchells 1998;
Outcome Measures: 1. Bowel and bladder management
Australia
questionnaire for physical, psychological, greatly improved in most cases,
and lifestyle effects after surgery resulting in improved quality of life for
Case Series
these patients.
N=27
2. Positive psychological effects
Long-term impact on renal health not
measured.
Discussion
While in rehabilitative care, clinical staff have an excellent opportunity to provide proper bladder
management education to significantly affect the quality of bladder management after
discharge. Cardenas et al. (2003) sought to answer this question in a randomized controlled
trial of 56 SCI patients suffering from UTIs. The educational intervention included written
material, a self-administered test, a review by nurse and physician, and a follow-up telephone
call. The control group did not receive the intervention and final interventional data was
compared to an equivalent baseline period. A significant decrease in urine colony count (UCC)
and increased Multidimensional Health Locus of Control scale (MHLC) score reflected the
beneficial effects of UTI educational intervention in improving bladder health and the patient’s
perception of control over their own health behaviour. This finding confirms an earlier
uncontrolled trial of educational intervention for urinary tract care (Anderson et al., 1983). When
patients completed a special urinary tract care education program consisting of classes, reading
material, written examinations, and demonstration of acquired skills, 71% of patients were
asymptomatic of UTI. Only 32% of patients had asymptomatic UTI when a group of patients, 4
years earlier in 1975, did not undergo the education program. Furthermore, as a result of the
education program only 5% of the educated group lost time from their usual daily activities
compared to 23% of the non-educated group losing time. However, both groups registered the
same incidence of confirmed or suspected UTI (62-63%). Therefore, the benefit translated into
early detection and definitive action resulting in less impairment and less lost time due to the
UTI.
Once discharged, some SCI patients experience unacceptable recurrence of UTIs. These high
risk individuals can be identified and re-educated with respect to proper technique and hygiene.
Barber et al. (1999), identified and re-educated 17 patients over 1000 consecutive outpatient
SCI clinic days, and found that 65% of these patients were able to reduce their number of UTIs
to be reclassified as not high risk (≥2 UTI/6months). A further subset of these patients (N=8)
required multiple counseling sessions to realize an effective reduction of number of UTIs.
13-43
Although the authors suggest that education intervention by a clinic nurse is a simple, cost-
effective means of decreasing the risk of UTIs in at risk SCI individuals, the sample size is small
and the study was neither randomized nor controlled.
Patients can also be educated with respect to additional definitive action for the prevention of
UTI in SCI such as anal or rectal stretch, crede, tapping, valsalva or more frequent
catheterization. With the aid of tapping and compression, Menon and Tan, (1991) (N=55, case
series study) reported that acceptable residual urine volumes (<100mL) were maintained by
patients who were catheter free (N=45), utilizing clean intermittent self-catheterization (N=8) or
had an indwelling catheter (N=2).
Another tool that may be useful in the bladder management education of SCI individuals is a
portable ultrasound device (PUD) to assist with optimization of SIC frequency and with decrease
in number of episodes of bladder over distension. Anton et al. (1998) randomized 57 SCI
patients with neuropathic bladder into groups using a PUD (or not) where SIC frequency,
bladder volumes and patient satisfaction were measured. The PUD group used significantly
fewer catheters per day while no significant difference was found between the two groups for
episodes of over distension. The authors felt that the change in number of episodes of over
distension (12.45 vs 14.76 episodes of over distension) would still be clinically significant even if
statistically non-significant. The majority (16/18) of PUD users expressed satisfaction with the
use of the device although less than half expressed that they would be willing to purchase such
a device to assist with their SIC program. Of note is the 33% drop out rate which may indicate
that not all patients would find the PUD an acceptable part of their SIC program. Perhaps
reporting a reduced incidence of UTIs would have been a more persuasive finding to advocate
for consistent PUD usage in this population. The contribution of small residual volumes on UTI
incidence was demonstrated in a case series of 12 SCI patients having documented residual
urine volumes after SIC as measured by ultrasonography (Jensen et al., 1995). There was a
low and non-significant correlation found between residual volume and frequency of urinary tract
infections. All but 2 patients had residual volumes after an initial catheterization while residual
volumes were reduced to <50ml after the 2nd or 3rd catheterization. Seven (19%) of the 36
catheterizations resulted in residual volumes exceeding 50ml and 2 of these patients had
residual volumes exceeding 100ml. It appears that even small residual volumes may
predispose patients to urinary tract infections.
Even though SIC had been popularized since the early 1970’s (Lapides et al., 1972; 1974),
quadriplegic patients did not have access to this area of independence due to the fears of
clinicians that insufficient hand function would create greater risk of UTI due to their inability to
maintain clean technique (Dailey and Michael, 1977). However, Sutton et al. (2002) have
provided evidence to the contrary where 81% of the 36 quadriplegic patients, taught CISC
during hospitalization, continued to use CISC at follow-up 2-9 years later. Similar findings were
reported by Maynard and Glass (1987) following a telephone interview and medical record
review of 40 SCI patients (para and quadriplegic) with neuropathic bladder. At least 80% of
patients who were discharged with CISC continued using CISC at 5 years post-discharge. The
majority of the Sutton et al. (2002) patients (24/29) performed CISC with total independence and
16/18 patients who were screened by urinalysis had sterile urine. This group also found that
there was a higher chance of CISC success with earlier CISC education. However, pre-/post-
discharge activities of daily living (ADL) scores did not correlate with CISC success.
In some instances, common bladder management techniques yield unsatisfactory results such
as chronic UTIs, hydronephrosis, recurrent renal calculi, vesico vaginal fistula, persistent
urethral or catheter leakages. For these patients, one option is for the elective formation of a
13-44
stoma via surgery. Craven and Etchells (1998) reviewed 27 medical records of SCI patients
who had undergone colostomy, ileostomy or urostomy. Eighteen of these patients were then
interviewed or completed a comprehensive questionnaire to assess the long-term physical,
psychological or lifestyle effects of the surgery. Although the impact of the stoma on lifestyle
was positive, the long-term impact to renal impairment could not be ignored for individuals with
neuropathic bladder secondary to SCI.
Conclusion
Level 1 evidence supports the use UTI educational intervention to provide benefits of
increased bladder health (i.e. decreased urine colony counts) that increase a patient’s
perception of the control they have of their own health behaviours and that may translate
into less impairment and less lost time due to UTI in SCI.
Weak level 4 evidence suggests that outpatient, nursing-mediated re-education of SCI

individuals at high risk of UTIs may be a cost-effective method of reducing the number of
UTI.
Level 4 evidence exists to support additional utilization of tapping and compression to

augment bladder management as expressed as acceptable residual urine volumes
(<100mL).
Level 1 evidence supports the acceptance and use of a portable ultrasound device to
significantly reduce the number of catheterizations required each day in individuals with
SCI who perform SIC to empty their bladder.
Level 5 evidence supports that quadriplegic patients educated to CISC may continue to
use CISC successfully for many years after discharge.
Level 4 evidence suggests that for SCI individuals with chronic or significant medical
issues related to common bladder management techniques, urostomy may not be a
viable alternative due to long-term renal impairment.
UTI educational intervention improves bladder health and a patient’s perception of

the control that they have of their own health behaviours.
Out-patient, nursing-mediated, re-education may be cost-effective in reducing the
number of UTIs in SCI individuals identified as high risk for UTI.
Adjunct tapping and compression may help to maintain acceptable residual urine
volumes in SCI bladder management.
The use of portable ultrasound devices is accepted by patients and the number of intermittent
catheterizations per day are reduced in patients using these devices.
Quadriplegic patients can be successful with clean intermittent catheterizations
for many years post-discharge.
Quadriplegic patients taught clean intermittent catheterizations may continue to use this
technique successfully for many years after discharge.
Urostomy as an alternative to insufficient common bladder management methods
may lead to long-term renal impairment.
13-45
13.6.2 Managing Possible Sources of Contaminants
Keeping the skin clean is one of the simplest methods to limit the source of bacteria that can be
introduced into the bladder of SCI individuals. Using clean versus sterile catheterization
supplies and instilling anti-bacterial solutions directly into the bladder are other alternative
methods to reduce the level of contaminants residing in the bladder.
Table 13.15 Individual Studies of the Effect of Managing Possible Contaminants in

Preventing and Treating UTIs
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI; Mean Age: 38.2±16.4 1. Lower incidence of UTIs (p=0.03) and
years; C5-Cauda Equina; AIS A-D; Post- asymptomatic bacteriuria (p=0.0244)
injury time: 18-60 days. of those using pre-lubricated catheters
Treatment: Assessment of “Instacath®” vs PVC.
nonhydrophilic pre-lubricated catheter vs 2. More epithelial cells found on
conventional uncoated PVC Nelaton conventional vs pre-lubricated catheter
catheter for IC (crossover design). (p=0.01) indicative of possible
Outcome measures: symptomatic UTI, microtrauma.
incidence of urethral complications 3. 2 people had urethral bleeding with
Giannantoni et al. 2001;
(ultrasound, CUG), urinalysis, visual analog conventional catheter, 0 with pre-
Italy
scale of patient satisfaction. Collected at lubricated.
PEDro=9
the start and end of 7 week study period. 4. Pre-lubricated catheters had
RCT
significantly higher satisfaction scores
N=18
for 4 of 5 items on the scale.
5. 3 subjects requiring assistance with
the conventional catheter became
independent with the pre-lubricated
catheter (order effect unreported)
6. No subject had impaired renal function
of upper & lower tract abnormalities
with either catheter.
Population: SCI using hydrophilic vs PVC 1. Lower incidence of UTIs of those using
catheter; Mean Age: 37.5±14.6 vs SpeediCath hydrophilic vs PVC
36.7±14.6 years; AIS A-D. (p=0.02).
Treatment: “SpeediCath®” hydrophilic 2. No difference in number of bleeding
catheters vs conventional uncoated PVC episodes or occurrence of hematuria,
catheter for IC. leukocyturia and bacteriuria between 2
De Ridder et al. 2005; Outcome measures: Occurrence of catheters.
Belgium, Spain symptomatic UTIs, hematuria, strictures, 3. More individuals expressed greater
PEDro=5 convenience of use, satisfaction with satisfaction with various aspects of the
RCT catheter collected over a 12 month period. hydrophilic catheter, although these
N=123 differences were not significant.
4. 54% dropout rate (slightly more so in
hydrophilic group) partially due to the
fact that many subjects no longer
needed to catheterize when bladder
function was retained within the 1 year
period.
Population: m=40; level of injury: T6 & 1. Urine pH lower in methenamine and
Krebs et al. 1984; USA above=27, T7 & below=13 hemiacidrin group (p<0.01).
PEDro=4 Treatment: Control group: intermittent 2. Control group had double the number
RCT catheterization without bacterial of positive cultures (p<0.001).
N=40 prophylaxis. Treatment group: instillation 3. UTI higher in controls (p<0.02).
of 45 ml. 5% hemiacidrin solution at each 4. Higher rate of symptomatic UTI in
13-46
Score
Methods Outcome
Research Design
Total Sample Size
catheterization and 2 mg methanamine controls (chi-square 3.84, p<0.05)

mandelate orally 4*daily.
Outcome Measures: Urinary pH
determination culture and antibiotic
susceptibility
Population: m=16, f=3 1. Bacteriuria reduced by washing with
Treatment: Patients washed daily in chlorhexidine vs soap. (X2=12.2,
Sanderson & Weissler chlorhexide or unmedicated soap. p<0.01).
1990a; UK Outcome Measures: Not specified 2. Bacteriuria less for those on antibiotics
2
PEDro=4 and using chlorhexidine (X =3.2,
RCT 0.05<p<0.01).
N=19 3. Antibiotics usage resulted in significant
increase in perineal swabs negative
for coliforms (p<0.01)
Population: m=16, f=13; ASIA: A-D; SCI. 1. No statistically significant results were
Prieto-Fingerhut et al. Treatment: rehab nursing catheterization reported.
1997; USA every 4 to 6 hours over a 3 month period. 2. Non-sterile catheterization programs =
PEDro=2 Outcome Measures: Number or % of more urinary tract infections (not
RCT urinary tract infections. significant).
N=29 3. Sterile catheterization program 277%
more costly.
Population: Traumatic SCI on inpatient 1. “No-touch” experimental group had
rehabilitation; “No-touch” vs traditional fewer infections (p=0.0001), and
straight IC method groups; Median Age: reduced duration of infections
Charbonneau-Smith
30.5 vs 30 years; 2 groups were similar (p=0.0004).
1993; Canada
with respect to age, gender, paraplegics vs 2. No difference on total cost (including
quadriplegics, level of lesion and extent of antibiotics) and # of infection-free days
lesion; LoS: 4.8 vs 11 weeks. (trends were in favour of “No-touch”).
Study (retrospective
Treatment: Assessment of no-touch vs 3. Similar number of catheters used
control group)
traditional straight IC method. despite > 2x longer LoS for traditional
N=110
Outcome measures: UTIs, infection free method.
days, duration of infection, Cost of 4. Majority of nurses reported they
antibiotics, nurse satisfaction with method. preferred “No touch” catheter.
Population: SCI, approx age 26.5, 70 1. Reduced Pseudomonas and Klebsiella
Treatment: External urinary collection in urethra, perineum or rectum only if
Gilmore et al. 1992; USA system (EUCS): Group 1-continuous no EUCS (p<.05),
Downs & Black score=10 EUCS, Group 2-EUCS during day only, 2. EUCS did not influence rate of
Prospective Controlled Group 3-no EUCS bacteriuria.
Trial Outcome Measures: # of Pseudomonas 3. Removal of the EUCS at night reduced
N=119 and Klebsiella in swab cultures of urethra, urethral colonization with
perineum, rectum; Significant bacteriuria Pseudomonas only (p=.03)
(10,000 bacteria/ml urine)
Discussion
Although the use of standard soap for cleansing is routine in rehabilitation facilities, the
prevention of bacterial colonization may require further measures. Sanderson and Weissler
(1990b) found that perineal colonization of SCI individuals was significantly correlated with
bacteriuria and may be a source of contamination of the environment and indirectly of the hands
of patients and staff. As a result of this finding, this group further examined the effect of
chlorhexidine antisepsis on bacteriuria, perineal colonization and environmental contamination
in spinally injured patients requiring intermittent catheterization (Sanderson and Weissler,
1990a). In male patients not receiving antibiotics, daily body washing in chlorhexidine and
13-47
application of chlorhexidine crème to the penis after every catheterization significantly reduced
bacteriuria to 60% from 74% in patients who were only washed with standard soap.
Chlorhexidine antisepsis did not affect perineal coliform colonization or contamination of the
environment.
Limiting the source of contaminants through the use of sterile vs clean catheter supplies may
superficially sound like a viable solution to reducing the rate of UTI but not surpisingly, costs of
sterile supplies may become prohibitive. Prieto-Fingerhut et al. (1997) conducted a randomized
trial on 29 SCI patients using sterile or nonsterile urethral catherization. Predictably, the
incidence of UTI was higher in the non-sterile group (incidence of 42.4% vs 28.6%) and the
subsequent cost of antibiotic treatment in the sterile group was only 43% of the non-sterile
group. However, the total cost of the sterile management group was 277% higher than the
non-sterile group. Charbonneau-Smith (1993), had previously reported that using “no-touch
method” of catheterization in a convenience sample of 18 traumatic SCI patients resulted in a
44.5% reduction of UTI rate. Athough a nurse satisfaction questionnaire revealed that this
method of intermittent catheterization was preferred over the traditional method, no reference
was made to a formal cost analysis between methods.
Sterility aside, the type of catheter also has an effect of the incidence of UTI in those who
practice IC to mange SCI neurogenic bladder. For example, Giannantoni et al. (2001) employed
a double-blind, crossover RCT design (N=18) to examine the difference between a pre-
lubricated nonhydrophillic Instantcath catheter as compared to a conventional polyvinyl chloride
(PVC) silicon-coated Nelaton catheter with respect to the occurrence of UTIs and urethral
trauma. The subjects were randomized to 1 of 2 groups which tried each catheter for a period of
7 weeks in an A-B, B-A design. Both incidence of UTIs and presence of asymptomatic
bacteriuria was reduced for the pre-lubricated catheter vs the conventional PVC catheter. In
terms of general satisfaction with use, subjects rated the pre-lubricated catheter significantly
higher than the conventional catheter with respect to ease of inserting and extracting, comfort
and handling.
A similar finding of reduced incidence of UTIs was reported by De Ridder et al. (2005), but in
this case the comparison was between a hydrophilic catheter as compared to the conventional
PVC catheter, with the hydrophilic catheter associated with fewer infections. There were no
other significant differences noted between the two groups including the number of bleeding
episodes or occurrence of hematuria, leukocyturia and bacteriuria. This multi-centre
investigation also employed a RCT design (N=123) but had a high drop-out rate (54%) with
slightly more individuals not completing the study from the hydrophilic catheter group. A
probable cause for many of these drop-outs was the lengthy treatment period of 1 year during
which many individuals were likely to improve bladder function such that IC was no longer
required.
Although catheters inserted into the body are an obvious source of bacterial introduced into the
bladder, condom catheters also can potentially be a source of bacterial colonization externally
where external colonization, especially of the perineum, has been suggested by Sanderson and
Weissler (1990b) to be significantly correlated with bacteriuria in SCI individuals. By
discontinuing night time use of the external urinary collection system (EUCS), Pseudomonas
colonization of the urethra was found to be significantly reduced where Klebsiella colonization
was not affected significantly (Gilmore et al., 1992, N=119). However, the prevalence of
bacteriuria caused by either gram-negative bacilli, did not have any significant correlation with
EUCS use.
13-48
Ensuring that the bladder is not a bacteria friendly environment, without the risk of encouraging
antibiotic resistance, is another way to combat the source of contaminants during intermittent
catheterization. Methenamine mandelate is a formaldehyde releasing compound that is rapidly
absorbed and excreted in the urine. In combination with a 5% hemiacidrin bladder instillant (a
citric acid solution), two 2mg oral methenamine mandelate tablets 4 times per day achieved
significantly lower urine pH and lower incidence of UTI in SCI patients requiring intermittent
catherterization than those who received the control treatment (Krebs et al., 1984, N=40).
Conclusion
Level 1 evidence (based on one high quality and several low quality RCTs) supports the
use of daily body washing in chlorohexidine and application of chlorhexidine crème to
the penis after every catheterization verses using standard soap in the endeavour to
significantly reduce bacteriuria.
Although the rate of UTI requiring antibiotic treatment is less with the use of sterile
catheterization technique, level 1 evidence supports the use of clean versus sterile
catheter supplies as a result of the prohibitive cost of the latter.
Level 4 evidence suggests that the prevalence of bacteriuria caused by gram-negative

bacilli, did not have any significant correlation with differing practices of external urinary
collection systems (i.e. continual vs discontinuation at night).
Poor quality level 1 evidence is supportive of the use of oral methenamine mandelate in
combination with hemiacidrin bladder instillant to lower urine pH and incident of UTI.
External chlorohexidine application or methenamine mandelate with hemiacidrin bladder

instillant are separate techniques that are likely to reduce the incidence of UTI.
Sterile vs clean catheterization technique is more effective at reducing rate of UTI
but is much more costly to maintain.
The prevalence of gram-negative bacteriuria is not affect by continual use
or night-time discontinuation of condom drainage.
Oral methenamine mandelate in combination with hemiacidrin bladder instillant
likely lowers the rate of UTI.
13.6.3 Bladder Management Techniques
Each type of bladder management technique comes with its own set of advantages and
disadvantages that the clinical team must assess at the time of initial bladder dysfunction
secondary to spinal cord injury. There is discussion amongst clinicians over the bladder
management technique that can best achieve optimum bladder control and rate of UTIs.
13-49
Table 13.16 Individual Studies of the Effect of Various Bladder Management Techniques
in Preventing and Treating UTIs
Score
Methods Outcome
Research Design
Total Sample Size
Population: Age:13-18yrs, level of injury: No statistically significant differences

SCI; time since injury: within 36hrs; between groups at 1 year post injury:
Lloyd et al. 1986; USA
complete/incomplete. 1. # chills and fevers
Treatment: Initial bladder management 2. rate of urinary infections
Case control
Outcome Measures: excretor urogram 3. upper tract changes,
Initial N=204;
(IVP) graded by 2 MDs for pyelocaliectasis, 4. genitourinary complications
Final N=203
renal plasma flow, episodes of chills and 5. frequency of urological procedures
fevers.
Population: Group A: m=26, f=1; SCI, 12- 1. Group A: 5 subjects had symptomatic
96 hrs post injury. Group B: 19 para and 2 UTI between 10 days-3mos (18.5%).
Yadav et al. 1993; India tetra; SCI, long-term clean intermittent 2. Group B: 0.07 episodes per patient
Downs & Black score=7 catheterization (CIC) per month symptomatic UTI (33%)
Case control Treatment: Group A-CIC started on day 1 CIC is safe and effective for acute and
Group A: n=27 of hospitalization. Group B-Long term CIC chronic SCI with acceptably low infective
Group B: n=21 (1-12 years) complications.
Outcome Measures: number of bladder
infections
Population: m=22,f=3; age=6-59yrs, level 1. 72% of self-catheterization groups
Wyndaele & De Taeye of lesion D7-D12 achieved a state of balanced bladder –
1990; USA Treatment: Self-catheterizations. able to empty bladder by tapping or
Downs & Black score=8 Outcome Measures: Not specified straining after a mean of 5 weeks.
Case Series 2. Urinary tract infections varied amongst
N=73 the group - all subjects had at least
one UTI .
Population: m=29; Age: 28-61 years, 1. Relief of symptoms within 3-4 days of
mean=45 yrs; ASIA Level A; SCI; appropriate antibiotic treatment.
Itermittent catheterization program (ICP): 2. Multiple organisms isolated in 62% of
Joshi & Daroucihe 1996; 10; Suprapubic tube (SPT): 10; Indwelling urine cultures.
USA foley catheters (IFC): 9. 3. Pyuria decreased by at least 65% and
Downs & Black score=10 Treatment: 7-day course of an appropriate 87% at midpoint and end of therapy,
Case Series antibiotic with urine sampled at mid and respectively..
Initial N=41; Final N=29 endpoint. 4. ICP group had lower residual pyuria at
Outcome Measures: Not specified mid and endpoint (p<0.05).
5. Pyuria response to treatment, best and
earlier assessed in ICP
Population: m=27, f=19; age 18-64yrs. 1. No statistical results reported.
Treatment: 2. Nine percent of patients (46/520) over
Kuhn et al. 1991; Intermittent Urethral Self-Catheterization 6 years utilizing IUSC at discharge.
Switzerland (IUSC) status at discharge and up to 5 yrs 3. 22/46 patients continue to use IUSC
Downs & Black score=7 later. after 4.6y for males, 6.6 y for females.
Case Series Outcomes Measures: bacteriological 4. Only 4.3% complication rate from
N=46 evolution, sterile vs. clean IUSC, frequency IUSC.
of daily catheterization, complications,
continence and acceptance of the method.
Discussion
Lloyd et al. (1986) studied a group of 204, young (13-18yo) SCI patients grouped according to
urological management techniques as follows: A) intermittent catheterization within 36h of
injury, B) suprapubic trocar drainage within 36 h of injury, C) urethral catheter drainage for
>36h prior to intermittent catheterization, D) indwelling urethral catheter drainage throughout
and after discharge from hospitalization, and E) intermittent catheterization placed in
13-50
community hospital. Overall, this group found that the method of initial bladder management
does not affect the incidence of UTI, genitourinary complications or frequency of urological
procedures at 1 year after injury. The only exception was group D who had a greater rate of
UTIs as a result of the placement and maintenance of indwelling urethral catheter drainage
throughout and after discharge from hospitalization. This corroborates the finding of Yadav et
al. (1993) that reported CIC to be superior to indwelling catheter for management by reducing
the clinical UTI rate in SCI individuals.
Wyndaele and De Taeye (1990) found that the rate of UTI or urethral trauma did not differ
between those patients who were taught intermittent self-catheterization (ISC) early after injury
compared to those where the procedure was done by a catheter team. However, of interest
was the finding that those who achieved early ISC also went home earlier for the weekend. The
results of this case control study should be interpreted cautiously as the sample size was quite
small (N=8). However, Yadav et al. (1993) in contrast, reported that patients managed with
clean intermittent catheterization from day 1 of hospitalization (i.e. early vs late) experienced a
lower (18.5%) clinical UTI rate compared to 26% reported for patients indwelling catheter in a
separate study (Maynard and Diokno, 1984).
Although the influence of the initial type of bladder management technique on rate of UTI is
considered by some to be equivocal (Lloyd et al., 1986), Joshi & Darouiche (1996) report that
the response to pyuria is better and can be assessed earlier in patients who utilize SIC over
those who’s bladder drainage is reliant on suprapubic tube or indwelling foley catheters. All
patients experienced relief from proper antibiotic therapy after 3-4 days, but the level of residual
pyuria was lowest at mid-therapy and after therapy completion in those patients using SIC as
measured by the hemocytometer chamber method.
A five-year follow-up study also showed results favouring the preparation of SCI patients to use
of SIC at time of discharge. Kuhn et al. (1991) found that of the 46 (9% of 520) patients who
met the criteria of achieving SIC at time of discharge, less that half (22) continued with ISC at
the 5-year follow-up. Also at the 5-year follow-up, six had switched to indwelling catheters, 13
had switched to other methods of bladder emptying and 5 had died. The rate of complications
was very low at 4.3% and pharmacological intervention was non-existent (no anti-cholinergic,
alpha-stimulating or continuous antibiotic-prophylaxis) and the degree of continence remained
stable throughout the 5 years. The authors concluded that with proper patient selection and
quality instruction during hospitalization, SIC has been a successful method of neurogenic
bladder management for their patients. 4
Conclusion
There is Level 3 evidence that sterile intermittent catheterization may lead to a lower rate
of UTI and complications with a maintained continence level after discharge as compared
to other bladder management techniques such as use of indwelling catheter.
Sterile intermittent catheterization is likely to provide successful bladder management with a

lower rate of UTI and complications with a maintained continence level after discharge.
13-51
13.7 Pharmacological Interventions for Preventing and Treating UTIs
The most common medical complication secondary to SCI neurogenic bladder is urinary tract
infection (UTIs). The latter can be responsible for a decline in quality of life and an increased
mortality rate in persons with SCI. Although prevention is the best “medicine”, many UTIs
(symptomatic or asymptomatic) will require treatment with pharmacological agents. Choosing
the right pharmacologic agent is dependent on the treatment stage, and the type of bacteria
found in the patient’s urine. Choosing the length of treatment depends on the patient’s history
(i.e. symptomatic or asymptomatic; occasional or chronic symptoms). The most common
antibiotics used for routine UTIs include fluoroquinolones, trimethorprin, sufamethoxazole,
amoxicillin, nitrofurantoin and ampicillin. Although antibiotic treatment is the most common
option, alternative treatments are also gaining momentum not only due to the increase in
antimicrobial resistance but also for health reasons and for reasons of cost reduction.
13.7.1 Preventative Pharmacological Interventions
Prevention of SCI UTI is the treatment option of choice and patients are educated in this
endeavour prior to hospital discharge. However, sterile technique is sometimes difficult for
those who have limited independent function, attendant care or access to sterile supplies.
Table 13.17 Individual Studies Assessing Pharmacological Interventions for Preventing

UTIs
Score
Methods Outcome
Research Design
Total Sample Size
Population: m=15; Age:18-49yrs 1. No significant difference (chi square,

Treatment: Trisdine bladder instillation no p value given) in number of
Pearman et al. 1988; following intermittent catheterisation vs episodes of bacteriuria between
Australia kanamycin + colistin bladder instillation Trisdine vs kanamycin-colistin bladder
PEDro=3 Outcome Measures: Episodes of instillations;
RCT bacteriuria, number of catheterizations, 2. 0.56% (9 of 1609) vs .53% (9 of 1704)
Initial N=18; Final N=15 duration of catheterizations of instillations were associated with
episodes of bacteriuria for Trisdine vs
kanamycin-colistin respectively.
Population: age 23-84 males matched to 1. No difference in therapy response
age, type of bladder drainage, location of between full vs limited approach
UTI, route of antibiotic admin, etc. (p=.4);
Treatment: Limited vs full microbiological 2. Limited approach antibiotic initiation
investigation for management of earlier at 1.2+/-1.4 days vs 3.3+/-2.5
Darouiche et al. 1997;
symptomatic polymicrobial urinary tract days for full approach (p=.01);
USA
(limited = cultures for specific organisms 3. Higher proportion of people in limited
PEDro=7
not used to guide antibiotic selection) group required no change in initial
RCT (study 1)
Outcome Measures: Clinical improvement antibiotic than with full approach 85%
Pre-post (study 2)
following symptomatic UTI (criteria defined vs 33% (p=.006);
as presence of bacteria + one symptom) by 4. Recurrence at 1 month due to at least
Study 1 Final N=40
4 days after treatment with antibiotic, time 1 of the originally infecting species
Study 2 N=12
to start antibiotic, cost of entire therapy and was similar for both groups (p=1.0);
lab tests 5. Costs for limited investigation-directed
therapy less @ $157+/- $174 vs $252
+/- $237 for full approach but not
significantly different (p=.18)
Horton et al. 1998; USA Population: SCI, inpatients. No significant difference between fresh and
PEDro=6 Treatment: urine sampleprocessing within refrigerated samples in:
RCT 4 hrs of sampling (“fresh”) vs 24 1. WBC (z =-0.353, p=0.724),
13-52
Score
Methods Outcome
Research Design
Total Sample Size
N=40 (“refrigerated” ) hours of refrigeration. 2. # bacteria (z -0.772, p = 0.440)

Outcome Measures: cultures, colony 3. leukocytes (z = -0.277, p = 0.782), or
counts, urinalysis. 4. colony counts of E. fecalis &
Pseudomonas (z=-1.00, p =0.317), E.
coli, Citrobacter, Streptococcus, Yeast,
or Acinetobacter (z=0.00, p=1.0).
Sig diff btwn fresh & refrigerated samples
with colony counts <50 k:
1. "mixed" organisms (z = -2.565, p =
0.010)
2. Staph aureus trend only (z=-
1.841, p=0.066)
No cultures/colony count changes in up to
24h refrigeration to alter treatment or
clinically significant urinalysis/culture
results.
Discussion
Practicality of treatment methods is a valid issue for consideration as evidenced by the study
conducted by Pearman and colleagues (1988, N=15). They investigated the use of two different
medicated bladder instillations used to prevent bacteriuria and UTI in SCI. They concluded that
although there was no difference between incidence of bacteriuria in catheterized patients
instilled with Kanamycin-Colistin versus Trisdine, the latter is preferred based on its stabilitiy at
room temperature, reduced likelihood of selecting antibiotic-resistant bacteria than antibiotics
and reduced cost compared to Kanamycin-Colistin. It is important to note that the preference of
Trisdine is not based on a reduced incidence of bacteriuria but rather by cost savings and
practicality. Although the latter are important factors for treatment choice, this study presents no
evidence for preferential beneficial effects based on incidence of bacteriuria.
Another practical approach to prevention and treatment of UTI in SCI patients was undertaken
by Salomon et al. (2006). They utilized a weekly oral cyclic antibiotic (WOCA) program that was
beneficial in preventing UTI in SCI patients, decreasing antibiotic consumption and decreasing
the number and length of hospitalizations, without severe adverse events or the emergence of
multi-drug resistant (MDR) bacteria. This paper will be discussed in more detail below along
with other antibiotic interventions for the treatment of acute UTI in SCI individuals.
Practicality and cost savings and practicality in UTI prevention and treatment may not have
been the prime motive in an investigation by Dariouche et al. (1997), but they did find that an
adequate clinical response to treatment was not significantly different as a result of limited vs full
microbial investigation. As well, the cost savings, at an average of $183 US per patient, was
significant between limited and full investigation. Althought this provides level 1 evidence in
favour of deferring to a limited microbial investigation for SCI UTI treatment selection, the
sample size was small (N=15) and warrants further study.
Sample deterioration between the time of sampling and processing is controversial. Horton et al
(1998) conducted a prospective blinded study to investigate the effects of refrigeration on
urinalysis and culture results. Samples were split and analyzed at 4 (“fresh”) and 24
(“refrigerated”) hours post-refrigeration. The bacterial counts of “mixed” organisms (p=0.10) and
13-53
Staph aureus (p=066) were altered with refrigeration but no changes in colony counts would
have altered the treatment regimen chosen based on urinalysis or culture results. This level 1
evidence provides a level of confidence for urine samples refrigerated (up to 24 hours) prior to
analysis.
Conclusion
There is level 2 evidence (based on a single poor quality RCT) reporting no difference
between incidence of bacteriuria in catheterized patients. However, Trisdine is the more
often chosen between the 2 treatments, based on the fact that it is not likely to contribute
to antiobiotic resistance, its stability at room temperature, and its lower cost.
Level 2 (based on a single RCT) evidence suggests that both limited and full microbial
investigation result in adequate clinical response to UTI treatment with antibiotics.
Therefore the cost savings attributed to a limited microbial investigation favours this
practice in the investigation of UTI.
Refrigeration (up to 24 hours) of urine samples prior to sample processing does not alter
urinalysis or urine culture results in SCI patients.
There is no difference between incidence of bacteriuria in catheterized patients

instilled with Kanamycin-Colistin versus Trisdine.
Both limited and full microbial investigation result in adequate clinical response
to UTI treatment with antibiotics.
Urinalysis and urine culture results of SCI patients is not affected by sample
refrigeration (up to 24 hours).
13.7.2 Antibiotic Interventions for Treating UTIs
Even though patients are thoroughly educated with regard to UTI prevention, the incidence of
UTI in SCI remains high at ~1.8 episodes/person/year at risk as estimated by Waites et al.
(1993). Detecting UTI is the first step towards treatment and in a prospective case review
undertaken by Linsenmeyer and Oakley (2003), only 61% (90/147) of patients were able to
correctly predict the presence of an UTI based on their symptoms. However, once a UTI has
occurred, selection of the appropriate treatment depends on microbial investigation.
Furthermore, it has been noted that 33% of SCI UTIs are polymicrobial (Dow et al., 2004). The
clinician must then decide between a limited or full microbial investigation in selecting the
appropriate treatment. The obvious benefit of a full microbial investigation (i.e. accuracy) is
offset with adverse effects due to the time delay for the bacterial sensitivity results and with the
cost of a full investigation.
13-54
Table 13.18 Individual Studies Examining Antibiotic Interventions for Treating UTIs
Score
Methods Outcome
Research Design
Total Sample Size
Population: m=51, f=9; age: mean 39yrs; Statistically significant results:

SCI; voiding mangament: intermittent 1. Higher microbiological cure for 14 day
catheterization n=50, condom drainage treatment (p<0.02).
n=10 2. Lower rates of clinical &
Dow et al. 2004; USA Treatment: 250 mg of ciprofloxacin orally microbiological relapse at short & long
PEDro=10 b.i.d for 3 days followed by 11days of term follow-up (p<.01)
RCT placebo or they received ciprofloxacin 3. E. faecalis associated with treatment
Initial N=60; Final N=52 (250mg) b.i.d. for 14 days. failure compared to other isolates
Outcome Measures: Urinalysis with (p<0.03).
leukocyte count, urine culture and Improved microbiological outcomes in
surveillance cultures were taken before favour of 14 vs 3 day course for treatment
and throughout the study of symptomatic UTI in SCI.
Population: Age: 18-75yrs, m=28, f=14; 1. Clinical cure rate in favour of Ofloxacin
Treatment: ofloxacin ( 300 mg bid) vs vs TMPSMX or other antibiotic at day
trimethoprim-sulphamethoxazole 4 (p=.003) and day 7 (p=.015);
Reid et al. 2000; Canada (TMPSMX 160/800 mg bid) or another 2. Biofilm clearance rate in favour of
PEDro=8 antibiotic if resistant to TMPSMX, either for Ofloxacin vs TMPSMX or other
RCT 7 days antibiotic at day 4 (p=.005); and day 7
N=42 Outcome Measures: presence of bacteria (p=.014);
in urine, biofilm presence (# of bacteria / 3. Both treatments effective at reducing
epithelial cell) bacterial biofilms at day 4 and 7
(p<.001).
Population: SCI, other neurological 1. Most common urine organism was
disease; Mean Age: 45.8 years; Gender: Enterococcus spp.; increased
49 male, 40 female; Mean Post-injury time: significantly for N-P group only
11.2 years. (p=0.02)
Treatment: Assessment of normal saline 2. Mean urinary pH for all 3 groups
Waites et al. 2006; USA
vs 0.25% acetic acid vs neomycin- increased from mean of 6.6 to 7.0—
PEDro=6
polymyxin (N-P) GU irrigant for treatment 7.2 range (p=0.01) at wk 8.
RCT
of bacteriuria. No sig increase in:
Outcome measures: Numbers and types 3. Urinary leukocytes in any group
of bacteria, urinary pH, urinary leukocytes, (p≥0.6).
generation of antimicrobial-resistant 4. MRSA (p≥0.37) or gram-negative
organisms. resistance to common UTI
antimicrobials (p≥0.11).
Population: SCI with asymptomatic UTI 1. No difference between:
Treatment: standard and low-dose ◊ dose strengths.
Sapico et al. 1980; USA tobramycin and amikacin (IM x5d) ◊ tobramycin and amikacin.
PEDro=6 Outcome Measures: UTI rate, 2. Low cure rate.
RCT persistence, relapse, reinfection with other 3. High urine antibiotic concentrations in
N=29 bacteria. all subjects
Tobramycin and amikacin not
recommended for use in this popl’n.
Population: SCI with neurogenic bladder 1. Ciprofloxacin vs placebo prophylaxis
Biering-Sorensen et al. dysfunction; m=18, f=3; median age 38y (6mos): # UTIs 5 vs 59 (p<0.00005)
1994; Denmark (19-73y). 2. 1 instance of ciprofloxacin resistant E.
PEDro=8 Treatment: Six months Ciprofloxacin coli found in the feces of 1 Cipro
RCT (100mg/night) vs placebo prophylaxis patient
N=21 Outcome Measures: # UTI, urine and 3. No severe side effects.
fecal cultures, side effects
Gribble & Puterman Population: acute SCI; m=112, f=17; TMP-SMX more efficacious than placebo
1993; Canada median age 38y (19-73y). (P) prophylaxis:
PEDro=8 Treatment: efficacy of trimethoprim- 1. Lower incidence/freq/relapse of
RCT sulfamethoxazole (TMP-SMX id; TMP 40 bacteriuria and symptomatic UTI in
N=129 mg, SMX 200 mg ) for UTI prophylaxis in males (p<0.003 /0.0001/0.0001 and
13-55
Score
Methods Outcome
Research Design
Total Sample Size
acute SCI, during the first 4 mos of 0.0003).

intermittent catheterization (IC) 2. Similar trends in women.
Outcome Measures: Clinical:, wkly rectal Other results:
and urethral swab, and urine cultures. 3. Adv. events similar btwn grps
Breakthrough bacteriuria treated with 4. ≥1 TMP-SMX-resistant bacteriuria in
conventional antimicrobial therapy and all P subj. by yr 3.
prophylaxis was continued. 5. Rectal/urethral swab TMP-SMX-
resistant organisms-both grps.
TMP-SMX UTI prophylaxis effective in
acute SCI/IC but emergent TMP-SMX-
resistance limits usefulness.
Population: m=66, f=3; SCI, Complete No statistical results reported.
n=58, incomplete n=11; Age: 18-69yrs; 1. 58/79 (73%) negative for UTI mid-
injured <6 mths n=5, injured >/=6mths treatment
n=64. 2. 5 to 7 days after administration of
Treatment: Oral norfloxacin 400 mg bid for norfloxacin, infection was eradicated in
14 days after initial bacteriologic 42 cases (53%) while 37 cases (47%)
confirmation of UTI had evidence of infection (>/=105
Waites et al. 1991; USA
Outcome Measures: bacterial cfu/mL on one or more of the
strain/species identification, culture results categories listed.
Case Series
mid and post treatment periods. 3. 8-12 wks after administration, 84%
N=69
(27/32) infected after previous
eradication.
4. Clinical cure in 67% (4/6) symptomatic
UTIs
5. Side effects in 8% of patients.
6. 16% treatment emergent resistance to
norfloxacin.
Population: Gender: m=22, f=16; Age: Before/after WOCA programme:
mean=45.9 ± 13.9 yrs (SD); SCI: # of daily 1. Symptomatic UTIs/ pt/yr p<0.01
catheterizations: mean 6 ± 1.4 2. Febrile UTI/pt/yr, p<0.04
Treatment: Weekly oral cyclic antibiotic 3. Hospitalizations p<0.01.
Salomon et al. 2006;
(WOCA): Wk 1-one antibiotic + wk 2 4. Decreased antibiotic consumption
France
another antibiotic (over 2 yrs). Antibiotic correlated with decreased incidence of
choice based on urine culture results: UTIs over the course of the study.
Case Series
amoxicillin 3000mg; trimethoprim/
N=38
sulfamethoxazole 320-1600mg; fosfomycin
trometamol 6000mg; nitrofurantoin 300mg;
cefixime 40mg.
Outcome Measures: Number of UTI's
Population: SCI inpatients; m=11, f=3; Non-prophylaxis vs TMPSMX prophylaxis
20-66y subjects:
Treatment: urine samples for culture and 1. 68% vs 54% (not significant; no p
sonication for 8 wks; monitored for UTI value reported)
signs and symptoms and treated with 2. E coli replaced by E faecalis as
appropriate antibiotic: ciprofloxacin 500mg dominant uropathogen with TMPSMX
Reid et al. 1994b;
bid, norfloxaqcin 400mg bid, amoxicillin use.
Canada
500mg q8h, ampicillin 250mg qid, co- 3. 44±49 vs 39±42 adherent
trimoxazole (TMPSMX 160/800 mg bid), bacteria/bladder cell (not significant;
Case Series
gentamycin (100mg q8h or nitrofurantoin no p value reported)
N=14
50mg qid. Laboratory results:
Outcome Measures: infection rate, extent 1. Counts of >20 adherent bacteria may
of biofilm formation, level of bacterial be predictive of symptomatic UTI.
adhesion 2. Reduced adhesion counts in favour of
Fluoroquinolone vs TMPSMX (63% vs
44%)
13-56
Score
Methods Outcome
Research Design
Total Sample Size
3. 92%, 71%, 56% biofilm reduction with

ciprofloxacin, ofloxacin & norfloxacin
Population: Gender: m=7, f=3; SCI; ASIA: NO statistical results reported.
A, B &D. 1. 9 bladder irrigation trials led to
Treatment: installed 30 cc of changed resistance.
Linsenmeyer et al. 1999;
neomycin/polymyxin solution 3 x with each 2. Of these 6 were able to receive an oral
USA
session (3 session/day for 5 days) antibiotic and 3 had change in the
Outcome Measures: Not clear sensitivities so that an oral antibiotic
Case Series
could be used (one subject not allergic
N=10
to antibiotic).
3. The remaining 3 bladder irrigations
were not successful.
Discussion
Once UTI presence is confirmed, the most common antibiotics chosen for UTI treatment include
fluorquinolones, trimethorprin, sufamethoxazole, amoxicillin, nitrofurantoin and ampicillin.
Fluorquinolones are chosen often because of their effectiveness over a wide spectrum of
bacterial strains (Waites et al., 1991). Although Waites et al. (1991) showed norfloxacin to be
73% effective in eradicating UTIs by mid-treatment, the rate of reinfection was 84% after 8 to 12
weeks post initial eradication. Furthermore, 16% of strains isolated after eradication became
resistant to norfloxacin. The authors concluded that norfloxacin is a reasonable treatment
choice for SCI UTI but the subsequent and problematic emergence of resistance must be
monitored (as with other antimicrobials).
Despite the efforts in reducing antimicrobial resistance, the incidence is still high and continues
to add further challenges to successful SCI UTI treatment. A novel approach to prevention and
treatment of UTI in SCI patients was undertaken by Salomon et al. (2006). After a prospective,
observational study with 2 year follow-up, they concluded that a weekly oral cyclic antibiotic
(WOCA) program was beneficial in preventing UTI in SCI patients, decreasing antibiotic
consumption and decreasing the number and length of hospitalizations, without severe adverse
events or the emergence of multi-drug resistant (MDR) bacteria. The WOCA regimen involved
alternating between two antibiotics, chosen based on allergy and antimicrobial susceptibility,
once per week over at least 2 years. The most frequent combination of antibiotics utilized were
trimethoprim / sulfamethoxazole and cefixime (30%) followed by cefixime and nitrofurantoin
(25%). The combination of antibiotics was modified in 40% of the patients once, 20% twice and
10% on three occasions during the follow-up. This level 4 evidence for the effectiveness of
WOCA in SCI UTI prevention, treatment and cost, and would serve well as guidance in design
of a randomized, double-blind, placebo-controlled study to confirm these results.
Although the WOCA approach is promising for prevention and treatment, this once weekly
dosing is not common practice. However, shorter courses of antibiotic treatment are currently
considered by clinicians and patients who are concerned with side effects, cost and
antimicrobial resistance due to longer term use. Treatment course durations as short 3 days are
not uncommon while the more common treatment duration is 14 days. Reid et al. (2000),
suggested that a 3-day regimen in the treatment of SCI UTI could be sufficient based on
significant biofilm eradication detected in bladder epithelial cells in patients treated with
Ofloxacin compared to trimethoprim-sulfamethoxazole. Ofloxacin is a fluoroquinolone antibiotic
13-57
shown to be promising in its ability to penetrate and eradicate bacterial biofilms in the bladder in
vitro and in SCI patients (Reid et al., 1994a;1994b). The earlier study (Reid et al., 1994a)
concluded that fluoroquinolone therapy was more effective at reducing bladder cell adhesion
counts in 63% of asymptomatic SCI UTIs vs 44% of SCI subjects treated with trimethoprim-
sulfamethoxazole. The difference in effective treatment duration, compared to the findings of
Dow et al. (2004), is likely due to the difference in anti-microbial used. However, further study
comparing the 2 antimicrobials (and others) and differing treatment durations are required to
clarify the question of optimum treatment duration for the antimicrobial being considered for use.
While the range of effective antibiotic treatment duration can vary widely depending on the
antibiotic used and the patients’ UTI history, there is a need for objective research to clarify
optimal treatment durations for individual antimicrobials. Dow et al. (2004), undertook to
compare a 14 vs 3 day course of ciprofloxin treatment in SCI patients with UTI symptoms or
microbially documented bacteriuria and concluded that a 14 day Ciprofloxin treatment results in
improved clinical and microbiological outcomes. Microbiological relapse rates were significantly
lower for those patients treated for 14 vs 3 days. Although, this high quality level 1 evidence
advocates for the use of a 14 vs 3 day course of ciprofloxacin in SCI UTI, it does not address
the optimal treatment period. Further studies comparing 7 and 10 day treatments vs the 14 day
treatment would be warranted. As well, optimal treatment periods may be antimicrobial specific
as evidenced by the study of Reid et al. (2000), where it was suggested that a 3-day regimen in
the treatment of SCI UTI could be sufficient based on significant biofilm eradication detected in
bladder epithelial cells in patients treated with Ofloxacin compared to trimethoprim-
sulfamethoxazole.
On the other end of the dose duration spectrum is the use of long-term, low-dose, prophylactic
use of antibiotics for the prevention of SCI UTI. An RCT comparing low-dose, long-term
treatment with ciprofloxacin (100mg each night) vs placebo concluded that ciprofloxacin
prophylaxis for up to 39 months resulted in a marked reduction from the pre-study infection rate.
(p<0.00005, corrected) with no severe side effects and 1 instance of ciprofloxacin resistant E.
coli found in the feces of 1 patient (Biering-Sorensen et al. 1994). Although prophylaxis with
trimethoprim-sulfamethoxazole (TMP-SMX; TMP 40mg, SMX 200mg once daily) over placebo
was also found to significantly reduce incidence (p=0.003) and frequency of bacteriuria
(p=0.0001) and symptomatic urinary tract infection (p=0.0003) in persons with recent acute
spinal cord injury using intermittent catheterization for bladder management, treatment
emergent adverse reactions were common with frequent colonization and breakthrough
bacteriuria with TMP-SMX-resistant organisms (Gribble and Puterman, 1993; RCT, N=129).
Gram-negative bacteria such as Pseudomonas, Acinetobacter, Enterobacter and mycobacteria

are susceptible to aminoglycosides such as tobramycin and amikacin which are often chosen
for complicated UTI treatment. Due to their toxicity and inconvenient route of administration (i.e.
intramuscular injection), their use is limited. To investigate the effectiveness of a lower dose of
these aminoglycosides, Sapico et al. (1980) compared infection, persistence and reinfection
rates of SCI UTI against a standard dose. An overall low rate of success and no differences
between the dose strengths and between tobramycin and amikacin even though high antibiotic
concentrations were found in the urine of all subjects suggested that alternative antimicrobial
agents were considered for use in this population.
The clinician is sometimes faced with additional treatment option challenges when multi-drug
resistant bacteria or the patient’s allergy to the appropriate antibiotic are encountered.
Linsenmeyer et al. (1999) investigated the use of medicated bladder irrigation as a method to
alter the existing antimicrobial resistance. They found that intermittent neomycin/polymyxin
13-58
bladder irrigation was effective in altering the resistance of the offending bladder organism(s) to
allow for appropriate antibiotic treatment. An RCT (Waites et al., 2006) comparing sterile saline
acetic acid and neomycin-polymyxin solution bladder irrigants did not have an effect of the
degree of bacteriuria/pyuria, or development of antimicrobial resistance. The first study utilized
a 3 times per day for 5 day treatment regimen with assessments done immediately pre- and
post-intervention while the latter study required twice daily irrigation for 8 weeks with
assessments done at baseline and 2, 4 and 8 weeks post-treatment. Both studies do not
recommend bladder irrigation for the treatment of bacteriuria in neurogenic bladder. However,
Linsenmeyer et al. (1999) do provide level 4 evidence advocating for a short course treatment of
neomycin/polymyxin irrigant to alter existing antimicrobial resistance.
Conclusion
Level 4 evidence suggests that norfloxacin may be a reasonable treatment choice for UTI
in SCI but subsequent resistance must be monitored.
Level 4 evidence supports weekly oral cyclic antibiotic (WOCA) use for UTI prevention in
SCI patients. It decreases antibiotic consumption, the number and length of
hospitalizations, and is used without severe adverse events or the emergence of multi-
drug resistant (MDR) bacteria.
Optimum antimicrobial treatment duration is controversial due to the lack of

comparative trials. High quality level 1 evidence supports the use of 14 vs 3 days of
Ciprofloxcin for improved clinical and microbiological outcomes in the treatment of UTI
in SCI individuals. Similarily level 1 evidence suggests that 3 day Ofloxacin treatment is
sufficient based on significant biofilm eradication detected in bladder epithelial cells in
SCI patients with UTI.
Successful SCI UTI treatment with low-dose, long-term antibiotic prophylaxis without a
high rate of treatment emergent adverse events is recommended for ciprofloxacin but
not trimethoprim-sulfamethoxazole (TMP-SMX) as confirmed by level 1 evidence.
A low success rate of aminoglycosides in the treatment of SCI UTI is supported by level 1
evidence.
Bladder irrigation is not effective in treating bacteriuria in neurogenic bladder as

confirmed by level 1 evidence
Level 4 evidence is reported for Intermittent neomycin/polymyxin bladder irrigation being

effective in altering the resistance of the offending bladder organism(s) to allow for
appropriate antibiotic treatment.
13-59
Norfloxacin may be a reasonable treatment choice for UTI in SCI but
subsequent resistance must be monitored.
Weekly oral cyclic antibiotic (WOCA) may be beneficial in preventing UTI in SCI patients.
Improved clinical and microbiological SCI UTI treatment outcome is achieved
after 14 (vs 3) days of treatment with Ciprofloxin.
Aminoglycosides have a low success rate in the treatment of SCI UTI.
Ofloxacin, after a 3 day treatment regimen resulted in significant UTI cure rate
and bladder cell biofilm eradication rate.
Successfully SCI UTI prophylaxis without appreciable side effects is possible
with low-dose, long-term ciprofloxacin but not TMP-SMX.
Bladder irrigation is ineffective to treat neurogenic bladder bacteriuria.
Intermittent neomycin/polymyxin bladder irrigation may be effective in altering the resistance of the
offending bladder organism(s) to allow for appropriate antibiotic treatment.
13.7.3 Dietary supplementation Based Interventions for Preventing UTIs
There is a trend to alternative health care use in individuals with physical disabilities (Krauss et
al, 1998). Given this milieu, it is not surprising that use of dietary supplementation based
interventions such as cranberries to acidfy the urine (Kinney & Blount 1979) and prevent UTIs
have been reported. Other dietary supplementation based interventions are also discussed
below.
Table 13.19 Individual Studies – Dietary Supplementation Based Interventions for

Preventing UTIs
Score
Methods Results
Level
Total Sample Size
Population: m=16m f=5; Level of injury: No statistically significant findings for the
C4-L1; # of UTI: 0 to 2. effect of cranberry tablets vs placebo:
Linsemeyer et al. 2004;
Treatment: Randomized, crossover: 1. Urinary bacterial count (t20=-0.05,
USA
placebo or cranberry tablets (400 mg) 3 p=0.96),
PEDro=6
times daily for 4 weeks. 2. WBC count (t20=1.14, p<0.27)or
RCT
Outcome measures: urinary bacterial 3. Urinary bacterial + WBC count
counts, white blood cell counts, combination (t20=1.14, p<0.27).
combination of both counts.
Population: Age: 20-73yrs, m=42, f=6; No significant differences between groups:
SCI; time since injury: 1-30yrs; 1. Bacterial colony counts, bladder
Complete=40/incomplete=6; management method, or within groups
Treatment: Randomized to cranberry or over time (p=0.758, 0.170, 0.302).
placebo capsules. 2. Urinary leukocyte counts /ml urine,
Waites et al. 2004; USA Microscopic and dipstick urinalyses pre bladder management method, or within
PEDro=5 enrollment and monthly. groups over time (p=0.929, 0.888,
RCT Bacteriuria defined as a urine colony of >/= 0.499).
Initial N=74; Final N=48 104 colonies/ml urine. 3. pH of urine, or within groups over time
Pyuria defined as >/=10 urinary (p=0.659, 0.246).
leukocytes/ml urine. 4. For each outcome, no interaction
Outcome measures: bacterial counts and between groups, bladder management
urinalysis. method, and time (p>0.05).
5. pH higher for external collection vs
13-60
Score
Methods Results
Level
Total Sample Size
intermittent catheter (p=0.046) for all

time periods for both groups combined.
Population: SCI; Age: 27.83±11.75 vs No significant difference in
Castello et al. 1996;
25.57±9.91 years; 9 male, 4 female; 1. baseline or post- treatment urine pH
Spain
tetra/para 1/12 for ascorbic acid or placebo.
PEDro=4
Treatment: Ascorbic acid vs placebo 2. number of patients developing UTI
RCT
(lactose) UTI prophylaxis between groups.
Outcome measures: Urine pH, culture.
Population: SCI, 21-78y; m=10, f=4. Cranberry juice vs water significantly
Treatment: 250 ml water / cranberry juice reduces:
Reid et al. 2001; Canada
with meals, each for 7days treatment arms 1. Biofilm load (p=0.028); and compared
separated by 2 days. to baseline (p=0.013,).
Case Conrol
Outcome Measures: biofilm load, bacterial 2. Bacterial Adhesion counts (p<0.033).
N=15
adhesion 3. Gram positive counts (p=0.022).
4. Gram negative counts (p=0.054).
Population: neurogenic bladder caused by No significant change in urine pH during
myelomeningocele (N=5), and traumatic the 2-week period when patient was on
SCI (N=2), and using clean intermittent phosphorus supplement (vs when off
catheterization; Age: 18-29 years; Gender: supplement).
3M, 4F; Level of Injury: L2 & 4, T6, 8 & 1. In 3 patients, mean pH dropped 0.1-
Schlager et al. 2005; 12(x2) and Sacral; Post-injury time: 2 or 0.4 units during suppl.
USA more years (SCI=5yrs post injury). 2. In 3 patients, mean pH increased by
Downs & Black score=14 Treatment: phosphorus supplement 0.2-0.6 units during suppl.
Case Control (Neutra-phos®) as urine-acidifying agent. 3. In 1 patient, no change in mean pH
N=7 Outcome measures: urinalysis (Urine pH during suppl.
st
measured 3x/day (1 morning, afternoon, 4. Urine acidification not achieved with
evening) for 4 wks; wk 2 and 3, patient phosphate suppl.
drank a phosphorus supplement 3x/day, (4 5. Frequency of bacteriuria in an
wk study period); urine sample individual patient was similar on and
cultured2x/wk. off supplementation.
Discussion
An RCT (PEDro=6) conducted by Linsenmeyer et al. (2004) (N=21) found that cranberry tablets
were not effective in changing bacterial or white blood cell (WBC) counts. This was confirmed
by an RCT (PEDro= 5) conducted by Waites et al. (2004) (N=48) which showed no difference
between cranberry extract or placebo in reducing bacteriuria or pyuria in individuals with SCI.
Both of these RCTs lacked an Intent To Treat (ITT) statistical analysis and therefore were not of
the highest quality. However evidence does exist in 2 good quality RCTs (Jepson et al., 2004 –
Cochrane Review) that cranberry product (juice or tablet) does reduce the number of UTIs in
women in the general population. Furthermore a pilot study conducted by Reid et al 2001
(N=15) showed that cranberry juice intake significantly reduced the adhesion of bacteria to
bladder cells where water intake did not significantly reduce the bacterial adhesion or biofilm
presence in individuals with SCI. The conflicting conclusions may be influenced by the different
populations studied, the spectrum of “dose” of cranberry product and outcome measures used
in the various studies discussed. In order to make valid conclusions regarding the use of
cranberry product for the treatment of UTI in SCI, properly designed studies with optimum
cranberry product dose and consistent outcome measures are required.
Acidifying urinary pH for the prevention of UTIs is based on the long known fact that pH
reduction to ≤5.0 will inhibit growth of urinary E. coli (Shohl and Janney, 1917), the most
13-61
prevalent bacteria in bacteriuria. Waites et al. (2006) in addition, found that 8 weeks of bladder
irrigation with some irrigants (saline, acetic acid and neomycin/polymycin solution) did
significantly increase the urinary pH (p=0.01) to a range that was favourable for the growth of E.
coli (i.e. pH 6.0-7.0; Shohl and Janney, 1917). Urine acidification with cranberry tablets vs
placebo was also ineffective (Waites et al., 2004). Similarily, 2 weeks of phosphate
supplementation or 2 gram per day of ascorbic acid in SCI neurogenic bladder managed with IC
or indwelling catheter were also ineffective in acidifying urine (Schlager et al., 2005; Castello et
al., 1996).
Conclusion
Conflicting level 1 evidence exists for the effectiveness of cranberry juice or extract in
the treatment of UTI. However, the negative evidence involved poorer quality studies
involving specifically SCI while the positive evidence was the result of higher quality
studies involving women in the general population. Further complicating the burden of
evidence is level 2 evidence supporting the use of cranberry juice over placebo (i.e.
water) in the reduction of bacterial adhesion or biofilm presence.
Level 1 evidence does not recommend the use of cranberry, phosphate or ascorbic acid
supplementation to acidify urine in SCI neurogenic bladder.
Conflicting evidence exists for the effectiveness of cranberry juice or

extracts used in the treatment of UTI.
Use of cranberry, phosphate or ascorbic acid supplementation is not
efficacious in acidifying the urine in SCI.
13.8 Bladder Function and Quality of Life
Table 13.20 Individual Studies – Quality of Life

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=212, f=39, SCI, 1. UTI’s occurred in majority of patients

complete/incomplete. regardless of level of injury.
Treatment: Various voiding techniques 2. Those with complete SCI (88%)and
and drugs to facilitate urination to reduce those with incomplete SCI (65%)
residual urine or to decrease urinary experienced an episode of
Kuo 1998; Taiwan incontinence. symptomatic UTI per yr (X2=16.89,
Downs & Black score=15 Outcome measures: Quality of life index p<0.05)
Case Series for urination 3. For those (n=77) who had surgical
N=251 interventions the QofL improved from -
0.27+ 0.39 (preoperatively) to
+1.54+0.38 postoperatively.
4. This contrast to those who had other
forms of active urological management
(mean QofL = +0.34+1.09)
Liguori et al. 1997; USA Population: age: Mean=42yrs m=67, 1. Higher functioning scores with para vs
Downs & Black score=12 f=14; SCI; complete/incomplete tetraplegia, p<0.01.
Observational Treatment: No treatment, survey mailed 2. Higher # UTI compared to normal
13-62
Score
Methods Outcome
Research Design
Total Sample Size
Initial N=360; Final N=81 home. voiding: IC p<0.01; CON p<0.07; IND
IC=intermittent catheterization p<0.05.
CON=condom catheters 3. Higher UTI rate with IND (p<0.05) and
IND=chronic indwelling catheterization CON (p<0.01) than IC.
Outcome Measures: Information on: UTI, 4. More prophylactic antibiotic with IC vs
bladder management, functioning, normal voiding, (T=3.06, p<0.01).
productivity and life satisfaction, was asked 5. Negative correlation between # UTIs /
in the mailed questionnaire. functioning (1yr r=
6. -.23, p<0.05; 3yr r=-.23, p<0.05).
7. Positive correlation between
functioning/productivity (r=.21,
p<0.05); functioning/life satisfaction
(r=.21, p<0.05).
8. Negative correlation between
productivity/UTI (1 yr r=-.24, p<0.5; 3
yr r=-.26, p<0.01).
9. Positive correlation between
productivity/global satisfaction (r=-.20,
p<0.01) and productivity/functioning
(r=.20, p<0.05).
Population: para/tetra: 21/6; m=16, f=11; 1. Reason for urostomy: paraplegics-
time since injury to stoma formation 0-31y chronic UTI, hydronephorosis,
Craven & Etchells 1998; with majority at 10y; age at time of recurrent renal calculi, bladder trauma,
Australia procedures 16-74y. fistula, persistent catheter leakage.
Downs & Black score=6 Treatment: No treatment, chart review Tetraplegics-chronic UTIs, recurrent
Case Series (n=27) and patient interviews (n=18). renal calculi, persistent catheter
N=27 patients (31 Outcome Measures: Content analysis; leakage.
procedures) grouped themes. 2. Improved QoL: freedom,
independence, hygiene, productivity,
less dysreflexia, less UTI.
Discussion
The quality of life of individuals having bladder management problems secondary to SCI is
affected by the urological management that they receive immediately after initial injury. Kuo et
al. (1998) assessed the quality of life of 251 SCI patients before and after treatment for voiding
or urological problems over an 8 year period. Thirty-one percent of the patients continued to
have voiding or urological problems after unsuccessful attempts to achieve satisfactory voiding
through voluntary means, intermittent self-catheterization (CISC) or Foley catheters. For these
patients, various surgical procedures (external sphincterotomy, entercystoplast,
autoaugmentation, continent urinary diversion, periurethral Teflon injection and transurethral
resection of the prostate) resulted in an improvement in the total satisfaction rating on the
quality of life after the surgical procedures. Some complications persisted after enterocystolast
and continent diversion. Repeat sphincterotomy was required in 16.7% of patients and half
were not satisfied with total incontinence after external sphinterotomy. This group concluded
that mandatory long-term follow-up for urological management was essential to eliminate
indwelling catheters, hydronephrosis and frequent UTIs in patients with SCI.
Once discharged from the hospital, the factors determining bladder health and the functional,
behavioural and social characteristics of the individual with SCI and how these factors relate to
incidence of UTIs is not well understood. Liguori et al. (1997), via a mail-out questionnaire
reported that higher functioning and work-productive individuals suffered from a lower incidence
13-63
of UTIs per year and over a 3 year period. One can speculate between the interpretation that
fewer UTIs allowed for more hours worked per week versus higher productivity benefiting
behavioural or psychological factors that in turn place these individuals at less risk for UTIs.
Regardless of the choice of interpretation, productivity correlated positively with global
satisfaction and functioning. The results were derived from 35% of 360 completed
questionnaires sent to a volunteer sample of SCI in- and out-patients previously treated at a
university rehabilitation center over a 3 year period. Please note that, common to many quality
of life studies, no intervention was delivered in this study. However results were included in this
analysis in lieu of the scarcity of interventional studies measuring quality of life of the impact of
UTI on patients with spinal cord injury.
Although some procedures improve quality of life in individuals with neuropathic bladder
secondary to SCI, other physical or psychological impacts may render the procedure ultimately
undesirable. The elective formation of a stoma via surgery is one procedure that has been
undertaken in some patients who do not have adequate bladder health with the more common
bladder management methods. Craven and Etchells (1998) reviewed 27 medical records of
SCI patients who had undergone colostomy, ileostomy or urostomy. Eighteen of these patients
were then interviewed or completed a comprehensive questionnaire to assess the long-term
physical, psychological or lifestyle effects of the surgery. Although the impact of the stoma on
lifestyle was positive, the long-term negative impact to renal health could not be ignored for
individuals with neuropathic bladder secondary to SCI. This study is an illustrative example how
no single outcome measure can capture the multi-dimensional nature of interventions and
highlights the importance of choosing effective outcome measures to monitor the range of
medical outcomes as suggested by Goldberg (1991): 1) technical outcome; 2) functional
outcome; 3) patient satisfaction and 4) cost effectiveness.
Conclusion
Level 4 evidence suggests that urological management and follow-up is essential to

optimize post-discharge bladder management techniques and improve quality of life in
There is Level 5 evidence to support the notion that higher functioning and work-
productivity correlates with higher global satisfaction. Individuals with higher
productivity suffered from a lower incidence of UTIs per year over a 3 year period.
Level 4 evidence suggests that although urostomy may improve quality of life in SCI
individuals with otherwise insufficient bladder health management methods, the
procedure is not likely to be a good alternative due to the long-term negative impact to
renal impairment.
Mandatory post-discharge urological management may improve quality of life in

Higher functioning and work-productive individuals seem to have fewer UTIs per year
and this is likely associated with higher global satisfaction.
Urostomy may not be a good long-term bladder management method although it
may improve quality of life when other methods fail.
13-64
13.9 Overall Comment
An overall comment that can be made regarding the study of UTI intervention treatments is the
lack of consistent outcome measures to allow a meaningful comparison between treatment
options. Studies under review in this chapter utilized the following UTI definitions and/or
outcome measures: 1) symptomatic UTI = >100,000 bacteria/ml catheter urine plus fatigue or
spasm or foul smelling urine or haematuria; 2) presence of bacteria plus one symptom; 3)
presence of bacteria in urine plus biofilm presence (number of bacteria/epithelial cell); 4)
clinical improvement following symptomatic UTI by 4 days after treatment; 5) time to start of
antibiotic; 6) bacteriologic confirmation; 7) bacteriuria defined as a ≥104 colonies per ml of
urine and pyuria defined as ≥10 urinary leukocytes per μl of urine; 8) number of episodes of
bacteriuria; 9) number or duration of catheterizations; 10) routine bacterial and WBC counts.
13.10 Summary
There is Level 4 evidence that indwelling urethral catheterization, employed acutely, has
abated is associated with a higher rate of acute urological complications than
intermittent catheterization.
There is Level 4 evidence that prolonged indwelling catheterization, whether suprapubic

or urethral, may result in a higher long-term rate of urological and renal complications
than IC, condom catheterization or triggered spontaneous voiding.
There is Level 4 evidence that intermittent catheterization, whether performed acutely or

chronically, has the lowest complication rate. Chronic use of a spontaneous triggered
voiding method has comparable long-term complication rates to intermittent
catheterization.
There is Level 4 evidence that acute use of intermittent catheterization is associated with
reduced time to become catheter-free in comparison with indwelling urethral or
suprapubic catheterization. There is likely no difference among these methods for the
likelihood with which one will become catheter-free.
There is Level 4 evidence that those who use intermittent catheterization at discharge
from rehabilitation may have difficulty continuing with particular difficulty for those with
tetraplegia and complete injuries. To a lesser degree females also have more difficulty
than males in maintaining compliance with IC procedures.
There is Level 2 evidence that early treatment with electroacupuncture may shorten the
time that it takes for urine to pass at low pressure with minimal residual volume, no
matter the primary method of bladder management.
There is Level 1 evidence based on 1 RCT that pre-lubricated hydrophilic catheters are
associated with fewer UTIs and reduced incidence of urethral bleeding and microtrauma
as compared to conventional Poly Vinyl Chloride catheters.
There is Level 2 evidence based on 1 RCT that fewer UTIs, but not necessarily urethral
bleeding may result with the use of hydrophilic catheters as compared to conventional
PVC catheters.
13-65
There is Level 4 evidence that those with neurogenic bladder due to SCI and managed
with IC may have a lower health-related quality of life on most domains assessed by the
SF-36.
There is Level 4 evidence that incontinence may be reduced with intermittent

catheterization and even moreso when oxybutynin is administered as well.
There is Level 4 evidence that triggering mechanisms such as the Valsalva or Crede
maneuvers may assist some individuals with neurogenic bladder to void spontaneously
but these are also associated with high intra-vesical pressures which could conceivably
lead to renal complications.
There is Level 4 evidence that penile implants may allow easier use of condom catheters,
thereby reducing incontinence.
There is Level 4 evidence that despite a significant incidence of urological and renal
complications associated with acute and chronic indwelling suprapubic catheterization,
this is still a reasonable choice for bladder management for some people.
There is Level 4 evidence that ongoing use of sacral anterior root stimulation
(accompanied in most cases by posterior sacral rhizotomy) results in reduced
incontinence for the majority of those implanted. This is associated with increased
bladder capacity and reduced post-void residual volume.
There is Level 4 evidence that sacral anterior root stimulation (accompanied in most
cases by posterior sacral rhizotomy) may be associated with reducing UTIs and
autonomic dysreflexia.
There is Level 4 evidence that other forms of neuroanatomically-related stimulation (e.g.,

dorsal penile nerve stimulation or direct bladder stimulation) may have similar effects to
sacral stimulation but require further study.
There is Level 4 evidence that epidural dorsal spinal cord stimulation originally intended
for reducing muscle spasticity may have little effect on bladder function.
There is Level 4 evidence that a program of functional electrical stimulation exercise

involving the quadriceps muscle originally intended for enhancing muscle function and
reducing muscle spasticity has only marginal (if any) effects on bladder function.
There is Level 2 evidence based on 1 RCT comparative study that both sphincterotomy
and implantation of a sphincteric stent resulted in enhanced bladder function, with little
need for subsequent catheterization. The only significant difference in these 2 treatments
was the reduced initial hospitalization associated with the stent, given the lesser degree
of invasiveness.
There is Level 2 evidence that both sphincterotomy and implantation of a sphincteric

stent are associated with reduced detrusor pressure and reduced post-void residual
volume but not changes in bladder capacity.
There is Level 4 evidence that implantation of a sphincteric stent may result in reduced
incidence of UTIs and bladder-related autonomic dysreflexia.
13-66
There is Level 4 evidence from long-term follow-up of those having a previous
sphincterotomy that the incidence of various upper and lower tract urological
complications is quite high.
There is Level 4 evidence that transurethral balloon dilation of the external sphincter may
be associated with enhanced bladder function, notably reduced detrusor pressure and
reduced post-void residual volume but not changes in bladder capacity. Most individuals
undergoing the procedure were able to discontinue use of indwelling catheters in favour
of condom catheterization.
There is Level 4 evidence that most individuals undergoing cutaneous ileal conduit (ileo-
ureterostomy) diversion became newly continent and were more satisfied than with their
previous bladder management method. Long-term follow-up demonstrated the presence
of a high incidence of urological or renal complications.
Level 1 evidence supports the use of propiverine to treat detrusor hyperreflexia by

significantly improving bladder capacity.
Early experience in the form of level 4 evidence (1 before/after trial with N=10 and 1 N=14,
case series study) exists to support the potential benefits of controlled-release
oxybutynin. Standard oxybutynin may be enhanced by co-verapamil administration, in
the treatment of detrusor hyperreflexia in individuals with SCI.
Level 1 evidence supports the use of tolterodine vs placebo to significantly increase

intermittent catheterization volumes and decrease incontinence in neurogenic detrusor
overactivity.
There is level 2 evidence that for neurogenic detrusor overactivity, efficacy of tolterodine
and oxybutynin is equivocal except that tolterodine results in less dry mouth as
confirmed by level 2 evidence.
Level 1 evidence supports the use of trospium chloride to increase bladder capacity and
compliance, and decrease bladder pressure with very few side effects in SCI individuals
with neurogenic bladder.
Level 1 evidence supports the use of Tamsulosin to improve bladder neck relaxation and
subsequent urine flow in SCI individuals.
Level 1 evidence suggests that moxisylyte decreases maximum urethral closure

pressure by 47.6% at 10 minutes after an optimum dose of 0.75mg/kg in individuals with
SCI.
Level 4 evidence (two non-RCT, N=28 & 9), supports Terazosin as an alternative
treatment for bladder neck dysfunction in SCI individuals provided that side effects and
drug tolerance are monitored.
Level 4 evidence derived from a single, case series study involving 46 subjects (41
completers) indicates a potential for phenoxybenzamine as an adjunct treatment for
neuropathic bladder following SCI, when tapping or crede is insufficient to achieve
residual urine volume of <100mL.
13-67
Level 4 evidence from 1 small retrospective chart review suggests that 6 months of alpha
1-blocker therapy may improve upper tract stasis secondary to SCI in men by decreasing
the duration of involuntary contractions.
Level 4 evidence is available from a single, small (N=9), case series study for the use of
intra-thecal clonidine to improve detrussor hyperreflexia in individuals with SCI when a
combination of oral treatment and sterile intermittent catheterization are insufficient.
There is Level 1 evidence that Intrathecal Baclofen may be beneficial for bladder function
improvement in individuals with SCI when oral pharmacological interventions are
insufficient.
Level 4 evidence based on 3 studies supports the use of Botox A injections into the
detrusor muscle to provide targeted treatment for detrusor hyperreflexia and urge
incontinence resistant to high-dose oral anticholinergic treatments with intermittent self-
catheterization in SCI.
Additional level 4 evidence supports Botox A injected into the external sphincter to
assist with SCI related voiding dysfunctions including neurogenic detrusor-sphincter
dyssynergia, pelvic floor spasticity, or acontractile detrusor.
Level 1 evidence for lack of efficacy, in combination with a FDA warning for risk of
serious cardiac arrhythmias, supports not using Cisapride for treatment of SCI bladder
dysfunction.
Level 1 evidence supports the use of vanillanoid compounds such as capsaicin or

resiniferatoxin to increase maximum bladder capacity and decrease urinary frequency
and leakages in neurogenic detrusor overactivity of spinal origin.
Level 4 evidence exists to suggest that intravesical capsaicin installation in bladders of

SCI individuals does not increase the rate of common bladder cancers after 5 years of
use.
Level 1 evidence supports the use of N/OFG, a nociceptin orphan peptide receptor
agonist for the treatment of neurogenic bladder in SCI.
Level 4 evidence from one small, case series study, suggests that intranasal DDVAP may
increase the time between the need to void or catheterization in SCI with neurogenic
bladder that is unresponsive to conventional therapy.
Level 1 evidence supports the use UTI educational intervention to provide benefits of
increased bladder health (i.e. decreased urine colony counts) that increase a patient’s
perception of the control they have of their own health behaviours and that may translate
into less impairment and less lost time due to UTI in SCI.
Weak level 4 evidence suggests that outpatient, nursing-mediated re-education of SCI

individuals at high risk of UTIs may be a cost-effective method of reducing the number of
UTI.
13-68
Level 4 evidence exists to support additional utilization of tapping and compression to
augment bladder management as expressed as acceptable residual urine volumes
(<100mL).
Level 1 evidence supports the acceptance and use of a portable ultrasound device to
significantly reduce the number of catheterizations required each day in individuals with
SCI who perform SIC to empty their bladder.
Level 5 evidence supports that quadriplegic patients educated to CISC may continue to
use CISC successfully for many years after discharge.
Level 4 evidence suggests that for SCI individuals with chronic or significant medical
issues related to common bladder management techniques, urostomy may not be a
viable alternative due to long-term renal impairment.
Level 1 evidence (based on one high quality and several low quality RCTs) supports the
use of daily body washing in chlorohexidine and application of chlorhexidine crème to
the penis after every catheterization verses using standard soap in the endeavour to
significantly reduce bacteriuria.
Although the rate of UTI requiring antibiotic treatment is less with the use of sterile
catheterization technique, level 1 evidence supports the use of clean versus sterile
catheter supplies as a result of the prohibitive cost of the latter.
Level 4 evidence suggests that the prevalence of bacteriuria caused by gram-negative

bacilli, did not have any significant correlation with differing practices of external urinary
collection systems (i.e. continual vs discontinuation at night).
Poor quality level 1 evidence is supportive of the use of oral methenamine mandelate in
combination with hemiacidrin bladder instillant to lower urine pH and incident of UTI.
There is Level 3 evidence that sterile intermittent catheterization may lead to a lower rate
of UTI and complications with a maintained continence level after discharge as compared
to other bladder management techniques such as use of indwelling catheter.
There is level 2 evidence (based on a single poor quality RCT) reporting no difference
between incidence of bacteriuria in catheterized patients. However, Trisdine is the more
often chosen between the 2 treatments, based on the fact that it is not likely to contribute
to antiobiotic resistance, its stability at room temperature, and its lower cost.
Level 2 (based on a single RCT) evidence suggests that both limited and full microbial
investigation result in adequate clinical response to UTI treatment with antibiotics.
Therefore the cost savings attributed to a limited microbial investigation favours this
practice in the investigation of UTI.
Refrigeration (up to 24 hours) of urine samples prior to sample processing does not alter
urinalysis or urine culture results in SCI patients.
Level 4 evidence suggests that norfloxacin may be a reasonable treatment choice for UTI
in SCI but subsequent resistance must be monitored.
13-69
Level 4 evidence supports weekly oral cyclic antibiotic (WOCA) use for UTI prevention in
SCI patients. It decreases antibiotic consumption, the number and length of
hospitalizations, and is used without severe adverse events or the emergence of multi-
drug resistant (MDR) bacteria.
Optimum antimicrobial treatment duration is controversial due to the lack of

comparative trials. High quality level 1 evidence supports the use of 14 vs 3 days of
Ciprofloxcin for improved clinical and microbiological outcomes in the treatment of UTI
in SCI individuals. Similarily level 1 evidence suggests that 3 day Ofloxacin treatment is
sufficient based on significant biofilm eradication detected in bladder epithelial cells in
SCI patients with UTI.
Successful SCI UTI treatment with low-dose, long-term antibiotic prophylaxis without a
high rate of treatment emergent adverse events is recommended for ciprofloxacin but
not trimethoprim-sulfamethoxazole (TMP-SMX) as confirmed by level 1 evidence.
A low success rate of aminoglycosides in the treatment of SCI UTI is supported by level 1
evidence.
Bladder irrigation is not effective in treating bacteriuria in neurogenic bladder as

confirmed by level 1 evidence
Level 4 evidence is reported for Intermittent neomycin/polymyxin bladder irrigation being

effective in altering the resistance of the offending bladder organism(s) to allow for
appropriate antibiotic treatment.
Conflicting level 1 evidence exists for the effectiveness of cranberry juice or extract in
the treatment of UTI. However, the negative evidence involved poorer quality studies
involving specifically SCI while the positive evidence was the result of higher quality
studies involving women in the general population. Further complicating the burden of
evidence is level 2 evidence supporting the use of cranberry juice over placebo (i.e.
water) in the reduction of bacterial adhesion or biofilm presence.
Level 1 evidence does not recommend the use of cranberry, phosphate or ascorbic acid
supplementation to acidify urine in SCI neurogenic bladder.
Type 4 evidence suggests that urological management and follow-up is essential to

optimize post-discharge bladder management techniques and improve quality of life in
There is Level 5 evidence to support the notion that higher functioning and work-
productivity correlates with higher global satisfaction. Individuals with higher
productivity suffered from a lower incidence of UTIs per year over a 3 year period.
Level 4 evidence suggests that although urostomy may improve quality of life in SCI
individuals with otherwise insufficient bladder health management methods, the
procedure is not likely to be a good alternative due to the long-term negative impact to
renal impairment.
13-70
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CHAPTER FOURTEEN
Pain Following Spinal Cord Injury

Jo-Anne Aubut, BA
Dalton L Wolfe, PhD
Jane TC Hsieh, MSc
Key Points
Pain post SCI has a significant effect on quality of life.
Post SCI pain is common and often severe beginning relatively early post-injury.
Post-SCI pain can most commonly be divided into neuropathic or musculoskeletal

pain.
Massage and heat might be helpful for post-SCI pain.
Acupuncture may reduce post-SCI pain.
Shoulder exercise protocol reduces post-SCI shoulder pain intensity.
Hypnosis may reduce pain intensity post-SCI.
Gabapentin improves pain post-SCI.
Tricyclic antidepressants do not reduce post-SCI pain.
Lidocaine through a subarachnoid lumbar catheter, I.V. Ketamine and Aflentanil

improve post-SCI pain short term.
Mexilitene does not improve SCI dysesthetic pain.
Intrathecal Baclofen improves musculoskeletal pain post-SCI and may help dysethetic
pain related to spasticity.
Cannabinoids are a potential new treatment for post-SCI pain in need of further study.
Intrathecal Clonidine alone does not provide pain relief although it may be helpful in
combination with Intrathecal Morphine
Spinal cord stimulation may improve post-SCI pain.

Table of Contents
14.1 Introduction ..................................................................................................................14-1
14.2 Incidence, Quality and Significance...........................................................................14-1
14.2.1 Incidence of Pain Post-SCI .........................................................................................14-1
14.2.2 Impact on Quality of Life .............................................................................................14-1
14.2.3 Severe Pain and SCI Location....................................................................................14-2
14.2.4 Natural History of SCI Pain .........................................................................................14-2
14.3 Location and Quality of SCI Pain ...............................................................................14-2
14.4 Classification of SCI Pain............................................................................................14-3
14.5 Musculoskeletal or Mechanical Pain..........................................................................14-4
14.6 Central or Neurogenic Dysesthetic Pain ...................................................................14-4
14.7 Borderzone or Segmental Pain...................................................................................14-5
14.8 Psychological Factors.................................................................................................14-6
14.9 Non-Pharmacological Management of Post-SCI Pain ..............................................14-7
14.9.1 Massage and Heat......................................................................................................14-7
14.9.2 Exercises for Shoulder Pain......................................................................................14-10
14.9.3 Hypnotic Suggestions ...............................................................................................14-12
14.10 Pharmacological Management of Post-SCI Pain ..................................................14-12
14.10.1 Pharmacological Measures Overall ........................................................................14-13
14.10.2 Anticonvulsants in SCI Pain....................................................................................14-14
14.11 Tricyclic Antidepressants in Post-SCI pain...........................................................14-16
14.12 Anaesthetic Medications.........................................................................................14-17
14.12.1 Antispasticity Medications.......................................................................................14-19
14.12.2 Opioids for Post-SCI Pain .......................................................................................14-21
14.12.3 Cannabinoids in Post-SCI Pain...............................................................................14-21
14.12.4 Clonidine for Post-SCI pain.....................................................................................14-22
14.13 Surgical Interventions .............................................................................................14-24
14.13.1 Spinal Cord Stimulation ..........................................................................................14-24
14.13.2 Destructive Neurosurgical Procedures ...................................................................14-24
14.13.3 Dorsal Rhizotomy....................................................................................................14-25
14.13.4 Sympathectomy ......................................................................................................14-25
14.13.5 Lateral Spinothalamic Tractotomy ..........................................................................14-25
14.13.6 Spinal Cordotomy ...................................................................................................14-25
14.14 Summary...................................................................................................................14-25
References............................................................................................................................14-27
Teasell RW, Aubut J, Wolfe DL, Hsieh JTC, Townson AF (2006). Pain Following Spinal Cord Injury. In: Eng JJ,
www.icord.org/scire
Pain Following Spinal Cord Injury
14.1 Introduction
The last few decades have witnessed increasing sophistication and advances in the
rehabilitation of spinal cord injured (SCI) patients with marked improvements in the quality of
care accompanied by significant reductions in morbidity and mortality. Despite these impressive
gains in bladder, skin, cardiovascular and respiratory care, the treatment of chronic pain in SCI
has proven largely refractory to medical management. This lack of treatment efficacy has been
complicated by an incomplete understanding of pain in individuals with spinal cord injuries and
lack of a standardized framework upon which to classify these injuries (Burchiel and Hsu 2001).
14.2 Incidence, Quality and Significance
14.2.1 Incidence of Pain Post-SCI
Pain is a frequent complication of traumatic spinal cord injury. Reported estimates of the
incidence of pain following SCI range anywhere from 11 to 94% (Botterell 1953, Burke 1973,
Davidoff 1987, Davis 1947, Donovan 1982, Kaplan 1962, Kennedy 1946, Munro 1948, 1950,
Nashold 1981) with more recent studies reporting an incidence from 48-94% (Davidoff et al.
1987, Cohen et al. 1988, Rose et al. 1988, Britell and Mariano 1991, Mariano 1992, Cairns et al.
1996). Estimates of debilitating or disabling pain range from 11-34% (Botterell 1953, Davis
1947, Kaplan 1962, Munro 1948, Nepomunceno 1979). Bonica (1991) noted that on combining
the data on 6 reported studies of pain in SCI and 1,028 subjects (Botterell 1953, Burke 1973,
Davis 1947, Nepomunceno 1979, Rose 1988, Woolsey 1986), 53% had various types of
“deafferent” pain. These wide ranging estimates are felt to be a relfection of significant
heterogenicity in defining pain in this population.
Bonica (1991) reviewed data contained in 10 reports that surveyed 2,449 SCI patients (Botterell
1953, Britell 1986, Burke 1973, Davis 1947, Kaplan 1962, Munro 1950, Nepomunceno 1979,
Richards 1980, Rose 1988, Woolsey 1986). Chronic pain was present in 1,695 (69%) and in
30% of these patients it was rated as severe. Six of the reports (Botterell 1953, Burke 1973,
Davis 1957, Nepomunceno 1979, Rose 1988, Woolsey 1986) analyzed the different types of
pain. Out of a total of 1,965 patients, 608 (31%) of the patients had central
pain/dysesthesia/phantom limb pain, 219 (12%) had root pain, and 198 (10%) had visceral pain
caused by a central mechanism. There were 1,028 (53%) SCI patients with deafferentation
pain.
14.2.2 Impact on Quality of Life
It is estimated that 30-40% of patients with SCI experience severe disabling pain (burke and
Woodward 1976). Pain is often reported as the most important factor for decreased quality of
life. Nepomuceno (1979) noted that 23% of individuals with cervical or high thoracic SCI and
37% of those with low thoracic or lumbosacral injury would trade the loss of sexual and/or bowel
and bladder function as well as hypothetical possibility for cure to obtain pain relief.
Rose et al. (1988) sent a questionnaire to 1,091 spinal cord injured individuals. 885 "suitable"
replies were received with a total of 615 subjects reporting pain at or below the level of the
14-1
injury. In 110 subjects this occurred in a nerve root distribution with the remainder below the
level of SCI. Pain, which was reported as constant in 43%, was considered severe at some
point in the day in half the sample and mild to moderate in 21% of respondents. Prior to the
SCI, 595 of the sample were employed; afterwards only 325 were employed. Interestingly 98
SCI individuals (11%) reported it was the severity of their pain and not their paralysis, which
stopped them from working. 269 of the 325 SCI subjects (83%) who were employed reported
that the pain interfered with their work. A total of 118 SCI subjects found that the pain was
severe enough to stop social activity. Pain appeared to be more severe in the evening and at
night, interfering with sleep in 325 of respondents (37%). This study clearly pointed out the
importance of chronic pain in determining disability and morbidity in SCI patients (Rose 1988).
Pain post-SCI has a significant effect of quality of life.
14.2.3 Severe Pain and SCI Location
Persons with SCI who complain of severe pain are more likely to have low spinal cord or cauda
equina lesions (Ragnarsson 1997, Davis and Martin 1947, Botterell et al. 1953, Nepomuceno et
al. 1979). Severe pain was noted in 10-15% of persons with quadriplegia; 25% of those with
thoracic paraplegia and 42-51% of those with lesions of the cauda equina (Ragnarsson 1997)
14.2.4 Natural History of SCI Pain
One study examining the timing of the development of pain post-SCI noted that in 901 patients
with SCI, pain started immediately after SCI in 34%, within the first year in 58%, pain increased
over time in 47% and decreased over time in 7%. (Turner et al 2001). Turner et al. (2001) noted
that pain most often started within the first 6 months following SCI. This has also been noted in
several other studies (Turner and Cardenas 1999, Stormer et al.1997, Nepomuceno et al. 1979,
Siddall et al. 1999).
Conclusion
For many SCI patients, pain has a significant impact on quality of life.
Over 50% of SCI patients develop chronic pain. Severe pain is more common the lower
down the lesion in the spinal cord. Pain post-SCI most often begins within the first 6-12
months post-SCI.
Post SCI pain is common and often severe beginning relatively early post-injury.
14.3 Location and Quality of SCI Pain
Widerstrom-Noga et al. (2001) conducted a careful analysis of the relationship between the
location of the pain and the patients’ description of the pain. In this study 217 of 330 patients
reporting chronic pain in a previous survey agreed to participate in the study. Participants had
been injured for an average of 8.2 ± 5.1 years and 55.4% were quadriplegic. Most subjects in
this study marked multiple areas on a pain drawing with the back area being most frequently
14-2
implicated (61.8%). 59.9% complained of a burning pain while 54.9% described an aching pain.
Interestingly burning pain was significantly associated with pain localized to the front of the torso
and genitals, buttocks and lower extremities. In contrast, aching type pain was significantly
associated with pain localized to the neck, shoulders and back.
Widerstrom-Noga et al. (2001) noted that the descriptor “burning” is often associated with
neuropathic pain (Siddall et al. 1999, Ragnarsson 1997, Fenollosa et al. 1993) whereas “aching”
is often associated with musculoskeletal pain (Siddall et al. 1999, Tunks 1986). However, the
authors do note “the substantial overlap in the clinical picture of SCI pain makes such
relationships uncertain” (Eide 1998, Bowsher 1996, (Widerstrom-Noga et al. 2001). The
authors then go on to suggest that musculoskeletal-type pain (best characterized by the aching
pain in the neck, shoulders and back) is potentially amenable to therapeutic interventions and
aggressive attempts should be made to ameliorate this type of pain. All of this underscores the
need for a reproducible classification system of the pain experienced following SCI.
Conclusion
The most common types of pain post SCI are: 1) a burning pain (likely neuropathic)
usually localized to the front of torso, buttock or legs or 2) an aching pain (likely
musculoskeletal) usually localized to the neck, shoulders and back.
Post-SCI pain can most commonly be divided into neuropathic or musculoskeletal pain.
14.4 Classification of SCI Pain
Siddall et al. (1997) noted that one of the concerns regarding SCI-related pain was a lack of
consensus over a classification system for SCI pain. This has in part led to "large variation in
the reported incidence and prevalence of pain following spinal cord injury." Twenty-eight (28)
classification schemes have been published between 1947 and 2000. A Task Force on Pain
Following Spinal Cord Injury of the International Association for the Study of Pain has
introduced a taxonomy, which classified SCI pain based on presumed etiology (Burchiel and
Hsu 2001, Siddall 2000).
Table 14.1 Proposed IASP Classification of Pain Related to SCI (Burchiel & Hsu 2001)
Broad Type Broad System
Specific Structure/Pathology (Tier 3)
(Tier 1) (Tier 2)
Bone, joint, muscle trauma, or inflammation
Mechanical instability
Musculoskeletal
Muscle spasm
Nociceptive
Secondary overuse syndromes
Renal calculus, bowel, sphincter dysfunction, etc.
Visceral
Dysreflexic headache
Compressive mononeuropathies
Above Level
Complex regional pain syndromes
Nerve root compression (including cauda equine)
Syringomyelia
Neuropathic At Level Spinal cord trauma/ischemia (transitional zone, etc.)
Dual-level cord and root trauma (double lesion
syndrome)
Spinal cord trauma/ischemia (central dysesthesia
Below Level
syndrome, etc.)
14-3
14.5 Musculoskeletal or Mechanical Pain
Musculoskeletal or mechanical pain occurs at or above the level of the lesion and is due to
changes in bone, tendons or joints (Guttmann 1973). This is referred to as nociceptive pain
caused by a variety of noxious stimuli to normally innervated parts of the body. (Ragnarsson
1997). Overuse of remaining functional muscles after spinal cord injury or those recruited for
unaccustomed activity may be of primary importance in some patients (Farkash 1986). Pain
may also be secondary to spinal osteoporosis or facet arthropathy (Farkash 1986). Instability of
the vertebral column may also be a problem (Farkash 1986). Pain is usually dull and aching in
character and although more common soon after SCI, it may become chronic.
Sie et al. (1992) studied 239 SCI outpatients for the presence of upper extremity pain. Of the
136 patients with quadriplegia, 55% reported upper extremity pain, most commonly at the
shoulder (46% of all subjects). In the case of shoulder pain, 45% were orthopedic-related
including tendonitis, bursitis, capsulitis and osteoarthritis. Of the 103 paraplegics, 66 reported
upper extremity pain with two-thirds reporting symptoms of carpal tunnel syndrome and 13
reporting musculoskeletal-related shoulder pain.
14.6 Central or Neurogenic Dysesthetic Pain
"Central" dysesthesia or "deafferentation" pain is the most common type of pain experienced
below the level of SCI and is generally characterized as a burning, aching and/or tingling
sensation. In many cases this dysesthetic or deafferentation pain has defied a
pathophysiological explanation (Britell,1991) although most researchers firmly support a central
nervous system origin for this pain. Nashold (1991) goes as far as stating that except for
radicular pain, all other pains of paraplegia are central or deafferentation in origin. This pain is
most often perceived in a generalized manner below the level of the lesion, often a diffuse
burning type of pain (Britell 1991, Tunks 1986). Burning pain is reportedly most common with
lesions at the lumbar levels, although it may be found with SCI at thoracic and cervical levels
(Tunks 1986). Nashold (1991) reported this pain occurred almost immediately after SCI and
persisted.
Beric (1997) refers to this pain as central dysesthetic pain (CDP) and found dissociative sensory
loss and absence of spinothalamic-anterolateral functions, with different degrees of dorsal
column function preservation present almost exclusively in incomplete SCI patients. CDP takes
weeks or months to appear and is often associated with recovery of some spinal cord function.
Paradoxically CDS is often characterized by complete loss of temperature, pinprick, and pain
perception below the level of the lesion. It rarely occurs in spinal cord Injuries with complete
sensory loss or loss of both sensory and motor functions below the level of the lesion. Davidoff
et al. (1987a) concurred and further noted dysesthetic pain was more likely to be found in
incomplete paraplegia resulting from penetrating wounds of the spinal cord, and in spinal
fractures treated with conservative management.
A number of factors may contribute to exacerbations of these "central" pain syndromes; these
include visceral diseases or disturbances, movement, smoking or alcohol, emotional factors,
fatigue, and even weather changes (Botterell 1953, Davis 1947, Davis 1975, Tunks 1986).
Pressure sores, particularly if infected, or an occult injury such as a fracture, may result in an
increase in burning, dysesthetic pain. These stimuli often provoke autonomic dysreflexic-like
symptoms and simultaneously also may aggravate this "burning" pain.
14-4
14.7 Borderzone or Segmental Pain
Individuals with SCI frequently experience a band of pain and hyperalgesia at the border zone
between diminished or abnormal and preserved sensation (Tunks 1986, Botterell 1953, Davis
1975, Heliporn 1978, Kaplan 1962, Maury 1978, Melzack 1978, Michaelis 1970). In the more
recent literature, this segmental pain is further described as occurring at or just above the level
of sensory loss in the cutaneous transition zone from the area of impaired/lost sensation to
areas of normal sensation, involving at least one to three dermatomes (Friedman 1989, Nashold
1991, Ragnarsson 1997) and is often associated with spontaneous painful tingling or burning
sensations in the same area. Ragnarsson (1997) also noted that in an individual with a cervical
cord injury, segmental pain may be described as tingling, burning or numbing pain in the
shoulders, arms or hands, those with a thoracic cord injury frequently describe a circumferential,
feeling of tightness and pain around the chest and abdomen while lumbar lesions tend to be
localized to the groins and different parts of the lower extremities. According to Nashold (1991)
paraplegics often complain that touching the skin in the pain region activates the pain causing it
to radiate into the lower parts of the body, especially the legs. Pain can be triggered by stroking
and/or touching the skin in adjacent painful dermatomes (Nashold 1991). Even light touch or
the pressure of clothing or bed sheets over this region may provoke marked discomfort (Tunks
1986). It may be accompanied by sweating or vasodilation at or below the level of hyperalgesia.
Segmental pain is generally symmetrical although a partial spinal cord injury with asymmetrical
neurological involvement will produce asymmetries (Nashold 1991).
This pain has also been described as "neuropathic at level pain" (Siddall et al 1997)
Although several theories have been proposed (Tunks 1986, Nashold 1981, Pollock 1951,
Matthews 1972, Levitt 1983, Melzack 1978) the neurological mechanism responsible for this
area of hyperalgesia after spinal injury is not well understood (Farkesh 1986). Although
radicular pain is most severe in incomplete SCI lesions, it is also seen in transected cauda
equina lesions which are by definition radicular types of pain (Heaton 1965, Siddall et al. 1997).
It may also be secondary to spinal cord instability by facet or disc material, or to direct damage
to the nerve root during the initial injury (Burke 1973, Nashold 1991). This “radicular” pain is
associated with sensory change in the involved painful dermatome (Nashold 1991) and is most
common to cervical or lumbosacral nerve roots. Non-neural structures, such as the dura mater,
have also been suggested as a source of radicular pain (Cyriax 1969, Farkash 1986). In
addition, it has been suggested that central borderzone pain may be generated in the damaged
spinal cord just proximal to the spinal cord injury (Nashold 1991, Pollock 1951). Unfortunately,
unless there is definitive evidence on imaging of nerve root damage, it is difficult to distinguish
between these various mechanisms of pain.
To reflect this uncertainty Siddall et al. (1997) in their proposed classification of SCI pain note
that this "neuropathic at level pain" is divided into radicular and central pain. Radicular pain is
due to nerve root pathology while central pain is due to changes within the spinal cord or
possibly supraspinal structures. Pain attributable to nerve root damage is suggested by
features of neuropathic pain (ie. burning, stabbing, shooting, electric-like pain, allodynia) and
increased pain with spinal movement. Sjolund (2002) notes that this pain is thought to occur
from nerve root entrapment and may occasionally benefit from decompression.
However, pain, which appears radicular in nature, may occur in the absence of nerve root
damage. This leads to the second grouping of borderzone pain, namely central pain or that
which is due to pathology within the spinal cord thought to be the result of damage to the gray
matter of the dorsal horn of the spinal cord (Ragnassaron 1997, Woolsey 1995). According to
Ragnassaron (1997), such an injury “has been said to result in hyperactivity of the nociceptor
14-5
cells within the dorsal horn (Nashold and Bullitt 1981, Nashold and Ostdahl 1979) which can be
electrically recorded (Nashold and Alexander 1989).” Sojlund(2002) notes that this second
type of at level neuropathic pain is experienced as a girdle pain uni- or bilaterally in 2-4
segments of the transitional region. This pain is described as stimulus independent, often
accompanied by troublesome alldodynia or hyperalgesia and thought to arise from segmental
deafferentation (Sjolund 2002).
14.8 Psychological Factors
Most studies of chronic SCI pain have focused on the medical causes and clinical
manifestations of pain while much less is understood about how psychosocial factors impact
SCI pain (Summers 1991). A negative psychosocial environment along with increased age,
depression, anxiety and intellect were found to be associated with reports of greater post-SCI
pain severity interfering with activities of daily living (Richards et al. 1980). Greater pain severity
was not associated with physiological factors such as injury level, completeness of injury,
surgical fusion and/or instrumentation or veteran status. The authors were unable to distinguish
whether the psychological factors were a consequence of, or contributors to, greater pain
severity. In the Summers et al (1991) study 54 SCI patients (19 with quadriplegia and 35 with
paraplegia) were studied, and of these 42 patients "revealed that anger and negative cognitions
were associated with greater pain severity” after a careful psychological assessment and Pain
Questionnaire. Patients who reported pain in response to a general prompt experienced more
severe pain than patients who reported pain only when directly questioned about the presence
of pain, but these different reporting groups did not differ on emotional variables. Those who
were less accepting of their disability reported greater pain severity. Additionally, patients who
perceived a significant other expressing punishing responses (e.g., expressing anger at the
patients or ignoring the patients) to their pain behaviours reported more severe pain. Finally,
pain was associated with emotional distress over and above the distress associated with the
SCI itself." The authors concluded that, "Overall, psychosocial factors, not physiological factors
were most closely associated with the experience of pain. Multidimensional aspects of pain are
used to explain these findings and suggest that treatment should be directed at the emotional
and cognitive sequelae of chronic SCI pain."
Cohen et al. (1988) found that patients with complete SCIs reported significantly less severe
pain than did pain clinic patients. However, they did not differ from patients with incomplete
lesions. Patients with complete SCIs and pain clinic patients showed a significantly more
disturbed MMPI (Minnesota Multiphasic Personality Inventory) profile than did patients with
incomplete SCIs. It was hypothesized that those patients with complete lesions view
themselves as more functionally limited than patients with incomplete lesions, and the
completeness of the SCI may be more important in determining psychosocial adjustment than
pain per se.
Rintala (1998) in community-based men with SCI found that chronic pain was associated with
more depressive symptoms, more perceived stress and poorer self-assessed health.
14.8.1 Catastrophizing and Pain Post-SCI

When pain post-SCI is refractory to pharmacological and surgical treatment, it is important to
fully understand the negative impact of the patient’s psychosocial environment prior to
undertaking more invasive approaches to treatment.
14-6
Table 14.2 Catastrophizing and Pain Post-SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=60, f=13, age: 21- 1. CSQ catastrophizing was associated
64yrs. with WHYMPI (p<0.05), CES-D
Treatment: no treatment, questionnaire. (p<0.001), SF-MPQ (sensory pain)
Outcome Measures: Coping strategies (p<0.01) and CSQ SF-MPQ (affective
questionnaire (CSQ), Short form McGill pain) (p<0.001).
Pain Questionnaire (SF-MPQ), West 2. Catastrophizing also accounted for
Haven-Yale Multidimensional Pain significant variance in sensory pain
Inventory (WHYMPI) solicitous subscale scores (t=2.63, p<0.05). An
Giardino et al. 2003; USA
and CES-D scale. interaction between relationship type
and catastrophizing was also found
Case Series
(p<0.05).
N=74
3. A significant relationship was noted
between affective pain score and
solicitousness (p<0.05) and
catastrophizing and solicitousness
(p<0.05).
4. Catastrophizing itself accounted for a
significant amount of variance in
affective pain scores (p<0.01).
Giardino et al (2003) noted that pain-related catastrophizing, or exaggerating the negative

consequences of a situation has been associated with greater pain intensity, emotional distress
and functional disability in patients with chronic pain conditions and SCI. This was thought to
provide partial support for a “communal coping” model of catastrophizing, where catastrophizing
in persons with pain may function as a social communication directed toward obtaining social
proximity, support or assistance.
14.9 Non-Pharmacological Management of Post-SCI Pain
Before moving to pharmacological and surgical interventions, it is important to deal with those
factors which may intensify or worsen the experience of pain. As mentioned previously, SCI
pain may be worsened by decubitus ulcers, a urinary tract infection or stone, autonomic
dysreflexia, increased spasticity, anxiety, depression, psychosocial factors and other
contributors to post-SCI pain (Davis 1998, Tunks 1987). There are a number of non-
pharmacological interventions for post-SCI pain which have been studied from massage to
hypnosis.
14.9.1 Massage and Heat
Massage and heat are used primarily to treat musculoskeletal pain. Their benefit is well known
in a number of musculoskeletal pain disorders, although there are significant differences among
therapists as to how treatment is delivered.
Table 14.3 Massage and Heat in Post-SCI Pain

Score
Methods Outcome
Research Design
Total Sample Size
Budh & Lundeberg 2004; Population: Gender: m=44, f=46, age:7- The authors noted that massage and heat
Sweden 83, time since injury: 14.4 yrs. appeared to be the best non-
Downs & Black score=19 Treatment: No treatment questionnaire. pharmacological treatments.
14-7
Score
Methods Outcome
Research Design
Total Sample Size
Case Series Outcome Measures: Pain questionnaire
Initial N=100; Final N=90 (looked at the use of pain relieving
techniques, pain intensities and pain
unpleasantness). Participants also
completed a life questionnaire, hospital
anxiety and depression scale, and a pain
drawing.
It stands to reason that local heat and massage therapy would be most effective for
musculoskeletal pain post-SCI. Budh and Lundeberg (2004) in a survey of SCI patients 3 years
post-injury found massage and heat were the best non-pharmacological treatments. No
prospective studies examining heat and massage as treatment modalities for post-SCI pain
have conducted.
Conclusion
There is limited level 4 evidence that massage and heat are the best non-
pharmacological treatments for pain post-SCI.
Massage and heat might be helpful for post-SCI pain.
14.9.1.1 Acupuncture and TENS
Acupuncture is a component of traditional Chinese medicine that has been used for the
treatment of pain for thousands of years and is based on the premise that illness arises from the
imbalance of energy flow (Qi) through the body (Dyson-Hudson et al. 2001). Needle
acupuncture involves inserting fine needles into specific points to correct these imbalances
(Pomeranz 1995; NIH Consensus 1998; Wong & Rapson 1999; Dyson-Hudson et al. 2001).
Acupuncture has been shown to activate type II and type III muscle afferent nerves or A delta
fibers, blocking the pain gate by stimulating large sensory neurons as well as releasing
endogenous opioids, neurotransmitters and neurohormones (Pomeranz 1995; Wong & Rapson
1999; Dyson-Hudson et al. 2001).
Table 14.4 Acupuncture in Post-SCI Pain

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=18, f=6, age: 28- 1. Analysis of treatment on PC-WUSPI
69yrs, time since injury: 5-33 yrs, Level of scores using ANOVA showed a
Dyson-Hudson et al.
injury: both paraplegic and tetraplegic, significant effect of time for both
2001; USA
length of shoulder pain: 4mths-22yrs. treatments (Acupuncture p<0.001 and
PEDro=7
Treatment: Subjects received either Trager p=0.001).
RCT
acupuncture treatments (sessions lasted 2. Overall a reduction of the PC-WUSPI
N=21
20 to 30 min) or Tager Psychophysical could be seen when looking at the
Integration - sessions lasted approx 45 data from the beginning of treatment to
min. Consisted for both table work and the end for both groups (p<0.05).
mentastic exercises. 3. Looking at the effect of treatment on
Outcome Measures: Intake questionnaire the numeric rating scores, the ANOVA
14-8
Score
Methods Outcome
Research Design
Total Sample Size
(demographics and medical history), showed a significant effect of time for
Weekly log, Wheelchair users shoulder both acupuncture and Trager groups
pain index (WUSPI), Numeric rating scale, for average pain & most severe pain
Verbal rating scale, range of motion. (p<0.01, p<0.001 respectively), for the
least severe pain the acupuncture
group showed a significant reduction
(p<0.01) compared to the Trager
group.
4. Verbal response scores-Looking at the
effect of treatment on the VRS scores
for both groups; there was a
statistically significant effect for both
groups (p=0.001).
Population: Gender m=15, f=7, age: 1. When looking at the 3 pain measures,
mean=43.14, Injury level: C1-L3, ASIA: A, pain intensity decreased over time-
C & D, complete and incomplete, injury worst pain: (p<0.05), average pain:
duration: 8.49yrs, pain duration: 8.46yrs. (p<0.01), present pain: (p<0.01).
Treatment: 15 acupuncture treatments 2. Post-treatment decline in pain intensity
were administered over a 7.5-week period was maintained at 3mth follow-up
using a specific set of acupuncture points (pretreatment vs follow-up: p<0.01).
with additional points being selected by 3. A difference in the ratings of pain
subjects based on individual history and intensity between pre and post-
clinical examination. treatment (p<0.001) was noted and
Nayak et al. 2001; USA
Outcome measures: Pain intensity: this was maintained 3 mths after the
numeric rating scale, general health: end of treatment (pretreatment vs
Pre-post
individualized symptom rating scale, pain follow-up: p<0.01).
impact and interference: activity scale, 4. Those that did report pain relief at 3-
mood, psychological well being-general mth follow up reported only moderate
well being schedule and expectations. levels of pain intensity on the NRS at
the beginning of the study (7.83 ± .75)
compared to those who did not report
pain relief (9.67 ± .58, p<0.01).
5. Pain interference: a decrease in pain
interference with ADLs was also noted
(p<0.05). Respondents showed a
reduction in interference with ADLs at
post-treatment (p<0.01).
Population: Gender: m=23, f=23, age: 17- 1. 24 participants improved in response
75, injury level: cervical to lumbar, pain to electro-acupuncture while 12
duration: <1mth->15yrs, # of tx:2-26. showed no improvement.
Treatment: SCI patients were given 2. Bilateral pain (n=21) more likely to
acupuncture treatment s. respond to electro-acupuncture than
Outcome measures: pain. those with unilateral pain (n=3)
Rapson et al. 2003; (p=0.014).
Canada 3. Those with symmetric pain had a
Downs & Black score=14 higher response to treatment than
Pre-Post those who asymmetric pain (p=0.26).
N=36 4. It was also noted that those with
burning pain that was bilateral and
symmetric (p=0.006) was more likely
to improve after electro-acupuncture.
5. Similar findings were noted for those
who experienced bilateral symmetric
constant burning pain (p=0.005).
14-9
Discussion
Dyson-Hudson et al. (2001) in an RCT compared acupuncture treatment to Trager Psychosocial

Integration performed by a certified Trager practitioner. Trager therapy is a form of bodywork
and movement re-education to induce relaxation and encourage the patient to identify and
correct painful patterns. The theory is that chronically contracted muscles shortened by stress
led to pain (Dyson-Hudson et al. 2001). There was a significant effect over time for both
treatments in reducing shoulder pain but there was no difference between the two groups.
Nayak et al. (2001) administered 15 acupuncture treatments over a 7.5-week period of time.
Pain intensity decreased from pre-treatment to post-treatment with post-treatment decline in
pain intensity being maintained at 3 month follow-up. Despite these results, 54.5% of those
treated reported a worsening of pain after treatment. Those that reported pain below their injury
did not respond to treatment (p<.05). Those who reported pain relief at 3 month follow-up
reported only moderate levels of pain intensity at the beginning of the study compared to those
who did not report pain relief at follow-up (p<.01). With the overall reduction in pain intensity
there were also a decrease in pain interference with ADLs and an improvement in overall well
being. The authors felt that 50% of patients demonstrated improvement in their pain with
acupuncture.
Rapson et al. (2003) asked patients to rate their pain intensity according to a visual analogue
scale after electroacupuncture treatments. Sixty-seven percent (24/36) of patients reported
improvement, with improvement best for those with bilateral symmetric constant burning pain.
Table 14.5 Summary of Acupuncture in SCI Pain

Study Study Type N Intervention Outcome
Dyson-Hudson et
RCT 24 Acupuncture or Trager therapy +
al. 2001
Nayak et al. 2001 Pre-Post 22 Acupuncture +/-
Rapson et al. 2003 Pre-Post 36 Electro-acupuncture +
Banerjee (1974) reported on five patients who developed burning, distressing pain below the
level of SCI and who responded to transcutaneous electrical nerve stimulation (TENS) strong
enough to lead to muscle contraction below the level of injury. The exact mechanism of action
for this analgesic response was not delineated.
Conclusion
There is level 2 evidence that in general acupuncture is no more effective than Trager
therapy for shoulder pain.
There is level 4 evidence that acupuncture reduces the pain of some patients with SCI.
Acupuncture may reduce post-SCI pain.
14.9.2 Exercises for Shoulder Pain
Shoulder pain is a common form of musculoskeletal pain following SCI and is often the result of
increased physical demands, awkward or over-use of the upper extremities as the individual
14-10
with SCI compensates for loss of lower limb functioning (Curtis et al, 1999). Curtis et al. (1999)
has noted, “tightness of the anterior shoulder musculature, combined with weakness of the
posterior shoulder musculature both seem to contribute to development of shoulder pain in
wheelchair users (Curtis et al 1999, Burnham et al. 1993, Powers et al. 1994, Millikan et al.
1991) and may be further complicated by paralysis and spasticity in the individual with
tetraplegia (Silverskiold and Waters 1991, Powers et al. 1994)”. The prevalence of shoulder
pain in SCI individuals ranges between 30-100% (Curtis et al. 1999) and is a consequence of
increased physical demands and overuse (Pentland and Twomey 1991, 1994, Nichols et al.
1979).
Table 14.6 Shoulder Pain Management Post-SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=35, f=7, age: 1. When looking at the effect of exercise
mean=35yrs, duration of wheelchair use: intervention on performance corrected
mean=24yrs, Injury level: cervical to (PC) WUSPI, a 2 factor repeated
lumbar, mixed etiology. measures ANOVA showed a
Treatment: The experimental group significant effect of time only
Curtis et al. 1999; USA
attended a 60min educational session (p=0.048).
PEDro =5
where they were instructed in 5 shoulder 2. There were no significant differences
RCT
exercises. between control and experimental
N=42
Outcome Measures: Self report group in age, years of wheelchair use
questionnaire (demographic and medical or activity levels although the control
info), Wheelchair User's Shoulder Pain group had much lower pain scores at
Index (WUSPI), and a visual analog scale baseline.
(VAS) used to rate intensity of pain.
Discussion
Curtis et al. (1999) in a RCT studied the effectiveness of a 6-month exercise protocol on
shoulder pain experienced by wheelchair users where 42 patients were randomized into a
treatment and a control group. Over 75% of all subjects reported a history of should pain since
beginning wheelchair use and 50% in both groups had current shoulder pain at the start of the
study. The treatment group performed two exercises designed to stretch the anterior shoulder
musculature and 3 exercises for strengthening the posterior shoulder musculature. Compliance
rates were higher-over 83% of the subjects completed the 6-month protocol. Subjects in the
treatment group decreased their average PC-WUSPI score by an average of 39.9% vs only
2.5% in the control group. Despite this very significant change, 48.3% decreased in the
paraplegic group and 27.2% in the tetraplegic group, the treatment group still had a higher
mean score than the control group at the end of the study because of disparate baseline scores.
Conclusion
There is level 2 evidence (from one RCT) that a shoulder exercise protocol reduces the
intensity of shoulder pain post-SCI.
Shoulder exercise protocol reduces post-SCI shoulder pain intensity.
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14.9.3 Hypnotic Suggestions
Hypnosis has been used to reduce pain in a number of painful clinical conditions as well as
experimental pain (Jensen et al 2000). Hypnosis is appealing as a potential treatment because
it is nonpharmacological although its use is controversial given the variability in hypnotic
responsiveness.
Table 14.7 Hypnotic Suggestion and Post-SCI Pain

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=64%, age: 24- 1. 86% reported decrease in pain
76yrs, time since injury: 1.75-42.33 yrs, intensity and unpleasantness from pre-
pain duration: mean 13.88yrs. induction to just after induction.
Treatment: Hypnotic suggestions for pain 2. A significant time effect emerged for
relief were given to each subject. both pain intensity (p<0.001) and pain
Outcome Measures: Pain intensity and unpleasantness (p<0.001).
unpleasantness and hypnotic 3. Significant effect for analgesic
responsiveness (modified version of the suggestion on pain intensity over and
Standford Hypnotic Clinical scale-SHCS. above the effects of the induction
alone, with a significant decrease
Jensen et al. 2000; USA occurring in reported pain intensity
Downs & Black score=16 before and after the analgesic
Pre-post suggestion (p<0.05).
N=22 4. Pre-induction, post-induction, and
post-analgesia suggestion pain
intensity ratings were all significantly
lower than average pain during the
previous 6 months (p<0.01, p<0.0001,
P<0.0001 respectively).
5. Statistical significance was noted for 2
of the associations: Effect of pain plus
analgesia suggestion on pain intensity
(P<0.01) and effect of induction alone
relative to least pain (p<0.05).
Discussion
Jensen et al. (2000), in a before and after study, examined the impact of hypnosis on pain post-
SCI. Eighty-six percent (86%) of the SCI patients reported a decrease in pain intensity and
unpleasantness after hypnosis. There was no control group.
Conclusion
There is level 2 evidence that hypnosis reduces pain intensity post-SCI.
Hypnosis may reduce pain intensity post-SCI.
14.10 Pharmacological Management of Post-SCI Pain
Pharmacological interventions are the standard treatment for SCI pain. The limited
effectiveness of non-pharmacological treatments has led to the increasing use of
pharmacological interventions to deal with what is often very severe and disabling pain.
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14.10.1 Pharmacological Measures Overall
Table 14.8 Pharmacological Interventions and Post-SCI Pain

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=94, f=26, age: 1. Overall 59.2% of participants used
mean=40.6, time since injury: mean=9.8 pharmacological or non-
yrs, level of injury: cervical and non- pharmacological treatments to control
cervical. pain. 40.8% indicated they had not
Treatment: No treatment-questionnaire. used nor had they been prescribed
Outcome Measures: Sociodemographic any medication for pain.
data and characteristics of injury, intensity 2. Pain Severity: Pain severity was
of pain, location of pain, quality of pain, found to be higher for those who had
allodynia (pain in response to a stimulus received pain medications (PM) (3.9 +
that would not provoke pain), MPI 1.3, p=0.001) compared to those who
(designed to assess the impact of pain and had not used any pain treatment. The
adaptation to chronic pain), difficulty in intensity of pain was higher for those
dealing with pain and pain treatments. on PM than for those not on PM
(p=0.022).
Widerstrom-Noga & Turk
3. Pain Locations: Those using PM
2003; USA
reported more painful areas than those
not using PM (p=0.001) with
Case Series
frontal/genital pain reported more often
N=120
(p<0.000).
4. Quality of Pain: Those on PM used
more descriptive adjectives to describe
their pain compared to those not using
PM (p=0.031).
5. Difficulty in Dealing with Pain:
Those using PM reported having more
difficulty dealing with pain than those
not using PM (p<0.000).
6. Pain impact: Those using PM had
higher scores for the pain severity
scale and the life interference scale
compared to the group not using PM
(p<0.002).
Discussion
Widerstrom-Noga and Turk (2003), not unexpectedly, found that SCI patients with more severe
pain, in more locations, those with allodynia or hyperalgesia, and those in whom the pain was
more likely to interfere with activities were more likely to use pain medications.
Trials of simple non-narcotic analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs),

acetaminophen or non-narcotic “muscle relaxants” are common clinical practice in SCI pain.
Unfortunately, these medications are often ineffective in complete SCI neuropathic pain relief
and have potential risks such as gastric ulceration with prolonged use.
For neuropathic or "central" pain seen following SCI, psychotropic drugs such as
antidepressants and anticonvulsants are reportedly the most effective (Donovan 1982). Despite
increasing popularity, few drugs (with the exception of Gabapentin) have regulatory approval for
use in neuropathic pain and selection for individual patients is largely based on anecdotal
evidence, of off-labeled use.
14-13
14.10.2 Anticonvulsants in SCI Pain
Anticonvulsant medications are often utilized in treating neurogenic or deafferent pain following
SCI based on the theory that these drugs alter sodium conduction in uncontrolled hyperactive
neurons (“convulsive environment”) in the spinal cord. Carbamazepine has been recognized as
being somewhat effective in the paroxysmal, sharp, shooting pain of trigeminal neuralgia
(Swerdlow 1984). Gibson and White (1971) described relief resulting from carbamazepine
treatment in two cases of L2 and T8 SCI with intractable pain below the level of SCI. A similar
effect of Carbamazepine (200 mg 2 x daily in combination with Amitriptyline 50 mg 3 x daily)
was reported in a complete C8 patient with dysesthesias below the level of the injury (Sandford
et al. 1992). Again controlled studies utilizing these drugs in SCI pain are lacking with the
exception of gabapentin.
Gabapentin is now regarded as a first-line treatment of neuropathic pain and post SCI
neuropathic pain (Ahn et al. (2003). have noted that although the analgesic mechanism of
action of Gabapentin is not fully understood, Gabapentin appears to potentiate GABA effects
centrally through enhancement of GABA synthesis and release. Levendoglu et al. (2004) note
that neuropathic pain is ultimately generated by excessive firing of pain-mediating nerve cells,
insufficiently controlled by segmental and nonsequental inhibitory circuits. Gabapentin works by
increasing GABA and reducing the release of glutamate thereby suppressing the sensitivity of
N-metyl-D-asparate (NMDA) receptor. This has been shown to reduce neuronal
hyperexcitability recorded at the spinal dorsal horn near the level of injury (Ahn et al. 2003).
Gabapentin is relatively well tolerated with only a few transient side effects, lack of organ
toxicity, and no evidence of significant interaction with other medications (Levendoghu et al.
2004).
Table 14.9 Anticonvulsants for SCI Pain

Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: range 23 to 62 yrs, 1. Both placebo and the gabapentin
Gender: m=13, f=7; Onset of pain post improved pain scores for the following:
injury: range 1 to 8 mths, Duration of pain: pain intensity (p<0.000), shape
range 6 to 45 mths. (p<0.000), hot (p<0.001),
Treatment: Subjects were randomized to unpleasantness (p<0.000), deep and
gabapentin or placebo for a 4 weeks surface pain (p<0.001), at the 4th
titration period. Following this 4 week week and again at the 8th week of
period subjects continued to receive max administration.
tolerated doses. After a 2 week washout 2. Intensity of pain decreased
period the treatments were switched in a significantly for the gabapentin groups
Levendoglu et al. 2004; crossover design. during treatment p<0.001) and the
Turkey Outcome Measures: Neuropathic pain intensity of pain differed between the
PEDro=9 scale, Short Form Beck Depression scale, two groups at all time periods
RCT Visual Analogue Scale, and Lattinen test (p<0.001).
N=20 were used to assess pain and quality of 3. VAS scores indicated that there was
sleep. significant pain relief, which began at
week 2 and continued until week 6
(p<0.05) and pain relief between the
two groups at the end of the stable
dosing periods was significantly
different p<0.000.
4. More experienced side effects in the
EX gr then in the placebo gr (p<0.05).
14-14
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=6,f=1, age: 27-47 1. Significant reduction of "unpleasant
yrs, level of injury C2-T7, duration of injury: feeling" with gabapentin vs placebo
1mth-20yrs. (p=0.028).
Treatment: Subjects with neuropathic pain 2. Trends of reductions with gabapentin
Tai et al. 2002; USA
were treated with gabapentin or placebo. vs placebo for "pain intensity"
PEDro=6
Outcome Measures: Neuropathic Pain (p=0.094) and "burning feeling"
RCT
Scale, which has 10 categories of pain (p=0.065).
N=7
types. 3. No other differences for any other pain
descriptors including "sharp", "dull",
"cold", "sensitive", "itchy", "deep",
"surface".
Population: Gender: m=28, f=10, age: 15- 1. 76% of subjects reported some
75, paraplegia/tetraplegia. improvement in pain after taking
To et al. 2002; Australia Treatment: Neuropathic pain were treated gabapentin.
Downs & Black score=18 with gabapentin. 2. The visual analogue score (VAS)
Case Series Outcome Measures: Level of pain decreased from 8.86 pre-treatment to
N=44 experienced by subjects. 4.13 post-treatment (6mths later)
(p<0.001), with a significant curvilinear
trend (p=0.001).
Population: Gender: m=19, f=12; level of 1. At the end of the study, both groups (1
injury: tetraplegia & paraplegia, Age: & 2) showed they had lower mean
~45yrs, Duration of pain: ~10yrs, Degree of scores for pain and sleep interference
lesion: complete & incomplete. score (p<0.05).
Treatment: Subjects were started on 300 2. Mean pain score for Group 1
Ahn et al. 2003; Korea mg of gabapentin, which was increased decreased more than it did for Group 2
Downs & Black score=17 over 18 days to 1500 mg, followed by a 5 (p<0.05).
Pre-post wk maintenance period. If pain score did 3. This score decreased more for Group
N=31 not decrease during this time period, meds 1 during weeks 2-8 than it did for
were increased to 2400 and 3600 mg/day. Group 2 (p<0.05).
Group1 had <6 mo of pain; group2 >6 mo. 4. Mean sleep interference score for
Outcome Measures: Pain and sleep Group 1 decreased more than it did for
interference scores of the 2 groups were Group 2 (p<0.05).
compared.
Discussion
As mentioned previously, gabapentin is the only anticonvulsant which has a strong research
basis for determining its effectiveness in treatment of pain post-SCI. To et al. (2002) studied the
impact of gabapentin on pain in a case series of 44 SCI patients with neuropathic pain and
reported a significant decrease (p<0.001) in visual analogue pain scale (VAS) in 76% of
subjects. Tai et al. (2002) studied the impact of gabapentin for pain treatment in a small RCT of
only 7 patients. There was a significant reduction of “unpleasant feeling” with gabapentin vs.
placebo (p=0.028) while “pain intensity” and “burning pain” only trended to significance (p=0.094
and 0.065, respectively) and no differences were detected for other pain descriptors such as
“sharp”, “dull”, “cold”, “sensitive”, “itchy”, “deep”, “surface”. Levendoglu et al. (2004) in a cross-
over design of 20 paraplegics with neuropathic pain > 6 months found that Gabapentin was
more effective (p<0.05) than placebo in reducing neuropathic pain. Ahn et al. (2003) in a before
and after trial found that Gabapentin was effective (p<0.05) in decreasing neuropathic pain
which was refractory to conventional analgesics for SCI patients with pain < 6 months and > 6
months and that the impact was greater for those patients with pain < 6 months in the post
recent pain group.
14-15
Table 14.10 Summary: Anticonvulsants to Treat Post-SCI Pain
Study N Study Type Drug Outcome
To et al. 2002 44 Case series Gabapentin +
Tai et al. 2002 7 RCT Gabapentin +
Levendeglu et al. 2004 20 RCT Gabapentin +
Ahn et al. 2003 31 Before and after Gabapentin + earlier onset
Despite the fact that none of the studies cited above involved large sample sizes, all showed a
benefit to using Gabapentin for post-SCI pain.
Conclusion
There is level 1 evidence that the anticonvulsant Gabapentin improves pain post-SCI.
There is level 4 evidence that the anticonvulsant Gabapentin is more effective when SCI
pain is <6 months than >6 months.
Gabapentin improves pain post-SCI.
14.11 Tricyclic Antidepressants in Post-SCI pain
Tricyclic antidepressant drugs are thought to modulate pain by inhibiting the uptake of
norepinephrine and serotonin in the CNS. Sandford et al. (1992) have suggested that the
tricyclic antidepressants exert an analgesic effect by making more serotonin available in the
CNS, thereby potentiating the inhibitory action of the dorsal horn of the spinal cord.
Unfortunately, these medications are often sedating and produce a variety of anticholinergic
side effects.
The partial effectiveness of tricyclic antidepressants (TCA) in some SCI patients with
dysesthetic pain suggests that this drug is simply affecting the pain by treating the depression.
Sandford et al. (1992) noted that pain and depression maybe chemically linked. Depression
can lower pain thresholds or pain tolerances thereby increasing the patient's experience of pain.
However Max et al. (1987) were able to show that tricyclic antidepressants (TCA) had analgesic
properties despite low doses or short treatment cycles with analgesic activity occurring
independent of mood changes.
Davidoff et al. (1987) reported trazodone's in-effictiveness in relieving pain in 19 SCI patients
with chronic dysesthetic pain, using a double-blind placebo controlled trial. Trazodone
reportedly selectively inhibits serotonin and norepinephrine uptake in a ratio of 25:1, and is
thought to produce greater analgesia and less anticholinergic side-effects compared to non-
selective agents such as amitriptyline.
Table 14.11 Tricyclic Antidepressants in Post-SCI Pain

Score
Methods Outcome
Research Design
Total Sample Size
Cardenas et al. 2002; Population: Gender: m=80%, f=20%, age: 1. There were no significant differences
USA ~41yrs, level of injury: Cervical-lumbar, between the 2 groups at baseline and
PEDro=9 ASIA: A-D, duration of SCI: ~169 mths at the 6 week time period for any of
1 RCT Treatment: Subjects with chronic pain the measures except satisfaction with
14-16
Score
Methods Outcome
Research Design
Total Sample Size
N=84 randomized to a 6 wk course of life which showed higher scores for
amitriptyline or placebo 1-2 hrs before those in the placebo group (p=0.004).
bedtime. 2. For those who remained on the two
Outcome Measures: Average pain medications, it was noted that those in
measure (scale 0-10), Short form McGill the amitriptyline group had significantly
pain questionnaire (SF-MPQ), Brief pain higher severity ratings for increased
inventory (BPI), Center for epidemiologic spasticity (p=0.005) than those in the
studies-depression scale (CES-D scale), control group.
Functional independence measure (FIM).
Population: Gender: m=16, f=2, Age: 39 1. No significant differences were noted
yrs, SCI, DIO: approx 49 mths. between the groups when looking at
Treatment: Subjects underwent a 2 week the MPQ, SPI, PAD.
Davidoff et al. 1987; USA
placebo lead-in period with a 6 week 2. More subjects reported side effects in
PEDro=6
randomization to 150 mg trazadone per the experimental gr (p<0.05).
RCT
day or placebo. 3. More subjects in the placebo group
Outcome Measures: McGill Pain completed the 8 wk study (p<0.01).
Questionnaire, Sternbach Pain Intensity &
Zung Pain and Distress Index.
Discussion
Tricyclic antidepressants are often recommended for the treatment of neuropathic pain following
non-SCI causes. Therefore, it is important to study the use of tricyclic antidepressants in the
treatment of post-SCI pain. Cardenas et al. (2002) reported no significant difference in
randomized spinal cord injury patients receiving either amitriptyline or placebo given 1-2 hours
before bedtime for a period of 6 weeks. Heilporn (1977) using combinations of melitracin and
TENS reported relief of pain in 8 of 11 SCI patients with dysesthetic pain.
Conclusion
There is level 1 evidence (based on two RCTs) that tricyclic antidepressants do not
reduce post-SCI pain.
Tricyclic antidepressants do not reduce post-SCI pain.
14.12 Anaesthetic Medications
Anaesthetic medication such as lidocaine and ketamine can be delivered by a number of routes.
Ketamine is a noncompetitive N-methyl-D-Aspartate (NMDA) receptor antagonist can be
administered epidurally and intrathecally to treat neuropathic pain syndromes (Hocking &
Cousins 2003).
Table 14.12 Anaesthetic Medications for Post-SCI Pain

Score
Methods Outcome
Research Design
Total Sample Size
Loubser & Donovan Population: Gender m=15, f=6, age: 18- 1. All 21 patients tolerated the injection
1991; USA 58, injury: cervical-lumbar, chronic pain (anaesthetics and placebo) well.
PEDro=8 >6mths duration. 2. Negative placebo response was noted
14-17
Score
Methods Outcome
Research Design
Total Sample Size
RCT Treatment: Subjects had a lumbar in 17 pts. Following lidocaine (n=13)
N=21 subarachnoid catheter inserted. Subjects patients showed a mean reduction in
recorded their pain intensity at baseline. pain (p<0.01) for an average of 123.1±
This was followed by 2 separate injections 95.3 mins.
(placebo and 5% lidocaine in dextrose). A 3. The decrease in pain reduction
decrease in pain was considered a positive following lidocaine was significant
response to the treatment. (p<0.01) for the EX gr only.
Outcome Measures: pain.
Population: Gender: m=11, f=2, Age: 1. Visual analogue showed no significant

mean=44yrs, SCI, ASIA A-E, time since differences for average pain levels
Chiou-Tan et al. 1996; injury: avg 7yrs. over the past week and pain at time of
USA Treatment: Following a 1 wk washout test regardless of which medication
PEDro=8 period subjects were given either 150 mg (drug or placebo) subject was taking.
RCT of mexiletine or placebo (150mg-3 x daily) 2. Results of the McGill Pain score also
Initial N=15; Final N=11 followed by another 1 wk washout period showed no significant differences
then subjects placed in opposite group. between the groups.
Outcome Measures: McGill pain score. 3. No change in level of function for
either group at any time of the study.
Population: Gender: m=8, f=1, age: 25-72, 1. Freidmann's two-way analysis by
level of injury: cervical to thoracic, ASIA: A- ranks showed differences between the
D, onset of pain: <6 mths post injury, length various treatments (p=0.005).
of pain: 14-94 mths 2. The effect of alfentanil and ketamine
Treatment: Ketamine hydrochloride, was also significant (p<0.01 & p<0.04
alfentanil or a placebo was given as respectively)
combination of bolus and continuous 3. No significant differences were noted
intravenous infusions. The bolus dose was between the actions of ketamine and
administered for 60 secs and the alfentanil (Wilcoxon p=0.19).
continuous intravenous infusion started 4. Significant differences were noted
Eide et al. 1995; Norway simultaneously and was delivered by IVAC between the treatment groups
PEDro=7 syringe pump. This lasted 17 to 21 (p=0.008). It was also noted that
RCT minutes while the testing was performed. allodynia was not more changed by
N=9 Outcome Measures: Continuous pain was ketamine than by alfentanil (Wilcoxon
measured by a 100 mm visual analogue p=0.93).
scale (no pain to unbearable pain (0 to 5. Alfentanil reduced wind-up-like pain
100)) before and after each drug treatment. (p=0.014) compared to the placebo
group. The effect of ketamine on
wind-up-like pain was not significantly
reduced (p=0.07).
6. A high correlation between the serum
concentration of ketamine and the
reduction of continuous pain (r=0.78,
p<0.002) and the reduction of wind-up-
like pain (r=0.83, p<0.002) was noted.
Discussion
Given the severity of post-SCI pain, treatments such as lumbar epidural and subarachnoid
infusions or anaesthetics are sometimes tried. There is some evidence for these treatments.
Loubser and Donovan (1991) conducted an RCT of 21 patients who were provided 2 separate
lumbar subarachnoid injections of placebo and 5% lidocaine in dextrose. Following lidocaine
(n=13) there was a significant mean reduction in pain (p<0.01) for an average of 2 hours
although 8 patients showed no changes. However, this treatment provided short-term relief of
pain only. The authors regarded the value of this treatment as more a diagnostic procedure
than a therapeutic one. Eide et al. (1995) in an RCT of intravenous ketamine hydrochloride
14-18
(NMDA receptor antagonist), alfentanil (μ-opioid receptor agonist) or placebo were provided as
combination of bolus and continuous intravenous infusions. There was a significant benefit to
ketamine or alfentanil vs. placebo for allodynia. Alfentanil reduced wind-up pain compared to
placebo but not ketamine overall; however, there was a high correlation between the serum
concentration of ketamine and the reduction in continuous pain and wind-up pain. The effects
of ketamine and alfentanil were significant when compared to placebo.
Conclusion
There is level 1 evidence (based on one RCT) that Lidocaine delivered through a
subarachnoid lumbar catheter provides short-term relief of pain greater than placebo.
There is level 1 evidence (based on one RCT) that intravenous Ketamine and Alfentanil
significantly reduces Allodynia when compared to placebo.
There is level 1 evidence (based on one RCT) that mexilitene (a derivative of lidocaine)
does not improve SCI dysesthetic pain when compared to placebo.
Lidocaine through a subarachnoid lumbar catheter, I.V. Ketamine and Aflentanil

improve post-SCI pain short term.
Mexilitene does not improve SCI dysesthetic pain.
14.12.1 Antispasticity Medications
Herman et al. (1997) note that baclofen is an α-aminobutyric acid (GABA)B receptor agonist and
acts to suppress spasticity in SCI patients centrally within the spinal cord itself. GABA is known
to be involved in several analgesics pathways (Savynok 1987) and experimentally induced
allodynia has been shown to be suppressed by baclofen (Henry 1982). However, baclofen, by
treating spasticity, may reduce the musculoskeletal pain associated with spasticity. Continuous
intrathecal infusion of baclofen can be effective, when oral baclofen is ineffective, in further
reducing post-SCI spasticity and/or pain (dysesthetic, musculoskeletal, neurogenic) (Penn &
Kroin 1987; Herman & D’Luzamsteg 1991).
Table 14.13 AntiSpastic Medications for Post-SCI Pain

Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: range 33 to 63; 1. Intrathecal baclofen also significantly
Diagnosis: MS=4, TMy=2, SCI=2, epiduaral suppressed the dysethetic (burning
absess=1; Gender: m=3, f=6; spasm quality) pain among 6 of the 7 RCT
related pain (SRP): range 1 to 10yrs; subjects (p<0.001). One of the onon-
Dysesthesia: 2-4 yrs. RCT n=5/Non-RCT RCT subjects who also noted
Herman et al. 1992; USA n=2 dysesthetic pain was abolished.
PEDro=8 Treatment: Baclofen and placebo were 2. Pinch inducted pain was not affected
RCT & Non RCT randomly administered into the L1-2 by either placebo or baclofen.
N=7 interspace of each subjects.
Outcomes Measures: Ashworth Scale
and tendon tap; VAS for dysesthetic pain
intensity; threshold/EMG relationships after
controlled pinch as an indication of
nociceptive pain.
14-19
Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: 21 to 63: Gender: m=15, 1. 12 out of 16 patients described chronic
f=1; Frankel classification: A to C; Type of pain prior to the procedure.
pain: neurogenic=6, musculosketal=6, 2. No significant differences were noted
mixed pain=3. between the visual analogue score
Treatment: Baclofen infusion pump (VAS) at the 6 and 12-month period
implantation. following the pump implantation.
Loubser & Akman1996; Outcome Measures: pain. 3. For those with neurogenic pain
USA symptoms, ANOVA revealed a non-
Downs & Black score=13 significant effect of intrathecal baclofen
Pre-post on pain at both 6 and 12 months. (F2,
N= 16 16), adjusted p=0.26.
4. In 5 of 6 patients with musculoskeletal
pain symptoms pain severity
decreased in conjunction with control
of spasticity. Musculoskeletal pain
responded to the Baclofen infusion
while neurogenic pain did not.
Discussion
Similar to above, the severity of post-SCI pain has led to the use of intrathecal Baclofen to treat
post-SCI pain. Herman et al. (1992) in a RCT found that intrathecal baclofen significantly
suppressed the dysesthetic (burning) pain among 6 of the 7 subjects (p<0.001). Only one of the
placebo patients noted the dysesthetic pain was abolished. Intrathecal baclofen did not have a
significant impact on pinch induced pain. Therefore, in this study, intrathecal baclofen appeared
to have an impact on post-SCI dysesthetic pain in addition to treating the spasticity. Loubser
and Akman (1992) performed a before and after study of implanted Baclofen infusion pumps
provided for spasticity. Twelve (12) of 16 patients described pre-existing chronic pain but there
was no significant difference in the VAS neurogenic pain symptoms at 6 and 12 months
(p=0.26) while musculoskeletal pain symptoms and pain severity decreased in conjunction with
control of spasticity in 5 of 6 patients. In this study, it appeared musculoskeletal pain was
reduced more with intrathecal baclofen, presumably by reducing spasticity.
Hence it would appear that intrathecal baclofen improves chronic post-SCI pain but the actual
mechanism has not been adequately established. It is treating neuropathic deafferentation type
pain or musculoskeletal pain associated with spasticity? The answer may actually be both
neuopathic and musculoskeletal pain, although some of the difficulties in coming to this
determination may in fact reflect difficulties chemically in being able to consistently distinguish
between neuropathic and musculoskeletal pain states. However, there is evidence that
Baclofen infusion pumps may provide positive benefits for both neuropathic and
musculoskeletal pain post-SCI.
Conclusion
There is level 1 evidence (based on one RCT) that Intrathecal Baclofen reduces
dysesthetic pain post-SCI. However, the sample size was small and a before and after
trial reported contradictory results.
There is level 4 evidence that Intrathecal Baclofen reduces musculoskeletal pain post-
SCI in conjuctiton with spasticity reduction.
14-20
Intrathecal Baclofen improves musculoskeletal pain post-SCI and may help
dysethetic pain related to spasticity.
14.12.2 Opioids for Post-SCI Pain
To date there are not research studies examining opioids in the treatment of SCI pain. There is
a substantial body of research investigating the benefits of opioid analgesics in the treatment of
non-cancer chronic pain and some of those studies examined the impact of opioids on
neuropathic pain. There are no studies employing opioid analgesics in post-SCI pain. Furton et
al (2006) conducted a meta-analysis of effectiveness and side-effects of opioid analgesics for
chronic non-cancer pain. Their meta-analysis found that opioids reduced pain and improved
functional outcomes when compared to placebo for both nociceptive and neuropathic pain
syndromes. Strong opioids (oxydone and morphine) were significantly superior to naproxen and
nortriptyline for pain relief but not functional outcomes. Weak opiods (propylene, tromadol and
codeine) did not significantly do better than NSAIDS or tricyclic anti-depressants for either pain
relief or functional outcomes (Furton et al. 2006). The same authors found that clinically, only
constipation and nausea were significantly more common with opioids (Furher et al 2006). The
big concern with opioids is of course addiction or opiod abuse. Unfortunately, as Furton et al.
(2006) notes in their meta-analysis, the existing randomized trials were not designed to evaluate
addiction.
14.12.3 Cannabinoids in Post-SCI Pain
Wade et al. (2003) note that delta-9-tetra hydrocannabinol (THC) and other cannabinoids have
been shown to improve both tremor and spasticity in animal models of multiple sclerosis
supported by anecdotal reports that cannabis relieves some of the troublesome symptoms of
multiple sclerosis and spinal cord injury (Dunn & Davis 1974; Petro & Ellenberger 1981;
Ungeleider et al. 1987; Meinck et al. 1989; Martyn et al. 1995; Consroe et al. 1997; Baker
2000). There is a clinical impression that marijuana smoking is very common among patients
post-SCI; however, there are social and legal implication to its use and medical concerns about
smoking as a delivery system.
Table 14.14 Cannaboids and Post-SCI Pain

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=10, f=10; age: 1. ANOVA scores indicate that
mean=48; MS=18, SCI=4, other=2. Cannabidiol (CBD) Cannabis
Treatment: Whole plant extracts of delta 9 medicinal extracts (CME) improved
tetrahydrocannabinol (THC) and pain significantly on VAS score when
cannabidiol in a 1:1 preparation were used. compared to placebo (mean=54.8 ±
These drugs were presented in pump 22.6, p<0.05).
Wade et al. 2003; UK
action sublingual spray that delivered 2.5 2. Similar results were also noted with
PEDro=8
mg THC and/or CBD at each actuation. A THC CME, which improved pain
RCT
placebo was also prepared and muscle spasm, spasticity & appetite
administered. (p<0.05).
Outcome Measures: Daily diary-scored 3. THC:CBD significantly improved
target symptoms by means of VAS, Short muscle spasm and sleep (p<0.05).
orientation memory concentration, the 4. Cannabis medicinal extracts (CME)
Barthel Activities of Daily Living Index, the produced significant improvements in
Rivermead Mobility Index, and the General ratings of spasticity (p<0.05), while
14-21
Score
Methods Outcome
Research Design
Total Sample Size
Health Questionnaire, Ashworth scale for using THC CME and THC:CBD
spasticity, Nine hole Peg test of manual reduced the muscle spasm frequency
dexterity, 10 metre timed walk. (p<0.05).
Discussion
Given that marijuana has anecdotally been thought to have benefits for post-SCI pain, Wade et
al. (2003) conducted an RCT of sublingual 2.5 mg tetrahydrocannabinol (THC) and/or
cannabidiol and found that it helped to reduce pain, muscle spasm, spasticity and sleep in a
group of largely multiple sclerosis patients with neuropathic pain. It is of note that only a small
percentage of the patients in this study had spinal cord injuries. Cannabinoids are a promising
treatment, which would benefit from other studies.
Conclusion
It is not known whether Cannabinoids are effective in treating pain post-SCI but good
results have been seen in treating multiple sclerosis patients.
Cannabinoids are a potential new treatment for Post-SCI pain in need of further study.
14.12.4 Clonidine for Post-SCI Pain
Clonidine is an alpha-2 adrenoceptor agonist which has been shown to activate spinal receptors
that reduce responses to painful stimuli (Yaksh 1985). Ackerman et al. (2003) note that
clonidine inhibits nociceptive impulses by activating alpha-2 adrencoceptors in the dorsal horn
of the spinal cord (Rainov et al. 2001). The anti-nociceptive effects of clonidine are thought to
be mediated via inhibitory interaction with pre- and post-synaptic primary afferent nociceptive
projections in the dorsal horn (Osenbach and Harvey 2001) and possibly by inhibition of
substance P release (Hassenbusch et al. 1999; Ackerman et al. 2003). Ackerman et al. (2003)
noted selective alpha-2 adrenergic antagonists (e.g. Yohimbine) have been shown to reverse
clonidine-induced analgesia (Osenbach & Harvey 2001). Teasell and Arnold (2004) were able
to show that venous alpha-adrenoceptor hyperresponsiveness was present in patients with
RSD, in diabetic peripheral neuropathy (Arnold et al. 1993) and below the level of lesion in
quadriplegics (Arnold et al. 1995). They speculated that this alpha-adrenoceptor
hyperresponsiveness was in fact due to alpha-2 adrenoceptor dysfunction leading to
overstimulation of the post-synaptic alpha-1 adrenoceptor peripherally. This would fit with the
observation that clonidine reduces pain post-SCI below the level of the lesion, presumably
through its alpha-2 adrenoceptor agonist function.
Ackerman et al. (2002) noted that clonidine may be useful for patients who are non-responsive
to opiods. Clonidine appears to work synergistically with opiods to provide pain relief (Plummer
et al. 1992; Tollerida et al. 1999; Siddall et al. 2000; Osenbach & Harvey 2001)
14-22
Table 14.15 Clonidine for Treatment of SCI Pain
Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: 26-78yrs; Neuropathic 1. The administration of morphine or
pain: 13 had below level neurpathic pain, 4 clonidine resulted in a mean reduction
at level of neuropathic pain, 3 had both in pain levels but this was not
types of pain. statistically significant compared to the
Treatment: Placebo, morphine or effect of placebo.
Clonidine was delivered via catheter into 2. When the mixture of morphine and
lumbar intrathecal spase. The subjects clonidine was administered there was
were first given either: 2-1mg of morphine, a significant reduction in pain when
Siddall et al. 2000; 50 to 100 mcg of Clonidine or placebo- compared to those on placebo
Australia dosage was increased if the subject had no (p=0.0084).
PEDro=8 side effects and no pain relief. Subjects
RCT could receive up to 1.5 times the initial drug
N=15 dosage if necessary. Once the subject
received satisfactory pain relief or side
effects from the drug they were on they
were given a mixture of morphine and
Clonidine.
Outcome Measures: Numerical pain
rating scale, numerical pain relief score, a
verbal pain rating and a nausea scale and
sedation scores were recorded.
Population: Gender m=4, f=6; age 34- 1. Subjects reported a good to excellent
77yrs; time since injury: 1-10yrs. pain reduction following the
Treatment: Subjects, once implanted with administration of Clonidine
a medical pump, were originally given 3 ml administration.
Uhle et al. 2000; of saline followed by 1 ml of morphine, this 2. After Clonidine bolus subjects
Germany was followed by a second dose of experienced an optimum pain
Downs & Black score=9 morphine (0.02 mg) provided no side reduction. Average dose of Clonidine
Prospective Controlled effects or benefits were noted. This was was initially 53 ug/day and this
Trial followed by Clonidine (30 ug in 1 ml) and decreased (or stabilized) to 44 ug/day.
N=10 then depending on side effects a final dose
of Clonidine (50 ug in 1 ml.). After each
drug administration the catheter was
flushed with saline.
Outcomes Measures: Not specified.
Discussion
Siddall et al. (2000) in a RCT/cross over trial of 20 subjects with post-SCI neuropathic pain.
Intracthecal morphine clonidine or placebo was given at the lumbar level. Once the subject
received satisfactory pain relief or drug side effects they were given a mixture of clonidine and
morphine. Morphine or clonidine showed a trend in pain reduction, which was not statistically
significant but when the combination of morphine and clonidine was administered there, was a
significant reduction in pain. Siddall et al. (2000) did postulate that by administering half the
effective minimum dose of clonidine and morphine together resulted in a synergistic addictive
effect above the simple summing up of each drug in isolation. Uhle et al. (2000) in a study of
study 10 patients were given morphine followed by clonidine via a medical pump. Patients
when given clonidine experienced a good to excellent reduction in their pain.
Conclusion
There is level 1 evidence (based on only one RCT) that Intrathecal Clonidine alone did
not provide pain relief greater than placebo, although there was a trend.
14-23
There is level 2 evidence (based on one prospective controlled study) that the
combination of Intrathecal Morphine and Clonidine did provide pain relief greater than
placebo.
Intrathecal Clonidine alone does not appear to provide pain relief although it may be helpful in
combination with Intrathecal Morphine.
4.13 Surgical Interventions
14.13.1 Spinal Cord Stimulation
Spinal cord stimulation has been used to try to treat intractable pain.
Table 14.16 Spinal Cord Stimulation Post-SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=19, f=6; age: 33- 1. Results reported as %'s only. No
76yrs; SCI; time since injury: 1-39yrs. statistical results reported.
Treatment: An epidural electrode was 2. During SC stimulation, 22 patients
inserted percutaneously over the posterior reported parasthesias overlapping the
Cioni et al. 1995; Italy columns of the spinal cord. Spinal cord painful area.
Downs & Black score=8 stimulation was performed with the 3. 9 pts enjoyed 50% pain relief at the
Case Series following parameters: 85 cycles/sec, end of the test period. No pain relief
N=25 duration of 210 msec and varied intensity was found in 3 of the patients.
for comfortable parasthesias30 mins every
3 hrs during the day. Mean follow-up was
37.25 mths.
Outcome Measures: Pain relief.
Cioni et al. (1995) in a case series reported inserting epidural electrodes percutaneously over
the posterior columns of the spinal cord to allow for spinal cord stimulation. During spinal cord
stimulation, 22 patients reported parasthesias overlapping the painful area. 9 patients reported
50% pain relief and 3 patients experienced no pain relief.
Conclusion
There is level 4 evidence that spinal cord stimulation improves post-SCI pain.
Spinal cord stimulation may improve post-SCI pain.
14.13.2 Destructive Neurosurgical Procedures
Destructive neurosurgical procedures work best on segmental and central dysesthetic pain
(Nashold, 1991). Nashold (1991) notes that surgery for pain is best done earlier than later. The
Dorsal Root Entry Zone (DREZ) procedure is reportedly the most successful procedure at the
present time (Nashold 1991); however, in many cases pain is either unresponsive or returns.
14-24
14.13.3 Dorsal Rhizotomy
Dorsal rhizotomy is a procedure where the sensory roots are divided either intradurally or
extradurally. According to Nashold (1991) a single one or two level root rhizotomy may be
appropriate when the pain is localized as in those patients with paraparesis and single root pain.
Moreover, Nashold (1991) reported the Dorsal Root Entry Zone (DREZ) procedure was more
likely to be successful in these patients.
14.13.4 Sympathectomy
Sympathectomy is not recommended for pain following SCI (Nashold 1991). As mentioned
previously, sympathetic blockade and sympathectomy have reportedly failed to relieve the
central pain of SCI (White 1969; Melzack 1978; Friedman 1986).
14.13.5 Lateral Spinothalamic Tractotomy
Hazouri and Mueller (1950) described three selected cases of patients with intractable root pain,
subsequent to severe trauma to the cauda equina which resulted in paraplegia (L2-4 lesions).
All three patients demonstrated a distinct increase in the threshold for perception of pain and
"an even more remarkable increase in the threshold for reaction to pain." Lateral spinothalamic
tractotomy in all three of these patients resulted in complete relief from pain. Threshold studies
subsequent to the tractotomy "revealed a striking return of perception and reaction thresholds to
a normal range."
14.13.6 Spinal Cordotomy
This procedure can be performed openly or percutaneously. Anterior spinothalamic tracts

subserving pain and temperature function are sectioned, often requiring a bilateral approach.
Spinal cordotomy is an option but is rarely employed and there is little evidence that it works.
14.14 Summary
Pain following SCI is quite common. The most common type of pain post SCI is central or
neuropathic in nature characterized by a dysesthetic, burning pain below the level of SCI.
Borderzone or segmental pain is much less common; occurring along the border between
normal and absent sensation. The precise etiology of central/neuropathic or borderzone
segmental pain is not known. There is some evidence suggesting an association may exist
between the central or neuropathic dysesthetic burning pain and abnormalities of the
sympathetic nervous system. Musculoskeletal pain, either secondary to the original trauma or
to overuse is both common and well understood. Unfortunately, the management of central or
neuropathic pain remains difficult and largely ineffective.
For many SCI patients pain has a significant impact on quality of life.
Over 50% of SCI patients develop chronic pain. Severe pain is more common the lower
down the lesion in the spinal cord. Pain post-SCI most often begins within the first 6-12
months post-SCI.
The most common types of pain post SCI are: 1) is a burning pain (likely neuropathic)
usually localized to the front of torso, buttock or legs; 2) an aching pain (likely
musculoskeletal) usually localized to the neck, shoulders and back.
14-25
There is limited level 4 evidence that Massage and Heat are the best non-
pharmacological treatments for pain post-SCI.
There is level 2 evidence that in general acupuncture is no more effective than Trager
therapy for shoulder pain.
There is level 4 evidence that acupuncture reduces the pain of patients with SCI.
There is level 2 evidence (from one RCT) that a shoulder exercise protocol reduces the
intensity of shoulder pain post-SCI.
There is level 4 evidence that hypnosis reduces pain intensity post-SCI.
There is level 1 evidence that the anticonvulsant Gabapentin improves pain post-SCI.
There is level 4 evidence that the anticonvulsant Gabapentin is more effective when SCI
pain is <6 mos than >6 mos.
There is level 1 evidence (based on two RCTs) that tricyclic antidepressants do not
reduce post-SCI pain.
There is level 1 evidence (based on one RCT) that Lidocaine delivered through a
subarachnoid lumbar catheter provides short-term relief of pain greater than placebo.
There is level 1 evidence (based on one RCT) that Intravenous Ketamine and Alfentanil
significantly reduces Allodynia when compared to placebo.
There is level 1 evidence (based on one RCT) that mexilitene (a derivative of lidocaine)
does not improve SCI dysesthetic pain when compared to placebo.
There is level 1 evidence (based on one RCT) that Intrathecal Baclofen reduces
dysesthetic pain post-SCI. However, the sample size was small and a before and after
trial reported contradictory results.
There is level 4 evidence that Intrathecal Baclofen reduces musculoskeletal pain post-
SCI by reducing spasticity.
It is not known whether Cannabinoids are effective in treating pain post-SCI but good
results have been seen in treating multiple sclerosis patients.
There is level 1 evidence (based on only one RCT) that Intrathecal Clonidine alone did
not provide pain relief greater than placebo, although there was a trend.
There is level 2 evidence (based on only one prospective controlled study) that the
combination of Intrathecal Morphine and Clonidine did provide pain relief greater than
placebo.
There is level 4 evidence that Spinal Cord Stimulation improves post-SCI pain.
14-26
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CHAPTER FIFTEEN

Jane TC Hsieh, MSc
Jo-Anne Aubut, BA
Linh Tu, BHSc
Key Points
Deep venous thrombosis is very common in spinal cord-injured patients not receiving
DVT prophylaxis.
There is insufficient evidence for Coumadin as a prophylactic treatment for venous

thrombosis post-SCI.
5,000 units s/c q12h of unfractionated heparin does not appear to prevent venous
thrombosis post-SCI while higher doses adjusted according to serum measures of
anticoagulation is more effective.
Low molecular weight heparin more effectively reduces the risk of venous
thromboembolism post-SCI than standard or unfractionated heparin prophylaxis with
less bleeding complications.
There appears to be no difference between Enoxaparin and Dalteparin in reducing the

risk of venous thrombosis post-SCI.
Mechanical compression may reduce the incidence of venous thromboembolism post-

SCI.
The use of rotating treatment tables reduces the incidence of venous thrombo-
embolism post-SCI.
A combined regiment of pneumatic compression, pressure stockings and low-dose

heparin given prophylactically may reduce the incidence of venous thrombosis and
the effect is better in early post-SCI.
Inferior vena cava filters significantly reduce the risk of pulmonary emboli in high-risk
SCI patients.
Enoxaparin subcutaneously can be considered as an alternative to intravenous

Heparin for acute DVTs post-SCI although more research needs to be done.
Table of Contents
15.1 Introduction ..................................................................................................................15-1
15.2 Incidence of Venous Thromboembolism Post SCI ...................................................15-1
15.3 Diagnosis of Venous Thromboembolism Post SCI ..................................................15-2

15.3.1 Venous Ultrasound .....................................................................................................15-2
15.3.2 Venography.................................................................................................................15-2
15.3.3 D-Dimer Assay............................................................................................................15-3
15.3.4 Diagnosis of DVT ........................................................................................................15-3
15.3.5 Clinical Presentation of Pulmonary Embolus ..............................................................15-3
15.3.6 Ventilation/Perfusion (V/Q) Scanning .........................................................................15-3
15.3.7 Pulmonary Angiography..............................................................................................15-4
15.3.8 Spiral CT Scan............................................................................................................15-4
15.4 Prophylaxis of Venous Thromboembolism Post SCI ...............................................15-4

15.4.1 Pharmacological Agents for DVT Prophylaxis ............................................................15-5
15.4.1.1 Coumadin as Prophylaxis for Venous Thromboembolism .......................................15-5
15.4.1.2 Unfractionated Heparin as Prophylaxis for Venous Thromboembolism Post-SCI ...15-6
15.4.1.3 Low Molecular Weight Heparin (LMWH) as Prophylaxis .........................................15-8
15.4.1.4 Heparin Analogues ..................................................................................................15-8
15.4.1.5 LMWH vs. UFH as Prophylaxis for Venous Thromboembolism...............................15-9
15.4.1.6 LMWH as a Prophylaxis of Venous Thrombosis....................................................15-12
15.5 Prevention of DVT through Mechanical Methods ...................................................15-13
15.6 Vena Cava Filtration ..................................................................................................15-17
15.7 Treatment of Acute Venous Thromboembolism in SCI..........................................15-20
15.8 Summary.....................................................................................................................15-21
References............................................................................................................................15-23
Teasell RW, Hsieh JTC, Aubut J, Eng JJ, Krassioukov A, Tu L (2006). Venous Thromboembolism Following Spinal
Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly
S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 15.1-15.25.
www.icord.org/scire
15.1 Introduction
Deep venous thrombosis (DVT) and subsequent pulmonary embolism (PE) remain a significant
cause of morbidity and mortality in spinal cord injured (SCI) patient. The incidence of DVT has
been reported by various authors to range between 9% - 100% during the acute stage of SCI,
with most occurring in the first 2 weeks post-injury, sometimes leading to a pulmonary embolism
which remains a common cause of death (Tribe 1963; Walsh & Tribe 1965; Watson 1968;
Stover et al. 1983; Winchelli et al. 1999; Aito et al. 2002; Chiou-Tan et al. 2003).
15.2 Incidence of Venous Thromboembolism Post SCI
The incidence of deep venous thrombosis in patients with acute spinal cord injury has been
reported to be very high, more than 50% in early prospective studies (Joffe 1975; Todd et al.
1976; Brach et al. 1977; Rossi et al. 1980; Becker et al. 1997) with the incidence of fatal
pulmonary embolism estimated to be as high as 2% in paraplegics (Joffe 1975). The
prevalence of DVT in acute SCI has been found to range from 14% to 100% (Chiou-Tan et al.
2003) or 9% to 90% (Aito et al. 2002). Chiou-Tan et al. (2003) have noted that this has been
examined in depth in the literature.
Table 15.1
Author/Year Treatment (n size) % of DVTs Test
Colachis & Clinchot Contrast venography
Prophylaxis Treatment (n=209) 14%
(1993) Ultrasound
Low-dose Heparin
Gundez et al. (1993) 53% Venography
(n= 31)
Prophylactic anticoagulant therapy
Yelink et al. (1991) 23% Venography
(n=147)
I125 fibrinogen scan
Impedance
Merli et al. (1988) Untreated group 47%
Plethysmography
Venography
125
I fibrinogen scan
Myllynen et al. (1985) Anticoagulant therapy (n=37) 100% of SCI pts
Venography
External pneumatic calf compression
78% untreated pts Platelet aggregation
Green et al. (1982) (ENCP) or ENCP + aspirin + dipyrid
33% treated pts studies
(n=28)
Rossi et al. (1980) N/A (n=18) 72% I125 fibrinogen scan
More recent and widespread reports, according to Aito et al. (2002), place the incidence of
DVTs at between 10-30% (Yelnick et al. 1991; Kulkarni et al. 1992; Colachis & Clinchot 1994;
Powell et al. 1999; Winemiller 1999).
The high risk of DVT in acute SCI patients is due to the simultaneous presence of the 3 factors
of Virchow’s triad: hypercoagulability, stasis and intimal (inner vessel layer) injury (Aito et al.
2002). Venous thromboembolism usually begins with a calf DVT (Nicolaides et al. 1971;
Philbrick et al. 1988; Cogo et al. 1998). Twenty percent of DVTs extend into the proximal veins
(Kakka et al. 1969; Lagestedt et al. 1985; Brandstater et al. 1992) and when DVTs causes
15-1
symptoms, over 80% of those involve the popliteal or more proximal veins (Kearon et al. 1998).
Non-extending distal (i.e. calf) DVTs rarely cause PEs and as such are rarely worrisome (Kakka
et al. 1969). Proximal (i.e. knee or above) DVTs often do cause PEs and are the source of
concern (Kakka et al. 1969). Pulmonary emboli (PE) are not uncommon post-SCI and most are
asymptomatic or unrecognized. Symptomatic PEs are large and with most large PEs, if fatal,
fatal within the first few minutes.
Deep venous thrombosis is very common in spinal cord-injured patients not receiving DVT
prophylaxis.
15.3 Diagnosis of Venous Thromboembolism Post SCI
The signs and symptoms of DVT are varied and depend on the severity. Generally DVTs can
cause pain, swelling, tenderness, skin discolouration and increased warmth of the affected area.
The signs and symptoms of PE are nonspecific and can include: sudden chest pain, shortness
of breath, difficulty breathing, or rapid breathing, coughing up blood, loss of consciousness
(fainting), which often leads to difficulties with diagnosis. Several methods and techniques are
currently used for diagnosis.
Although the various methods of DVT detection will be discussed, it is important for health care
professionals, patients, family members and caregivers to be educated in the early signs and
symptoms. Expert consensus, as noted by the PVA Consortium of Spinal Cord Medicine 2005
guideline for the prevention of thromboembolism, suggests that all extremities should be
inspected twice daily for an increase in the calf or thigh venous pattern or circumference, low-
grade fever of unknown origin or pain/tenderness/heaviness of an affected extremity. Since
patients can sometimes be asymptomatic, it is also suggested that health care providers,
including family and caregivers, be familiarized with risk factors such as lower limb fractures,
dehydration, obesity, age, malignancy, congestive heart failure, estrogen therapy, pregnancy,
and a history of thrombosis.
Another measure, considered by expert consensus to be important and preventative, is the

routine practice of active and passive range-of-motion exercises. Mobilization and movement of
the extremities (with careful consideration of spinal stability in the acute phase) should be
essential to the prevention of DVT in SCI.
15.3.1 Venous Ultrasound
Venous ultrasound is often used to diagnose a DVT. The sensitivity of the test is 95% in all
patients with symptomatic proximal DVTs. The sensitivity falls to 73% for distal DVTs.
However, distal DVTs are generally not dangerous until they extend proximally at which they are
at a much higher risk of travelling anteriorly to become a pulmonary embolus. Since the
majority of DVTs that do so extend within the first week, serial venous ultrasounds are useful to
detect clots extending in symptomatic patients even if initial tests are negative.
15.3.2 Venography
Venography is an invasive study whereby contrast dye is injected into the leg veins and is
considered a definitive test for DVT. Diagnosis of DVT is made if an intraluminal-filling defect is
noted.
15.3.3 D-Dimer Assay
D-dimer assay tests are rapid, noninvasive and inexpensive (Gill and Nahum 2000). Fibrin is
the main component of thrombus formation and fibrin degradation products include d-dimers
(Gill & Nahum 2000). A positive d-dimer test is highly sensitive but lacks specificity since d-
dimers are found in other disease states, including cancer, congestive heart failure and
inflammatory conditions (Raimondi et al. 1993). D-dimer assays have a high negative predictive
value, which means when it is negative it is unlikely that the patient has a DVT. However, it has
poor positive predictive value so that when it is positive the cause could be a condition other
than DVT (i.e. false positive). To illustrate, Akman et al. (2004) reported that the sensitivity and
negative predictive values of the D-dimer test were high, at 95.2% and 96.2%, respectively in a
group of 68 rehabilitating patients admitted with a diagnosis of stroke, spinal cord injury, hip
arthroplasty or traumatic brain injury. The specificity and positive predictive value were low, at
55.3% and 48.7%.
15.3.4 Diagnosis of DVT
A positive diagnosis of a DVT can only be made if the venogram is positive or there is a positive
venous ultrasound at two or more sites of the proximal veins. A negative diagnosis for DVT can
be made if there is a negative venogram, a negative d-dimer test or a normal venous ultrasound
assuming the venous ultrasound is accompanied by one of the following findings: 1) low clinical
suspicion for DVT, or 2) normal d-dimer test, or 3) normal serial testing with the test interval
being no greater than 1 week.
15.3.5 Clinical Presentation of Pulmonary Embolus
The clinical diagnosis of pulmonary emboli is unreliable, being both insensitive and nonspecific.
Many cases are clinically silent with only 30% having the clinical features of a DVT and only
70% demonstrating a DVT on venography. Patients with a massive pulmonary embolus who
suffer compromise of more than 60% of the pulmonary circulation are considered critically ill.
Right heart failure may progress to cardiovascular collapse with hypertension, coma and death.
A submassive pulmonary embolus presents with tachycardia, tachypnea and signs of
pulmonary infarction with consolidation, rales, hemoptysis, pleuritic chest pain, pleural friction
rub, pleural effusion and fever. In most cases there are usually only a few clinical findings and
the presentation may be nonspecific with the major clinical complaints of malaise and fever.
15.3.6 Ventilation/Perfusion (V/Q) Scanning
Nuclear ventilation/perfusion scans are often used to diagnose a PE. A normal perfusion scan
excludes a PE but is found in the minority of patients with a PE. Perfusion defects are non-
specific; about a third of those with defects actually have a PE. The probability that a perfusion
defect is a PE increases with the size, shape and number of defects as well as the presence of
a normal ventilation scan. Mismatched perfusion defects (normal ventilation scan), which are
segmental in size or larger are “high probability” defects and are associated with approximately
an 80% prevalence of PE. Three or more mismatched defects are associated with a prevalence
of approximately 90%. If a patient has a positive V/Q scan and high clinical suspicion of a PE
then they should be treated.
Table 15.2 Probability of Pulmonary Embolism Based on Ventilation-perfusion Scan
Results and Clinical Suspicion in Prospective Investigation of Pulmonary Embolism
Diagnosis Study (PIOPED) Study
Clinical suspicion of pulmonary embolism*
Ventilation-perfusion scan results
Low Intermediate High
High probability 56% 88% 96%
Intermediate probability 16% 28% 66%
Low probability 4% 16% 40%
Normal/near-normal probability 2% 6% 0%
* Percentage of patients with pulmonary embolism
Adapted from the PIOPED Investigators (Gill and Nahum 2000, PIOPED Investigators 1990).
PIOPED (prospective investigation of pulmonary embolism diagnosis) demonstrated that a low-

probability or normal ventilation-perfusion scan with a low clinical suspicion of pulmonary
embolism essentially excludes the diagnosis of pulmonary embolism (negative predictive values
of 96% and 98% respectively) (Gill & Nahum 2000; PIOPED Investigators 1990). When clinical
suspicion is high and the scan indicates a high probability of pulmonary embolism, the positive
predictive value is 96% (Gill & Nahum 2000; PIOPED Investigators 1990).
15.3.7 Pulmonary Angiography
Pulmonary angiography is the definitive diagnosis for pulmonary embolism (Gill & Nahum 2000).
It involves percutaneous catheterization and injection of contrast dye into a pulmonary artery
branch (Gill & Nahum 2000). It is used when the V/Q scan is nondiagnostic but the clinical
suspicion remains high. It is an expensive test and is associated with some significant risk of
complications. Relative contraindications include significant bleeding risk, allergy to contrast
medium, and renal insufficiency (Gill & Nahum 2000). It is associated with a mortality rate of up
to 0.5% (Newman 1989; Stein et al. 1992). Pulmonary angiography is most commonly used
when ventilation-perfusion scanning is nondiagnostic but clinical suspicion remains high
(Tapson et al. 1999). A negative pulmonary angiogram excludes clinically relevant pulmonary
embolism (Tapson et al. 1999; Gill & Nahum 2000).
15.3.8 Spiral CT Scan
A spiral CT scan is a quick, less expensive CT scan which can scan the entire thorax in one
breath-hold. It has a sensitivity ranging from 64-93% with a specificity of 89-100% - it is most
accurate when the embolism is large and less accurate when the clot is small. It actually
visualizes the clot and has the added benefit of diagnosing other disease states in the
differential diagnosis. The majority of ventilation perfusion scans have nondiagnostic results,
requiring further testing (PIOPED Investigators, 1990).
15.4 Prophylaxis of Venous Thromboembolism Post SCI
Anticoagulants can prevent thrombi from forming in the deep veins of the leg. The deep veins
(DVTs) can break off and travel to the lungs, resulting in a pulmonary embolism (PE) – the most
clinically important consequence of DVT. However anticoagulants can lead to serious
complications such as intracerebral hemorrhaging.
The consortium for spinal cord medicine published clinical practice guidelines for the prevention
of thromboembolism in SCI (2002). They recommended 5,000 units of unfractionated heparin
for motor-incomplete patients for 8 weeks and either heparin adjusted to high normal activated
partial thromboplastin time or low molecular weight heparin for motor-complete patients for 8-12
weeks. Chiou-Tan et al. (2003) note that this recommendation is based on studies that showed
that the risk of thromboembolism in SCI increases rapidly after injury and is maximal between
days 7 and 10 (Green et al. 1982; Merli et al. 1988; Geerts et al. 1994).
15.4.1 Pharmacological Agents for DVT Prophylaxis
15.4.1.1 Coumadin as Prophylaxis for Venous Thromboembolism
Warfarin (Coumadin) is the most widely prescribed oral anticoagulant. As an agonist of vitamin
K, warfarin acts by inhibiting the synthesis of clotting factors. Therapeutic doses of warfarin
reduce the production of functional vitamin K dependent clotting factors by approximately 30 to
50 percent. Antagonism of vitamin K reduces the rate at which these factors and proteins are
produced (Horton & Bushwick 1999). Clinical evidence indicates that an International
Normalized Ratio (INR) of 2.0-3.0 is sufficient for prophylaxis and treatment of venous
thromboembolism while minimizing the risk of hemorrhage associated with higher INRs.
The antithrombotic effect of warfarin, or the inability to expand or form clots, is not present until
approximately the fifth day of therapy. Therefore, concomitant use of heparin is usually required
during the transition in therapy. To ensure continuous anticoagulation, it is advisable to
continue full dose heparin therapy and therefore Coumadin needs to be overlapped with heparin
for 4 to 5 days, until Coumadin has produced the desired therapeutic response as determined
by the PT/ INR. When Coumadin has produced the desired PT/ INR or prothrombin activity,
heparin may be discontinued. A small decrease in the INR will likely occur once unfractionated
heparin therapy is discontinued. The presence of a therapeutic INR does not confer protection
from clot formation and expansion during the first few days of warfarin therapy because of the
delay in the therapeutic inhibition of prothrombin (Horton & Bushwick 1999).
Table 15.3 Coumadin Anticoagulation as Prophylaxis for Venous Thromboembolism

Score
Total sample size
Population: Gender: m=8; age: 22-56 yrs; No statistically significant results reported.
SCI; time since injury:10-38days; traumatic 1. One patient developed
injury thromboembolism 9 days after the
Treatment: Anticoagulation therapy disontiuation of prophylactic therpay;
Outcome Measures: Complete blood 2. Drug interaction was observed in 2
Perkash 1980; USA
picture, coagulation profile patients in whom marked potentiation
of coumadin action occurred during
Case Series
simultaneous Co-trimoxazole therapy;
N=8
3. Thromboembolism occurred in 3
patients; due to inadequate dose, early
discontinuation of coumadin theapy
4. Five patients had a total of seven
episodes of minor bleeding
Discussion
Coumadin is not tradionally used as a prophylactic treatment for venous thromboembolism and
so it is not surprising that there is a dearth of studies. In the one study found, Perkash (1980)
studied 8 male SCI patients who were treated with anticoagulation therapy. One patient
developed thromboembolism 9 days after the discontinuation of prophylactic therapy, 2 patients
developed drug interactions with Septra, while 3 patients developed thromoboembolism – two
occurred after early discontinuation of coumadin therapy and one as a consequence of
inadequate dosing while 5 patients suffered 7 episodes of minor bleeding. This one poor quality
study with n=8 patients is really not sufficient to draw conclusions on coumadin alone as a
prophylactic treatment. Although there is a strong logical basis for using coumadin,
prophylactically focused research is lacking.
Conclusion
The data on Coumadin as a prophylactic treatment for venous thromboembolism post-

SCI is insufficient to come to any conclusions except that there were an exceptional
numbers of minor bleeding episodes.
There is insufficient evidence for Coumadin as a prophylactic treatment for

venous thrombosis post-SCI.
15.4.1.2 Unfractionated Heparin as Prophylaxis for Venous Thromboembolism Post-SCI
Heparin acts as an anticoagulant by forming a complex with antithrombin, catalysing the

inhibition of several activated blood coagulation factors: XIIa, XIa, IXa, Xa and thrombin.
Heparin’s onset of action is immediate. It is most often used in acute conditions, and must be
given parenterally. Although low molecular weight heparin has become more popular in the
treatment of DVT, the effects of intravenous heparin can be reversed rapidly. Bleeding is the
most common adverse effect of heparin. Osteoporosis is associated with the prolonged use of
high doses of heparin, although its occurrence is infrequent. Thrombocytopenia is an
uncommon but serious side-effect of the treatment (Pineo 2004).
Table 5.4 Efficacy of Unfractionated Heparin vs. Placebo as Prophylaxis

Score
Methods Outcome
Research Design
Total sample size
Population: SCI 1. Electric stimulation plus heparin
Treatment: administration of low-dose significantly lowered (p<0.05) the
Merli et al. 1988; USA heparin combined electric stimulation incidence of DVT.
PEDro=4 Outcome Measures: incidence of Deep 2. No differences were noted between
RCT Vein thrombosis the heparin and placebo group.
Initial N=53; Final N=48 3. Pooled data (heparin and placebo
group) and comparing it to the heparin
plus electric stimulation group, level of
significance was much greater
(p<0.008).
Population: mean age=27±11 years 1. Venous thrombosis was unexpectedly
(treatment) and 28±12 years (control); uncommon in both the control (1/17)
Frisbie & Sasahara 1981; cervical-lumbar; 24 tetraplegics and 8 and the heparinised (1/15) group.
USA paraplegics (determined from level of
Downs & Black score=10 lesion);
Prospective Controlled Treatment: Patients in the heparin group
Trial were treated with 5000 units aqueous
N=32 sodium heparin subcutaneously every 12h
until the 60th day post injury occurred
Outcome Measures: incidence of deep
venous thrombosis
Table 5.5 Fixed vs. Adjusted Dose Heparin in Prophylaxis of Thromboembolism in Spinal
Cord Injury
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=63, f=12 age 13- 1. Patients on the adjusted-dose regimen
81 years; SCI; all complete received a mean of 13200±2200U of
Treatment: Patients were randomized to heparin per dose and had a APTT 1
one of 2 regimens of heparin treatment: and 1/2 times higher than those on a
fixed dose or adjusted dose heparin. fixed-dose regimen.
Outcome Measures: incidence of deep 2. Thromboembolism was detected in
Green et al. 1988; USA
vein thrombosis and bleeding 9/29 patients randomized to the fixed-
PEDro=7
dose regimen and 2/29 on the
RCT
adjusted-dose regimen.
3. While no patient who received the
adjusted-dose and whose APTT
reached the target level had a
thrombosis, bleeding occurred in 7
patients. No patient on the fixed-dose
regimen bled.
Discussion
Unfractionated heparin (UFH) has for a long time has been the standard treatment for venous
thromboembolism post-SCI. Merli et al. (1988) evaluated 53 acute SCI patients who were
randomly assigned to placebo saline (n=17), 5000 IU heparin (n=16) and heparin plus electrical
stimulation of the tibialis anterior and gastrocnemius muscles (n=15) over 28 days. There was
no difference between the placebo saline and heparin groups in the incidence of DVT while
there was a significant improvement in the heparin and electrical stimulation group. The study
was prematurely discontinued because of the benefit of the heparin plus electrical stimulation
group and lack of efficacy in the control group. Frisbie and Sasahara (1981) in a controlled, non-
randomized trial of 32 SCI patients saw half the patients receive no treatment and the other
group receive 5,000 units s/c q12h until day 60 post-SCI onset. Venous thrombosis was
unexpectedly uncommon in both the control (1/17) and the heparinized group (1/15). Green et
al. (1988) studied 75 SCI patients who were randomized to receive either fixed dose or adjusted
dose heparin. The fixed dose heparin was 5,000 units s/c q12h while the second group started
off at 5,000 units s/c q12h which was adjusted according to the aPTT (activated Partial
Thromboplastin Time) to a maximum of 15,000 units s/c q12h. Patients on the adjusted-dose
regimen received a mean of 13,200 units s/c q12h. Thromboembolism was detected in 9/29 on
fixed dose regimen with no bleeding complications while 2/29 on the adjusted-dose regimen
developed thromboembolism and 7 had bleeding complications.
Typically prophylactic treatment involves 5,000 units s/c of heparin. One RCT and one
controlled study examining the efficacy of this dose and a placebo found no difference in the
incidence of venous thrombosis in both the treatment and the placebo groups. Interestingly,
Merli et al. (1988) found that heparin plus electrical muscle stimulation significantly reduced the
incidence of venous thrombosis when compared to heparin alone. Green et al. (1988)
compared 5,000 units s/c of heparin q12h with an adjusted dose of heparin according to the
APTT (mean dose of 13,000 units s/c q12h) and the adjusted dose significantly reduced the
incidence of venous thrombosis. Hence, although it appears that 5,000 units s/c of heparin
q12h was not an effective dose in reducing the incidence of thromboembolism, higher doses
were more effective but had a higher risk of bleeding complications. Further research is needed
before a definitive statement can be made.
Conclusion
There is level 2 evidence (based on one low quality RCT and one non-randomized
controlled trial) that 5,000 units s/c of unfractionated heparin is no more effective than
placebo in the prophylaxis of venous thrombosis post-SCI.
There is level 1 evidence (based on one RCT) that adjusted (higher) dose s/c heparin is
more effective in prophylaxis of venous thromboembolism than 5,000 s/c heparin q12h
and has a higher incidence of bleeding complications.
5,000 units s/c q12h of unfractionated heparin does not appear to prevent venous thrombosis
post-SCI while higher doses adjusted according to serum measures of
anticoagulation is more effective.
15.4.1.3 Low Molecular Weight Heparin (LMWH) as Prophylaxis
Low-molecular-weight heparin (LMWH) is derived from standard heparin through either

chemical or enzymatic depolymerization. Whereas standard heparin has a molecular weight of
5,000 to 30,000 daltons, LMWH ranges from 1,000 to 10,000 Daltons. LMWH binds less
strongly to protein, has enhanced bioavailability, interacts less with platelets and yields a very
predictable dose response. The clinical advantages of LMWH include predictability, dose-
dependent plasma levels, a long half-life and less bleeding for a given antithrombotic effect.
Thrombocytopenia is not associated with short-term use of low-molecular-weight heparin.
LMWH is administered once or twice daily, both during the high-risk period when prophylaxis for
DVT is recommended and also while waiting for oral anticoagulation to take effect in the
treatment of DVT. The activated partial thromboplastin time (aPTT) does not need to be
monitored, and the dosage does not need to be adjusted (Rydberg et al. 1999).
Table 5.6 Generic and Trade-names of Low Molecular Weight Heparin

Generic Name Trade-name
Dalteparin Fragmin
Danaparoid Orgaran
Enoxaparin Lovenox
Ardeparin Normiflo
Parnaparin, Reviparin Clivarine
Tinzaparin Logiparin, Innohep
Certoporain Alphaparin, Sandoparin
15.4.1.4 Heparin Analogues
Danaparoid sodium (Orgaran) is an alternative anticoagulant for patients who develop heparin-
induced thrombocytopenia from heparin therapy. Danaparoid is a low molecular weight
heparinoid. Its active components consist of heparan sulfate, dermatan sulfate and chondroitin
sulfate. The major difference between danaparoid and other low molecular weight heparins
(LMWH) is that danaparoid is devoid of heparin or heparin fragments. However, it exerts effects
similarly to other LMWHs. Danaparoid acts by inactivating thrombin.
15.4.1.5 LMWH vs. UFH as Prophylaxis for Venous Thromboembolism
The most commonly studied LMWH is th prophylaxis of venous thromboembolism post-SCI is

enoxaparin. Enoxaparin was the first LMWH in the United States. Enoxaparin has a plasma
half-life of 4.4 hours compared with 0.35 hours for UFH and its subcutaneous bioavailability is
50%, compared to 20% for UFH (Tomaio et al. 1998)
Table 5.7 Low Molecular Weight Heparin vs. Unfractionated Heparin as Prophylaxis
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=389, f=87; SCI; 1. Among 107 assessable patients, the
ASIA: A-D, Acute; Traumatic SCI incidence of venous thromboembolism
Spinal Cord Injury Treatment: Enrolled patients were was 63.3% with UFH-IPC versus
Thromboprophylaxis assigned to receive thromboprophylaxis 65.5% with enoxaparin (p=0.81).
Investigators with either the combination of low-dose 2. The incidence of pulmonary embolism
2003; USA unfractionated heparin (UFH) (5000 U was 18.4% with UFH-IPC versus 5.2%
PEDro=9 subcutaneously every 8 h) plus intermittent with enoxaparin (p=0.03).
RCT pneumatic compression (IPC) (to be used 3. Among all randomized patients, the
Initial N=476; at least 22h/day) or enoxaparin (30 mg incidence of major bleeding was 5.3%
Final N=107 subcutaneously every 12 h). with UFH-IPC versus 2.6% with
Outcome Measures: Deep vein enoxaparin (p=0.14).
thrombosis, pulmonary embolism, major
bleeding.
Population: Gender: f=7, m=34; Age: 1. The cumulative event rate was 34.7%
mean 28 yrs complete, SCI (95% CI, 13.7%-55.2%). None of the
Green et al. 1990; USA Treatment: Patients were assigned to patients treated with low-molecular-
PEDro=8 receive either UFH LMWH (5000uts/8hrs or weight heparin had thrombosis or
RCT 3500 anti-Xa uts/daily). bleeding (95% CI, 0%-14%).
Initial N=41; Final N=32 Outcome Measures: documentation of 2. The difference between the 2 groups
thromboembolism was significant (p=0.006, log-rank test)
Population: Retrospective review of No statistical results reported.
173:Group1: age: 10->60: SCI; Acute; 1. 4 patients in UFH and 13 patients in
Traumatic; complete/incomplete LMWH developed venous
Intervention: 101 received a combination thromboembolic episodes.
of heparin followed by warfarin and 2. 3 of 13 on enoxaparin 40mg OD and
mechanical treatments for 10 of 59 on 20 mg OD.
Thumbikat et al. 2002; thromboprophylaxis. 72 received 3. UFH group, one of the thrombotic
UK enoxaparin as a thromboprophylactic events occurred post-mobilization.
Downs & Black score=18 agent, started on the day of admission. 4. Six of the 13 thrombotic events in
Case Series Outcome Measure: Documentation of DVT, LMWH occurred after the patients had
N=173 PE, Complication and duration of been mobilized and anticoagulation
anticoagulation, results of Doppler studies, stopped.
V/Q scans and unexplained decrease in 5. 2 periods of peak incidence of venous
haemoglobin and platelet levels thromboembolism were noticed in both
groups - the first at 20-30 days
following injury and the second at 90-
100 days post-injury.
Population: mean age ~ 34.0, SCI; 1. New VTE was demonstrated in 13 of
ASIA:A-C; traumatic; duration of 60 UFH versus 5 of 59 enoxaparin
Spinal Cord Injury rehabilitation:~36days, Acute patients (21.7% vs. 8.5%; p = 0.052).
Thromboprophylaxis Treatment: Administration of low-dose 2. Enoxaparin appeared more effective
Investigators (UFH n=60) UFH and enoxaparin (n=59) in than heparin in the prevention of
2001; USA a 6-wk rehab phase: UFH 5,000 U every 8 thromboembolic complications during
Downs & Black score=17 hours, but IPC was discontinued; rehabilitation after spinal cord injury.
Pre-post Enoxaparin 40mg once daily 3. Both interventions were safe in this
Initial N=119; Outcome Measures: thromboprophylactic population.
Final N=117 efficacy and safety
Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: ~mean 25yrs SCI; 1. Multivariate analysis suggested that
Traumatic injuries; Acute; Frankel scores: sequential pneumatic compression
A or B devices (SCD) or gradient elastic
Treatment: prophylaxis on SCI patients stockings (GES) were associated with
with deep vein thrombosis or pulmonary a reduced risk of venous
Winemiller et al. 1999; embolism were put on antithrombotic thromboembolism.
USA prophylaxis for 42 days after injury. 2. Multivariate analysis also suggested
Downs & Black score=13 Outcome Measures: demographic an decreased risk of thromboembolism
Case Series characteristics; venous thromboembolism in patients with SCI treated with
N=285 risk factors; methods of surveillance and heparin within the first 14 days or
prophylaxis, and thromboembolic events anytime within 42 days.
within the first 6 weeks following injury 3. Although the estimated risk reduction
for heparin was about twice that for
SCD/GES, it was not statistically
significant.
Population: n=48 Gender: m=39, f=9 age 1. The differences in bleeding between
range=14-83 years; SCI; Acute the two forms of heparin are significant
Treatment: LMWH in a dose of 3500anti- (p=0.04) favoring LMWH, and that
Xa U given subcutaneously once daily- all there is a trend toward fewer
Green et al. 1994; USA
subjects received this medication at this thrombotic events with LMWH
dose for 8 wks, then if the venous colour (p=0.15).
Pre-post
flow ultrasonography was negative meds
N=48
were discontinued.
Outcome Measures: incidence of deep
vein thrombosis, pulmonary embolism, and
bleeding
Discussion
Low Molecular Weight Heparin (LMWH) is the newest treatment for prophylaxis of venous
thromboembolism and has already been described in the introduction. Because UFH for years
has been the standard treatment and LMWH appears to offer advantages over UFH it is not
surprising that there are a number of trials comparing the 2 treatments.
There have been three trials, which have compared UFH and LMWH. The SCI
Thromboprophylaxis Investigators (2001) conducted a controlled non-randomized trial of low
dose UFH (5,000 units s/c q8h) and enoxaparin (40 mg once daily) during a 6-week
rehabilitation phase. A new venous thromboembolism was detected in 21.7% of UFH and 8.5%
of enoxaprin patients (p = 0.052). Enoxaprin appeared to be more effective in this population
than UFH.
One trial compared UHF plus intermittent pneumatic compression to LMWH. SCI
Thromboprophylaxis Investigators (2003) conducted a RCT of 476 SCI patients who were
assigned to receive thromboprophylaxis with either a combination of low-dose UFH (5000 units
s/c q8h) plus intermittent pneumatic compression (IPC) to be used at least 22 hours each day or
enoxaparin 30 mg s/c q12h. Among 107 assessable patients, the incidence of venous
thromboembolism was 63.3% with UFH/IPC versus 65.5% with enoxaparin (p=0.81). The
incidence of PE was 18.4% in the UFH/IPC group versus 5.2% with enoxaparin (p=0.03).
Among all the randomized patients, the incidence of major bleeding was 5.3% in the UFH/IPC
versus 2.6% with enoxaparin (p=0.14). This is the only study where the incidence of venous
thromoboemolism was not significantly less with LMWH when compared to UFH. However,
there was a significant difference in favour of UFH/IPC for incidence of PEs which is
undoubtedly a result of the added benefit of pneumatic compression given with UFH only in this
study
Thumbikat et al. (2002) in a retrospective study compared one group of SCI patients (n=101)
who received a combination of heparin followed by warfarin and another group (n=72) who
received enoxaparin. Four patients in the UFH group and 13 patients in the LMWH group
developed venous thromboembolic episodes. Of the 72 patients on enoxaparin, 2/13 on 40 mg
daily (OD) and 10/59 on 20 daily developed DVT/PE. One patient in group 1 and 6 patients in
group 2 developed DVT post-mobilization with discontinuation of anticoagulation.
Green et al. 1990 in an RCT randomized 41 SCI subjects to either standard heparin or LMWH.
Five patients in the standard heparin group had thrombotic events including 2 patients with fatal
pulmonary embolism. Two other patients had bleeding severe enough to necessitate
withdrawal of the heparin. The cumulative event rate was 34% while the LMWH group had no
thrombotic events or bleeding. The difference between the 2 groups was significant (p=0.006).
Green et al. 1994 studied 60 acute SCI patients with complete motor paraplegia all of who
received low molecular weight heparin in a dose of 3500 units s/c daily. Forty-eight were able to
complete the study. Treatment began within 72 hours of injury and continued for 8 weeks. Forty
patients completed the 8 weeks of prophylaxis uneventfully while 8 suffered a thrombotic event.
Of the thrombotic events, 2 were pulmonary emboli, 4 were proximal DVTs while 2 were distal
calf DVTs. The differences in bleeding between standard heparin, when combining data from a
previous study (68 LMWH (20 from previous study) and 79 UFH), were significant (p=0.04)
favoring LMWH with a trend toward fewer thrombotic events with the LMWH (P=0.15).
There is strong evidence based on the results for these RCTs that LMWH in particular
enoxaparin is more effective than standard UFH. This strong evidence in favour of LMWH
outweighs the conflicting conclusions of a large, nonrandomized study by Thumbikat et al. 2002.
Table 5.8 Studies Evaluating Low Molecular Weight Heparin or Unfractionated Heparin
N
Author/Year Treatments Results
& Type of Study
SCI Thromboprophylaxis 119
UFH vs. Enoxaparin Enoxaparin more effective
Investigators / 2001 nonrandomized
UFH plus intermittent
SCI Thromboprophylaxis 107 Enoxaparin more effective for PE
pneumatic compression
Investigators / 2003 RCT only with less complications
vs enoxaparin
172 UFH followed by warfarin
Thumbakit et al. / 2002 UFH and warfarin more effective
nonrandomized vs enoxaparin
41 LMWH more effective with less
Green et al. / 1990 UFH vs LMWH
RCT complcations
Trend to LMWH more effective.
147
Green et al. / 1994 UFH vs LMWH Significantly less bleeding
nonrandomized
complications
- Indicates a reduction in the incidence of DVT compared to placebo/alternative treatment
+ Indicates no difference in the incidence of DVT compared to placebo/alternative treatment
Conclusion
There is level 1 evidence (based on 2 RCTs) that low molecular weight heparin, in
particular enoxaparin, is more effective in reducing venous thromboembolic events,
when compared to the standard s/c heparin prophylaxis. Moreover, the incidence of
bleeding complications was less in the LMWH group.
Low molecular weight heparin more effectively reduces the risk of venous thromboembolism
post-SCI than standard or unfractionated heparin prophylaxis with less bleeding complications.
15.4.1.6 LMWH as a Prophylaxis of Venous Thrombosis
Three studies were found which examined LMWH alone, compared different dosages of LMWH
or compared different LMWHs.
Table 5.9 LMW Heparin Alone in Prophylaxis of Venous Thromboembolism Post-SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Age ~36yrs, SCI; No statistically significant results reported
complete/incomplete; length of injury: 1. 6% of the patients developed DVT
<6wks while receiving enoxaparin and 4%
2
Treatment: Enrolled patients were while receiving dalteparin (X =.44,
Chiou-Tan et al. 2003; randomized into two treatment groups. p=.51).
USA One group received 30 mg of enoxaparin 2. 4% developed bleeding while receiving
PEDro=6 subcutaneously every 12 hr and the other dalteparin and 2% while receiving
RCT received 5000 IU of dalteparin enoxaparin (X2=.13, p=.72).
N=95 subcutaneously once daily. 3. There were no DVTs or hemorrhages
Outcome Measures: Daily Logbook, Short reported after discharge to home.
Form Health Status Survey, follow-up 4. There was 99% compliance (X2=.88,
questionnaire p=.5) with taking medication while in
hosp.
Population: Retrospective review SCI, 1. Equivalent prophylaxis efficacy was
Acute seen in both enoxaparin groups.
Treatment: administration of 2. Symptomatic venous
subcutaneous Enoxaparin (40mg once thromboembolism did not differ, with
daily or 30mg twice daily) deep vein thromboses occurring in 1 of
Outcome Measures: safety and efficacy of 49 (2.0%) patients receiving twice-
enoxaparin, cost analysis daily enoxaparin, and 1 of 80 (1.25%)
patients receiving once-daily
Hebbeler et al. 2004; enoxaparin (X2 = 0.125, NS).
USA 3. Pulmonary embolism was seen in 1 of
Downs & Black score=15 49 (2.0%) patients treated with twice-
Case Control daily enoxaparin and in none of the
2
N=129 patients in the once-daily group (X =
1.64, NS).
4. Bleeding complications also did not
differ between the 2 treatment groups;
these were observed in 2 of 49 (4.1%)
patients receiving twice-daily
enoxaparin and in 5 of 80 (6.3%)
patients receiving once-daily
enoxaparin (X2 = 0.228, NS).
Population: age 15-84 years; No statistical results reported
Harris et al. 1996; USA complete/incomplete; SCI; length of 1. No patient developed clinical evidence
Downs & Black score=7 injury=6-104 days of thromboembolism, and none of the
Case Series Treatment: All patients received 30 mg of 60 venous ultrasound examinations
Initial N=105; enoxaparin subcutaneously every 12 h showed a deep vein thrombus.
Final N=101 beginning at the time of admission.
Outcome Measures: Not specified.
Discussion
From the previous discussion it is clear that LMWH is superior to UFH both in venous
thromboembolism phrophylaxis and in reducing the risk of bleeding complications. In line with
this Harris et al. 1996 studied 105 subjects of whom 66 had SCI in an observational
retrospective study. All patients received 30 mg of enoxaparin s/c q12h beginning at the time of
admission. If a patient was scheduled for surgery, the drug was withheld for the morning of the
operation, resumed 24 hours later, and continued until the patients’ discharge. No patient
developed clinical evidence of venous thromboembolism and none of the 60 venous ultrasound
examinations showed a DVT.
The optimal dose of enoxaparin has not been established to date. Hebbeler et al. 2004 reported
on a nonrandomized trial of 129 acute SCI patients who received either enoxaparin 40 mg daily
vs. 30 mg twice daily prophylactically. Symptomatic thromboembolism did not differ between
the two groups with DVT occurring in only one patient in each group. There was no difference
in bleeding complications between the 2 groups.
There are many new LMWHs available and it is inevitable that there will be studies comparing
their efficacy. Chiou-Tan et al. 2001 randomized 95 acute SCI patients into one group who
received enoxaparin (30 mg s/c q12h) and another who received 5000 IU of dalteparin s/c daily.
There were no significant groups between the two groups in terms of DVTs or bleeding
complications. Enoxaparin was more expensive than the dalteparin.
Conclusion
There was level 4 (limited) evidence that 40 mg Enoxaparin is no more effective than 30
mg of Enoxaparin in reducing the incidence of deep venous thrombosis or bleeding
complications when used prophylactically.
There is level 1 evidence (based on one RCT) that Enoxaparin is no more effective than
Dalteparin in reducing the risk of deep venous thrombosis or bleeding complications
although Enoxaparin is more expensive.
There appears to be no difference between Enoxaparin and Dalteparin in reducing

the risk of venous thrombosis post-SCI.
15.5. Prevention of DVT through Mechanical Methods
Although pharmacological measures have been generally the preferred treatment for venous
thromboembolism prophylaxis post-SCI, mechanical means of limiting venous stasis can also
serve to reduce the incidence of DVT post-SCI. Mechanical treatments are designed to limit
stasis in the paralyzed lower extremities. However, it should be noted that use of these devices
should be accompanied by the twice daily inspection for skin discolourations or breakdown, or
broken blood vessels. As well, pneumatic compression devices are not suitable for patients
with severe arterial insufficiency.
Table 5.10 Evaluating the Physical Methods for the Prevention of DVT
Author Year; Country Methods Results
Score
Level
Total Sample Size
Population: Gender: m=389, f=87; SCI; 1. Among 107 assessable patients, the
ASIA: A-D, Acute; Traumatic SCI incidence of venous thromboembolism
Treatment: Enrolled patients were was 63.3% with UFH-IPC versus
Spinal Cord Injury
assigned to receive thromboprophylaxis 65.5% with enoxaparin (p=0.81).
Thromboprophylaxis
with either the combination of low-dose 2. The incidence of pulmonary embolism
Investigators 2003;
unfractionated heparin (UFH) (5000 U was 18.4% with UFH-IPC versus 5.2%
USA
subcutaneously every 8 h) plus intermittent with enoxaparin (p=0.03).
PEDro=9
pneumatic compression (IPC) (to be used 3. Among all randomized patients, the
Level 1 RCT
at least 22h/day) or enoxaparin (30 mg incidence of major bleeding was 5.3%
Initial N=476;
subcutaneously every 12 h). with UFH-IPC versus 2.6% with
Final N=107
Outcome Measures: Deep vein enoxaparin (p=0.14).
thrombosis, pulmonary embolism, major
bleeding
Population: Age range 17 to 75 1. 4/5 control patients developed positive
Gender: m=11, f=3, SCI fibrinogen leg scans.
Becker et al. 1987; USA complete/incomplete, Acute 2. All had also become positive by
PEDro=6 Treatment: rotating treatment tables impedance plethysmography. Four of
RCT Outcome Measures: impedance blood the treatment patients developed
N=15 plethysmography fibrinogen but not impedance
plethysmography. This difference was
significant with p=0.017.
Population: Age: ~mean 25yrs SCI; 1. Multivariate analysis suggested that
Traumatic injuries; Acute; Frankel scores: sequential pneumatic compression
A or B devices (SCD) or gradient elastic
Treatment: prophylaxis on SCI patients stockings (GES) were associated with
with deep vein thrombosis or pulmonary a reduced risk of venous
Winemiller et al. 1999; embolism were put on antithrombotic thromboembolism.
USA prophylaxis for 42 days after injury. 2. Multivariate analysis also suggested
Downs & Black score=13 Outcome Measures: demographic an decreased risk of thromboembolism
Case Series characteristics; venous thromboembolism in patients with SCI treated with
N=285 risk factors; methods of surveillance and heparin within the first 14 days or
prophylaxis, and thromboembolic events anytime within 42 days.
within the first 6 weeks following injury 3. Although the estimated risk reduction
for heparin was about twice that for
SCD/GES, it was not statistically
significant.
Discussion
WineMiller et al. (1999) did chart audits to conduct a case-control study of 285 SCI patients.
Multivariate analysis suggested that sequential pneumatic compression devices (SCD) or
gradient elastic stockings (GES) were associated with a reduced risk of venous
thromboembolism. Multivariate analysis also suggested a decreased risk of venous
thromboembolism in patients with SCI treated with heparin within the first 14 days or anytime
within 42 days. Although the risk reduction was approximately twice that at of SCD/GES it was
not statistically significant.
Becker et al. (1987) studied whether rotating treatment tables would prevent the development
and progression of DVT in acute SCI patients. The authors noted that rotating treatment tables
had been used up to that time in acute SCI patients to maintain spinal cord alignment while
facilitating nursing care, allowing even distribution of ventilation and preventing pressure sores.
It was hypothesized that because these appliances rotated continuously, they might serve to
inhibit thrombosis formation by reducing venous stasis. This randomized trial involved 15
patients with acute SCIs. Four of the 5 control (nonrotated) patients developed distal and
proximal thrombi, assessed by 125I fibrinogen scanning and impedance plethysmography while
only one of the 10 treated (rotated) SCI patients developed both distal and proximal venous
thrombi (p=0.007).
Conclusion
There was level 4 (limited) evidence that sequential pneumatic compression devices
(SCD) or gradient elastic stockings (GES) were associated with a reduced risk of venous
thromboembolism post-SCI.
There is level 1 evidence (based on one small RCT) that rotating treatment tables reduce
the incidence of venous thrombi in acute spinal cord injured patients.
Mechanical compression may reduce the incidence of venous thromboembolism post-SCI.

The use of rotating treatment tables reduces the incidence of
venous thrombo-embolis post-SCI.
Table 5.11 Combined Pharmacological and Physical Measures for the Prophylaxis of
Venous Thromboembolism Post-SCI
Author, Year; Country
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: f=4 m=24, all 1. Of the 27 patients that completed the
complete; SCI study, DVT was detected in 9/27
Treatment: Subjects were randomized to patients, an incidence significantly less
one of two regimens: external pneumatic than the 78 % they previously
calf compression (EPCC) alone (n=15), recorded in 37 patients not receiving
and EPCC combined with aspirin (ASA), prophylaxis (p<0.001).
300 mg bid, and dipyridamole (Dip) 75 mg 2. Thrombi developed in 6/15 patients
Green et al. 1982; USA bid (n=13). treated solely with EPCC, and in 3/12
PEDro=7 Outcome Measures: Incidence of deep receiving ASA/Dip as well as EPCC
RCT vein thrombosis; platelet aggregation ratios (p<0.1).
Initial N=28; Final N=27 (PAR); Factor VIII coagulant activity 3. No differences were observed in the
PAR of patients treated with EPCC
alone or EPCC combined with ASA
and Dip.
4. Factor VIII levels of patients treated
with EPCC alone as compared to
those also receiving ASA and Dip
revealed that the latter in general had
lower levels.
Population: Gender: m=25, f=11 SCI; 1. Of the 19 patients, 17 had negative
complete/incomplete Frankel: A&B; Acute fibrinogen scanning upon completion
Treatment: Patients received prophylaxis of the study.
with external pneumatic compression plus 2. The 2 remaining patients developed a
Merli et al. 1992; USA
gradient elastic stockings and low dose positive fibrinogen scan on days 6 and
Downs & Black score=
heparin for 2 weeks. 8 of the study.
12
Outcome Measures: incidence of deep 3. In comparison, the control group
Case Series
vein thrombosis; Marder score developed positive 125 I fibrinogen
scans in 6/17 patents and all were
confirmed by venography.
4. The incidence of thrombosis was
significantly different than that of the
Score
Methods Outcome
Research Design
Total Sample Size
treated group (p=0.04).
Population: Age ~ 42 years; length of No statistical results reported.
injury: within 72 hrs of being injured (n=99) 1. DVT incidence in early admitted pts
or post 8 days (n=176); ASIA: A-D; SCI; was 2%. The incidence of DVT in later
SCI; Acute admitted pts was 26%.
injury 2. Of those 60% were detected on
Aito et al. 2002; Italy
Treatment: Permanently dressed gradient admission, while the remaining 40%
elastic stockings (PGES). Subcutaneous developed in a period not exceeding 6
Case Series
low molecular weight heparin (LMWH) wks of hospitalization. 65% of
N=275
(nadroparin) .4 ml once a day. External detected DVT did not show any
sequential pneumatic compression (ESPC) evident clinical sign.
Outcome Measure: diagnosis of DVT 3. ASIA A were more likely to develop
DVT (36%) while in ASIA D on
admission only 7% did so.
Discussion
Merli et al. (1992) studied 37 SCI patients who received 2 weeks of prophylaxis with external
pneumatic compression plus gradient elastic stockings and low dose heparin 5,000 s/c q12h.
Of 19 patients treated, 17 had negative fibrinogen scanning upon completion of the study while
the 2 remaining patients developed a positive fibrinogen scan on days 6 and 8 of the study. In
comparison, the control group developed positive I125 fibrinogen scans in 6/17 patients and all
were confirmed by venography. The incidence of thrombosis was significantly different than
that of the treated group (p=0.04).
Aito et al. (2002) studied 275 SCI patients, 99 of whom were treated within 72 hours of injury
while 176 were treated after 8 days post-SCI. The treatment involved permanently dressed
gradient elastic stockings, s/c LMWH 0.4 ml once a day, and external sequential pneumatic
compression (ESPC) of the lower limbs 3 hrs per day given in 2 applications. There was early
mobilization of the lower limbs. The complete prophylactic treatment lasted at least 30 days
post-SCI; LMWH and ESPC were continued for 2 more months depending on the patient’s
progress. For the earlier treated group, DVT incidence was 2% while the incidence in the later
treated group was 26%. Of those 60% were detected at the time of later admission, while the
remaining 40% developed in a period not exceeding 6 weeks of hospitalization. Sixty-five
percent of detected DVT did not show any obvious clinical sign. ASIA A patients were more
likely to develop a DVT (36%) while only 7% of ASIA D patients did so on admission.
Green et al. (1982) randomized 28 SCI patients with complete injuries, were randomized to
either external pneumatic calf compression (EPCC) alone, and EPCC combined with aspirin
(ASA) 300 mg bid and dipyridamole 75 mg bid. Twenty-seven subjects completed the study –
DVT was detected in 9/27 patients, an incidence significantly less than the 78% previously
recorded in the 37 patients not receiving prophylaxis (p<0.001). Thrombi developed in 6/15
patients treated solely with EPCC and in 3/12 receiving ASA/Dipyridamole as well as EPCC
(p<0.1). The authors concluded that early application of pharmacological plus mechanical
treatments markedly reduced the risk of DVT complications.
Although there was no moderate to strong evidence that combined measures to provide
effective DVT prophylaxis this was a consequence of the quality of the studies. However, it
makes sense intuitively, given Virchrow’s trial that different measures designed to treat different
risk factors would have an additive effect and hence be more effective than individual
treatments.
Conclusion
There is level 4 (limited) evidence that a comprehensive prophylactic treatment of

external pneumatic compression, gradient pressure stockings and low dose heparin
reduces venous thrombosis post-SCI.
There is level 4 (limited) evidence that a comprehensive prophylactic regimen of

pharmacological and physical measures is more effective in preventing venous
thrombosis post-SCI when instituted early rather than later.
There was a trend (supported by one RCT) that pneumatic compression plus antiplatelet
agents (ASA and Dipyridamole) was more effective than pneumatic compression alone.
Although an RCT, the numbers were small thus the trend was non-significant (p<0.1).
A combined regiment of pneumatic compression, pressure stockings and low-dose heparin

given prophylactically may reduce the incidence of venous thrombosis and
the effect is better in early post-SCI.
15.6 Vena Cava Filtration
Vena cava filtration involves inserting a mechanical filter in the inferior vena cava to prevent
devastating pulmonary emboli from occurring.
Table 5.13 Prophylactic Greenfield Filter Placement in Selected High-Risk Trauma

Patients
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=151 f=48; Age ~ There were no statistical differences
37 yrs; Traumatic age; Acute injuries; SCI, between the two groups.
Acute 1. None of the patients in the PGF group
Treatment: prophylactic Greenfield filter had a PE.
Khansarinia et al. 1995;
(PGF) placement 2. In the control group, 13 patients had a
USA
Outcome Measures: Injury Severity PE, nine of which were fatal.
Score, Glasgow Coma Scale, fluoroscopy, 3. These differences were statistically
Case Control
B-mode ultrasonography, significant for both PE (p < 0.009) and
Initial N=324;
ventilation/perfusion scanning, pulmonary PE-related death (p < 0.03).
Final N=259
arteriography 4. The overall mortality rate was reduced
in the PGF group (18 of 108, 16%)
versus the control group (47 of 216,
22%); not statistically significant.
Table 5.14 Prophylactic Vena Cava Insertion in Patients with Traumatic SCI
Score
Methods Outcome
Research Design
Total Sample Size
Maxwell et al. 2002; USA Population: Age: range 15-91;average 1. 111/8269 SCI pts with an incidence of
Downs & Black score=19 hospital length of stay 23.5±20.5 days; DVT and PE of 9.0% and 1.8%,
Score
Methods Outcome
Research Design
Total Sample Size
Case Series SCI; Traumatic, Acute respectively.
N=111 Treatment: DVT prophylaxis with 2. 41.4% were paraplegics and 58.6%
sequential compression devices and were tetraplegics, and 17.1% of
unfractionated heparin 5,000 unites patients had severe closed-head
subcutaneously every 12 giyrs (then to 30 injury.
mg subcutaneously every 12 hours 3. Hospital stay: 23±20 days for SCI
Outcome Measures: Injury Severity patients.
Score, incidence of DVT and PE 4. The incidence of DVT and PE in those
patients with SCDs alone was 7.1%
and 2.3%; for SCDs plus
subcutaneous heparin, the incidence
was 11.1% and 2.8%; and for SCDs
plus low-molecular-weight heparin, the
incidence was 7.4% and 0%,
respectively
5. The incidence of DVT in SCI patients
with long bone fractures was 37.5%,
which was significantly greater than
the total SCI population (p < 0.02).
Population: Age:18-49 yrs; Injury Severity 1. No complications were associated with
Score: 25-41, SCI, Traumatic, Acute vena cava filter insertion.
Treatment: Prophylactic Vena Cava Filter 2. No patients developed venous
Insertion thrombosis during acute
Wilson et al. 1994; USA
Outcome Measures: Injury Severity hospitalization (median 22 d), and no
Score, Impedance Plethysmography, patients have developed PE after filter
Case Control
Lower extremity Duplex Ultrasound insertion.
N=22
3. A follow-up deep abdominal Duplex
scan of the vena cava was performed,
with a 30-day patency of 100% and 1-
year follow-up is felt to represent the
trapping of thrombus.
Population: Gender: m=73%, f=27%; 1. Time from admission to prophylactic
Age:38.9±19.3yrs; Injury Severity Score insertion of a vena cava filter was
31.5±9.4; SCI; Traumatic Injury 4.3±3.9 days.
Treatment: The insertion of prophylactic 2. 3 cases of deep vein thrombosis
vena cava filters occurred after discharge from hospital.
Outcome Measures: incidence of 3. Overall there were 19 patients (30%)
Rogers et al. 1995; USA pulmonary embolism with prophylactic vena cava filters who
Downs & Black score=13 had deep vein thrombosis develop.
Case Control 4. When the incidence of pulmonary
Initial N=71; Final N=63 embolism was compared in the high-
risk trauma population before and after
instituting a policy of inserting a
prophylactic vena cava filter, there was
a significant (p<0.00072) reduction in
the incidence of pulmonary embolism
in the group receiving filters.
Population: SCI, Acute No statistical findings reported
Treatment: The Kim-Ray Greenfield filter 1. All patients with an indication for the
is inserted into the IVC below the renal Kim-Ray Greenfield filter were
Jarrell et al. 1983; USA veins to interrupt the IVC. The patient technically capable of having the
Downs & Black score=11 remains on full anti-coagulation throughout device inserted.
Case Series the performance of the procedure. A 2. There has been one death due to PE
N=21 repeat IVCgram is performed if there is any in a patient with a filter to date.
doubt about the position of the filter or 3. There have been no other instances of
patency of the IVC. suspected or proved PE after insertion
Outcome Measures: documentation of of a filter since the institution of
DVT or PE requiring a preoperative IVCgram and
Score
Methods Outcome
Research Design
Total Sample Size
postoperative studies to prove proper
location.
4. Follow-up on the 23 remaining patients
revealed 2 instances of thrombosis of
the IVC.
Discussion
The data supporting the use of inferior vena cava (IVC) filters in the prophylaxis of PE post-SCI
is far from compelling. Observational trials and case series are the primary evidence.
Jarrell et al. (1983) studied 21 acute SCI patients in whom a Kim-Ray Greenfield filter was
inserted in the inferior vena cava. One patient with a filter died of a PE. On follow-up no other
PEs were noted while there were two instances of thrombosis of the inferior vena cava
.
Wilson et al. (1994) in a retrospective chart audit studied 22 acute traumatic SCI patients who
were treated with a vena cava filter insertion. No complications were associated with vena cava
filter insertion. No patients developed venous thrombosis during acute hospitalization (median
22 days) and no patients developed PE after filter insertion.
Khansarinia et al. (1995) in an experimental non-RCT compared 108 patients who sustained
multiple trauma with known high risk of PE (including SCI patients) and who received a
prospectively placed prophylactic Greenfiled filter (PGF), to 216 historically matched control
patients. None of the patients in the PGF group had a pulmonary embolism while 13 patients in
the control group had a PE (p<0.009), 9 of which were fatal (p<0.03). The overall mortality rate
was reduced in the PGF group (18 of 108, 16%) versus the control group (47 of 216, 22%) but
this result was not deemed to be statistically significant.
Rogers et al. (1995) in a chart audit, pre-post and comparison with historical controls studied 63
patients receiving prophylactic vena cava filter – 15 of these patients had head injuries, 25 had
SCIs and 23 had pelvic fractures. Of 3151 admissions to a trauma service, 71 were considered
to be in a high-risk category for PE of whom 63 received a prophylactic vena cava filter. The
mean time to insertion of the vena cava filter was 4.3 days post-admission. Overall, there were
19 patients (30%) with prophylactic vena cava filters who developed a DVT. When the
incidence of pulmonary embolism in a high-risk patient population was compared before and
after the prophylactic vena cava filter policy was instituted, there was a significant reduction
(p<0.00072) in the incidence of PE in the group receiving the filters.
Maxwell et al. (2002) in a retrospective chart audit studied 111 SCI patients to determine if they
were different than other trauma patients in terms of the incidence of DVT and PE. They
concluded that inferior vena cava filters were not necessarily needed for SCI patients as the
incidence of DVTs and PEs were not that much different than other trauma patients. Maxwell et
al. have noted, “there are high risk of patients with SCI …that probably deserve phrophylactic
IVC filter placement. They include patients that have failed DVT prohylaxis or have
contraindications to anticoagulation. SCI patients with long bone fractures also appear to be at
extreme risk for DVT and may also benefit from IVC filter placement” (p. 902).
Conclusion
There is level 3 evidence that inferior vena cava filters significantly reduce the risk of
pulmonary emboli in high-risk SCI patients.
Inferior vena cava filters significantly reduce the risk of pulmonary emboli
in high-risk SCI patients.
15.7 Treatment of Acute Venous Thromboembolism in SCI
Virtually all of the research to date has focused on the prevention of venous thromboembolism
but there has been focus on the treatment of newly diagnosed venous thromboembolism in SCI.
The standard treatment is anticoagulation, generally with intravenous unfractionated heparin
immediately followed by a gradual transition to Coumadin which is generally maintained for 3-6
months. We were able to find one small study which compared UFH to LMWH.
Table 5.15 Unfractionated Heparin vs. LMW Heparin

Score
Methods Outcome
Research Design
Total Sample Size
Population: n=6; age 33-60; SCI; ASIA: A- 1. The average cost of initial
D anticoagulation of Group 1 (IV
Treatment: 3 were give IV Heparin Heparin) patients was $413.33 (range
followed by warfarin, while 3 were treated $331.20-$502.80), which includes the
with SQ Enoxaparin followed by warfarin cost of heparin, IV pump and tubing,
Outcome Measures: Cost analysis and laboratory monitoring of the PTT.
2. The average cost in Group 2
(enoxaparin) patients was $362.27
Tomaio et al. 1998; USA
(range $197.60-$617.50), which
includes only the cost of medication.
Case Series
3. Enoxaparin is slightly less expensive
N=6
(mean cost of enoxaparin = $362.27,
IV heparin = $413.33) when peripheral
cost are taken into account.
4. Subcutaneous enoxaparin is a safe,
cost-effective, and less labor-intensive
treatment, and can be of substantial
benefit in the treatment of DVT in SCI
patients in the rehabilitation setting.
Discussion
Again, there are remarkably few studies examining treatment of venous thrombolembolism post-
SCI with most of the research focus to date on prophylaxis. Tomaio et al. (1988) studied 6 SCI
patients with acute DVT, half of whom were treated by IV Heparin followed by Warfarin and half
who were treated by s/c enoxaparin followed by Warfarin. Though the study was extremely
small the author did a careful cost analysis. S/C enoxaparin was regarded as a safe, cost-
effective and less labour intensive treatment and could be of substantial benefit in the treatment
of DVT in SCI patients. Obviously more research needs to be done.
Conclusion
There is level 4 (limited) evidence that Enoxaparin subcutaneously appears to be a safe,

cost-effective and less labour-intensive treatment than intravenous heparin for acute
DVTs post-SCI.
Enoxaparin subcutaneously can be considered as an alternative to intravenous Heparin for

acute DVTs post-SCI although more research needs to be done.
15.8 Summary
Venous thromboembolism following SCI is a source of significant morbidity and mortality.

Virtually all of the research is focused on prophylaxis of venous thromboembolism in this very
high-risk population. Guidelines based on best evidence for DVT prophylaxis in SCI include use
of sequential compression devices for 2 weeks and anticoagulant for 8-12 weeks after injury
(Maxwell et al. 2002). There is evidence in the literature the 5,000 units S/C of unfractionated
heparin delivered every 12 hours is this population may not be sufficient to provide adequate
protection. The good news is that low molecular weight heparin with enoxaparin, being the
primary drug studied, appears to be more effective and should be considered the new standard
of treatment, given the added benefit of lower risk of bleeding complications. Physical
measures in particular gradient pressure stockings and intermittent pneumatic compression are
designed to reduce the impact of stasis due to prolonged and immobilized lower extremities and
have been shown to have a limited impact. There is an intuitive benefit to combining treatment
(i.e. pharmacological with mechanical treatment) although the evidence suggests
pharmacological measures are the more important of the two in prophylaxis.
The data on Coumadin as a prophylactic treatment for venous thromboembolism post-

SCI is insufficient to come to any conclusions except that there were exceptional
numbers of minor bleeding episodes.
There is level 2 evidence (based on one low quality RCT and one non-randomized
controlled trial) that 5,000 units s/c of unfractionated heparin is no more effective than
placebo in the prophylaxis of venous thrombosis post-SCI.
There is level 1 evidence (based on one RCT) that adjusted (higher) dose s/c heparin is
more effective in prophylaxis of venous thromboembolism than 5,000 s/c heparin q12h
and has a higher incidence of bleeding complications.
There is level 1 evidence (based on 2 RCTs) that low molecular weight heparin, in
particular enoxaparin, is more effective in reducing venous thromboembolic events,
when compared to the standard s/c heparin prophylaxis. Moreover, the incidence of
bleeding complications was less in the LMWH group.
There was level 4 (limited) evidence that 40 mg Enoxaparin is no more effective than 30
mg of Enoxaparin in reducing the incidence of deep venous thrombosis or bleeding
complications when used prophylactically.
There is level 1 evidence (based on one RCT) that Enoxaparin is no more effective than
Dalteparin in reducing the risk of deep venous thrombosis or bleeding complications
although Enoxaparin is more expensive.
There was level 4 (limited) evidence that sequential pneumatic compression devices
(SCD) or gradient elastic stockings (GES) were associated with a reduced risk of venous
thromboembolism post-SCI.
There is level 1 evidence (based on one small RCT) that rotating treatment tables reduce
the incidence of venous thrombi in acute spinal cord injured patients.
There is level 4 (limited) evidence that a comprehensive prophylactic treatment of

external pneumatic compression, gradient pressure stockings and low dose heparin
reduces venous thrombosis post-SCI.
There is level 4 (limited) evidence that a comprehensive prophylactic regimen of

pharmacological and physical measures is more effective in preventing venous
thrombosis post-SCI when instituted early rather than later.
There was a trend (supported by one RCT) that pneumatic compression plus antiplatelet
agents (ASA and Dipyridamole) was more effective than pneumatic compression alone.
Although an RCT, the numbers were small thus the trend was non-significant (p<0.1).
There is level 3 evidence that inferior vena cava filters significantly reduce the risk of
pulmonary emboli in high-risk SCI patients.
There is limited evidence that Enoxaparin subcutaneously appears to be a safe, cost-

effective and less labour-intensive treatment than intravenous heparin for acute DVTs
post-SCI.
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CHAPTER SIXTEEN
Orthostatic Hypotension

Robert W Teasell, MD, FRCPC
Key Points
Midodrine hydrochloride should be included in the management protocol of OH in

individuals with spinal cord injury.
There is limited evidence that fludrocortisone is effective for the management of OH in

SCI.
There is limited evidence that ergotamine is effective for the management of OH in

SCI.
There is little evidence that ephedrine is effective for the management of OH in SCI.
There is limited evidence that L-DOPS is effective for the management of OH in SCI.
The benefits of salt loading have not been sufficiently proven in individuals with SCI.
There is insufficient evidence that elastic stockings or abdominal binders have any
effect on the cardiovascular responses in SCI
The use of FES is an effective adjunct treatment to minimize cardiovascular changes

during changes in position.
Simultaneous arm exercise during a tilt test is not effective for improving orthostatic
tolerance.
The benefits of body-weight supported treadmill training for management of OH have

not been sufficiently proven in SCI.
Table of Contents
16.1 Introduction ..................................................................................................................16-1
16.2 Pharmacological Management of OH in SCI .............................................................16-2
16.3 Non-pharmacological Management of OH in SCI .....................................................16-6

16.3.1 Fluid and Salt Intake for Management of OH in SCI ...................................................16-6
16.3.2 Effect of Pressure Interventions in Management of OH in SCI ...................................16-8
16.3.3 Effect of FES on OH in SCI.........................................................................................16-9
16.3.4 Effect of Exercise on OH in SCI................................................................................16-12
16.4 Summary.....................................................................................................................16-14
References............................................................................................................................16-15
Krassioukov A, Warburton DER, Teasell RW, Eng JJ (2006). Orthostatic Hypotension Following Spinal Cord Injury.
www.icord.org/scire
Orthostatic Hypotension Following SCI
16.1 Introduction
The Consensus Committee of the American Autonomic Society and the American Academy of
Neurology (CCAAS&AAN 1996) defined orthostatic hypotension (OH) as a decrease in systolic
blood pressure of 20mmHg or more, or a reduction in diastolic blood pressure of 10mmHg or
more, upon the change in body position from a supine position to an upright posture, regardless
of the presence of symptoms. Numerous studies have documented the presence of OH
following SCI (Mathias 1995; Faghri et al. 2001; Cariga et al. 2002). This condition is evident in
the acute period post-injury and persists in a significant number of individuals for many years
(Frisbie & Steele 1997; Claydon et al. 2006). Standard mobilization treatment during
physiotherapy (e.g., sitting or standing) are reported to induce blood pressure decreases that
are diagnostic of orthostatic hypotension in 74% of SCI patients, and cause symptoms of
orthostatic hypotension (such as lightheadedness or dizziness) in 59% of SCI individuals (Illman
et al. 2000). This may have a negative impact upon the ability of SCI individuals to participate in
rehabilitation. Management of OH consists of pharmacological and non-pharmacological
interventions.
The low level of efferent sympathetic nervous activity and the loss of the reflex vasoconstriction
following SCI are among the major causes of OH. The decrease in blood pressure following the
change to an upright position in individuals with SCI appears to be related to excessive pooling
of blood in the abdominal viscera and lower extremities (Mathias 1995; Krassioukov & Claydon,
2005; Claydon et al. 2006). This is compounded by the loss of lower extremity muscle function
post-SCI that is known to be important in counteracting venous pooling in the upright position.
The excessive venous pooling in the lower extremities, and reduced blood volume in the
intrathoracic veins leads to a decrease in ventricular end-diastolic filling pressure and end-
diastolic volume leading to a decreased left ventricular stroke volume (Ten Harkel et al. 1994).
The reduced ventricular filling and emptying ultimately leads to a reduction in cardiac output,
and subsequently arterial pressure (provided the reductions in cardiac output are marked).
Tachycardia may occur as a response to reduced cardiac parasympathetic (vagal) activity,
reflexly induced by the unloading of the arterial baroreceptors. However, this tachycardic
response is often not sufficient to compensate for the decreased stroke volume, leading to a
reduction in cardiac output and in turn arterial blood pressure.
Several other factors may predispose spinal cord-injured individuals to OH. These include low
plasma volume, hyponatremia, and cardiovascular deconditioning due to a prolong bed-rest
(Mathias 1995; Illman et al. 2000; Claydon et al. 2006). The prevalence of OH is greater in
patients with higher spinal cord lesions, and thus it is more common in tetraplegia (Frisbie &
Steele 1997; Claydon et al. 2006; Mathias 2006). Furthermore, individuals with cervical SCI
also experience larger falls in blood pressure associated with postural change than those with
paraplegia (Mathias 1995; Claydon et al. 2006). There is also an increased risk of OH in
individuals who sustain a traumatic SCI than in nontraumatic injury such as spinal stenosis
(Mckinley et al. 1999).
16-1
Table 16.1 Factors Predisposing to OH following SCI
• Multifactorial Claydon et al. 2006
• Loss of tonic sympathetic control Wallin & Stjernberg 1984; Houtman et al. 2000
• Altered baroreceptor sensitivity Munakata et al. 1997; Wecht et al. 2003
• Lack of skeletal muscle pumps Ten Harkel et al. 1994; Faghri & Yount
2002; Raymond et al. 2002
• Cardiovascular deconditioning Hopman et al. 2002; Vaziri 2003
• Altered salt and water balance Frisbie 2004
The pooling of blood in the lower extremities and decrease in blood pressure results in a
reduction in cerebral flow which presents as a number of signs and symptoms in Table 16.2.
Table 16.2 Signs and Symptoms of OH

• Light-headedness
• Dizziness
• Fainting
• Blurred vision
• Fatigue
• Muscle weakness
• Syncope (temporary loss of consciousness)
16.2 Pharmacological Management of OH in SCI
The majority of our knowledge on management of OH is obtained from patients who are
presenting OH consequent to non-SCI causes, such as heart disease, Parkinson’s disease, and
dyautonomia. Numerous medications have been successfully used to manage OH in these
chronic conditions such Midodrine, fludrocortisone, and ephedrine. However, given that the
mechanisms of development of OH are different in individuals with SCI, it is important to assess
the effectiveness of these medications specifically in people with SCI.
Table 16.3 Pharmacological Management of OH in SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Age range=28-41 years, SCI; 1. Midodrine, 10 mg elevated systolic
chronic motor complete tetraplegia blood pressure during exercise in 3
Treatment: Midodrine 5mg, 10 mg, or participants. Peak systolic BPs ranged
Nieshoff et al. 2004; USA
placebo (unmarked capsule). Double-blind, from 90 to 126 mmHg under baseline
PEDro=5
placebo-controlled cross-over design. and placebo conditions, 114-148 after 5
RCT
Measure of cardiovascular parameters mg of midodrine, and 104 to 200 mmHg
N=4
during wheelchair ergometer test. after 10 mg.
Outcome Measures: Oxygen consumption, 2. Two participants showed ↓perceived
blood pressure. exertion and ↑VO2.
3. No adverse effects of midodrine.
16-2
Score
Methods Outcome
Research Design
Total Sample Size
Population: 45-year-old chronic complete 1. Individual with SCI showed significant
traumatic paraplegia; 6 non-SCI male alpha adrenergic supersensitivity.
controls; age range=44-50 years 2. The increase in systolic blood pressure
Senard et al. 1991;
Treatment: Clonidine (150 µg, 2X/day) induced by midodrine (10 mg) was
France
and midodrine (specific alpha 1-agonist) significantly higher in the patient
(10 mg, 2X daily) Heart rate assessed by (change of 56 mmHg) than in controls
Pre-post
blinded tester. (change of 15 mmHg).
N=7
Outcome Measures: Blood pressure, 3. Midodrine and clonidine alone or two
heart parameters, plasma catecholamine, drugs in combination led to an increase
alpha-adrenoceptor sensitivity. in resting BP and decrease severity of
OH.
Population: 2 cases of acute motor 1. Fludrocortisone in both patients
complete tetraplegia. resulted in pitting edema of hands and
Barber et al. 2000; USA
Treatment: Administration of lower limbs. No effect of
fludrocortisone acetate 0.1 mg 4X/day or fludrocortisone on OH.
Case Series
midodrine 10 mg 3X/day. 2. Initiation of the midodrine hydrochloride
N=2
Outcome Measures: Blood pressure, resolved orthostatic symptoms in both
heart rate, and symptoms of OH. individuals without any complications.
Population: 28-year-old with chronic C5 1. Following 10 days with fludrocortisone

tetraplegia. patient able to tolerate sitting.
Groomes et al. 1991; Treatment: Administration of Ergotamine Following additional ergotamine, the
USA (2 mg), daily combined with fludrocortisone patient able to tolerate an upright
Downs &Black score=9 (0.1- .05 mg) position without symptoms.
Case Series Outcome Measures: Blood pressure. 2. Supine BP was 94/70 mmHg. Sitting
N=1 BP was 78/50mmHg after 30 seconds
in a sitting position, and stabilized to
84/70mmHg after 3 minutes.
Population: 72-year old woman with non- 1. After salt supplement, a marked ↑BP
traumatic SCI and paroxysmal and NE were observed in response to
hypotension. sitting. There is also a decrease in
Treatment: Several weeks of salt basal plasma rennin activity was
Muneta et al. 1992; supplement (7 then 15 g/day) was followed observed.
Japan by L-threo-3,4-dihydroxyphenylserine (100 2. Addition of L-threo-3,4-
Downs & Black score=9 mg up to 600 mg/day) dihydroxyphenylserine for 2 weeks,
Case Series Outcome Measures: Blood pressure, showed elevation in catecholamines (E
N=1 catecholamines, plasma rennin activity. &NE) about 5 and 10 times without an
apparent increase in resting BP level.
3. Significant improvement in the
symptoms of the paroxysmal
hypotension and patient able to
participate in rehabilitation program.
Population: 21-year old male; SCI; 1. Gradual increase of dose of midodrine
traumatic; C6 tetraplegia; ASIA C, with from 2.5mg to 10 mg (at 0800, 1200
Mukand et al. 2001; USA
symptomatic orthostatic hypotension. and 1600 hrs) resulted in resolution of
Treatment: Administration of midodrine ssymptoms and orthostasis. Patient
Case Series
(2.5 to 15 mg 3X/day). able to participate fully in the rehab
N=1
Outcome Measures: Blood pressure program.
(systolic and diastolic), pulse rate, and
symptoms of OH.
16-3
Score
Methods Outcome
Research Design
Total Sample Size
Population: Age range=68-83 1. With decreasing ephedrine dose (and
years;chronic cervical complete tetraplegia; OH severity), there was an↑mean daily
ASIA A output of urine sodium (from 50 to 181
Frisbie 2004; USA
Treatment: Evaluation of urinary salt and mEq), ↑water (from 1.5 to 5.3 L),↑ rate
water output in relation to prescribed of creatinine secretion, ↑rates of water
Observational
dosage of ephedrine (doses range from 0 excretion, ↓urine osmolality, and
N=4
to 100 mg daily) ↑sodium concentrations.
Outcome Measures: Severity of OH,
urinary output.
Population: SCI; Ephedrine group: mean 1. OH was greatest in tetraplegic, motor
age=57±15 years, duration of paralysis complete patients (24 of 73 patients,
26±15 years; Non-ephedrine group: mean 33%).
age=51±15.2 years, 22±13.5 years post- 2. Symptoms of OH were reduced
Frisbie & Steele 1997; injury consciousness (100% of subjects),
USA Treatment: Retrospective chart review of strength (75%), vision (56%) and
Downs & Black score=18 ephedrine, salt supplementation, breath (53%). Precipitating factors were
Observational fludrocortisone or physical therapy. hot weather (77%) bowel care (33%)
N=231 Outcome Measures: OH symptoms, and meals (30%).
serum sodium and urine osmolality. 3. Low blood sodium found in 54% of the
OH patients and 16% of those without,
P < 0.001.
Discussion
Midodrine (ProAmatine)
Midodrine is a selective apha1 adrenergic agonist, and exerts its actions via activation of the
alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in
vascular tone and elevation of blood pressure. The plasma levels of Midodrine peak after about
half an hour, and decline with a half-life of approximately 25 minutes, while the metabolite
reaches peak blood concentrations about 1 to 2 hours after a dose of Midodrine and has a half-
life of about 3 to 4 hours. Usual doses are 2.5mg at breakfast and lunch or three times daily.
Doses are increased quickly until a response occurs or a dose of 30 mg/day is attained (Wright
et al. 1998). Midodrine does not cross the blood-brain barrier and it is thus not associated with
CNS effects.
The benefits of Midodrine in the management of OH in individuals with spinal cord injury were
reported in a level 1 RCT (Nieshoff et al. 2004) and three level 4 studies (Senard et al. 1991;
Barber et al. 2000; Mukand et al. 2001). Although only 4 studies with a total of 8 subjects have
been reported, Nieshoff et al. (2004) was a double-blind placebo-controlled, randomized, cross-
over trial using a within-subjects design. Not only was systolic blood pressure increased during
peak exercise (3/4 subjects), but exercise performance was also enhanced.
Fludrocortisone (Florinef)
Fludrocortisone is a mineralocorticoid which forces more salt into the bloodstream. It increase
blood volume and may also enhance sensitivity of blood vessels to circulating catecholamine
(Schatz 1984; Van Lieshout et al. 2000). The starting dose is 0.1 mg daily. Blood pressure rises
gradually over several days with maximum effect at 1-2 weeks. Doses should be adjusted at
weekly or biweekly intervals. Hypokalemia (low potassium) occurs in 50% of individuals, and
hypomagnesemia in 5%. These may need to be corrected with supplements. Florinef should not
be used in persons with congestive heart failure. Headache is a common side effect.
16-4
The benefit of Fludrocortisone has not been sufficiently proven in individuals with SCI. One
level 3 retrospective study (Frisbie & Steele 1997) and level 4 case series (Groomes & Huang
1991; Barber et al. 2000) described its use for management of OH in the SCI population.
Dihydroergotamine
Dihydroergotamine or Ergotamine is an ergot alkaloid which interacts with alpha adrenergic
receptors and has selective vasoconstrictive effects in peripheral and cranial blood vessels.
Peak plasma levels are reached about 2 hours after ingestion. The benefit of Ergotamine has
not been sufficiently proven in individuals with SCI since there is only one case report that
combined Ergotamine with fludrocortisone to successfully prevented symptomatic OH in one
individual with SCI (Groomes & Huang 1991).
Ephedrine
Ephedrine is a non-selective, alpha and beta receptor agonist, with central and peripheral
action. Its peripheral actions are due partly to norepinephrine release and partly to direct effects
on receptors. 12.5-25 mg orally 3X/day. Side effects may include tachycardia, tremor and
supine hypertension. It raises blood pressure both by increasing cardiac output and inducing
peripheral vasoconstriction. It has a plasma half-life ranging from 3 to 6 hours (Kobayashi et al.
2003). The benefits of Ephedrine have not been sufficiently proven in individuals with SCI. One
retrospective chart review exists (Frisbie & Steele 1997) and a case report (level 4) (Frisbie
2004) which reported that daily urinary output of salt and water was inversely related to the
prescribed ephedrine dose in patients with OH (but they did not monitor blood pressure).
L-threo-3,4-dihydroxyphenylserine (L-DOPS)
L-DOPS is an exogenous, neutral amino acid, precursor of noradrenalin. The benefits of L-
DOPS have not been sufficiently proven in individuals with SCI. Only one level 4 case series is
published (Muneta et al. 1992) with evaluation of effects of the L-DOPS on OH in nontraumatic
SCI. In this study, treatment with salt supplementation in combination with L-threo-3,4-
dihydroxyphenylserine, markedly improved the syncopal attacks, decreased drowsiness
associated with hypotension and increased the patient's daily activity.
General Discussion
In summary, the studies addressing the pharmacological management of OH following SCI

involve a small number of trials with low number of subjects and numerous case reports.
Furthermore, it is often difficult to determine the effects of individual medications when used as
combination therapies. Midodrine hydrochloride should be included in the management
protocol of OH in individuals with spinal cord injury. Further research needs to quantify the
effects of the many pharmacological interventions which have been shown to be effective in
conditions other than spinal cord injury.
Conclusion
There is level 2 evidence that Midodrine enhances exercise performance in some

individuals with SCI, similar to other clinical populations with cardiovascular autonomic
dysfunction.
There is level 4 evidence that the use of clonidine and midodrine resulted in successful
treatment of OH based on one study using one individual.
16-5
There is level 4 evidence on case series that show evidence of fludrocortisone is
effective for OH in SCI.
There is level 4 evidence based on 1 case series that Ergotamine, daily combined with
fludrocortisone, successfully prevented symptomatic OH in one individual with SCI
(Groomes & Huang 1991).
There is level 4 evidence that L-DOPS, in conjunction with salt supplementation in one
individual is effective for reducing OH
There is level 5 evidence that Ephedrine may prevent some symptoms of OH.
Midodrine hydrochloride should be included in the management protocol

of OH in individuals with spinal cord injury.
There is limited evidence that fludrocortisone is effective for the management of OH in SCI
There is limited evidence that ergotamine is effective for the management of OH in SCI
There is little evidence that ephedrine is effective for the management of OH in SCI
There is limited evidence that L-DOPS is effective for the management of OH in SCI
16.3 Non-pharmacological Management of OH in SCI
Non-pharmacological management includes the regulation of fluids and salt intake, as well as
physical modalities such as abdominal binders, physical activities, and electrical muscle
stimulation.
16.3.1 Fluid and Salt Intake for Management of OH in SCI
OH is common among patients with higher levels of paralysis, symptoms are variable, and
abnormal salt and water metabolism often coexist. Increases in fluid intake and high salt diet
can expand extracelular fluid volume and augment orthostatic responses. This simple
intervention appears to be effective in patients with idiopathic OH without SCI (Davidson et al.
1976; Claydon & Hainsworth 2004).
Table 16.4 Fluid and Salt Intake for Management of OH in SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI; Ephedrine group: mean 1. OH was greatest in tetraplegic, motor
age=57±15 years, duration of paralysis complete patients (24 of 73 patients,
Frisbie & Steele 1997;
26±15 years; Non-ephedrine group: mean 33%).
USA
age=51±15.2 years, duration of paralysis 2. Symptoms of OH were reduced
22±13.5 years. consciousness (100% of subjects),
Observational
Treatments: Retrospective review with strength (75%), vision (56%) and
N=231
more than 1 treatment provided to some: breath (53%). Precipitating factors were
Ephedrine (n=30), salt supplementation hot weather (77%) bowel care (33%)
(n=6), fludrocortisone (n=3) or physical and meals (30%).
16-6
Score
Methods Outcome
Research Design
Total Sample Size
therapy (n=29). 3. Symptoms worsened with the duration
Outcome Measures: Symptoms of OH, of paralysis in 12 patients.
incidence of hyponatremia, serum sodium 4. Chronic hyponatremia was found in
and urine osmolality. 54% of the PH patients and 16% of
those without, P < 0.001.
Population: Age range=68-83 1. The increasing OH severity in SCI

years;chronic cervical complete tetraplegia; patients, was characterized by
Frisbie 2004; USA
ASIA A. decreasing rates of creatinine
Treatment: Evaluation of urinary salt and secretion, decreasing rates of water
Observational
water output in relation to prescribed excretion, increasing urine osmolality
N=4
dosage of ephedrine (0 to 100 mg daily). and decreasing sodium concentrations.
Outcome Measures: Severity of OH,
urinary output of sodium and water.
Population: 72-year old woman with non- 1. After initiation of the salt supplement, ↑
traumatic SCI and paroxysmal BP and NE in response to sitting.
hypotension. There is also a decrease in resting
Muneta et al. 1992; Treatment: Several weeks of salt plasma rennin activity.
Japan supplement (7 then15 g/day) was followed 2. Addition of L-threo-3,4-
Downs & Black score=9 by L-threo-3,4-dihydroxyphenylserine (100 dihydroxyphenylserine for 2 weeks,
Case Series mg up to 600 mg/day). showed ↑plasma E and NE about 5 and
N=1 Outcome Measures: Blood pressure to 10 times without ↑ in basal BP level.
sitting, catecholamines (E, NE), plasma 3. Improvement in the symptoms of the
rennin activity. paroxysmal hypotension and patient
was able to participate in rehabilitation
program.
Discussion
The estimated daily intake of salt and water was inversely related to the ephedrine requirements
in patients with OH and suggests greater salt and water intake may lead to a more balanced
renal action (Frisbie 2004). OH is common among myelopathy patients with higher levels of
paralysis, symptoms are variable, and abnormal salt and water metabolism often coexist. Few
observational studies and one case report suggested that salt loading, was effective in the
reduction of symptoms of OH (Frisbie 2004). Currently, guidelines that suggest appropriate
water and salt intake specific to people with spinal cord injury do not exist.
Conclusion
The research studies used salt and fluid regulation in combination with other
pharmacological interventions and thus, the effects of salt and fluid regulation cannot be
determined. No evidence exists on the effect of salt or fluid regulation alone for OH
management in SCI.
The benefits of salt loading have not been sufficiently proven in individuals with SCI.
16-7
16.3.2 Effect of Pressure Interventions in Management of OH in SCI
The application of external counterpressure by devices such as abdominal binders or pressure

stockings is thought to decrease capacitance of the vasculature beds in legs and abdominal
cavity which are the major areas of blood pooling during standing.
Table 16.5 Pressure Interventions for Management of OH in SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: m=9 SCI; mean age=34±9 1. The supine posture increased VO2peak
years (5, tetraplegics) and 28±7 years (4, in tetraplegics, but reduced HR in
paraplegics); 8 complete & 1 incomplete; paraplegics compared to sitting.
mean duration of injury=11.4±8.1 years 2. The anti-G suit, stockings plus
(tetraplegics) and 7.0±4.5 years abdominal binder or FES did not have
(paraplegics). any effect on VO2, HR, ventilatory
Hopman et al. 1998; USA
Treatment: 5 discontinuous maximal arm exchange or power output. The anti-G
PEDro=5
ergometer tests on different days while: 1) suit did significantly reduce the
RCT
sitting, 2) supine, 3) sitting plus an anti-G perceived exertion for the tetraplegics
N=9
suit, 4) sitting plus stockings and only.
abdominal binder, and 5) sitting plus FES 3. Results suggested that stockings and
of the leg muscles. abdominal binders, FES or do not
provide hemodynamic benefits.
Outcome Measures: Oxygen uptake,
carbon dioxide output, respiratory
parameters, HR, BP.
Population: 5 tetraplegic SCI; 4 paraplegic 1. Tetraplegics: ↑ VO2, cardiac output,
SCI (same subjects as above study). stroke volume, BP and stroke volume
Hopman et al. 1998;
Treatment: 5 conditions as above, except with FES; ↑ cardiac output, ↑ stroke
Netherlands
submaximal exercise at 20, 40 and 60% of volume and ↓ HR with binders and
PEDro=5
maximum power output. stockings ; ↓ HR and ↑ BP with anti-G
RCT
Outcome measures: Oxygen uptake, suit.
N=9
carbon dioxide output, respiratory 2. Paraplegics: ↑ VO2 and ↓ HR with FES;
parameters, HR, BP. ↓ VO2 and ↓ HR with anti-G suit; ↓ VO2
with stockings and binders.
Population: 6 Tetraplegic complete, 5 1. Orthostatic stress significantly
Paraplegic complete, mean age=31.8±11.3 decreased arterial blood pressure only
years; age range=21-55 years, ASIA A; 9 in individuals with cervical SCI
able bodied controls, mean age: 23.4±9.3 (P<0.05).
Krassioukov & Harkema;
years, age range=19-48 years. 2. Harness application had no effect on
2006
Treatment: With and without harness for cardiovascular parameters in able-
Canada
locomotor training during supine, sitting bodied individuals, whereas diastolic
and standing (within subject analysis). blood pressure was significantly
Outcomes measures: Blood pressure, increased in those with SCI.
Trial
heart rate. 3. Orthostatic changes in cervical SCI
N=20
when sitting were ameliorated by
harness application. However, while
standing with harness, individuals with
cervical SCI still developed orthostatic
hypotension.
Population: 8 male complete paraplegia, 4. LBNP elicited a ↓ stroke volume (by
mean age=41.3±6.5 years; 8 male able- 23% and 22%), ↑cardiac output (by
Raymond et al. 2002;
bodied controls, mean age=41.1±6.6 years. 15% and 18%), and ↑HR (by 10% and
Australia
Treatment: Subjects were evaluated: (1) 9%), ↑total peripheral resistance (by
during supine rest, (2) supine with lower- 23% and 17%) and ↑ calf volume (by
body negative pressure (LBNP), and (3) for 1.51% and 4.04%) in SCI and controls,
Trial
SCI only, LBNP with leg electrical respectively.
N=16
stimulation. 5. LBNP + stimulation had ↑stroke volume
Outcome measures: Heart rate, stroke (by 20%), ↑ cardiac output (by 16%),
16-8
Score
Methods Outcome
Research Design
Total Sample Size
volume, cardiac output, total peripheral and ↓total peripheral resistance (by
resistance. 12%) in SCI group compared to LBNP
alone.
Population: f=4,m=2;chronic complete 1. 5/6 subjects demonstrated a mean
paraplegia; age range=20-25 years; mean increase of 31 % in forced vital capacity
Kerk et al. 1995; USA
age=21.8 years. with binder compared to without. No
Treatment: Cross-over design: abdominal statistical significance but this may be
binder (experimental condition) or not because the sixth subject showed an
Trial
wearing (the control condition). 18% decrease in forced vital capacity
N=6
Outcome Measures: BP, HR, VO2max, when wearing the binder.
respiratory parameters, and wheelchair
propulsion.
Discussion
One expert opinion (Bhambhani 2002) and three small experimental studies showed conflicting
data. Kerk et al. (1995) stated that there were no statistically significant effects of the abdominal
binder on any of the cardiovascular or kinematic variables at submaximal or maximal levels of
exercise (Kerk et al. 1995). Bhambhani in his review also concluded that the use of abdominal
binders does not influence cardiovascular physiological responses (Bhambhani 2002).
However, Hopman et al. (1998a) demonstrated in a small group of SCI subjects (n=9) that
stockings and an abdominal binder do have effect on cardiovascular responses during
submaximal exercises (Hopman et al. 1998a), but not during maximal exercises (Hopman et al.
2002).
Conclusion
There is conflicting evidence based on limited research that elastic stockings/abdominal

binders have any effect on cardiovascular responses in individuals with SCI.
There is level 2 evidence that application of a harness in individuals with SCI could alter
baseline cardiovascular parameters and the response to orthostatic stress.
There is insufficient evidence that elastic stockings or abdominal binders have any
effect on the cardiovascular responses in SCI
16.3.3 Effect of FES on OH in SCI
The application of FES activates the physiologic muscle pump via intermittent muscle
contractions that produce a pumping mechanism of both the superficial and deep veins of the
legs.
16-9
Table 16.6 FES on OH in SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: 2 tetraplegics, 3 paraplegics; 1. At tilt angles of 15, 30, 45 and 60
complete; mean age=29±4.3; in acute degrees, systolic BP was significantly
period of SCI - 2-4 weeks post-injury. lower when FNS was not applied
Treatment: Tilt table - 6 minutes at each compared to when it was administered,
Elokda et al. 2000; USA tilt angle (0, 15, 30, 45 and 60 degrees), and it was more marked with increasing
PEDro=5 with 4 minutes of recovery between each, tilt angles.
RCT with or without bilateral ankle plantar flexor 2. There was a progressive decrease in
N=5 and knee extensor electrical stimulation. blood pressures with increasing tilt
Application order or absence of FNS was angle and this increase was less
counterbalanced. pronounced in the FNS condition.
Outcome Measures: HR, blood pressure, 3. Post hoc analysis showed that HR was
perceived exertion. significantly higher with FNS compared
to without FNS at 60 degrees tilt.
Population: n=14 SCI, mean age= 1. Reductions (p < 0.05) up to 10% BP
35±9.41 years; n=15 able-bodied, mean measures for SCI subjects from sitting
age=29±6 years; 7 paraplegia, 7 to passive standing; but minimal
Faghri & Yount 2002; tetraplegia; 4 incomplete, 10 complete; changes when moving to FES standing.
USA time post-injury 77±64 months. 2. After 30 min of passive standing (no
PEDro=5 Treatment: Random order of standing with FES), there is a reduction in stroke
RCT or without FES (30 mins) for SCI subjects; volume and cardiac output. After 30
N=29 voluntary tiptoe contractions during 30 min of FES standing, the pre-standing
minutes standing for able-bodied subjects. haemodynamics are maintained except
Outcome Measures: Hemodynamics for a significant reduction in stroke
during supine-sitting-30 min standing. volume.
Population : n=14 SCI; Gender: m=11, 1. BP changed 8-9% when moving from
f=3;mean age=35±9yrs (range 20- sitting to passive standing (no FES).
56yrs);mean length post injury The augmented FES condition
Faghri et al. 2001; USA 77.3±64.4months (range 7-170 months);7 prevented BP change when moving
Downs & Black score=22 tetraplegia, 7 paraplegia; 4 incomplete, 10 from sitting to standing.
Prospective Controlled complete.
Trial Treatment: FES augmented standing
N=14 (active) and non-FES standing (passive),
for 30min duration; tests were separated
by at least 24hours.
Outcome Measures: Hemodynamics.
Population: 8 male complete paraplegia, 1. LBNP elicited a ↓ stroke volume (by
mean age=41.3±6.5 years; 8 male able- 23% and 22%), ↑cardiac output (by
bodied controls, mean age=41.1±6.6 15% and 18%), and ↑HR (by 10% and
Raymond et al. 2002; years. 9%), ↑total peripheral resistance (by
Australia Treatment: Subjects were evaluated: (1) 23% and 17%) and ↑ calf volume (by
Downs & Black score=16 during supine rest, (2) supine with lower- 1.51% and 4.04%) in SCI and controls,
Prospective Controlled body negative pressure (LBNP), and (3) for respectively.
Trial SCI only, LBNP with leg electrical 2. LBNP + stimulation had ↑stroke volume
N=16 stimulation. (by 20%), ↑ cardiac output (by 16%),
Outcome measures: Heart rate, stroke and ↓total peripheral resistance (by
volume, cardiac output, total peripheral 12%) in SCI group compared to LBNP
resistance. alone.
Population: Motor complete SCI (lesions 1. ↑HR increased for both groups with ↑
above T6); (3 with recent injury, 3 with long incline angle. Mean diastolic BP was
standing injury); age range=17-46 years lower for the recent SCI subjects (105
Sampson et al. 2000;
old; ASIA class A n=4, B n=2. mmHg) with chronic (123 mmHg).
USA
Treatment: With and without lower- 2. ↑systolic and diastolic BP with
PEDro=5
extremity FES while tilted by 10º ↑stimulation intensities and ↓BP with
RCT
increments every 3 minutes, from 0-90º ↑incline angle (p < .001) regardless of
N=6
with varying intensities of stimulation. the site of stimulation.
3. Subjects tolerated higher angles of
Outcome Measures: Blood pressure, incline with FES than without. The
16-10
Score
Methods Outcome
Research Design
Total Sample Size
heart rate, perceived syncope score. higher the intensity of FES, regardless
of stimulation site, the greater the tilt
incline tolerated.
Population: m=15, f=1 SCI; motor 1. With increasing tilt angle, ↓ systolic and
complete tetraplegia; age range=15-70 diastolic BP and ↑heart rate with and
years old; time since injury: 2-324 months without FES.
(118.9±104.2 months); ASIA class A n=11, 2. Adding FES to tilting significantly
Chao & Cheing 2005; B n=5. attenuated the drop in systolic BP by
China Treatment: Progressive head-up tilting 3.7±1.1 mmHg (p = .005), the drop in
Downs & Black score=15 maneuver with and without the FES to 4 diastolic BP by 2.3±0.9 mmHg (P =
Post muscle groups. .018), and heart rate increase by
N=16 Outcome Measures: BP, heart rate, 1.0±0.5 beats/min (p = .039) for every
perceived presyncope score. 15 degrees increment in the tilt angle.
3. FES increased the overall mean
standing time by 14.3±3.9 min (p =
.003).
Population: n=6 paraplegics (T4-T10); 1. After training, ↑ resting HR and systolic
n=7 tetraplegics (C4-C7); mean age=30.5 BP in tetraplegics and ↓systolic and
years; mean time post injury = 8 years. diastolic BP in paraplegics.
Treatment: FES-leg cycle ergometer 2. In both groups, HR and BP during
Faghri et al. 1992; USA training, 3X/week, for about 12 weeks (36 submaximal exercise significantly
Downs & Black score=14 sessions). decreased and stroke volume and
Pre-post Outcome Measures: Oxygen uptake cardiac output significantly increased
N=13 (VO2), pulmonary ventilation (Ve), after program.
respiratory exchange ratio (RER), BP, HR, 3. These results suggest that FES-LCE
stroke volume (SV) and cardiac output (Q). training improves peripheral muscular
and central cardiovascular fitness in
SCI subjects.
Discussion
FES may be an important treatment adjunct to minimize cardiovascular changes during postural
orthostatic stress in individuals with SCI. Several studies have suggested that FES-induced
contractions of the leg muscles increases cardiac output and stroke volume, which is
attributable to increased venous return (Raymond et al. 2002). This increases ventricular filling
and left ventricular end-diastolic volume (i.e., enhanced cardiac preload). According to the
Frank-Starling effect, an increase in ventricular preload will lead to a greater stretch of the
myocytes and a concomitant increase in left ventricular stroke volume. The increased stroke
volume may allow cardiac output and as such arterial blood pressure to be increased.
Therefore, FES-induced contraction of the leg muscles may attenuate the drop in systolic BP in
response to an orthostatic challenge.
FES-induced contraction in the leg muscles may also artificially restore the body’s ability to
redistribute blood from below the level of the lesion back to the heart. In fact, FES may be
effective during the orthostatic challenge by redistributing blood volume from the regions of the
body that are below the level of the SCI (Davis et al. 1990). FES of leg muscles resulted in
increase of cardiac output and stroke volume (Davis et al. 1990). These studies suggested that
FES of leg muscles could alleviate the lower limb pooling effect during the orthostatic challenge.
FES causes a dose-dependent increase in blood pressure independent of stimulation site that
may be useful in treating orthostatic hypotension (Sampson et al. 2000). FES may be an
important treatment adjunct to minimize cardiovascular changes during postural orthostatic
16-11
stress in individuals with acute spinal cord injury. Two level 2 RCTs and non-randomized
controlled trials with small number of individuals provide support for use of FES in individuals
with SCI. FES of the lower extremity could be used by persons with SCI as an adjunct during
standing to prevent orthostatic hypotension and circulatory hypokinesis. An FES-induced leg
muscle contraction is an effective adjunct treatment to delay orthostatic hypotension caused by
tilting; it allows people with tetraplegia to stand up more frequently and for longer durations
(Elokda et al. 2000; Sampson et al. 2000).This effect may be more beneficial to those with
tetraplegia who have a compromised autonomic nervous system and may not be able to adjust
their hemodynamics to the change in position (Faghri et al. 2001).
Conclusion
There is level 2 evidence from randomized controlled trials that FES is an important
treatment adjunct to minimize cardiovascular changes during postural orthostatic stress
in individuals with SCI.
The use of FES is an effective adjunct treatment to minimize cardiovascular

changes during changes in position.
16.3.4 Effect of Exercise on OH in SCI
Following exercise, individuals with SCI could exhibit positive changes in autonomic regulation
of cardiovascular system (Lopes et al. 1984). Exercise or even passive movement of the legs
could potentially stabilize the reduced central blood volume in individuals with SCI during the
orthostatic challenge (Dela et al. 2003). There is also some evidence that exercise training
could enhance sympathetic outflow in individuals with SCI as shown by increase in
catecholamine response to maximal arm ergometry exercise (Bloomfield et al. 1994)
Table 16.7 Exercise on OH in SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: m=12 SCI, 6 experimental (5 1. No significant difference between the
tetraplegia, 1 paraplegia. mean age=40.3, active upper extremity exercise group
mean 7.2 weeks post injury); 6 control (6 versus non-exercise group with
tetraplegia, mean age=22.5 years; mean reference to tolerance to progressive
8.2 weeks post injury. vertical tilt.
Treatment: Random assignment to active
Lopes et al. 1984; USA exercise (60 bilateral forearm flexion and
PEDro=2 extension movements per minute during
RCT the first and third minute of each tilt angle)
N=12 versus no upper limb exercises during tilt
from 0-70 degrees by 10 degrees
increments at five-minute intervals until
blood pressure dropped below 70/40.
Outcome measures: BP, hypotensive
symptoms.
Ditor et al. 2005; Canada Population: Sensory incomplete cervical 1. ↓ Resting HR but no change in BP after
Downs & Black score=18 SCI; m=6, f=2; mean age= 27.6±5.2 years; BWSTT.
Pre-post level of injury C4-C5; ASIA B-C; 9.6±7.5 2. No effect on BP or HR on the 60° Head
N=8 years post-injury. Up Test.
16-12
Score
Methods Outcome
Research Design
Total Sample Size
Treatment: 6 month of body weight- 3. A trend (p=0.09) towards a relative
supported treadmill training (BWSTT). exaggeration of the pressor response
Outcomes measures: HR, BP, and to orthostatic stress during tilt test
orthostatic responses, heart-rate variability. (measured by↓low frequency power of
heart rate) and suggests improved
orthostatic tolerance.
Only two exercise studies exist and are very diverse in protocol. Lopes et al. (1984) found no
effects on orthostatic tolerance with the addition of upper extremity exercises during a
progressive vertical tilt protocol. Such findings are not surprising given the small muscle mass
involved in the upper limbs and the fact that venous pooling occurs primarily in the lower limbs.
The study by Ditor et al. (2005) demonstrate that individuals with incomplete tetraplegia retain
the ability to make positive changes in cardiovascular autonomic regulation with body weight-
support treadmill training. Six months of BWSTT did not substantially affect the ability of SCI
subjects to tolerate orthostatic stress, however, the authors found this encouraging as it
suggests that orthostatic tolerance is retained after exercise training, even though this
intervention probably reduced peripheral vascular resistance.
Conclusion
There is level 2 evidence that simultaneous upper extremity exercises does not improve
orthostatic tolerance during a progressive tilt exercise. There is level 4 evidence that 6
months of body-weight support treadmill training does not substantially improve
orthostatic tolerance during a tilt test.
Simultaneous arm exercise during a tilt test is not effective for improving orthostatic tolerance.
The benefits of body-weight supported treadmill training for management
of OH have not been sufficiently proven in SCI.
General Discussion
The major part of our present understanding of pathophysiology and management of

incapacitating symptoms of OH is derived from the management of this condition in individuals
with both central autonomic neurodegenerative disorders, such as multiple system atrophy and
Parkinson’s disease, and peripheral autonomic disorders, such as the autonomic peripheral
neuropathies and pure autonomic failure (Mathias 1995; Freeman 2003). From previous
studies in non SCI individuals it is well established that combination of patient education and
use of pharmacological and non-pharmacological modalities could lead to successful
management of the OH. The therapeutic goal for management of OH is not to normalize the
blood pressure values but rather to ameliorate symptoms while avoiding side effects.
(Kaufmann et al. 2006) The general approach in management of OH is that the therapeutic
interventions should be implemented in stages dependent upon the severity of symptoms
(Kaufmann et al. 2006). It is also well known from previous studies in non SCI population that
nonpharmacologic measures alone are often insufficient to prevent symptoms of OH.
Pharmacological interventions are needed particularly in SCI patients with moderate to severe
OH symptoms.
16-13
Although a wide array of physical and pharmacological measures are recommended for the
general management of OH (Kaufman et al. 2006), very few have been evaluated for use in
SCI. Of the pharmacological interventions, only minodrine has some evidence, while the FES is
one of the only non-pharmacological interventions which has limited evidence to support its
utility.
16.4 Summary
There is Level 1 evidence that Midodrine enhances exercise performance in some

individuals with SCI, similar to other clinical populations with cardiovascular autonomic
dysfunction.
There is Level 4 evidence that the use of clonidine and midodrine resulted in successful
treatment of OH based on one study using one individual.
There is level 4 evidence on case series that show evidence of fludrocortisone is

effective for OH in SCI
There is level 4 evidence based on 1 case series that Ergotamine, daily combined with
fludrocortisone, successfully prevented symptomatic OH in one individual with SCI
(Groomes & Huang 1991).
There is level 5 evidence that Ephedrine may prevent some symptoms of OH.
There is level 4 evidence that L-DOPS, in conjunction with salt supplementation in one
individual is effective for reducing OH
The studies used salt and fluid regulation in combination with other pharmacological
interventions and thus, the effects of salt and fluid regulation cannot be determined. No
evidence exists on the effect of salt or fluid regulation alone for OH management in SCI.
There is conflicting evidence that elastic stockings/abdominal binders have any effect on
cardiovascular responses in individuals with SCI.
There is level 2 evidence that an application of a harness in individuals with SCI could
alter baseline cardiovascular parameters and the response to orthostatic stress.
There is level 2 evidence from randomized controlled trials that FES is an important
treatment adjunct to minimize cardiovascular changes during postural orthostatic stress
in individuals with SCI.
There is level 2 evidence that simultaneous upper extremity exercises does not improve
orthostatic tolerance during a progressive tilt exercise. There is level 4 evidence that 6
months of body-weight support treadmill training does not substantially improve
orthostatic tolerance during a tilt test.
16-14
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16-17
CHAPTER SEVENTEEN
Autonomic Dysreflexia

Robert W Teasell, MD, FRCPC
Janice J Eng BSc (PT/OT), PhD
Key Points
The identification of the possible trigger and decrease of afferent stimulation to the
spinal cord is the most effective prevention strategy in clinical practice.
Botulinum toxin injections into the detrusor seem to be a safe and valuable
therapeutic option in SCI patients who perform clean intermittent self-catheterization
and have incontinence resistant to anticholinergic medications.
Capsaicin and its analogue, resiniferatoxin, are effective in the management of AD
in patients with SCI.
Anticholinergics do not appear to be sufficient for the management of AD in SCI.
It is not known whether sacral deafferentation reduces AD during urodynamic
investigations.
Enterocystoplasty has demonstrated long-term viability compared to sphincterotomy.
Lidocaine anal block can limits the AD response in susceptible patients
undergoing anorectal procedures.
Topical lidocaine does not prevent AD during anorectal procedures.
Adequate anesthesia (spinal or epidural if possible) is needed with vaginal delivery,
cesarean delivery or instrumental delivery is required.
Epidural anesthesia is preferred and effective for most women
with AD during labor and delivery.
Anesthesia should be used during surgical procedures in individuals with SCI despite
apparent lack of sensation.
Topical anesthetic is not effective for the prevention of AD during FES
Nifedipine may be useful to prevent or control AD in SCI individuals.
Nitrates are commonly used in the control of AD in SCI, but not studies have been
done to show their effectiveness or safety in SCI.
Preliminary evidence suggests that captopril is effective for the management of
autonomic dysreflexia in SCI
There is limited evidence for the use of Terazosin as an agent for control of AD in SCI
individuals.
Prazosin can reduce severity and duration of AD episodes in SCI.
It is not known whether Phenoxybenzamine is effective for the management of AD in
SCI
Prostaglandin E2 may reduce BP responses during eletroejactulation.
Sildenafil has no effect on AD responses in men with SCI during ejaculation.
Table of Contents
17.1 Introduction ..................................................................................................................17-1
17.2 Pathophysiology of AD ...............................................................................................17-1
17.3 Management .................................................................................................................17-2
17.4 Prevention strategies ..................................................................................................17-2

17.4.1 Prevention of AD during bladder procedures..............................................................17-3
17.4.1.1 Botulinum toxin and AD ...........................................................................................17-3
17.4.1.2 Capsaicin .................................................................................................................17-4
17.4.1.3 Anticholinergics........................................................................................................17-6
17.4.1.4 Sacral denervation ...................................................................................................17-6
17.4.1.5 Bladder and urethral sphincter surgery....................................................................17-7
17.4.2 Treatments to reduce AD during anorectal procedures ..............................................17-9
17.4.3 Prevention of AD during Pregnancy and Labour ......................................................17-10
17.4.4 Prevention of AD during surgery...............................................................................17-11
17.4.5 Prevention of AD during FES Exercise .....................................................................17-12
17.5 Pharmacological management of AD ......................................................................17-13

17.5.1 Nifedipine (Adalat, Procardia) ...................................................................................17-13
17.5.2 Nitrates (Nitroglycerine, Depo-Nit, Nitrostat, Nitrol, Nitro-Bid) ..................................17-15
17.5.3 Captopril....................................................................................................................17-16
17.5.4 Terazosin ..................................................................................................................17-16
17.5.5 Prazosin (Minipress ..................................................................................................17-18
17.5.5 Prazosin (Minipress ..................................................................................................17-18
17.5.6 Phenoxybenzamine (Dibenzyline) ............................................................................17-18
17.5.6 Phenoxybenzamine (Dibenzyline) ............................................................................17-18
17.5.7 Prostoglandin E2.......................................................................................................17-19
17.5.8 Sildanefil (Viagra)......................................................................................................17-20
17.5.9 Other pharmacological agents tested for management of AD. .................................17-20
17.6 Summary.....................................................................................................................17-21
References............................................................................................................................17-23
Krassioukov A, Warburton DER, Teasell RW, Eng JJ (2006). Autonomic Dysreflexia Following Spinal Cord Injury.
www.icord.org/scire
Autonomic Dysreflexia Following
Spinal Cord Injury
17.1 Introduction
Autonomic dysreflexia (AD) is a well-known clinical emergency in individuals with spinal cord
injury (SCI). It commonly occurs in individuals with injury at level T6 and above. (Mathias &
Frankel 1988; Teasell et al. 2000; Mathias & Frankel 2002) An episode of AD is characterized
by acute elevation of arterial blood pressure (BP) and bradycardia (slow heart rate), although
tachycardia (fast heart rate) may also occur. Objectively, an increase in systolic BP greater
than 20–30mmHg is considered a dysreflexic episode. (Teasell et al. 2000) Intensity of AD can
vary from asymptomatic (Linsenmeyer et al. 1996), mild discomfort and headache to a life
threatening emergency when systolic blood pressure can reach 300mmHg (Mathias & Frankel
2002). Untreated episodes of autonomic dysreflexia may have serious consequences, including
intracranial hemorrhage, retinal detachments, seizures and death (Yarkony et al. 1986; Pine et
al. 1991; Eltorai et al. 1992; Valles et al. 2005).
It has been observed that the higher the level of the SCI, the greater the degree of clinical
manifestations of cardiovascular dysfunctions (Mathias & Frankel 1992; Curt et al. 1997;
Krassioukov et al. 2003). Another crucial factor for the severity of AD is completeness of spinal
injury: only 27% of incomplete tetraplegics presented signs of AD in comparison with 91% of
tetraplegics with complete lesions (Curt et al. 1997). AD is three times more prevalent in
tetraplegics with a complete injury, in comparison to those with an incomplete injury (Curt et al.
1997). It is important to note, however, that although autonomic dysreflexia occurs more often
in the chronic stage of spinal cord injury at or above the 6th thoracic segment, there is clinical
evidence of early episodes of autonomic dysreflexia in the first days and weeks after the injury
(Silver 2000; Krassioukov et al. 2003).
17.2 Pathophysiology of AD
Most commonly AD is triggered by urinary bladder or colon irritation. However, many other
causes were reported in the literature (Teasell et al. 2000; Mathias & Frankel 2002). AD is
caused by massive sympathetic discharge triggered by either noxious or non-noxious stimuli
below the level of the SCI (Krassioukov & Claydon, 2005). Numerous reports of AD have been
described in the literature: these are usually short- lived either due to treatment or being self-
limiting. However, there are reports of AD triggered by a specific stimulus, which then continued
to be present for a period of days to weeks (Elliott & Krassioukov 2006).
Numerous mechanisms have been proposed for the development of AD. It is known from
animals experiments that autonomic instability following SCI result from plastic changes
occurring within the spinal autonomic circuits in both the acute and chronic stages following
injury (Mathias & Frankel 1988; Teasell et al. 2000; Mathias & Frankel 2002; Krassioukov 2005).
The destruction of the descending vasomotor pathways results in the loss of inhibitory and
excitatory supraspinal input to the sympathetic preganglionic neurons, and is currently
considered as the major factor underlying the unstable blood pressure control following SCI
(Furlan et al. 2003). Furthermore, there is numerous animal and human data suggesting that
plastic changes within the spinal cord (specifically spinal sympathetic neurons and primary
17-1
afferents) underlies the abnormal cardiovascular control and AD following SCI. Altered
sensitivity of peripheral alphaadrenergic receptors (receptors in the sympathetic nervous
system) is one mechanism that may contribute to AD (Osborn et al. 1990; Arnold et al. 1995;
Krassioukov & Weaver 1995, 1996; Karlsson 1999; Krassioukov et al. 1999; Krassioukov et al.
2002).
Table 17.1 Signs and Symptoms
• severe headache
• feeling of anxiety
• profuse sweating above the level of injury
• flushing and piloerection (body hair “stands on end”) above the injury
• dry and pale skin due to vasoconstriction below the level of injury
• blurred vision
• nasal congestion
• cardiac arrhythmias, atrial fibrillation
17.3 Management
Presently there is a well established protocol of management of AD developed by the

Consortium for Spinal Cord Medicine (Consortium for Spinal Cord Medicine 1997). In patients
with spinal cord injury, appropriate bladder and bowel routines, in addition to pressure sore
prevention are the most effective measures for prevention of autonomic dysreflexia. However,
for each individual, the identification and elimination of specific triggers for autonomic
dysreflexia should also be employed to manage and prevent episodes of autonomic dysreflexia
(Teasell et al. 2000; Mathias & Frankel 2002; Blackmer 2003).
When AD develops, the initial management of an episode involves placing the patient in an
upright position to take advantage of an orthostatic reduction in blood pressure, and the
loosening of any tight clothing (Consortium for Spinal Cord Medicine 1997). Throughout the
episode, the blood pressure should be checked at 5 min intervals. It is then necessary to
search for and eliminate the precipitating stimulus most commonly (in 85% of cases) related to
either bladder distention or bowel impaction (Teasell et al. 2000; Mathias & Frankel 2002). The
use of antihypertensive drugs should be considered as a last resort, but may be necessary if the
blood pressure remains at 150 mmHg or greater following the steps outlined above (Consortium
for Spinal Cord Medicine 1997). The goal of such an intervention is to alleviate symptoms and
avoid the complications associated with uncontrolled hypertension (Yarkony et al. 1986; Pine et
al. 1991; Eltorai et al. 1992; Valles et al. 2005).
The identification of the possible trigger and decrease of afferent stimulation to the spinal cord
is the most effective prevention strategy in clinical practice.
17.4 Prevention Strategies
The most effective approach to AD is the prevention of occurrence of this disabling and life
threatening condition (Braddom & Rocco 1991). This includes careful evaluation of individuals
with SCI and early recognition of possible triggers that could result in AD. Improved clinician
awareness of AD and greater attention on the need to eliminate noxious stimuli in individuals
with SCI is a priority. Clinicians, family members, and care givers should be aware that
17-2
increased afferent stimulation (e.g., via surgery, invasive investigational procedures, labour) to
persons with SCI will increase the risk for development of AD. A variety of procedures can be
used to prevent occurrence of episodes of AD.
17.4.1 Prevention of AD during Bladder Procedures
Urinary bladder irritation or stimulation is the major trigger of AD following SCI (McGuire &
Kumar, 1986; Linsenmeyer et al. 1996; Giannantoni et al. 1998; Teasell et al. 2000; Mathias &
Frankel 2002). A bladder management program and continuous urological follow-up are
important elements of the medical care of individuals with SCI (Waites et al. 1993a;
Vaidyanathan et al. 1994; Vaidyanathan et al. 2004). An established bladder management
program with intermittent catheterization or an indwelling Foley catheter allows individuals with
SCI to plan for bladder emptying when convenient or necessary. Urological follow up includes
annual urodynamic evaluations and cystoscopy examinations depending on the bladder
management program. During the last decade, these strategies have decreased the frequency
of urinary tract infections and development of renal failure in individuals with SCI (Waites et al.
1993a; Waites et al. 1993b; DeVivo et al. 1999). Urodynamic procedures and cystoscopy are
associated with significant activation of the urinary bladder afferents and have potential to
trigger AD (Snow et al. 1977; Dykstra et al. 1987; Chancellor et al. 1993; Linsenmeyer et al.
1996). Therefore, numerous studies focus on strategies designed to decrease afferent
stimulation to the urinary bladder to prevent development of AD.
The ideal management of urinary bladder following SCI is the reduction of the intravesical
pressure, allowing efficient drainage with intermittent self catheterization and preferably with
minimal activation of bladder afferents that could lead to AD. This can be achieved either by
addressing the detrusor or the urethral sphincter.
17.4.1.1 Botulinum Toxin and AD
Injection of Botulinum toxin into the detrusor muscle is an effective method for treating urinary
incontinence secondary to neurogenic detrusor overactivity.
Table 17.2 Botulinum Toxin and AD

Score
Methods Outcome
Research Design
Total Sample Size
Population: 11 men with SCI and 1. All 10 patients evaluated by
detrusor-sphincter dyssynergia electromyography after injection
Treatment: low dose botulinum A toxin at showed signs of sphincter
the neuromuscular junction to denervate denervation.
the rhabdosphincter. 2. The urethral pressure profile in the 7
Outcome Measures: urethral pressure, patients in whom it was measured
Dykstra et al. 1988; USA
symptoms of AD before and after treatment decreased
an average of 27 cm H20 after toxin
Pre-post
injections.
N=11
3. Post-void residual urine volume
decreased by an average of 146 cc
after the toxin injections in 8 patients.
4. In the 8 patients for whom it could be
determined, toxin effects lasted an
average of 50 days.
17-3
Score
Methods Outcome
Research Design
Total Sample Size
Population: traumatic SCI, mean age: 1. At 6-week follow-up 17/19 patients
36.7 years, 18 paraplegia, 3 tetraplegia, 17 were completely continent.
complete, 4 incomplete, 60.2 months post- 2. Urodynamic evaluation in all 19 cases
Schurch et al. 2000; injury, incontinence resistant to revealed significant increases in mean
Switzerland anticholinergic medication reflex volume (p<.016) and maximum
Downs & Black score=11 Treatment: Botulinum-A toxin was injected cystometric bladder capacity (p<.016).
Pre-post under cystoscopic control into the detrusor 3. 3 patients with tetraplegia with severe
N=31 muscle. AD with bladder emptying found this
Outcome Measures: voiding and detrusor disappeared after treatment.
pressure, diary of incontinence, AD
symptoms
Discussion
The duration of effect seems to be last up to 9 months. Both studies were level 4 (Dykstra et al.
1988; Schurch et al. 2000) and showed positive effects. In fact, following Botulinum toxin
treatment for AD associated with bladder emptying, the AD disappeared in 3 individuals with
tetraplegia.
Conclusion
There is level 4 evidence (from 2 pre-post studies) that Botulinum toxin injections into
the detrusor seem to be a safe and valuable therapeutic option in SCI patients who
perform clean intermittent self-catheterization and have incontinence resistant to
anticholinergic medications.
Botulinum toxin injections into the detrusor seem to be a safe and valuable therapeutic
option in SCI patients who perform clean intermittent self-catheterization
and have incontinence resistant to anticholinergic medications.
17.4.1.2 Capsaicin
Capsaicin is the pungent extract from red pepper and exerts a selective action on certain
sensory nerves, most notably those involved in reflex contractions of the bladder after spinal
cord injury.
Table 17.3 Capsaicin

Score
Methods Outcome
Research Design
Total Sample Size
Population: 22 males, 14 females, 1. No statistical significance due to
neurologically impaired patients (20 SCI, 7 small sample sizes.
multiple sclerosis, 9 other) with 2. Intravesical RTX administration
Kim et al. 2003; USA
urodynamically verified detrusor was well-tolerated. This patient
PEDro=9
hyperreflexia group was refractory to all previous
RCT
Treatment: Randomized double-bind, oral pharmacologic therapy, yet
N=36
placebo-controlled trial. Intravesical some patients responded with
instillation of Resiniferatoxin (RTX) 0.005, improvement in bladder capacity
0.025, 0.05, 0.10, 0.2, 0.5, or 1.0 microM of and continence function shortly
17-4
Score
Methods Outcome
Research Design
Total Sample Size
RTX (n = 4 each group) or placebo (n=8). after RTX administration.
Outcome Measures: incontinence 3. In some cases, mean cystometric
episodes, bladder capacity capacity increased up to 500% over
baseline.
4. Incontinence episodes decreased
by over 50% for the 2 highest
doses.
5. No data available on long term
effect of RXT on AD.
Population: 24 SCI patients with refractory 1. There was no significant
detrusor hyperreflexia urodynamic or clinical improvement
Treatment: Randomized two treatments in the capsaicin group at 30 and 60
a) single dose of 2 mM. capsaicin in 30 ml days of follow-up.
ethanol plus 70 ml 0.9% sodium chloride 2. In the resiniferatoxin group the
OR mean uninhibited detrusor
Giannantoni et al. 2002; b) 100 mM. resiniferatoxin in 100 ml 0.9% contraction threshold increased
Italy sodium chloride from mean 176 ±54 to 250±107 ml
PEDro=6 Outcome Measures: Urodynamics, at 30 days and to 275±98 ml at 60
RCT frequency of daily catheterizations, days (p<.05) and bladder capacity
N=23 incontinence episodes and side effects was increased from 196±75 to 365±113
recorded ml at 30 days and to 357 ±101 ml.
at 60 days (p <0.001).
3. AD, limb spasms, suprapubic
discomfort and hematuria
developed in most patients who
received capsaicin but in none who
received resiniferatoxin.
Population: 5 cervical and 2 thoracic SCI 1. Bladder distension increased
patients (p<.001) the mean blood pressure
Igawa et al. 2003; Japan Treatment: bladder instillation with before capsaicin treatment at
Downs & Black score=13 capsaicin solution under general empty and full, but this response
Pre-post anesthesia. was attenuated (p<.01) after
N=7 Outcome Measures: blood pressure, treatment.
heart rate, serum catecholamines, blood
ethanol concentration
Discussion
One pre-post study (Igawa et al. 2003) demonstrated that intravesical capsaicin diminished
episodes of AD in patients with SCI during catheterization which suggested that intravesical
capsaicin may be a promising therapy for both AD and detrusor hyperreflexia in SCI patients.
However, two studies (Giannantoni et al. 2002; Kim et al. 2003) used an analogue of capsaicin
(resiniferatoxin RXT) which is more than 1,000 times more potent in desensitizing C-fiber
bladder afferents and found reduced episodes of AD. In addition, in a randomized controlled
trial, Giannantoni et al. (2002) found that intravesical administration of resiniferatoxin was
superior to that of capsaicin in terms of urodynamic results and clinical benefits in SCI patients
and it does not cause the inflammatory side effects associated with capsaicin. However, no
data on long term effect on AD were presented.
Conclusion
There is level 4 evidence (from 1 pre-post study) that intravesical capsaicin is effective
for reducing episodes of AD in SCI
17-5
There is level 1 evidence (from 2 RCTs) that intravesical resiniferatoxin is effective for
reducing episodes of AD in patients with SCI.
There is level 1 evidence (from 1 RCT) that intravesical resiniferatoxin is more effective
than intravesical capsaicin.
Capsaicin and its analogue, resiniferatoxin, are effective in the management of AD

in patients with SCI.
17.4.1.3 Anticholinergics
Anticholinergics are a class of medications that inhibit parasympathetic nerve signals by

selectively blocking the binding of the neurotransmitter acetylcholine to its receptor in nerve
cells. The nerve fibers of the parasympathetic system are responsible for the involuntary
movements of smooth muscles such as those found in the urinary tract.
Table 17.4 Anticholinergics

Score
Methods Outcome
Research Design
Total Sample Size
Population: 48 SCI patients, prospective 1. During urodynamic evaluation all
study the patients with lesion level above
Treatment: anticholinergic drugs T6 showed signs of sympathetic
Outcome Measures: neurological and stimulation, although only some
Giannantoni et al. 1998;
urological examination and urodynamic showed dangerous blood pressure
Italy
evaluation with concurrent recording of values.
blood pressure, heart rate, symptoms of 2. Presence of detrusor uninhibited
Observational
AD contractions and bladder distension
N=48
both contribute to AD crisis.
3. Treatment with anticholinergic
drugs is not sufficient to prevent AD
starting from the bladder, unless it
induces detrusor areflexia.
Conclusion
There is level 5 evidence that anticholinergics (from 1 observational study) are not
sufficient for the treatment of AD.
Anticholinergics do not appear to be sufficient for the management of AD in SCI.
17.4.1.4 Sacral Denervation
When detrusor hyperreflexia post-SCI does not respond to conservative treatment, and patients
are not eligible for ventral sacral root stimulation for electrically induced micturition, sacral
bladder denervation may be considered as a stand-alone procedure to treat urinary
incontinence and AD.
17-6
Table17.5 Sacral Denervation
Score
Methods Outcome
Research Design
Total Sample Size
Population: 10 SCI patients with AD 1. There was a marked elevation in
Treatment: sacral deafferentation systolic and diastolic BP with
Outcome measures: continuous non- bradycardia during the urodynamic
Schurch et al. 1998;
invasive recordings of BP and HR during examination in all eight patients,
Switzerland
urodynamic recordings, pre- and post- despite complete intra-operative de-
operative data afferentation of the bladder in five.
Case Series
2. Even after complete sacral de-
N=10
afferentation, AD persisted in
patients with SCI and always
occurred during the stimulation-
induced voiding phase.
Population: 9 patients (8 men and 1 1. Detrusor hyperreflexia and
woman), 21-58 years old, traumatic SCI, autonomic dysreflexia were
detrusor hyperreflexia eliminated in all cases.
Treatment: sacral bladder denervation 2. Bladder capacity increased from
Hohenfellner et al. 2001 Outcome Measures: bladder capacity, 177.8 ± 39.6 to 668.9± 64.3 mL and
Germany blood pressure, symptomatic AD intravesical pressure decreased
Downs & Black score=11 from 89.3± 19.1 to 20.2± 2.7 cm
Pre-post H2O.
N=9 3. In the 5 patients with AD, the
systolic blood pressure was
lowered from 196± 16.9 to 124± 9.3
mmHg and the diastolic blood
pressure from 114± 5.1 to 76± 5.1
mmHg.
Two level 4 studies with sacral denervation reported conflicting results. Hohenfellner et al.
(2001) reported that sacral bladder denervation is a valuable treatment option in patients with
detrusor hyperreflexia. However, Schurch et al. (1998) showed that complete bladder de-
afferentation did not abolish AD during bladder urodynamic investigations.
Conclusion
There is conflicting evidence (from two level 4 studies) for sacral deafferentation for
prevention of AD.
It is not known whether sacral deafferentation reduces AD during urodynamic investigations.
17.4.1.5 Bladder and Urethral Sphincter Surgery
The association between episodes of AD and the presence of detrusor sphincter dyssynergia,
high intravesical pressure and urethral pressure has led to the development of numerous
surgical procedures to alleviate voiding dysfunctions and consequently AD.
17-7
Table 17.6 Bladder and Urethral Sphincter Surgery
Score
Methods Outcome
Research Design
Total Sample Size
Population: 16 patients with SCI (5 1. ↓intravesical and urethral
thoracic, 8 cervical), mean age: 32.2±2
Barton et al. 1986; USA pressures compared to before
years (cervical), 35±3 years (thoracic), 47-
Downs & Black score=12 sphincterotomy (p<.001) and ↓
285 months post-injury
Case Series
Treatment: modified transurethral external blood pressure (p<.01). Other
N=16
sphincterotomy. responses related to AD also were
Outcome Measures: bladder and urethral markedly attenuated.
pressures and volumes, blood pressures
Population: 12 adults with SCI, mean age: 1. By 4 months post-op, 11/12 patients
22-53 years, C5-T11, 9 complete, 3 were totally continent on clean
incomplete, 2-27 years post-injury intermittent self-catheterization every
Treatment: augmentation 4-6 hours.
Sidi et al. 1990; USA enterocystoplasty 2. Of the 3 patients in whom an artificial
Downs & Black score=11 Outcome Measures: functional bladder urinary sphincter was implanted, 2
Pre-post capacity, levels of blood urea nitrogen, became continent after sphincter
N=12 creatinine, electrolytes activation and 1 had achieved
continence without sphincter
activation.
3. The mean functional bladder capacity
post-op was 562 cc and the bladder
compliance was excellent.
Population: 12 patients with suprasacral 1. The mean bladder capacity was
SCI, mean age: 35 years, mean 3.5 years increased from 180 ml (baseline) to
Kochakarn & Muangman post-injury, failure of treatment to suppress 300 ml (intraoperation) and 800 ml (1
2001; Thailand hyperreflexic bladder. year post).
Downs & Black score=6 Treatment: follow-up of Mitrofanoff 2. No complications up to 1 year post
Case Series procedure with enterocystoplasty. except one subject with orchitis.
N=12 Outcome Measures: bladder capacity, 3. At one year post, all still had
adverse effects continence and self-intermittent
catheterization done via continent
stoma at the abdominal wall.
External sphincterotomies are not commonly done as they are associated with significant risks,
including hemorrhage, erectile dysfunction and the need for repeat procedures. Thus,
alternatives have been investigated, such as urethral stents and botulinum toxin injection
(Ahmed et al. 2006). The augmentation enterocystoplasty has demonstrated long-term success
based on urodynamic evaluation and clinical assessment of individuals with SCI (Chartier-
Kastler et al. 2000). Enterocystoplasty with a Mitrofanoff Procedure has now become a frequent
choice of bladder augmentation in individuals with SCI (Kochakarn & Muangman 2001).
Conclusion
There is level 4 evidence (based on three pre-post/case series) that urinary bladder
surgical augmentations resulted in a decrease of intravesical and urethral pressure and
significantly diminished or completely resolved episodes of AD. Enterocystoplasty has
demonstrated long-term viability compared to sphincterotomy.
Enterocystoplasty has demonstrated long-term viability compared to sphincterotomy.
17-8
17.4.2 Treatments to Reduce AD during Anorectal Procedures
Pain or irritation within the colorectal area is the second most common cause of AD.
Constipation, hemorrhoids, and anal fissures are frequently can be observed in patients with
SCI and be responsible for episodes of AD (McGuire & Kumar 1986; Hawkins, Jr. et al. 1994;
Teichman et al. 1998; Teasell et al. 2000). Furthermore, bowel routines in SCI individuals
frequently involves digital stimulation that can trigger AD. Rectosignmoid distension and anal
manipulation can thus be iatrogenic triggers of AD in this population (Cosman & Vu 2005).
Table 17.7 Treatments to Reduce AD during Anorectal Procedures

Score
Methods Outcome
Research Design
Total Sample Size
Population: complete SCI, mean 46-49 1. The mean maximal systolic blood
years, mean 15-25 years post-injury, C7±3 pressure increase for the lidocaine
Cosman & Vu 2005; USA
level of injury group (22±14 mmHg) was lower than
PEDro=11
Treatment: intersphincteric anal block with the placebo group (47±31 mmHg) (p =
RCT
300 mg 1% lidocaine or normal saline 0.01) suggesting that AD risk was
N=25
(placebo) before sigmoidoscopy or reduced with lidocaine.
anoscopic hemorrhoid ligation procedure.
Outcome Measures: blood pressure
Population: 45 patients (44 male, 1 2. Topical lidocaine had no significant
female) with chronic, complete SCI, injury effect on mean maximal systolic blood
level of T6 or above pressure (SBP; ↑ 35±25 mmHg in the
Cosman et al. 2002; USA Treatment: Double-blind, placebo- lidocaine group vs. ↑ 45± 30 mmHg in
PEDro=9 controlled trial. Patients undergoing the control group).
RCT anoscopy and/or flexible sigmoidoscopies 3. Greater SBP increase with anoscopic
N=45 were randomized to receive 2% topical procedure compared to
lidocaine jelly (n=18) or nonmedicated sigmoidoscopic procedures (49±29 vs.
lubricant (control, n=32) just prior to the 25± 20 mmHg, respectively).
procedure.
Outcome Measures: blood pressure
Discussion
Rectosigmoid distention and anal manipulation are among the common stimuli that may trigger
AD. In two small RCTs, investigators evaluated effect of topical versus local anesthesia of
anorectal area for prevention of AD during the anorectal procedures. Investigators
demonstrated that anoscopy, which involves stretching of the anal sphincters, was a more
potent stimulus for AD than flexible sigmoidoscopy, which involves gaseous distention of the
rectosigmoid. Anal sphincter stretch and rectosigmoid distention, rather than a mucosal
stimulus, are likely nociceptive triggers for procedure-associated AD (Cosman et al. 2002). In
one randomized, double-blind, placebo-controlled trial AD was not abolished during the
anorectal procedure by topical lidocaine in the rectum (Cosman et al. 2002). However, the
same investigators in a latter RCT demonstrated that lidocaine anal sphincter block was
effective in limiting anorectal procedure-associated AD (Cosman & Vu 2005).
Conclusion
Both anoscopy and flexible sigmoidoscopy caused significant blood pressure elevation.
There is level 1 evidence (from 1 RCT) that lidocaine anal block significantly limits the AD
response in susceptible patients undergoing anorectal procedures.
17-9
There is level 1 evidence (from 1 RCT) that topical lidocaine did not significantly limit or
prevent AD in susceptible patients during anorectal procedures.
Lidocaine anal block can limits the AD response in susceptible patients

undergoing anorectal procedures.
Topical lidocaine does not prevent AD during anorectal procedures.
17.4.3 Prevention of AD during Pregnancy and Labour
Based on North American statistics, women represent a third of the SCI population, not an
insignificant proportion (Ackery et al. 2004). In the United states, 3,000 women of childbearing
age are affected by SCI (Cross et al. 1992). The ability of women to have children is not usually
affected once their menstrual cycle resumes (Jackson & Wadley 1999). There are increasing
numbers of women with SCI who become pregnant and have healthy babies (Cross et al.
1992). However, women with SCI are at high risk of developing uncontrolled AD during labor
and delivery (Sipski 1991; Sipski & Arenas 2006).
Recognition and prevention of this life threatening emergency is critical for the management of
labor in women with SCI (McGregor & Meeuwsen 1985).
Table 17.8 Prevention of AD during Pregnancy and Labour

Score
Methods Outcome
Research Design
Total Sample Size
Population: 22 woman with SCI, 11 1. AD was experienced in 9/16
cervical, 11 thoracic, 10 incomplete, 12 pregnancies of patients whose
complete injury level was above T6.
Treatment: epidural anesthesia 2. Most of the patients who
Outcome Measures: presence of experience AD had motor complete
Cross et al. 1992; USA autonomic hyperreflexia, type of injuries.
Downs & Black score=4 anesthesia, type of delivery, complications 3. One patient had two grand mal
Case Series seizures during labour, which may
N=22 have been triggered by her severe
AD and the subsequent
intravenous administration of
diazepam.
4. Six patients had epidural
anesthesia, which was effective for
the control of AD.
Population: 17 pregnancies in 15 women 1. Labour tended to be diagnosed by
with SCI, age range: 19-39 years, level of dysreflexic symptoms or membrane
injury: T4-L3, length of injury not reported rupture with confirmation by palpation
Treatment: management and outcome of of contractions and vaginal
Hughes et al. 1991; UK
pregnancies in women with SCI. examination.
Outcome Measures: antenatal care and 2. Initial management of AD included
Observational
problems, labour diagnosis and outcome elevation of head of the bed, nifedipine
N=15
and nitrates.
3. The most effective measure for
controlling AD was to identify the
cause and interrupt the triggering
afferent input to the spinal cord.
Cross et al. 1991; USA Population: 7 cervical, 9 thoracic SCI, 1. Of the 16 women, 25 pregnancies
Downs & Black score=4 length of injury: 1-11 years occurred, resulting in 22 babies & 3
17-10
Score
Methods Outcome
Research Design
Total Sample Size
Observational Treatment: questionnaire (in person or abortions.
N=16 telephone) and hospital records review. 2. 2/15 vaginal deliveries and 5/7
Outcome Measures: outcomes of caesarian section had AD during
pregnancies - # of babies, # of abortions, delivery with 4 of these receiving
fetal birth weights & Apgar scores, epidural anesthesia for the control of
complications AD.
3. 1 patient required epidural catheter 5
days postpartum to control AD.
In women with SCI the onset of AD during the labor is intermittently timed with uterine
contractions. In the majority of women with SCI above T10, the uterine contractions may
present as only abdominal discomfort, an increase in spasticity and AD (Hughes et al. 1991).
Numerous observational studies, case reports and expert opinions recommend adequate
anesthesia in women with SCI during labor and delivery despite the apparent lack of sensation.
Epidural anesthesia was reported as the best choice for the control of AD. The American
College of Obstetrics and Gynecology (2002) emphasized that it is important that obstetricians
caring for these patients are aware of the specific problems related to SCIs (2002). Autonomic
dysreflexia is the most significant medical complication seen in women with SCIs, and
precautions should be taken to avoid stimuli that can lead to this potentially fatal syndrome
(McGregor & Meeuwsen 1985).
Conclusion
There is level 4 evidence that women with SCI may give birth vaginally. With vaginal
delivery or when cesarean delivery or instrumental delivery is indicated, adequate
anesthesia (spinal or epidural if possible) is needed.
There is level 4 evidence (from 1 case series and 2 observational studies) that epidural
anesthesia is preferred and effective for most patients with AD during labor and delivery.
Adequate anesthesia (spinal or epidural if possible) is needed with vaginal delivery,

cesarean delivery or instrumental delivery is required.
Epidural anesthesia is preferred and effective for most women

with AD during labor and delivery.
17.4.4 Prevention of AD during Surgery
AD may be precipitated by a host of somatic and visceral noxious or non-noxious stimuli below
the level of injury. Therefore a variety of interventions have been used to decrease afferent
information to the spinal cord by either peripheral anesthetic blocks, epidural anesthesia,
general anesthesia, or even dorsal rhizotomy (McGregor & Meeuwsen 1985; Barton et al. 1986;
Cosman et al. 2002; Cosman & Vu 2005; Kutzenberger et al. 2005). Despite the partial or total
loss of sensation below the level of injury, it is important to recognize that surgical procedures or
manipulations can potentially initiate episodes of AD. Anesthesiologists and surgeons
undertaking surgery with SCI patients must be aware of the interactions of the anesthetic and its
effects on AD and how to prevent or manage AD during these procedures.
17-11
Table 17.9 Prevention of AD during Surgery
Score
Methods Outcome
Research Design
Total Sample Size
Population: 50 SCI patients, injury above 1. Hypertension occurred more
T6, complete, mean of 6.5 years post-injury significantly with topical or no
Lambert et al. 1982; USA Treatment: retrospective review of 78 anesthesia (15/19) compared to
Downs & Black score=13 procedures. Three groups: 1) topical or no general anesthesia (3/13) (p=.011)
Observational anesthesia sedation (n=19), 2) general and spinal anesthesia (3/46)
N=50 anesthesia (n=13), and 3) spinal (p<.001).
anesthesia (n=46). 2. No difference between general and
Outcome Measures: blood pressure spinal anesthesia groups (p=.114).
Population: mean age: 53.5 yrs, range: 1. AD occurred most commonly

23-81 yrs, level of injury C1-T10, mean during the start of anesthesia
length of injury: 22.3 yrs, range: 0-50 yrs (induction) with the greatest
Treatment: retrospective review of frequency when no anesthesia was
anesthetic methods during surgery provided.
Eltorai et al. 1997; USA Outcome Measures: blood pressure 2. During induction, systolic blood
Downs & Black score=4 pressure increased in 68.7% of
Observational procedures during combined local
N=591 anesthesia and intravenous (IV)
sedation, in 65.4% of IV sedation
alone, in 62.1% of local anesthesia
alone, in 51.5% of spinal or
epidural anesthesia, in 51.5% of
general anesthesia, and in 88.8%
of no anesthesia.
Two observational studies presented evidence that AD is a common complication during the
general surgery in individuals with SCI. Up to 90 % of individuals undergoing surgery with
topical anesthesia or no anesthesia developed AD. Both studies concluded that patients at risk
for AD could be protected by either general or spinal anesthesia.
Conclusion
There is level 5 evidence (from 2 observational studies) that indicate that patients at risk
for autonomic dysreflexia are protected from developing intraoperative hypertension by
either general or spinal anesthesia.
Anesthesiologists and surgeons dealing with SCI patients must know how to recognize
the AD syndrome, how to prevent its occurrence and how to manage it aggressively.
Anesthesia should be used during surgical procedures in individuals with SCI despite
apparent lack of sensation.
17.4.5 Prevention of AD during FES Exercise
Functional electrical stimulation (FES) is a popular modality during the rehabilitation of

individuals with SCI ( Sampson et al. 2000; Wood et al. 2001). Unfortunately, similar to any
non-noxious or noxious stimuli below the level of injury, FES can result in significant afferent
stimulation and trigger the development of AD (Ashley et al. 1993; Matthews et al. 1997).
17-12
Table 17.10 Prevention of AD during FES Exercise
Score
Methods Outcome
Research Design
Total Sample Size
Population: 7 subjects with cervical (C4- 1. Decrease in HR and increase in
C7) complete SCI, 23-44 years, 3-21 years systolic and diastolic BP were seen
Matthews et al. 1997;
post-injury (p<.05), which is typical of the
Canada
Treatment: Double-blind and randomized previously reported FES-induced AD
PEDro=7
to topical anaesthetic or placebo creams. response.
RCT
This was applied to the quadriceps 2. No differences in HR, BP or
N=7
muscles during graded FES exercise. catecholamine responses or FES force
Outcome Measures: heart rate, blood were seen between the two conditions.
pressure, serum catecholamines
One RCT evaluated the effect of topical anaesthetic or placebo creams on two different days
applied to the skin area over quadriceps muscle 1 hr prior to FES (Matthews et al. 1997).
Cardiovascular and AD responses during FES were unaffected by the use of topical anaesthetic
cream on the skin at the stimulation site. The authors suggested that mechanisms other than
skin nociception contribute to the FES-induced AD.
Conclusion
There is level 1 evidence (from one RCT) supporting no effect of topical anesthetic for
the prevention of AD during FES.
Topical anesthetic is not effective for the prevention of AD during FES
17.5 Pharmacological Management of AD
Episodes of AD in individuals with SCI can vary in severity, be asymptomatic and be managed
by the individual once they are familiar with their own triggers and symptoms (Linsenmeyer et
al. 1996). However, in some individuals it is difficult to find the trigger for the acute blood
pressure elevation and immediate medical attention is required (Elliott & Krassioukov 2006).
Antihypertensive drugs with a rapid onset and short duration of action should be used in
management of acute episodes (Blackmer 2003). The Consortium for Spinal Cord Medicine
(1997) recommends that if non-pharmacological measures (sit patient upright, loosen clothes,
reduce irritation to the bladder and bowel) fail and arterial blood pressure is 150 mmHg or
greater, then pharmacological management should be initiated. However, the Consortium for
Spinal Cord Medicine (1997) does not identify any particular medication for management of AD.
Numerous pharmacological agents have been proposed for management of episodes of
autonomic dysreflexia (Naftchi & Richardson 1997; Blackmer, 2003). The majority of the
recommendations are based on the clinical practice of management of hypertensive crises in
able-bodied population.
17.5.1 Nifedipine (Adalat, Procardia)
Nifedipine is a calcium ion influx inhibitor (Ca-channel blocker) which selectively inhibits calcium
ion influx across the cell membrane of cardiac muscle and vascular smooth muscle without
changing serum calcium concentrations. In man, Nifedipine causes decreased peripheral
vascular resistance and a modest fall in systolic and diastolic pressure (5-10mm Hg systolic),
17-13
but sometimes larger. Nifedipine is generally given using the "bite and swallow" method, in a
dose of 10 mg.
Table 17.11 Nifedipine (Adalat, Procardia)

Score
Methods Outcome
Research Design
Total Sample Size
Population: 10 SCI males with a history of 1. In all but one case, blood pressures
AD, mean age: 30 years (range 26-38), were markedly lower after nifedipine
injury levels above T5, mean 9 years post- pretreatment.
Steinberger et al. 1990;
injury (range 3-21 years) 2. Systolic BP during electroejaculation
USA
Treatment: 10-30 mg nifedipine was lower with nifedipine pretreatment
sublingually 15 min prior to (168 mmHg) compared to no
electroejaculation. 25 trials with nifedipine treatment (196 mmHg).
Trial
pretreatment and 56 trials without (1-3 3. In all but one patient, tolerance to
N=10
trials per patient). electrical stimulation was equal or
Outcome Measures: blood pressure, greater after nifedipine pretreatment.
voltage and current delivered during
electroejaculation
Lindan 1985; USA Population: 12 tetraplegic individuals 1. Given as regular medication twice
Downs & Black score=8 Treatment: phenoxybenzamine (10mg bid) daily, neither drug was effective in
Prospective Controlled versus nifedipine (20mg bid) administration preventing AD responses to bladder
Trial during cystometry. filling, and a significant number of
N=12 Outcome Measures: blood pressure patients developed troublesome
hypotension.
Population: 10 patients with cervical or 1. In each patient there was a decrease
high thoracic SCI in the maximum systolic and diastolic
Treatment: 10 mg nifedipine sublingually BP after the administration of
Thyberg et al. 1994; during cystometry nifedipine.
Sweden Outcome Measures: blood pressure 2. The group mean maximum systolic
Downs & Black score=13 pressure decreased significantly from
Pre-post 147 mmHg (range 119-165 mmHg) to
N=10 118 mmHg (range 99-145 mmHg).
3. The ↓in blood pressure was due to a
↓of the baseline pressure and ↓in the
blood pressure response during
cystometry.
Population: 19 men and 1 woman with 1. All but one SCI patient demonstrated
SCI, mean age: 45 years (range 20-63 AD during ESWL with maximal
years), 10 tetraplegia, 10 paraplegia increase in systolic BP of 74 mmHg.
Kabalin et al. 1993; USA Treatment: 10-30 mg nifedipine 2. Nifedipine was administered
Downs & Black score=10 sublingually during Estracorporal shock sublingually and controlled BP
Case Series wave lithotripsy (ESWL) for kidney stone elevation.
N=20 treatment. 3. For severe, acute increases in BP,
Outcome Measures: electrocardiogram, ESWL stimulation was momentarily
blood pressure, pulse rate, peripheral discontinued until pharmacological
oxygen saturation control of the BP was achieved, after
which treatment was continued.
Population: 7 males, 21-48 years, 2-15 1. Nifedipine alleviated AD when given
years post-injury, complete, cervical sublingually during cystoscopy and
injuries prevented autonomic hyperreflexia
Dykstra et al. 1987; USA
Treatment: 10 mg nifedipine during when given orally 30 minutes before
cystosopy procedure cystoscopy.
Pre-post
Outcome measures: blood pressure, 2. No adverse drug effects were
N=7
presence of AD observed.
17-14
Nifedipine was successfully tested in one non-randomized controlled trial with SCI individuals
undergoing electroejaculation (Steinberger et al. 1990). Steinberger and co-investigators
reported that sublingual nifedipine decreased peak systolic, diastolic, and mean BB during the
procedure (Steinberger et al. 1990). Furthermore, Braddom surveyed 86 physicians with an
average of 16.8 years experience in management of patients with SCI and management of AD
(Braddom & Rocco 1991). They found that current pharmacologic treatment of AD varies greatly
from physician to physician. Antihypertensive medications are the most frequently used
medications. Nifedipine was a drug of choice in 48% of minor AD and in 58% of severe
symptomatic AD.
Although nifedipine has been the most commonly used agent for management of AD in
individuals with SCI (Dykstra et al. 1987; Braddom & Rocco 1991; Thyberg et al. 1994; Esmail
et al. 2002), its use has declined recently (Frost 2002; Anton & Townson 2004). There have
been no reported adverse events from the use of nifedipine in the treatment of autonomic
dysreflexia (Blackmer 2003), although all had very small samples. However, a review of
nifedipine for the management of hypertensive emergencies not specific to SCI, found serious
adverse effects such as stroke, acute myocardial infarction, death and numerous instances of
severe hypotension (Grossman et al. 1996). Due to several reports of serious adverse
reactions occurring after administration of immediate-release nifedipine, the Joint National
Committee on Detection, Evaluation and Treatment of High Blood Pressure (1997) has
discouraged use of this drug.
Conclusion
There is level 2 evidence (from 2 prospective controlled trials) that Nifedipine may be
useful to prevent dangerous blood pressure reactions, e.g. during cystoscopy and other
diagnostic or therapeutic procedures in SCI injured patients with AD.
Nifedipine may be useful to prevent or control AD in SCI individuals.
17.5.2 Nitrates (Nitroglycerine, Depo-Nit, Nitrostat, Nitrol, Nitro-Bid)
Nitrates cause relaxation of vascular smooth muscle, producing vasodilator effects on peripheral
arteries and veins. Dilation of postcapillary vessels, including large veins, promotes peripheral
pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-
diastolic pressure (preload). Arteriolar relaxation reduces systemic vascular resistance and
arterial pressure (after-load).
Before nitrates are administered (such as nitroglycerin, isosorbide dinitrate, or sodium

nitroprusside), a person with spinal cord injury presenting with acute AD should be questioned
regarding their use of sildenafil. If this agent has been used within the last 24 hours, it is
recommended that an alternative short-acting, rapid-onset antihypertensive agent be used.
Nitrates are the second after nifedipine most commonly used agent for management of AD in
individuals with SCI ( Braddom & Rocco 1991; Consortium for Spinal Cord Medicine 1997).
However, no studies exist to support their use in SCI.
Conclusion
17-15
There is level 5 evidence (clinical consensus from Braddom & Rocco 1991), but no
clinical studies which support the use of nitrates in the control of AD in SCI.
Nitrates are commonly used in the control of AD in SCI, but not studies have been done to
show their effectiveness or safety in SCI.
17.5.3 Captopril
Captopril is a specific competitive inhibitor of angiotensin I-converting enzyme (ACE). During

an episode of AD, captopril 25mg is recommended to administer sublingually.
Table 17.12 Captopril

Score
Methods Outcome
Research Design
Total Sample Size
Population: 26 consecutive patients older 1. A total of 33 autonomic dysreflexia
than 15 years with SCI above T6 episodes were documented, of which
Treatment: administration of a) captopril 18 episodes in 5 patients were treated
25mg sublingually if systolic blood pressure with drug therapy.
Esmail et al. 2002; (SBP) was at or above 150mmHg, b) 5mg 2. Captopril alone was effective in 4 of 5
Canada of immediate-release nifedipine if SBP initial episodes (80%).
Downs & Black score=9 remained elevated 30 minutes after 3. Mean SBPs at baseline and 30
Case Series captopril administration minutes after captopril were
N=7 Outcome Measures: systolic BP 178±18mmHg and 133±28mmHg,
respectively. The addition of
nifedipine successfully reduced SBP in
the remaining patient. 94% of
episodes were successfully treated
with the protocol.
Discussion
Captopril appears to be safe and effective for autonomic dysreflexia management. One
prospective open labeled study (Esmail et al. 2002) and numerous experts opinion suggest the
use of the captopril as a primary medication in management of AD (Frost 2002; Anton &
Townson 2004).
Conclusion
There is level 4 evidence (from one case series) for the use of captopril in the
management of AD in SCI.
Preliminary evidence suggests that captopril is effective for the management

of autonomic dysreflexia in SCI
17.5.4 Terazosin
Terazosin is a long-acting, alpha-1adrenoceptor selective blocking agent. Selective alpha 1

blockade has been suggested as a good pharmacological choice in the management of AD
because of its dual effect at the bladder level (inhibition of urinary sphincter and relaxation of the
smooth muscles of blood vessels).
17-16
Table 17.13 Terazosin
Score
Methods Outcome
Research Design
Total Sample Size
Population: 18 adults with tetraplegia (17 1. The AD symptoms subsided
male, 1 female), 3 children with ventilator- completely with the Terazosin
dependent tetraplegia and 3 adult males therapy in all the patients.
Vaidyanathan et al. 1998; with paraplegia. All had AD in the 2. Adult patients required a dose
UK absence of an acute predisposing factor. between 1-10 mg and children
Downs & Black score=12 Treatment: Terazosin with starting dose required between 1-2 mg.
Pre-post of 1 mg (adults) or 0.5 mg (children). 3. The side effects of postural
N=24 Step-wise increments of these doses hypotension and drowsiness were
were given at 3-4 day intervals. transient and mild. One tetraplegic
Outcome Measures: drug-induced patient developed persistent
hypotension, adverse effects, AD dizziness and therapy was
symptoms discontinued.
Population: 6 paraplegic, 6 quadriplegic, 1. Detrusor compliance improved in all

6 cervical, 5 thoracic, 1 lumbar, 7 patients during the treatment phase.
complete, 5 incomplete, age range: 22-65 2. The change in bladder pressure and
Swierzewski et al. 1994;
yrs, 13-120 months post-injury the safe bladder volume were
USA
Treatment: nightly Terazosin statistically and clinically significant.
administration for 4 weeks (5 mg starting
Pre-post
dose).
N=12
Outcome Measures: physical
examination, symptom score and
synchronous cystoscopy and cystometry
before, during and after Terazosin therapy
Population: 21 individuals with complete 1. There was a statistically significant
SCI; mean age: 34 years (range 20-53 decrease in the AD severity score
years), C3-T5 from baseline at one week, 1 month
Treatment: Terazosin administration. and 3 months.
Chancellor et al. 1994; USA
Outcome Measures: blood pressure and 2. Degree of muscle spasm and degree
autonomic dysreflexia frequency and of headache did not improve.
Pre-post
severity scores 3. There was decrease in the frequency
N=21
of AD at 1-week follow-up and was
maintained at 1 and 3 months.
4. Systolic blood pressure did not
statistically change after 3 months of
Terazosin (p=.26).
Discussion
Terazosin was evaluated in several level 4 experimental studies and appears to be effective in
preventing AD without erectile function impairment (Chancellor et al. 1994). Patients report
moderate to excellent improvement (Chancellor et al. 1994) or even complete termination of the
dysreflexic symptoms (Vaidyanathan et al. 1998).
Conclusion
There is level 4 evidence (from 3 pre-post studies) that Terazosin may have positive
effects on incontinence and AD.
17-17
There is limited evidence for the use of Terazosin as an agent for control
of AD in SCI individuals.
17.5.5 Prazosin (Minipress)
Prazosin is a postsynaptic alpha-1 adrenoceptor blocker, which lowers blood pressure by

relaxing blood vessels. Prazosin has a minimal effect on cardiac function due to its alpha-1
receptor selectivity. The recommended starting dose in adults is 0.5 or 1 milligram (mg) two or
three times a day.
Table 17.14 Prazosin (Minipress)

Score
Methods Outcome
Research Design
Total Sample Size
Population: T6 or above, at least 2 1. Prazosin was well tolerated and did
episodes of AD in last 7 days not significantly lower resting BP.
Krum et al. 1992; Treatment: double-blind, randomized to Compared to baseline, the Prazosin
Australia Prazosin 3 mg bid. (n=8) or placebo (n=7) group had fewer severe episodes of
PEDro=9 for 2 weeks. AD (reduced rise in BP, shorter
RCT Outcome Measures: frequency and symptom duration and less need for
N=15 severity of AD, blood pressure acute antihypertensive medication).
2. The severity of headache during
individual AD episodes was also
diminished with Prazosin therapy.
Discussion
Prazosin is well tolerated and does not affect the baseline blood pressure, and AD episodes
were less severe and shorter in duration (Krum et al. 1992).
Conclusion
There is level 1 evidence (from one RCT) that Prazosin is superior to placebo in the
prophylactic management of AD.
Prazosin can reduce severity and duration of AD episodes in SCI.
17.5.6 Phenoxybenzamine (Dibenzyline)
Phenoxybenzamine is a long-acting, adrenergic, alpha-receptor blocking agent and can

increase blood flow to skin, mucosae, and abdominal viscera and lower supine and erect blood
pressures. The initial does is 10 mg of Dibenzyline (phenoxybenzamine hydrochloride) bid with
increases once daily, usually to 20-40 mg 2-3 times/days.
Table 17.15 Phenoxybenzamine (Dibenzyline)

Score
Methods Outcome
Research Design
Total Sample Size
McGuire et al. 1976; USA Population: 9 SCI individuals with severe 1. Subjects had a dramatic relief of
17-18
Score
Methods Outcome
Research Design
Total Sample Size
Downs & Black score=9 AD symptoms.
Case Series Treatment: phenoxybenzamine (alpha-
N=9 sympatholytic agent)
Outcome Measures: blood, bladder and
urethral pressures
Population: 12 tetraplegic individuals 1. Given as regular medication twice

Lindan 1985; USA
Treatment: phenoxybenzamine and daily, neither drug was effective in
nifedipine preventing AD responses to bladder
Pre-post
Outcome Measures: blood pressure filling and a significant number of
N=12
patients developed troublesome
hypotension.
Conclusion
There is level 4 evidence for use of Phenoxybenzamine in the management of AD,

however, the results are conflicting with no effects in one study (Lindan et al. 1985) and
positive effects in the other (McGuire et al. 1976).
It is not known whether Phenoxybenzamine is effective for the management of AD in SCI
17.5.7 Prostaglandin E2
Prostaglandin E2 is a group of hormone-like substances that participate in a wide range of body

functions such as the contraction and relaxation of smooth muscle, the dilation and constriction
of blood vessels and control of blood pressure.
Table 17.16 Prostaglandin E2

Score
Methods Outcome
Research Design
Total Sample Size
Population: 5 patients with complete SCI, 1. Resting BP decreased and resting HR
Frankel & Mathias 1980;
age range: 25-37 years, C5-T4, 5-108 increased with Prostaglandin E2.
UK
months post-injury 2. BP decreased during electrical
Treatment: trans-rectal electrical stimulation, which enabled tolerance of
ejaculation with and without intravenous more intense stimulation and
Trial
administration of Prostaglandin E2. successful ejaculation in 2 patients.
N=4
Outcome Measures: heart rate, blood
pressure, electrocardiogram.
Conclusion
There is level 2 evidence from a very small prospective controlled study which used
subjects as their own controls which showed that the level of BP recorded during
electrical ejaculation was substantially reduced with Prostaglandin E2.
Prostaglandin E2 may reduce BP responses during eletroejactulation.
17-19
17.5.8 Sildanefil (Viagra)
Sildanefil is an inhibitor of phosphodiesterase type 5 (PDE5) and causes increased levels of

cGMP in the corpus cavernosum, smooth muscle relaxation and inflow of blood to the corpus
cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual
stimulation. The recommended dose is 50 mg taken, as needed, approximately 1 hour before
sexual activity, but may be taken anywhere from 4 hours to 0.5 hour before sexual activity.
Sildanefil is known to potentiate the hypotensive effects of nitrates and nitrates in any form is
therefore contraindicated with sildanefil use.
Table 17.17 Sildanefil (Viagra)

Score
Methods Outcome
Research Design
Total Sample Size
Population: males with cervical (n = 8) 1. Sildenafil decreased base BP in
or thoracic (n = 5) SCI cervical SCI.
Treatment: oral dose of sildenafil citrate 2. Men with cervical SCI had more
Sheel et al. 2005;
(25-100 mg) or no medication during pronounced AD during penile
Canada
penile vibratory stimulation vibrostimulation than men with
PEDro=5
Outcomes Measures: ECG, blood thoracic injuries.
RCT
pressure 3. Administration of sildenafil had no
N=13
effect on HR or BP during AD
triggered by penile vibratory
stimulation in men with SCI.
The effect of sildenafil on AD was reported in one small prospective study (Sheel et al. 2005).
Although sildenafil decreased the resting BP, there was no effect on magnitude of AD resulting
from vibrostimulation in men with SCI.
Conclusion
There is level 1 evidence (from 1 RCT) that sildaenafil citrate had no effect on changes in
BP during episodes of AD initiated by vibrostimulation in man with SCI
Sildenafil has no effect on AD responses in men with SCI during ejaculation.
17.5.9 Other Pharmacological Agents Tested for Management of AD
There are several other pharmacological agents supported by case reports or expert opinion for
the management of AD in individuals with SCI. These agents are listed below but do not have
sufficient evidence to warrant their recommendation.
Table 17.18 Other Pharmacological Agents Tested for Management of AD

Drug Name Evidence Author
Hydralazine (Apresoline) Expert opinion Erickson 1980
Beta blockers Case report Pasquina et al. 1998
Mecamylamine (Inversine) Case report Braddom & Rocco 1991
Magnesium sulphate Case report Jones & Jones 2002; Maehama et al. 2000
Diazoxide (Hyperstat) Expert opinion Erickson 1980
Phenazopyridine Case report Paola et al. 2003
17-20
17.6 Summary
There is level 4 evidence (from 2 pre-post studies) that Botulinum toxin injections into
the detrusor seem to be a safe and valuable therapeutic option in SCI patients who
perform clean intermittent self-catheterization and have incontinence resistant to
anticholinergic medications.
There is level 4 evidence (from 1 pre-post study) that intravesical capsaicin is effective
for reducing episodes of AD in SCI
There is level 1 evidence (from 2 RCTs) that intravesical resiniferatoxin is effective for
reducing episodes of AD in patients with SCI.
There is level 1 evidence (from 1 RCT) that intravesical resiniferatoxin is more effective
than intravesical capsaicin.
There is level 5 evidence that anticholinergics (from 1 observational study) are not
sufficient for the treatment of AD.
There is conflicting evidence (from two level 4 studies) for sacral deafferentation for
prevention of AD.
There is level 4 evidence (based on three pre-post/case series) that urinary bladder
surgical augmentations resulted in a decrease of intravesical and urethral pressure and
significantly diminished or completely resolved episodes of AD. Enterocystoplasty has
demonstrated long-term viability compared to sphincterotomy.
Both anoscopy and flexible sigmoidoscopy caused significant blood pressure elevation.
There is level 1 evidence (from 1 RCT) that lidocaine anal block significantly limits the AD
response in susceptible patients undergoing anorectal procedures.
There is level 1 evidence (from 1 RCT) that topical lidocaine did not significantly limit or
prevent AD in susceptible patients during anorectal procedures.
There is level 4 evidence that women with SCI may give birth vaginally. With vaginal
delivery or when cesarean delivery or instrumental delivery is indicated, adequate
anesthesia (spinal or epidural if possible) is needed.
There is level 4 evidence (from 1 case series and 2 observational studies) that epidural
anesthesia is preferred and effective for most patients with AD during labor and delivery.
There is level 5 evidence (from 2 observational studies) that indicate that patients at risk
for autonomic dysreflexia are protected from developing intraoperative hypertension by
either general or spinal anesthesia.
Anesthesiologists and surgeons dealing with SCI patients must know how to recognize
the AD syndrome, how to prevent its occurrence and how to manage it aggressively.
There is level 1 evidence (from one RCT) supporting no effect of topical anesthetic for
the prevention of AD during FES.
17-21
There is level 2 evidence (from 2 prospective controlled trials) that Nifedipine may be
useful to prevent dangerous blood pressure reactions, e.g. during cystoscopy and other
diagnostic or therapeutic procedures in SCI injured patients with AD.
There is level 5 evidence (clinical consensus from Braddom & Rocco 1991), but no
clinical studies which support the use of nitrates in the control of AD in SCI.
There is level 4 evidence (from one case series) for the use of captopril in the
management of AD in SCI.
There is level 4 evidence (from 3 pre-post studies) that Terazosin may have positive
effects on incontinence and AD.
There is level 1 evidence (from one RCT) that Prazosin is superior to placebo in the
prophylactic management of AD.
There is level 4 evidence for use of Phenoxybenzamine in the management of AD,

however, the results are conflicting with no effects in one study (Lindan et al. 1985) and
positive effects in the other (McGuire et al. 1976).
There is level 2 evidence from a very small prospective controlled study which used
subjects as their own controls which showed that the level of BP recorded during
electrical ejaculation was substantially reduced with Prostaglandin E2.
There is level 1 evidence (from 1 RCT) that sildaenafil citrate had no effect on changes in
BP during episodes of AD initiated by vibrostimulation in man with SCI
17-22
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17-27
CHAPTER EIGHTEEN

Jo-Anne Aubut, BA
Maureen C Ashe, PhD, PT
Linh Tu, BHSc
Key Points
Anti-inflammatory medications given early post-SCI reduces development of

heterotopic ossification.
Warfarin may inhibit the development of heterotopic ossification post-SCI.
Etidronate can halt the progression of heterotopic ossification.
Radiotherapy can reduce the progression of heterotopic ossification.

Table of Contents
18.1 Introduction ..................................................................................................................18-1
18.2 Pathophysiology of Heterotopic Ossification ..........................................................18-1
18.3 Clinical Presentation and Natural History .................................................................18-1
18.4 Treatment of Heterotopic Ossification.......................................................................18-2

18.4.1 Non-Steroidal Anti-Inflammatory Drugs as Prophylaxis ..............................................18-2
18.4.2 Warfarin as Prophylaxis ..............................................................................................18-3
18.4.3 Etidronate....................................................................................................................18-3
18.4.4 Radiation Therapy.......................................................................................................18-5
18.5 Summary.......................................................................................................................18-6
References..............................................................................................................................18-7
Teasell RW, Aubut J, Ashe MC, Tu L. (2006). Heterotopic Ossification Following Spinal Cord Injury. In: Eng JJ,
www.icord.org/scire
18.1 Introduction
Heterotopic ossification (HO) is the formation of pathological bone in muscle or soft tissue. In
patients following a spinal cord injury, the incidence has been thought to vary greatly, ranging
from 10-78% (van Kuijk et al. 2002, Banovac 2001). Banovac et al. (2001) notes HO occurs
most frequently in the first 2 months after SCI below the level of paralysis. The etiology of HO is
not fully understood which creates challenges in determining appropriate diagnostic and
therapeutic approaches.
18.2 Pathophysiology of Heterotopic Ossification
The mechanism underlying heterotopic ossification following spinal cord injury is not well
understood but it is believed to be initiated by a change of mesenchymal cells into bone
precursor cells (Schuetz et al. 2005). HO forms through a typical process beginning with the
formation of a protein mixture created by bone cells (osteoid) that eventually calcificies within a
matter of weeks (Pape et al. 2001). Over the next few months, the calcified osteoid remodels
and matures into well-organized trabecular bone (Pape et al. 2001). Months following the initial
trauma patients develop bone formation in muscle and the soft tissues adjacent to a joint
(paraarticular) with resultant restriction in range of motion, pain and ankylosis (Banovac and
Gonzalez 1997, Garland et al. 1980). The bony lesion has a high metabolic rate, adding new
bone tissue more than three times the rate of normal bone and an osteoclastic (bone removal
cell) density more than twice the number of osteoclasts found in healthy bone (Puzas et al.
1987). Pape and coworkers (2004) noted that mesenchymal stem cells can differentiate into
osteogenic cells under the right stimuli within the right environment, even within soft tissues
(Chalmers et al. 1975). These mesenchymal stem cells can generate cartilage, bone, muscles,
tendons, ligaments or fat (Williams et al. 1999) and are thought to play a pivotal role in the
development of HO (Pape et al. 2004). It is suspected there may be a neurogenic factor
contributing to HO but the mechanism is poorly understood (Hurvitz et al. 1992, Pape et al.
2001, Pape et al. 2004).
18.3 Clinical Presentation and Natural History
Schuetz and coworkers (2005) has noted that the symptoms of heterotopic ossification appear
3-12 weeks after spinal cord injury. SCI patients typically present with joint and muscle pain,
parasthesias and tissue swelling in the involved region, accompanied by mild fever (Thomas &
Amstutz 1987; Orzel and Rudd 1985; Smith 1998; Shehab et al. 2002). In the initial stages of
HO, clinical signs of inflammation are nonspecific (Neal 2003). Measurement of biochemical
markers such as osteocalcin and alkaline phosphatase, as well as three-phase bone scan have
allowed earlier diagnosis of HO and earlier treatment (Banovac & Gonzalez 1997; Wilkinson et
al. 2003).
18-1
18.4 Treatment of Heterotopic Ossification
Treatment of HO consists of four treatments: non-steroidal anti-inflammatory drugs, warfarin,

etidronate and radiation.
18.4.1 Non-Steroidal Anti-Inflammatory Drugs as Prophylaxis
This is a broad range of medications that act to reduce inflammation within the offending
tissues.
Table 18.1: Anti-Inflammatory Drugs as Prophylaxis

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=65 , f= 11; 1. A significantly lower incidence of HO
complete/incomplete; SCI; ASIA A-C; was found in rofecoxib group (13.4%)
Time since injury: mean 24 days than in the placebo group (33.3%,
Banovac et al. 2004;
Interventions: The treatment group p<0.05).
USA
received PO rofecoxib 25 mg daily X 4 2. In patients receiving rofecoxib, there
PEDro=10
wks. was 2.5X lower relative risk of
RCT
Outcomes Measures: incidence of developing HO than in the placebo
N=76
heterotopic ossification and swelling of group.
joint(s).
Population: Gender: m=33; Age: 1. There was a significantly higher

Mean=33 yrs, SCI; ASIA A-D; Treatment incidence of early HO, diagnosed on
n=16, placebo n=17. nuclear bone scan, in the placebo
Treatment: Treatment was slow-release group (11/17) than in the group taking
indomethacin 75mg daily vs placebo X indomethacin (4/16) (p<.001).
3wks. Pts were followed up clinically until 2. In the placebo group, 7/17 pts
they showed signs and symptoms of HO; developed x-ray evidence of HO as did
USA
all were followed up with x-rays q2mos X 2/16 in the indomethacin treated group
PEDro=9
6mos. Where pts had evidence of a +ve (p<.001).
RCT
nuclear bone scan for HO, the study was
N=33
D/C and patient initiated on disodium
etidronate.
Outcomes: The effect of indomethacin
administration on the incidence of
There were two highly rated RCTs examining the use of non-steroidal anti-inflammatory drugs in
the early phase after a SCI in an attempt to reduce the incidence of HO Banovac and
coworkers (2001) randomized 33 SCI patients approximately 3 weeks post-SCI and treated
them prophylactically with either slow-release indomethacin 75 mg daily or placebo for a total of
3 weeks. Patients were carefully followed with regular clinical follow-up and nuclear bone
scans. There was a significantly higher incidence of HO, diagnosed on nuclear bone scan and
on X-ray, in the placebo group compared with the group taking indomethacin (p<.001).
Banovac and coworkers (2004) in a more recent study randomized 76 patients in the early
phase post-SCI into 2 goups: the treatment group who received 25 mg rofecoxib 25 mg daily for
weeks and a placebo group. A significantly lower incidence of HO was found in the rofecoxib
group (13.4%) than in the placebo group (33.3%) (p<.05). Both of these RCTs provided
compelling evidence that anti-inflammatory drugs, given prophylactically reduce the likelihood of
developing HO. Rofecoxib is no longer available due to cardiovascular side effects.
18-2
Conclusions
There is Level 1 evidence that non-steroidal anti-inflammatory medications can reduce

the incidence of heterotopic ossification when administered early after a spinal cord
injury.
Anti-inflammatory medications given early post-SCI reduces development of

18.4.2 Warfarin as Prophylaxis
Warfarin is a well-known anti-coagulant which may also be useful in the prevention of

heterotopic ossification post-SCI.
Table 18.2: Warfarin as a Prophylaxis

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender M=94%, F=6%; Age: 1. Warfarin administration and
Buschbacher et al. 1992;
17-75 yrs complete/incomplete; SCI development of HO were found to be
USA
Treatment: Patients treated with warfarin significantly related (p<.01).
Downs &Black score=9
for 5.4 weeks (mean time) post-SCI for 2. None of the pts treated with Warfarin
Observational
DVT with no X-rays taken to rule out HO. (n=33) developed HO and none of the
Retrospective (chart
HO diagnostic tests only if clinical signs patients with HO (n=34) had been
review)
suggested. Outcome Measures: not treated with Warfarin.
N=227
specified
There is only one observational retrospective study examining the association between Warfarin
use and heterotopic ossification post-SCI. Buschbacher et al. (1992) studied 227 patients with
SCI. None of the 33 patients treated with Warfarin an average of 5.4 weeks post-SCI were
diagnosed as suffering from heterotopic ossification; of the remainder 34 patients were
diagnosed as suffering from HO and no patient with a diagnosis of HO had been treated with
Warfarin. The authors speculated that Warfarin provided a protective or inhibitory effect against
HO.
Conclusion
There is Level 5 evidence that Warfarin inhibits the development of heterotopic

ossification post spinal cord injury.
Warfarin may inhibit the development of heterotopic ossification post-SCI.
18.4.3 Etidronate
Etidronate was introduced in the 1970’s for treatment of heterotopic ossification post-SCI and is still
commonly used today (Banovac et al. 1997; Fleisch 1991). The medication works by inhibiting the
transformation of amorphous calcium phosphate into crystalline hydroxyapetite (Fleisch 1991; Fleisch et
18-3
al. 1969; Banovac et al. 1997). Although commonly used its efficacy in prophylaxis has been questioned
(Finerman & Stover 1981).
Table 18.3: Etidronate in the Treatment of Heterotopic Ossification

Score
Methods Results
Research Design
Total Sample Size
Population: Gender: m=25, f=2 Age:15-64 1. After initial IV therapy, 20 pts showed
yrs; Time since injury: 2-6 wks : Frankel prompt reduction in swelling 1st 48 hrs,
Class: A=15, B=12 ; SCI; while 7 pts had no change or an
USA
complete/incomplete increase in swelling.
Treatment: 300mg of Etidronate Disodium 2. Overall, treatment reduced swelling
was administered by IV over a 3 hr period (p<0.01).
Trial
for 3-5days. After parenteral therapy 20 3. No significant differences noted
N=27
mg of etidronate was administered orally between the IV and orally treated
for 6 months groups in effect on HO.
Population: Gender: m=44, f=2; Age:16- 1. Group 1 (+ve bone scan and –ve x-
55 yrs SCI; Time since injury:,2-5 wks : ray for HO, n=33), 5 pts discontinued
ASIA A-C therapy and showed gradual
Treatment: 3 hrs of IV disodium etidronate development of HO. Of the remaining
on day of HO dx and continued for 3 28 pts, 22 had no x-ray evidence of
USA
successive days followed by PO etidronate HO while 6 developed x-ray dx HO by
X6 mos. F/U.
Outcome Measures: degree of 2. Group 2 (+ve bone scan and x-ray,
Trial
heterotopic ossification n=13) 6 patients’ progression of soft
N=46
tissue ossification was inhibited by
etidronate while the remaining 7 did
not respond to Rx and showed
progression of HO.
Population: Gender: m=7; Age: 47-68 yrs; No statistical results reported
1 thoracic lesion, 2 tetraplegics. 1. None of the pts treated with
Schuetz et al. 2005; Treatment: All pts underwent excision- pamidronate showed clinical, x-ray or
Switzerland surgery for removal of HO. Pamidronate lab signs of HO recurrence or new
Downs & Black score=9 was administered IV peri- and post-op, forming HO at time of F/U 5-54 months
Case Series starting at a dose level of 120 mg for 1st 12 post-op.
N=7 hrs and gradually increasing for a total of 6-
14 days.
Outcome Measures: not specified
Population: Gender: m=39, f=1 Age: No statistical results reported
mean=23 yrs: SCI; Time since injury: mean 1. 11/40 patients developed radiographic
Banovac 1999; Denmark 2-5 wks, ASIA A& B. evidence of HO from 1.5 to 6 yrs post
Downs & Black score=7 Treatment: All pts with +ve clinical findings treatment.
Case Series and +ve nuclear bone scan were treated 2. In 95% of cases of recurrent HO in
N=40 with IV etidronate sodium and then PO developed in different areas involving
20mg/kg/day X 6mos. different joints.
Subbarao et al. 1986; Population: Age 29-41 yrs,: SCI; Time No statistical results reported
USA since injury: 18-197mths 1. All pts at last F/U were able to function
Downs & Black score=8 Treatment: Didronel given 10 days – 2 independently in their wheelchairs
Case Series wks preoperatively, medication withheld for except one but was able to function
N=5 immediate postop period (72 hrs) and independently in a semireclining W/C.
continued for min. of 3 mos. All 5 pts 2. Pts had severe restriction of ROM in
underwent wedge resection at hip to permit involved joints.
free movement of hip in flexion.
Banovac et al. (1993) provided IV etidronate for 3-5 days followed by PO etidronate for 6
months to 27 SCI patients following diagnosis of heterotopic ossification and then compared to
11 SCI patients treated with PO etidronate for 6 months alone. After initial IV therapy, 20
18-4
patients showed prompt reduction in swelling over the first 48 hours while 7 patients had no
change or an increase in swelling. Overall, treatment reduced swelling (p<.01). There was no
significant difference noted between the IV and orally treated groups in its effect on heterotopic
ossification. Banovac et al. (1997) subsequently studied 46 patients (of whom 5 were excluded
because of discontinuation of therapy) who were treated with 3 days of IV disodium etidronate
followed by PO etidronate for 6 months. 33 patients had a positive bone scan but a negative x-
ray for HO and of these 5 discontinued treatment and showed gradual progression of HO. Of
the remaining 28 patients, 22 had no x-ray evidence of HO while 6 developed HO on x-ray. 13
patients had a positive bone scan and a positive x-ray, 6 patients progression of soft tissue
ossification was inhibited by etidronate while the remaining 7 did not respond to treatment and
showed progression of HO. Banovac (1999) studied 40 SCI patients with HO, diagnosed early
with positive bone scan and negative x-rays, were treated with etidronate (IV x 3days and then
PO x 6months). 11 of the 40 (27.5%) developed radiographic evidence of HO from 1.5-6.0
years post initiation of therapy. Subbarao et al. (1986, N=5) and Schuetz et al. (2005, N=7)
used edridonate pre and post surgical hip wedge resection and pamidronate pre and post
heterotopic ossification surgical removal with no occurrence of heterotopic ossification.
However, numbers were small.
These results are difficult to interpret because of the lack of RCTs and the different treatment
scenarios. It appears that etidronate is able to delay or inhibit HO progression once it is
diagnosed and it tends to work with early after the SCI rather than waiting.
Conclusions
There is Level 2 evidence that etidronate can stop the progression of heterotopic
ossification once the diagnosis is made; it is most effective if given at the time the
nuclear bone scan is positive but the radiographs are negative.
Etidronate can halt the progression of heterotopic ossification.
18.4.4 Radiation Therapy
Radiation therapy or radiotherapy is the use of ionizing therapy in the treatment of heterotopic
ossification.
Table18. 4: Radiation Therapy in Treatment of Heterotopic Ossification Post-SCI

Score
Methods Results
Research Design
Total Sample Size
Population: Gender: m-32, f=4; age: 17-59 No statistically significant results reported.
yrs; Follow-up: 4-98 months. 1. 16 of the 32 hips treated with
Sautter-Bihl et al. 2000; Treatment: 25/36 subjects received 10 Gy radiotherapy only did not show any
Germany in fraction of 2-2.5Gy, while 4 pts received abnormalities on F/U
Downs & Black score =9 higher doses. In phase 2- 7 subjects 2. No progression of HO was noted in
Experimental Non-RCT received a single does of irradiation with 30/36 subjects.
N=36 8Gy. In total 46 joints were irradiated. 3. Reossification after therapy, which led
Outcome measures: not specified to a decrease in joint mobility, was
noted in 3 subjects.
18-5
Sautter-Bihl et al. (2000) studied 36 patients with heterotopic ossification of whom 27 patients
(32 joints) received radiotherapy only to treat myositis initiated ASAP when ossification was
minimal. 11 patients (13 joints) had manifest ossifications, which had to be resected. Post-op
radiotherapy was performed 24-36 hours post-op. 2 patients received radiotherapy both before
and after surgery. Mean duration of follow-up was 23.6 months. 30 of the 36 irradiated patients
showed no progression of HO. In 3 patients reossifications after therapy caused a moderate
decrease in joint mobility.
Conclusion
There is Level 2 evidence that radiotherapy reduces the progression of

Radiotherapy can reduce the progression of heterotopic ossification
18.5 Summary
Schuetz and coworkers (2005) note that after a SCI, heterotopic ossification still remains a
therapeutic challenge. Anti-inflammatory medications provided early on prevents the
development of HO while warfarin was associated with a decreased risk of HO but this needs
further investigation. Both radiotherapy and etidronate appear to halt the progression of
heterotopic ossification once it is diagnosed. Although more research is needed, early work in
encouraging suggesting that heterotopic ossification post-SCI is treatable.
There is strong Level 1 evidence that anti-inflammatory medications provided early on

post spinal cord injury reduces the likelihood of developing heterotopic ossification.
There is Level 5 evidence that Warfarin inhibits the development of heterotopic

ossification post spinal cord injury.
There is Level 2 evidence that etidronate can stop the progression of heterotopic
ossification once the diagnosis is made; it is most effective if given at the time the
nuclear bone scan is positive but the radiographs are negative.
There is limited Level 2 evidence that radiotherapy reduces the progression of

18-6
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Banovac K, Renfree KJ & Hornicek FJ. Heterotopic ossification after brain and spinal cord injury. Crit
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Banovac K, Williams JM, Patrick LD & Haniff YM. Prevention of heterotopic ossification after spinal cord
injury with indomethacin. Spinal Cord 2001;39:370-374.
Banovac K, Williams JM, Patrick LD & Levi A. Prevention of heterotopic ossification after spinal cord
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Blane CE & Perkash I. True heterotopic bone in the paralyzed patient. Skel Radiol 1981;7:21-25.
Bravo-Payno P, Esclarin A, Arzoz T, Arroyo O & Labarta C. Incidence and risk factors in the appearance
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Buschbacher R, McKinley W, Buschbacher L, Devaney CW & Coplin B. Warfarin in prevention of
heterotopic ossification. American J Phys Med Rehabil 1992;71:86-91.
Chalmers J, Gray DH, Rush J. Observations on the induction of bone in soft tissues. J Bone Joint Surg Br
1975; 57:36-45.
Colachis SC & Clinchot DM. The association between deep venous thrombosis and heterotopic
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Dejerine A & Cellier A. Paraosteoarthopathies of paraplegic patients by spinal cord lesion: Clinical and
roentgenographic study (translated, condensed, and abridged from Ann Med 5:497, 1918). Clin
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Finerman GA & Stover SL. Heterotopic ossification following hip replacement or spinal cord injury. Two
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Fleisch H. Biphosphonates. Pharmacology and use in the treatment of tumour-induced hypercalcaemic
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Freed JH, Hahn H, Menter R & Dillon T. The use of the three-phase bone scan in the early diagnosis of
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Garland DE & Orwin JF. Resection of heterotopic ossification in patients with spinal cord injuries. Clin
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Garland DE. A clinical perspective on common forms of acquired heterotopic ossification. Clin Ortho Rel
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18-8
CHAPTER NINETEEN
Nutrition Issues Following

Spinal Cord Injury
Chris Fraser, HBSc, RD

Stephanie Muir-Derbyshire, MSc SLP(C) Reg CASLPA
Candice A Rideout, PhD (Candidate)
Key Points
A combined diet and exercise program can help patients reduce weight following SCI
without compromising total lean mass and overall health.
Participation in a holistic wellness program is positively associated with improved

eating and weight-related behaviours in persons with SCI.
Dietary counseling results in improved lipid profile; consultation with a registered

dietitian should be obtained, because individualized diets may enhance compliance.
Blood concentrations of DHA and EPA increased as the result of n-3 fatty acid
supplementation; however, no significant changes in lipid profile were identified.
Individuals with SCI should be screened for vitamin D deficiency and, if needed,
Creatine supplementation does not result in improvements in muscle strength,

endurance or function in weak upper limb muscles.
Clinicians should conduct early screening for and treatment of vitamin B12
deficiency.

More research is needed to evaluate the role of nutrition in the management of post-
acute SCI to provide the evidence base required for optimal clinical decisions.
Table of Contents
19.1 Introduction ..................................................................................................................19-1
19.2 Nutrition-related Complications .................................................................................19-1

19.2.1 Altered Glucose Metabolism .......................................................................................19-1
19.2.2 Neurogenic Bowel.......................................................................................................19-1
19.2.3 Neurogenic Bladder and Risk for Urinary Tract Infections ..........................................19-2
19.2.4 Pressure Ulcers ..........................................................................................................19-2
19.2.5 Osteoporosis...............................................................................................................19-2
19.3 Nutritional Intervention Programs for Obesity & Wellness......................................19-2

19.3.1 Energy Imbalance .......................................................................................................19-2
19.3.2 Health Promotion ........................................................................................................19-4
19.4 Nutritional Interventions for Dyslipidemia ................................................................19-5

19.4.1 Nutrition Counseling for Dyslipidemia and Cardiovascular Disease Risk ...................19-5
19.4.1.1 Omega-3 Fatty Acid Supplementation .....................................................................19-6
19.5 Vitamin Deficiencies and Supplementation ..............................................................19-7

19.5.1 Vitamin D Supplementation ........................................................................................19-7
19.5.2 Vitamin B12.................................................................................................................19-9
19.6 Creatine Supplementation for Muscle Function .....................................................19-10
19.7 Summary......................................................................................................................19-11
References............................................................................................................................19-12
Fraser C, Muir-Derbyshire S, Rideout CA, Teasell RW (2006). Nutrition Issues Following Spinal Cord Injury. In: Eng
JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal
Cord Injury Rehabilitation Evidence. Vancouver, p 19.1-19.13.
www.icord.org/scire
Nutrition Issues Following
Spinal Cord Injury
19.1 Introduction
Given that traumatic spinal cord injuries tend to occur among young previously well-nourished
persons, declines in nutritional status most likely occur post injury. These declines are likely
due to the combined effects of altered metabolism and lifestyle choices. Many secondary
complications of SCI are related to changes in energy, glucose, lipid and vitamin metabolism,
including undesirable weight gain, cardiovascular disease risk, insulin resistance and
osteoporosis. Additional nutrition-related complications which can negatively impact quality of
life include pressure ulcers and neurogenic bowel and bladder.
At this point, little is known about the most effective health promotion activities,
including nutrition interventions, required to promote long-term wellness for persons
after SCI. However, it is clear that adequate nutrition following SCI will help reduce the
likelihood of further morbidity associated with post-SCI physiological and metabolic changes.
This chapter will summarize what is currently known regarding nutrition issues in the post-acute
SCI population.
19.2 Nutrition-related Complications
19.2.1 Altered Glucose Metabolism
Many factors contribute to increased risk of insulin resistance and hyperinsulinemia, glucose
intolerance, cardiovascular disease and obesity in persons with SCI. These factors tend to
correlate with the severity and level of the neurological deficit (Javierre et al. 2005). It is
hypothesized that the decreased lean muscle mass and increased adipose tissue which follow a
SCI lead to impaired glucose uptake and affect whole body glucose homeostasis (Javierre et al.
2005). Pathogenesis of SCI and lifestyle factors impact blood glucose management and
increase the risk of morbidity and mortality due to cardiovascular diseases, the principal cause
of death among persons with SCI (Arrowwood et al. 1987; Yekutiel et al. 1989; Javierre et al.
2005). Abnormalities in lipid metabolism in SCI develop early following injury and tend to
progress over time (Brenes et al. 1986; Bauman et al. 1992; Kocina 1997; Szlachcic et al.
2000). Insulin resistance and exaggerated hyperinsulinemia in response to an oral glucose
challenge are associated with the development of Type II diabetes mellitus, atherosclerosis and
ischemic heart disease in the SCI population (Duckworth et al. 1983; Defronzo et al. 1991;
Bauman et al. 1992; Mohr et al. 2000).
19.2.2 Neurogenic Bowel
Alterations in the central or peripheral nervous system can result in delayed gastric emptying,
prolongation of intestinal transit time, and poor colonic motility, collectively known as neurogenic
bowel. Neurogenic bowel has a significant impact on the quality of life of spinal cord injured
patients, causing morbidity and even death (Correa & Rotter 2000). Modifications to dietary
fibre consumption may assist with the management of neurogenic bowel following SCI. For
further discussion on neurogenic bowel and specific nutrition interventions, see Chapter 12.
19-1
19.2.3 Neurogenic Bladder and Risk for Urinary Tract Infections
Functional foods are products that are demonstrated to have health benefits and/or reduce the
risk of chronic disease beyond their basic nutritional functions (Health Canada 2002). Cranberry
juice as it pertains to urinary tract infection risk may fall under the category of a functional food.
Refer to Chapter 13 for further information on the potential impact of cranberry juice on urinary
tract infection in the SCI population.
19.2.4 Pressure Ulcers
Pressure ulcers are common following SCI, and healing can be compromised by suboptimal
nutrition status. SCI patients with pressure ulcers have lower zinc, albumin and prealbumin
levels than those without pressure ulcers (Cruse et al. 2000a). Impaired nutritional status
contributes to delayed or incomplete wound healing (Cruse et al. 2000b). Refer to Chapter 20
for additional information regarding pressure ulcers in the SCI population.
19.2.5 Osteoporosis
Osteoporosis is a common sequelae of SCI resulting in increased bone fragility and fracture risk
(Warden et al. 2001). In addition to pharmacological and other management strategies,
supplementation with nutrients such as calcium and vitamin D may play a role in bone health
following SCI. Refer to Chapter 9 for further details.
19.3 Nutritional Intervention Programs for Obesity & Wellness
19.3.1 Energy Imbalance
Obesity is a common secondary complication of chronic SCI and is associated with adverse
metabolic sequelae. In order to maintain a healthy weight, one must stay in energy balance,
with energy intake equaling energy expenditure. Total daily energy expenditure is determined
by three factors: resting metabolic rate, physical activity and the thermic effect of food. Each of
these factors is altered following a SCI, rendering it challenging for SCI patients to achieve and
maintain energy balance. The resting metabolic rate of people with chronic SCI is estimated to
be 14–27% lower than their able-bodied counterparts, largely due to reductions in fat-free mass
and reduced sympathetic nervous system activity (Buchholz & Pencharz 2004). Physical
activity levels of persons with SCI are generally lower than that of able-bodied persons
(Buchholz & Pencharz 2004. In addition, a lower thermic effect of food has been reported in
persons with a SCI compared to able-bodied controls (Monroe et al. 1998). Without appropriate
modification of dietary intake following SCI, energy intake readily exceeds daily energy
expenditure, thus predisposing persons with SCI to undesirable weight gain (Cox et al. 1985).
Given alterations in resting energy expenditure, it can be challenging to accurately estimate

daily energy requirements for individuals with post-acute SCI. Equations validated and used in
able-bodied populations to predict resting metabolic rate overestimate actual measured energy
needs in the SCI population (Buchholz & Pencharz 2004). For this reason, it has been
suggested that energy needs following SCI are best assessed by indirect calorimetry using a
metabolic cart (Hadley 2002). Because not all health care centers have access to metabolic
carts to measure resting metabolic rate, validated equations specific to the SCI population are
needed.
It is important to note that despite widespread emphasis on obesity-related health risks in
persons with SCI, limited research has been carried out to address this problem. There is a
lack of information regarding the health outcomes of weight loss in this population. In addition,
there are limited educational resources available on nutrition issues and weight control for this
high-risk group (Chen et al. 2006).
Table 19.1 Energy Expenditure and Overweight/Obesity

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=9, f=7; SCI, ASIA: 1. During intervention: 14 subjects lost
A –D: family history of overweight/obesity: weight (4.2 ± 2.7kg)
yes n=11, no n=5 2. Decreases were noted in BMI
Treatment: Attended 12 wks (90 min/wk) (p<0.05), waist circumference
Chen et al. 2006; USA of classes that were focused on nutrition (p<0.0005), neck circumference
Downs & Black score=16 and exercise on weight control, weight (p<0.02), skinfold thickness
Pre-post reduction, and 6 wks (30-min exercise (p<0.0005).
Initial N=17; Final N=16 session was introduced). (Clarify) 3. HDL levels decreased significantly
Outcome measures: Physiologic (p<0.03).
measures, diet behaviour, psychosocial 4. Post intervention follow-up (n=13): 6
well being. continued to lose wt (2.1 ± 1.8 kg), 4
kept wt off, 3 gained wt (3.0± 2.2 kg).
Discussion
Chen et al (2006) conducted a study to assess the effect of a weight loss program on body
weight, body mass index, waist and neck circumference, skinfold thickness, fat vs. lean mass,
bone mineral content, blood pressure, serum lipids, hemoglobin, albumin, eating habits, nutrition
knowledge, bowel function and indicators of psychosocial well-being. A total of 16 subjects with
chronic SCI who were overweight or obese completed the intervention program (15 = traumatic
SCI; 1 = spina bifida). Subjects attended 90 minute counseling sessions once per week for 12
weeks, led primarily by a registered dietitian. The dietary approach emphasized high-fibre,
nutrient-dense foods (fruits, vegetables, grains, cereals) and the moderation of meats, cheeses,
sugars and fats (Weinsier et al. 1983). The program included exercise and behaviour
modification. Reported results included an average weight loss of 3.5 kg (3.8% of initial weight),
significant reductions in body mass index, anthropometric measures and fat mass. Lean mass,
hemoglobin, albumin and bone mineral content were maintained. There was no significant
change in blood pressure or LDL cholesterol. There was a decrease in HDL cholesterol. There
was a trend between weight lost and decrease in waist circumference, increase in nutritional
quality of diet, increase in fibre consumption and decrease in time required for bowel movement.
Changes in psychosocial and physical functioning were also reported.
Conclusion
There is level 4 evidence (from one pre-post trial) that an intervention program
combining diet and exercise is effective for reducing weight among overweight persons
with SCI.
A combined diet and exercise program can help patients reduce weight following SCI without
compromising total lean mass and overall health.
19.3.2 Health Promotion
Little is known about the most effective health promotion activities, including nutrition
interventions, to meet the long-term wellness needs for persons after SCI. A holistic wellness
program intervention was developed, conducted and assessed by Zemper et al. 2003.
Table 19.2 Nutritional Intervention and Long-Term Wellness Needs for Individuals after
SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=30, f=13;Age:22- 1. Treatment groups scores on the SAHP
80; Time since injury: 1-49yrs; improved following treatment (p<0.05)
Incomplete/complete, SCI as well as on the HLPH-II (total score)
Treatment: Subjects attended a series of & the HPLP-II health related subscale
six 4 hr workshop sessions over a 3mth score (p<0.001).
period 2. Treatment group scores improved
Outcome measures: Wellness survey, post-treatment on the HELP-II
Health Promoting Lifestyle Profile-II (nutrition subscale) (p<0.05).
(HPLP), Secondary Conditions Scale, Self- 3. Mean scores for the treatment groups
Rated Abilities for Health Practices Scale improved significantly for the HPLP-II
(SAHP), Perceived Stress Scale, & stress management subscale
Physical Activities with Disability (PADS) , (p=0.001). Treatment group's stress
Zemper et al. 2003; USA Questionnaire. scores also improved, indicating less
PEDro=8 stress (p<0.05).
RCT 4. HPLP-II physical activity scores
Initial N=76; Final N=43 improved post treatment for the
treatment group only (p=0.001). No
significant differences were noted for
the PADS score for either group post
treatment.
5. Secondary Conditions Scale score
decreased for the treatment group,
post treatment (p=0.001), indicating
fewer and less sever problems with
secondary conditions. Number of
secondary conditions was decreased
for the treatment group post treatment
(p<0.01).
Discussion
In this study, 43 adults with SCI were randomly assigned to intervention or control groups. The
intervention group attended 6 half-day wellness workshops over a 3-month period which
included nutrition, physical activity, lifestyle management and prevention of secondary
conditions. Among other measurements, total cholesterol and body mass index were assessed.
Health Promoting Lifestyle Profile-II (HPLP-II) was used to assess nutrition and other health
promotion habits. There was improvement in the HPLP-II nutrition subscale mean score for the
intervention group. Mean body mass index values actually increased for both groups. Total
cholesterol values rose for both groups (the study reported on total cholesterol only; changes in
HDL and LDL cholesterol values were not reported). There were significant improvements in
reported eating and weight related behaviours.
Conclusion
There is level 1 evidence (based on one RCT) that improved health related behaviours are
adopted following a holistic wellness program for individuals with SCI.
Participation in a holistic wellness program is positively associated with improved eating and
weight-related behaviours in persons with SCI.
19.4 Nutritional Interventions for Dyslipidemia
19.4.1 Nutrition Counseling for Dyslipidemia and Cardiovascular Disease Risk
Cardiovascular disease appears prematurely in SCI patients. It is the most frequent cause of
death among persons surviving more than 30 years following injury and accounts for 45% of all
SCI deaths (Devivo et al. 1999). Abnormalities in lipid metabolism in individuals with SCI
develop shortly after injury and tend to progress over time (Brenes et al. 1986; Bauman et al.
1992; Kocina 1997; Szlachcic et al. 2000). Despite the high risk for CVD morbidity and mortality
in individuals with SCI, few studies have addressed the benefits of risk reduction interventions
aimed at modifiable factors and those that exist have been limited to exercise interventions.
This section discusses what is known about the value of nutrition counseling in improving
dyslipidemia in persons with SCI.
Table 19.3 The Effect of Nutrition Counseling on Dyslipidemia and Cardiovascular

Disease Risk
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender m=198, f=24; 1. Total cholesterol decreased in the
minimum 2 years post-injury, SCI; dietary counseling group (from 234 to
complete/incomplete. 224 mg/dL, P < 0.001) and slightly
Treatment: Subjects who had a increased in the control group (from
Szlachcic et al. 2001;
cholesterol level >200mg/dL (n=86) were 162 to 166 mg/dL, P = 0.006).
USA
referred to dietary consultation and advised 2. LDL was reduced (from 159 to 151
to modify daily intakes as follows: total fat mg/dL, P = 0.004) in the dietary
<30% of kcal, saturated fat <10% of kcal, counseling group and did not change
Trial
cholesterol <300 mg, carbohydrate = 60% significantly among controls.
N=222
of kcal. Compliance was assessed twice. 3. Neither group experienced significant
The remaining subjects acted as a control changes in HDL or triglyceride values.
group.
Outcome measures: change in blood lipid
profile.
Discussion
Szlachcic et al. 2001 evaluated the effects of dietary education for individuals with SCI at least 2
years post-injury who had moderately elevated total cholesterol levels (>200 mg/dL) and
reported significant decreases in total and low-density lipoprotein (LDL) cholesterol. Individuals
who were assessed at baseline as having total cholesterol values greater than 5.2 mmol/L (200
mg/dL) (N = 86; control group) were referred to the staff registered dietitian for counseling.
Specifically, individuals were advised to limit daily fat intake to <30% of total daily calories, daily
saturated fat intake to <10%, daily cholesterol intake to <300 mg and to consume 60% of total
daily calories as carbohydrate. Subjects in the treatment group were seen by a dietitian at least
twice to assess their dietary compliance. The remaining 136 subjects (control group) did not
receive nutrition consultation. Subjects in the treatment group were significantly older and had a
greater number of years post-injury than those in the control group; therefore, changes in lipid
profile were analyzed controlling for differences in age and duration post-injury. A summary of
results is as follows – Total cholesterol – Treatment group demonstrated a significant decrease
in TC; control group showed a significant increase in TC; 69% of those in the treatment group
had decreases in TC compared to 43% in the control group. LDL – The treatment group
demonstrated significant declines in LDL while LDL in the control group showed a non-
significant increase between baseline and follow-up. In the treatment group, 67% had
decreases in LDL compared with 47% of those in the control group. High-density lipoprotein
cholesterol (HDL) – Although there were no significant changes in either group, one third of all
subjects in both groups had HDL-C values below the recommended range at baseline.
Triglycerides (TG) – Although there was a significant group-by-examination interaction for the
mean triglyceride values, univariate analyses did not detect a significant difference between the
initial and follow-up values for either groups; 60% of the treatment group compared with 45% of
control group had declines in TG values.
Conclusions
There is level 2 evidence that standard dietary counseling (total fat <30% of daily kcal,
saturated fat <10% of kcal, cholesterol <300 mg, carbohydrate 60% of kcal) can reduce
total and LDL cholesterol among individuals with SCI who have total cholesterol >200
mg/dL.
Dietary counseling results in improved lipid profile; consultation with a registered dietitian
should be obtained, because individualized diets may enhance compliance.
19.4.1.1 Omega-3 Fatty Acid Supplementation
Recent studies suggest that n-3 polyunsaturated fatty acids (found primarily in fatty fish, and in
smaller amounts in flax, soy, canola, olive and wheat germ oils and black walnuts) have
beneficial effects on cardiovascular disorders including anti-inflammatory, antithrombotic,
hypolipemic and vasodilatory effects and contribute to primary and secondary prevention of
ischemic heart disease in the general population (Hirafuji et al. 2003; Simopoulos 1999).
Table 19.4 Nutrient Supplementation and Lipid Profile Post SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI, ASIA: A –D, Time since 1. Plasma EPA and DHA increased
injury >12 yrs. significantly (p<0.05) in response to
Treatment: Subjects were administered the intake of the supplement.
Javierre et al. 2005; daily doses of DHA (1.5g) and EPA (.75g) 2. An increase was noted when
Spain in the form of gelatin pearls, 6 per day to comparing the levels before and after
Downs & Black score=15 be taken with their principal meals. EPA was administered in the 3rd
Pre-post Outcome Measures: Plasma DHA, EPA, month period and again at the 6-month
N=10 cholesterol (total, HDL, LDL, VLDL), period (p<0.05). The same could be
triglycerides, and glucose measured seen when looking at the percentages
following an overnight fast at baseline, 3 of DHA between the 3 time periods. A
and 6 months. significant increase was noted
Score
Methods Outcome
Research Design
Total Sample Size
(p<0.05)
3. No differences in cholesterol (total,
HDL, LDL, VLDL), triglycerides, or
glucose were observed.
Discussion
Javierre et al. (2005) assessed the effects on lipid profile and fasting blood glucose in 19 adult
males with SCI at 3 and 6 months following daily supplementation of 1.5 grams
docosahexaenoic acid (DHA) and 0.75 grams of eicosapentaenoic acid (EPA). Despite
significant increases in the plasma concentration of DHA and EPA, plasma concentrations of
glucose, total, HDL and LDL cholesterols, very low density lipoprotein cholesterol and
triglycerides did not show differences as the result of n-3 fatty acid supplementation.
Conclusion
There is level 4 evidence that daily supplementation with DHA (1.5 g) and EPA (0.75 g)
increases plasma DHA and EPA levels but does not alter total cholesterol, HDL, LDL,
VLDL, triglycerides, or glucose.
Blood concentrations of DHA and EPA increased as the result of n-3 fatty acid
supplementation; however, no significant changes in lipid profile were identified.
19.5 Vitamin Deficiencies and Supplementation
Although little work has been done examining the vitamin profiles of individuals following SCI it
is generally thought the vitamin deficiency is a significant issue. Moussavi et al. (2003) reported
that 16 to 37% of community-dwelling SCI subjects had serum levels below the reference range
for vitamins A, C and E compared with general population norms.
A case controlled study by Lynch et al. (2002) assessed complete blood count, white blood
cells, iron status, ferritin, red blood cell folate, vitamin B12, magnesium, zinc, albumin and
prealbumin in persons with chronic SCI and compared values to those of age and gender-
matched non-SCI controls. Results were not outside the normal ranges for either group;
however, the SCI group had significantly different median values than the control group for
hemoglobin, white blood cell count, albumin, prealbumin, serum iron and % saturation.
19.5.1 Vitamin D Supplementation
Individuals with SCI have an increased occurrence of vitamin D deficiency, resulting from a
number of factors including decreased exposure to sunlight, inadequate dietary intake and the
effect of medications. In turn, vitamin D deficiency promotes calcium deficiency and secondary
hyperparathyroidism, resulting in further bone loss and exacerbating osteoporosis. Myopathy
and nonspecific musculoskeletal pain may also develop as a consequence of vitamin D
deficiency (Bauman et al. 2005; Holick 2005).
Observational studies have shown that vitamin D deficiency is common among individuals with
SCI. Bauman et al. (1995) reported that 32 of100 SCI subjects had 25(OH)D levels below
normal range; 11 of the 32 had elevated serum PTH levels. Zhou et al. (1992) measured the
25(OH)D, serum calcium, magnesium and albumin concentrations of 92 men with SCI, 38 of
whom had single or multiple pressure ulcers, and compared these values with those of able-
bodied controls. The SCI group had lower serum 25(OH)D, total calcium and albumin
concentrations. Quadriplegics had lower 25(OH)D levels than paraplegics. Additionally, the
SCI subgroup with pressure ulcers demonstrated significantly lower serum 25(OH)D, calcium
and magnesium levels than the SCI subjects without ulcers.
Table 19.5 Vitamin D Supplementation Post SCI

Score Methods Results
Research Design
Total Sample Size
Population: Study 1: Age: Study 1:
mean=53±15yrs; SCI. Study 2: Age: 1. After 2 weeks, serum 25(OH)D
mean=43±13 yrs; SCI increased (from 8.8 to 14.7 ng/mL, P <
Treatment: Study 1: All were given 50μg 0.005) but 8 of 10 subjects still had
(2000 IU) vitamin D (25-hydroxyvitamin D3) values below the normal range (< 16
twice weekly and 1.5 g elemental calcium ng/mL).
daily for 2 weeks. Blood and urine were 2. Serum PTH decreased from 35 to 18
collected at baseline and after 2 weeks. pg/mL (P < 0.05), serum calcium was
Bauman et al. 2005; USA Study 2: 10μg (400 IU) vitamin D3, a not significantly different, and urinary
Downs & Black score=16 multivitamin with an additional 10μg (400 calcium increased from 103 to 239
Pre-post IU) vitamin D3, and 0.5 g elemental calcium mg/d (P = 0.01).
Study 1: N=10 daily for 12 months. Blood and urine were Study 2:
Study 2: N=40 collected at baseline, 6 and 12 months. 1. After 6 and 12 months, serum
Outcome measures: Changes in serum 25(OH)D increased (from 10.7 to 19.6
25(OH)D, calcium and PTH, and urinary to 22.5 ng/mL, P < 0.0001).
calcium. 2. At baseline, 33 subjects were vitamin
D deficient (< 16 ng/mL) compared to
9 after 12 months.
3. Serum PTH decreased (from 37 to 27
to 25 pg/mL, P < 0.005), and
measures of calcium were not
significantly different.
Discussion
Bauman et al. (2005) determined that healthy individuals with chronic SCI living in the
community have vitamin D deficiency. Ten subjects with chronic SCI and a diagnosis of
absolute vitamin D (25(OH)D) deficiency received 50 ug (2000 IU) of 25-hydroxyvitamin D3
twice per week for 2 weeks in addition to 1.5 grams (1500 mg) of elemental calcium daily.
Serum 25(OH)D levels significantly increased by day 14; however, levels remained below
normal range in 8/10 subjects. Serum calcium level was not significantly different but urinary
calcium significantly increased. Serum PTH levels significantly decreased. Forty subjects with
chronic SCI, regardless of initial serum vitamin D status, received 10 ug (400 IU) of vitamin D3
daily in addition to a multivitamin that contained 10 ug (400 IU) vitamin D3 for a total of 20 ug
(800 IU) daily for 12 months. Subjects were encouraged to have at least 0.8 grams (800 mg) of
calcium in their daily diet and were supplemented daily with 0.5 grams (500 mg) elemental
calcium. Vitamin D levels significantly increased from baseline at 6 and 12 months. There was
no significant association of level of injury with baseline 25(OH)D levels. Serum and ionized
calcium were not significantly different after 12 months of treatment. Serum PTH was
significantly reduced at 6 and 12 months. It is important to note that at baseline, 33 of the 40
subjects had 25(OH)D levels that were below the lower limit of normal, and that after 12 months
of supplementation at 800 IU, only 8 of the 40 subjects had serum 25(OH)D values greater than
30 ng/mL which is not adequate to reverse elevated parathyroid levels and reduce bone
turnover, despite significant decreases in PTH at 12 months. Finally, 40 subjects were
simultaneously enrolled in a placebo-controlled study on the effect of a vitamin D analog (4
ug/day of 1-alpha hydroxyvitamin D2) on lower extremity bone mineral density. Following
randomization, 19 of the 40 subjects received the analog or placebo. The vitamin D analog was
not considered to appreciably affect the serum 25(OH)D response to vitamin D
supplementation. Subjects were encouraged to have at least 0.8 grams (800 mg) of calcium in
their daily diets and were supplemented daily with 0.5 g (500 mg) elemental calcium. There
was no significant difference at 6 and 12 months in serum PTH level between individuals who
were receiving 1-alpha hydroxyvitamin D2 or placebo.
Vitamin D supplementation resulted in significant increases in 25(OH)D levels and reductions in

parathyroid hormone; however, suboptimal 25(OH)D levels persisted, suggesting the need for
higher doses of vitamin D supplementation and/or longer periods of administration.
Conclusion
There is level 4 evidence that vitamin D supplementation raises serum 25(OH)D levels in
persons with chronic SCI. However, the dose and duration required to ensure vitamin D
sufficiency remains unclear.
Individuals with SCI should be screened for vitamin D deficiency and, if needed,
19.5.2 Vitamin B12
The prevalence of vitamin B12 deficiency in persons with SCI is reported to be between 5.7 and
19% (Petchkrua et al. 2002). Symptoms may include declining gait, depression or fatigue,
upper limb weakness, memory loss and worsening pain (Petchkrua et al. 2002; Petchkrua et al.
2003). Vitamin B12 deficiency usually responds to supplementation.
Petchkrua et al. (2003) conducted a cross-sectional study with prospective blood collection and
retrospective medical record review to assess the prevalence of vitamin B12 deficiency in
persons with SCI. Biochemical vitamin B12 deficiency was reported in 13% of the subjects.
While hematologic abnormalities were infrequent, neuropsychiatric symptoms were observed in
half of the subjects. The age range most associated with vitamin B12 deficiency was 40 – 59
years; among subjects older than 59 years, 9% had B12 deficiency. No deficiency was noted in
subjects within the age range of 20 – 39 years. Deficiency was more predominant in subjects
with complete SCI.
Petchkrua et al. (2002) followed a retrospective chart review of patients with SCI who had
received serum vitamin B12 testing over a 10 year period. The most common symptoms
among subjects identified as having deficient, subnormal or low normal vitamin B12 levels were
declining gait, depression, fatigue, upper limb weakness, memory loss or worsening pain. In
this report, greater than half of the cases of probable vitamin B12 deficiency occurred in young
persons with no known risk factors. Neurologic and/or psychiatric symptoms improved in 88% of
SCI subjects following high-dose oral or monthly parenteral vitamin B12 supplementation. It is
recommended that clinicians conduct early screening and treatment of vitamin B12 deficiency.
However, definitive trials have not been done.
Given the potential for permanent neurological deficits, the relatively low cost of screening and
the low cost and high efficacy of high-dose oral supplementation, Petchkrua et al. (2002)
suggest that clinicians conduct early screening and treatment of vitamin B12 deficiency.
Additional investigations into the predisposing risk factors for vitamin B12 deficiency in persons
with SCI are warranted.
Clinicians should conduct early screening for and treatment of vitamin B12 deficiency.
19.6 Creatine Supplementation for Muscle Function
Creatine serves as a short duration reservoir for the energy required for muscle contraction in
skeletal muscle. Low levels of intramuscular creatine are seen in some neuromuscular
diseases. Creatine supplementation improves muscle strength in some patient populations with
neurological disorders (Kendall et al, 2005).
Table 19.6 Creatine Administration Post SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI; Cause of SCI was not No significant findings were noted
stated; time since injury-mean 16.5yrs; between:
Kendall et al. 2005; USA ASIA-A-C; level of injuryC5/C6. 1. Placebo and supplementation
PEDro=9 Treatment: Subjects were randomized into conditions;
RCT one of two groups. They either received 2. Endurance times between the two
Initial N=9; Final N=8 creatine or placebo, then following a wash treatments;
out period they received the other 3. Or the mean summed GRT scores for
medication. creatine and placebo.
Outcome Measures: Hand function was
assessed by using the GRT. Subjects
completed the Functional Independence
Measure. Looked at eating, grooming,
dressing and transferring.
GRT = Grasp and Release Test
Discussion
Kendall et al (2005) reported findings of a study that sought to determine whether creatine
supplementation improves muscle strength, endurance and function in weak upper limb
muscles in person with tetraplegia. Eight individuals with tetraplegia and mild wrist extensor
weakness were randomized to receive creatine or a placebo in a double-blind crossover design.
During creatine supplementation, participants received oral doses of creatine monohydrate
powder (10 grams orally twice per day for 6 days then were maintained on 5 grams daily until
they underwent testing). There was no change in any of the functional tests performed by the
participants and none of the participants had a change in self-reported motor Functional
Independence Measure (FIM) scores.
Conclusion
There is level 1 evidence (based on one RCT) that creatine supplementation did not
result in improvements in wrist extensor strength or muscle function.

19.7 Summary
There is a paucity of intervention studies investigating nutritional status and associated

risk of persons with SCI. Many descriptive and observational publications address the
risk for obesity, dyslipidemia and cardiovascular disease, impaired glycemic control and
diabetes mellitus. Blood lipid profiles and indicators of impaired glucose tolerance and
hyperinsulinemia of persons with SCI have been compared with those of able-bodied
controls. Despite the high risk for CVD morbidity and mortality in individuals with SCI as
evidenced by blood values, metabolic and lifestyle factors, few studies have addressed
the benefits of risk reduction interventions aimed at modifiable factors and have been
limited to exercise. Other studies have compared vitamin and mineral status of persons
with SCI and compared values to those of able-bodied controls or to general population
norms and have found lower levels of a variety of nutrients in the SCI population. Few
publications have suggested screening and supplementation strategies to address these
trends.
There is level 4 evidence (from one pre-post trial) that an intervention program
combining diet and exercise is effective for reducing weight among overweight persons
with SCI.
There is level 1 evidence (based on one RCT) that improved health related behaviours are
adopted following a holistic wellness program for individuals with SCI.
There is level 2 evidence that standard dietary counseling (daily total fat <30% of kcal,
saturated fat <10% of kcal, cholesterol <300 mg, carbohydrate 60% of kcal) can reduce
total and LDL cholesterol among individuals with SCI and total cholesterol >200 mg/dL.
There is level 4 evidence that daily supplementation with DHA (1.5 g) and EPA (0.75 g)
increases plasma DHA and EPA levels but does not alter total cholesterol, HDL, LDL,
VLDL, triglycerides, or glucose.
There is level 4 evidence that vitamin D supplementation raises serum 25(OH)D levels.
However, the dose and duration required to ensure vitamin D sufficiency remains
unclear.
There is level 1 (based on one RCT) that creatine supplementation did not result in
improvements in wrist extensor strength or muscle function.
More research is needed to evaluate the role of nutrition in the management of post-
acute SCI to provide the evidence base required for optimal clinical decisions.
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13.
CHAPTER TWENTY
Pressure Ulcers Following

Spinal Cord Injury
MaryAnn Regan, RN BSCN CNN(C)

David Keast, MD FRCPC
William B Mortenson, BScOT, MSc
Jo-Anne Aubut, BA
Key Points
Electrical stimulation may decrease ischial pressures.
Electrical stimulation may increase blood flow to tissues. More research is needed to
see if increasing blood flow to tissues will help prevent pressure ulcers post-SCI.
The type and duration of pressure relief by position changing must be individualized
post-SCI using pressure mapping or similar techniques.
No one cushion is suitable for all individuals with SCI.
Cushion selection should be based on a combination of pressure mapping results,

individual characteristics and preference.
Adding lumbar support to the wheelchairs of individuals with chronic SCI is unlikely
to have a role in pressure ulcer prevention post-SCI.
Research is needed to determine the role of behavioral contingencies in pressure

ulcer prevention post-SCI.
Research is needed to determine more fully why some individuals adhere to pressure
ulcer prevention strategies and others do not.
Telerehabilitation’s role in delivering prevention education and treatment to those

individuals with SCI living in the community is not yet proven.
Early attendance at specialized seating assessment clinics should be part of a

comprehensive rehabilitation program.
Electrical stimulation should be added to standard wound management to promote

healing of Stage III/IV pressure ulcers post-SCI.
Laser treatment does not improve pressure ulcer healing post-SCI.
US/UVC should be considered as an added treatment when pressure ulcers are not
healing with standard wound care post-SCI.
Pulsed electromagnetic energy improves wound healing in Stage II and Stage III
pressure ulcers post-SCI.
Anabolic steroid agents may promote healing of serious pressure ulcers post -SCI.
Table of Contents
20.1 Introduction ..................................................................................................................20-1

20.1.1 Impact of Pressure Ulcers...........................................................................................20-1
20.1.2 Incidence and Prevalence...........................................................................................20-1
20.1.3 Risk Factors ................................................................................................................20-2
20.1.4 Stages (I-IV) of Pressure Ulcers .................................................................................20-2
20.1.5 Prevention...................................................................................................................20-3
20.1.6 Treatment....................................................................................................................20-3
20.2 Prevention ....................................................................................................................20-4

20.2.1 Effects of Electrical Stimulation on Reducing Ischial Pressure Post-SCI....................20-4
20.2.2 Electrical Stimulation for Promoting Tissue Health by Increasing Local Blood Flow to
Tissues at Risk for Pressure Ulcer Formation Post-SCI ..........................................................20-5
20.2.3 Pressure Relief Practices on Pressure Ulcer Prevention Post-SCI ............................20-6
20.2.4 Wheelchair Cushion Selection and Pressure Ulcer Prevention in Post-SCI ...............20-8
20.2.5 Lumbar Support Thickness on Reducing Ischial Pressures Post-SCI ......................20-10
20.2.6 Effect of Behavioral Contingencies on Pressure Ulcer Prevention Post SCI ............20-11
20.2.7 Telerehabilitation and Pressure Ulcer Management Post SCI..................................20-12
20.2.8 The Effect of Specialized Seating Clinics on Pressure Ulcer Prevention Post-SCI ..20-13
20.3 Treatment....................................................................................................................20-15
20.3.1 Electrical Stimulation for Pressure Ulcer Healing Post-SCI ......................................20-15
20.3.2 Laser Treatment for Pressure Ulcer Healing Post-SCI .............................................20-17
20.3.3 Ultrasound/Ultraviolet C for Pressure ulcer healing Post-SCI...................................20-18
20.3.4 Effects of Non-Thermal Pulsed Electromagnetic Energy Treatment for Healing of
Pressure Ulcers Post SCI ......................................................................................................20-19
20.3.5 Anabolic Steroid Agents for Healing of Pressure Ulcers Post-SCI ...........................20-21
20.4 Summary.....................................................................................................................20-21
References............................................................................................................................20-24
Regan M, Teasell RW, Keast D, Mortenson WB, Aubut J. (2006). Pressure Ulcers Following Spinal Cord Injury.
www.icord.org/scire
Pressure Ulcers Following Spinal Cord Injury
20.1 Introduction
20.1.1 Impact of Pressure Ulcers
Traumatic spinal cord injury (SCI) has a major impact on affected individuals and their families.
As well as dealing with the direct consequences of the SCI, individuals are also at risk for a
number of secondary complications (Krause & Broderick, 2004).
Pressure ulcers are a serious, lifelong secondary complication of SCI that have the potential to
“interfere with physical, psychological and social well being and to impact overall quality of life”
(Consortium for Spinal Cord Medicine 2000; p9). Although preventable in most situations,
pressure ulcers may disrupt rehabilitation, prevent individuals with SCI from working or
attending school and interfere with community reintegration (Fuhrer et al. 1993; Krause 1998;
Consortium for Spinal Cord Medicine 2000; Jones et al. 2003).
It has been estimated that pressure ulcers can account for approximately one-fourth of the cost
of care for individuals with SCI. In the United States alone, it has been estimated that the cost
of care for pressure ulcers is about 1.2-1.3 billion dollars annually while prevention could cost
about one-tenth of this (Bogie et al. 2000; Jones et al. 2003). Because of the costs associated
with treating pressure ulcers, Krause et al. (2001) state, “they have received more attention
among rehabilitation and public health professionals than any other type of secondary
complications associated with SCI” (p107). Despite the attention given to prevention strategies,
pressure ulcers are common among individuals with SCI (Krause et al. 2001).
20.1.2 Incidence and Prevalence
Pressure ulcers (term used in the current document), also known as pressure ulcers, decubitius
ulcer, ischemic ulcer, bed sores or skin sores, have been defined as a lesion on any skin
surface that results from pressure, friction or shear forces. (Crenshaw & Vistnes 1989; Salzberg
et al. 1996; Richards et al. 2004). The primary cause of pressure ulcers is felt to be externally
applied pressure for a prolonged period of time over bony prominences such as the sacrum and
ischial tuberosities. This applied pressure leads to decreased blood supply to the overlying soft
tissues; tissue ischemia and can ultimately lead to tissue necrosis (Lamid & Ghatit 1983;
Crenshaw & Vistnes 1989; Bogie et al. 1995). DeLisa and Mikulic (1985) have noted that “the
visible ulcer represents only the tip of the iceberg” or the apex of the lesion (p 210). Deeper
tissues such as muscle are more sensitive than skin to ischemia caused by pressure
(Consortium for Spinal Cord Medicine 2000).
Different investigators have reported a wide range of incidence of pressure ulcers varying from
20 to 80% of the SCI population with many individuals having more than one (Richardson et al.
1981; Richards et al. 2004). Most SCI patients develop pressure ulcers within the first 5 years
of sustaining their injury (Vidal & Sarrias 1991; Bryne et al. 1996). Fuhrer et al. (1993) noted
that less extensive pressure ulcers, stages I & II, comprise about 75% of the total number of
ulcers observed, leaving 25% as more severe or stage III and IV ulcers.
When the pressure ulcer is severe and not treated aggressively it can lead to further disability
such as decreased mobility and loss of independence, surgical interventions, fatal infections
and even amputations (Krause 1998). It has been estimated that 7-8% of those who develop
20-1
pressure ulcers will die from related complications (Richards et al. 2004). Due to the increasing
life expectancy for those who sustain an SCI, the risk of developing pressure ulcers is even
greater; thus making prevention a priority and a daily concern for individuals with SCI and health
care providers.
20.1.3 Risk Factors
Prevention of pressure ulcers requires recognizing risk factors. The number of risk factors that
have been associated with pressure ulcers post-SCI is numerous and yet there is limited
evidence that with more understanding of these risk factors a decrease in pressure ulcer
incidence will occur (Salzberg et al. 1996). Many risk assessment tools in existence were
designed for the general population and for this reason their “predictive value” is imprecise in
the SCI population and those that have been developed for use in the SCI population need
more study (Consortium for Spinal Cord Medicine 2000).
Risk factors that have been identified most often include: limitiation in activity and mobility, injury
completeness, moisture from bowel and bladder incontinence, lack of sensation, muscle
atrophy, nutritional status and being underweight (DeLisa & Mikulic 1985; Bryne et al. 1996;
Krause et al. 2001). Studies have also found that those most likely to develop pressure ulcers
are male, have lower levels of education, are unemployed and do not practice standing (Bryne
et al. 1996; Schryvers 2000; Ash 2002; Richards et al. 2004). Other risk factors include:
smoking (Lamid & Ghatit 1993; Salzberg et al. 1996; Niazi et al. 1997; Krause et al. 2001), the
number of comorbidities especially renal, cardiovascular, pulmonary disease and diabetes
(Salzberg et al. 1996; Niazi et al. 1997; Ash 2002); autonomic dysreflexia (Salzberg et al. 1996),
anemia and hypoalbuminenia (Delisa & Mikulic 1985; Scivoletto et al. 2004); spasticity and a
history of previous ulcers (Vidal & Sarrias 1991; Bryne et al. 1996). Identifying the significant
risk factors associated with pressure ulcer development and being able to predict which
individuals are most at risk are key elements of prevention for individuals with SCI.
20.1.4 Stages (I-IV) of Pressure Ulcers
“The assessment of an individual with a pressure ulcer is the basis for planning treatments,
evaluating treatment effects and communicating with other caregivers” (AHCPR, Executive
Summary #15 p 3). One key piece of this assessment is the staging of the pressure ulcer to
classify the degree of tissue damage observed by the clinician (AHCPR 1992). In 1989, the
following staging system was recommended by the National Pressure Ulcer Advisory Panel
(NPUAP). This staging system is widely used and supported (AHCPR 1992; Consortium of
Spinal Cord Medicine 2000; RNAO 2002).
Since 1989, the following staging system has been used consistently in the literature. However,
authors of earlier studies have used numerous ways of documenting the severity of pressure
ulcers making it challenging to draw parallels between studies.
Stage 1: Observable pressure-related alteration of intact skin, which may include changes in
skin temperature, tissue consistency and/or sensation.
Stage 2: Partial thickness skin loss involving epidermis, dermis or both. The ulcer is usually
superficial and presents clinically as an abrasion, blister or shallow crater.
Stage 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that
may extend down to, but not through, underlying fascia. The ulcer presents clinically as deep
crater with or without undermining of adjacent tissue.
20-2
Stage 4: Full thickness skin loss with extensive destruction, tissue necrosis or damage to
muscle, bone or supporting structures e.g. tendon joint capsule. Undermining and sinus tracts
also may be associated with stage 4 ulcers. (NPUAP-2003)
Stage 1 pressure ulcers may be difficult to observe in darkly pigmented skin. It is also not
possible to accurately determine the stage of a pressure ulcer with eschar present (AHCPR
1992). Another type of pressure ulcer which has been identified has been called a deep tissue
injury (Ankrom et al. 2005). This is a pressure related injury to subcutaneous tissues under
intact skin which initially looks like a bruise but may go on to develop a stage III—IV pressure
ulcer. Current staging systems do not address this issue making tracking difficult (Ankrom et al.
2005).
20.1.5 Prevention
Preventing pressure ulcers is ultimately the best medicine. Lifelong prevention

recommendations include: examining skin daily to allow for early detection of a pressure ulcer;
shifting body weight in bed and wheelchair on a regular basis independently or with assistance;
keeping moisture accumulation to a minimum and cleaning and drying skin promptly after
soiling; having an individually prescribed wheelchair, pressure reducing cushion and power tilt
mechanism if manual pressure relief is not possible; ensuring all equipment is maintained and
functioning properly; decreasing or stopping smoking and limiting alcohol intake (Consortium for
Spinal Cord Medicine 2000). Krause et al. (2001) notes that effective prevention strategies
require the individual with SCI to take responsibility for his/her skin care.
Whenever possible, individuals who are at risk for pressure ulcer development or who are being
treated for a pressure ulcer should be referred to a registered dietician for assessment and
intervention as necessary (Keast et al. 2006). Eating a well balanced, nutritionally complete diet
with appropriate calories, proteins, micronutrients (vitamins and minerals) and fluids is essential
and such a nutrition plan must be individualized based on the assessed needs (Consortium for
Spinal Cord Medicine 2006; Keast et al. 2006). If a pressure ulcer were present, the plan would
need to be optimized using foods, supplements and/or enteral nutrition if warranted (Keast et al.
2006). The individual’s weight must be monitored as an undesirable weight trend has been
identified as an early indicator of risk (Keast et al. 2006). Further information on nutrition can be
found in the section on Nutrition and SCI.
The following potential preventative techniques found in the SCI literature have been reviewed
and discussed in the following section: effect of electrical stimulation on ischial pressures and
blood flow, pressure relief practices, wheelchair cushion selection, effect of lumbar support
thickness on ischial pressures, behavioral contingencies, telerehabilitation, and specialized
seating clinics.
20.1.6 Treatment
Once a pressure ulcer has begun it is important to prevent if from worsening and ultimately to
have it heal quickly. As previously stated, severe pressure ulcers can lead to further disability,
surgery, amputations and death (Krause 1998). According to Chen et al. (2005) pressure ulcers
are among the leading cause of unplanned rehospitalization post-SCI and can contribute to
longer length of stays and more costly treatment than other medical conditions. Once an
individual has had an ulcer they are at increased risk for recurrence (Krause & Broderick 2004).
Pressure ulcer treatment is more costly than prevention (Bogie et al. 2000; Jones et al. 2003).
20-3
Research has looked at the effect of: electrical stimulation, laser, US/UVC, non-thermal pulsed
electromagnetic energy and anabolic steroid therapy for healing of pressure ulcers post-SCI.
Each of these treatments will be discussed in subsequent sections.
20.2 Prevention
20.2.1 Effects of Electrical Stimulation on Reducing Ischial Pressure Post-SCI
Electrical stimulation has been used since the 1960’s to enhance healing of various chronic
wounds including pressure ulcers on both the able bodied and spinal cord injured individual
(Kloth & Feeder 1988; Baker et al. 1996, Bogie et al. 2000). More recently electrical stimulation
has been studied to assess its potential for pressure ulcer prevention post-SCI.
Given that the primary cause of pressure ulcers is felt to be externally applied pressure over
bony prominences such as ischial tuberosities (Bogie et al. 1995), researchers have studied the
role of electrical stimulation in reducing ischial pressures and redistributing seating interface
pressures both of which could assist with pressure ulcer prevention (Bogie et al. 2006).
Prevention studies are focusing on skin vs muscle stimulation, dynamic vs long-term effects and
surface vs implanted devices (Levine et al. 1990; Bogie et al. 1995; 2000; 2006).
Table 20.1 Effects of Electrical Stimulation on Reducing Ischial Pressure Post-SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=7, f=1; age at start 1. Overall, with chronic neuromuscular
of study: 27 to 47; SCI; ASIA score: 56.70 electrical stimulation (NMES), mean
Bogie & Triolo 2003; to 113.40 interface pressure showed no
USA Treatment: The exercise regimen included significant differences between
Downs & Black score=13 3 different stimulation patterns. Duration of baseline and post exercise levels.
Pre-post exercise were varied over the 8 wk training 2. Mean ischial region interface pressure
N=8 period as the muscles became conditioned. had a uniform tendency to decrease
post exercise assessment, p<.01.
Population: SCI ; Age:21-56, SCI 1. The difference between resting and
Ferguson et al. 1992; Treatment: A 2-channel neuromuscular stimulated pressures at ischia were
Scotland (UK) stimulator with surface electrodes was statistically significant (p<.001) for 8/9
Downs & Black score=12 used to apply stimulation to the quadriceps patients. Mean pressure drop with
Case Series 30 minutes/day for at least 5 days/week. stimulation was right (44mmHg) and
N=9 left (27mmHg).
Discussion
Two articles were found that examined the effects of electrical stimulation on ischial pressure
(Ferguson et al. 1992; Bogie & Triolo 2003). Bogie and Triolo (2003) have studied changes in
interface pressure distribution at the support/surface interface following 8 weeks of chronic
electrical stimulation (NMES) delivered via an implanted neuroprosthesis. With chronic NMES,
mean ischial regional interface pressure had a uniform tendency to decrease post exercise
assessment, p<.01.
Ferguson et al. (1992) applied dynamic functional electrical stimulation (FES) to the conditioned
quadriceps muscles of 9 subjects. In 8/9 of these individuals, the difference between resting
and stimulated pressures at the ischia were significant (p<.001). The mean pressure drop with
stimulation was right (44mmHg), left (27mmHg).
While it is difficult to compare these results because one study used chronic NMES versus
dynamic FES, it does appear that electrical stimulation decreases ischial pressures. More
20-4
research is needed to study the effect of electrical stimulation on reducing ischial pressures and
whether this leads to prevention of pressure ulcers post SCI.
Conclusion
There is limited level 4 evidence that electrical stimulation decreases ischial pressures
post SCI.
Electrical stimulation may decrease ischial pressures.
20.2.2 Electrical Stimulation for Promoting Tissue Health by Increasing Local Blood Flow
to Tissues at Risk for Pressure Ulcer Formation Post-SCI
As was stated previously, researchers are focusing on the effects of electrical stimulation, which
may have a role in pressure ulcer prevention post-SCI. One such effect under investigation is
changes in blood flow to skin and muscle. Bogie et al. (2006) state that with increasing
interface pressures over bony prominences, regional blood flow is adversely affected. It is
believed that by increasing regional blood flow, tissue health would be enhanced assisting with
pressure ulcer prevention (Levine et al. 1990; Bogie et al. 1995; 2000; 2006).
Table 20.2 Electrical Stimulation for Increasing Tissue Blood Flow Post-SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=7, f=1; age at start 1. Baseline mean unloaded tissue
of study: 27 to 47; Level of injury: C5/6 to oxygen levels increased by 1-36% at
T9; ASIA score: 56.70 to 113.40; Ht: 1.65 post exercise assessment for 5/8
Bogie & Triolo 2003;
to 1.88 meters; Wt: 18.30 to 32.10. subjects.
USA
Treatment: Electrical stimulation delivered 2. Differences between baseline and post
via an implanted neuroprosthesis, which exercise tissue oxygen levels did not
Pre-post
included gluteal electrodes, 8 weeks of show any statistical significance.
N=8
conditioning exercises followed.
Outcome measures: Transcutaneous
Oxygen Levels (PTCO2)
Population: Age: range 18-57yrs; Site of 1. Experiment 1: Subsequent
ulcer= sacral n=7, heel n=2, other n=1; experiments were performed using 75
Ulcer grade: 1-4, SCI volts as no additional effect on
Treatment: Study was carried out on SCI trancutaneous oxygen tension (PTCO2 )
pts lying on egg crate mattresses. Sensor was seen when 100 volts was used.
was applied to the skin at approximately 2. Experiment 3: No change in PTCO2
the second sacral segment along the with simulated high voltage pulsed
midline using a two sided airtight seal. 2 galvanic stimulation (HVPGS).
Mawson et al. 1993; USA electrodes and conductive sponges, 3. Experiment 4: No significant
Downs & Black score=10 measuring 4 cm in diameter were used for differences were observed (p=0.66 in
Case Series administering electrical stimulation. all comparisons) when experiment 2
N=29 Outcome measures: PTCO2 and 4 results were compared.
4. Experiment 4: Compared to final
baseline PTCO2 reading (mean ± SD)
of 49±21mmHg, the level reached at
the 30min period of HVPGS was
66±18 mmHg -- 35% higher
(p<0.00001).
20-5
Score
Methods Outcome
Research Design
Total Sample Size
5. The level fell slightly following the first
15 minutes post stimulation period
(p<0.00001).
Discussion
Mawson et al. (1993) administered high voltage pulsed galvanic stimulation (HVPGS) to 29 SCI
subjects lying supine. Baseline transcutaneous oxygen tension (PTCO2) levels were compared
to levels reached at the end of 30 minutes of HVPGS. The authors found PTCO2 level at the end
of stimulation was 66±18 mmHg – 35% higher (F=39.42, p<.00001).
Bogie and Triolo (2003) administered 8 weeks of neuromuscular electrical stimulation (NMES)
to 8 subjects using gluteal electrodes. They then assessed unloaded gluteal tissue blood flow
through assessment of local transcutaneous oxygen levels (PTCO2). While the results did not
reach statistical significance, baseline mean unloaded tissue oxygen levels increased by 1-36%
in 5/8 subjects.
Given the very limited evidence to date, more research is needed to determine the effect of
various forms of electrical stimulation on increasing blood flow to tissue at risk for pressure ulcer
development post-SCI.
Conclusion
There is level 4 evidence that electrical stimulation may increase blood flow at sacral and
gluteal areas post-SCI.
Electrical stimulation may increase blood flow to tissues. More research is needed to see if
increasing blood flow to tissues will help prevent pressure ulcers post-SCI.
20.2.3 Pressure Relief Practices on Pressure Ulcer Prevention Post-SCI
Teaching individuals with spinal cord injuries to shift their weight regularly is an important aspect
of pressure sore prevention in rehabilitation. The absence of such health promoting behaviors
places the person with SCI at higher risk for pressure ulcers (Krause 1998). Bogie et al. (1995)
stated that pressure relief “includes lifting the whole ischial region clear of the seating surface
for about 30 seconds or leaning forward or side to side as far as possible for 1-2 minutes”
(p141). The techniques chosen depend on the physical and cognitive status of the individual.
When a manual weight shift cannot be performed, an alternative is mechanical reclining or using
a power tilt wheelchair. Pressure relief should be optimally performed every 15-30 minutes
(Consortium for Spinal Cord Medicine 2000).
Table 20.3 Pressure Relief Practices on Preventing Ulcers Post-SCI

Score
Methods Outcome
Research Design
Total Sample Size
Coggrave & Rose 2003; Population: Gender: f=13, m=33; Age:20 1. Mean duration of pressure relief
UK to 83 required to raise tissue oxygen to
20-6
Score
Methods Outcome
Research Design
Total Sample Size
Downs & Black score=14 Duration of injury: 5 wks-50yrs unloaded levels was 1 min 51 sec
Case Series SCI, Frankel grade A-D (range 42 secs-3½ mins).
N=50 Treatment: Retrospective chart review 2. Leaning forward with elbows or chest
Outcome Measures: Effect of pressure on knees leaning from side to side and
relief TCPO2 tilting back in wheelchair to > 65o were
all effective for pressure relief (raising
TCPO2 to unloaded levels) and more
easily sustained for most individuals
than a pressure lift.
3. Resulted in a change in practice at the
seating clinic.
Population: Gender: m=9, f=1; Age: 22 to 1. Average pressure in the resting seated
67; SCI position were 189mmHg for point
Time since injury 1mth to 7yrs pressure area and 114mmHg for the
Treatment: Subjects sat upright in circumscribed area.
Henderson et al. 1994; o
wheelchair in neutral position; tipped 2. When patients were in the 65
USA
backward at 35o & 65o; assisted to lean backward tip position there was a 47%
forward (>45o from wheelchair backrest). reduction in maximum point pressure
Case Series
Pressures were measured at ischial and 36% for the circumscribed area
N=10
tuberosity (IT) (point pressure) and pressure. (p<0.05).
circumscribed area around IT. 3. In the leaning forward position there
Outcome Measures: Pressure levels was a 78% reduction in maximum
point pressure and a 70% reduction in
circumscribes area (p<0.05)
Discussion
There are very few studies that have researched which techniques provide adequate pressure
relief and how long a weight shift must be performed to unload weight-bearing areas such as
the ischia.
Coggrave and Rose (2003), in a retrospective chart review of 46 SCI subjects seen in a seating
clinic, assessed the duration of various pressure relief positions required for loaded
transcutaneous oxygen tension (TCPO2) to recover to unloaded levels. Results indicated that it
took approximately 2 minutes of pressure relief to raise tissue oxygen to unloaded levels for
most subjects. This length of pressure relief was more easily sustained by the subjects leaning
forward, side to side or having the wheelchair tipped back at > 65º compared to a pressure relief
lift.
Henderson et al. (1994) pressure mapped 10 SCI subjects and recorded pressures at the ischial
tuberosity (IT) and a circumscribed area around the IT. The authors then pressure mapped the
subjects with their wheelchairs tipped back at 35º, 65º and after the subjects were assisted into
a forward leaning position. Results showed that the wheelchairs tipped back at 65º and the
subjects in a forward leaning position demonstrated statistically significant pressure reduction at
the IT and circumscribed area (p<0.05) with the forward lean showing the greatest reduction
(78% reduction at IT, 70% reduction circumscribed area).
The two studies discussed, demonstrate through pressure mapping and the effect of pressure
relief on tissue oxygen levels, that a forward leaning position and having the wheelchair tipped
back at > 65º are effective pressure relief techniques if sustained for an appropriate time period,
which varies from individual to individual. Coggrave and Rose (2003) showed leaning side to
side, or doing a pressure relief lift is also effective if sustained for the appropriate length of time.
20-7
The traditional pressure relief lift (15-30sec) was ineffective in reducing tissue oxygen levels to
unloaded levels.
Conclusion
There is level 4 evidence to support the forward leaning position and the wheelchair
tipped back position (> 65º) as effective methods of pressure relief.
The type and duration of pressure relief by position changing must be individualized post-SCI
using pressure mapping or similar techniques.
20.2.4 Wheelchair Cushion Selection and Pressure Ulcer Prevention in Post-SCI
Wheelchair cushion selection is important when an individual with SCI is prescribed a

wheelchair. The purpose of the cushion is to relieve pressure along with other pressure relief
practices while the individual is seated. Bogie et al. (1995) stated that 47% of pressure ulcers
occur at the ischial tuberosities or sacrum and are therefore more likely to have been initiated
while seated. There are numerous cushions on the market, each citing specific characteristics
along with various amounts of pressure reduction that make that cushion “superior”. While
pressure reduction can be objectively measured using techniques such as pressure mapping,
clinical judgment and individual preference also have a role in a complete cushion evaluation;
these are more difficult to measure. Many factors must be assessed and no single cushion is
appropriate for every individual with SCI underscoring the need for individualized cushion
prescriptions (Garber 1985; Seymour et al.1985; Brienza & Karg 1998).
Table 20.4 Wheelchair Cushion Selection

Score Methods
Outcome
Research Design
Total Sample Size
Population: Age: 21-52 yrs; BMI: 17-32.3 1. Depth values for the SCI group↑ from
kg/m2: SCI 37.9 ± 6.5 mm to 52.5 ± 11.5 mm
Treatment: Assessed forces for 3 different (p<0.001).
surfaces (flat foam, the initial contour and 2. A significant increase was also noted
final optimized contour) with the force for the elderly group.
Brienza & Karg 1998;
sensing array (FAS) pad between the 3. The mean max depth of the final
USA
cushion and buttocks. Compared SCI to contour was deeper for the SCI group
seniors group. (p=0.016).
Case Series
Outcome Measures: Pressure mapping, 4. Mean pressure values for initial and
N=12
BMI final cushions were significantly less
than for flat cushions (p=0.006,
p=0.003 respectively).
5. BMI was significantly related to peak
and mean pressure values.
Population: Age: 16-35yrs, wt: 40.6- 1. Greatest pressure was seen under the
72.5kg, 10 cases & 10 controls. soft tissue areas of most subjects, no
Seymour et al. 1985; Treatment: 7 commercially available significant differences between the
USA cushions and 1 experimental cushion were cases and controls
Downs & Black score=13 evaluated for each subject. 2. Temperatures were lowest for gel,
Case Control Outcome Measures: Temperature and water and air cushions and highest for
N=20 pressure effects for each cushion. alternating pressure and foam
Subjects were asked to rate each cushion cushions.
as to cosmesis, handling and suitability for 3. SCI group—Greatest pressure under a
purchase. bony area occurred most often with
20-8
Score Methods
Outcome
Research Design
Total Sample Size
the Spenco cushion (90.10 ± 8.75);
controls- it occurred most often with
the Tri-pad (89.20 ±11.40) indicating
that these cushions did not compare
favorably to others.
4. There was wide variability in pressure
measurements in individual subjects
(SD=12.21 mmHg)
5. Cosmesis (83%) and handling (73%)
were related to purchase decisions
Population: Gender: m=207, f=44; SCI No statistical results reported.
Treatment: Assessment of pressure 1. The air filled cushion (Roho which was
distribution for 7 cushions. 1 of 2 used) produced the greatest
Outcome Measures: Seated Pressure pressure reduction in 51% of the
subjects.
2. A foam cushion (the stainless comfy
Garber 1985; USA
hard cushion) was effective for only
18% of the subjects even though it
Case Series
was the second most frequently
N=251
prescribed cushion.
3. More quadriplegic subjects received
the Rohos than paraplegic subjects
(55% vs 45%) while more paraplegic
subjects were prescribed the Jay
cushion (a combination of foam and
floatation materials (19%vs7%).
Discussion
Brienza and Karg (1998) had subjects sit on 3 different surfaces (flat foam, initial contour and
final contour). Interface pressures were measured using a pressure-sensing pad. Results
indicated that when SCI subjects were compared to the elderly subjects depth values increased
and the mean maximum depth of the final contour was deeper for the SCI group, suggesting
that pressure distributions for the SCI group are more sensitive to support surface
characteristics than elderly subjects.
Seymour et al. (1985) evaluated 8 cushions for pressure, temperature effects and subjective
factors influencing cushion purchase. While data indicated a wide variability in pressure
measurements in individual subjects, the air filled cushion had the best pressure readings. The
alternating pressure and foam had consistently higher temperature reading across both groups.
Garber (1985) evaluated 7 cushions based on amount of pressure reduction. The author also
looked at how frequently each cushion was prescribed to subjects with quadriplegia and
paraplegia. The roho cushion produced the greatest pressure reduction in the majority of
subjects (51%) but was prescribed more often for subjects with quadriplegia vs paraplegia (55%
vs 45%).
All 3 studies looked at various indicators of wheelchair cushion suitability, which are thought to
have a role in pressure ulcer formation. Collectively the results support the need for wheelchair
cushion prescriptions to be based on objective findings such as pressure mapping but also
clinical knowledge of the individuals and his or her subjective reports. Individualized cushion
prescriptions will optimize pressure ulcer prevention characteristics and compliance with
cushion usage.
20-9
Conclusion
There is level 4 evidence to support individualized wheelchair cushion prescriptions to

optimize pressure ulcer prevention post-SCI.
No one cushion is suitable for all individuals with SCI.

Cushion selection should be based on a combination of pressure mapping results, individual
characteristics and preference.
20.2.5 Lumbar Support Thickness on Reducing Ischial Pressures Post-SCI
Shields and Cook (1992) discussed the role spinal deformities such as kyphosis, may play in
the formation of pressure ulcers in individuals with chronic SCI. In previous research with non-
disabled subjects, they had demonstrated that the addition of lumbar support reduced highest
seated buttock pressure and was associated with a change in pelvic tilt. If those findings were
to hold true in the SCI population, the authors noted this could lead to ways to “monitor seated
postures for optimal pressure distribution” and augment electric wheelchair seating systems to
assist with pressure shifts, aiding in pressure ulcer prevention.
Table 20.5 Lumbar Support Thickness on Reducing Ischial Pressures Post-SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=20, f=16; Age: 21 1. Significantly reduced pressures were
to 52 yrs; SCI & non=SCI seen with greater thickness of lumbar
Treatment: All were seated onto a supports (2.5—7.5 cm) for controls but
pressure sensing transducer incorporated not those with SCI (p<0.0001).
into an adjustable chair. The output was 2. The highest-pressure areas were
calibrated so that eight pressure intervals greater for SCI group (p<0.05) than
Shields & Cook; 1992
were displayed. control group for all lumbar support
Outcome Measures: Pressure distribution conditions.
Case Control
3. The mean area of lowest pressure for
N=36
all support conditions was significantly
less for SCI groups than control group.
4. SCI group had significantly lower
pelvifemoral angles than control
groups in all lumbar support conditions
(p<0.05).
Discussion
Shields and Cook (1992) studied 18 SCI and able-bodied subjects to test the effect of varying
lumbar support thickness (0, 2.5, 5.0, 7.5 cm) on seated buttock pressures at the ischial
tuberosities. With the SCI group a 2% decrease in mean high pressure was seen with the 7.5
cm lumbar support compared to a 90% reduction for the control group. With the 2.5 cm and the
5 cm lumbar support there was an increase in mean high pressure of 12% and 13% respectively
compared to reductions in the control group of 25% and 80%, respectively. Surprisingly, the
findings showed that the addition of lumbar support to wheelchairs had a minimal effect on
reducing highest seated buttock pressure at the ischial tuberosities of subjects with chronic ≥ 3
years SCI. Given the minimal effect noted on reducing pressures at the IT, adding lumbar
20-10
support to the wheelchair of those with chronic SCI is unlikely to have a role in prevention of
Conclusion
There is level 3 evidence that adding lumbar support to the wheelchair of those with
chronic SCI has a negligible effect on reducing seated buttock pressures at the ischial
tuberosities.
Adding lumbar support to the wheelchairs of individuals with chronic SCI is unlikely to have a
role in pressure ulcer prevention post-SCI.
20.2.6 Effect of Behavioral Contingencies on Pressure Ulcer Prevention Post SCI
Jones et al. (2003) documented that “despite what we know about pressure ulcers and methods
of prevention, the problem persists. Little is known about why some patients do not establish
and maintain the health behaviors necessary for optimal skin care and pressure ulcer
prevention” (p. 796). The questions are, does rewarding positive prevention strategies reduce
the severity of pressure ulcers and hopefully prevent them entirely, and are the results
sustainable allowing the rewards to be withdrawn?
Table 20.6 Effect of Behavioral Contingencies on Pressure Ulcer Prevention Post SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=6, f=2; Age: 25- Study 1:
40yrs Paraplegia; Time since injury: 12- 1. Average Pressure Ulcer Scale for
20yrs. Healing (PUSH) decreased from
Interventions: Study 1-Behavioral baseline by an average of 10.5 points
Intervention: 3 primary components-health per participant (range 5.4-19.2).
plan, clinic visits and financial rewards. 2. 6 participants were hospitalized (not
Study 2- Behavioral intervention: 2 during the intervention) a total of 16
treatments components were implemented times during baseline for treatment of
Jones et al. 2003; USA
(Health plan and visits) during the initial pressure ulcers.
phase. Phase 2 - which began after the 3. Fewer hospitalizations were also noted
Pre-post
patient began to experience skin problems during the post-intervention phase
Study 1: Initial N=8
(Included visits plus payment) compared to the baseline phase.
Study 1: Final N=6
Outcome Measures: Severity of pressure Average monthly cost of care
Study 2: Initial N=4
sores were recorded at each level; Ulcer decreased from $6262.00/participant
Study 2: Final N=3
severity- classified using PUSH tool to $235.00 (US)
Study 2:
1. Mean PUSH scores decreased from
baseline by 8.3 pts (visits only) and
11.4 pts (visits & payment phase)
2. Total number of hospitalization
decreased from baseline to post
intervention phase.
Discussion
Results of study 1 showed average Pressure Ulcer Scale for Healing (PUSH) scores were lower
by 10.5 points from baseline; no hospitalizations were required and ultimately costs during the
20-11
intervention phase went from $6263.00 (US) to $235.00 (US). In the post intervention phase, 3
subjects were able to maintain the lower PUSH scores and 3 were not. In study 2, the results
were highly variable. There was a small drop in mean PUSH scores across the 3 subjects once
payments were introduced. 2 out of 3 participants showed that the PUSH scores rose again
during the post intervention phase.
Although this was a very small study, the data from study 1indicates that when behavioral
contingencies were introduced, positive behaviors resulted. For some participants results were
sustainable once behavioral contingencies were withdrawn. More research is needed to
determine the role of behavioral contingencies in pressure ulcer prevention post-SCI.
Conclusion
There is very limited level 4 evidence to suggest that the introduction of behavioral
contingencies are associated with a reduction in pressure ulcer severity and decreased
health care costs.
Research is needed to determine the role of behavioral contingencies in pressure ulcer

prevention post-SCI.
Research is needed to determine more fully why some individuals adhere to pressure ulcer
prevention strategies and others do not.
20.2.7 Telerehabilitation and Pressure Ulcer Management Post SCI
“Telerehabilitation is the use of telecommunication technology to deliver rehabilitation services

at a distance” (Vesmarovich et al. 1999; p 264). Telerehabilitation allows visual and verbal
interaction between the individual with SCI and the health care provider. Impaired mobility and
distance to specialized SCI centers often make follow up care difficult for individuals with SCI
(Mathewson et al. 2000; Galea et al. 2006). Telerehabilation has the potential to deliver
medical rehabilitation, nutritional and psychosocial elements of health care at a distance
facilitating continuity of care. Pressure ulcer management is one area where telerehabilitation is
being used (Galea et al. 2006).
Table 20.7 Telerehabilitation and Pressure Ulcer Management Post SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: ~35 yrs 1. Overall it was found that the video
Treatment: videoconferencing was used to group reported the largest number of
assist patients in treating and monitoring ulcers, followed by the standard care
pressure ulcers. group and the telephone group.
Outcome Measures: number of pressure 2. The standard care group reported the
ulcers, emergency room (ER) visits, lowest number of ER visits,
Phillips et al. 1999; USA
hospitalization, doctor’s visits annually and hospitalization, and health care
employment rate provider visits.
Case Control
3. The numbers of visits were similar for
the other two groups.
4. Over half the members of each group
had no hospitalizations during the
study period. It was also noted that
26% of the subjects had returned to
work 6 mths after injury.
20-12
Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=8; Age: 38-78yrs; No statistical results reported
SCI 1. Subjects were seen approx 7 times
Treatment: The outpatient nurse using the (range 1-18 visits).
Vesmarovich et al. 1999;
Picasso Still Image Videophone conducted 2. 7 wound sites healed completely, 2-
USA
weekly telerehabiliatation visits. Subjects needed surgery.
and family members received 30 min of 3. Subjects and family were highly
Case Series
education; equipment was sent home with satisfied
N=8
subjects. Interviews were conducted to
determine level of satisfaction
Discussion
Vesmarovich et al. (1999) described the use of telerehabilitation delivered via a videophone
system that transmitted still images and audio to treat stage III/IV ulcers. While no statistical
results were reported, 7 out of 12 ulcer sites healed.
Philips et al. (1999) using the same videophone system divided SCI participants into 3 groups.
The video group had the highest number of identified and or reported ulcers. The annualized
data for emergency room (ER) visits, hospitalizations and health care visits were similar for the
video and telephone groups while hospitalizations and visits were less in the standard care
group. No differences were significant at p<0.05.
Results of these two small studies fail to support the use of telerehabilitation in delivery of cost
effective prevention strategies and early pressure ulcer identification and treatment. More
research is needed to determine how telerehabilitation can be used to deliver and monitor
compliance with pressure ulcer prevention strategies as well as its use in identification and
treatment of pressure ulcers post SCI.
Conclusion
The data collected to date does not support a role for telerehabilitation in prevention and
treatment of pressure ulcers post SCI. More research is needed to explore its
usefulness.
Telerehabilitation’s role in delivering prevention education and treatment to those individuals

with SCI living in the community is not yet proven.
20.2.8 The Effect of Specialized Seating Clinics on Pressure Ulcer Prevention Post-SCI
Developing the ability to maintain skin integrity and prevent pressure ulcer formation is an
important component of any SCI rehabilitation program. Education for prevention includes an
emphasis on taking personal responsibility for maintaining healthy skin through personal care,
inspection of skin, pressure relief and correct use of prescribed equipment (Bogie et al. 1995).
The incorporation of seating clinics into both the inpatient and outpatient rehabilitation program
has been shown to reduce the incidence of pressure ulcers and readmission rates due to
pressure ulcers (Dover et al. 1992). Seating clinics not only provide education but also make
recommendations for appropriate seating systems based on interface pressures, thermography
20-13
and assessment of tissue viability. Verbal and visual feedback is provided to the individual with
SCI and active participation is encouraged (Dover et al. 1992; Coggrave & Rose 2003; Kennedy
et al. 2003).
Table 20.8 The Effect of Specialized Clinics on Pressure Ulcer Prevention

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=37, f=13; Age:16- 1. Significant differences were identified
74 yrs , SCI, between group 1 & 3 at both NAC 1
Treatment: Postural assessment took (p<0.05) and NAC 2 (p<0.01).
place while the individual adopted their 2. Skin management “to be achieved”
usual posture in the wheelchair. Physical scores were significantly lower for
alignment was documented and correct patients who had attended specialized
Kennedy et al. 2003; UK
positioning of adjustable parts of the chair seating assessment clinic (SSA)
was checked. Any abnormal posture was before their first NAC at both time
Cohort
then checked for correct ability and the set- points.
N=50
up of the seating was adjusted where 3. Significant differences were also
required. observed between the skin
Outcome Measures: Skin management management “to be achieved” scores
subscale of the Needs Assessment at the first & second NAC within all
Checklist (NAC) to assess skin groups: Group 1 (p<0.0001), groups 2
management rehab (p<0.01) & group 3 (p<0.01)
Discussion
Kennedy et al. (2003) studied 50 individuals with SCI participating in a comprehensive

rehabilitation program. The individuals were divided into 3 groups to determine if attendance at
a specialized seating assessment clinic (SSA) would improve skin management ability as
evidenced by lower “ to be achieved” scores on the skin subscale of the Needs Assessment
Checklist (NAC); optimal timing of attendance at the SSA was also studied. Results indicated
significant differences between group 1 (attendance at SSA prior to NAC 1) and group 3 (no
attendance at SSA) at both NAC 1 (p<0.05) and NAC 2 (P<0.01). Skin management “ to be
achieved” scores were significantly lower for individuals who attended SSA before their first
NAC at both time points. Significant differences were also observed between “ to be achieved”
scores at first and second NAC within all groups: Group 1(p<0.0001), Group 2 (p<0.01) and
Group 3 (p<0.01). Results indicate that attendance at a SSA did improve individual’s skin
management abilities and that early attendance was optimal. The results also indicate that
attendance at SSA is an adjunct to the skin management abilities learned during a
comprehensive rehabilitation program. More research is needed to determine if early
attendance at an SSA translates into prevention of pressure ulcers over time.
Conclusion
There is Level 2 evidence showing that early attendance at specialized seating

assessment clinics (SSA) increases the skin management abilities of individuals post-
SCI. More research is needed to determine if early attendance at an SSA results in
pressure ulcer prevention over time.
Early attendance at specialized seating assessment clinics should be part of a comprehensive

rehabilitation program.
20-14
20.3 Treatment
20.3.1 Electrical Stimulation for Pressure Ulcer Healing Post-SCI
The use of various forms of electrical current in augmenting tissue repair was reported as early
as the 1600’s when charged goldleaf was used to prevent scarring in smallpox survivors (Kloth
& Feedar 1988). The therapeutic effects of electrical stimulation for wound healing has been
well documented since the 1960’s especially for wounds not responding to standard forms of
treatment (Kloth & Feeder 1988; Baker et al. 1996; Bogie et al. 2000).
One theory as to why electrical stimulation is effective in promoting wound healing includes the
possibility that the electrical current promotes migration of cells such as epithelial,
macrophages, neutrophils and fibroblasts-galvanotaxis (Feedar et al. 1991; Baker et al. 1996;
Bogie et al. 2000). Under normal circumstances there is a flow of charged particles from an
uninjured area to an injured area triggering a biological repair system. The belief is that
application of exogenous electrical current should be able to enhance healing in non healing
wounds by mimicing the body’s own healing system. (Carley & Wainapel 1985; Baker et al.
1996). A second theory believes that application of electric current activates cutaneous nerves
and creates a centrally mediated increase in circulation to the wound thereby promoting healing
(Baker et al. 1996). Despite the usage of electrical stimulation to promote wound healing, there
remains a lack of clear understanding as to how it works to repair tissue (Bogie et al. 2000).
Some of the effects of electrical stimulation on wound healing include decreased healing time,
increased collagen synthesis, increased wound tensile strength, increased rate of wound
epithelialization and bactericidal effects (Kloth & Feedar 1988). Electrical stimulation has also
been shown to improve tissue perfusion and reduce edema formation indirectly stimulating
healing by improving oxygen delivery to tissues (Houghton & Campbell 2001). The studies on
electrical stimulation for wound healing have looked at low intensity direct current, high voltage
pulsed direct current, and alternating current. The literature shows a high variability as to which
protocols are the most effective for a specific patient or ulcer (Bogie et al. 2000).
The use of electrical stimulation to promote closure of pressure ulcers when combined with
standard wound interventions has been recommended in both the able bodied and spinal cord
injured individual. Most studies discuss the role of electrical stimulation in pressure ulcers which
have failed to respond to standard treatments and electrical stimulation is seen as an adjunctive
modality to standard wound treatments (Consortium of Spinal Cord Medicine 2000; Keast et al.
2006; AHCPR1992).
Table 20.9 Electrical Stimulation for Pressure Ulcer Healing Post-SCI

Score
Methods Results
Research Design
Total Sample Size
Population: age: 10 to 74yrs; duration of 1. Percentage of change decreased in
SCI: 4 to 1,820 wks; Ulcer duration: 1- the wound surface area (WSA)
116wks; Treatment: Patients with pelvic exhibited by the HVPC group was
(sacral/coccygeal or gluteal/ischial) ulcers greater than placebo group at day 5
Griffin et al. 1991; USA
received high voltage pulsed direct current (p=.03), day 15 (p=.05) and day 20
PEDro=7
(HVPC) or placebo HVPC for one hour a (p=.05)
RCT
day for 20 consecutive days. All patients
N=20
received equivalent dressing changes.
Wounds were mechanically debrided as
necessary. “Efforts” were made to relieve
pressure, but this was not described.
20-15
Score
Methods Results
Research Design
Total Sample Size
Outcome Measures: Pressure Ulcer
Status
Population: Age: 21 to 60 yrs; Ulcer 1. Surface area of pressure ulcers of IDC
surface area: approx 15.8mm ; Ulcer group decreased by 22.2% versus
Adegoke & Badmos
location: trochanter & sacrum; SCI 2.6% in placebo IDC group.
2001;
Treatment: Stimulation with interrupted 2. Most of the decrease in surface area
Nigeria
direct current (IDC) and nursing care or occurred during the first two weeks of
PEDro=6
placebo IDC and nursing care; 3-45 minute the study (IDC group 13.3 ± 14.1, %
RCT
treatments three times/week for 4 weeks. change 15.8; placebo IDC group 15.1
N=7
Outcome Measures: Surface area of ± 3.6, % change 1.9)
pressure ulcers
Population: Age: 17 to 76; Gender: m=66, 1. No statistical differences were noted
f=14; SCI Complete, incomplete; Total between the initial or discharge ulcer
number of wounds: 192. areas or in the mean healing rates
Treatment: Stimulation of A (asymmetric among the four treatment groups.
biphasic), vs B (symmetric biphasic) vs 2. Comparing the descriptive data by
microcurrent (MC) group originally thought classifying them as good or poor
to incorporate stimulation below effective healing responses failed to identify any
level became the 3rd treatment group when statistically significant differences
some early therapeutic effect was noted. between the 2 groups.
Baker et al. 1996; USA
All remained on their stimulation protocols 3. When looking at the good response
PEDro=4
until their ulcers healed, the MD intervened group, the group A protocol was most
RCT
or subject withdrew from study. Control effective as compared to the MC and
N=80
group received sham for 4 wks then were C protocols (p<0.05). No significant
entered into either A or B groups. Electrical differences were found between B
stimulation treatment for all subjects protocol and other treatments.
consisted of 1.5 hrs of stimulation 4. Those in the control group who had
5/days/wk wounds healed by either protocol A or
Outcome Measure: Pressure ulcer status B showed that the healing rate was
greater (43.3% ± 12.5% Δ/week) than
it was during the control period (9.7%
± 3.4% Δ/week).
Population: Not described 1. The healing rate for the AC group (N =
Treatment: Currents were applied across 42) was significantly better than the
the wounds by a pair of self-adhesive skin other two groups DC (N=12), CO
Stefanovska et al. 1993; electrodes. Low density (DC) group (N=34) p=0.003, after excluding those
Slovenia (N=18) treated with low-density direct with very deep, superficial or long term
Downs & Black=14 currents (600µA) for two hours daily. AC wounds.
Prospective Controlled group (N = 82) were treated with low
Trial frequency pulsed currents for two hours
N=150 daily. CO group (N=50) received
“conventional” treatment (not described) for
the first month.
Outcome Measures: Pressure Ulcer
Status
Discussion
Griffin et al. (1991) showed the efficacy of high voltage pulsed direct current (HVPC) for the
healing of pelvic pressure ulcers in subjects with SCI. When compared with the placebo group,
the subjects healed with HVPC showed a greater percentage of change decrease in wound
surface area (WSA) at day 5 (p=.03), day 15 (p=.05) and day 20 (p=.05). Several studies also
reported similar finding (Stefanovska et al. 1993; Baker 1996; Adegoke & Badmos 2001).
Stefanovska et al. (1993) showed that the healing rate for wounds treated with low frequency
pulsed current (AC) was significantly better than the groups treated with direct current or
conventional treatment alone (p=.003). Baker (1996) showed that for ulcers that responded to
20-16
any form of electrical simulation (“good responses”), asymmetric biphasic stimulation (group A)
was most effective for enhanced wound healing. Wounds that were already showing healing in
the control group, with the addition of either protocol A or B (symmetrical Biphasic) showed that
healing rate was greater (43.3% ± 12.5% Δ/ week) when compared to control period (9.7% ±
3.4% Δ/ week). Adegoke and Badmos (2001) showed that the surface area of grade IV pelvic
pressure ulcers treated with interrupted direct current (IDC) and nursing care decreased by
22.2% versus 2.6% in the placebo group.
While there were differences in the type and duration of electric current applied in the 4 studies,
they all demonstrated that when used in conjunction with standard wound management,
electrical stimulation did accelerate the healing rate of pressure ulcers in patients with SCI.
More research is needed to determine which type of electric current and application protocol will
be most useful to enhance healing of pressure ulcers post-SCI.
Conclusion
There is level I evidence from 2 studies to support the use of electrical stimulation to
accelerate the healing rate of stage III/IV pressure ulcers when combined with standard
wound management.
Electrical stimulation should be added to standard wound management to promote healing of

Stage III/IV pressure ulcers post-SCI.
20.3.2 Laser Treatment for Pressure Ulcer Healing Post-SCI
The Consortium for Spinal Cord Medicine (2000) reviewed the literature on adjunctive wound
therapies including laser and did not find enough supporting evidence to recommend laser for
the treatment of pressure ulcers in individuals with SCI. No controlled clinical trials involving
pressure ulcers and laser were found and existing data specific to treatment of pressure ulcer
with laser in the SCI population was minimal. The two studies presented in this document
support the conclusion of the consortium.
Table 20.10 Laser Treatment for Pressure Ulcer Healing Post-SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=27, f=8; Age: 8 to 1. Overall no significant differences were
65 yrs, Stage of ulcers: 55 stage 2, 8 stage found between the control and
3, 3 stage 4 treatment groups. 14 ulcers healed
Treatment: Treatment for the experimental completely compared to 18 in the
group consisted of multi-wavelength light treatment group (p<0.802)
Taly et al. 2004; India therapy (gallium-aluminum arsenide laser 2. The mean time taken to heal was 2.45
PEDro=10 source) in addition to conventional ± 2.06 weeks in the treatment group
RCT treatment. For the control group, the light and 1.78 ± 2.13 in the control group
N = 64 (ulcers) in 35 therapy source was held over the ulcer (p<0.330).
patients after switching off the beam. 14 treatments 3. Multi-wavelength light therapy reduced
were given, 1 every other day,3 X per the time taken by a small subgroup
week. Treatments ended when the ulcer (N=4) of stage three and four ulcers to
healed or after the 14 treatment exposures reach stage two, 2.25 ± 0.5 weeks;
Outcome measures: number of ulcers control group (N=5) it took 4.33 ± 1.53
that healed. weeks. (t=2.621, p=.047)
20-17
Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: 15 to 61; Gender: m=16, 1. US/UVC and laser treatment with
f=2; SCI; Urinary tract infection: n=16 US/UVC showing greater effect on
Treatment: Control group received wound healing than laser or control.
“standard” wound care consisting of twice Mean percentage of change per week
daily cleansing with Hygeol (1:20) and in ulcer size (±1 SD) from day 0 to
Nussbaum et al. 1994;
Jelonet dressing, and avoidance of complete healing for control (32.4%),
Canada
pressure on existing ulcers; Laser group US/UVC (53.5%), and laser (23.7%)
PEDro=6
received standard wound care plus laser 2. Several subjects showed deterioration
RCT
treatment 3x weekly; Ultrasound/Ultraviolet over the study. Ulcers increased in
C (US/UVC) group received standard size; (laser=3, 62-167% change;
wound care with US and UVC treatments control =1, 58% change; US/UVC=1,
alternating over a 5 day period. 1% change). All ulcers healed by end
Outcome measures: Pressure ulcer of study with last ulcer healed in laser
status group by week 20 as opposed to
US/UVC group at week 6.
Discussion
Taly et al. (2004) studied 35 subjects (64 ulcers) using multi-wavelength light therapy compared
to “standard” wound care alone. Overall no significant differences were found between the two
groups with regard to the number of ulcers healed and time taken to heal. Both of these studies
demonstrated that laser treatment was no more effective in promoting wound healing than
standard wound care alone post-SCI.
Nussbaum et al. (1994) studied 16 patients and compared standard wound care alone to
standard care combined with either laser or Ultrasound/Ultraviolet C (US/UVC). Results
showed that laser treatment combined with standard wound care had the least effect on wound
healing compared to the control group and US/UVC group. A significant difference was found
between the US/UVC and laser group with the US/UVC treatment showing the greater effect on
wound healing.
Conclusion
There is level 1 evidence (from two RCTs) to suggest that laser treatment has no added
benefit in pressure ulcer healing post-SCI than standard wound care alone.
Laser treatment does not improve pressure ulcer healing post-SCI.
20.3.3 Ultrasound/Ultraviolet C for Pressure ulcer healing Post-SCI
Houghton and Campbell (2001) note that both ultrasound (US) and ultraviolet light C (UVC)
have been used in the treatment of chronic wounds. Ultrasound acts mainly at the
“inflammatory stage of the wound healing cascade to stimulate the release of chemical
mediators of cells which in turn produces changes in the amount and strength or integrity of the
scar tissue” (p464). The bactericidal effects of UVC suggest that it is indicated for the treatment
of chronic infected wounds where there is much surface bacteria or where bacteria have
become resistant to antibiotic therapy. The authors go on to say that there is research to
support the positive effects of these two treatments for chronic wounds. The Consortium of
20-18
Spinal Cord Medicine (2000) found minimal data specific to the use of US or UVC to treat
pressure ulcers in SCI. One small RCT will be discussed that combined US/UVC and
compared its effects to laser and standard wound care.
Table 20.11 Ultrasound/Ultraviolet C for Pressure Ulcer Healing Post-SCI

Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: 15 to 61; Gender: m=16, 1. Healing rate was not equal under all
f=2; SCI; Urinary tract infection: n=16 treatment conditions
Treatment: Subjects were assigned into 2. Paired comparisons showed the
one of three groups: control group received significant difference was between
“standard” wound care consisting of twice US/UVC and laser treatment with
daily cleansing with Hygeol (1:20) and US/UVC showing greater effect on
Jelonet dressing, and avoidance of wound healing.
Nussbaum et al. 1994; pressure on existing ulcers; Laser group 3. Mean percentage of change per week
Canada received standard wound care plus laser in ulcer size (±1 SD) from day 0 to
PEDro=6 treatment 3x weekly; Ultrasound/Utraviolet complete healing for control (32.4%),
RCT C (US/UVC) group received standard US/UVC (53.5%), and laser (23.7%)
N=16 wound care with US and UVC treatments 4. Several subjects showed deterioration
alternating over a 5 day period. over the study. Ulcers increased in
size; (laser=3, 62-167% change;
control =1, 58% change; US/UVC=1,
1% change). All ulcers healed by end
of study with last ulcer healed in laser
group by week 20 as opposed to
US/UVC group at week 6.
Discussion
In one small RCT (n=16) Nussbaum et al. (1994) demonstrated that when compared to
standard wound care alone or laser combined with standard wound care, Ultrasound/Ultraviolet
C (US/UVC) plus standard wound care showed a greater effect on wound healing in a shorter
period of time. As US/UVC were alternated over 5 days and seen as one treatment,
conclusions cannot be drawn as to the individual effects of US or UVC. More research is
needed to study the effects of US and UVC (alone or in combination) on pressure ulcer healing
post-SCI.
Conclusion
There is level 1 evidence, from 1 small RCT, to suggest that combining US/UVC with
standard wound care decreases wound healing time of pressure ulcers post-SCI.
US/UVC should be considered as an added treatment when pressure ulcers are not healing
with standard wound care post-SCI.
20.3.4 Effects of Non-Thermal Pulsed Electromagnetic Energy Treatment for Healing of

Pressure Ulcers Post SCI
Keast et al. (2006) in updating best practices recommendations for the prevention and treatment
of pressure ulcers, recommends considering electromagnetic fields as one adjunctive modality
20-19
for stimulating closure of chronic non-healing pressure ulcers. Salzberg (1995) states that the
effect of non-thermal pulsed electromagnetic energy (PEE) on wound healing has been studied
though not in the spinal cord population hence the rationale for his study.
Table 20.12 Non-Thermal Pulsed Electromagnetic Energy for Healing of Pressure Ulcers
Post-SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: Stage II group: age 24-69 yrs 1. Stage II group:Treatment (N=10),
Treatment: A non-thermal pulsed high control (N=10). After 1 week, the
frequency, high peak power, treatment group had a greater
electromagnetic energy (PEE), was percentage of ulcer healed (84%)
delivered through a treatment head placed compared to the control group (40%),
in light contact with the wound site and p=.01 and the median size of ulcer
tuned to resonance in the area of the was also smaller at one week (2.7
wound. Treatment was non-invasive and versus 16.5 cm2, p=.015).
delivered through wound dressings for 30 2. For complete healing, the treatment
minutes, twice daily for 12 weeks or until group healed in a median of 13 days
Salzberg 1995; USA
healed. The control group received 12 versus 31.5 days for the controls
PEDro=8
weeks of sham treatment. (p<.001).
RCT
Outcome Measures: Pressure Ulcer 3. Given that there were more large
N=30
Status ulcers (>60cm2) in the sham group,
data was reanalyzed for 15 subjects
with ulcers <60cm2 with similar results
as found initially.
4. Stage III group: Treatment N=5,
control N=5. 3/5 healed with an
average of 43 days of treatment. 0/5
healed in control group. Ulcer area
decreased by average 70.6% versus
20.7% in control group.
Discussion
One RCT was found that studied the effects of electromagnetic energy on pressure ulcer
healing in patients with SCI. Salzberg (1995) evaluated the effects of non-thermal pulsed
electromagnetic energy (PEE) for healing of stage II/III ulcers in patients with SCI. In the stage
II treatment group (N=10), a greater proportion of ulcers healed (84%) after 1 week versus
control (40%), p=.01. For complete healing, the treatment group healed in a median 13 days
versus 31.5 days for controls (p<.001). Given that there were a larger number of ulcers with
size >60cm2 in the sham group, the data was reanalyzed and results obtained were consistent
with initial findings that the treatment group showed a greater proportion healed at one week
(p=.002) and the number of days to fully healed was less (p=.007). In the stage III group,
healing was also associated with PEE treatment. 3/5 healed on average within 43 days; while
0/5 healed in control group. Ulcer area decreased 70.6% versus 20.7% in control group.
More research will be needed to further our understanding of the mechanism of action of PEE
and its role in pressure ulcer healing in individuals post-SCI.
Conclusion
There is level I evidence from one RCT to support the efficacy of pulsed electromagnetic
energy to accelerate healing of stage II/III pressure ulcers post-SCI.
20-20
Pulsed electromagnetic energy improves wound healing in Stage II and Stage III
20.3.5 Anabolic Steroid Agents for Healing of Pressure Ulcers Post-SCI
Impaired nutritional status and decreased nutritional intake are significantly associated with
development and healing of pressure ulcers (Consortium for Spinal Cord Medicine 2000).
Spungen (2001) stated that use of anabolic steroids and increased protein intake have been
associated with promoting anabolism, weight gain and in turn wound closure in burn patients.
Since a “hypermetabolic, potentially catabolic state also is associated with pressure ulcers” (p
140), the use of an anabolic steroid agent may also promote closure of nonhealing, pressure
ulcers in the SCI population.
Table 20.13 Anabolic Steroid Agents for Healing of Pressure Ulcers Post-SCI
Score
Methods Outcome
Research Design
Total Sample Size
Population: Age: 24 to 73 yrs; SCI m=9; 1. After oxandrolone and glutamine
Total # of PU since SCI: 1 to 7. treatment, 8/9 subjects were
Spungen et al. 2001;
Treatment: subjects with stage III/IV completely healed, the majority within
USA
pressure ulcers were treated with 20mg of 3-6 months. 2 subjects required 12
oxandrolone daily with 20g of glutamine months of treatment for complete
Case Series
dissolved in orange juice. Pressure ulcer healing.
N=9
care and support surfaces remained
consistent
Discussion
In a case series of nine subjects with stage III/IV pressure ulcers, Spungen et al. (2001)
demonstrated complete healing in 8/9 subjects 3-12 months after administration of 20mg
oxandrolone. Given that this is only one small case series, more research is needed to
determine the role of anabolic steroid agents (oxandrolone) for promotion of healing of stage
III/IV pressure ulcers post-SCI.
Conclusion
There is very limited level 4 evidence to support the use of anabolic steroid agents
(oxandrolone) to promote healing of stage III/IV pressure ulcers post-SCI.
Anabolic steroid agents may promote healing of serious pressure ulcers post -SCI.
20.4 Summary
Numerous studies cited in this document have spoken to the fact that pressure ulcers, though
largely preventable, are still a common, potentially serious lifelong secondary complication of
SCI. Pressure ulcers have the potential to impact overall quality of life (Consortium for Spinal
Cord Medicine 2000); disrupt rehabilitation, vocational and educational pursuits and community
20-21
reintegration (Fuhrer et al. 1993; Krause 1998; Consortium for Spinal Cord Medicine 2000;
Jones et al. 2003); and lead to increased hospital readmission rates with longer length of stays
(Chen 2005). Pressure ulcer prevention is more cost effective than treatment (Bogie et al.
2000; Jones et al. 2003). Despite the attention given to prevention strategies, pressure ulcers
are still occurring.
Of the 21 articles found for this review only 7 are RCTS and those studies have all looked at
ways to treat ulcers once they have occurred. This author has not found any level 1 or 2
evidence to support the prevention strategies discussed in this document, most of which are
being recommended for use by individuals post SCI in rehabilitation and after discharge to the
community.
Given the human and economic costs of pressure ulcer formation post SCI, more quality
research needs to be done on all aspects of pressure ulcer management, especially prevention
so that solid evidence is available to individuals with SCI, their families and health care
providers so they know what works and what does not work. Pressure ulcers are potentially
preventable.
There is limited level 4 evidence that electrical stimulation decreases ischial pressures
post SCI.
There is level 4 evidence that electrical stimulation may increase blood flow at sacral and
gluteal areas post-SCI.
There is level 4 evidence to support the forward leaning position and the wheelchair
tipped back position (> 65º) as effective methods of pressure relief.
There is level 4 evidence to support individualized wheelchair cushion prescriptions to

optimize pressure ulcer prevention post-SCI.
There is level 3 evidence that adding lumbar support to the wheelchair of those with
chronic SCI has a negligible effect on reducing seated buttock pressures at the ischial
tuberosities.
There is very limited level 4 evidence to suggest that the introduction of behavioral
contingencies are associated with a reduction in pressure ulcer severity and decreased
health care costs.
The data collected to date does not support a role for telerehabilitation in prevention and
treatment of pressure ulcers post SCI. More research is needed to explore its
usefulness.
There is Level 2 evidence showing that early attendance at specialized seating

assessment clinics (SSA) increases the skin management abilities of individuals post-
SCI. More research is needed to determine if early attendance at an SSA results in
pressure ulcer prevention over time.
There is level I evidence from 2 studies to support the use of electrical stimulation to
accelerate the healing rate of stage III/IV pressure ulcers when combined with standard
wound management.
20-22
There is level 1 evidence (from two RCTs) to suggest that laser treatment has no added
benefit in pressure ulcer healing post-SCI than standard wound care alone.
There is level 1 evidence, from 1 small RCT, to suggest that combining US/UVC with
standard wound care decreases wound healing time of pressure ulcers post-SCI.
There is level I evidence from one RCT to support the efficacy of pulsed electromagnetic
energy to accelerate healing of stage II/III pressure ulcers post-SCI.
There is very limited level 4 evidence to support the use of anabolic steroid agents
(oxandrolone) to promote healing of stage III/IV pressure ulcers post-SCI.
20-23
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CHAPTER TWENTY-ONE
Spasticity Following Spinal Cord Injury
Jane TC Hsieh, MSc

Dalton L Wolfe, PhD
Sandra Connolly, BHScOT(C), OT Reg (Ont.)
Armin Curt, MD FRCPC
Jeff Blackmer, MD FRCPC
Keith Sequeira, MD FRCPC
Jo-Anne Aubut, BA
Key Points
Rhythmic passive movements may produce short-term reductions in spasticity.
Prolonged standing or other methods of producing muscle stretch may result in

reduced spasticity.
Active exercise interventions such as hydrotherapy and (FES) functional electrical

stimulation-assisted walking may produce short-term reductions in spasticity.
Electrical stimulation applied to individual muscles may produce a short term

decrease in spasticity. There is also some concern that long-term use of electrical
stimulation may increase spasticity.
Ongoing (TENS) transcutaneous electrical nerve stimulation programs result in short-

term reductions in spasticity which may last for up to 24 hours.
Penile vibration and rectal probe stimulation may be effective at reducing lower limb
muscle spasticity for several hours.
Other forms of afferent stimulation including massage, cryotherapy, hippotherapy and

helium-neon irradiation may result in immediate spasticity reduction but require more
research to examine long-term effects.
Spinal cord stimulation may provide spasticity relief over a few months but long-term
effectiveness and cost-effectiveness is less certain.
Dorsal longitudinal T-myelotomy may result in reduced spasticity.
Oral baclofen reduces muscle spasticity in people with SCI.
Bolus or long-term intrathecal Baclofen decreases spasticity and may improve

functional outcomes with low complication rates and is a cost effective intervention.
Tizanidine, Clonidine, Cyproheptadine and Gabapentin may be useful in treating SCI

spasticity.
The usefulness of Diazepam, Dantrolene, 4-Aminopyridine, L-Threonine and Cannabis

in the treatment of SCI spasticity requires confirmation through additional well
designed studies.
Well designed studies should include effective outcome measures that meet minimum
standards and that encompass the range of medical outcomes relevant to the
treatment and the patients.
Table of Contents
21.1 Introduction ..................................................................................................................21-1
21.2 Non-Pharmacological Interventions for Spasticity...................................................21-1

21.2.2 Interventions Based on Active Movement (Including FES-assisted Movement).........21-5
21.2.3 Interventions Based on Direct Muscle Electrical Stimulation ......................................21-7
21.2.5 Interventions Based on Direct Spinal Cord Stimulation ............................................21-18
21.3 Neuro-Surgical Interventions....................................................................................21-20
21.4 Pharmacological Treatment of Spasticity ...............................................................21-22

21.4.1 Oral Baclofen ............................................................................................................21-22
21.4.2 Intrathecal Baclofen for Reducing Spasticity ............................................................21-25
21.4.3 Effect of Medications Other than Baclofen on Spasticity after SCI ...........................21-32
21.4.4 Neurolysis with Botulinum Neurotoxin ......................................................................21-42
21.5 Spasticity Outcome Measures..................................................................................21-45
21.6 Summary.....................................................................................................................21-47
References............................................................................................................................21-50
Hsieh JTC, Wolfe DL, Connolly S, Townson AF, Curt A, Blackmer J, Sequeira K, Aubut J (2006). Spasticity Following
Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC,
Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 21.1-21.56.
www.icord.org/scire
Spasticity Following Spinal Cord Injury
21.1 Introduction
Spasticity has been described as being “inclusive of velocity-dependent increases in tonic

stretch reflexes, exaggerated phasic stretch reflexes, hyperactive cutaneous reflexes, increased
autonomic reflexes, and abnormal postures that are the result of excessive involuntary motor
activity reacting to excitatory stimuli” (Young 1989; 1994). Pandyan et al. 2005 (adapted from
Tardieau et al. 1954) has proposed a new definition of spasticity as follows: “disordered
sensori-motor control, resulting from an upper motor neurone lesion, presenting as intermittent
or sustained involuntary activation of muscle”. This definition is more inclusive of clinical signs
and symptoms of “spasticity” but has yet to be validated for clinical relevance.
It has been estimated that 53% (Walter et al. 2002) to 78% (Maynard et al. 1990; Levi et al.
1995) of individuals report spasticity secondary to SCI. Furthermore, approximately 41% (Levi
et al. 1995) of these individuals with spasticity secondary to chronic SCI list it as one of the
major medical obstacles to community and workplace re-integration (CPA WPNS 1996).
Although a variety of management strategies are currently available for the treatment of
spasticity in spinal cord injury, an assessment of treatment goals and costs is necessary initially.
Often, increased spasticity is beneficial for transfers and mobility and the reduction of tone may
negatively impact those activities of daily living. The goal should not be to modify the excitability
and rigorousness of reflexes, but to overcome functional impairments related to “spasticity”
(Dietz 2000). Therefore, the decision to treat “spasticity” should not only be based on the
findings gained by the examination in a passive (lying bed, sitting in the wheelchair) but also in
an active condition (like walking, doing transfer etc.). Incrementally applying the less invasive
and cost efficient treatments will likely lead to a combination of treatments necessary to achieve
the most successful outcome specific for each individual. Simultaneously with the completion of
an assessment that clearly delineates the treatment goals, objective measures of spasticity are
important to identify in order to confidently assess the success of treatment choice(s).
Physical therapy, surgery, pharmacotherapy and neurolysis are among the most common
treatment options currently employed to manage spasticity in SCI. Physical therapy is initiated
during rehabilitation and usually continues post-discharge either formally or through patient
education and caregiver administration. Pharmacotherapies are thought to be the most
efficacious for treatment of the velocity-dependent increase in hyperexcitable tonic stretch
reflexes, one component of the upper motor neuron syndrome defined by Lance (1980).
Surgery and neurolysis may be necessary to treat focal spasticity. A combination treatment
regimen can be individualized and appears to be a common approach in clinical practice.
21.2 Non-Pharmacological Interventions for Spasticity
As noted above, there are a wide variety of approaches in treating spasticity. It is generally
accepted practice to employ more conservative approaches initially and gradually administer
more invasive treatments with the understanding that no one approach is likely to be universally
successful for all individuals (Kirshblum 1999). However, some have contended that this
stepwise approach is not necessarily the ideal. For example, Gormley Jr. et al. (1997) have
asserted that in the hands of an experienced clinical team, it may be decided that aggressive
21-1
measures are needed early on based on the individual presentation and the many factors that
may influence spasticity. Regardless, effective clinical management requires an individualized
and often a combination approach, thereby necessitating a broad knowledge of the various
options available. In the present section, non-pharmacological interventions are outlined - from
the more conservative options such as passive and active movement-based interventions, to
those based on forms of electrical and other types of stimulation and finally to more invasive
neurosurgical interventions.
For the purpose of this review we have classified the various non-pharmacological approaches
into 6 general categories. These include interventions based on i) passive movement, ii) active
movement, iii) direct muscle electrical stimulation, iv) various forms of afferent stimulation, v)
direct spinal cord stimulation and vi) neuro-surgical approaches. It should be noted that
although we have tried to be as specific as possible within these distinctions, there may be
some overlap across the categories for specific modalities. For example, passive movements
produce afferent outflow and may have also been classified as a form of afferent stimulation.
Hydrotherapy, classified as an active movement-based intervention given the bouyancy and
viscous properties of water in aiding active movement exercise (Kesiktas et al. 2004), often
involve passive movements as well as the contributions of afferent stimulation associated with
heated water. We have tried to categorize the approaches based on the primary intent of the
authors in describing the various interventions. In addition, when considering final conclusions
we have tried to be as specific as possible within each category, despite the obvious need to
bring together evidence from different sources.
21.2.1 Interventions Based on Passive Movement or Stretching
It has been reported that self-stretching, regular physiotherapy and physical activities affect
spasticity and should be considered as a therapeutic approach prior to antispastic medication
and surgical procedures (Merrit 1981). In particular, therapies based on physical interventions
are advantageous as they generally have fewer related adverse events although they also
typically have short-lasting effects. Movement therapies can be differentiated into passive or
active maneuvers that are assumed to affect both spinal neuronal circuits and fibro-elastic
properties of the muscles, thereby potentially reducing spasticity. An underlying physiologic
paradigm that explains why passive movements have an influence on spasticity in patients with
a lesion of the upper motor neuron is equivocal (Katz 1991).
Passive movement may be accomplished by therapist or self-mediated limb movement focusing

on muscle stretching or on preserving full range of motion over joints that may be immobilized.
Alternatively, a mechanical device may be employed such as a motorized therapy table (Skold
2000) or exercise cycle (Kakebeeke et al. 2005; Kiser et al. 2005). These mechanical devices
have the advantages for research purposes of producing repeatable movements over a specific
range and also in standardizing other parameters (e.g., frequency, speed).
Although it has been suggested by some that repetitive movements are deemed necessary for
obtaining a clinical effect (Rosche et al. 1997), there have been several reports of reduced
spasticity associated with engaging in regular periods of passive standing (Odeen & Knutsson
1981; Bohannon 1993; Kunkel et al. 1993; Dunn et al. 1998; Eng et al. 2001; Shields & Dudley-
Javoroski 2005). The majority of these are individual case reports (Bohannon 1993; Kunkel et
al. 1993; Shields & Dudley-Javoroski 2005) or user satisfaction surveys (Dunn et al. 1998; Eng
et al. 2001) and have not been included in Table 21.1 (i.e., other than Odeen & Knutsson, 1981)
which outlines the specific investigations of effectiveness of these “passive” approaches. The
individuals examined in all 3 case reports reported reductions in lower limb spasticity associated
21-2
with passive standing despite the fact that different procedures and devices were used across
the reports including a tilt table (Bohannon 1993), a standing frame (Kunkel et al. 1993) and a
stand-up wheelchair (Shields & Dudley-Javoroski 2005). In addition, a significant number of
people have indicated they receive benefit with respect to reduced spasticity in response to
surveys about prolonged standing programs. Specifically, Eng et al. (2001) reported that 24%
and Dunn et al. (1998) reported that 42% of individuals engaged in this activity find it beneficial
in reducing spasticity. However, it should be noted that in each of these studies some
individuals also reported an increase in spasticity with this activity (13% and 3% respectively).
Table 21.1 Studies of Passive Movement-based Approaches for Reducing Spasticity

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=39, f=6, age: 17- 1. Spasticity decreased after each
47, time since injury: 3-26 years, ASIA: A- intervention session as indicated by
D, cervical-thoracic injuries. (Passive VAS (p<0.001) and MAS (p<0.001).
stretches performed on n=12, thoracic 2. Spasticity reductions were maintained
ASIA C, D). in VAS values (albeit to a lesser
Treatment: Repetitive passive movements degree) after treatment was
Sköld 2000; Sweden
of standardized range of motion in 3 discontinued for 4 days (p<0.018).
different positions administered with
Pre-post
motorized table, 10 minutes per position,
N=45 (Passive stretches
20-30 movements/minute, 2 sessions/week
peformed on n=12)
for 6 weeks.
Outcome Measures: self-reported Visual
Analogue Scale (VAS): "no spasticity" to
"most imaginable spasticity", modified
Ashworth scale (MAS), collected just prior
and after each treatment session.
Population: Gender m=9, f=1, Age 23 to 1. 6/10 subjects estimated that their
60 yrs, Injury level C6 to T12, ASIA: A & B, spasticity was less after cycling and
1-25 years post-injury (median 2 years). 3/10 estimated it was less after no
Kakebeeke et al. 2005;
Treatment: Passive cycling with motorized cycling.
Switzerland
cycle for 30 minutes at 40 RPM (1 session) 2. No effect on spasticity was noted as
vs no cycling. indicated by no differences with torque
Pre-post
Outcome Measures: Torque resistance to before and after cycling or before and
N=10
movement on isokinetic dynamometer, after the control (no cycling) condition.
subjective subject assessment collected
just prior and following cycling (or control).
Population: Gender m=8, f=1, Age 21 to 1. Average reduction in resistance to
67 yrs, > 3 years post-injury. passive movement at 1 cycle/s was
Treatment: Standing in forced dorsiflexion 32%, 26% and 17 % for standing in
or plantarflexion (i.e., load applied) vs dorsiflexion, standing in plantarflexion
Odeen & Knutsson 1998; stretch applied to plantarflexors while and supine dorsiflexion respectively.
Sweden supine. 30 minute sessions 2. Greater reductions were seen at 1
Downs & Black score=12 Outcome Measures: Torque resistance cycle/s than at 0.25 cylce/s, although
Pre-post and angular displacement to sinusoidal significant reductions were still seen
N=9 ankle movement as measured by strain for both conditions of dorsiflexion
gauge transducer and potentiometer stretch (i.e., standing and supine) at
respectively. EMG recorded for some the slower test speed.
subjects as well. All collected just prior and
following treatment.
Discussion
Kakebeeke et al. (2005) employed externally applied repetitive cycling movements to the lower
limbs with a specifically adapted motorized exercise bicycle. This study employed an
21-3
experimental non-RCT design with each subject acting as his or her own control (i.e., cycling vs.
no cycling 1 week apart). However, it involved only a single intervention session and no
clinically relevant outcome measures were employed. In addition to a self-report measure of
“more”, “less” or “equal” amounts of spasticity, a Cybex II isokinetic dynamometer was used to
measure torque resistance to 2 different speeds of knee flexion/extension. The majority of
subjects tested (i.e., 6 of 10) reported subjectively that their spasticity was reduced following
cycling; however, some subjects (i.e., 3 of 10) also indicated it was reduced following the control
(no cycling) condition. No changes were seen for either condition with the objective torque
resistance response to movement. Given the mixed results of this study and uncertainty of the
clinical relevance of the outcome measures the findings of this study are deemed equivocal.
Although a weaker study design (i.e., Pre-Post Trial), Sköld (2000) employed a more rigorous
methodology with clinically relevant outcome measures (i.e., modified Ashworth and a self-
report visual analogue scale) and an intervention administered over 6 weeks. This intervention
involved the evaluation of standardized, repetitive passive movements of prone and supine hip
flexion/extension and lumbar lateral flexion elicited by a motorized table in a subset of subjects
with ASIA C and D paraplegia. These subjects were drawn from a larger study examining self-
vs. clinically rated spasticity fluctuations. Results of the study indicated that there was a
significant reduction in the modified Ashworth Score and also a significant decrease in the self-
report measure of spasticity immediately following passive movement. In addition, it was
reported that these reductions in spasticity were partially maintained when self-report
assessments (but not clinical evaluations) were conducted 4 days following the discontinuation
of the intervention.
Odeen and Knutsson (1981) employed a tilt table and 9 subjects with spastic paraparesis due to
spinal cord lesions to examine whether benefits of reduced spasticity with passive activity were
due to increased muscle load or muscle stretch. These investigators examined the effect of
various conditions on resistance to passive sinusoidal ankle movement by loading the tibialis
anterior or gastrocnemius while standing by having the subject stand at an angle of 85º with the
ankle dorsi- or plantarflexed by 10-15º or by applying stretch to the gastrocnemius muscles
while supine. All procedures tested resulted in reduced resistance to passive movement (i.e.,
reduced tone or spasticity) with the most significant reductions noted for standing in forced
dorsiflexion with load applied (i.e., stretch applied to calf muscles, p<0.001) (Odeen & Knutsson,
1981).
Conclusion
There is level 4 evidence that rhythmic, passive movements may result in a short-term
reduction in spasticity.
There is level 4 evidence that externally applied forces or passive muscle stretch as are
applied in assisted standing programs may result in short-term reduction in spasticity.
This is supported by individual case studies and anecdotal reports from survey-based
research.
Rhythmic passive movements may produce short-term reductions in spasticity.

Prolonged standing or other methods of producing muscle stretch may result
in reduced spasticity.
21-4
21.2.2 Interventions Based on Active Movement (Including FES-assisted Movement)
Physical therapy approaches are often advocated as the first treatment choices for reducing
spasticity and are deemed as the foundation upon which other therapies are built (Merritt 1981;
Kirshblum 1999; Rosche 2002). Despite these contentions, there is a relative paucity of
literature addressing the efficacy of either the passive techniques noted in the previous section
or approaches involving active movement. In practice, active movement approaches may be
conducted using a variety of exercise forms that may also provide benefits beyond spasticity
reduction (e.g., strength, endurance, gait re-training). The studies meeting the criteria for the
present review involve exercises performed in a therapeutic pool (i.e., hydrotherapy) (Kesiktas
et al. 2004) or those associated with locomotor training programs, whether assisted by FES
(Granat et al. 1993; Mirbagheri et al. 2002) or a FES-powered orthosis (Thoumie et al. 1995).
Table 21.2 Studies of Active Movement-based Approaches for Reducing Spasticity

Score
Methods Outcome
Research Design
Total Sample Size
Population: gender m=20, f=1, age: 20- 1. No group analysis reported for
53, level of injury: C8-T12, time post-injury: spasticity measure – No marked
4-72 months (mean 26 months). changes reported, decrease in
Treatment: Fitting of a Reciprocating Gait spasticity for 7 subjects at 0.5-5 hours
Orthosis II (RGO) hybrid (FES-assisted) and increase in spasticity for 4
system and subsequent locomotor training subjects at 0.5-1 hour. No long-term
Thoumie et al. 1995;
program of 2 – 1 hour sessions/week for 3- effects were observed.
France
14 months.
Outcome measures: Spasticity
Pre-post
(Subjective self-report scale based on
N=21
Ashworth scale), Cardiovascular function
(HR, VO2, blood lactate), Constipation
(Radiopaque markers transit).
Osteoporosis (Bone mineral density)
collected prior to and following the 3-14
month trial.
Population: Groups: Hydrotherapy vs 1. Both groups showed a significant
Control, gender m/f = 8/2 vs 7/3, age = decrease in Ashworth scores
32.1 vs 33.1 years, level of injury: C5-6/T8- (hydrotherapy = p<0.01 and control =
9 = 3/7 vs 3/7, ASIA: A/B-C/D = 3/3/4 vs p<0.02) with hydrotherapy having a
3/3/4, time post-injury = 7.7 vs 8.6 years. larger reduction in spasticity but this
difference was not significant.
Treatment: 20 min of underwater 2. Spasticity was significantly reduced
exercises at 71°F, 3 times/week for 10 with hydrotherapy (p<0.001) and with
Kesiktas et al. 2004;
weeks in addition to conventional Control (p<0.05) as indicated by Penn
Turkey
rehabilitation (passive ROM exercises, oral Spasm Severity. Post-treatment
baclofen, psychotherapy) vs conventional hydrotherapy scores were reduced vs
Experimental Non-RCT
rehabilitation alone. Controls (p<0.02).
N=20
3. Oral baclofen intake was significantly
Outcome Measures: Ashworth Scale, reduced for the hydrotherapy group
Penn Spasm Severity, FIM scores and oral but not for the control group (p<0.002).
baclofen intake were recorded weekly and 4. Both groups demonstrated significant
evaluated at the beginning and end of the increases in FIM scores (hydrotherapy
treatment period. = p<0.0001 and control = p<0.01), with
a larger increase for the hydrotherapy
group (p<0.001).
Mirbagheri et al. 2002; Population: gender m=5, f=4, age: 25- 1. Spasticity was reduced in those that
Canada 48.9, level of injury: C5-L1, ASIA: C-D, time did FES-assisted walking as indicated
Downs & Black score=17 post-injury: 3.1-12.3 years. (1 unplanned by reductions in decreased reflex
Pre-post control, dropout from training) (p<0.001) and intrinsic (p<0.001)
(1 unplanned control, Treatment: FES-assisted walking for as stiffness.
21-5
Score
Methods Outcome
Research Design
Total Sample Size
dropout from training) much time as possible during daily living 2. Spasticity increased for the non-FES
Initial N=9; Final N=5 (~1-3 hours/day) for 16-18 months subject as indicated by increased
following 4 weeks of training. reflex stiffness and no change in
Outcome measures: Reflex and intrinsic intrinsic stiffness.
stiffness (mathematical modelled 3. The modified Ashworth score either
responses of torque resistance to showed no change following the
movement), modified Ashworth scale training period or was not collected
collected prior to and following the 16-18 (this was not clearly presented by the
month trial. authors).
Population: 6 incomplete SCI (3 males, 3 1. Significant reductions in spasticity as
females), aged 20-40, 2-18 years post indicated by increased relaxation index
injury with lesion levels from C4 to L1, 3 of pendulum test (p<0.05).
Frankel C, 3 Frankel D. 2. No changes were evident with
Treatment: FES-assisted locomotor Ashworth scale.
training for at least half an hour each day 3. Gait and muscle strength changes are
Granat et al. 1993; for a minimum of 5 days/week for a elaborated in Chapter entitled “Lower
Scotland minimum of 3 months. Limb Rehabilitation”.
Downs & Black score=5 Outcome Measures: Spasticity (Ashworth
Pre-post Scale and Pendulum Test), Manual muscle
N=6 tests using Oxford Scale (MMT), maximum
voluntary contraction (MVC), Upright motor
control, Gait Performance (Energy Cost),
postural stability (Centre of Pressure) and
modified Barthel Index. Spasticity tests
were conducted at least 24 hours after FES
use.
Discussion
All studies demonstrated positive benefits for at least one outcome measure associated with
spasticity. However, it should be noted that results between two spasticity-related outcome
measures within some studies were not consistent and that there was also little uniformity
across studies with respect to homogeneous outcome measure selection.
Kesiktas et al. (2004) employed an experimental non-RCT design to test the effectiveness of a
water-based exercise (i.e., hydrotherapy) program in reducing spasticity in a group of individuals
(n=10) with complete and incomplete paraplegia and tetraplegia. Subjects were matched within
a treatment group (i.e., hydrotherapy + conventional rehabilitation) vs. a control group
(conventional rehabilitation only) on the basis of age, gender, time post-injury, injury level and
severity, spasticity (Ashworth) and function (FIM). This study produced consistent results across
all spasticity-related measures with spasticity reductions evident following the 10 week
hydrotherapy treatment program for both Ashworth Scale scores and the Penn Spasm Severity
scores. The control group also showed significant spasticity reductions relative to baseline with
these measures but not to the same degree. In addition to these measures, dosages of oral
baclofen were significantly reduced for those receiving hydrotherapy vs. conventional
rehabilitation only (i.e., > 50%) and the hydrotherapy treated group made much greater FIM
gains than did the control group. These latter results may reflect the deleterious effect that high
baclofen doses can have on motor and cognitive function and also the benefits of reduced
spasticity on motor function. Kesiktas et al. (2004) did not mention how soon after the final
intervention the measures were taken so there is no indication of how long the beneficial effect
might be maintained.
21-6
The remaining studies using active movement-based approaches involved pre-post trial designs
of FES-assisted walking with and without orthoses. Mirbagheri et al. (2002) calculated reflex
and intrinsic stiffness of the ankle by employing a mathematical model of position vs torque
resistance in response to perturbations as a means of assessing spasticity prior to and following
a FES-assisted walking training program. This program involved 4 individuals with longstanding
ASIA C or D SCI who participated a minimum of 16 months. Both reflex and intrinsic stiffness
were reduced following training while another individual with SCI, but not actively involved in
FES-assisted walking, demonstrated no reduction in spasticity. Although the modified Ashworth
scale was noted as an outcome measure in the Methods the authors failed to report the final
results associated with this clinical measure.
Granat et al. (1993), in a similar trial of FES-assisted walking in people with Frankel C or D
longstanding SCI, also found reductions in spasticity by employing a pendulum drop test but
were unable to show any change pre- and post-training when considering Ashworth scale
scores. Granat et al. (1993) performed the final spasticity assessment 24 hours after the final
FES-assisted walking session; thereby ensuring the final outcomes would not be unduly
influenced by the short-term effects of muscle stimulation.
Thoumie et al. (1995) examined the effects of a FES-assisted Reciprocting Gait Orthosis II
(RGO) on spasticity following a long-term program (i.e., 3-13 months) of gait training. No group
results were reported for spasticity although it appeared that no systematic effects were
obtained on a customized self-report version of the Ashworth scale. Some subjects (n=7)
reported decreases in spasticity in the short-term, while others reported increased spasticity
(n=4).
Conclusions
There is level 2 evidence that hydrotherapy is effective in producing a short-term

There is level 4 evidence that a program of FES-assisted walking acts to reduce ankle
spasticity in the short-term (i.e., ≤24 hours).
There is no evidence that describes the length and time course of the treatment effect
related to spasticity for hydrotherapy or FES-assisted walking.
Active exercise interventions such as hydrotherapy and (FES) functional electrical stimulation-
assisted walking may produce short-term reductions in spasticity.
21.2.3 Interventions Based on Direct Muscle Electrical Stimulation
A variety of electrical stimulation methods have been employed to reduce spasticity including
direct muscle stimulation, sometimes also termed patterned electrical stimulation (PES) or
patterned neuromuscular stimulation (PNS), functional electrical stimulation (FES) and
transcutaneous electrical nerve stimulation (TENS). In the present section, we will examine the
effect of interventions based on direct muscle stimulation. The objective of direct muscle
stimulation (or stimulation of the motor nerve) is to produce a muscle contraction and related
therapies are focused on the beneficial effects of series’ of muscle contractions. Often this
stimulation is cyclical in nature (patterned) so as to simulate natural physiologic conditions such
21-7
as might be seen in walking or cycling. With FES, the stimulation parameters are set to produce
a coordinated contraction of several muscles with the intent of producing purposeful movement.
This approach is often used to assist or simulate active exercise paradigms and therefore, the
articles addressing FES have been summarized in the previous section on active movement-
based approaches. TENS, on the other hand, is focused on stimulating large, low threshold
afferent nerves so as to alter motor-neuron excitability and thereby reduce spasticity.
Stimulation intensities are maintained subthreshold for eliciting muscle contraction when
stimulating mixed motor and sensory nerves so that only lower threshold sensory nerves are
selectively stimulated. For this reason articles concerning TENS will be included in the next
section that is directed towards interventions based on afferent stimulation.
Table 21.3 Studies of Direct Muscle Stimulation for Reducing Spasticity

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: m=8, f=2; age 21-42 1. Only the agonist muscle stimulation
yrs, level of injury: C3-T11, time since differed significantly (46% reduction)
injury: 28-275 months, ASIA: 9 A and 1 C. from the placebo as indicated by
Treatment: Electrical motor (agonist or reduced MAS (p<0.001)
antagonist) or afferent (S1 dermatomal) 2. No significant carry-over effect (over 2
Van der Salm et al. 2006; stimulation of the triceps surae or a hours) although there was a trend of
Netherlands placebo (application of electrodes but no continued reductions for the MAS
Downs & Black score=18 current). 1 – 45 minute session of each (p=0.113).
Prospective Controlled type of stimulation. Intensity @ 3 x motor 3. No significant intervention effect was
Trial threshold for motor stimulation and 80% of shown for the clonus score or the H/M
N=10 motor threshold for afferent stimulation. ratio.
Outcome measures: modified Ashworth 4. The reflex-initiating angle showed a
scale (MAS), clonus score, H reflex, and significant change for antagonist
H/M ratios. Measurements were conducted stimulation (n=8, p<0.015) but the
just prior to, immediately after, 1 hour after carryover effect was not significant.
and 2 hours after the intervention for each
of the 4 conditions.
Population: Age 19-73yrs, gender: m=6, 1. Spasticity was reduced in 9/10
f=4, duration of injury 3-16yrs (n=5 SCI), 1- participants (p<0.05) (p<0.05 for SCI
6 yrs (n=5 TBI). subjects only) and this was sustained
Treatment: 1, 20 minute session of for 24 hours over all subjects (p<0.01)
electrical stimulation over the tibialis but not for SCI subjects only.
Seib et al. 1994; USA anterior measured in ipsilateral (treatment) 2. Spasticity was not reduced
Downs & Black score=14 and contralateral (control) leg vs a sham immediately or after 24 hours in the
Prospective Controlled stimulation (control). contralateral leg nor with sham
Trial Outcome Measures: Viscous and elastic stimulation.
N=10 ankle stiffness measured by frequency- 3. Subjective spasticity assessment
dependent torque resistance immediately immediately post-stim only recorded
post-stimulation (n=10/9), and 24 hours notable reductions for SCI subjects for
post-stimulation (n=9/8), and immediate up to 6 hours post-simulation.
post-stimulation subjective spasticity
assessment (n=9).
Population: Age 21-62yrs, 6 paraplegics / 1. Decrease in spasticity was noted with
6 quadriplegics, complete(6)/incomplete(6) pendulum test (average R2n increased
Treatment: 1, 20 minute session of in most cases) (p<0.005).
Robinson et al. 1988; electrical stimulation of quadriceps with leg 2. The greatest reduction in spasticity
USA maintained at 60° flexion (isometric after stimulation was noted for patients
Downs & Black score=15 exercise). who were the most spastic before
Pre-post Outcome measures: Normalized stimulation.
N=12 relaxation index obtained during Pendulum 3. No carry over effect of stimulation in
test (R2n) collected prior and immediately spasticity measured 24 hours later.
after stimulation.
21-8
Score
Methods Outcome
Research Design
Total Sample Size
Population: Paraplegic (15)/quadriplegic 1. Most participants had increased
(16), complete/incomplete injuries, time spasticity after four weeks of
since injury: <1yr (15), >1yr (16). reconditioning but not after eight
Treatment: 4-8 wk quad reconditioning weeks.
Robinson et al. 1988; program of twice daily 20-minute 2. Twice as many legs had R2n
USA stimulation sessions of quadriceps, which decreases (spasticity increases) as
Downs & Black score=14 were at least 4 hours apart, six days per had increases or no change.
Pre-post week. Stimulus currents were set at 120- 3. Baseline vs 4wk left and right R2n
Initial N=31; Final N=8 160mA. yielded a significant within subject
4wk tx N=21, Outcome Measures: R2n-index of difference between baseline and 4wk
8wk tx N=8 spasticity (by means of pendulum drop values (p=0.008).
test). Peak isometric quad torque in
response to surface electrical stimulation.
Biweekly tests of spasticity and torque at
baseline, 4 and 8 weeks (1-3 evals
performed each time).
Discussion
Van der Salm et al. (2006), Seib et al. (1994) and Robinson et al. (1988a) tested the effects of a
single session of muscle stimulation on spasticity. Each employed slightly different stimulation
parameters and a variety of outcome measures. Of note, Van der Salm et al. (2006) and Seib et
al. (1994) each employed controlled trials of electrical stimulation and demonstrated immediate
effects of reduced spasticity although these effects waned and were mostly absent by the next
day. In particular, Van der Salm et al. (2006) examined 3 different stimulation methodologies vs.
a placebo condition and assessed ankle plantar flexor spasticity with the modified Ashworth
scale, a clonus score and via EMG responses (i.e., H-reflex and H/M ratio). The various
stimulation methods examined consisted of stimulation over the triceps surae (agonist), the
tibialis anterior (antagonist) and the S1 dermatome vs a control placebo condition of electrode
application but no current being generated. Presumably, subjects were not aware of this
because all subjects had no sensation in the stimulated areas. Significant spasticity reductions
were only obtained with agonist muscle stimulation for the modified Ashworth scale (p<0.001)
and not the clonus or EMG responses. This was not sustained for 2 hours post-stimulation
although there was still a trend for reduced modified Ashworth scores at this time (p=0.113).
Spasticity was also reduced (but not statistically significantly) with antagonist muscle stimulation
but not for dermatomal or sham (placebo) stimulation
Interestingly, Van der Salm et al. (2006) noted that if they had examined their data by employing
t-tests to test for pre-post effects (i.e., univariate analysis) within a specific stimulation method,
they also would have demonstrated a reduction in spasticity for antagonist muscle stimulation,
thereby illustrating the potential of obtaining false positives in uncontrolled or poorly controlled
studies. Robinson et al. (1988a) conducted a pre-post study design without control conditions
and Seib et al. (1994) conducted an experimental non-RCT with appropriate control conditions
but then inappropriately employed univariate analysis. Regardless, the results of these studies
corroborate the finding of an immediate post-stimulation effect by Van der Salm et al. (2006).
Seib et al. (1994) and Robinson et al. (1988a) employed stimulation of different muscles (tibialis
anterior, i.e., ankle dorsiflexion and quadriceps, i.e., knee extension respectively) and each
demonstrated short lasting reductions in spasticity. Similar to the findings of Van der Salm et al.
(2006), Seib et al. (1994) reported the effect of reduced spasticity waned quickly but was still
evident up to 6 hours post-stimulation (mean 4.4 hours) as indicated by subject self-report.
21-9
In the only study of the long-term effects of simulation, Robinson et al. (1988b) employed a
similar stimulation protocol for the quadriceps as noted above over a period of 4–8 weeks with
twice daily 20-minute sessions at least four hours apart, six days per week. Although 31
individuals initiated the study and 21 completed 4 weeks of the stimulation program, the study
had severe subject retention issues with only 8 individuals continuing participation for the
intended 8 weeks. Study results showed that most subjects actually had increased spasticity at
four weeks but for the subjects who remained in the study for 8 weeks there was no significant
difference. This null result begs further study of the long-term effects of muscle stimulation given
the beneficial results obtained with short-term stimulation and in reports involving individuals
with other etiologies (Chen et al. 2005; Ozer et al. 2006)
The other aspect of these studies worth noting is the variability across even just these 4 studies
with respect to outcome measure selection. Within these papers there were measures that were
clinical, neurophysiological, biomechanical and subject self-report in nature. The study with the
strongest design (i.e., Van der Salm et al. 2006) employed clinical and neurophysiological
measures with the modified Ashworth scale, clonus score and H-reflex testing. Seib et al. (1994)
employed a biomechanical approach by using a spasticity measurement system which
monitored ankle viscoelastic stiffness through measurements of resistance torque to repetitive
sinusoidal ankle movements. Robinson et al. (1988a;1988b) used a clinical/biomechanical
approach in measuring the normalized relaxation index (R2n) obtained from the pendulum drop
test. Others have noted that spasticity is a multi-faceted construct with individual components of
spasticity weakly related to each other suggesting that while different tools may measure unique
aspects of spasticity the overall construct is best measured with an appropriate battery of tests
(Priebe et al. 1996).
Conclusions
There is level 2 evidence that a single bout of surface muscle stimulation reduces local
muscle spasticity with agonist stimulation more effective than stimulation to the
antagonist.
There is conflicting evidence for how long the effects of a single bout of electrical
stimulation on muscle spasticity persist, although they appear to be relatively short
lasting (i.e., ≤ 6 hours).
There is no evidence that a long-term program of muscle stimulation has an effect on

reducing muscle spasticity and may even increase local muscle spasticity.
Electrical stimulation applied to individual muscles may produce a short term decrease in
spasticity. There is also some concern that long-term use of electrical
stimulation may increase spasticity.
21.2.4 Interventions Based on Various Forms of Afferent Stimulation
There are a variety of approaches that have been investigated which employ afferent (i.e.,
sensory) stimulation for the reduction of spasticity in people with SCI. As noted previously,
electrical stimulation, in particular TENS, is one of the preferred methods for providing afferent
stimulation. This technique differs from the approaches noted in the previous sections that
involve stimulation to the motor system, whether via muscles or motor nerves. TENS may
21-10
involve the stimulation of large, low threshold afferent nerves (Goulet et al. 1996) or dermatomal
stimulation which is directed towards cutaneous skin receptors supplying the skin in the
dermatome of the muscle of interest (Bajd et al. 1985; van der Salm et al. 2006). These
methods are aimed at altering motor-neuron excitability through sensory reflex arcs, thereby
reducing spasticity. An alternate approach employing electrical stimulation involves rectal probe
stimulation, developed originally to overcome anejaculation in males and heretofore a technique
employed only within fertility clinics (Halstead & Seager 1991).
In addition, a variety of methods of mechanical stimulation to various afferent systems have also
been studied. These include therapeutic massage over the spastic muscle (Goldberg et al.
1994), penile vibration (Laessoe et al. 2004; Alaca et al. 2005;) and hippotherapy (Lechner et al.
2003). Although the specific mechanisms by which an antispastic effect may be achieved with
hippotherapy is unkown, it is postulated that it may be brought about by the combination of the
sensorimotor stimulation, psychomatic effects and the specific postural requirements and
passive and active movements necessary for riding a horse (Lechner et al. 2003).
Finally, other sensory stimulation examined for antispasticity properties include thermal
stimulation, with the application of cold (i.e., cryotherapy) to reduce local muscle spasticity
(Price et al. 1993) and also irradiation of the skin overlying sensory nerves with a helium-neon
laser purported to induce photochemical reactions which may trigger neural activity (Walker,
1985). It should be noted that the article examining cryotherapy (i.e., Price et al. 1993) did not
meet the review criteria of having 50% of subjects with SCI. Regardless, the article was
included in the review as individual results were presented for all subjects with SCI (N=7),
enabling discernment of the effects on SCI.
Table 21.4 Studies of Various Forms of Afferent Stimulation for Reducing Spasticity
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI (n=21), chronic, complete 1. For both treatment groups a significant
and incomplete, traumatic vs health improvement was noted immediately
controls (n=20) post treatment in the lower limb
Ashworth score (p<0.011 baclofen
Treatment: Either oral baclofen (titrated up group and p<0.020 TENS group), SFS
to 80 mg/day) for 8 weeks or (p<0.014 for both groups), deep
Trancutaneous Electrical Nerve Stimulation tendon reflex score (p=0.025 for both
(TENS) for 15 minutes/day for 15 days. groups) as well as in measures of
disability (FIM - baclofen group
Outcome measures: Penn Spasm p<0.005, TENS group p<0.003; FDS--
Frequency Scale (SFS), Painful Spasm baclofen group p=0.004, TENS group
Aydin et al. 2005; Turkey Scale, Ashworth Scale, various clinical p=0.003.
PEDro = 6 (clonus, deep tendon reflexes, response to 2. In comparison with baseline, TENS
RCT plantar stimulation) or electrophysiologic showed a trend for a reduced
N=41 measures (H-reflex latency and amplitude, Ashworth immediately after the first
H/M ratio) of spasticity as well as measures treatment (p=0.059), a significant
of function (FIM and functional disability reduction immediately after the last
score (FDS)). Measures were taken pretreatment (p=0.006) and a significant
and post- first treatment (15 minutes after) but lesser reduction 24 hours after the
and 15 minutes and 24 hours after the last last treatment (p=0.020). Similar
TENS session. findings were obtained for Deep
Tendon Reflex scores. Plantar
Stimulus Response scores were only
significantly reduced immediately
following the last treatment session
(p=0.034) whereas clonus scores
21-11
Score
Methods Outcome
Research Design
Total Sample Size
were only significantly reduced
immediately following the first
treatment (p=0.046).
3. There was a significant reduction in H-
reflex maximal amplitude (p=0.032) 24
hours after the final session. This
reduction was even more apparent
when tested only 15 minutes after the
last treatment (p=0.026). There were
only small (statistically non-significant)
changes in other electrophysiologic
variables with either baclofen or
TENS.
Population: Gender: m=9, f=0, age: 27-67 1. There was a significant decrease in
yrs, time post-injury: 4 months - 50 yrs. spasticty after penile stimulation as
Level of injury: C2-T8, ASIA A – D. indicated by decreases in Modified
Treatment: Penile Vibratory stimulation for Ashworth Scale (0<0.01). This was not
5 minutes or to ejaculation. sustained at 24 hours.
Outcome Measures: Modified Ashworth 2. There was a slight reduction in the
Scale, Penn Spasm Frequency Scale, 24 Penn Spasm Frequency Scale 24
hour EMG recordings of quadriceps and hours after penile stimulation but this
Laessoe et al. 2004;
tibialis anterior activity. All collected pre- was not significant.
Denmark
stimulation and 24 hours post-stimulation. 3. There was a significant reduction in
PEDro=6
The Modified Ashworth was also collected EMG activity in the initial 3 hours after
RCT
immediately after stimulation. vibration, as compared to before
N=9
vibration (p<0.05). This was not seen
in the no-vibration condition.
4. The largest reduction in EMG activity
occurred in the first hour after
vibration, after which the events
gradually decreased until no significant
effect was observed following the 3rd
hour after vibration.
Population: Level of injury: T12-L2, time 1. No statistical comparisons reported.
since injury: > 2 years. 2. 40 s of laser irradiation and 1 hour of
Treatment: Helium-neon laser irradiation electrical stimulation similarly produce
to peripheral nerve sites (radial, median, complete suppression of clonus lasting
saphenous nerves) for 20 or 40s to each 30 and 60 minutes after cessation of
site versus a variety of control conditions stimulation.
including sham irradiation (same probe but 3. 20 s of laser irradiation and 45 min of
Walker 1985; USA
not emitting laser), irradiation to skin not electrical stimulation similarly only
PEDro=4
innervated by peripheral nerves and produce partial suppression of clonus.
RCT
electrical stimulation for 45 min or 1 hr over 4. Distal nerve irradiation or electrical
N=41
innervated and non-innervated areas. stimulation still produced clonus
(N=5-7 in various experimental groups). suppression but not when stimulation
Outcome Measures: Clonus count after was applied to skin not overlying a
brisk dorsiflexion of the foot by a blinded peripheral nerve.
registered PT before treatment and at 30-
minute intervals up to 2 hours after
irradiation.
Population: Gender: m=8, f=2; age 21-42 1. No significant difference was seen with
yrs, level of injury: C3-T11, time since S1 dermatomal stimulation. Only the
Van der Salm et al. 2006;
injury: 28-275 months, ASIA: 9 A and 1 C. agonist muscle stimulation differed
The Netherlands
Treatment: Electrical motor (agonist or significantly (46% reduction) from the
antagonist) or afferent (S1 dermatomal) placebo as indicated by reduced MAS
Pre-post
stimulation of the triceps surae or a (p<0.001)
N=10
placebo (application of electrodes but no 2. No significant carry-over effect (over 2
current). 1 – 45 minute session of each hours) although there was a trend of
21-12
Score
Methods Outcome
Research Design
Total Sample Size
type of stimulation. Intensity @ 3 x motor continued reductions for the MAS
threshold for motor stimulation and 80% of (p=0.113).
motor threshold for afferent stimulation. 3. No significant intervention effect was
Outcome measures: modified Ashworth shown for the clonus score or the H/M
scale (MAS), clonus score, H reflex, and ratio.
H/M ratios. Measurements were conducted 4. The reflex-initiating angle showed a
just prior to, immediately after, 1 hour after significant change for antagonist
and 2 hours after the intervention for each stimulation (n=8, p<0.015) but the
of the 4 conditions. carryover effect was not significant.
Population: Gender: m=6, f=3; age 21- 1. Spasticity was reduced as indicated by
41yrs, time since injury: 0.5-15yrs, Frankel: reduced Ashworth scores assessed
A=4 or B=5, Level: Quad=6, Para=3. within 1 hour post-stimulation (p<0.01).
Treatment: At least 6 sessions of Rectal 2. Spasticity relief as indicated by self-
Probe Electrical Stimulation (RPES) 6 report was for 7.8/9.5 hours
times spaced 1-4 weeks apart. Each (quad/para mean values).
session consisted of 7 or 15 stimulations of 3. No significant correlation of RPES
~1 second duration and lasted 5-10 min. effect on spasticity were seen with
Three subjects underwent a placebo with age, duration of injury, level of injury or
Halstead et al. 1993; probe insertion but no stimulation. completeness.
USA Outcome Measures: Ashworth scale, 4. In general, spasticity was reduced as
Downs & Black score=17 Penn Spasm Frequency Scale, Deep indicated by the pendulum test in the 4
Pre-post Tendon Reflexes, Ankle Clonus, Subject subjects assessed.
N=9 self-report (5 point scale) on interference of 5. SSEPs were abolished in the 2
spasticity on selected self-care activities. subjects tested following stimulation.
All were collected just prior to stimulation, 6. Probe size, number of stimuli, voltage
within 1 hour after and 2-4 hours after. and current did not reveal any
Subject self-report was collected every 2 significant correlation with the amount
hours up to 24 hours after stimulation. of relief provided.
Pendulum tests were collected on 4
subjects and somatosensory evoked
potentials (SSEPs) on 2 subjects pre and
post.
Population: Gender: m=10, f=0, age: 22- 1. There was a significant decrease in
35 yrs, time post-injury: 1.1-9 years, Level spasticty after penile stimulation as
of injury: C8-L1, ASIA A. indicated by decreases in the
Treatment: Penile Vibratory stimulation for Ashworth Scale (0<0.001). This was
6, 3 minute periods (separated by 1 significantly lower than baseline at
minute) or to ejaculation. hour 3 (p=0.001) and 6 (p=0.03) with a
Alaca et al. 2005; Turkey Outcome Measures: Ashworth Scale, trend lower at 24 hours (p=0.08).
Downs & Black score=16 Penn Spasm Frequency Scale and nominal 2. There were slight (nonsignificant)
Pre-post scales of painful spasms, plantar reductions in the Penn Spasm
N=10 stimulation response, deep tendon Frequency Scale and clonus scores at
reflexes, clonus and effect on function. All hour 3.
collected pre-stimulation and 3, 6, 24 and 3. There were no changes in painful
48 hours post-stimulation. spasms, plantar stimulation
responses, deep tendon reflexes and
effect on function scale scores with
penile vibration.
Population: Gender: m=13, f=1; age 21- 1. Significant decreases were seen in
54yrs, level of injury: C4-T12, time since clinical measures of spasticity as seen
injury: 2-194mths, ASIA: A-D. by reductions in modified Ashworth
Goulet et al. 1996;
Treatment: TENS stimulation (i.e., low (p=0.04), ATR (p=0.01), and global
Canada
threshold afferent nerve stimulation) over spasticity scores (p=0.01). A trend was
the common peroneal nerve for 30 seen with reduced clonus scores
Pre-post
minutes. (p=0.11).
N=14
Outcome measures: modified Ashworth 2. No significant effects of TENS were
scale, Clonus score, Achilles tendon reflex seen with electrophysiological
score (ATR), H-reflex amplitude, and H- measures of spasticity as indicated by
21-13
Score
Methods Outcome
Research Design
Total Sample Size
reflex/M response ratio collected just prior H-reflex amplitudes (p=0.89) and H/M
to and after TENS. H-reflex and M ratio (p=0.50).
responses were also collected during
TENS.
Population: Gender: m=9, f=1; age: 21-33 1. Significant decrease in H-reflex
yrs, level of injury: C4-T10, time since amplitude during massage as
injury: 3-11 months, ASIA: complete and compared to before and after
incomplete. (Study 2). (p=0.008). The response 3 minutes
[Study 1 N=7 (healthy controls)] after massage is somewhat reduced
Treatment: One-handed petrissage but not to the same extent as during
Goldberg et al. 1994;
(massage) applied to the belly of the the massage.
Canada
triceps surae muscle group for 3 minutes. 2. No difference between M-response
Outcome Measures: H-reflex peak amplitudes (p=0.13) or H-Reflex
Pre-post
amplitude, H-reflex latency (Study 2, SCI latencies (p=0.22) before, during or
N=17
only), M-responses collected during after massage.
massage plus 3 and 6 minutes prior and 3 3. Study 1: Verified that H-reflex
and 6 minutes after massage (10 amplitude decreases seen in controls
responses of each averaged). in supine position were also able to be
obtained in prone position which was
preferred position for SCI subjects.
Population: Gender: m=28, f=4, age: 16- 1. 93% of treatment sessions led to lower
72yrs (mean 37yrs), time since injury: 1mth Ashworth scores immediately after
to 6 yr, injury level: C4-T12, ASIA A-D. sessions.
Treatment: Hippotherapy-K® (HTK; 2. Significant decrease in muscle tone as
Lechner et al. 2003; Kuenzle 2000): An average of 11 sessions indicated by reduced Ashworth scores
Switzerland (5-24) each lasting 25-30 minutes. in the lower limbs (p<0.001).
Downs & Black score=13 Sheepskin (no saddle) on Icelander horse. 3. There was no carry-over effect from
Pre-post Outcome Measures: Ashworth scale of 8 session to session as there was no
N=32 limb movements bilaterally for a summed longitudinal trend or trend of the before
score of 16-80. Measures were taken pre and after session differences.
and post each session and the proportion 4. No significant difference between
of scores with a +ive or –ive change was para/tetraplegic subjects (p=0.4).
recorded.
Population: 25 subjects with stroke (9), SCI Results
head injury (9) and SCI (7); no information 1. Clinically significant reductions in
provided on subject details spasticity as indicated by a reduction
in total path length of 11Nm/rad or
Treatment: Cryotherapy (water and ice greater were seen in 5 of 7 subjects
placed on calf for 20 minutes). with SCI during cryotherapy and 5 of 7
one hour after.
Outcome Measures: Elastic and viscous Overall Results
Price et al. 1993 ; USA components of ankle stiffness represented 1. Reduction in spasticity as indicated by
Downs & Black score=12 by mathematical modelling of torque vs total (p=0.009) and elastic (p=0.006)
Pre-post position in response to 5° sinusoidal ankle path length resulted from cryotherapy
N=25 displacements at frequencies from 3 to 12 compared to the baseline measures.
Hz. This resulted in measures of total path 2. Significant differences between the
length associated mainly with passive baseline measure and 1 hour after
spasticity of the ankle and elastic path treatment were noted in spasticity as
length associated with viscous stiffness. indicated by elastic path length
Data was collected prior to, during and 1 (p=0.0198) but only a trend was noted
hour after cryotherapy. for total path length (p=0.058).
Bajd et al. 1985; Population: 6 in- and outpatients with 1. Group statistical analysis was not
Yugoslavia SCI, age: 11-52 yrs, time postinjury: 5-48 conducted.
Downs & Black score=10 months, level of injury: C5-T9, 4 complete, 2. In 3 patients, spasticity decreased
Pre-post 2 incomplete. markedly as indicated by increased
N= 6 Treatment: TENS stimulation over L3, 4 relaxation index values immediately
21-14
Score
Methods Outcome
Research Design
Total Sample Size
dermatomes. Stimulation amplitude of up after the stimulation and returned to
to 50mA was used and applied pre-stimulation values at 2 hours. The
continuously for 20 mins. remaining 3 individuals showed no
Outcome Measures: Pendulum test change.
(relaxation index) performed just prior to
and just after stimulation as well as 2 hours
post-stimulation.
Discussion
Aydin et al. (2005) employed a RCT design to compare oral baclofen (N=10) and TENS (N=11)
to the bilateral tibial nerves (i.e., innervating gastrocnemius muscle) in reducing lower limb
spasticity. Most important, this is the only trial examining ongoing applications of TENS. Fifteen
minute sessions of TENS were applied to the tibial nerve over 15 days demonstrating
significantly reduced spasticity as indicated by reductions in the following measures assessed
immediately after the last treatment session: Ashworth Scale, Spasm Frequency Scale, deep
tendon reflex score, FIM and Functional Disability Scores and H-reflex amplitude. In addition,
there were also some lasting effects over the next 24 hours as repeat testing the next day
indicated continued spasticity reductions although to a lesser degree. It should also be noted
that significant reductions were obtained on some measures (but not all) following a single
session. However, the long-term effects were more profound than those obtained following a
single session.
Other researchers have examined the effects of TENS following a single session (Bajd et al.
1985; Goulet et al. 1996; van der Salm et al. 2006). Goulet et al. (1996) employed a single 30
minute bout of TENS over the common peroneal nerve in an attempt to reduce plantarflexor
spasticity in 14 individuals with SCI. This study showed significant decreases in scores for the
modified Ashworth scale and the Achilles tendon reflex but no significant changes were seen for
H-reflex amplitude. A trend for decreased clonus scores was observed but this was not
statistically significant. In this trial, TENS appears to be effective in reducing spinal spasticity
following a single session.
In contrast, van der Salm et al. (2006) and Bajd et al. (1985) each examined dermatomal TENS
as opposed to direct nerve stimulation with conflicting results. Bajd et al. (1985), in a small pre-
post trial (n=6) reported reduced spasticity in 3 subjects as indicated by increased relaxation
indexes associated with the pendulum test although provided no mean data or group statistical
analysis. Van der Salm et al. (2006) conducted a more thorough analysis of the effect of a
single 45 minute session of TENS to the L1 dermatome in 10 individuals with longstanding SCI
(mostly ASIA A) and obtained no short- term effects, although as noted in the previous section
obtained benefits with motor stimulation. A critical element within these investigations of single-
session effects is the precise time of assessment, relative to treatment, a detail not always
precisely reported in the various studies, although it is clear that van der Salm et al. (2006)
assessed individuals as close as possible to treatment end.
Halstead et al. (1993) have evaluated another form of electrical stimulation, rectal
electrostimulation, when they observed patients undergoing this procedure for the purpose of
sperm retrieval reporting improved spasticity. These investigators conducted a prospective pre-
post trial examining the effects of a minimum of 6 sessions of rectal probe electrostimulation on
various clinical measures of spasticity including the Ashworth scale, Penn Spasm Frequency
21-15
Scale, deep tendon reflexes and ankle clonus. Although they achieved good to excellent effects
in more than half of the patients examined including significant reductions in the Ashworth scale
(p<0.01) and with the effects outlasting the intervention by a mean of 8.2 hours according to
patient self-report further therapeutic development of this approach has not continued.
Afferent stimulation may also be produced via mechanical means. Goldberg et al. (1994) have
employed therapeutic massage over the triceps surae muscle and assessed H-reflex amplitude
to demonstrate that ∝-motor neuron excitability is reduced significantly during a short 3 minute
period of massage and somewhat reduced 3 minutes after but not 6 minutes after. Reductions
in ∝-motor neuron excitability are indicative of decreased spasticity.
Penile vibration has also been investigated as a method of providing sensory stimulation to
reduce spasticty (Laessoe et al. 2004; Alaca et al. 2005). In particular, Læssoe et al. (2004)
employed an unblinded, crossover RCT design (N=9) in which male participants either received
penile vibration or not followed by completed the opposite condition. The modified Ashworth
scale and Penn Spasm Frequency Scale were conducted in addition to an EMG assessment in
which ongoing muscle activity was recorded over a 24 hour period. Penile vibration was shown
to be effective in reducing spasticity as indicated by reductions in modified Ashworth scale
scores (p<0.01) and a slight trend for reduced Penn Spasm Frequency Scale Scores (p=0.26).
These were not maintained over 24 hours. The EMG analysis showed that reduced muscle
activity was most apparent in the first hour post-stimulation, and had returned to baseline by 3
hours suggesting the effect lasted no more than 3 hours. The authors attempted to include
female subjects involving clitoral vibratory stimulation but were only able to recruit 2 subjects
willing to submit to the procedure. Both women reported similar reductions in spasticity although
evaluation of the effectiveness of the stimulation was more difficult (i.e., no ejaculation to guide).
The results of Alaca et al. (2005) confirmed the overall study findings as penile vibratory
stimulation in 10 males resulted in significant reductions in Ashworth Scale scores as assessed
3 hours after stimulation (p=0.001) and maintained at 6 hours (p=0.03) with a trend for reduced
values still apparent at 24 hours (p=0.08). The longer carry over effect in this study may have
been due to a prolonged stimulus period as Alaca et al. (2005) employed 6, 3 minute periods of
stimulation (separated by 1 minute) whereas Læssoe et al. (2004) used a single 5 minute
period.
Lechner et al. (2003) evaluated the short term effect of hippotherapy on the spasticity of 32
patients. The results of the study indicated that hippotherapy had a short term effect on
decreasing spasticity of the lower extremity, as demonstrated by significant decreases in muscle
tone (i.e., reduced Ashworth scores, p<0.001). Ninety-three percent of treatment sessions led to
lower Ashworth scores immediately after the session relative to the pre-session score, however
there was no carry-over effect from session to session. As noted previously, it is difficult to know
if afferent stimulation is the primary mechanism for this antispastic effect, although it is
purported as one of the contributors to any putative benefits (Lechner et al. 2003).
The short-term effect of cryotherapy was investigated by Price et al. (1993) who used a
biomechanical approach similar to that described earlier (i.e., Seib et al.1994) to monitored
ankle viscoelastic stiffness through measurements of resistance torque to repetitive sinusoidal
ankle movements. Although the majority of subjects were individuals with stroke or head injury,
5 of 7 people with SCI showed a significant reduction in spasticity both immediately following
cryotherapy and also at 1 hour after the cold stimulus was removed.
Walker (1985) employed a helium-neon laser to irradiate the skin overlying sensory nerves and
demonstrated a similar beneficial effect of suppressing clonus as seen with electrical stimulation
of sensory nerves. This investigator employed a RCT design with a variety of small group
21-16
control conditions (N=5 to 7), but failed to report several important experimental details (i.e.,
method of concealment, method of analysis and statistical comparisons). This approach has not
been investigated since this brief 1985 report.
It should be noted that several of the modalities noted in this section have not been employed in
regular clinical practice and may be deemed as more investigational in nature. For example,
helium-neon laser irradiation has only been employed in one investigation and has not been
considered as a viable therapeutic approach. Similarly, penile and rectal stimulation, first noted
as delivering potential benefits within fertility clinic investigations, may not be acceptable forms
of therapy to individuals from either a safety or a psychological perspective. Other therapies
might simply be impractical to implement. For example, hippotherapy requires access to a
suitable equine facility with appropriately trained individuals.
Conclusions
There is level 1 evidence that an ongoing program of TENS acts to reduce spasticity as
demonstrated by clinical and electrophysiological measures.
There is level 1 evidence that reductions in spasticity with ongoing programs of TENS
may persist for up to 24 hours.
There is level 1 evidence that a single bout of TENS acts to reduce spasticity but to a
lesser degree than that seen with ongoing programs of TENS. This evidence is muted
somewhat by conflicting results with a null result (level 2) compared with 2 positive
results (level 4).
There is level 4 evidence that several sessions of rectal probe stimulation reduces lower
limb muscle spasticity for up to 8 hours.
There is level 4 evidence that short periods of massage (e.g., 3 minutes) of the triceps
surae results in reduced H-reflexes with the effect lasting no longer than a few minutes.
There is level 1 evidence that a single bout of penile vibration acts to reduce spasticity
lasting for at least 3 hours and possibly up to 6 hours.
There is level 4 evidence that hippotherapy may reduce lower limb muscle spasticity
immediately following an individual session.
There is level 4 evidence that cryotherapy may reduce muscle spasticity for up to 1 hour
after removal of the cold stimulus.
There is level 2 evidence that helium-neon irradiation of sensory nerves may suppress
ankle clonus for up to 60 minutes following 40 seconds of stimulation.
21-17
Ongoing (TENS) transcutaneous electrical nerve stimulation programs result in short-term
reductions in spasticity which may last for up to 24 hours.
Penile vibration and rectal probe stimulation may be effective at reducing lower limb
muscle spasticity for several hours.
Other forms of afferent stimulation including massage, cryotherapy, hippotherapy and
helium-neon irradiation may result in immediate spasticity reduction but require
more research to examine long-term effects.
21.2.5 Interventions Based on Direct Spinal Cord Stimulation
Initial investigations of spinal cord stimulation were conducted in the early 1970’s and were
directed at individuals with multiple sclerosis (Cook & Weinstein 1973). Later studies have
examined the effect of this approach in people with SCI to enhance bladder or bowel function
and also for the relief of pain and spasticity (Richardson & McLone 1978; Illis et al. 1983;
Dimitrijevic et al. 1986a; Barolat et al. 1988). Typically, these studies employ a surgically
implanted electrode under either general or local anaesthesia placed over the dorsal columns of
the spinal cord which supplies ongoing electrical stimulation. Pinter et al. (2000) noted a
declining interest with this approach in the 1990’s because of technical concerns and “the
realization that spinal cord stimulation was less effective in patients with severe spasms of the
lower limbs (Dimitrijevic et al. 1986b; Barolat et al. 1995).”
Table 21.5 Studies of Spinal Cord Stimulation for Reducing Spasticity

Score
Methods Outcome
Research Design
Total Sample Size
Population: Gender: 90% males, age: 17- 1. Of 48 initial subjects, 40 provided
66 yrs, time post-injury: 6 –545 months data at 3 months, 33 at 6 months, 31
(mean 89.9 months), Level of injury: 67% at 1 year and 18 at 2 years. The
cervical, 33% thoracic, 53% complete, 47% remainder were discontinued due to
incomplete. lack of efficacy or lost to follow up.
Treatment: Spinal cord stimulation 2. Average # of spasms/hour improved =
following surgical implantation of the 19.9 initially, 11.3 at 3 months, 9.2 at
Medtronic Resume® electrode in the dorsal 6 months, 8.8 at 1 year and 12.9 at 2
epidural space. Stimulus parameters years.
determined in a training period 1-2 days 3. A significantly greater proportion of
after implantation typically resulted in a subjects indicated reduced severity
Barolat et al. 1995; USA therapeutic window of stimulation between scores over time with significant
Downs & Black score=15 the motor and sensory threshold. differences at 6 months (p=0.0424), 1
Pre-post Outcome measures: Average number of year (p=0.0001and 2 years
N=48 spasms, intensity of spasms and frequency (p=0.0012) relative to baseline.
of spasms. Severity score including both 4. Spasm intensity showed improvement
the intensity and frequency of the spasms. over time with the proportion of
All were collected just prior and 3, 6, 12 individuals experiencing severe
and 24 months after implantation. spasms being 83% initially,33% at 3
months, 45% at 6 months, 32% at 1
year and 28% at 2 years.
5. Subjective rating of spasm relief also
decreased with 68% of individuals
experiencing good or excellent relief
at 3 months, 69% at 6 months, 70%
at 1 year and 79% at 2 years.
Pinter et al. 2000; Population: Gender: m=4, f=4, age: 18-34 1. Spasticity was reduced as indicated by
Austria & USA yrs, time post-injury: 19 –94 months, Level reduced Ashworth scale scores
21-18
Score
Methods Outcome
Research Design
Total Sample Size
Downs & Black score=10 of injury: C5-T6, ASIA A – C. (p=0.0117).
Pre-post (Pilot study) Treatment: Epidural spinal cord 2. Pendulum test in 4 of 8 subjects
N=8 stimulation over the upper lumbar cord. showed reduced spasticity when
Final internal placement for surgical stimulator was on for at least 1 hour vs
implantation determined following an 8 off for > 12 hours.
week trial period during which the 3. 6 subjects showed marked reductions
stimulator was external. and 2 subjects showed moderate
Outcome Measures: Ashworth scale, reductions with the clinical rating
Clinical Rating Scale, Pendulum test, EMG scale. It was not described what this
activity in response to passive stretch. Data entailed.
collection schedule was not described. 4. EMG responses to stretch in the
presence of stimulation were
significantly reduced for all muscles
combined of the left (p=0.0040) and
the right (p=0.0035).
5. Antispastic medication discontinued in
all but 1 patient when continuous
stimulation started. This patient had
baclofen dose reduced and tizanidine
discontinued.
Population: Age: 29-63 years, time post- 1. At the time of the retrospective study,
injury: 6 months – 30 years, Level of injury: 1 of 17 patients reported that the
C4-T10, complete, incomplete. epidural stimulator was producing
Treatment: Retrospective analysis of symptomatic relief.
those having undergone implantation of an 2. The average length of time that all
Midha & Schmitt 1998;
epidural stimulator between 1986-1988. units produced symptomatic relief was
USA
Outcome Measures: Telephone follow-up 6 months (range 0-96 months).
(asked to quantify symptom relief on a 3. Fourteen units were removed within
Case Series
scale from 0-10, 10=total symptom relief) 3.4 years (5 days -7years); 9
N=29
and how long they had had the symptom implantations failed from the day of
relief since the time of the implantation. implantation.
4. Total cost of initial implantation (not
including follow-up) is $23,600 per
unit.
Discussion
Pinter et al. (2000) showed improvements following implantation with a variety of clinical
measures including significant decreases in Ashworth scale scores (p=0.0117)), the pendulum
test and muscle activity as indicated by reduced summed EMG activity collected during passive
movements in both the left (p=0.0040) and the right (p=0.0035) lower limb. In addition, it was
possible to discontinue anti-spastic medication in 7 of 8 subjects and reduce the dose in the
remaining subject. These positive findings were achieved in a rather small population (N=8) and
further studies from independent groups are required to further demonstrate the feasibility and
efficacy of this approach. In particular, the long-term effectiveness of spinal cord stimulation is
uncertain, as this study did not specify the specific time points when measures were collected,
although they did state that spinal cord stimulation had been conducted for a mean of 14.38
months (Pinter et al. 2000). These authors asserted that better results were obtained with their
approach as they were more careful in optimising location and other methodological aspects
and outcomes could be further enhanced by improved stimulator design.
Barolat et al. (1995) also reported beneficial reductions in spasticity with epidural spinal cord
stimulation as assessed by subjective scales of spasm frequency and intensity. The spasm
intensity and spasm frequency was reduced significantly over the follow-up period of 2 years
21-19
and a significantly greater proportion of subjects indicated reduced spasticity severity scores
over time with significant differences at 6 months (p=0.0424), 1 year (p=0.0001and 2 years
(p=0.0012) relative to baseline. It should be noted that the positive nature of the long-term
findings are somewhat muted as subjects were increasingly dropped from the analysis over time
when they were lost to follow-up or discontinued due to lack of efficacy. Of 48 initial subjects, 40
provided data at 3 months, 33 at 6 months, 31 at 1 year and 18 at 2 years (Barolat et al. 1995).
In contrast to these more recent findings, (Midha & Schmitt 1998) conducted a telephone or in-
person follow-up of individuals having epidural stimulators implanted between 1986 and 1988 to
determine their long-term status (N=17). In only 1 of these individuals was the stimulator
continuing to provide symptomatic relief although most felt it was initially effective with an
average time of effectiveness of 6 months. The rate of stimulator failures was high with several
removals and re-implantations of devices. At the time of follow-up only 10 individuals reported
having an implanted stimulator.
Conclusions
There is Level 4 evidence that ongoing spinal cord stimulation may provide some relief
from otherwise intractable spasticity for some time (i.e., months to years).
There is level 4 evidence that the beneficial effects of spinal cord stimulation will subside
for most initial users. This, combined with the potential for equipment failure and
adverse events, suggests that spinal cord stimulation is not a cost-effective approach for
managing spasticity.
Spinal cord stimulation may provide spasticity relief over a few months but long-term
effectiveness and cost-effectiveness is less certain.
21.3 Neuro-Surgical Interventions
Surgical approaches have been considered as a treatment option for those individuals with
severe spasticity which has been refractory to more conservative approaches and for which no
useful or potential function exists below the level of the lesion (Livshits et al. 2002). There are
few well-controlled neuro-surgical interventional studies that have examined the influence of this
approach on spasticity as their main purpose. The primary and most commonly investigated
technique is that of longitudinal myelotomy and this approach has also been applied to pain
management and spasticty reduction in other etiologies, although spasticty in individuals with
SCI is the most common application (Laitinen & Singounas 1971; Yamada et al. 1976; Fogel et
al. 1985; Putty & Shapiro 1991).
Table 21.6 Neurosurgical Interventions for Reducing Spasticity

Score
Methods Outcome
Research Design
Total Sample Size
Population: Groups: Pourpre vs Bischof II 1. Authors states that “good” vs “bad”
Livshits et al. 2002; Israel
Surgical technique, Mean Age: 27.6 vs results with respect to spasticity were
PEDro=5
27.1 years, Gender: 15m&5f vs 14m&6f, obtained with the Pourpre technique in
RCT
Time with spasticity: 2.75 vs 2.75 years, 90% of subjects at 6 months, 75% at 5
Level of injury: paraplegia only, complete years and 64.7% at 10 years. The
21-20
Score
Methods Outcome
Research Design
Total Sample Size
and incomplete. Bischof II technique was less effective
in that “good” effects were seen in
Treatment: Longitudinal T-myelotomy by 65% of subjects at 6 months, 45% at 5
Pourpre vs Bischof II technique for the years and 40% at 10 years. The
treatment of painful spasticity. author did not specify what constituted
a “good” vs a “bad” effect other than to
say it was a return of spasticty.
Outcome Measures: Short form of McGill
2. Ashworth scale scores and Penn
pain questionnaire (SFM), Present Pain
Spasm Frequency scale scores were
Intensity (PPI), Visual analog score for pain
significantly reduced relative to pre-
(VAS), Ashworth scale, Penn Spasm
surgery values (p values unreported).
Frequency scale. All collected prior to
3. People undergoing the Pourpre
surgery and 6 months, 5 years and 10
technique had significantly reduced
years post-surgery.
Ashworth scale scores and Penn
Spasm Frequency scale scores than
those undergoing the Bischof II
technique (p values unreported).
4. Pain measures were relieved in all
cases although there were
successively increasing SFM, PPI and
VAS scores at 6 months vs 5 years vs
10 years (p<0.0001 for all).
5. Pain was relieved better (i.e., lower
scores for all measures at all follow-up
times) for the Pourpre technique vs
Bischof II technique.
Population: 11 with SCI, 7 with MS, 2 1. No statistical results were reported. 9
others, Gender: male=12 female=8, Age: of 10 patients with SCI had relief from
Putty & Shapiro 1991; 22-69 years, time post-injury: 2 – 23 years, spasms (1 died, unrelated to surgery).
USA Level of injury: C5-T9, complete and
Downs & Black score=9 incomplete.
Case series Treatment: Subjects underwent a
Initial N=23; Final N=20 modification of posterior T-myelotomy.
Outcome Measures: subjective clinical
impression.
Discussion
(Livshits et al. 2002) conducted a study comparing two approaches of dorsal longitudinal T-
myelotomy technique (i.e., Pourpre vs Bischof II) on the effectiveness of reducing pain and
spasticity in people with SCI (N=40) with a follow-up period of up to 10 years. For the purpose of
this review we have assessed this article as a low-quality RCT (i.e., Level 2 evidence,
PEDro<6). The authors presented the article as a prospective trial with the two surgical
techniques that were “randomly” applied as “it was unknown which of the operations would
prove to be more effective” (Livshits et al. 2002). Unfortunately, the method of randomisation
was not clearly stated and the explicit designation as a prospective trial was not noted.
Regardless, it was demonstrated that good to excellent results were obtained with either of
these surgical techniques with Ashworth scale scores and Penn Spasm Frequency scale scores
significantly reduced relative to pre-surgery values (p values unreported). More individuals had
positive results with the Pourpre technique vs the Bischof II technique in that 64.7% of subjects
had maintained benefits at 10 years with the former as compared to 40% with the latter. These
results are laudable considering these patients were originally refractory to more conservative
treatment.
21-21
Putty and Shapiro (1991) in a retrospective review of 20 subjects (n=11 with SCI) employed a
modified posterior T-myelotomy technique to reduce spasticity and improve nursing care.
Although group results were not reported and no standardized measures of spasticity were
employed, these authors concluded that this intervention achieved relief from spasms in almost
all patients while the impact on nursing care and patient comfort was less specified.
Conclusions
There is Level 2 evidence that dorsal longitudinal T-myelotomy may result in reduced
spasticity in those individuals initially refractory to more conservative approaches.
These reductions may not always be maintained over the course of several years.
There is Level 2 evidence that Pourpre’s technique for dorsal longitudinal T-myelotomy
is more effective in maintaining reduced levels of spasticity than the Bischof II technique.
Dorsal longitudinal T-myelotomy may result in reduced spasticity.
21.4 Pharmacological Treatment of Spasticity
21.4.1 Oral Baclofen
Baclofen, a derivative of gamma aminobutyric acid (GABA), is widely used as the first line of
pharmacological treatment for spasticity in people with SCI1 (Kirshblum 1999; Taricco et al.
2006). Baclofen, also identified as Lioresal®, CIBA Ba-34647 and β-(parachlorophenyl) gamma
aminobutyric acid, crosses the blood-brain barrier more readily than GABA itself and is believed
to reduce spasticity by enhancing inhibitory influences on the spinal stretch reflex via increasing
presynaptic inhibition (Kirshblum 1999).
In typical practice, baclofen requires a careful dose titration period with a usual maximal
recommended dose of 20 mg qid (Burchiel & Hsu 2001) which is also the dosage employed in
the majority of studies involving people with SCI (Aydin et al. 2005; Nance 1994; Hinderer et al.
1990). Baclofen may be especially effective in reducing flexor spasms (Shahani & Young 1974;
Duncan et al. 1976; Gracies et al. 1997) although these effects may also act to impair specific
functional tasks such as walking or standing (Kirshblum 1999; Burchiel & Hsu 2001). A variety
of adverse events may limit the use of baclofen including lowering of seizure threshold, sedatory
effects (i.e., drowsiness), insomnia, dizziness, weakness, ataxia, anxiety and mental confusion
(Hinderer 1990; Gracies et al. 1997; Kirshblum 1999; Burchiel & Hsu 2001). Sudden
discontinuation or withdrawal of baclofen can result in seizures, confusion, hallucinations and
rebound muscle overactivity with fever (Gracies et al. 1997). For the most part, tolerance with
sustained use of baclofen is possible (Knutsson et al. 1974), but is not a major issue (Roussan
et al. 1985; Gracies et al. 1997; Kirshblum 1999).
1
Once it has been demonstrated that additional measures are required after traditional conservative approaches
such as removal of potential mitigating factors, stretching and other forms of physical therapy have been attempted
(Kirshblum, 1999).
21-22
Table 21.7 Oral Baclofen for Reducing Spasticity
Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI, chronic, complete and 1. No systematic effect of baclofen was
incomplete, traumatic, male. noted. Of 300 total comparisons made,
Treatment: Baseline placebo period of only 1 comparison reached
varying length (2.5-4.5 wks), followed by a significance, with an increased viscous
Hinderer et al. 1990; 2 week dose titration period of baclofen at stiffness apparent at a frequency of 4
USA half target dose (40 mg/day), followed by cycles/sec when comparing placebo
PEDro= 9 2.5-4.5 weeks of 80 mg/day. with initiation of baclofen at 40 mg per
RCT (single subject Outcome Measures: Viscous and elastic day (p<0.05).
design) stiffness as assessed by measuring 2. Visual inspection of the results for
N=5 viscous and elastic torque responses to a individual subjects showed no
sinusoidal ankle perturbation of 5° at 3 to evidence for a therapeutic response of
12 Hz. Testing occurred twice per week baclofen that might not have been
(Mon/Thu or Tue/Fri) over 9 weeks. demonstrated by group statistical
analysis.
Population: SCI (n=11), MS (n=11), 3 1. Number of spasms was significantly
dropouts (etiology unknown). reduced with baclofen vs placebo
(p<.01) as was number of nocturnal
Treatment: Either oral baclofen (titrated up awakenings (p<.01).
to 100 mg/day) for 4 weeks or identical 2. 11 of 22 subjects demonstrated less
looking placebo. resistance to passive movement by at
least 2 grades on the initial 5 point
Outcome Measures: Self-report of # of scale with baclofen vs 1/22 with
spasms, nocturnal awakenings (daily) and placebo and this was significant
Duncan et al. 1976; USA global impression of treatment (at end of (p<.01).
PEDro = 8 each treatment period). Clinician also 3. No improvement in gait was seen in
RCT provided global impression (at end of any of those who could walk (n=8) nor
N=22 treatment period) and also assessed were any improvements seen in
resistance to movement and rated change tendon jerks, strength or voluntary
on 5 point scale (weekly). Also rated movement.
clonus, impressions of pain, use of limbs 4. In 9 cases (41%) both patients and
and transfer activity (weekly). clinicians felt continued use of
baclofen was warranted.
5. 15 subjects identified mild side effects
while on baclofen (4 on placebo). All
were deemed insignificant.
Population: SCI (n=6), chronic, complete 1. No group statistical results were

and incomplete, traumatic, quadriplegic. provided.
Treatment: Placebo or active drug (CIBA 2. All 6 subjects had a reduced
Burke et al.1971;
34,647-Ba) was titrated to a maximum of EMG/velocity ratio for any given speed
Australia
60 mg daily over a period of 2 weeks in a tested with baclofen vs placebo (e.g.,
PEDro=7
crossover, double-blind design. decreased to 37.5% (range 0%-67%)
RCT
Outcome Measures: Surface slope of at a velocity of 200°/s).
N=6
EMG (quadriceps) vs velocity relationship 3. All subjects displayed clinical effects
associated with passive flexion of the knee. with baclofen such as reduced stretch
reflex responses.
Population: SCI (n=21), chronic, complete 1. For both treatment groups a significant
and incomplete, traumatic vs health improvement was noted post
controls (n=20) treatment in the lower limb Ashworth
score (p<0.011 baclofen group and
Aydin et al. 2005; Turkey
Treatment: Either oral baclofen (titrated up p<0.020 TENS group), SFS (p<0.014
PEDro=6
to 80 mg/day) for 8 weeks or for both groups), deep tendon reflex
RCT
Trancutaneous Electrical Nerve Stimulation score (p=0.025 for both groups) as
N=41
(TENS) for 15 minutes/day for 15 days. well as in measures of disability (FIM -
baclofen group p<0.005, TENS group
Outcome Measures: Spasm Frequency p<0.003; FDS--baclofen group
Scale (SFS), Painful Spasm Scale, p=0.004, TENS group p=0.003.
21-23
Score
Methods Outcome
Research Design
Total Sample Size
Ashworth Scale, various clinical (clonus, 2. There were only small (statistically
deep tendon reflexes, response to plantar non-significant) changes in
stimulation) or electrophysiologic measures electrophysiologic variables with either
(H-reflex latency and amplitude, H/M ratio) baclofen or TENS, other than a
of spasticity as well as measures of significant reduction in H-reflex
function (FIM and functional disability score maximal amplitude (p=.032) 24 hours
(FDS)). Measures were taken pre and after the final session of TENS. This
post-treatment. reduction was even more apparent
when tested only 15 minutes after the
last treatment (p=0.026).
Population: SCI (n=25), all male, complete 1. A significant reduction in spasticity
and incomplete, tetraplegic and paraplegic was seen with baclofen in all 3
Treatment: 1 wk up-titration, 1 wk target outcome measures - as with the other
Nance 1994; Canada dose (0.05 mg bid clonidine; 4 mg qid 2 drugs tested (p<0.0001).
Downs & Black score=15 cyproheptadine; 20 mg qid baclofen), 1 wk 2. Generally, baclofen results were
Pre-post down-titration among the most improved as
N=25 Outcome Measures: Ashworth Scale, compared to the other 2 drugs
Pendulum test, Vibratory Inhibition Index although this was only significant for
(VII) the pendulum test (p=0.06) and VII
(p<0.0007 – along w/ cyproheptadine).
Discussion
Despite the general acceptance and clinical experience of using oral baclofen to reduce
spasticity in people with SCI, at least 2 systematic reviews have noted a relative paucity of high
quality studies (i.e., RCTs) demonstrating specific or comparative efficacy (Chou et al. 2004;
Taricco et al. 2006). Taricco et al. (2006) conducted a Cochrane Review of all pharmacological
interventions for spasticity following SCI. Only one study examining the effect of oral baclofen
(Burke et al. 1971) met the review inclusion criteria (i.e., RCT with at least 50% of participants
with SCI published up to July 2004). The reviewers deemed this study to have been relatively
poor quality with small n (6) so did not provide a positive assessment of the efficacy of oral
baclofen.
Since the latest report for the Cochrane Review, an additional RCT (Aydin et al. 2005) has been
published (n=21) demonstrating a significant reduction in spasticity with oral baclofen on
Ashworth Scale, Spasm Frequency Scale, deep tendon reflex score, FIM and Functional
Disability Scores, but not for most electrophysiological measures. Another RCT (Duncan et al.
1976) demonstrated reduced spasticity on Ashworth Scale and Spasm Frequency Scale.
Further support for the efficacy of oral baclofen was provided by a pre-post study by Nance
(1994) in which baclofen was compared to clonidine and cyproheptadine in 25 subjects with
SCI. In general, all three agents were shown to be effective in relieving spasticity with baclofen
among the most effective for each of the measures.
In contrast to these studies, a counter-therapeutic response to baclofen was found by Hinderer

et al. (1990). In this single-subject randomized-controlled design study (n=5) the effect of
baclofen on spasticity was studied by examining the viscous stiffness (resistance torque)
following a 5° sinusoidal ankle perturbation at 3-12 Hz. No difference was noted between
baclofen and placebo on this measure. No other outcome measures were assessed. This study
illustrates one of the limitations in establishing the efficacy for any spasticity-relieving agent –
the heterogeneity of outcome measures used across studies (Chou et al. 2004; Taricco et al.
2006). Spasticity is multi-dimensional with a variety of clinical manifestations and much day-to-
21-24
day variation within an individual. A battery of measures is needed to obtain valid and reliable
measurement of spasticity within a given trial (Priebe et al. 1996). The range of studies outlined
in the present review demonstrates various physiological, clinical and functional measures, yet
there is minimal consistency of outcome measure selection across trials.
Conclusions Regarding the Effect of Oral Baclofen
There is Level 1 evidence that oral baclofen improves muscle spasticity secondary to
SCI. This conclusion is based on the results from 3 positive small-scale RCTs although is
muted somewhat by a negative finding from a low n (5) single-subject design RCT and an
overall lack of homogeneity in outcome measures and study participants. Additional
uncontrolled cohort and case series studies also provide support for the use of oral
baclofen in reducing spasticity.
Oral baclofen reduces muscle spasticity in people with SCI.
21.4.2 Intrathecal Baclofen for Reducing Spasticity
Programmable pumps can be implanted for the treatment of spasticity in spinal cord injury. The
most commonly delivered drug is intrathecal baclofen. Many of the studies looking at intrathecal
baclofen in spasticity combine different causes of spasticity such as spinal cord injury, multiple
sclerosis and cerebral palsy making the results difficult to interpret.
Outcome measures for intrathecal baclofen include direct spasticity measures such as Ashworth
scale and spasm frequency scale, indirect measures such as functional outcome measures,
complication rates and quality of life as well as cost-benefit analyses.
Table 21.8 Intrathecal Baclofen for Reducing Spasticity

Score
Methods Outcome
Research Design
Total Sample Size
Population: SCI (C5-T8, Frankel A-B) and 1. Test dose: Intrathecal baclofen 50 mcg
MS (SCI n=5). decreased the average Ashworth
Treatment: Test dose: A daily bolus of score.
placebo or baclofen (12.5 to 100 mcg 2. Long-term: A decrease in Ashworth
titrated dose). score mean = 1.8 (p<0.005) and
Long-term: Intrathecal baclofen pump spasm frequency score mean =0.8
Nance et al. 1995; implantation. (p<0.005) and an improved leg swing
Canada Outcome Measures: Ashworth scale, in pendulum test. No change in
PEDro=9 spasm frequency score, Pendulum test, bladder or respiratory function.
RCT for test dose Hospital Cost Analysis, bladder and Improvements in ADLs noted.
N=7 respiratory function, adverse events. 3. N= 6 were included in the cost
analysis. Overall savings of $153,120
were calculated based on a reduction
in hospital related spasticity treatment
following pump implantation.
4. Follow-up ranged from 24 to 41
months.
Parke et al. 1989; USA Population: MS (n=4) and SCI (n=4) 1. No statistical results were reported
PEDro=9 Treatment Intrathecal baclofen pump although all subjects showed an
Pre-post implantation. improvement in Ashworth. Muscle
N=8 Outcome Measures: Ashworth scale, strength did not change.
21-25
Score
Methods Outcome
Research Design
Total Sample Size
muscle strength and modified PECS scale. Improvements were also noted in the
PECS scores.
2. Follow-up was at least 6 months.
Population:: 10 MS and 10 SCI (C5-T9). 1. Test dose: In both the SCI and MS
Treatment Test dose: A 3 day infusion of groups, the period of baclofen
saline or intrathecal baclofen (100 administration could be identified from
mcg/milliliter) via programmable pump. the saline administration period by the
Penn et al. 1989; USA Long-term: An open label long-term improvement in Ashworth and spasm
PEDro=9 observation of intrathecal baclofen. frequency scores (p<0.01). Overall (all
Randomized double blind Outcome measures: Ashworth scale and subjects combined), the Ashworth
crossover study test spasm frequency scale, laboratory analysis score decreased from 4.0 + 1.0 to 1.2
dose; Open label of motor control (EMG) and patient + 0.4 (p<0.0001) and the spasm
observation long term impression frequency scale decreased from 3.3 +
study 1.2 to 0.4 + 0.8 (p<0.0005).
N=20 2. Long-term: For all patients combined,
the Ashworth scale and spasm
frequency scale decreased.
3. Follow-up ranged from 10-33 months
(average 19).
Population: SCI, MS and other spinal 1. Test dose: 88 patients (94.6%)
pathology (SCI n=59) responded to the test dose with a
Coffey et al. 1993; USA Treatment: Test dose: Randomized trial decrease in Ashworth and spasm
PEDro=8 test injection baclofen versus placebo with scale. No patients responded to
Randomized test dose; up-titration from 50 mcg to 100 mcg. placebo.
Before and After long Long-term: Intrathecal baclofen pump 2. Long-term: For the SCI group, the
term follow-up implantation. Ashworth score and spasm score
N=75 Outcome Measures: Ashworth and spasm decreased post-pump.
scales 3. Patients were followed for 5-41
months (mean 19 months).
Population: MS, SCI and other causes of 1. Test dose: All 66 patients responded
spinal spasticity (SCI n=27). positively to test bolus dose and none
Treatment: Test dose: N=9 patients were of the 9 randomized patients
randomized to receive normal saline or test responded to placebo.
Ordia et al. 1996; USA dose intrathecal baclofen. Subsequent test 2. Long-term: A decrease in Ashworth
PEDro=6 doses were not open label. score and improvement in decreased
RCT for trial dose Long-term: Intrathecal baclofen pump from 4.3 pre-operatively to 1.4
N=9 implantation. (p<0.0005)at last follow-up, spasm
Observational study for N=10 patients were studied for costs study frequency scale improved from 3.6 to
long-term comparing 1 year pre and post pump 0.5 (p<0.0005) at last follow-up.
N=66 implantation. 3. An average reduction in 2.7
Outcome Measures: Ashworth scores, hospitalization days per patient was
spasm frequency scale, drug tolerance, found for a cost savings of $2500 per
treatment complications, cost-benefit day institutional costs (or $6700 per
analysis. patient) with the cost of the treatment
paid back in <2.5 years.
21-26
Score
Methods Outcome
Research Design
Total Sample Size
Population: MS and SCI (C5-T11, Frankel 1. Improvement in Ashworth score,
A-D) (SCI n=12). spasm frequency score and At 6
Treatment Intrathecal baclofen pump months, Ashworth score was improved
implantation. Z= -3.79 (p<0.001), spasm frequency
Outcome Measures: Ashworth, spasm score was improved Z= -3.78
Azouvi et al. 1996; frequency score, FIM. (p<0.001). FIM. The most dramatic
France improvements were seen in the 12
Downs & Black score=25 patients with thoracic or low cervical
Pre-post lesions (FIM evolved from 50.9±9.7 to
N=18 76.3±14.5, Z=-3.06, p<0.01) . The
following items gained ≥2 FIM scores:
bathing, dressing lower body, and the
3 items related to transfers..
(average 37.4)
Population: MS and (n=7) SCI (C4 to 1. The SCI group demonstrated a lower
T11). Ashworth score (4.57 to 2.57,
p=0.0134) and a decrease in spasm
Treatment: Intrathecal baclofen pump scale (3.71 to 1.28, p=0.00006) po
implantation. Subjects were implanted with post pump insertion.
an infusion pump delivering a continuous 2. All patients reported improved function
flow at a fixed rate of bolus intrathecal after surgery with an increase in
baclofen. Barthel Index Score increased as a
Boviatsis et al. 2005; result of the treatment in the SCI group
Greece Outcomes: Barthel index scale, Ashworth (from 17.1 before to 50.7 after
Downs & Black score=18 scale and Penn spasm scale, self- treatment, p<0.0073). Dressing and
Case Series assessment pain scale transfers were 2 activities that
Initial N=22; Final N=21 improved significantly (p=0.0465 and
p=0.0016, respectively).The degree of
improvement was different according
to level of lesion.
3. The self-assessment pain scale
revealed a limited improvement in
pain(p=0.0941).
(median 35 months).
Population: SCI, MS and cerebral 1. At final assessment average VAS
Plassat et al. 2004; spasticity (SCI= 17). satisfaction with the pump was 7.4.
France Treatment: intrathecal baclofen pump 2. Ambulation status was unchanged in
Downs & Black score=16 placement 85%. Improvements were noted in
Case series Outcome Measures: VAS satisfaction pain and sleep and Ashworth score
Initial N=41;Final N=37 score locomotion, pain, sleep, Ashworth. decreased.
3. Follow-up average 4 years
Population: MS and SCI and other spinal 1. Improvement in Ashworth score from
spasticity(SCI n=6). baseline 2.82 to final assessment
Treatment: Intrathecal baclofen pump 0.91 (p<0.05) and spasm score from
implantation. baseline 1.79 to final assessment
Outcome measures: Ashworth scale, 0.67 (p<0.05).
Zahavi et al. 2004; spasm score, Expanded disability status 2. Worsening in EDSS, AI and ISS (all
Netherlands scale, ambulation index, Incapacity status p<0.05) compared with baseline (in
Downs & Black score=16 scale, Sickness impact profile, Hopkins progressive and non-progressive
Observational (long-term) symptom check list. groups of patient disabilities).
Initial N=38; Final N=21 Worsening in level of disability (EDSS
and ISS p<0.05) and the psychosocial
aspect of the perceived health status
scale (SIP) ( p<0.05) were seen when
compared from baseline and at 26
weeks.
21-27
Score
Methods Outcome
Research Design
Total Sample Size
3. Follow-up ranged from 66 to 108
months with a mean of 84.9 months.
Population: MS and SCI (C4-T12 ASIA A- 1. Test dose: Decrease in Ashworth and
Abel & Smith 1994; USA D) (SCI n=17) spasm score.
Downs & Black score=13 Treatment: Intrathecal baclofen pump 2. Long-term: Decrease in Ashworth
Observational implantation. scores
N=23 Outcome Measures: Ashworth score and 3. Follow-up ranged from 2-34 months
spasm score. with average 16 months.
Population: Traumatic non-progressive 1. Test dose: A decrease was seen in
SCI, all male, C2-T12 (n=9). optimal reflex score (t=7.69, p<0.001)
Treatment: Test dose: 5 day infusion of and the Ashworth score with baclofen.
varying doses of baclofen and a single 12 grade (t=6.05, p<0.001), between
hour placebo infusion over a 5 day period placebo and optimal reflex score a
to determine optimum intrathecal baclofen change was noted (t=3.68, p<0.01)
dosage. Long-term: Intrathecal baclofen and Ashworth grade (t=6.0, p<0.001)
Loubser et al. 1991; USA pump implantation. and between placebo and control
Downs & Black score=13 Outcome Measures: Ashworth scale, Ashworth grade (t=2.95, p<0.02). At
Randomized test dose; neurological reflex scale, evaluation of optimum intrathecal baclofen dosage,
Before and After long functional abilities, evaluation of personal 8/9 patients benefited in functional
term follow-up independence and global assessment evaluations.
N=9 scale. 2. Long-term: Only 7 subjects
participated. The Ashworth score and
mean reflex score decreased from
3.79 + 0.69 to 2.00 + 0.96 (t=12.9,
p<0.001). The mean reflex score
decreased from 3.85 + 0.62 to 2.18 +
0.43 (t=6.76, P<0.001).
3. Follow-up ranged from 3-22 months.
Population: MS and SCI (SCI=32). 1. Test dose: 64/66 patients responded
Treatment: Intrathecal baclofen pump to a test dose of intrathecal baclofen
Penn 1992; USA implantation. with a decrease in either Ashworth or
Downs & Black score=13 Outcome Measures: Ashworth score and spasm frequency scale.
Review spasm frequency scale. 2. Long-term: 84% treated adequately for
N=66 spasticity.
3. Follow-up average 30 months (up to
81 months).
Population: SCI (T3-L1), MS and cerebral 1. Reduction in Ashworth and spasm
spasticity. (SCI n=5) frequency scale improvement in
Treatment: Implantation of programmable hyperreflexia, objective improvements
Broseta et al. 1990;
pump in transfer activities and skilled acts,
Spain
Outcome Measures: Ashworth, spasm improved comfort, reduced H/M ratio
frequency scale, reflex assessment, and improved bladder function
Case series
cystomanometry and perineal 2. Mean follow-up 11 months.
N=19
electromyography for assessment of
neurological bladder dysfunction,
electrophysiological H/M ratio, total dose.
Population: SCI (n=12), all male. 1. Significant post-operative reduction of
muscle tone and spasm (P<0.05).
Treatment Intrathecal baclofen pump Ashworth decreased from 4.2 to 2.2 in
implantation. the lower limbs and from 2.2 to 1.0 in
Korenkov et al. 2002;
the UE. Decrease in Ashworth score.
Germany
Outcome Measures: Ashworth scale and 2. Self-care, nursing care, PT, transfers,
spasm frequency score. sitting tolerance, muscle pain and
Pre-post
sleeplessness were all reported as
N=12
improved but no measures were
reported.
3. Follow-up was 12 months.
21-28
Score
Methods Outcome
Research Design
Total Sample Size
Ochs et al. 1989; Population: MS and SCI (SCI n=10) 1. Improvement in Ashworth and spasm
Germany Treatment: Intrathecal baclofen pump frequency scale. Intrathecal baclofen
Downs & Black score=10 implantation. had an effect on electrophysiological
Prospective open design Outcome Measures: Ashworth and spasm data
N=28 frequency scale, electrophysiological data. 2. Follow-up up to 2 years.
Discussion
Spasticity Outcome
There are 5 studies employing a randomized controlled trial design to evaluate the effects of
test doses of intrathecal baclofen in SCI. Although these studies are small and combine different
etiologies of spasticity, they do provide a limited body of level 1 evidence to support the use of
intrathecal baclofen test doses to decrease spasticity in SCI as measured by Ashworth scale
and spasm frequency score (Penn et al. 1989; Loubser et al. 1991; Coffey et al. 1993; Nance et
al. 1995; Ordia et al. 1996).
Table 21.9 Summary Intrathecal Baclofen RCTs for Reducing Spasticity – Spasticity
Outcome
Author Year;
Methods Outcome
Total Sample Size
Test dose: Randomized trial test injection Test dose: 88 patients (94.6%) responded
baclofen versus placebo with up-titration to the test dose with a decrease in
from 50 mcg to 100 mcg. Ashworth and spasm scale. No patients
Coffey et al. 1993; Long-term: Intrathecal baclofen pump responded to placebo.
N=75 (SCI =59) implantation. Long-term: For the SCI group, the
Ashworth score and spasm score
decreased post-pump.
Test dose: 5 day infusion of varying doses Test dose: At optimum intrathecal
of baclofen and a single 12 hour placebo baclofen dosage, 8/9 patients benefited in
infusion over a 5 day period to determine functional evaluations.
Loubser et al. 1991;
optimum intrathecal baclofen dosage. Long-term: Only 7 subjects participated.
N=9 (SCI =9)
Long-term: Intrathecal baclofen pump The Ashworth score and mean reflex score
implantation. decreased.
Test dose: A 3 day infusion of saline or Test dose & Long-term: Overall (all
intrathecal baclofen (100 mcg/milliliter) via subjects combined), significant decreases
Penn et al. 1989; programmable pump. for the Ashworth score and the spasm
N=20 (SCI N= 10) Long-term: An open label long-term frequency scale decreased as a result of
observation of intrathecal baclofen. intrathecal Baclofen.
Test dose: N=9 patients were randomized Test dose: All 66 patients responded
to receive normal saline or test dose positively to test bolus dose and none of
Ordia et al. 1996;
intrathecal baclofen. Subsequent test the 9 randomized patients responded to
doses were not open label. placebo.
(SCI =27)
Long-term: Intrathecal baclofen pump Long-term: A significant decrease in
implantation. Ashworth score and spasm frequency
scale at last follow-up
Test dose: A daily bolus of placebo or Test dose: Intrathecal baclofen 50 mcg
Nance et al. 1995; baclofen (12.5 to 100 mcg titrated dose). decreased the average Ashworth score.
Initial N=7; Final N=6 Long-term: Intrathecal baclofen pump Long-term: A significant decrease in
(SCI =5) implantation. Ashworth score and spasm frequency
score and an improved leg swing in
pendulum test.
21-29
It is unlikely that randomized controlled trials will be undertaken to look at the long-term
effectiveness of intrathecal baclofen given the effectiveness of test doses. However, several
level 4 studies support the long term use of intrathecal baclofen to decrease spasticity with the
most frequently used outcomes measures being the Ashworth scale and spasm frequency
scales (Ochs et al. 1989; Penn et al. 1989; Broseta et al. 1990; Loubser et al. 1991; Penn 1992;
Coffey et al. 1993; Abel & Smith 1994; Nance et al. 1995; Ordia et al. 1996; Korenkov et al.
2002; Plassat et al. 2004; Boviatsis et al. 2005).
The effects of intrathecal baclofen are more pronounced in the lower extremities than the upper
extremities (Korenkov et al. 2002)
Functional outcome
The effects of intrathecal baclofen on functional outcomes are much harder to summarize. Most
studies are observational, pre-post studies with small numbers of SCI patients grouped in
combination with several other diagnoses (most often multiple sclerosis, MS). In addition, there
is a lack of standardized outcome measures used to study functional outcomes. Finally, the
majority of studies are not stratified by SCI level or ASIA impairment scale.
There are several observational studies looking at the short-term and long-term complication
rates seen with intrathecal baclofen. Overall, complication rates are low and can be categorized
as medication related or pump related. However, complications can be severe and include
death. (Loubser et al. 1991; Penn et al. 1992; Coffey et al. 1993; Abel & Smith 1994; Nance et
al. 1995; Azouvi et al. 1996; Ordia et al. 1996; Stempien & Tsai 2000; Korenkov et al. 2002;
Plassat et al. 2004)
Tolerance to intrathecal baclofen has been observed (Ochs et al. 1989; Coffey et al. 1993; Abel
1994; Ordia et al. 1996)
Overall, there is level 4 evidence to suggest that functional outcomes as measured by scales
such as Barthel index scale and FIM improve with intrathecal baclofen (Parke et al. 1989;
Broseta et al. 1990; Nance et al. 1995; Azouvi et al. 1996; Ordia et al. 1996; Plassat et al. 2004;
Boviatsis et al. 2005). However, it is notable that Zahavi reports a small statistically significant
deterioration in disability as measured by the expanded disability status scale, ambulation index
and incapacity status scale. The article notes that this may not be a clinically significant
deterioration (Zahavi et al. 2004). Loubser reports the potential for decreased functional
outcomes especially with respect to ambulatory status in patients who may depend on their
spasticity for ambulation (Loubser et al. 1991).
Table 21.10 Summary Intrathecal Baclofen Observational Studies for Reducing Spasticity
– Functional Outcome
Author Year;
Methods Outcome
Total Sample Size
Treatment: Intrathecal baclofen pump All patients reported improved function
implantation. Subjects were implanted with after surgery but the degree of
Boviatsis et al. 2005;
an infusion pump delivering a continuous improvement was different according to
N=22 (SCI =7)
flow at a fixed rate of bolus intrathecal level of lesion.
baclofen.
Parke et al. 1989; Treatment: Intrathecal baclofen pump Improvements were noted in the PECS
N=8 (SCI N=4) implantation. scores.
Ordia et al. 1996; Long-term: Intrathecal baclofen pump Long-term: A decrease in Ashworth score
N=66 (SCI =27) implantation. and spasm frequency scale at last follow-up.
Azouvi et al. 1996; Treatment: Intrathecal baclofen pump Improvement in FIM at 6 months. - ≥2 FIM
N=18 (SCI = 12) implantation. scores: bathing, dressing lower body, and
21-30
Author Year;
Methods Outcome
Total Sample Size
the 3 items related to transfers.
Most improvement in 12 patients with
thoracic or low cervical lesions.
Nance et al. 1995; Long-term: Intrathecal baclofen pump Improvements in ADLs noted.
Initial N=7; Final N=6 implantation.
(SCI =5)
Treatment: Implantation of programmable Objective improvements in transfer
Broseta et al. 1990; pump. activities and skilled acts, improved
N=19 (SCI =5) comfort, reduced H/M ratio and improved
bladder function
Plassat et al; 2004; Treatment: intrathecal baclofen pump Improvements were noted in pain and
N=41 (SCI= 17) placement sleep and Ashworth score decreased.
Treatment: Intrathecal baclofen pump Worsening in EDSS, AI and ISS and the
Zahavi et al. 2004; implantation. psychosocial aspect of the perceived
N=38 (SCI =6) health status scale (SIP) were seen when
compared from baseline and at 26 weeks.
Test dose: 5 day infusion of varying doses At optimum intrathecal baclofen dosage,
of baclofen and a single 12 hour placebo 8/9 patients benefited in functional
Loubser et al. 1991; infusion over a 5 day period to determine evaluations.
N=9 (SCI =9) optimum intrathecal baclofen dosage.
Long-term: Intrathecal baclofen pump
implantation.
Cost-effectiveness
There are 2 level 4 studies looking at cost-effectiveness with the usage of intrathecal baclofen
(Nance et al. 1995; Ordia et al. 1996). Ordia’s study does not specify whether SCI or MS
subjects were studied for cost-effectiveness, but does report gross cost savings with intrathecal
baclofen due to an overall reduction in hospital days post pump implantation (Ordia et al. 1996)
Table 21.11 Summary Intrathecal Baclofen for Reducing Spasticity – Cost Analysis
Author Year;
Methods Outcome
Total Sample Size
Long-term: Intrathecal baclofen pump N= 6 were included in the cost analysis.
Nance et al. 1995;
implantation. Overall savings of $153,120 were
calculated based on a reduction in
(SCI =5)
hospital related spasticity treatment
following pump implantation.
Long-term: Intrathecal baclofen pump An average reduction in 2.7
Ordia et al. 1996; implantation. hospitalization days per patient was
Initial N=66; Final N=57 N=10 patients were studied for costs found for a cost savings of $2500 per day
(SCI =27) study comparing 1 year pre and post institutional costs (or $6700 per patient)
pump implantation. with the cost of the treatment paid back in
<2.5 years.
Nance’s study also combines MS and SCI. In contrast to Ordia who looked at overall hospital
days, Nance looked only at hospital days related to spasticity and found a net savings in costs
related to pump implantation (Nance et al. 1995)
Conclusions
There is Level 1 evidence that bolus or test dose intrathecal baclofen decreases
spasticity.
21-31
There is Level 4 evidence that the use of long-term intrathecal baclofen decreases
spasticity.
There is Level 4 evidence that intrathecal baclofen may improve functional outcomes.
There is Level 4 evidence that complication rates with the long-term use of intrathecal
baclofen are relatively low.
There is Level 4 evidence that intrathecal baclofen is a cost-effective intervention.
Bolus or long-term intrathecal Baclofen decreases spasticity and may improve functional
outcomes with low complication rates and is a cost effective intervention.
21.4.3 Effect of Medications Other than Baclofen on Spasticity after SCI
Although Baclofen is the most widely used drug for the treatment of spasticity in SCI, other
drugs used as anti-spasmodics include tizanidine, cyproheptadine, diazepam, gabapentin, L-
threonine, cannibis, dantrolene, clonidine (oral, transdermal and intrathecal), 4-aminopyridine
(intravenous, intrathecal, immediate and sustained release) and others that will each be
discussed briefly.
Table 21.12 Effect of Medications Other than Baclofen for Reducing Spasticity
Score
Methods Outcome
Research Design
Total Sample Size
Tizanidine
Population: SCI with moderate spasticity 1. Ashworth: Tizanidine produced
Treatment: Tizanidine significantly (p<0.0001) greater
Outcome Measures: Ashworth (hip decreases in muscle tone from
adductors, knee flexors/extensors - baseline to end of titration (T3), end of
bilateral), Pendulum, modified Klein-Bell plateau (P2) and end point (EP) as
scale (ADL), Golabal evaluation of compared with placebo.
antispastic efficacy, Adverse Events. 2. Pendulum: Tizanidine produced
Nance et al. 1994;
significantly greater decreases in the
US & Canada
swing parameters from based to T3
PEDro=10
(p<0.0135), P2 (p<0.0401) and EP
RCT (DB)
(p<0.0038) as compared to placebo.
N=118
3. Modified Klein-Bell showed no change
from baseline in their ADL score.
4. Global changes were larger in
Tizanidine vs Placebo but were not
significant between groups.
5. Adverse Events significantly greater in
Tizanidine vs Placebo (P=0.002).
Population: SCI 1. Ashworth: peak reduction between 1-
Treatment: Single-dose (8mg), tizanidine. 1.5 hrs (p<0.05 with spasticity
Three pre-drug measurements 15 minutes returning to baseline by 4th hour; no
Mathias et al. 1989; apart after breakfast and 30 minute rebound spasticity measured at 12 and
United Kingdom equilibration. Observations continued at 24 hours.
Downs & Black score=14 0.5, 1.0, 1.5, 2.0, 3, 4, 5, 6, 12, 24 hours. 2. Muscle power: no effects on impaired
Pre-post These measurements were repeated on a or unimpaired muscles at any stage of
N=10 separate occasion (except measurements the study.
of sedation and blood collection) without 3. No significant changes to vitals except
drug administration. with heart rate (decrease in HR;
Outcome measures: Ashworth, Manual p<0.05 after 1.5hrs)
21-32
Score
Methods Outcome
Research Design
Total Sample Size
muscle testing, vitals, sedation, 4. Sedation: Sedation in tetras>paras
pharmacokinetics (Pk), and adverse but increased in both with
events. considerable variability. Peak within
first hour with gradual waning to fully
awake by 3rd hour. PK:
5. Pk - Plasma levels rose at 0.5hrs and
peaked by 1 hour. At 6 hrs, level was
at 85% peak and still detectable but
low levels at 12 and 24 hrs. Plasma
half-life was 2.7±0.06hrs.
6. Adverse Events: Sedation and dry
mouth.
Clonidine
Population: Chronic, traumatic and non- 1. 1/3 paretic patients had marked
traumatic SCI. progression from non-ambulation to
Treatment: 2-week washout period limited independent ambulation. The
between 4 weeks of randomly assigned other 2 paretics who presented limited
Clonidine or Placebo treatment. spasticity showed minimal changes
Medication was administered orally 2 or 3 while on clonidine.
times per day. Initial dosage was 2. Spasticity -/+/0: VAS 6/1/2, Daily
0.02mg/day and systematically increased spasms 2/0/2, Daily clonus 4/0/1,
Stewart et al. 1991;
to an optimal level (0.05-0.25mg/day) Ankle TSR 5/2/2, Knee TSR 5/0/2,
Canada
Outcome Measures: Body weight Evoked clonus 3/1/5.
PEDro=8
supported (BWS) treadmill assisted 3. Side Effects in 8/9 patients during
RCT-DBPC
walking with surface EMG, footswitch and dose titration included dryness of eyes
N=12
video recordings. Spasticity assessments: and mouth, lethargy, mild hypotension
VAS subject self report, daily spasticity and constipation. The majority were
diary, tonic stretch reflex (TSR) transient or negligible while 2 patients
assessment at the ankle/knee and experienced moderate to severe
assessment of ankle clonus), and Side lethargy and constipation.
Effects (AEs).
Nance et al. 1989; Population: SCI 1. VII significantly reduced by clonidine

Canada Treatment: Clonidine, clonidine and (p<0.001) but not the other
Downs & Black=16 desipramine, diazepam, placebo interventions.
Non-randomized Outcome Measures: Vibratory inhibition 2. Achilles reflex not affected by any
Controlled Trial (Single index (VII) of the H-reflex; Achilles reflex; intervention.
Blind) duration of clonus 3. Duration of clonus not affected by any
N=6 intervention.
Population: Chronic complete and 1. Ashworth and Pendulum correlated
incomplete SCI with at least moderate well (r=0.88) in no-drug condition.
spasticity 2. Ashworth significantly reduced,
Treatment: 1 wk up-titration, 1 wk target significantly increased first swing
dose (0.05mg bid clonidine; 4mg qid amplitude, and increased VII in all
cyproheptadine; 20 mg qid baclofen) , 1 wk three drug conditions (p<0.0001, all 3
Nance 1994; Canada
down-titration outcome measures) with baclofen
Outcome Measures: Ashworth, showing the most improvement
Pre-post
Pendulum, Vibratory Inhibition Index (VII) (p=0.06).
N =25
3. No difference between treatments
(p=0.2618) for Ashworth and
Pendulum.
4. Cyproheptadine and Baclofen
produced a greater reduction in the VII
than Clonidine, p<0.01.
Weingarden & Belen Population: SCI, traumatic. 1. 5/17 had clinically significant relief.
1992; USA Treatment: Transdermal clonidine 2. 12/15 continued to use the medication.
Downs & Black score=13 Outcome Measures: Clinically significant 3. 10/15 were able to decrease or
Case Series relief of spasticity; continuation of study discontinue their current antispasticity
21-33
Score
Methods Outcome
Research Design
Total Sample Size
N=17 drug after trial; discontinuation of other medications.
anti-spasticity medications
Population: SCI, complete and 1. Results indicate that quadriplegics
incomplete, paraplegics and quadriplegics. responded to the medication better
Donovan et al. 1988;
Treatment: Oral clonidine - 0.05mg bid than the paraplegics. (p<0.033).
USA
and increased to 0.4mg bid if tolerated by 2. No significant difference based on
the subject. complete vs incomplete lesions.
Case Series
Outcome Measures: Success of 3. 31/55 subjects responded to clonidine.
N=55
medication was defined as a decrease in
hypertonicity.
Population: Incomplete, paraplegic SCI. 1. Significant decrease in Ashworth
Treatment: Responders (walking capacity spasticity score (p<0.0001) at all
preserved) to a 60ug intrathecal test dose doses levels (30, 60, 90) with no
were scheduled for 3, 15-90ug doses of consistent significant differences
Remy-Neris et al. 1999;
clonidine, and a placebo, by L2-3 puncture. detected in reflexes.
France
Non-responders were given 30 and 15ug 2. Statistically significant increase in the
Downs & Black
clonidine and a placebo when possible. A velocity at maximal overground speed
score=11
minimum interval of 3 days separated each (P-0.03) due to an increase in the
Non-randomized,
injection. stride amplitude (P=0.0009), without
placebo controlled trial
Outcome Measures: Ashworth scores any significant decrease in the cycle
N=11
(bilateral quadriceps), walking parameters, duration (P=0.28).
H-reflex, polysynaptic reflexes - recorded 3. 90 and 120 ug doses did not produce
before and every hour for 4-6 hours after significant improvement in 3 subjects
an i.t. injection of clonidine or placebo. able to walk after 60ug.
Population: subacute, traumatic Cervical 1. Case 1: marked improvement noted in
Yablon & Sipski 1993; SCI. relief of flexor spasms;
USA Treatment: 0.1-0.3 mg/wk Transdermal 2. Case 2: Excellent improvement noted
Downs & Black score=10 Clonidine patch (Constant/continuous in both spastic hypertonia and flexor
Case Series systemic delivery). spasms;
Initial N=3; Final N=3 Outcome measures: Change in spasticity 3. Case 3: Moderate improvement in
(no specific measure noted). spastic hypertonia and flexor spasms.
Population: Incomplete SCI. 1. FRR amplitude change significant
Treatment: Intrathecal clonidine injection (P<0.02) between 30 and 90 ug IT
(30/60/90 ug). Clonidine but not significant between
Outcome Measures: Amplitude and 30 and 50 ug between 30 and 90, NS
stimulation threshold of flexor reflex for 30/60).
responses (FRR) in tibialis anterior after 2. FRR stimulation threshold significantly
posterior tibial nerve stimulation; Ashworth increased for each Clonidine dose
score / pendulum test, and EMG latency / compared to pre-injection. (P<0.05 for
amplitude of quadriceps stretch reflex dose-dependent effect; no change in
placebo effects showing no effect of
lumbar puncture).
Remy-Neris et al. 2001; 3. Decrease in Ashworth score appeared
France a few minutes after injection, which
Downs & Black score=6 lasted 4-6 hrs after a single 60ug
Non-RCT dose.
N=15 4. Latencies of the quadriceps stretch
showed a significant increase in the
latency after clonidine in all but 1
subject.
5. Amplitudes of the quadriceps stretch
showed a significant decrease in the
latency after clonidine in all subjects.
6. Parallel results seen in integrated
rectified EMG observed with pendulum
test.
21-34
Score
Methods Outcome
Research Design
Total Sample Size
7. Reported AEs include hypotension,
feelings of negativism and depression,
sedation
4-Aminopyridine
Population: chronic SCI Significant benefit of Fampridine-SR over
Treatment: Subjects were randomized into placebo:
one of two treatments and given either 1. Motor scores (adjusted to only paretic
Fampridine-SR (12.5 mg bid to start with segments; p1 < 0.01).
an increase to 17.5 mg bid) or placebo 2. Sensory scores (p1 < 0.01), including
over a period of 2 weeks then following a both pin prick and light touch (p1 =
washout period they were given the 0.059 and 0.058).
Potter et al. 1998; alternate treatment. 3. Ashworth (p2 < 0.05).
Canada & USA Outcome Measures: motor index, sensory 4. Patient satisfaction and quality of life
PEDro=10 index, present pain intensity, spasm scores (McNemar's test, p2 < 0.01 and
RCT frequency, modified Ashworth scale, bowel <0.05).
N=29 and bladder scores, clinical interview 5. No statistical significance on measures
questionnaire, global patient satisfaction of pain, bowel/ bladder/sexual function
questionnaire, seven point terrible or FIM.
delighted scale and FIM 6. Side effects: lightheadedness and
nausea –transient/trivial relative to
efficacy.
7. ~30% of patients reported a wish to
continue to use.
Population: SCI, complete and 1. No significant differences were noted
incomplete. pre-post infusion between 4-AP and
Treatment: Drug or placebo was the placebo. No differences between
administered for 2 hours through an the motor incomplete and the motor
indwelling venous catheter attached to an complete groups.
infusion pump (4-AP reached doses of 30 2. The intravenous route may not be the
Donovan et al. 2000;USA
to 80 ng/ml at the end of a 2 h) best way to administer this drug as no
PEDro=9
Outcome Measures: Patients were serially short term benefits were observed.
RCT
examined during and after infusion
N=12
clinically for – Pain (McGill questionnaire);
Sensorimotor function (ASIA);
Hypertonicity (Ashworth scale , Reflex
scale); Electrophysiologic measurements
(Brain motor control assessment); Blood
and CSR sampling.
Population: Chronic, traumatic SCI. 1. Enhanced somatosensory evoked
Treatment: Under fasting conditions, potentials (N=3), Improved motor
patients received 24-25mg 4-AP IV. evoked potentials (N=4), Increased
Monitoring for effect pre to 2 hours post voluntary EMG interference (N=2)
and at 24 hours post drug administration 2. Three of 6 patients reported
Outcome Measures: Neurophysiological neurological benefits of the drug (N=2
Hayes et al. 1994; and standard neurological examination. for reduced spasticity; N=1 for pain;
Canada & USA Adverse Event monitoring. N=1 for increased sensation; N=3 for
Downs & Black score=15 increased limb movement and N=1 for
Case Series restored bowel control.
N=6 3. Adverse Events: aching IV site (N=6),
transient lightheadedness (N=2), mild
perioral paresthesia (N=1), +20mm Hg
in systolic BP after 24 mg 4-AP (N=2),
exacerbation of ankle phlebitis pain
(N=1) and facial flushing after waking
1 day after the trial (N=1).
Potter et al. 1998; Population: Incomplete, traumatic, A. Physical Exam:
Canada & USA chronic, cervical SCI. 1. Improved bladder function (N=1),
Downs & Black score=10 Treatment: Day 1- single 10mg capsule of 2. Improved spasticity (UE N=1, LE N=2),
21-35
Score
Methods Outcome
Research Design
Total Sample Size
Case Series 4-AP followed by physical and 3. Reduced pain (N=1)
N=3 neurophysiological examination pre and 4. Improved motor function (N=3)
post administration up to 24 hours. Day 4: 5. Improved gait (N=2)
10mg bid to tid by Day 6, if tolerated. 6. Improved sensory function (N=1),
Tolerated dosing regimen continued for 4 7. Improved penile tumescence (N=1)
months with prn intermittent assessments. and a
Outcome Measures: A. Physical exam: 8. Nonspecific but consistently "renewed
ASIA motor and sensory classification; vigour" (N=2).
Modified Ashworth rating of spasticity. B. Neurophysiological results;
B. Neurophysiological exam: Motor 9. MEPs increased in amplitude (N=1).
evoked potentials (MEPs) following 10. Ankle hypertonicity reduced (N=1).
transcranial magnetic stimulation of motor C. Pharmacokinetics and Adverse
cortex, quantitative assessment of ankle Events:
hypertonicity. C. Pharmacokinetics and 11. Pk: 1-1.5 h Tmax; 75.05-121.27 ng/ml
Adverse Event monitoring. Cmax; 5.21-12.61L/h CL; 139.84-
306.84 /L Vss; 16.9-19.08h t1/2.
12. Wakefulness (1 case limited to bid
rather than tid dosing) and transient
light-headedness.
Cyproheptadine
Population: Chronic, incomplete, Improvements in favour of Cyproheptadine
traumatic, non-traumatic SCI. vs placebo (descriptive statistics only; no p-
Treatment: One week washout between values provided):
Cyproheptadine or placebo (identically 1. Spasticity: all subjects reported a
appearing tablets) in random order dose- decrease in the severity and frequency
titrated over 3 weeks (1 week each at 2mg, of involuntary movements.
4mg and 8mg 5id). Four subjects also 2. Walking pattern: A) Marked decrease
Wainberg et al. 1990;
were tested after open-label long term in forward trunk flexion but no major
Canada
Cyproheptadine (optimized dosing) of at changes for medial ham and TA EMG
PEDro=7
least 6 months. Con meds and therapies burst activity B) Maximum comfortable
RCT
were maintained for at least 3 months prior walking speed increased over control
N=8
to the study. speed: decrease in cycle duration,
Outcome Measures: Treadmill walking percentage stance and associated
without overhead harness BWS when decrease in the % double support
possible, or 40% BWS - Temporal duration.
distance, surface EMG, Joint angular
displacement, spasm severity in 2
positions, spasticity diary.
Population: SCI and MS with spasticity of 1. Muscle strength decreased in 4/6
spinal origin. patients.
Barbeau et al. 1982 ; Treatment: Oral Cyproheptadine 2. EMG activity decreased in 3/6.
Canada progressively increased from 6 mg to 24 3. Patient log of clonus and spasms
Downs & Black score=12 mg per day over 4 to 24 months, including showed decreased spontaneous
Case series – Pre-post a placebo substitution period spasms in 5/6.
N=6 Outcome Measures: Muscle strength; 4. Ankle clonus decreased in 6/6.
EMG activity; patient log of clonus and
spasms; ankle clonus
Gabapentin
Population: subacute to chronic SCI. 1. Gabapentin resulted in an 11%
Treatment: Eleven day washout between reduction in the median Ashworth
2 day Gabapentin (400 mg total in 3 Scale (z=2.011, P=0.044) and a 20%
Gruenthal et al. 1997;
divided doses) or placebo with evaluations reduction in the median Likert Scale
USA
prior to, on second day within 5h of last score (z=3.214, P=0.013) when
PEDro=7
dose and after washout for each treatment. compared to placebo.
RCT
Outcome Measures: Each evaluation: 1) 2. Other measures did not yield
N=28
U/LE Ashworth and 6 point Likert ratings of significant differences.
spasticity 2) muscle stretch reflexes, 3) 3. No treatment order effect.
presence or absence of ankle/wrist clonus 4. No significant changes in any measure
21-36
Score
Methods Outcome
Research Design
Total Sample Size
4) reflex withdrawal to noxious stimuli in seen when placebo compared to
finger and foot. baseline.
5. No Adverse Events.
L-Threonine
Population: MS and traumatic and non- Modest but definite antispastic effect in
traumatic SCI with spasticity of spinal favour of L-threonine vs placebo:
origin. 1. Mean spasm score reduced for both
Treatment: 6g/da y- 500mg L-Threonine or treatments - weak correlation between
Placebo capsules taken 3x/day on empty spasm score and spasticity reduction.
stomach. 2. No change in BI or Kurtzke with either
Outcome Measures: Ashworth (bilat. hip treatment.
adductors-flexors-extensors and knee 3. Dramatic rise in plasma threonine
Lee & Patterson 1993 flexors-extensors) - 6 highest summed for during active treatment but no change
USA & Ireland spasticity score, which was used in plasma glycine.
PEDro=8 throughout the study. Secondary outcome 4. Weak correlation between plasma
RCT measures: Spasm frequency and severity threonine and spasticity reduction.
N=33 score (spasm score was derived by 5. Patient-carer’s subjective report–6/2
multiplying two variables together over 2wk threonine/placebo responders.
period using specially designed chart), 6. AEs included minor side effects during
Barthel Index, Kurtzke Disability Status treatment (N=2) and Placebo (N=1).
Scale, Patient & Caregiver subjective 7. Four dropouts - 2 for medical and 2 for
responses, AEs, and glycine/thronine non-medical reasons.
plasma concentrations. Measurements pre
and post treatment. All measures
conducted by a single investigator.
Cannabis
Hypothesis: To examine the perceived 1. SCI persons reported decreased
effects of cannabis on spasticity of spinal spasticity with marijuana use;
cord injured persons 2. present use of marijuana correlated
Treatment: No treatment positively with past use; and
Outcome Measures: In addition to 3. the person's reference or peer group
demographic information (age range, sex, contributed significantly to current use.
marital status, education, and range of time 53% reported using mj during last year
since injury), 8 other questions asked in 3 with correlation to mj use prior to SCI
categories of questions: 1) choice of 5 (r=0.78, p<0.001, n=43; agrees with
categories of marijuana use - never, once other studies). Also correlated with
or twice, 3-12 times, 12-24 times, >24 degree of mj use in present social
times, for the previous year and for the reference group (r=0.32, p<0.05,
year prior to SCI 2) via Lickert-type n=38) and prior social reference group
scare, indicate how characteristic (r=0.30, p<0.05, n=37). Age was
Malec et al. 1982; USA
marijuana use is of the people they "admire negatively correlated with current mj
and identify with" at present and before use (r=-0.56, p<0.001, n=43)
Cohort
their injury and how similar they felt their Reduction in spasticity via mj use was
N=43
ideas, beliefs, values, and the like" were to reported in 88% (21/24) while 12%
most other people in society, both at reported no change. No correlation
present and before their injury 3) via 5- between Spasticity Change Index and
point scale ranging from not present to very any variable (if significant correlation,
severe, indicate the severity of spasticity then perhaps placebo effect)
they experienced when under and when Education moderately correlated with
not under the influence of marijuana 4) reported change in spasticity (r=-0.65,
spasticity Change Index, describing the p<0.001, n=23): lower education
amount of change in spasticity, was associated with greater reported
computed by subtracting level of spasticity change in Spasticity Change Index.
in the drug-state from level of spasticity in
the non-drug-state. MJ use prevalent (53%, 23/43) among
SCI surveyed and especially of SCI
<30y (76%, 16/21)
* Studies from 1980 to date, involving a spasticity intervention with ≥3 and ≥50% SCI have been included in this table.
21-37
Discussion
Tizanidine
Table 21.13 Summary of Tizanidine Studies for Reducing Spasticity

Author Year;
Methods Outcome
Total Sample Size
Nance et al. 1994; Treatment: Tizanidine vs Placebo 1. Ashworth and Pendulum: significant
Initial N=118; Final N=78 change in favour of tizanidine.
Treatment: Single-dose (8mg), tizanidine. 1. Ashworth: peak reduction between 1-
Three pre-drug measurements 15 minutes 1.5 hrs with spasticity returning to
Mathias et al. 1989
apart after breakfast and 30 minute baseline by 4th hr; no rebound
N=10
equilibration. Observations continued at spasticity measured at 12-24 hrs.
0.5, 1.0, 1.5, 2.0, 3, 4, 5, 6, 12, 24 hours. 2. Muscle power: no effects.
A randomized, placebo-controlled trial specifically conducted to elucidate the anti-spasmodic

effect of tizanidine, an α2-adrenergic agonist, revealed significant spasticity improvements in
favour of tizanidine over placebo where Ashworth and Pendulum were the primary measures
used (p<0.0001 and p<0.002, respectively; Nance et al. 1994; N=118). Although this study
represents level 1evidence, it is noteworthy to mention that 34% of subjects who received study
treatment and discontinued prematurely due to adverse events, lack of efficacy and other
reasons not specified, were not included in the study analysis. Another single dose, pre-test,
post-test study (Mathias et al. 1989; N=10) presented evidence to corroborate the reduction in
spasticity as measured by Ashworth and furthermore revealed that muscle power was not
affected at any stage in the study.
Clonidine
Another commonly used anti-spasmodic is Clonidine, also an α2-adrenergic agonist (selective,

central acting).
Table 21.14 Summary of Clonidine Studies for Reducing Spasticity

Author Year;
Methods Outcome
Total Sample Size
Treatment: Two week washout period 1. 1/3 paretic patients had marked
between 4 weeks of randomly assigned progression from non-ambulation to
Clonidine or Placebo treatment. limited independent ambulation
Stewart et al. 1991;
Medication was administered orally 2 or 3 2. Spasticity -/+/0: Visual analogue
times per day. Initial dosage was scale (VAS) 6/1/2, Daily spasms 2/0/2,
0.02mg/day and systematically increased Daily clonus 4/0/1, Ankle Tendon
to an optimal level (0.05-0.25mg/day) Stretch Reflex (TSR) 5/2/2, Knee TSR
5/0/2, Evoked clonus 3/1/5.
Treatment: Responders (walking capacity 1. Significant decrease in Ashworth
preserved) to a 60ug intrathecal test dose spasticity score at all doses levels
were scheduled for 3, 15-90ug doses of 2. Significant increase in the velocity at
Remy-Neris et al. 1999; clonidine, and a placebo, by L2-3 puncture. maximal overground speed due to an
Initial N=11; Final N=11 Non-responders were given 30 and 15ug increase in the stride amplitude,
clonidine and a placebo when possible. A without any significant decrease in the
minimum interval of 3 days separated each cycle duration.
injection.
Treatment: 1 wk up-titration, 1 wk target 1. Significant Ashworth reduction,
Nance 1994; dose (0.05mg bid clonidine; 4mg qid Pendulum first swing amplitude
Initial N=25; Final N=25 cyproheptadine; 20 mg qid baclofen) , 1 wk increase, and Vibratory Inhibition
down-titration Index (VII) as a result of clonidine
Treatment: Clonidine, clonidine and 1. VII significantly reduced by Clonidine
Nance et al. 1989;
desipramine, diazepam, placebo only.
21-38
Author Year;
Methods Outcome
Total Sample Size
Treatment: Transdermal clonidine 1. 15/17 had clinically significant relief
Weingarden & Belen
and 12/15 continued use while 10/15
1992;
were able to decrease or discontinue
their current antispasticity medications.
Treatment: Oral clonidine - 0.05mg bid 1. 31/55 responded to Clonidine.
Donovan et al. 1988; and increased to 0.4mg bid if tolerated by 2. Quadriplegics responded to the
Initial N=55; Final N=55 the subject. medication significantly better than the
paraplegics but no difference between
complete and incomplete
Treatment: Intrathecal clonidine injection 1. Flexion Reflex Response (FRR)
(30/60/90 ug) amplitude change significant between
30 and 90 ug IT Clonidine only.
2. FRR stimulation threshold significantly
Remy-Neris et al. 2001; increased for all Clonidine doses.
N=15 3. Ashworth score decreased 4-6 hrs
after a single 60ug dose.
4. Quadriceps stretch reflex latency
increased and amplitude decreased
significantly
Treatment: 0.1-0.3 mg/wk Transdermal 1. Moderate to excellent improvement in
Yablon & Sipski 1993;
Clonidine patch (Constant/continuous spastic hypertonia and/or flexor
systemic delivery). spasms.
There are 2 placebo controlled trials (Stewart et al. 1991; N=12 and Remy-Neris et al. 1999;
N=11) providing evidence for Clonidine’s effectiveness in reducing SCI spasticity. Stewart et al
used oral Clonidine in a randomized trial but the spasticity outcome measures are not validated
or well known clinically compared to the Ashworth measure used by Remy-Neris et al’s,
intrathecal clonidine study. However the latter study was not randomized and therefore lacked
somewhat in scientific rigor. Both studies had small sample sizes. Another non-randomized,
placebo controlled study with a small sample size (Nance et al. 1989; N=6) concurred with
Clonidine’s antispasmodic properties through the use of a non-validated Vibratory Inhibition
Index (VII) which is not commonly known clinically. A subsequent pre-test post-test study by the
same author (Nance 1994; N=25) using the Ashworth and Pendulum measures as well as the
VII compared Clonidine with Cyproheptadine and Baclofen for their anti-spastic properties.
Although all three treatments were significantly beneficial in reducing spasticity as measured by
the Ashworth and Pendulum tests, Clonidine was significantly inferior to Baclofen and
Cyproheptadine as measured by the VII. The remaining reports of antispastic effects of
clonidine in various formulations (oral, transdermal and additional intrathecal studies) are
derived from case series studies (Donovan et al. 1988, N=55; Weingarden & Belen 1992, N=17;
Yablon & Sipski 1993, N=3; Remy-Neris et al. 2001, N=15). All presented results in favour of
using Clonidine as an anti-spasmodic but all outcome measures chosen for each study were
either not specified or unique to the study.
4-Aminopyridine
Beginning in 1993, anecdotal reports emerged on the antispasmodic effects of a new class of
K+ channel blocking drug, 4-aminopyridine (4-AP, immediate release oral and IV ; Hansebout et
al. 1993; Hayes et al. 1994; Potter et al. 1998a; Segal et al. 1999).
Table 21.15 Summary of 4-Aminopyridine Studies for Reducing Spasticity

Author Year;
Methods Outcome
Total Sample Size
Donovan et al. 2000; Treatment: Drug or placebo was 1. The intravenous route may not be the
Initial N=12; Final N=12 administered for 2 hours through an best way to administer this drug as no
21-39
Author Year;
Methods Outcome
Total Sample Size
indwelling venous catheter attached to an short term benefits were observed.
infusion pump (4-AP reached doses of 30
to 80 ng/ml at the end of a 2 h)
Treatment: Fampridine-SR (12.5 mg to 1. Significant benefit of Fampridine-SR
Potter et al. 1998; 17.5 mg bid) or placebo over a period of 2 over placebo as measured by the
Initial N=29; Final N=26 weeks with a washout period between Ashworth score.
treatments.
Treatment: 10mg id to tid 4AP capsules 1. Improved spasticity (UE N=1, LE N=2),
over 6 days with physical and 2. Ankle hypertonicity reduced (N=1).
Potter et al. 1998; neurophysiological examination pre and
Initial N=3; Final N=3 post administration up to 24 hrs . Tolerated
regimen continued for 4 months with prn
intermittent assessments.
Treatment: 24-25mg 4-AP IV (fasting). 1. N=2 for reduced spasticity.
Hayes et al. 1994;
Monitoring for effect pre to 2 hours post
and at 24 hours post drug administration
Two randomized, placebo-controlled trials for 4-Aminopyridine both employed the Ashworth
measure of spasticity but neither study was specifically designed to study spasticity (Donovan et
al. 2000 N=12; Potter et al. 1998 N=29). Only the latter study, using a sustained-release
formulation of 4-AP (Fampridine-SR) reported a statistically significant reduction in spasticity as
measured by the Ashworth (p<0.05, McNemar’s 2-tailed test). Intravenous administration was
employed by Donovan et al and the study concluded that this mode of administration is not
optimal based on the observation of no short term benefits. The remaining 2 case series
studies, also not specifically designed to study spasticity alone, present only minimal evidence
for the anti-spasmodic effects of 4-AP. Recent phase 3 clinical trial results of Fampridine-SR
effects on spasticity in chronic SCI are yet to be published.
Cyproheptadine
Cyproheptadine is a non-selective serotonergic antagonist and antihistamine that has been

reported to improve spasticity in SCI.
Table 21.16 Summary of Cyproheptadine Studies for Reducing Spasticity

Author Year;
Methods Outcome
Total Sample Size
Treatment: Cyproheptadine (1 week each Improvements in favour of Cyproheptadine
at 2mg, 4mg and 8mg id) or placebo in vs. placebo (descriptive statistics only; no
random order dose-titrated over 3 weeks p-values provided):
Wainberg et al. 1990;
with 1 week washout between treatment 1. Spasticity: all subjects reported a
arms. Open-label long-term study (N=4): decrease in the severity and frequency
Cyproheptadine (optimized dosing) of at of involuntary movements.
least 6 months.
Treatment: Oral Cyproheptadine - 6 mg to 1. Log of clonus and spasms showed
Barbeau et al. 1982; 24 mg per day over 4 to 24 months, decreased spontaneous spasms in
Initial N=6; Final N=6 including a placebo substitution period. 5/6.
Ankle clonus decreased in 6/6.
Treatment: 1 wk up-titration, 1 wk target 1. Ashworth significantly reduced,
dose (0.05mg bid clonidine; 4mg qid significantly increased first swing
cyproheptadine; 20 mg qid baclofen) , 1 wk amplitude, and increased Vibratory
down-titration Inhibition Index (VII) in all three drug
Nance 1994;
conditions with baclofen showing the
most improvement
2. Cyproheptadine and Baclofen
produced a greater reduction in the VII
than Clonidine.
21-40
Cyproheptadine performed favourably versus placebo in improving spasticity and walking in a
small sample of chronic SCI patients (Wainberg et al. 1990, N=8). Although the study design
was randomized and placebo controlled, reductions in spasticity were only subjectively
measured as subject reports of severity and frequency of involuntary movements. Similarly,
Barbeau et al. (1982) in a case series study involving 6 subjects confirmed this antispasmodic
effect of Cyproheptadine using subjective patient logs of clonus and spasms. Norman et al.*
1998 (N=12) corroborated the reduction in ankle clonus in a study of various drugs and gait in
SCI. Validated outcome measures (i.e. Ashworth and Pendulum tests) were used by Nance
1994 (N=25) in a pre-test post-test study that provided statistically significant evidence
supporting the use of Cyproheptadine in treating SCI spasticity.
Gabapentin
Limited level 1 evidence supports the use of Gabapentin for spasticity treatment. Gruenthal et
al. 1997 (N=28) conducted a randomized, placebo-controlled trial and were able to reveal
modest improvements as measured by Ashworth and Likert Scale scores (p=0.044 and 0.013,
respectively). Despite the robust study design, no confidence intervals were reported and the
sample size was relatively small.
Other potential anti-spasmodics
Other potential anti-spasmodics used in SCI include L-threonine, Diazepam, Dantrolene and
Cannabis. A randomized, controlled study of L-threonine (Lee & Patterson 1993; N=33) only
showed minimal effects on spasticity. Nance et al. 1989 in a study of Clonidine for SCI
spasticity showed that effects of diazepam and placebo were not different from pre-treatment
values. However, an earlier cross-over study (Corbett et al.* 1972, N=19) showed that Valium
was more effective than Amytal and Placebo in reducing spasticity (p<0.02-0.05). No current
studies (*1980 to date) were found that investigated the specific use of Dantrolene in the
treatment of SCI spasticity.
Cannabis has been rumoured to be effective in treating SCI spasticity and although scientifically
robust studies investigating its use for this condition do not yet exist, a questionnaire study (no
intervention) involving a sample of 43 subjects showed no consistent correlation between
cannabis use and the Spasticity Change Index (i.e. spasticity level of drug state subtracted from
spasticity level of non-drug state; Malec et al* 1982, N=43).
Conclusions
Although Level 1 evidence supports the use of tizanidine for the treatment of SCI
spasticity, it is noteworthy to mention that 34% of subjects who received study treatment
and discontinued prematurely due to adverse events, lack of efficacy and other reasons
not specified, were not included in the study analysis.
Level 1 evidence exists in favour of using Clonidine as a SCI anti-spasmodic. However,

outcome measures chosen for each study included in this review were either not
specified or unique to the study (i.e. invalidated).
Currently there is conflicting evidence for the anti-spasmodic effects of 4-AP. Recent
Phase 3 clinical trial results of Fampridine-SR effects on spasticity in chronic SCI are yet
to be published.
21-41
Limited Level 1 evidence (small sample size, N=7; and invalidated, subjective outcome
measures) supports the use of Cyproheptadine in the treatment of spasticity in chronic
SCI patients (Wainberg et al. 1990, N=8). However, level 4 evidence resulting from
validated outcome measures collected from a larger sample (N=25) did corroborate the
finding that Cyproheptadine is effective in treating chronic SCI patients with spasticity.
A single RCT provided evidence towards modest improvements in spasticity with the use
of Gabapentin (Gruenthal et al. 1997; N=28). Despite the robust study design and
validated outcome measures, no confidence intervals were reported and the sample size
was relatively small.
Despite current use, very little evidence supports the use of other potential SCI anti-
spasmodics such as Diazepam, Dantrolene and Cannabis. An RCT investigating L-
threonine for the treatment of SCI spasticity (Lee & Patterson 1973) showed only minimal
effects on spasticity.
Tizanidine, Clonidine, Cyproheptadine and Gabapentin may be useful in treating SCI spasticity.
The usefulness of Diazepam, Dantrolene, 4-Aminopyridine, L-Threonine and Cannabis in the

treatment of SCI spasticity requires confirmation through additional well-designed studies.
21.4.4 Neurolysis with Botulinum Neurotoxin
Botulinum neurotoxins represent a variety of distinct immunologic serotypes (types A-G)

synthesized by Clostridium botulinum (Yablon 2001). In particular, Type A (BTX-A) and Type B
botulinum neurotoxins have been employed clinically to relieve focal muscle spasticity in a
variety of etiologies, most notably cerebral palsy, multiple sclerosis, stroke and acquired brain
injury. Across these various etiologies, several RCTs have been conducted which provide Type
1 level evidence for the efficacy of botulinum neurotoxin in ameliorating focal muscle spasticity
(Snow et al. 1990; Simpson et al. 1996; Corry et al. 1997; Simpson 1997; Richardson et al.
2000; Smith et al. 2000; Hyman et al 2000; Bakheit et al. 2001; Wasiak et al. 2004). In addition,
there are several treatment guidelines and other information available for assisting the clinician
with dosing and medication administration decisions (Brin 1997a; Brin 1997b; Gormley Jr. et al.
1997; O'Brien 1997; Ward 2002; Francisco 2004).
Clinicians and researchers have advocated the use of botulinum neurotoxin for relieving focal
muscle spasticity in individuals with SCI (Brin 1997b; Kirshblum 1999; Fried & Fried 2003) and
the Spasticity Study Group purport that the decision to use botulinum neurotoxin “is independent
of the etiology of the spasticity, depending rather on the presence of an increase in muscle tone
that interferes with function” (Brin 1997b). The advantages for its use have been outlined
including the ability to achieve a focal response, a relative ease of administration and avoiding
the sedation common with other pharmacological alternatives (Fried & Fried 2003). In spite of
this information and the recognition that spasticity comprises a significant functional limitation for
many people with SCI, (Maynard et al. 1990; Skold et al. 1996; 1999) there are relatively few
studies directed specifically at this patient population. In fact, no studies have been identified
which meet the criteria established for the present review (i.e., English language articles with
21-42
N=3 and at least half of the subjects having a SCI).2 In lieu of these, we present the results of
three studies which examined the effect of BTX-A on spasticity secondary to SCI but had either
insufficient n (i.e, individual case studies) (Richardson et al. 1997; Al-Khodairy et al. 1998) or a
subject pool comprised mainly of people having a stroke or acquired brain injury with only a
small subset of subjects with spasticity secondary to SCI (Richardson et al. 2000). It should be
noted that botulinum neurotoxin has also been employed successfully to overcome bladder
detrusor-sphincter dyssynergia in people with SCI (Dykstra & Sidi 1990; Schurch et al. 1996;
deSeze et al. 2002) and this will be addressed separately in the chapter dealing with bladder
function.
Table 21.17 Botulinum Neurotoxin for Reducing Spasticity

Score
Methods Outcome
Research Design
Total Sample Size
Population: Stroke (23), Head Injury (12), 1. Spasticity was significantly reduced for
SCI (6) and others with focal spasticity, active Tx vs placebo (as shown by
details of SCI unknown modified Ashworth aggregate scores)
(p<.02). The main reduction for both
Intervention: EMG guided injection of Tx and placebo groups occurred
BTX-A with doses and specific muscles between baseline and week 3 with
injected based on clinical judgment. little further improvement thereafter. Tx
group had more marked reduction
than placebo group.
Richardson et al. 2004; Outcome Measures: modified Ashworth); 2. Range of Motion was significantly
England passive ROM; Subjective rating of Problem improved for both groups but
PEDro=9 Severity, 9-hole peg test (upper limb significantly more for Tx vs placebo
RCT problems only), timed 10 m walk test (lower group (p<.03). As with modified
N=52 (6 with SCI) limb problems only), Goal Attainment Scale Ashworth most marked changes were
, Rivermead Motor Assessment Scale @ 3, between baselines - 3 weeks.
6, 9 & 12 weeks 3. In general, the various functional
measures showed no systematic
significant differences other than
Subjective Rating of Problem Severity
with aggregate outcome scores
significantly better for active Tx vs
placebo (p<.025).
4.
Population: 23 year old male, incomplete 1. Spasticity was reduced (most
C5/6, 18 months post-injury Ashworth scores went from 3 to 1 –
finger flexors to 2 for all time periods
Intervention: EMG guided injection of after baseline) and range of motion
BTX-A (210 units total) (in various muscles was increased (70° to 90°). These
of the hand) + wrist/thumb splint + hand measures were maintained over
exercise. testing period to 12 weeks.
Richardson et al. 1997;
2. Grip strength was reduced initially but
England
Outcome Measures: Ashworth Scale, grip recovered close to baseline by 6
strength (Jamar dynamometer), passive weeks.
Case Study
ROM, Jebsen Hand Function Test, 3. Jebsen hand function deteriorated on
N=1
Rivermead Motor Assessment Scale @ 3, most tasks initially, then recovered on
6, 9 & 12 weeks most but remained less agile at turning
cards over and stacking draughts - yet
improved on picking up objects.
2
3 non-English language articles have been identified which examined the effects of botulinum neurotoxin on muscle
spasticity in SCI (Oechsner, 2002; Keren et al., 2000; Takenaga et al., 1995).
21-43
Score
Methods Outcome
Research Design
Total Sample Size
Population: 50 year old male, T12, ASIA 1. Spasticity was reduced in that
A, 22 years post-injury Ashworth scores went from 2-3 to 1+
and the Spasm Frequency Score went
Intervention: 8 successive treatments of from 4 to 2.
Al-Khodairy et al. 1998; EMG-guided BTX-A (first in gastrocnemius, 2. Pain Visual Analog Scale Scores went
Switzerland then other muscles as well) from 8 to 1.
Downs & Black score=7 3. The subject also reported less difficulty
Case Study Outcome Measures: Modified Ashworth with ADLs and better sitting tolerance.
N=1 Scale, Spasm Frequency Score, Pain 4. Unlike preceding treatments, the final
Visual Analogue Scale treatment (8th over 2 year period) had
no beneficial clinical effect with no
explanation for what may have caused
this phenomenon.
Discussion
Individual case studies employing botulinum neurotoxin in individuals with SCI have been
conducted by Richardson et al. (1997) and Al-Khodairy et al. (1998). Each of these reports
employed EMG-guided BTX-A injections. Richardson et al. (1997) injected several wrist and
hand muscles in a single chronic SCI subject. Spasticity was reduced as assessed by the
Ashworth Scale and range of motion was increased with these measures maintained over the
testing period to 12 weeks. Al-Khodairy et al. (1998) conducted a 2-year follow-up study of a
chronic incomplete paraplegic male. Spasticity was reduced as determined by Ashworth Scale
scores and the Spasm Frequency Score. In addition, pain due to spasticity was also markedly
reduced and the subject reported less difficulty with activities of daily living, better sitting
tolerance and fewer sleep disturbances. The final treatment delivered in this series (i.e., 8th over
2 year period) was without effect leaving the possibility of drug tolerance but this was not
confirmed.
Richardson et al. (2000) investigated the effects of BTX-A on impairment and focal disability in a
group of 52 subjects with various etiologies using a prospective, randomized, double-blind,
placebo-controlled, parallel group design. Subjects with stroke (23) and acquired brain injury
(12) made up the majority of the sample with only 6 SCI subjects participating in addition to
other individuals with spasticity due to other etiologies such as tumour (5), cerebral palsy (3)
and anoxic brain damage (3). Subjects were not matched relative to their etiologies; rather they
were randomized into separate treatment vs placebo groups depending on whether their
identified problem with focal spasticity was in the upper vs the lower limb. BTX-A was injected
via EMG-guided techniques in 1 or more muscles based on clinical judgment. Modified
Ashworth scores demonstrated reduced spasticity across the appropriate joints when tested at
3, 6, 9 and 12 months with both active treatment and placebo although there was a significantly
greater reduction with BTX-A (p<.02). Despite the randomized controlled trial utilizing a
validated spasticity outcome measure, the conclusions must be cautiously interpreted with
respect to BTX-A use in SCI, given that only 6/52 subjects had spasticity of confirmed spinal
origin.
Conclusions Regarding the Effect of Botulinum Neurotoxin
Based on 2 case studies, there is Level 4 evidence that botulinum neurotoxin improves
focal muscle spasticity secondary to SCI. This is cautiously supported by an RCT where
only 6/52 subjects had spasticity of confirmed spinal origin.
21-44
The effect of long-term administration of botulinum neurotoxin is based on the results of
a single case study involving 8 treatments over 2 years (limited Level 4 evidence).
Tolerance to BTX-A may occur with prolonged administration and requires further study.
Botulinum neurotoxin appears to improve focal muscle spasticity in people with SCI.
21.5 Spasticity Outcome Measures
The studies reviewed in this section involve a variety of outcome measures that have been
summarized into 4 categories: 1) Known Clinical Measures; 2) Other Measures; 3)
Electrophysiological Measures and 4) Quality of Life Measures. Among the known measures,
some are validated and only a subset of those is used frequently by clinicians. The abundance
of outcome measures in the other category are not well understood by the majority of clinicians
and increases the difficulties encountered when comparing studies and treatments. Very few
studies included measures addressing quality of life despite the need to ensure that treatments
are well tolerated as well as functionally and practically effective for patients.
Table 21.18 Summary of Outcome Measures used in Spasticity Intervention Studies

Electrophysiological
Known Clinical Measures Other Measures Quality of Life Measures
Measures
1. Ambulation Index 1. Adverse Event 1. “Electrophysiologic 1. Hopkins symptom
2. American Spinal Injury monitoring testing” check list (HSCL)
Assessment (ASIA; 2. “Clinical interview 2. EMG/velocity ratio for 2. Sickness Impact
motor and sensory questionnaire” any given speed – Profile (SIP)
index) 3. “Clinical Rating Score stretch reflex response 3. Global Impression
3. Ashworth (Original and (CRS)” 3. Flexion reflex (Patient and/or
Modified) 4. “Clinically significant measurement Peak Clinician)
4. Barthel Index Clonus relief of spasticity” isometric quad torque
(count or duration) 5. “Continuation of study in response to surface
5. Deep Tendon drug after trial” electrical stimulation
Reflexes (DTR) 6. Cost effectiveness 4. Gait analysis
6. Expanded disability analysis. 5. H-Reflex and H/M ratio
status scale (EDSS) 7. Cystomanometry (latency and
7. Functional 8. “Evaluation of amplitude)
Independence functional abilities” 6. Joint angular
Measure (FIM) 9. “Decrease in displacement
8. Goal Attainment Scale hypertonicity” 7. Motor Evoked
9. Grip strength (Jamar 10. “Discontinuation of Potentials (MEP)
dynamometer) other antispasticity 8. Polysynaptic reflex
10. Global Impression medications” measurement
(Patient and/or 11. “Evaluation of 9. Quantitative
Clinician) personal assessment of ankle
11. Incapacity Status independence” hypertonicity
Scale* 12. “Five point scale 10. Viscous and elastic
12. Klein-Bell ADL scale (“interference of stiffness to sinusoidal
13. Jebsen Hand Function spasticity on selected ankle perturbation of
Test self care activities” and 5° at 3 to 12 Hz.
14. Manual Muscle weekly rate of
Testing resistance to
15. Nine-hole peg test movement)
(upper limb problems 13. “Functional disability
only) score (FDS)”
16. Passive joint ROM 14. “Gait spasticity and
17. Patient Evaluation and transfer activity”
21-45
Electrophysiological
Known Clinical Measures Other Measures Quality of Life Measures
Measures
Conference System 15. “Impression of pain”
(PECS) 16. “Neurological reflex
18. Pendulum test scale”
19. Plantar stimulation 17. Outcome measure not
response specified.
20. Present Pain Intensity 18. “Painful Spasm Scale”
21. Rivermead Mobility 19. “Patient Caregiver
Index (RMI) subjective responses”
22. Seven point terrible- 20. Patient/Clinician
delighted scale Global measure (4
23. Six point Likert scale point scale)
(spasticity) 21. Patient Daily Diary or
24. Spasm Frequency Log (spasticity, clonus,
Scale (SFS) nocturnal awakenings
25. Spasm Severity Scale related to spasms)
(SSS) 22. Subjective ratings
26. Standard neurological (problem severity,
examination spasticity assessment,
27. Timed 10 m walk test pain)
(lower limb problems 23. “Telephone
only) questionnaire
28. Visual Analogue Scale regarding decrease in
(VAS: Spasticity, Pain, symptoms”
Satisfaction) 24. “Use of limbs and
transfer activity
(weekly)”
25. Vibratory Inhibition
Index (VII)
The gold-standard for clinical testing is the double-blind, randomized, placebo-controlled study
design, particularly for the measurement of short term treatment effects. However, the results of
a well-designed trial are more easily interpreted if the outcome measures used follow outcome
measure standards as outlined by Pierson 1997. In summary, effective outcome measures
should be selected based on 1) understandability for administration/scoring/interpretation and
validity/reliability; 2) relevancy to the clinical situation and population measured; 4) having a
reasonable risk-benefit ratio; 5) requirement for strict adherence to test conditions and
procedures; and 6) practicality in terms of personnel, time, equipment, cost, space and impact
on the subject. No single outcome measure can capture the multi-dimensional nature of
spasticity. Therefore, it is important, not only to choose an effective outcome measure but also
to choose effective outcome measures to monitor the range of medical outcomes as suggested
by Goldberg (1991): 1) technical outcome (i.e. reduction of spasm frequency); 2) functional
outcome; 3) patient satisfaction and; 4) cost effectiveness.
Some of the measures that have been tested for various aspects of spasticity and for validity
and/or reliability include the Ashworth (Ashworth 1964) and Modified Ashworth (Bohannon &
Smith 1987; Haas et al 1996) spasticity scale, Spasm Frequency scale (Penn 1988; Priebe
1996) and the Pendulum test (Nance 1994). Please refer to the chapter on outcome measures
for a discussion of these measures.
Well designed studies should include effective outcome measures that meet minimum
standards and that encompass the range of medical outcomes relevant to the treatment and
the patients.
21-46
21.6 Summary
There is level 4 evidence that rhythmic, passive movements may result in a short-term
There is level 4 evidence that externally applied forces or passive muscle stretch as are
applied in assisted standing programs may result in short-term reduction in spasticity.
This is supported by individual case studies and anecdotal reports from survey-based
research.
There is level 2 evidence that hydrotherapy is effective in producing a short-term

There is level 4 evidence that a program of FES-assisted walking acts to reduce ankle
spasticity in the short-term (i.e., ≤24 hours).
There is no evidence that describes the length and time course of the treatment effect
related to spasticity for hydrotherapy or FES-assisted walking.
There is level 2 evidence that a single bout of surface muscle stimulation reduces local
muscle spasticity with agonist stimulation more effective than stimulation to the
antagonist.
There is conflicting evidence for how long the effects of a single bout of electrical
stimulation on muscle spasticity persist, although they appear to be relatively short
lasting (i.e., ≤ 6 hours).
There is no evidence that a long-term program of muscle stimulation has an effect on

reducing muscle spasticity and may even increase local muscle spasticity.
There is level 1 evidence that an ongoing program of TENS acts to reduce spasticity as
demonstrated by clinical and electrophysiological measures.
There is level 1 evidence that reductions in spasticity with ongoing programs of TENS
may persist for up to 24 hours.
There is level 1 evidence that a single bout of TENS acts to reduce spasticity but to a
lesser degree than that seen with ongoing programs of TENS. This evidence is muted
somewhat by conflicting results with a null result (level 2) compared with 2 positive
results (level 4).
There is level 4 evidence that several sessions of rectal probe stimulation reduces lower
limb muscle spasticity for up to 8 hours.
There is level 4 evidence that short periods of massage (e.g., 3 minutes) of the triceps
surae results in reduced H-reflexes with the effect lasting no longer than a few minutes.
There is level 1 evidence that a single bout of penile vibration acts to reduce spasticity
lasting for at least 3 hours and possibly up to 6 hours.
There is level 4 evidence that hippotherapy may reduce lower limb muscle spasticity
immediately following an individual session.
21-47
There is level 4 evidence that cryotherapy may reduce muscle spasticity for up to 1 hour
after removal of the cold stimulus.
There is level 2 evidence that helium-neon irradiation of sensory nerves may suppress
ankle clonus for up to 60 minutes following 40 seconds of stimulation.
There is Level 4 evidence that ongoing spinal cord stimulation may provide some relief
from otherwise intractable spasticity for some time (i.e., months to years).
There is level 4 evidence that the beneficial effects of spinal cord stimulation will subside
for most initial users. This, combined with the potential for equipment failure and
adverse events, suggests that spinal cord stimulation is not a cost-effective approach for
managing spasticity.
There is Level 2 evidence that dorsal longitudinal T-myelotomy may result in reduced
spasticity in those individuals initially refractory to more conservative approaches.
These reductions may not always be maintained over the course of several years.
There is Level 2 evidence that Pourpre’s technique for dorsal longitudinal T-myelotomy
is more effective in maintaining reduced levels of spasticity than the Bischof II technique.
There is Level 1 evidence that oral baclofen improves muscle spasticity secondary to
SCI. This conclusion is based on the results from 4 positive small-scale RCTs although is
muted somewhat by a negative finding from a low n (5) single-subject design RCT and an
overall lack of homogeneity in outcome measures and study participants. Additional
uncontrolled cohort and case series studies also provide support for the use of oral
baclofen in reducing spasticity.
There is Level 1 evidence that bolus or test dose intrathecal baclofen decreases
spasticity.
There is Level 4 evidence that the use of long-term intrathecal baclofen decreases
spasticity.
There is Level 4 evidence that intrathecal baclofen may improve functional outcomes.
There is Level 4 evidence that complication rates with the long-term use of intrathecal
baclofen are relatively low.
There is Level 4 evidence that intrathecal baclofen is a cost-effective intervention.
Although Level 1 evidence supports the use of tizanidine for the treatment of SCI
spasticity, it is noteworthy to mention that 34% of subjects who received study treatment
and discontinued prematurely due to adverse events, lack of efficacy and other reasons
not specified, were not included in the study analysis.
Level 1 evidence exists in favour of using Clonidine as a SCI anti-spasmodic. However,

outcome measures chosen for each study included in this review were either not
specified or unique to the study (i.e. invalidated).
Currently there is conflicting evidence for the anti-spasmodic effects of 4-AP. Recent
Phase 3 clinical trial results of Fampridine-SR effects on spasticity in chronic SCI are yet
to be published.
21-48
Limited Level 1 evidence (small sample size, N=7; and invalidated, subjective outcome
measures) supports the use of Cyproheptadine in the treatment of spasticity in chronic
SCI patients (Wainberg et al. 1990, N=8). However, level 4 evidence resulting from
validated outcome measures collected from a larger sample (N=25) did corroborate the
finding that Cyproheptadine is effective in treating chronic SCI patients with spasticity.
A single RCT provided evidence towards modest improvements in spasticity with the use
of Gabapentin (Gruenthal et al. 1997; N=28). Despite the robust study design and
validated outcome measures, no confidence intervals were reported and the sample size
was relatively small.
Despite current use, very little evidence supports the use of other potential SCI anti-
spasmodics such as Diazepam, Dantrolene and Cannabis. An RCT investigating L-
threonine for the treatment of SCI spasticity (Lee & Patterson, 1973) showed only
minimal effects on spasticity.
Based on 2 case studies, there is Level 4 evidence that botulinum neurotoxin improves
focal muscle spasticity secondary to SCI. This is cautiously supported by an RCT where
only 6/52 subjects had spasticity of confirmed spinal origin.
The effect of long-term administration of botulinum neurotoxin is based on the results of

a single case study involving 8 treatments over 2 years (limited Level 4 evidence).
Tolerance to BTX-A may occur with prolonged administration and requires further study.
21-49
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21-56
CHAPTER TWENTY-TWO
Outcome Measures

Armin Curt, MD, FRCPC
Stacy Elliott, MD
Jane TC Hsieh, MSc
William B Mortenson, MSc, BScOT
Vanessa Noonan, MSc, BScPT
Luc Noreau, PhD
Steve Orenczuk, PhD
Bonita Sawatzky, PhD
John Steeves, PhD
Shannon Wilkinson, BScOT
Dalton L Wolfe, PhD
Table of Contents
22.1 Introduction ..................................................................................................................22-1

Introduction References...........................................................................................................22-9
22.2 Body Function / Structure .........................................................................................22-11

22.2.1.1 The CAGE Questionnaire ......................................................................................22-12
22.2.1.2 Center for Epidemiological Studies Depression Scale (CES-D) ............................22-13
22.2.1.3 Patient Health Questionnaire (PHQ-9)...................................................................22-14
22.2.1.4 Zung Self-Rating Depression Scale (SDS) ............................................................22-15
22.2.2.1 Classification System for Chronic Pain in SCI .......................................................22-16
22.2.2.2 Donovan SCI Pain Classification System ..............................................................22-17
22.2.2.3 Tunk’s Classification Scheme ................................................................................22-18
22.2.2.4 Wheelchair Users Shoulder Pain Index (WUSPI) ..................................................22-19
22.2.3.1 Wingate Anaerobic Testing (WAnT) ......................................................................22-20
22.2.4.1 The “American Spinal Injury Association: International Standards for Neurological
Classification of Spinal Cord Injury” .......................................................................22-21
22.2.4.2 Ashworth and Modified Ashworth ..........................................................................22-22
22.2.4.3 Penn Spasm Frequency Scale (PSFS)..................................................................22-23
22.2.4.4 Surface Electromyography (sEMG) .......................................................................22-24
22.2.5.1 Braden Scale .........................................................................................................22-25
22.2.5.2 Gosnell Measure....................................................................................................22-26
22.2.5.3 Norton Measure .....................................................................................................22-27
22.2.5.4 Spinal Cord Injury Pressure Ulcer Scale (SCIPUS) Measure ................................22-28
22.2.5.5 Spinal Cord Injury Pressure Ulcer Scale - Acute(SCIPUS-A) ................................22-29
22.2.5.6 Waterlow Scale ......................................................................................................22-30
22.2.6.1 Emotional Quality of the Relationship Scale (EQR) ...............................................22-31
22.2.6.2 Knowledge, Comfort, Approach and Attitude towards Sexuality Scale (KCAASS)22-32
22.2.6.3 Sexual Attitude and Information Questionnaire .....................................................22-33
22.2.6.4 Sexual Behaviour Scale (SB).................................................................................22-34
22.2.6.5 Sexual Interest, Activity and Satisfaction (SIAS) / Sexual Activity and Satisfaction
(SAS) Scales..........................................................................................................22-35
22.2.6.6 Sexual Interest and Satisfaction Scale (SIS) .........................................................22-36
Body Function / Structure References ...................................................................................22-37
22.3 Activity ..........................................................................................................................22-41

22.3.1.1 4 Functional Tests for Persons who Self-Propel a Manual Wheelchair
(4FTPSMW) ......................................................................................................22-42
22.3.1.2 10 Meter Walking Test (10 MWT) ..........................................................................22-43
22.3.1.3 Functional Standing Test (FST) .............................................................................22-44
22.3.1.4 Modified Functional Reach Test (mFRT) ...............................................................22-45
22.3.1.5 Tetraplegia Hand Activity Questionnaire (THAQ) ..................................................22-46
22.3.1.6 Timed Motor Test (TMT) ........................................................................................22-47
Table of Contents (Cont.)
22.3.1.7 Timed Up and Go Test (TUG)................................................................................22-48

22.3.1.8 Walking Index for Spinal Cord Injury (WISCI) and WISCI II...................................22-49
22.3.1.9 Wheelchair Circuit (WC) ........................................................................................22-50
22.3.1.10 Wheelchair Skills Test............................................................................................22-51
22.3.2.1 The Barthel Index...................................................................................................22-52
22.3.2.2 Functional Indepedence Measure (FIM) ................................................................22-53
22.3.2.3 Quadriplegia Index of Function (QIF).....................................................................22-55
22.3.2.4 Self Care Assessment Tool (SCAT) ......................................................................22-56
22.3.2.5 Skin Management Needs Assessment Checklist (SMNAC) ..................................22-57
22.3.2.6 Spinal Cord Injury Lifestyle Scale (SCILS) ............................................................22-58
22.3.2.7 The Spinal Cord Independence Measure (SCIM) ..................................................22-59
Activity References ................................................................................................................22-60
22.4 Participation .................................................................................................................22-64

22.4.1 Assessment of Life Habits Scale (LIFE-H)................................................................22-67
22.4.2 Canadian Occupational Performance Measure (COPM) ..........................................22-68
22.4.3 The Craig Handicap Assessment & Reporting Technique (CHART) ........................22-69
22.4.4 Impact on Participation and Autonomy Questionnaire (IPAQ) ..................................22-70
22.4.5 Participation Survey/Mobility (PARTS/M...................................................................22-71
22.4.6 Perceived Handicap Questionnaire (PHQ) ...............................................................22-72
22.4.7 The Physical Activity Recall Assessment for People with Spinal Cord injury
(PARA-SCI)...............................................................................................................22-73
22.4.8 Reintegration to Normal Living (RNL) Index ...............................................................22-74
Participation References........................................................................................................22-75
22.5 Quality of Life ...............................................................................................................22-77

22.5.1 Life Satisfaction Questionnaire (LISAT -9 -11) .........................................................22-79
22.5.2 Quality of Life Index (QLI, Ferrans & Powers) ..........................................................22-80
22.5.3 Quality of Life Profile for Adults with Physical Disabilities (QOLP-PD) .....................22-81
22.5.4 Quality of Well Being.................................................................................................22-82
22.5.5 Qualiveen..................................................................................................................22-83
22.5.6 Satisfaction with Life Scale (SWLS, Deiner Scale) ...................................................22-84
22.5.7 The Short Form 12 (SF-12) and Short Form 36 (SF-36) ..........................................22-85
22.5.8 The Sickness Impact Profile 68 (SIP 68) ..................................................................22-86
22.5.9 WHOQOL (BREF).....................................................................................................22-87
Quality of Life References......................................................................................................22-88
Miller WC, Curt A, Elliott S, Hsieh JTC, Mortenson WB, Noonan V, Noreau L, Orenczuk S, Sawatzky B, Steeves J,
Wilkinson S, Wolfe DL (2006). Outcome Measures. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF,
Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 22.1-
22.89.
www.icord.org/scire
Outcome Measures
22.1 Introduction
Good science and good clinical practice both depend on sound information which in turn relies
on sound measurement. Measurement, the process of assigning numbers to represent
quantities of a trait, attribute or characteristic (Nunnally & Bernstein 1995), enables health care
professionals and researchers to describe, predict and evaluate in order to provide benchmarks
and summarize change (Law 1987; Wade 2004) related to the condition and care of individuals
with spinal cord injury.
Despite past evidence that suggested clinicians in the rehabilitation field did not regularly use
outcome measures (Cole et al. 1994; Deathe et al. 2002; Skinner et al. 2006), there is mounting
evidence that now confirms more clinicians are now reporting their findings using some ordinal
or quantifiable outcome tool (Kay et al. 2001; Skinner et al. 2006). Beyond the administrative
push to use datasets to track patient outcomes in relation to health care costs, clinical
investigators recognize that using an appropriate outcome tool, to determine the validity of a
therapeutic intervention, is the key to establishing or changing the models of best practice (Cole
et al. 1994). There is a sincere desire to move beyond minimal data collected through datasets
such as the mandatory Canadian Institutes of Health Information (CIHI) Rehabilitation Minimum
Data Set or the Functional Independence Measure (FIM). Nevertheless there is a lack of
validated tools for many disciplines within rehabilitation research. There is also uncertainty as to
the strength and limitations for each type of assessment. It is hoped that this book will help
demystify the various tools and provide the reader with the necessary confidence to move their
clinical practice and research forward on a more rigorous basis.
The language used when discussing methods used (eg. screen, tool, instrument, measure,
scale) is often misused leading to confusion (Wade 2004). For the purposes of this review the
terms listed will be used interchangeably to indicate a method used to capture data in a
standardized manner.
Why assess tools with the SCI Population?
Why is there a need to assess the psychometric or clinometric properties of an outcome

measure in different clinical populations? This is a fair question. For example, there is a
considerable body of research suggesting the Functional Independence Measure (FIM) is a
valid and reliable measure. Do we really need to test it in different diagnostic populations? The
short answer is ‘absolutely’. The long answer is a bit academic, but important all the same.
The FIM was developed to assess the burden of care in the stroke population (Granger et al.
1986). There has been significant investment in the development of the FIM and it has become
the gold standard for the assessment of basic function (e.g. transfers, mobility, dressing,
grooming, bowel and bladder). In fact it is core to the minimum dataset used in many
administrative databases such as the CIHI Rehabilitation Reporting System and the Uniform
Data Set for Medical Rehabilitation Centers in the United States. Despite the popularity of FIM
(now a proprietary entity) and its universal recognition, the attempts to use it across a broad
range of disabling physical disorders, including SCI, has revealed deficiencies and
inadequacies. In fact, Catz and colleagues (1997) created the Spinal Cord Independence
22-1
Measure (SCIM) in response to frustrations related to using the FIM to categorize the functional
changes associated with Activities of Daily Living (ADL) during SCI rehabilitation. The results
demonstrate that the responsiveness, or the ability to detect change, is better in the SCIM than
the FIM (Catz et al. 1997; 2006; Itzkovich et al. 2003).
Another example is the Short Form-36 (Ware & Sherbourne 1992) and its lesser cousin the
Short-Form-12. These extremely popular generic surveys of health related Quality of Life (QoL)
include items which are oriented around activity limitation at the personal level, as well as
participation or restriction at a societal level (e.g. can you lift and carry and object; can you climb
stairs?). It seems obvious that a good proportion of the SCI population would not be able to
complete many of these activities. This is why it is critical to assess that each survey item is first
and foremost appropriate for the level of SCI being assessed, as unacceptable items can alter
the individual’s response (seriousness to answer) or confound the data from each study cohort.
This stance does not mean that new tools should be created for every diagnosis, health
condition or situation (Streiner & Norman 2004), but it does make sense that existing tools must
be validated for each study population so they are both sufficiently accurate and sensitive to
detect a meaningful difference in a functionally significant clinical endpoint between the
experimental and control groups of the trial (Steeves et al. 2006)..
If the above reasons are not compelling enough, Portney and Watkins (2000), in their
discussion of generalizability theory (the concept of reliability theory in which measurement error
is viewed as multidimensional) remind us that establishing the population-specific reliability is
essential especially to clinical practice. The nuances of many factors such as pain, spasticity
and deformity can alter the reliability of any obtained result. In short, while a lack of evidence
does not mean evidence is lacking, we are obligated to demonstrate and document the
reliability and validity of a test score in order to have faith in our results.
Inclusion Criteria for Measurement Tools of Interest to SCI
Initially the measures targeted for this review included any and all tools for which there was at
minimum one study that examined psychometric properties (reliability, validity, responsiveness)
using a spinal cord population. More specifically, only those peer-reviewed manuscripts that
directly reported values for their sample of SCI individuals were included. A list of 168 tools was
originally derived (approximately 10 were different formats of a similar tool). Given the vast
number of tools inclusion criteria was further narrowed to select tools for review based on
clinician familiarity and interest (N=50) as well as some tools (N=4) such as the Barthel Index
that are commonly known and used internationally.
A table identifying all tools was developed and clinicians (nurses, occupational therapists,
physiatrists, physical therapists, psychologists, recreation therapists and social workers) from
GF Strong Rehabilitation Centre (Vancouver, British Columbia) and Parkwood Hospital
(London, Ontario) were surveyed. Tools were then selected for review based on receiving at
least 5 tallies of interest and/or familiarity.
Note, while we recognize that in many randomized controlled trials investigators assess the
reliability between their raters. Most often these efforts are to ensure stability of the results
within the research team and therefore the results are not to generalize to the larger pool of tool
users. As a result the statistical model chosen to calculate the intra class correlation coefficient
(ICC) for example is different given this purpose (Shrout & Fleiss 1979). Given the dearth of
RCTs conducted in SCI research the number of studies lost is potentially very small.
22-2
Searching the Literature
The Pubmed, MedLine, CINHAL, Embase, HaPI, Psycinfo, and Sportdiscus electronic
databases were searched (1986 to January 2006) in an effort to locate papers reporting on
measures. Additional searching was conducted by archiving the references of papers obtained
from the electronic search. The key word spinal cord injury was used across each of the
databases while the following terms varied in combination with spinal cord injury depending on
the database used: validation studies, instrument validation, external validity, internal validity,
criterion-related validity, concurrent validity, discriminant validity, content validity, face validity,
predictive validity, reliability, interrater reliability, intrarater reliability, test-retest reliability,
reproducibility, responsiveness, sensitivity to change, evidence-based medicine, outcome
measures, clinical assessment tools, scales and measures. A database file was established
using RefWorks to organize potential articles of interest. After eliminating duplicate manuscripts
data extractors reviewed titles and abstracts in order to retain relevant papers. At this point all of
the articles were read and the relevant information (reliability, validity and responsiveness
coefficients and descriptions) was extracted. See Appendix 1 on page 22-8 for a copy of the
data extraction form.
Classifying the Tools
To assist with the process or organizing the tools we used a conceptual framework developed
by the World Health Organization called the International Classification of Functioning, Disability
and Health or ICF for short (WHO 2001). See Figure 22.1. The advantages of using this
framework include: 1) it is well recognized and used by the international community; 2) it was
created to provide standard language for use when discussing health and health-related
domains; 3) other reviews of outcome measures have used the ICF for similar purposes (Salter
et al. 2005).
Figure 22.1 Overview of the International Classification of Function, Disability and Health
Health condition
(disorder or
disease)
Body Functions Activities Participation

and Structures
Environmental Personal
Factors Factors
According to the clinical practice guidelines (Consortium for Spinal Cord Medicine 1999) the
expected outcomes after SCI range from basic physiological function such as motor/sensory
function to higher level outcomes such as functional independence and social integration. The
22-3
ICF accounts for these within the 4 constructs of its Functioning and Disability component. The
tools were classified according to the body function/structure, activity and participation
constructs. Table 22.1 briefly outlines the definitions.
Table 22.1 Definitions for Body Function/Structure, Activity and Participation

Functioning Disability
(positive aspect) (negative aspect)
Body function – the physiological functions of the body Impairment – problems with body function or structure.
systems including psychological functions.
Body structure – the anatomical parts of the body such
as organs, limbs and their components.
Activity – the execution of a task or action by an Activity Limitation – difficulties an individual might
individual experience in completing a given activity.
Participation – involvement in a life situation. Participation Restriction – problems an individual may
experience with involvement in a life situation.
Quality of life (QoL) surveys are a newly emerging category of outcome measurements. To
capture these assessment tools, we included an additional dimension in order to help classify
QOL tools. While some clinical physiologists might question whether QOL is a true ‘outcome’
tool, the Food and Drug Administration (FDA) asks that QoL assessments be included as part of
any clinical trial protocol and program (often as a secondary outcome measure). Since the
perceived benefit by the target market population of any therapeutic intervention is an important
consideration we have included QoL in our review.
Three classifiers knowledgeable to both outcome measures and the ICF independently
categorized all of the tools (N=168). The classifiers later met to reconcile any disagreement
about classification of the tools. When a multidimensional tool covered more than one construct
(e.g. activity and participation) they placed it in the category where the tool had the most items.
The tools were divided once again into sub-classifications based on the sub-domains within
each of the body function/structure, activity and participation areas. Upon classification into the
main domains, the tools were further categorized into appropriate subgroups based on the ICF
definitions. See Table 22.2 which outlines these subcategories.
Table 22.2 Subcategories used for classifying tools

Body Functions/Structures Activities Participation Quality of Life
• Mental functions & • Learning and • Domestic life • Subjective
structures of the nervous applying knowledge • Interpersonal • Objective
system • General tasks and interactions and
• Sensory functions and pain demands relationships
& the eye, ear and related • Communication • Major life areas
structures • Mobility • Community, social
• Functions & structures • Self-care and civic life
involved in voice and
speech
• Functions & structures of
the cardiovascular,
haematological,
immunological and
respiratory systems
the digestive, metabolic and
endocrine systems
the genitourinary and
reproductive systems
• Neuromusculoskeletal and
22-4
movement-related functions
& structures
• Functions of the skin and
related structures
Assessing the Tools
The team of reviewers who assessed each tool consisted of clinicians and scientists who have
long established expertise in a wide variety of relevant research areas. Combining their
knowledge of SCI with the data on the properties of the outcome tools, allowed us to generate
the summaries for this chapter.
Countless numbers of books and manuscripts have been written classifying and discussing
psychometric principles and standards for the selection or validation of clinical tools. It is not our
intent to replicate this process, but instead refer the reader to a couple of key dispositions such
as Streiner and Norman’s Health Measurement Scales (2003) and Portney and Watkin’s
chapters (4, 5 and 6) on reliability and validity (2000). For an excellent overview that provides
insightful tips for selecting tools directly related to rehabilitation, read Finch and colleagues
Physical Rehabilitation Outcome Measures (1999).
Data was extracted from manuscripts reporting findings about the psychometric properties and
several “pragmatic” factors for each of the various tools. In accordance with similar projects
designed to review outcome measures (Salter et al. 2005) we relied heavily on the work by
Fitzpatrick and colleagues (1998) for the methods and standards related to data extraction. Our
evaluation criteria as well as the standard for quantifying the rating where possible are
presented in Table 22.3. For an example of the data extraction forms used for the project see
Appendix 1 on page 22-8.
Table 22.3 Criteria for Rating Outcome Measures

Criterion Definition Standard
Reliability - the reproducibility and internal - Internal consistency ratings are: excellent
consistency of the tool (synonyms include (≥0.80), adequate (0.70-0.79), or poor (≤0.70)
stability, repeatability, etc) (Andresen 2000).
- Reproducibility is the degree to which - ICC and Kappa for inter/intra and test-retest
the score is free from random error. Test ratings are: excellent (≥0.75), adequate (0.4-0.70),
retest, inter/intra observer reliability are or poor (≤0.40). (Andresen 2000).
commonly evaluated using statistics
including ICC, Pearson’s or Spearman’s
coefficients and kappa coefficients
(weighted or unweighted).
- Internal consistency assesses the
homogeneity of the scale items. It is
generally examined using split-half
reliability or Cronbach’s alpha statistics.
Item-to-item and item-to-scale correlations
are also accepted methods.
Validity Does the instrument measure what it Construct/convergent and concurrent correlations:
purports to measure? Forms of validity Excellent (≥0.60), Adequate (0.31-0.59), Poor
include face, content, construct and (≤0.30) (Andresen 2000)
criterion. Concurrent, convergent or ROC analysis – AUC: Excellent (≥0.90), Adequate
discriminative and predictive validity are (0.70-0.89), Poor (<0.70) (McDowell & Newell
all considered to be forms of criterion 1996)
validity. However, concurrent, convergent There are no agreed on standards by which to
and discriminative validity all depend on judge sensitivity and specificity as a validity index.
the existence of a “gold standard” to (Riddle & Stratford 1999)
provide a basis for comparison. If no gold
standard exists, they represent a form of
22-5
construct validity in which the relationship
to another measure is hypothesized
(Finch et al. 2002)
Responsiveness Sensitivity to changes within patients over Sensitivity to change:
time (which might be indicative of Excellent:
therapeutic effects). Evidence of change in expected direction using
Responsiveness is most commonly methods such as standardized effect sizes:
evaluated through correlation with other Small (<0.50), Moderate (0.50-0.80), Large
changes scores, effect sizes, (≥0.80)
standardized response means, relative Also, by the way of standardized response means,
efficiency, sensitivity & specificity of ROC analysis of change scores (area under the
change scores and ROC analysis. curve – see above) or relative efficiency.
Assessment of possible floor and ceiling Adequate:
effects is included as they indicate limits Evidence of moderate/less change than expected;
to the range of detectable change beyond conflicting evidence.
which no further improvement or Poor:
deterioration can be noted. Weak evidence based solely on p-values
(statistical significance) (Andresen 2000).
Floor/Ceiling Effects:
Excellent: No floor or ceiling effects
Adequate: Floor and ceiling affects ≤20% of
patients who attain either the minimum (floor) or
maximum (ceiling) score.
Poor: >20%. (Hobart et al. 2001)
Interpretability How meaningful are the scores? Are Jutai & Teasell (2003) point out these practical
there consistent definitions and issues should not be separated from consideration
classifications for results? Are there of the values that underscore the selection of
norms available for comparison? outcome measures. A brief assessment of
Acceptability How acceptable the scale is in terms of practicality will accompany each summary
completion by the patient – does it evaluation.
represent a burden? Can the assessment
be completed by proxy, if necessary? Are
there different formats available?
Feasibility Extent of effort, burden, expense &
disruption to staff/clinical care arising from
the administration of the instrument.
Availability of the tool or representative
version of the tool. Cost of the tool.
Clinical Will the tool prove useful in clinical
Summary situations? What SCI sub groups is it
suitable to use with? What type of
information is generated (descriptive,
predictive, and evaluative)? Will it help
with discharge planning? Is the tool used
as a component of an administrative data
base?
Review Rigor
In order to summarize the quality of each assessment tool with respect to the reported reliability,
validity and responsiveness, a summary table, similar to Table 22.4 below is presented at the
end of each review. The standards for rigor were adapted from McDowell and Newell’s (1996),
as well as Andersen’s (2000) recent overview of Criteria for Outcome Measures.
22-6
Table 22.4 Definitions of Rigor used to Rate the Psychometric Properties of the Measures
Excellent (+++): at least 2 studies involving subjects with SCI that corroborate each other’s findings (e.g., 2
studies with inter-rater reliability of > 0.75).
Adequate (++): a single study involving subjects with SCI which has adequate to excellent findings of
reliability, validity and / or responsiveness
Poor (+): a single study involving SCI subjects which has findings of reliability, validity and / or responsiveness
and less than adequate findings of reliability, validity and or responsiveness.
Not Available (N/A) (-): no information is available.
Assessments of rigor, using the above standards, are provided along with the evaluation ratings
of the reliability, validity and responsiveness for each measure at the bottom of each summary.
The information is presented in tabular format, as outlined below.
Table 22.5 Psychometric Summary

Reliability Validity Responsiveness
Rigor Results Rigor Results Rigor Results Floor/ceiling
Summary tables of the extracted data (coefficients) can be obtained by contacting Ms. Caroline
Abramson at Caroline.Abramson@vch.ca.
22-7
Appendix 1: Outcome Measure Data Extraction Form
Reviewer ID: ICF Level:
Type of Outcome Measure: Total articles:
Description:
Author Year Study Setting Population (sample Group (i.e. trans-femoral amputee)
ID Design size, age)
1. RELIABILITY
Author Internal Consistency Test-retest Inter-rater Reliability Statistics

ID Reliability reliability Coefficient
2. VALIDITY
Author Content Validity Construct Validity Concurrent Predictive Classification
ID (Divergent/convergent/ Criterion Criterion sensitivity/specificity
Known groups) Validity Validity (Screening measures)
3. RESPONSIVENESS
Author Floor/ceiling effects Responsiveness over time (p-values, SRM, ES
ID etc.)
Other Formats
Advantages
Derived from evidence source Derived from expert opinion
Limitations
Derived from evidence source Derived from expert opinion
Summary
Interpretability
Acceptability
Feasibility
Recommendation
Strongly Recommended Recommended (Proceed to ICF) Do not Recommended
(proceed to ICF)
22-8
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22-9
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22-10
22.2 Body Function / Structure
We start our review with outcome measures that represent the areas of body function and
structure as they can be considered the foundational for any personal activity, quality of life, and
societal participation.
The majority of outcome measures used in clinical rehabilitation come from the Body Function
and Body Structure components of ICF (Dahl 2002). While the components covered under this
dimension are still mechanistically complex and by and large unresolved in terms of clinical
treatment (e.g. motor function, spasticity, autonomic nervous system activity, or pain), when
compared to the complexity or validity of the tools used to assess activity or activity limitation at
the personal or societal level (e.g. self-care, community function, and quality of life), these
measures of SCI function are perhaps more straight forward. Of course, this really underscores
the complexity of valid SCI outcome assessments!
The outcome measures reviewed under this category include:
22.2 Body Function / Structure .............................................................................................22-11

22.2.1.1 The CAGE Questionnaire ......................................................................................22-12
22.2.1.2 Center for Epidemiological Studies Depression Scale (CES-D) ............................22-13
22.2.1.3 Patient Health Questionnaire (PHQ-9)...................................................................22-14
22.2.1.4 Zung Self-Rating Depression Scale (SDS) ............................................................22-15
22.2.2.1 Classification System for Chronic Pain in SCI .......................................................22-16
22.2.2.2 Donovan SCI Pain Classification System ..............................................................22-17
22.2.2.3 Tunk’s Classification Scheme ................................................................................22-18
22.2.2.4 Wheelchair Users Shoulder Pain Index (WUSPI) ..................................................22-19
22.2.3.1 Wingate Anaerobic Testing (WAnT) ......................................................................22-20
22.2.4.1 The “American Spinal Injury Association: International Standards for Neurological
Classification of Spinal Cord Injury” .......................................................................22-21
22.2.4.2 Ashworth and Modified Ashworth ..........................................................................22-22
22.2.4.3 Penn Spasm Frequency Scale (PSFS)..................................................................22-23
22.2.4.4 Surface Electromyography (sEMG) .......................................................................22-24
22.2.5.1 Braden Scale .........................................................................................................22-25
22.2.5.2 Gosnell Measure....................................................................................................22-26
22.2.5.3 Norton Measure .....................................................................................................22-27
22.2.5.4 Spinal Cord Injury Pressure Ulcer Scale (SCIPUS) Measure ................................22-28
22.2.5.5 Spinal Cord Injury Pressure Ulcer Scale - Acute(SCIPUS-A) ................................22-29
22.2.5.6 Waterlow Scale ......................................................................................................22-30
22.2.6.1 Emotional Quality of the Relationship Scale (EQR) ...............................................22-31
22.2.6.2 Knowledge, Comfort, Approach and Attitude towards Sexuality Scale (KCAASS)22-32
22.2.6.3 Sexual Attitude and Information Questionnaire .....................................................22-33
22.2.6.4 Sexual Behaviour Scale (SB).................................................................................22-34
(SAS) Scales..........................................................................................................22-35
22.2.6.6 Sexual Interest and Satisfaction Scale (SIS) .........................................................22-36
22-11
22.2.1 Mental Functions & Structures of the Nervous System
22.2.1.1 The CAGE Questionnaire

The CAGE is a 4 item screening questionnaire used to identify those individuals for whom more
extensive evaluation of alcohol use is recommended. Initially developed by J. A. Ewing (1984), it
is the oldest and likely most extensively used questionnaire across a variety of clinical and
research settings. Originally developed for use with adults, it has been used in elderly
populations as well.
Procedure: A self report pen/paper or interview format. Responses of “yes/no” to the following:
• Have you ever felt you should Cut down on your drinking?
• Have people Annoyed you by criticizing your drinking?
• Have you ever felt bad or Guilty about drinking?
• Have you ever taken a drink first thing in the morning (Eye opener) to steady your
nerves or get rid of a hangover?
Advantages: Brief, extensively used in variety of settings.
Limitations: Susceptible to underreporting. Minimum age 16 years. Not recommended for use
with adolescents. Not to be used as a diagnostic instrument (with increasing scores implying a
continuum of increasing risk for alcohol use) but rather a screening index to cue for further
evaluation.
Acceptability: Less than 5 minutes to complete.
Feasibility: Easy to administer and score. Flesch-Kincaid grade level of 5.1. A PDF version is
available at http://www.lifewisewa.com/pdfs/012695.pdf.
Interpretability: Typically, two or more of the questions answered affirmatively are considered
to be “CAGE positive”, though some suggest a positive response to a single item warrants more
in-depth investigation of consumption. In non-SCI populations, the CAGE test (scores >=2) has
a sensitivity of 93% and a specificity of 76% for the identification of problem drinkers (Bernadt et
al. 1982).
Clinical Summary: Score correlates positively with pre-SCI consumption patterns and a greater
incidence of medical complications (Tate 2003). Important that questions refer to whole life
history rather than a particular period. As such, it does not discriminate between active and
inactive drinkers. Used in combination with information regarding usual consumption patterns
(e.g., frequency/quantity/heaviest consumption). In some populations, such inquiry can inhibit
responses to CAGE questions, if it precedes them.
Psychometric Summary
N/A N/A ++ Construct ++ N/A N/A N/A
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information
22-12
22.2.1.2 Center for Epidemiological Studies Depression Scale (CES-D)

This 20 item screening measure was developed by the National Institute of Mental Health to
identify current depressive symptomatology related to major or clinical depression in the general
population (adults and adolescents). The items were generated from other previously validated
scales (Radloff 1977). The items include depressed mood, feelings of guilt, worthlessness and
helplessness, psychomotor retardation, loss of appetite and sleep difficulties. It has an
emphasis upon affective symptoms. It has been extensively used in large studies and norms are
available. Since 1980, the CES-D has been cited in approximately 50 articles involving
adjustment to SCI.
Responses are based on the frequency of occurrence during the past week. Uses a 4-point
ordinal scale:
• Rarely or none of the time (less than 1 day)
• Some or a little of the time (1-2 days)
• Occasionally or a moderate amount of the time (3-4 days)
• Most or all of the time (5-7 days)
Procedure: Self report using pen/paper or interview. A summary score is calculated - 4 items
are rated in positive direction to avoid response set.
Advantages: 5 – 10 minutes to complete. Several translations are available (Dutch, Spanish,
Thai, Chinese, Italian)
Limitations: Not a diagnostic tool - a screening measure to help identify individuals at risk for
depression. Created for the general population. Two psychometric studies with SCI populations
one of which studies the Thai version of the CES-D (Kuptniratsaikul et al. 2002). Sensitivity and
specificity adequate for Thai version but not for English version (small n for latter).
Acceptability: Easy to complete. Flesch-Kincaid Grade Level 4.1. Shorter versions such as
the 10, 8 and 4 item are available but have not been assessed in the SCI population.
Feasibility: Easy to administer and score. Copyright Center for Epidemiological Studies,
National Institute of Mental Health; West Publishing Company. PDF version available at
http://www.chcr.brown.edu/pcoc/cesdscale.pdf
Interpretability: The range of scores on the CES-D is 0-60 with higher scores indicating
greater symptoms. A cutoff score of 16 is indicative of “significant” or “mild” depressive
symptomatology. It is equivalent to experiencing six symptoms for most of the previous week or
a majority of symptoms on one or two days. Scores of 22 or greater consistent with probable
major depression. Some suggest increasing the cutting score in primary care settings to reduce
the number of false positives. For example, the Thai version (Kuptniratsaikul et al. 2002) used a
cutoff score of 19 to identify depression in the SCI sample. Has been used in sample of
adolescents and young adults (Radloff 1991) and more recently in studies of older adults.
Clinical Summary: Radloff (1977) cautions that the instrument should not be used for clinical
diagnoses nor should individual scores be interpreted. It may fail to separate depression from
generalized anxiety or from depression secondary to other diagnoses. In some clinical
applications, the Beck Depression Inventory (second edition) or the PHQ-9 may be preferable
as these survey a two week period consistent with DSM–IV criteria for major depression.
Further, they both include an item specific to suicidal ideation.
Psychometric Summary:
++ IC +++ ++ Predictive ++ N/A N/A N/A
SS ++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; IC=internal consistency;
SS=Sensitivity/Specificity
22-13
22.2.1.3 Patient Health Questionnaire (PHQ-9)

The PHQ-9 is a 9 item screening measure devised to identify probable major depressive
disorder (MDD) among adult primary care patients (Bombardier et al. 2004). The items parallel
the diagnostic criteria of major depression, according to the Diagnostic and Statistical Manual of
Mental Disorders (DSM-IV). It was developed for use with medical patients to establish validity
in populations with high rates of nonspecific physical symptoms that can confound a diagnosis
of major depression. Assessment of symptoms and functional impairment indicating a
diagnosis, and a severity score can be derived to help monitor treatment effects (Bombardier et
al. 2004).
Items are rated in terms of how persistent the symptoms have been in the past 2 weeks:
0 – not at all, 1 – several days, 2 – more than half of the days, 3 – nearly every day
Procedure: Self report pen/paper or interview format. Symptomatology and severity scores can
be derived based on the inclusion of specific items or by summing response categories.
Advantages: Easy to understand and complete. Corresponds with nosological criteria (DSM-
IV).
Limitations: One study of SCI patients assessed at one year post injury.
Acceptability: Takes 5 minutes to complete. Items easy to understand. Appears acceptable to
non-psychiatric samples. English and Spanish versions available.
Feasibility: Easy to administer and score. Measure available online in PDF format Copyright ©
Pfizer Inc. after agreeing to several conditions including use for research, in clinical programs or
physician education (http://www.pfizer.com/pfizer/phq-9/index.jsp) or http://www.depression-
primarycare.org/clinicians/toolkits/materials/forms/phq9/ (includes scoring guide).
Interpretability: Symptomatology and functional impairment for making a diagnosis of MDD
requires a positive response to at least one of “feelings of depression’ OR ‘anhedonia’ for more
than half the days in the past 2 weeks AND at least ‘somewhat difficult’ functioning at
work/home or getting alone with others.
Severity scores are derived by adding the response options with scores ranging from 0-27.
Scores of > 20 indicate major depression (severe), 15-19 major depression (moderately
severe), 10-14 moderate and 5-9 mild depressive symptomatology.
Clinical Summary: While having demonstrated good internal consistency, construct validity,
sensitivity and specificity in a group of SCI survivors 1 year post injury, the PHQ-9 requires
additional comparison with a criterion standard. Further, diagnostic specificity of somatic
symptoms during inpatient acute rehabilitation is yet to be established. Available findings
support that somatic symptoms are not simply nonspecific symptoms of SCI, but rather, are also
predictive of MDD and should be included in arriving at a diagnosis in post-acute SCI sample
(Bombardier et al. 2004).
++ IC +++ ++ Construct ++ N/A N/A N/A
SS +++
22-14
22.2.1.4 Zung Self-Rating Depression Scale (SDS)

The Zung Self-Rating Depression Scale (SDS) is a well-established (Zung 1965) screening
measure of adult depression severity that has been used in a variety of mental health areas
including primary care, psychiatric, drug trials, and related clinical, institutional, and research
settings. The 20-item instrument identifies various symptoms of depression related to:
• Affective (e.g., feeling downhearted and blue, crying spells)
• Psychological (e.g., hopeless, irritable, suicidal ideation)
• Somatic (e.g., agitation; retardation)
Symptoms “over the past several days” are rated according to a 4-point (1 to 4) ordinal scale.
Half the items are worded positively and half are worded negatively (total possible of 80 points)
• 1 - Little or none of the time
• 2 - Some of the time
• 3 - A large part of the time
• 4 - Most or all of the time
Procedure: Self-report pen and pencil or interview format.
Advantages: Can be used to measure intervention outcomes over time. Useful for clinical and
research purposes.
Limitations: Limited information regarding use in SCI population (Tate et al. 1993). Items are
similar to, but do not exactly match DSM-IV criterion for major depressive disorder. Has been
criticized due to its focus upon symptom frequency rather than severity, though its intent was to
assess the latter.
Acceptability: Quick to complete (<10 minutes). The positive and negative item wording may
be confusing for some individuals. Available in English, Chinese, Russian, Thai, Czech, Farsi,
Indonesian, Lithuanian. Appears acceptable to non-psychiatric samples.
Feasibility: Easy to administer and score. Has been translated into many languages.
Copyright American Medical Association. Measure widely available in PDF versions (with
scoring key) at: http://healthnet.umassmed.edu/mhealth/ZungSelfRatedDepressionScale.pdf.
An online version is available at: http://www.afraidtoask.com/depression/depressionzung.htm.
Other language versions available at:
www.who.int/substance_abuse/research_tools/zungdepressionscale/en/index.html.
Interpretability: Scores range from 20 to 80 with higher scores indicating increased depressive
symptoms. Scores over 50 suggest depression with scores over 69 indicating severe
depression. Sensitivity to correctly identify when depression is present using clinician ratings as
the gold standard was 86% in the SCI population (Tate et al. 2003).
Clinical Summary: The Zung provides information that enables description and evaluation of
patients/subjects. Since 1980, has been cited in approximately 25 investigations of adjustment
to SCI.
In some clinical applications however, the Beck Depression Inventory (second edition) or the
PHQ-9 may be preferable as they survey a two week period consistent with DSM–IV criteria for
major depression. Further, they include an item specific to suicidal ideation.
++ IC +++ ++ Construct ++ N/A N/A N/A
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; IC=internal consistency
22-15
22.2.2 Sensory Functions and Pain & the Eye, Ear and Related Structures
22.2.2.1 Classification System for Chronic Pain in SCI

This tool proposes a pain classification scheme with 2 major categories: neuropathic and
musculoskeletal. Neuropathic pain is divided into 4 subcategories: SCI pain, transition zone
pain, radicular pain and visceral pain. Musculoskeletal pain is divided into mechanical spine
pain and over use pain. This scheme is design to help with the standardization of pain
terminology used in the SCI population (Cardenas et al. 2002). Pain is categorized by pain
location and distribution, as related to level of spinal injury (e.g. above level, at level or below
level). This information is combined with a classification of the subject’s SCI pain.
Procedure: A 188 item questionnaire is administered by a clinician but could also be completed
by the patient. The person identifies the worst pain problem on a body diagram and indicates
whether pain worsens with activity, position or change of position or light touch. This procedure
is repeated for second worse pain etc. Categorization is outlined in the table below.
Pain Category Pain Location Related Affected Worse
(major) Category to by with light
(Specific) activity position touch
Neurologic SCI Pain Below injury in area without normal + _ +
sensation
Transition At level of injury, bilateral _ _ +
zone pain
Radicular Pain At any dermatome level, usually + + _
unilateral, usually radiates
Visceral In abdomen _ _ _
Musculoskeletal Mechanical In back or neck, often bilateral + +
spine pain
Overuse pain Often above injury in areas of normal + + _
sensation in an incomplete, can be
below
+ yes, - no, + maybe
Advantages: This tool has the best reliability (within (κ=0.68) and between (κ=0.66) raters),
standardized system for classifying pain in people with SCI using well defined terminology.
Limitations: There is no information about validity or responsiveness and reliability results are
based on a single study. Time taken to complete is considerable.
Interpretability: This pain classification provides a nice summary table that makes it easy for
clinicians to identify key problem areas that the patient has expressed.
Acceptability: The initial patient burden is high however follow up session will require less time.
Interview format improves utility for those with limited hand function.
Feasibility: Considerable time (estimate not available) is required to complete the questions.
No special equipment or training is necessary however expertise understanding pain would be
an asset. See article for a copy of the tool (Cardenas et al. 2002).
Clinical Summary: This tool has considerable promise but it requires additional study. This
chronic pain classification scheme may be useful for individuals with complex pain conditions in
order to map and monitor a patient’s progress related to pain management, as well as be used
to compare intervention protocols across patient groups. This table can also be compared
quickly with follow-up visits to determine improvement or deterioration in an area.
++ Inter O ++ N/A N/A N/A N/A N/A
Intra O ++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; Inter O=Interobserver; Intra
O=intraobserver
22-16
22.2.2.2 Donovan SCI Pain Classification System

The Donovan Pain Classification system proposes 5 pain types, including segmental nerve and
cauda equina, spinal cord, visceral, mechanical and psychogenic. This system combines both
mechanistic (eg. slow fibre conduction from skin) and descriptive factors such as time to onset
post-injury, characteristics of pain (eg. Burning, stabbing, dull aching, etc), pain duration, and
factors that make it worse or better (Donovan et al. 1982).
Procedure: This information is obtained through a semi-structured interview.
Advantages: The patient describes not only the location and degree of pain they are having but
also the type of pain and factors that make it worse or improved. It is an open ended style of
assessment with less chance to lead the patient towards any specific pain statements.
Limitations: Since the classification system does not follow a systematic method for acquiring
the data from the patients, it is possible for some sites to be overlooked. This accounts for the
relatively poor reliability with a inter rater consistency of only 50-62% (Richards et al. 2002) and
modest retest reliability (Putzke et al. 2003).
Interpretability: One may put the information into a tabular format for charting or research
purposes may be very helpful for interpretation and clarity using the following table.
Pain Type Time of Character Duration Aggravating Diminishing Possible causative
Onset Post factors factors factors
Injury
Segmental Days to Burning Seconds Rest Activity Slow fibre conduction from
nerve weeks Stabbing skin
Cauda Equina
Spinal Cord Weeks to Tingling Constant Activity Rest All fibre conduction within
months Numbness cord
Visceral Weeks to Burning Constant Variable Variable Slow fibre conduction from
months viscera
Mechanical Weeks to Dull Variable Activity Rest Slow fibre conducton from
months Aching muscles or ligaments
Psychic Variable Variable Variable Variable Variable Preoccupation with
unpleasant environmental
stimuli
Acceptability: This may be a time consuming method for collecting this type of data but some
clinicians may really find this type of approach more suitable for the more difficult cases to
clarify the problems. This method allows the patients to explain their pain in their own language
rather than being forced to pick specific descriptors for their pain.
Feasibility: This is an inexpensive pen and paper method, but time consuming method to
collect pain data for individuals with complex pain issues. Clinicians may not have time to do
this for all SCI pain, which would take about 20-40 minutes, depending upon the number of sites
and intensity of pain an individual may have.
Clinical Summary: This may be a useful tool to help delineate what type of pain an individual is
experiencing and the possible mechanism for that particular pain. Often individuals with SCI have
pain in multiple sites with different origins. This break down of pain into the 5 categories would
help clinicians work through the problems more methodologically via a semi-structured interview.
++ TR++ N/A N/A N/A N/A N/A
Inter O ++
Intra O ++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test; Inter O=interobserver;
Intra O=intraobserver
22-17
22.2.2.3 Tunk’s Classification Scheme

Classifying the type and location of pain enables better diagnostic and intervention results. The
Tunks model identifies 11 types of pain for those with spinal cord injury according to the lesion
level (Tunks 1986).
Above the lesion level At the lesion level Below the lesion level
1) Myofacial 4) Radicular 8) Diffuse burning
2) Syringomyelia 5) Hyperalgesic border reaction 9) Phantom
3) Non spinal cord 6) Fracture 10) Visceral
7) Myofacial (incomplete lesion) 11) Myofacial (incomplete lesion)
Procedure: This information is obtained through a semi-structured interview.

Advantages: This pain classification allows the clinician to describe the general location and
whether the pain differentiates between several types of pain.
Limitations: Since the classification system does not follow a systematic method for acquiring
the data from the patients, thus making consistency difficult from one time to another or
between individuals very difficult. This system is very clinician dependent as it requires
considerable knowledge about the various origins of pain to be able to interpret the patient’s
comments into the defined classification scheme. This makes it a very inconsistent measure.
The interrater reliability of the Tunks’ scheme is considered poor (Putzke et al. 2003).
Interpretability: This system requires considerable knowledge from the clinician classifying the
pain as well as other health care professionals who may be using the information to help with
pain management, as it may be difficult to interpret what the classification system means for
management of pain.
Acceptability: Although this system has merit for giving more categories for which to describe
the various types of pain an individual may have, it most likely would be useful for more complex
pain cases where more time is allocated towards understanding the origins of the individual’s
pain.
Feasibility: The interview takes 15-20 minutes. No formal training is required but knowledge
about neuro anatomy and physiology specifically sensation and theories of pain is an asset.
Clinical Summary: This may be a useful tool to help break down of pain into the 11 categories
in an open and relatively quick way. However, for the more complex patients, it may take
substantially more time than is indicated. It would be an intermediary point for clinicians to
identify qualitative elements of pain but it should be augmented using a battery of other tools
that would address pain duration, location and intensity in order to provide a complete picture of
pain involvement. The disappointing reliability results suggest that identifying two broad types of
pain, mechanical and neuropathic may be the best approach until specific diagnostic tools can
be developed for each of the purported subtypes of SCI pain (Putzke et al. 2003).
+ Inter O + N/A N/A N/A N/A N/A
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; Inter O=interobserver
22-18
22.2.2.4 Wheelchair Users Shoulder Pain Index (WUSPI)

The WUSPI score is a 15 item questionnaire designed to measure shoulder pain that limits
function in individuals who use wheelchairs (Curtis et al. 1995). The scale was modeled on the
Shoulder Pain and Disability Index (Roach et al. 1991; Curtis et al. 1995). Modifications made in
the creation of the WUSPI included inclusion of common activities performed by the wheelchair
user. Content validity was developed by having long term wheelchair users verify important
items. It targets activity limitation resulting from shoulder pain on a 10 cm visual analogue scale.
It covers 4 subsections which include transfers (4 items), wheelchair mobility (2 items), self-care
(5 items), and general activities (4 items). The anchors for the items range from 0 “no
interference due to pain” to 10 “completely interferes due to shoulder pain”.
Procedure: A self report pen and paper format is used. A total score is derived by adding the
individual item scores. Total scores range from 0 (no pain) to 150 (extreme pain). Subscale
scores can be derived although there is minimal research supporting the use of these.
Advantages: The WUSPI is a simple and effective joint specific method of quickly determining
the degree of interference due to pain when doing typical tasks of daily living.
Limitations: This tool is specific to shoulder pain. It does not obtain information about the type
or frequency of pain experienced during the activities. No strategies are suggested to assist with
scoring if a person indicates they do not do certain activities (e.g./ load their chair into a car)
although it may be possible to use a percentage score out of 150 max rather than using an
absolute score to compare between individuals or groups (Sawatzky et al. 2005). No
psychometric evidence is available for responsiveness and the majority of research for reliability
and validity has been conducted using a mixed sample (not just SCI). The excellent total score
and inter items retest ICCs are likely related to baseline and reassessment occurring during the
same day. It seems plausible that floor effects are possible for new wheelchair users.
Interpretability: Higher scores indicate more limitation due to pain. No information is available
regarding norms or meaningful cut scores.
Acceptability: The items selected reflect common activities performed by the general
population of wheelchairs users across diagnostic classification. The very high internal
consistency (alpha =.98) suggests there may be overlap in the items and therefore a shorter
scale may be feasible. The WUSPI takes about 5 minutes to complete.
Feasibility: The WUSPI requires approximately 10 minutes to score the VAS for each item with
a ruler. No special training is required to administer or score the questionnaire. A copy can be
obtained from K.A. Curtis the tool developer.
Clinical Summary: The WUSPI presents the functional cost of shoulder pain in wheelchair
users. It provides unique information that may enable clinicians to consider more detailed
assessment based on specific items to explore strategies or equipment may be useful to
decrease activity specific pain. Responsiveness data is required prior to recommending the
index for clinical evaluation of interventions.
++ TR +++ ++ Concurrent ++ N/A N/A N/A
IC +++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test; IC=Internal
Consistency
22-19
22.2.3 Functions & Structures of the Cardiovascular, Haematological, Immunological and
Respiratory Systems
22.2.3.1 Wingate Anaerobic Testing (WAnT)

The WAnT is a method of assessing muscle power. It involves a 30 second maximal effort trial
on a leg or arm ergometer. It was first validated in able bodied individuals to use as a predictor
of physical performance of anaerobic activities (Ayalon et al. 1974; Bar-Or et al. 1977). Leg
WAnT was closely associated with 40 m running (r=0.84) and running speed (r=0.85) (Bar-Or &
Inbar 1978). Arm and leg WAnT correlated with swimming performance (Hawley & Williams
1992). Arm WAnT has also been used in persons with paraplegia to compare to performance of
upper limb anaerobic tasks such as transferring in and out of the car (r=0.81) and 26m
wheelchair sprints (r=0.70) (Bar-Or et al. 1976).
Procedure: The WAnT requires the use of an arm ergometer or an adapted leg ergometer
suitable for arm use that allows for consistent resistance to be applied. The ergometer system is
typically linked to a computer with specific software to calculate peak power based on
resistance and speed (the highest average power output at any given 5 sec period) and mean
power (average power output over a 30 sec trial). The individual typically “free wheels” with no
resistance for 3-5 minutes, after which they increase the cadence to 100 rev/min. The
resistance load is then applied (3.5% body weight) and the subject pedals as fast as they can
for 30 seconds, followed by a 1-2 minute cool down without resistance.
Advantages: Without a test like this, there is no standardized test, device or protocol to
monitor upper extremity strength and power. Most assessments look at aerobic function rather
than anaerobic tasks. This test has been shown to be valid and reliable across a wide range of
able bodied and disabled individuals, including those with paraplegia (Jacobs et al. 2003).
Limitations: This test requires significant financial investment (ergometer, computer and
software).
Interpretability: The outcome measures (peak and mean power) are easily interpreted as the
higher the output, the greater strength the individual exhibits. Norms for non-disabled individuals
(adults & children) are available for comparison (Jacobs et al. 2003; 2005).
Acceptability: Since the test is quick (max. 8 minutes, including “free wheeling”) and the
number of repetitions are relatively low, it generally does not contribute to overuse injuries in the
wrist or shoulder. If the person already experiences symptoms of these injuries, this test may
trigger pain.
Feasibility: It is a relatively easy and inexpensive test to administer with appropriate equipment
available; however, initial expenditure is significant. It does not require a highly trained individual
to implement the test.
Clinical Summary: The WAnT is a good measure of upper extremity strength and power that
does link to other functional tasks such as transferring in and out of the car or wheeling up
ramps/hills. It is also a well established protocol that has been used in many populations, and
thus, comparisons are possible.
++ TR +++ ++ Content +++ N/A N/A N/A
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test
22-20
22.2.4 Neuromusculoskeletal and Movement-Related Functions & Structures
22.2.4.1 The “American Spinal Injury Association: International Standards for

Neurological Classification of Spinal Cord Injury”
The International Standards for Neurological Classification of SCI (ASIA 2002) is a multi-
dimensional approach to categorize motor and sensory impairment in individuals with SCI.
Currently in its 6th edition, it identifies sensory and motor levels indicative of the most rostral
spinal levels demonstrating “unimpaired” function. Twenty-eight dermatomes are assessed
bilaterally using pinprick and light touch sensation and 10 key muscles are assessed bilaterally
with manual muscle testing. The results are summed to produce overall sensory and motor
scores and are used in combination with evaluation of anal sensory and motor function as a
basis for the determination of the ASIA Impairment Scale (AIS).
Procedure: A clinical examination is conducted to test whether sensation is 0=”absent”,
1=”impaired” or 2=”normal”. Muscle function is rated from 0=”total paralysis” to 5=”(normal), i.e.
active movement, full ROM against significant resistance”. The presence of anal sensation and
voluntary anal contraction are assessed as a yes/no. Bilateral motor and sensory levels and the
AIS are based on the results of these examinations. A more accurate representation of motor
function has been demonstrated when overall ASIA motor scores are divided into separate
upper and lower limb scores (Marino & Graves 2004; Graves et al. 2006).
Advantages: This is an internationally recognized standard which is widely used for research
and clinical purposes. Its historical development and continued evolution are well grounded in
expert clinical consensus thereby ensuring high content validity (Cohen et al. 1996). In addition,
there is evidence that ASIA motor scores collected relatively early following injury have some
predictive validity in explaining functional outcomes (Lazar et al. 1989; Blaustein et al. 1993).
Limitations: ASIA scores have been assessed as having only moderate inter-rater reliability
(Priebe & Waring 1991; Jonsson et al. 2000) with even poorer results following sensory
examinations or associated with specific cases of incomplete SCI (Priebe and Waring 1991;
Cohen et al. 1996). Inter-rater reliability for assignment of motor and sensory levels and AIS
classifications is less than optimal. Enhanced training methods and materials have been
recommended to improve inter-rater reliability (Priebe & Waring 1991; Cohen et al. 1998;
Jonsson et al. 2000)
Interpretability: The AIS scores are clearly defined and understood by most clinicians. The
AIS (5 point ordinal scale), based on the Frankel scale (Frankel et al. 1969), classifies
individuals from “A” (complete SCI) to “E” (normal sensory and motor function). Preservation of
function in the sacral segments (S4-S5) is key for determining the AIS.
Acceptability: The assessment is generally well tolerated although sensory testing can be
problem with severe hypersensitivity and testing for voluntary anal contraction can result in the
stimulation of a bowel movement.
Feasibility: Takes approximately 20 minutes to conduct/score. Training is mandatory and no
specialized equipment is required. For a copy see
www.asiaspinalinjury.org/publications/2001_Classif_worksheet.pdf#search=%22ASia%20motor
%20score%22
Clinical Summary: ASIA scores are considered essential when classifying persons with SCI as
to their neurological status. ASIA scores are routinely collected in administrative data bases
such the Model Systems and CIHI National Rehabilitation Reporting System.
+++ TR ++ ++ Construct +++ N/A N/A N/A
22-21
22.2.4.2 Ashworth and Modified Ashworth

The Ashworth measure of spasticity was developed as a simple clinical classification to assess
the anti-spastic effects of carisoprodol in multiple sclerosis (Ashworth 1964). It is a 5-point
nominal scale using subjective clinical assessment of tone ranging from 0 – “no increases in
tone” to 4 – “limb rigid in flexion or extension [abduction/adduction]”. An additional grade was
added (1+) for the Modified Ashworth (MAS) to enhance sensitivity and accommodate
hemiplegic patients who typically graded at the lower end of the scale (Bohannon & Smith
1986). These measures have been adopted for measuring spasticity in a variety of other
indications including spinal cord injury (Haas et al. 1996), although some have noted that there
are differences in the characteristics of spasticity with different etiologies (Noth 1991; Lechner et
al. 2006).
Procedure: A clinical examination performed on a relaxed supine patient. The muscle is
assessed by rating the resistance to passive range of motion (ROM) about a single joint.
Advantages: Both measures have been used for clinical and research purposes. The MAS
correlates well with a self-rating visual analogue scale of spasticity (Skold 2000) and the
Ashworth correlates strongly with the patellar tendon tap and the adductor tap (Priebe et al.
1996). The Ashworth correlates well with the Spinal Cord Assessment Tool for Spastic Reflexes
(Benz et al. 1995) which measures different types and severity of spastic reflexes in SCI.
Limitations: These measures assess single-joint resistance to passive ROM or a velocity
dependent stretch reflex. They do not address spasm frequency or severity, nor do they
differentiate between phasic and tonic components of spasticity (Priebe et al. 1996). The
observation of resistance is subjective and requires experienced clinical judgment. Reliability
varies muscle to muscle (Øreliable in plantar flexors, × reliable in adductors; Haas et al. 1996).
Interpretability: The Ashworth scale is easily interpretable with discrete categories that reflect
clinical experience. The MAS adds an additional grade at the lower end of spasticity.
Acceptability: Well accepted and tolerated by patients as the procedures consist of range of
motion movements similar to non-assessment ROM movements.
Feasibility: These measures are easily administered during routine clinic visits. No specialized
equipment is required. Clinical experience increases inter-rater reliability (Bohannon & Smith
1987; Haas et al. 1996). Standardization of speed of movement in the assessment is required
since spasticity is velocity dependent (eg. use of metronome is helpful). Some consider the
Ashworth to be of limited use in the assessment of spasticity in the lower limb of patients with
SCI without this standardization (Haas 1996).
Clinical Summary: These measures are the clinical gold standard for assessing spasticity in
people with SCI. However, it should be noted that spasticity is a multi-faceted construct with
individual components of spasticity weakly related to each other suggesting that different clinical
scales measure unique aspects of spasticity (Priebe et al. 1996). Therefore, the overall
construct is best measured with an appropriate battery of tests including the Ashworth Scale.
Ashworth
+++ TR+++ Overall +++ Construct ++ +++ + N/A
TR++ adductors
TR+ plantar flexor
MAS
+++ TR+ Overall TR+++ +++ Construct ++ +++ + N/A
With velocity
standardization
TR++ adductors
TR+ plantar flexor
22-22
22.2.4.3 Penn Spasm Frequency Scale (PSFS)

The Penn Spasm Frequency Scale (PSFS) is self report measure of the frequency or reported
muscle spasms (Penn et al. 1989; Priebe et al. 1996) which is commonly used to quantify
spasticity (Benz et al. 2006). The PSFS is a 2 component self-report scale developed to
augment clinical ratings of spasticity and provide a more comprehensive understanding of an
individual’s spasticity status. The first component is a 5 point scale assessing the frequency with
which spasms occur ranging from “0 = No spasms” to “4 = Spontaneous spasms occurring more
than ten times per hour”. The second component is a 3 point scale assessing the severity of
spasms ranging from “1 = Mild” to “3 = Severe”. The second component is not answered if the
person indicates they have no spasms in part 1.
Procedure: Patients report their perceptions of spasticity with regards to frequency and
severity.
Advantages: This measure is simple and appropriate to the clinical setting and does not require
specialized equipment to perform. Validity has been partially established with “adequate”
correlations with other clinical tools such as the Ashworth scale and the Spinal Cord
Assessment Tool for Spastic Reflexes (SCATS) (Benz et al. 2005). Although not directly tested,
responsiveness has been demonstrated in several studies employing this measure within a test
battery to assess spasticity (Gianino et al. 1998; Aydin et al. 2005; Boviatsis et al. 2005).
Limitations: The scale is subject to concomitant subclinical conditions such as fullness of the
bladder, development of a symptomatic urinary tract infection, anxiety level, room temperature,
subject comfort, and many other conditions. Although not directly tested, test-retest reliability
and repeatability has been reported as highly variable (Priebe et al. 1996) since test
administration timing is not standardized and subtle changes in underlying conditions affecting
spasticity may not be considered at the time of test administration.
Interpretability: The specific grades simple to interpret although no standardization of time
frame is specified for test administration (i.e. within the last hour, day, week, etc.) and specific
grades for spasm severity may mean different things to different people.
Acceptability: The PSFS presents minimal patient burden and is easy for them to understand.
Feasibility: The test is quick to administer and score. No training is required however
understanding and experience of spacticity likely improves its utility. .
Clinical Summary: These self-report measures of spasticity correlate only moderately with
clinical examination suggesting that the elements of spasticity evaluated in the physical
examination do not represent what is important to persons with SCI spasticity (Priebe et al.
1996). To more fully understand spasticity as experienced by the client, self-report spasticity
measures are an important adjunct to other clinical measures of spasticity. However, the PSFS
is suggested to have only modest repeatability and test-retest reliability (Priebe et al. 1996) and
requires further investigation taking into consideration the slight changes in the patient’s
concomitant subclinical condition(s) and the standardization of test administration timing. In
addition, the PSFS was found to correlate highest with the SCATS clonus measure as
compared to the flexor and extensor spasm components of SCATS suggesting that the role of
clonus most represents the clients perception of spasticity (Benz et al. 2005). This measure is
easily administered during routine clinic visits.
22-23
22.2.4.4 Surface Electromyography (sEMG)

Surface electromyography (sEMG) is a noninvasive technique used to measure muscle activity
(both voluntary and involuntary) in individuals with neuromuscular diseases (Pullman et al.
2000).
Procedure: Surface electrodes are placed on the skin overlying the muscles of interest.
Patients are instructed to voluntarily activate lower limb muscles to provide either maximal
muscle strength or to perform simple movements (eg/ ankle flexion/extension).
Advantages: These measures are simple to apply and complementary to the clinical evaluation
by providing objective and quantifiable non-ordinal measures. Calancie et al. (2001) showed
reasonable validity by analyzing the correlations between the sEMG recordings and MMT both
for the upper and lower limb muscles in patients with acute and subacute SCI. Interestingly the
correlation coefficients were lower in the acute than subacute stage of SCI. The studies
performed by Lim et al. (2005) and Lim & Sherwood (2005) revealed high correlation
coefficients to the clinical motor testing using the ASIA motor score for face validity and
demonstrated good to very good retest reliability using Intra-class correlation (ICC) analysis
based on same day and 1 week retest.
Limitations: The extrapolation of sEMG values to absolute forces and the comparison between
subjects is limited and does not allow direct comparisons. While the individual follow up of motor
recovery can be performed the measures are of limited value to precisely diagnose motor
impairments. The measures are not specific to the kind and timing of neurogenic lesion (no
distinction between the affect on the central or peripheral nervous system and acute versus
chronic). The control of the movement performance either due to motivation and the desired
kinematics is difficult to achieve and other confounding factors as pain or non-neuronal
complications (muscle – tendon – joint effects) have to be carefully excluded.
Interpretability: The data can be quantified however the interpretation is not standardized. No
normative values exist.
Acceptability: Minimal burden for patients. The technique is tolerated well by patients and is
much less intrusive than the gold standard (needle EMG).
Feasibility: An EMG study takes approximately 15-20 minutes to complete however times vary
based on the number and complexity of the muscle groups studied. An EMG can range in cost
from several hundred to over a thousand dollars depending on features. Special training is
mandatory to conduct and interpret the results.
Clinical Summary: sEMG recordings can complement the clinical examination specifically by
providing objective and quantifiable measures of muscle activity. They have been shown to be
valid in comparison to the clinical testing of motor strength and might be of highest value to
monitor motor recovery in incomplete SCI. As these measures need special training and
equipment they will be most suitable in the frame of clinical studies rather than for clinical day to
day routine. The proven re-test reliability and validation makes them a valuable asset to the
clinical examination by providing more objective and statistically applicable data. So far sEMG
has only been applied by a few specialized research groups and independent replications and
confirmations of clinical usefulness need to be done.
++ TR ++ ++ Construct ++ N/A N/A N/A
Concurrent +++
SS +++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test retest reliability;
22-24
22.2.5 Functions of the Skin and Related Structures
22.2.5.1 Braden Scale

The Braden Scale is an assessment tool for determining a patient’s risk level for incurring skin
breakdown. It has been tested in acute care and long-term-care settings (Bergstrom et al.
1987). Items were developed based on expert consensus and predictive validity has been
studied in several acute care settings with good sensitivity and specificity demonstrated
(Bergstrom et al. 1987). The scale was developed based on a conceptual schema of pressure
sore development which identified a variety of pressure and tissue tolerance issues that
predispose individuals to develop pressure ulcers. A patient is evaluated in six domains (one
item per domain): (1) sensory perception, (2) moisture, (3) activity, (4) mobility, (5) nutrition, and
(6) friction and shear and receives a score between 1-3 or 4 point ordinal scale for each domain.
Procedure: Raters indicate client status in the five domains (which could be based on personal
experience or chart review). Each domain is given a rating of 1-3 or 4 based on an ordinal scale
based on descriptive criteria provided on the scoring sheet, which are summed for a total of
between 6 (worst prognosis) to 23 (best prognosis).
Advantages: A commonly used tool, which has been used extensively in research. Familiarity
with the scale facilitates communication of findings. The test is quick to administer, readily
available and alternative cut-off scores have suggested depending on the population.
Limitations: The scale omits items that Salzburg et al. (1999) found to be important predictors
of pressure ulcer development for people with SCI and includes three factors (sensory
perception, mobility and nutritional variables) that were not significantly related to pressure ulcer
development for individuals with SCI. The reliability of the scale has been demonstrated in a
variety of settings (Bergstrom et al. 1987), but not specifically with individuals with SCI. Cut-off
scores have been shown to fluctuate between populations, and so the original cut off scores
between groups do not seem appropriate for individual with SCI (Salzberg et al. 1999). Wellard
& Lo (2000) found that Spearman’s correlations comparing ulcer severity scores and scores on
the Braden were not significant.
Interpretability: Although a cut off score of 16 was originally suggested as indicative of those
who develop a pressure sore (100% sensitivity and 64% sensitivity) (Bergstrom et al. 1987), 11
or less has been suggested for an ICU trauma population and less than or equal to 10 has been
suggested for individuals with SCI (74.7% sensitivity and 56.6% specificity) (Salzberg et al.
1999). Scoring instructions are relatively detailed. Free pressure ulcer prevention protocols are
available, based on Braden Scale scores (www.Bradenscale.com).
Acceptability: There is minimal examiner and no respondent burden as the patient is not asked
to perform any special activities. The scale has been translated into many languages.
Feasibility: The scale takes 5-10 minutes and no formal training is required. The scale, scoring
information (free) and a video tape manual ($150 US) are available at <www.bradenscale.com>.
Clinical Summary: The Braden scale is quick and easy to use, although there may be issues
with interpretation of the scores. The scale provides predictive information and evidence of
validity is adequate, but there has been no reliability or responsiveness testing with these
individuals with SCI. The Agency for Health Care Policy and Research (AHCPR) (1992)
recommended the use of either the Braden or the Norton scales for the prevention of pressure
ulcers for best practice. Pressure ulcer prevention protocols, which describe appropriate
interventions based a patient’s Braden scale score are also available. These include
suggestions about how to manage nutrition and deal with potential friction or shear problems.
+ +++ ++ Construct + N/A N/A N/A
Predictive ++
SS ++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; SS=Sensitivity/Specificity
22-25
22.2.5.2 Gosnell Measure

The Gosnell scale was developed to identify individuals living in extended care and over the age
of 65 who were at risk for developing a pressure ulcer (Gosnell 1973). Items were identified
based on research by Norton which examined indicators of pressure ulcer development. It
therefore includes four of the five domains/items included in the Norton scale, but omits general
physical condition. Every patient is evaluated on five domains: 1) mental status, 2) continence,
3) mobility (the amount and control of movement of one's body), 4) activity (ability to ambulate)
and 5) nutrition ( the process of food intake). In addition the evaluation includes recording of:
vital signs (which includes temperature pulse respirations and blood pressure), skin condition
(which includes appearance, skin tone and sensation) and medications but these are not
scored. Items from the 5 domains are scored on domain specific ordinal scales from 1 to 4
based on the descriptors provided.
Procedure: Raters indicate client status on each of the items (which could be based on
personal experience or chart review). Scales are scored based on descriptive criteria provided
on the scoring sheet. This produces a summary score from between 5 (worst prognosis) to 20
(best prognosis).
Advantages: The test is quick to administer, readily available and is commonly used.
Limitations: The scale omits items such as pulmonary disease, serum creatinine > 1.0, extent
of paralysis, albumim < 3.4 or T, protein < 6.4, autonomic dysreflexia or severe spacticity, age,
tobacco use/smoking, disease, cardiac disease or glucose > 110 mg/dl, renal disease, living in
a nursing home or hospital, and hematorcrit <36.0% that Salzburg et al. (1996 & 1999) found to
be important predictors of pressure ulcer development for people with SCI in acute and
rehabilitation settings. No information on the reliability of the scale with any population could be
located.
Interpretability: There are issues with the interpretability of the measure given lack of detail in
how to evaluate additional findings. Using a retrospective logistic regression anlaysis of hospital
data from 226 patients, Salzberg (1999) found that the Gosnell had 18.4% sensitivity and 90.4%
specificity for predicting the development of pressure ulcers in individuals with SCI within the
first 30 days of admission. Salzberg did not indicate what cut-off score was used to achieve this
level. Salzberg found correlations between scores on the Gosnell and stage of first pressure
ulcer and number of pressure ulcers of r= 0.241 and 0.297 respectively.
Acceptability: The score is easy for a health care provider to calculate, but additional items
such as the assessment of skin condition may require additional patient assessment. Items on
the scale would not represent a burden to either patients or researchers, if this data was already
collected as part of the normal plan of care. However, if these items needed to be performed as
additional procedures, however, it would represent considerable rater burden and some
respondent burden. No different formats or translation in languages other than English could be
located.
Feasibility: Scoring takes 5-10 minutes and no special training is required. The scale is readily
available from the original article and electronically.
Clinical Summary: The Gosnell scale is a quick and easy to use, but validity evidence is poor
with persons with SCI, and there has been no reliability or responsiveness testing. In light of
these findings other generic scales (such as the Braden) or SCI specific scales such as the
SCIPUS or SCIPUS-A would be recommended.
N/A N/A + Predictive + N/A N/A N/A
SS ++
22-26
22.2.5.3 Norton Measure

The 5 item Norton scale was the first pressure ulcer risk assessment that was developed and
was intended for use with a geriatric hospital population (Norton et al. 1962). The measure was
developed based on the researcher’s clinical expertise. Five domains relevant to skin condition
are considered: (1) physical condition, (2) mental condition, (3) activity, (4) mobility and (5)
incontinence. They are measured on an ordinal scale from 1 to 4.
Procedure: Raters indicate client status based on personal observation or chart review. Scales
are scored on a domain specific ordinal scale from 1 to 4. Each item comes with standardized
descriptive criteria recorded on the score sheet. A summary score ranging from 5 (worst
prognosis) to 20 (best prognosis) is calculated.
Advantages: The test is quick to administer, readily available. Ash (2002) indicated the
Waterloo, Braden, Norton and SCIPUS-A all had similar moderate predictive power. The Norton
is a commonly used scale with a variety of populations.
Limitations: The scale omits items that Salzburg et al. (1996; 1999) found to be important
predictors of pressure ulcer development for people with SCI such as pulmonary disease,
serum creatinine > 1.0, extent of paralysis, albumim < 3.4 or T, protein < 6.4, autonomic
dysreflexia or severe spacticity, age, tobacco use/smoking, disease, cardiac disease or glucose
> 110 mg/dl, renal disease, living in a nursing home or hospital, and hematorcrit <36.0%. The
reliability of the scale has not been demonstrated with a SCI population. Descriptors for item
scoring are very brief (Wellard & Lo 2000). Salzberg (1999) found that the Norton was the worst
measure for predicting stage and number of pressure ulcers in individuals with SCI during the
first 30 days of admission compared to the SCIPUS, SCUIPUS-A, Braden, Gosnell and
Abruzzese. Salzberg (1999) found correlations between scores on the Norton and stage of first
pressure ulcer and number of pressure ulcers of r= -0.192 and -0.197 respectively.
Interpretability: A cut-off score of 14 was suggested as a cut off score to identify individuals at
risk for developing pressure sores, however, no evidence to support the use of this value (no
sensitivity / specificity data) was provided (Norton et al. 1962). Because scoring descriptors are
minimal, they may be subject to misinterpretation.
Acceptability: Scoring and administration is easy. There is no patient burden. No alternative
formats or version in languages other than English could be located.
Feasibility: The Norton scale takes 5-10 minutes to administer and score. No training is
required however knowledge of the area of wound care may is readily available for free on line
or from the original publication.
Clinical Summary: The Norton scale is a quick and easy to use, although there may be issues
with interpretation of the scores. Validity evidence is poor and there has been no reliability or
responsiveness testing with these individuals with SCI. Use of the Norton Scale is
recommended by the Agency for Health Care Policy and Research (1992) but In light of the
above findings other generic scales (such as the Braden) or SCI specific scales such as the
SCIPUS or SCIPUS-A would be recommended.
N/A N/A ++ Predictive + N/A N/A N/A
Construct ++
SS ++
22-27
22.2.5.4 Spinal Cord Injury Pressure Ulcer Scale (SCIPUS) Measure

The SCIPUS scale was developed as a measure of the risk for pressure ulcer development for
individuals with spinal cord injury who are in a rehabilitation centre (Salzberg et al. 1996). Items
for the scale were identified based on statistical analysis of data from 176 individuals with SCI,
which compared development of pressure ulcers with demographic variables and potential
pressure ulcer risk factors. Every patient is evaluated in fifteen domains (one item per domain):
1) level of activity, 2) mobility, 3) complete SCI, 4) urine incontinence or constantly moist, 5)
autonomic dysreflexia or sever spacticity, 6) age, 7) tobacco use/smoking, 8) pulmonary
disease, 9) cardiac disease or glucose > 110 mg/dl, 11) renal disease, 12) impaired cognitive
function, 13) in a nursing home or hospital, 14) albumim < 3.4 or T, protein < 6.4 and 15)
hematorcrit <36.0%. Most items are scored dichotomously as either present or absent, but 4
items have three response options.
Procedure: Raters indicate client status based on personal knowledge of the of the client or
chart review. Dichotomous items are given a weighted score of 0 when absent and 1 or 2 when
present and non dichotomous items are given a weighted score based on the descriptive criteria
provided on the scoring sheet. For example, the presence of pulmonary disease (ICD codes
450, 460-519 & 796.0) = a score of 2. By adding domain scores together a summary score is
calculated which ranges from 0 = best prognosis to 25 = worst prognosis.
Advantages: The content validity for the tool is likely the best for SCI as each of the items were
identified based on data from individuals with spinal cord injury and needed to 1) demonstrate a
significant statistical association with pressure ulcer development, 2) improve prediction, 3) be
supported by the literature and 4) be biologically plausible. Correlations between scores on the
SCIPUS and stage of first pressure ulcer and number of pressure ulcers are r= 0.343 and r=
0.339 respectively for individual with SCI in the first 30 days of admission.
Limitations: Although the SCIPUS is reported to be the best measure for this population
(Salzberg et al. 1996), the factors were identified with the same retrospective data that was
used to determine the measure’s sensitivity and specificity, which may artificially inflate these
numbers. The reliability of the scale has not been demonstrated with a SCI population. The
scale was developed specifically for use in rehabilitation centers and has not been tested in
community dwelling populations. The rationale for item scores is not well described. For
example, the authors do not indicate why the presence of pulmonary disease receives a score
of 2, whereas impaired renal function receives a score of 1.
Interpretability: A cut off score of 6 has a sensitivity of 75.6% and a specificity of 74.4%.
(Salzberg et al.1996). Response category scoring descriptors are operationalized in detail as
noted in the level of activity example above.
Acceptability: There is minimal burden related to administering or scoring the scale if tests for
diabetes, albumin and hemocrit are already part of the patient’s medical record. Otherwise the
blood tests required would be invasive and create respondent burden. No different formats or
alternate language versions could be found.
Feasibility: The SCIPUS takes 10-15 minutes to administer as long as laboratory data is
already available otherwise additional time and burden is required. No special training is
required to administer or score. The scale and its operational scoring definitions are available in
the article that describes its development and testing (Salzberg et al. 1996).
Clinical Summary: The SCIPUS scale is a quick and easy to use measure (if laboratory data is
already available) that provides predictive information about risk of pressure sore. Despite the
good content validity, other validity evidence is only adequate, and there has been no reliability
or responsiveness testing. Additional reliability and responsiveness data is necessary.
N/A N/A ++ Predictive ++ N/A N/A N/A
22-28
22.2.5.5 Spinal Cord Injury Pressure Ulcer Scale – Acute (SCIPUS-A)

The SCIPUS-A scale was developed as a measure of the risk for pressure ulcer development
for individuals with spinal cord injury who are in the acute phase of injury (within 30 days of
admission) (Salzberg et al. 1999). Items for the scale were identified based on statistical
analysis of data from 226 individuals with SCI, which compared development of pressure ulcers
with demographic variables and 50 potential pressure ulcer risk factors. It consists of 8 items
evaluating eight domains which include: 1) extent of paralysis, 2) moisture, 3) serum creatinine,
4) incontinence, 5) albumin, 6) mobility, 7) pulmonary disease, and 8) level of activity.
Response categories are either dichotomous (present/ absent (score = 1 to 2 or 0, respectively)
or have 3 to 5 options. For example, for extent of paralysis, none (ie. no paralysis) is awarded a
score of 0, paraparesis =1, quadriparesis =4, paraplegia = 8 and quadriplegia = 10.
Procedure: Raters indicate client function status based on personal experience or chart review.
Scales are scored based on descriptive criteria provided on the scoring sheet. As noted above,
responses to each item are awarded a value between 0 to 1-10 and these are added together to
create a summary score of 0 = best prognosis to 25 = worst prognosis.
Advantages: The content validity for the tool is high as it was designed for individuals with SCI.
Domains were identified from data analysis from 226 individuals with spinal cord injury and
needed to 1) demonstrate a statistical significant association with pressure ulcer development,
2) improve prediction, 3) be supported by the literature and 4) be biologically plausible.
Weighting for factors was identified based on their regression coefficients. The SCIPUS-A had
the highest correlations, for construct validity, compared to the SCIPUS, Braden, Gosnell,
Abruzzese & Norton with this population (Salzburg et al. 1999).
Limitations: Although the SCIPUS-A is reported to be the best measure for this population
(Salzberg et al. 1999), the same retrospective data was used to determine the measure’s
sensitivity and specificity and identify the domains used, which likely contributed to the higher
values compared to other measures. As well, Ash (2002) indicated the Waterloo, Braden,
Norton and SCIPUS-A all had similar moderate predictive power (however, the SCIPUS would
have been more appropriate given the population he studied). Salzberg et al. (1999) indicated
for individuals with SCI and a cut-off score of 10 the Braden scale had a 74.7% sensitivity and
56.6% specificity, which is only marginally worse than that of the SCIPUS-A (see below).
Interpretability: Sensitivity and specificity percentages are provided at a variety of cut-off
scores. A cut-off score of 18 has a sensitivity of 88.5% and a specificity of 59.0% for example.
Response category descriptors are operationalized in detail as noted in the extent of paralysis
example above.
Acceptability: There is minimal burden related to administering or scoring the scale if tests for
albumin and serum creatinine are already part of the patient’s medical record. Otherwise the
blood tests required would be invasive and create respondent burden. No different formats or
alternate language versions could be found.
Feasibility: The SCIPUS takes 5-10 minutes to administer as long as laboratory data is already
available otherwise additional time and burden is required. No special training is required to
administer or score. The scale and its operational scoring definitions is available in the article
that describes its development and testing (Salzberg et al. 1999).
Clinical Summary: The SCIPUS-A scale is a quick and easy to use measure (if laboratory data
is readily available) that provides predictive information about risk of pressure sore
development. Despite the good content validity, other validity evidence is only adequate, and
there has been no reliability or responsiveness testing with these individuals with SCI.
Additional reliability and responsive data is necessary for this tool.
N/A N/A ++ Predictive ++ N/A N/A N/A
22-29
22.2.5.6 Waterlow Scale

The Waterlow scale (Waterlow 1985) is a risk for pressure ulcer development assessment tool
that was created to provide better sensitivity and specificity than the Norton by increasing the
number of items used (Wellard & Lo 2000). Every patient is evaluated on eight domains(using 8
items): 1 ) age, 2) sex, 3) body build, 4)appetite, 5) continence of urine and feces, 6) mobility, 7)
skin appearance in risk areas and (8) special risks (disorders associated with tissue
malnutrition, neurological deficits, medication, recent surgery or trauma).
Procedure: Raters indicate client status based on personal knowledge of the client or chart
review. Items are scored as either dichotomous (yes/no) or on domain specific scales that range
from 0-1 to 3-5. Domains are scored based on descriptive criteria provided on the scoring sheet
(for example, for body build, average=0, above average =1, obese = 2 below average = 3) and
totaled to produce a summary score from between 3 (best prognosis) to 45 (worst prognosis).
Advantages: The test is quick to administer and readily available. Ash (2002) indicated the
Waterlow (area under the curve (AUC) = 76% with a 68-84% confidence interval), Braden,
Norton and SCIPUS-A all had similar moderate predictive power for patients with SCI.
Limitations: Scoring for some scale items is poorly operationalized as noted in the example
above. The weighting of items is not explained, but does make some intuitive sense as it
frequently reflects weightings from other measures. The scale omits items that Salzburg et al.
(1996; 1999) found to be important predictors of pressure ulcer development for people with SCI
in acute and rehabilitation settings. The reliability of the scale has not been demonstrated with a
SCI population, but poor inter-rater reliability has been reported in other populations (Kelly
2005). A revised version of the scale has been published but no research has been conducted
regarding its psychometric properties.
Interpretability: Interpreting scores is difficult given lack of detail in item descriptions. Scores of
10+ denote risk of developing a pressure ulcer, 15+ high risk and 20+ very high risk. No
rationale is provided for how these numbers were determined.
Acceptability: Easy to score and administrate with no patient burden. No other
versions/formats or translation into other languages could be located.
Feasibility: The scale takes 5-10 minutes to administer and no training is required. The original
scale can be found at
http://www.aelseating.com/pdfs/waterlow.pdf#search=%22Waterlow%20scale%22.
The revised scale is available for free over the internet http://www.judy-
waterlow.co.uk/downloads/Waterlow%20Score%20Card.pdf. The Waterlow Pressure Ulcer
Prevention Manual is available for £6.95 from http://www.judy-waterlow.co.uk/the-waterlow-
manual.htm.
Clinical Summary: The Waterlow scale is quick and easy to use screen that provides
predictive information about the risk of developing a pressure sore. Validity evidence is
adequate, but there has been no reliability or responsiveness testing with individuals with SCI.
Although it is the most common measure used in the United Kingdom (Wellard & Lo 2000; Kelly
2005), reliability issues with the original scale in non SCI populations and lack of psychometric
testing with the revised scale, suggest that other generic measures (such as the Braden) or SCI
specific measures, such as the SCIPUS or SCIPUS-A should be considered for use.
+ Inter O + ++ AUC ++ N/A N/A N/A
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; Inter O=interobserver; AUC=area
under curve
22-30
22.2.6 Functions of the Reproductive System
22.2.6.1 Emotional Quality of the Relationship Scale (EQR)

The EQR scale measures feelings of affection and intimacy, ability to solve problems within the
relationship, ability to communicate about sex with the partner and satisfaction with these areas
and the relationship as a whole (Kreuter et al. 1994a). The 7 item EQR covers these topics as
follows: affection and problem-solving (1 item each), communication (2 items) and satisfaction
(3 items). Responses are scored on a four-point ordinal scale ranging from 4 (very great) to 1
(very poor) (Kreuter et al. 1996).
Procedure: The EQR is a self-report instrument. Scores are summed resulting in a composite
score that ranges from a maximum value of 28 to a minimum of 7. A higher score indicates that
the emotional quality of the relationship is stronger.
Advantages: The EQR is useful in looking at aspects of relationships experienced by
individuals with spinal cord injuries. No other similar measures of these characteristics exist.
Limitations: There is insufficient information provided that adequately describes the EQR. This
tool has only been utilized in 3 studies referenced (Kreuter et al. 1994a; 1994b; 1996), but it was
only one of a battery of questionnaires and was not used on its own. The lack of
responsiveness limits the utility of the scale to measure changes after intervention.
Interpretability: A greater summary score demonstrates better emotional quality of a
relationship. There are no definitions and classifications of the results provided. Kreuter et al.
(1994a; 1994b; 1996) reported mean values for SCI patients ranging from 21.6±5.0 to 23.9±3.9.
Acceptability: The EQR questions are easily understood and the time participants take to
complete the questionnaire is minimal. Kreuter et al. (1994a) found 33% and Kreuter et al.
(1994b) found 40% of the subjects thought the questions talking about sex difficult to answer. It
is currently only available in English.
Feasibility: Staff burden is limited given the self-report nature of the scale and the estimated
time for completion is 2-5minutes. No special equipment or training is required, however, the
items may illicit an emotional response in the subject that requires professional attention.
Copies of the tool can be obtained from the article referenced (Kreuter et al. 1996).
Clinical Summary: Further investigation of tool is required before useful recommendations can
be made. The tool could feasibly be used with both individuals with tetraplegia and paraplegia.
Due to the lack of current literature using this tool, other more mainstream methods such as
client interview should be used in conjunction with this scale.
++ IC +++ +++ Construct ++ N/A N/A N/A
22-31
22.2.6.2 Knowledge, Comfort, Approach and Attitude towards Sexuality Scale (KCAASS)
The 45 item Knowledge, Comfort, Approach and Attitude towards Sexuality Scale was
developed to assess the training needs and professional skills of staff working in sexuality
rehabilitation with spinal cord injury patients (Kendall et al. 2003). Four subscales are found
within the questionnaire: knowledge (14 items), comfort (21 items), approach (5 items), and
attitudes (5 items). A four-point Likert scale is used for all subscales, where 1=no knowledge/no
discomfort/strongly disagree (for both approach and attitudes subscales) and 4=excellent
knowledge/high discomfort/strongly agree (for both approach and attitudes subscales).
Procedure: The KCAASS is administered by interview. Summary scores for each of the four
aspects of sexuality are calculated (knowledge (/56); comfort (/104); approach (/20); attitude
(/20)) with higher scores representing greater knowledge and skills. The subscales comfort,
approach and attitude are reverse scored (Kendall et al. 2003). A maximum composite score of
200 is obtained by summing up the subscales.
Advantages: The KCAASS is an SCI specific tool that identifies the individual training needs of
staff working in sexual rehabilitation and aids in the development of educational programs.
Principal components factor analysis confirmed the presence of 5 individual factors (knowledge,
comfort, attitudes, approach and appropriateness), which accounted for 66% of the overall
variance. The alpha coefficients for the subscales are all high (>.80) suggesting the items are
internally consistent. Fronek et al. (2005) evaluated the change in each subscale using
treatment and control groups, and discovered significant improvement across all subscales
demonstrating the effectiveness of such a program. The scale was developed specifically for
use within the spinal cord population.
Limitations: There was weak item-total correlation between the composite score and attitude
and the approach subscales illustrating these subscales should be considered separately. This
is not a concern as the utility of having a composite score for developing an educational
program is questionable.
Interpretability: Scores for each scale provide an assessment of where education time should
be allocated when creating a sexual education program. There are no classifications for the
results as the purpose of the scale is to assess where the greatest need for education lies.
Mean values for comparison are available in the Kendall et al. (2003) and Fronek et al. (2005)
articles in case comparisons with other users need to be made.
Acceptability: The scale items were developed based on literature review and are SCI specific.
The scale appears to be comprehensive in nature. The tool is available in English and Dutch.
Feasibility: The KCAASS is easy to administer and score. Approximately 10-15 minutes is
required to complete the scale although interviewing different learners may be time-consuming
and may not assist in course development for a group. If the KCAASS is self-administered then
staff burden and timing issues are reduced. Copies of the questionnaire can be accessed by
obtaining the paper by Kendall et al. 2003.
Clinical Summary: The KCAASS addresses a broad range of potential topics which helps
identify specific areas that should be focused on when developing sexual education programs
for staff working within the spinal cord population. Information elicited from this tool could
enhance the quality and comfort of sexual education for both the staff and client.
++ IC +++ ++ Content ++ ++ + N/A
22-32
22.2.6.3 Sexual Attitude and Information Questionnaire

The SAIQ was developed to evaluate the impact of counseling programs and sexual education
for persons with SCI and their partners (Brockway et al. 1978). The original SAIQ (number of
items not stated) consists of four scales while the revised 39-item SAIQ includes more items
within each scale and a single rating of overall concern for one’s ability to have a satisfactory
sexual relationship. The revisions to the original SAIQ were made to enhance reliability and
validity (Brockway & Steger 1980). The SAIQ-revised is broken down as follows: scale I, sexual
information (18 multiple-choice questions), scale II, sexual behavior acceptability (6 items),
scale III, sexual concerns (8 items), and scale IV, non-sexual concerns (6 items). Scales II and
III and the overall rating of sexual concern are scored using a 6-point Likert-scale (from 1=
totally disagree/extremely concerned to 6=totally agree/not concerned) and scale IV also uses a
6-point scale, but scores are inversed (1=not concerned to 6=extremely concerned).
Procedure: SAIQ is a self-report questionnaire. The subscales are scored independently of one
another. Scale I is scored according to the number of items answered correctly. The scale
scores for scales II, III and IV are found by summing ratings across items.
Advantages: SAIQ considers not only sexual behavior but also sexual and non-sexual
concerns, illustrating a more client-centered questionnaire. A lack of change in ratings for non-
sexual functioning demonstrates that sexual education and counseling programs are specific in
emphasizing change of attitude towards sexuality and not other non-sexual concerns (Brockway
et al. 1978).
Limitations: Responsiveness data may be questionable, as control groups were not used and
learning effects may be responsible for the changes seen (Brockway et al. 1978). The
questionnaire may require up-dating, as there has been a considerable increase in public
awareness and understanding of issues such as erectile dysfunction since its publication in
1980.
Interpretability: Each subscale presents separate information: higher scores for scale I
suggest individuals are knowledgeable about physiological aspects of sexual functioning, higher
scores on scale II represents acceptance of sexual behaviors, higher scores on scale III
indicates little concern about sexual functioning, and higher scores on scale IV suggests
considerable concern about non-sexual functioning (Brockway & Steger 1980).
Acceptability: The SAIQ is easy to complete and the phasing is clear and not misleading;
however, the content may be culturally sensitive. Some sex specific issues are considered (e.g.
issues related to the menstrual cycle). The SAIQ is currently only available in English.
Feasibility: Administration and scoring of the tool takes 10-15 minutes. No special equipment is
required. If used as part of a counseling or training program then staff training is required.
Contact the author at brockja@u.washington.edu to obtain a copy of the scale.
Clinical Summary: The SAIQ may prove to be a useful tool to evaluate the effectiveness of
sexual counseling and education programs designed for individuals with tetraplegia and/or
paraplegia. Also, the tool may be useful for identifying individuals who would benefit from such a
program.
+++ IC +++ ++ Construct + ++ + N/A
TR +++ Concurrent ++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test; IC=internal
consistency
22-33
22.2.6.4 Sexual Behaviour Scale (SB)

The SB scale measures the sexual expressions used by couples. There are seven items that
cover touching, kissing, manual and oral stimulation of genital and other erogenous zones, and
sexual intercourse (Kreuter et al. 1996).
Procedure: The SB is a self-report instrument. Items are summed resulting in a composite
score that ranges from a maximum value of 49 to a minimum value of 7.
Advantages: There is high internal consistency (alpha=.96) suggesting the stability of the items
is good and the high factor loadings of the items using principle components suggest the scale
is measuring a single dimension (behaviour).
Limitations: There is no description of the response categories used with this scale. The scale
has only been used as part of a larger battery of questionnaires and not on its own. Additional
study of the psychometrics such as test-retest reliability is required.
Interpretability: There are no definitions or classifications, important cut point or norms
provided to assist with interpreting the scores. No descriptions of scores are given, other than
the higher the score the better.
Acceptability: The time taken to complete the SB is less than 5 minutes.
Feasibility: Staff burden is minimal. No special equipment or training is required. Contact the
author at margareta.kreuter@fhs.gu.se to obtain a copy of the scale.
Clinical Summary: The SB allows a couple to gain insight into the type and degree of sexual
expression they experience together. The information obtained from this tool might be useful in
assisting couples with issues related to sexual intimacy. There is limited information found on
the SB and further study is required before recommending this tool for clinical use.
++ IC ++ ++ FA ++ N/A N/A N/A
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; IC=internal consistency; FA=factor
analysis
22-34
(SAS) Scales
The SAIS (Kreuter et al. 1994a; 1994b) and SAS (Kreuter et al. 1996) are tools used to
investigate the sexual activity and satisfaction of individuals with SCI. The SAIS consists of 6
items covering the following areas: sexual desire (1 item; scale from 1, very often, to 4, never),
sexual activity (1 item; scale from 1, never, to 8, every other day), and sexual satisfaction (4
items; differing scales from a 3-point to 5-point response; see tool). Based on research by the
developers (Kreuter et al. 1994; 1996), the 3-item SAS was created by removing the sexual
desire item and two sexual satisfaction items from the SAIS, thus leaving the sexual activity item
(same scale as above) and two sexual satisfaction items (scale from 1, not at all, to 4, very
much).
Procedure: The SAIS and SAS are self-report questionnaires. The response items can be
summed without weights or standardization. The composite score ranges from 28 to 6 for SAIS
and 16 to 3 for SAS. A higher score indicates greater sexual activity and satisfaction.
Advantages: This tool is one of the better researched measures within the area of sexual
interest and satisfaction. There is strong psychometric support for the scales with alpha values
between .8 and .9. Validity is supported by principle components analysis which demonstrates
strong uni-dimensionality (the scale consists of a single dimension) with both SCI and general
population samples. Support for construct validity exists based on hypothesis testing.
Limitations: Detailed explanation of the purpose of the scale modification is not provided in the
literature. Independent replication of the psychometrics and additional studies of test-retest
reliability and responsiveness is require if the scale is to be used for evaluating the effect of
interventions.
Interpretability: There are no consistent definitions or classifications for the results detailed
within the paper that developed SAS (Kreuter et al. 1996). For mean values for normative
comparisons consult Kreuter et al. (1994a; 1994b) for the SAIS and Kreuter et al. (1996) for the
SAS.
Acceptability: These scales take between 1-2 minutes to complete. The items may contain
content that is culturally sensitive. These tools are only available in English. The tool may be
administered in interview format if required.
Feasibility: There is relatively no staff burden due to the short length of this measure. No
special training is required to score or administer the SAS. The articles referenced contain the
tools (Kreuter et al. 1994;1996).
Clinical Summary: Both of these tools may be clinically useful to assist in understanding,
describing and quantifying the sexual activity and satisfaction of individuals with SCI (both tetra
and paraplegia). The tools may provide a platform from which to explore issues of sexuality.
Upon further study, the tool may also be effective in evaluating the effectiveness of sex specific
interventions.
+++ IC +++ +++ Construct ++ N/A N/A N/A
consistency
22-35
22.2.6.6 Sexual Interest and Satisfaction Scale (SIS)

The 7-item SIS scale measures sexual adjustment after SCI. The tool was designed to assess
different aspects of sexuality before and after injury. Four items determine the impact SCI had
on sexuality and sexual function using a 4-point response scale (increased=3, unchanged=2,
decreased=1, and absent=0). The remaining 3 questions assess general satisfaction before and
after injury, using a modified visual analogue scale with 7 marked intervals and end point
descriptors of very dissatisfied (1) to very satisfied (7) (Siosteen et al. 1990).
Procedure: The SIS is self-administered then checked by personal interview. The scores for
the 3 satisfaction items are rescaled to a range of 0 to 3 in order to enable calculation of a
composite score. The composite score is a sum of 6 items (satisfaction pre-injury is not used)
and has a maximum value of 18 and a minimum value of 0.
Advantages: The SIS was developed for use in the spinal cord population. It provides a quick
review of the individual’s sexual experiences, while factoring in their pre-injury state. The
internal consistency (alpha=.96) is extremely high and the factor analysis indicates this tool
represents a single dimension, despite the tool name. Furthermore, it has strong construct
validity, for example, frequency of sexual intercourse predicts 56% of the variance in the SIS.
Limitations: The type of spinal cord injury needs to be taken into consideration when
interpreting the results. Sexual adjustment for those with incomplete injuries may differ
considerably when compared to complete injuries. Lack of depth and breadth of the SIS items
may limit the usefulness to clinicians. Furthermore, description of the SIS is inconsistent within
the literature. Independent assessment of the reliability and validity and investigation of the test-
retest reliability and responsiveness of the tool is warranted.
Interpretability: Achieving a high score on the SIS illustrates greater sexual adjustment while a
lower scorer demonstrates poor sexual adjustments after spinal cord injury. There are no known
cut points or norms to assist with interpretation.
Acceptability: Patient burden in completing the SIS is minimal due to the small number of
questions. Items should be acceptable to both males and females. Question items may seem
personal and embarrassing to some. This tool is available only in English.
Feasibility: Administration and scoring requires approximately 5 minutes. No special training is
required to administer or score this tool and it can be found in Siosteen et al. (1990).
Clinical Summary: Sexual satisfaction and interest is an area of serious concern for the SCI
population. The SIS provides a reasonably well defined spinal cord specific measure that may
be useful in eliciting information regarding a sensitive area. Although it has not been widely
used and psychometric properties have been reported by only one study, it is one of few
sexuality scales that have been used within the SCI population. When comparing pre and post
injury results in those with tetraplegia, one must consider the time since injury, as this variable
affects sexual function and satisfaction.
++ IC +++ ++ Content ++ N/A N/A N/A
22-36
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22-40
22.3 Activity
Activity as defined for use in the International Classification of Function, Health and Disability
(WHO 2001) is the execution of a task or action. As such activity can be considered to occur at
a person level rather than a systems level such as body function. A debate exists regarding the
segregation of activity and participation as separate components or in our case classifications
and even the (WHO 2001) acknowledges this difficulty and therefore presents the domains as a
single list. Recently Jette et al. (2003) tested the hypothesis that activity and participation were
distinct dimensions within physical function. They concluded that distinct concepts were indeed
identifiable for mobility and daily activities and social/participation. As such we present tools
mobility and self care (daily) activity tools in the following section. The reader is reminded that
several tools cross not only domains (mobility, daily activity) but also components (activity,
participation). In this case we have classified the tool in the area most clearly represented by
measure. For example in a self report questionnaire this would be reflected by the area with the
most questions (items).
The outcome measures reviewed under this category include.
22.3.1 Mobility......................................................................................................................22-42
22.3.1.1 4 Functional Tests for Persons who Self-Propel a Manual Wheelchair
(4FTPSMW) ........................................................................................................22-42
22.3.1.2 10 Meter Walking Test (10 MWT) ..........................................................................22-43
22.3.1.3 Functional Standing Test (FST) .............................................................................22-44
22.3.1.4 Modified Functional Reach Test (mFRT) ...............................................................22-45
22.3.1.5 Tetraplegia Hand Activity Questionnaire (THAQ) ..................................................22-46
22.3.1.6 Timed Motor Test (TMT) ........................................................................................22-47
22.3.1.7 Timed Up and Go Test (TUG)................................................................................22-48
22.3.1.8 Walking Index for Spinal Cord Injury (WISCI) and WISCI II...................................22-49
22.3.1.9 Wheelchair Circuit (WC) ........................................................................................22-50
22.3.1.10 Wheelchair Skills Test..........................................................................................22-51
22.3.2 Self-care....................................................................................................................22-52
22.3.2.1 The Barthel Index...................................................................................................22-52
22.3.2.2 Functional Indepedence Measure (FIM) ................................................................22-53
22.3.2.3 Quadriplegia Index of Function (QIF).....................................................................22-55
22.3.2.4 Self Care Assessment Tool (SCAT) ......................................................................22-56
22.3.2.5 Skin Management Needs Assessment Checklist (SMNAC) ..................................22-57
22.3.2.6 Spinal Cord Injury Lifestyle Scale (SCILS) ............................................................22-58
22.3.2.7 The Spinal Cord Independence Measure (SCIM) ..................................................22-59
22-41
22.3.1 Mobility
22.3.1.1 4 Functional Tests for Persons who Self-Propel a Manual Wheelchair (4FTPSMW)
The 4 Functional Tests for Persons who Self-Propel a Manual Wheelchair (4FTPSMW) was
developed to assist clinicians in assessing the effect of different postural supports (e.g. back
support and seat cushions) (May et al. 2003). The assessment of postural supports is important
because they can influence sitting comfort, postural alignment, buttock pressure and functional
abilities (May et al. 2003). Existing tests assessing wheelchair skills such as the Wheelchair
Skills Test are not ideal due to the crude nature of the scoring schema (i.e. pass/fail). A test
assessing sitting balance, such as the modified Functional Reach Test, are not well suited to
assessing postural supports since the individual reaches forward and removes contact with their
back support. The test was developed by an experienced group of physiotherapists. A literature
review was conducted and input from individuals with SCI and researchers were obtained. The
test includes 4 tasks: 1) timed forward wheeling; 2) ramp ascent (forward wheeling); 3) forward
vertical reach distance; and 4) one-stroke push replaced ramp decline. Five minute rest breaks
were provided between tasks to limit fatigue.
Procedure: The tasks in the 4FTPSMW are scored as follows: 1) timed forward wheeling
(seconds); 2) ramp ascent (forwards wheeling) (seconds); 3) forward vertical reach distance
(cm); and 4) one-stroke push (cm).
Advantages: The 4FTPSMW was conceptually well developed to be a functional test suited for
the clinical setting (May et al. 2003). For example the timed forward wheeling task is based on a
distance of 23 meters (plus length of the wheelbase), which is the average length of a crosswalk
in a 4 lane intersection.
Limitations: The 4FTPSMW is a relatively new test and has not been widely tested. To date,
the test has not included female subjects and limited information was available on the types of
SCI included in the initial study (i.e. no information was available on the ASIA impairment grade,
level or completeness of injury). It is only relevant to individual who use a manual wheelchair
(i.e. not suited to individuals who use an electric wheelchair).
Interpretability: The 4FTPSMW assesses the capacity of an individual to complete functional
tasks wheelchair task which will enable postural supports to be compared. The scoring system
is useful since it is objective and has ratio level properties. No normative data is available.
Acceptability: The tasks included in the 4FTPSMW were tolerated well by participants, only the
ramp ascend task was difficult for an individual with C6 SCI at 4 months post injury.
Feasibility: The 4FTPSMW is well suited to be administered in the clinical setting. The tasks
have been well described which allows the test to be administered in a standardized manner.
The equipment required for the test includes: 23 m corridor, 1 m measuring stick, ramp (10.3 m
and 1:13 grade), carpeted surface (1.5 cm pile), and a stop watch. The test takes between 30 -
45 minutes to complete 2 trials of the 4 functional tasks including rest breaks (note: 2 trials were
required for test re-test reliability rather than to eliminate the practice effect).
Clinical Summary: The 4FTPSMW appears to be a useful test to assess postural support in
individuals with SCI, however data to validate that it can discriminate between different postural
supports has not been provided (May et al. 2003). Future research should compare tests such
as the 4FTPSMW with the modified Functional Reach Test and the Wheelchair Skills Test to
assist clinicians in determining what information is provided by each test and the test(s) needed
to prescribe wheelchairs, cushions, back supports and to assess wheelchair skills.
++ TR +++ N/A N/A N/A N/A N/A
++ Inter O +++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test; Inter O=interobserver
22-42
22.3.1 Mobility
22.3.1.2 10 Meter Walking Test (10 MWT)

The 10 Meter Walk Test (10 MWT) assesses short duration walking speed (m/sec). It has been
used in various patient populations including stroke, Parkinson’s disease, patients with general
neurologic movement disorders and only recently has been assessed in individuals with SCI
(van Hedel et al. 2005; 2006). The 10 MWT measures the measures the time (seconds) for an
individual to walk 10 meters. It is performed using a “flying start”, patient walks 14 meters and
the time is measured for the intermediate 10 meters. The individual walks at their preferred
walking speed. Individuals can use an assistive device and must wear shoes.
Procedure: The time (seconds) is reported and can also calculate a walking speed m/sec.
Advantages: The 10 MWT is easy to administer in the clinical setting or in the community. The
equipment required is available in the clinical setting and includes a 14 m corridor and a
stopwatch. Responsiveness has been assessed in patients with incomplete SCI at 1, 3, 6 and
12 months after SCI and was reported to be superior to measures with an interval scale (i.e.
WISCI II) (van Hedel et al. 2006).
Limitations: The 10 MWT only assesses walking ability and does not consider the amount of
physical assistance required, devices or endurance. The test is also conducted in a controlled
environment (i.e. lab setting) and so results can not be directly translated to the environment
(i.e. crossing a busy street). The 10 MWT also requires an individual to ambulate a minimum of
14 m. There have been reports in the literature that the distance is not always standardized (i.e.
10 m versus 14 m).
Interpretability: The information obtained from the 10 MWT can be reported as a time
(seconds) or a walking speed. Results of the 10 MWT have been reported in the literature for
individuals with incomplete SCI. An average 10 MWT was 30+28 seconds (van Hedel et al.
2005) with a walking speed of 4.5 km h-1 (1.25 m s-1). Normative values are available for
walking speed (i.e. reported to be 4.7 km h-1 [1.31 m s-1]). It is also possible to compare results
for various patient populations.
Acceptability: The 10 MWT is a short test taking approximately 30 sec and is suitable for
individuals who can at a minimum, ambulate in household settings (i.e. > 14 m).
Feasibility: The 10 MWT is quick and easy to administer in the clinical setting, does not require
any special equipment, and does not require advanced training.
Clinical Summary: The 10 MWT assesses short distance capacity in ambulation and other
measures are required to assess balance, physical assistance required and endurance. It
appears to be a useful measure in the SCI population for both research and clinical practice.
The scale properties (time in sec or m/sec) of the 10 MWT make it a responsive test well suited
to evaluating clinical interventions.
+ Inter O +++ ++ Construct +++** + +++* N/A
Intra O +++ Concurrent ++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; Inter O=interobserver; Intra
O=intraobserver; varied (re. floor/ceiling effects; mixed results).
* Responsiveness assessed using the Freidman’s test.
** For construct validity, the results with other walking tests (i.e. TUG & 6 MWT) were considered stronger evidence
to support validity compared to LEMS based on ASIA.
22-43
22.3.1 Mobility
22.3.1.3 Functional Standing Test (FST)

The Functional Standing Test (FST) is designed to assess an individual’s ability to perform one
handed reaching tasks while standing (Triolo et al. 1994). This test was originally developed
using able-bodied individuals and has been modified for individuals with SCI. The FST is unique
because it defines standing as a stable upright posture that frees at least one upper extremity to
manipulate objects, while other standing tests focus on specific factors such as balance,
endurance, coordination etc. The FST consists of 21 tasks, 6 of which are the same as in the
Jebson Test of Hand Function. Tasks involve gross to fine motor skills, crossing midline, lifting
and lowering light and heavy objects to and from a set of shelves which is intended to simulate
a kitchen cabinet. Examples of tasks include: lifting light objects down from the lowest shelf;
stacking checkers on the counter top at the midline; lifting heavy objects up to the top shelf. The
tasks are done as quickly as possible and the individual is allowed to use assistive devices such
as knee-ankle-foot-orthoses (KAFO) or functional neuromuscular stimulation. A practice test is
not required based on the data from able-bodied individuals.
Procedure: The time in minutes/seconds to complete each of the 21 tasks is recorded.
Advantages: It evaluates the functional ability of standing while using technology. The tasks
simulate skills required to work in a kitchen environment but theses skills are easily transferred
to other environments (e.g. shopping). The tasks cover a broad range of difficulty.
Limitations: There has been limited testing of the FST in individuals with SCI and it has been
done in individuals with T3-6. Some tasks were not reliable in individuals with SCI (i.e. total
standing time, lifting heavy objects down from low shelves, pulling objects from the nondominant
side and pouring). Caution must be used when comparing to able-bodied data since only half of
the tasks were equally reliable between groups (i.e. SCI and able-bodied) (Triolo et al. 1994).
Interpretability: The FST could be used to assess which types of technology maximize
standing balance. Information from the FST provides a measure of an individual’s skill/capacity
to perform various tasks while standing. The FST was originally developed and tested on 69
able-bodied adolescents, so some data is available to compare to able-bodied individuals.
Acceptability: The FST was tested in individuals who were one year post injury and who
received therapy using assistive devices (i.e. KAFO’s). The time to complete the entire test (i.e.
total standing time) was 15.58 + 2.99 minutes. Time required for each task ranged from 1.86 to
13.70 seconds for individuals with SCI.
Feasibility: Equipment is required to conduct the FST and includes the standard Jebson Test
board and a set of shelves mounted on a counter top 36 inches high in order to simulate a
kitchen cabinet. This type of equipment may not be available in most clinical or research
settings. Training is required to administer the test.
Clinical Summary: The FST has been used to assess functional tasks while standing in
individuals requiring technological assistance (i.e. KAFO’s or functional neuromuscular
stimulation). It is a potentially useful measure for individuals with SCI but more research is
needed to assess modifying the test (removing the unreliable items) and assessing the validity
and responsiveness. The specialized equipment may limit its usefulness in some
clinical/research settings.
++ Inter O +* + SS + N/A N/A N/A
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; Inter O=interobserver;
* Note: the ICC values for the IO reliability ranged from 0.13 – 0.98. If the tasks that were identified as being
unreliable in the SCI group were eliminated, then the results for reliability would be assessed as ++.
22-44
22.3.1 Mobility
22.3.1.4 Modified Functional Reach Test (mFRT)

The Functional Reach Test (FRT) was originally designed as a simple reach test designed to
assess standing balance. Lynch et al. (1998) modified the FRT to assess sitting balance in
individuals with SCI (i.e. modified FRT), since no suitable measures existed at the time this
paper was published.
Sitting balance was defined in the study as the ability to maintain control over upright posture
during forward reach without stabilization (Lynch et al. 1998). The individual is seated on a
bench and the maximum distance forward they could reach was measured with the upper
extremity flexed to 90 degrees. The anatomical landmark was the ulnar styloid process since
individuals with tetraplegia could not make a fist. No weight bearing was allowed through the
non reaching arm. The individual is allowed two practice trials and then the following three trials
are recorded.
Procedure: A clinician administers the test. The average of the three trials is reported in either
cm or inches.
Advantages: The mFRT is a very functional activity that is required in daily living. It can
distinguish between individuals who have abdominal and back extensors (i.e. high
tetraplegia/high paraplegia versus low paraplegia) but not between individuals with high lesions.
Information from the mFRT may be assist clinicians in prescribing equipment (e.g. cushions and
wheelchairs) to maximize sitting balance (Lynch et al. 1998).
Limitations: The mFRT requires an individual to have 90 degrees of shoulder flexion and it is
therefore not suitable for individuals with limited range of motion or musculoskeletal deformity.
More data on the psychometric properties of the test is required since the only data published in
on the test re-test reliability with just one rater using a small sample of men (Lynch et al. 1998).
Interpretability: No normative data exists for the mFRT for any health care condition at this
time. Lynch et al. (1998) reported that the maximal reach for C5-6 group was 14.7+ 7.6 cm
(3.3-27.4); T1-4 was 15.5 + 4.3 cm (7.6 -21.3); and T10-12 was 22.9 + 5.6 cm (14.7-29.2).
Acceptability: The mFRT has been developed specifically for individuals with SCI. As long as
an individual has 90 degrees of shoulder flexion, then it is possible to complete the test.
Feasibility: The equipment required should be available in a rehabilitation setting. It includes: a
meterstick/yardstick (attached horizontally to the wall); seat (mat or bench approximately 61 cm
in width); and a backboard (at an angle of 80 degrees).
Clinical Summary: The mFRT can be used to assess sitting balance in individuals with SCI. It
may prove to be a useful tool to assist clinicians in prescribing equipment and to evaluate the
effects of rehabilitation therapy. More research is required to establish its psychometric
properties before it should be used to evaluate clinical interventions (Lynch et al. 1998).
++ TR +++ N/A N/A N/A N/A N/A
22-45
22.3.1 Mobility
22.3.1.5 Tetraplegia Hand Activity Questionnaire (THAQ)

The Tetraplegia Hand Activity Questionnaire (THAQ) is a disease specific measure (Land et al.
2004) of arm and hand function of individuals with tetraplegia. The scale was designed to
provide information on the body function, activity and participation levels of the WHOs
International Classification of Function. It consists of 153 items within 9 subclasses: self-care
(22 items), dressing (15 items), continence (15 items), mobility (14 items), eating and drinking
(25 items), work/admin/telecom (17 items), leisure (10 items), household (13 items) and
miscellaneous (22 items). Items are scored based on 3 dimensions Performance or Doing (0=
without difficulty to 3=help from others); Use of an aid (0=never and 3=always); Importance of
performing activity independently (0=not important to 2 very important).
Procedure: Information is collected using an interview format
Advantages: The THAQ was designed to be sensitive to treatment effects of interventions of
the arm and hand for tetraplegics who traditionally score poorly on other measures that are
designed for paraplegics. Conceptually well founded and well developed using items identified
as important by expert clinicians and clients. The THAQ focuses on the activities that individuals
do versus what they can do in a treatment setting.
Limitations: Information on psychometric properties is not yet published. Currently there are no
studies using this tool in the literature. It is not clear at what point the THAQ should be
administered (acute/chronic, inpatient, outpatient, after community reintegration).
Interpretability: No information regarding interpretability of the scores (eg/ norms).
Acceptability: Specific to the tetraplegic population; individual items identified by client
population. At present the THAQ is available in English but no other language.
Feasibility: No special training is required to administer the THAQ although experience is likely
an asset. It takes 30-45 minutes to complete. Contact Land et al. (2004) for a copy of the tool.
Clinical Summary: The THAQ is a SCI specific questionnaire used to assess performance, use
of an aid and importance in completing actual activities. It has relevant application for individuals
with tetraplegia who have completed in-patient rehabilitation. The test may not be useful when
the individual is an in-patient as exposure to out of facility activities related to community living,
work, leisure, which are not typically addressed in early phases of in patient rehabilitation. The
THAQ could potentially be used as a method of goal identification for intervention and/or as a
test to measure change after intervention. However, while the THAQ is promising considerable
additional development and psychometric assessment is required before recommendations can
be made to use the scale clinically.
N/A N/A N/A N/A N/A N/A N/A
22-46
22.3.1 Mobility
22.3.1.6 Timed Motor Test (TMT)

The Timed Motor Test (TMT) is a performance test assessing function for children with SCI who
use a manual wheelchair. It was developed because existing functional measures for children
either measure burden of care/assistance required (i.e. Wee FIM) or are not appropriate for
children requiring a wheelchair (i.e. Pediatric Outcomes Data Collection Instrument or the
Pediatric Quality of Life Inventory include walking related tasks/questions)(Chafetz et al. 2004).
The TMT includes 6 tasks: donning a shirt; donning sweat pants; performance of even transfers;
performance of uneven transfers (4 inch height difference); wheelchair propulsion on even
surfaces; and wheelchair performance up a ramp. The individual completes each task 5 times,
except for wheelchair skills which is only done 3 times. They are instructed to complete the task
quickly but safely. If they are unsuccessful in completing the task, they can re-try it and if they
are not able to complete all 5 trials then no time was reported. If the individual requires more
than 20 seconds to complete the task then it is considered “incomplete”.
Procedure: A clinician records the time (seconds) to complete each task. Based on the results
of the reliability data it was decided to use the fastest 3 trials for scoring each task.
Advantages: The TMT includes common ADL tasks for children with SCI. This test can be used
to assess the impact of wearing a brace such as a TLSO on everyday function (Chafetz et al.
2004). An objective scale such as time (seconds) is useful to detect change. The necessary
equipment for the TMT is usually available in the rehabilitation setting and includes: adjustable
mat; an 80 foot (24.3 m) corridor; and a 45 foot (13.72 m) ramp with an 8 degree angle.
Limitations: Only reliability data has been reported and there is a need to conduct more
research to assess the validity and responsiveness of the TMT. It may be tiring for some
children to complete each task 5 times. There is no information regarding how the TMT
compares to other manual wheelchair tests.
Interpretability: The TMT is designed to assess the capacity to perform ADL in children with
SCI (Chafetz et al. 2004). This tool is still in the early stages of development and more research
is required to determine how to score it (i.e. confirm that the 3 fastest trials should be averaged).
No norms are available and the results for the 3 fastest trials for each task were not reported.
Acceptability: All individuals were able to complete 5 trials of the TMT (except 3 trials of the
wheelchair skills) without a brace (i.e. TLSO) but some of the tasks (i.e. donning pants and
propelling the wheelchair on flat surfaces and a ramp) were more difficult with a brace.
Feasibility: It takes between 60–90 minutes to complete. No special training is required.
Clinical Summary: The TMT is potentially useful measure for in-patient or out-patient
rehabilitation settings to assess the impact of interventions (e.g. surgery or braces) on function
for children requiring manual wheelchairs. More research is needed to assess the psychometric
properties (i.e. reliability, validity and responsiveness).
++ TR ++* ++ Construct ++** N/A N/A N/A
++ Inter O +++
++ Intra O +++
Intra O=intraobserver
* TR values for each of the 6 tasks were >0.75 for 4 tasks, 0.67 for one task and 0.30 for one task. An overall value
of adequate (++) was selected to best represent the range of values.
** There is support for construct validity by using the data comparing known groups (TLSO versus no brace). F
values were reported and 5 out of 6 tasks demonstrated that the TLSO times were significantly (p<0.05) compared to
no brace.
22-47
22.3.1 Mobility
22.3.1.7 Timed Up and Go Test (TUG)

The Timed Up and Go Test (TUG) is a timed walking test designed to measure gait
performance and balance. It was originally developed as a clinical measure of balance in
elderly individuals (Mathias et al. 1986). The individual is instructed to stand up from an arm
chair, walk 3 meters, return to the chair and sit down at their preferred walking speed. Assistive
devices can be used. A practice test is recommended to improve the reliability of the test.
Procedure: The individual is timed and a score is reported in seconds.
Advantages: The TUG is a quick and easy test to administer and can be done in any setting
(i.e. clinical setting or community). The task is very functional and incorporates mobility, balance
and lower extremity leg strength.
Limitations: The distance walked in the TUG is only 3 meters and so it is not a good test of
endurance. The test has also not been reported to be reliable in individuals who require longer
than 40 seconds to complete the test. To date the TUG has not been widely used in the SCI
patient population. In order to complete the TUG an individual is required to be able to stand up
from sitting and walk 3 meters and so it may not be suitable for some individuals with SCI who
are not able to do both of these skills.
Interpretability: Results from the TUG provide an objective measure of time required to
complete functional task. Results from the study by van Hedel et al. (2005) reported that the
time required to complete the TUG ranged between 8 and 156 seconds, with a mean of 36+27
seconds. Since the TUG has been used in other patient populations (e.g. elderly, stroke etc.) it
is possible to compare results, but it will not be possible to determine if an assistive device was
used.
Acceptability: The TUG appears acceptable to individuals (i.e. all individuals completed the
test).
Feasibility: The TUG is easy to administer in the clinical setting and does not require any
special training to administer. The equipment required is commonly found in most clinical
settings and includes an armchair, stopwatch, and 3m corridor. It is difficult to obtain information
on how to standardize the test as it has been used in various patient populations and the details
of how it was administer are not always clearly stated (e.g. can an individual turn to their right or
left, height of the arm chair, number of practice tests, what is a “preferred walking speed”, etc.).
Clinical Summary: The TUG appears to be a very useful measure for individuals with
incomplete SCI who have lower extremity function and provides some information on a basic
mobility task. The TUG may be useful to assist in the clinical assessment of whether an
individual should ambulate or use a wheelchair in a home environment. More research is
required to assess the psychometric properties, especially responsiveness in individuals with
SCI before it should be used to assess clinical interventions.
++ TR< 40 sec +++ ++ Construct +++ N/A N/A N/A
TR>40 sec +
Inter O<40 sec +++
Inter O>40 sec ++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test; InterO=interobserver
22-48
22.3.1 Mobility
22.3.1.8 Walking Index for Spinal Cord Injury (WISCI) and WISCI II
The WISCI a measure of ambulation was developed for specifically for SCI clinical trials using a
modified Delphi technique (Ditunno et al. 2000). Existing measures of function (e.g. FIM, Barthel
Index, Rivermead Mobility Index) do not adequately measure walking ability due to the limited
scale responses (i.e. not sufficient incremental differences between levels). The WISCI
evaluates the amount of physical assistance, braces or devices required to walk at 10 m. The
original WISCI incorporated 19 levels, including increasing levels of physical assistance and
devices (arm devices for using parallel bars, walkers, crutches and canes as well as leg braces)
required for walking. Level 0 was “patient is unable to stand and/or participate in walking” to
level 19 “ambulates with no devices, no braces and physical assistance, 10m”. The WISCI II
contains an additional item “ambulates with no devices, with brace and no assistance” (Ditunno
& Ditunno 2001; Ditunno et al. 2005; Morganti et al. 2005). Ten meter distance selected as it
represents household ambulation and it represents the international metric.
Procedure: The clinician observes and rates the level which the person is considered safe. For
the WISCI II, a score from 0 to 20 is assigned. It is not clear if practice tests are allowed.
Advantages: The WISCI II is an SCI specific test. It covers the entire range of walking ability.
Unlike other tests such as the Timed Up and Go, the WISCI II scoring includes the type of
assistance or device required. A score is possible even if the individual cannot walk 10 m.
Limitations: The WISCI II does not consider walking speed or energy consumption required for
walking or an indication of endurance since the distance covered is only 10m. Because the
furthest walk distance is 10m, it would not be suitable for individuals with minor impairments. In
one study, 17% (42/249) of individuals had a score of 20 (i.e. ceiling effect) (Morganti et al.
2005). Comparisons with timed tests (e.g. 6 Minute Walk Test, 10 Meter Walk Test) indicated
that the WISCI II is not as responsive. Morganti et al. (2005) and van Hedel et al. (2005)
suggest walking speed data would improve responsiveness and decrease the ceiling effect.
Interpretability: No normative data or cut scores are available but the WISCI II is gaining
popularity and comparisons can be made with existing studies. Scores are self evident.
Acceptability: The WISCI levels are relevant to individuals with SCI. There is no additional
burden is as the test falls into typical clinical practice parameters.
Feasibility: Equipment required is typically available in the clinical setting and includes: 5 meter
parallel bars and walking devices (e.g. braces, cane, walker). Administration time is client
dependent. Special training beyond knowledge of ambulation is not required. Scoring definitions
provided are clear. Information regarding specific instructions (eg/ practice attempts) is lacking.
Copies of WISCI I & II are available in the Ditunno et al. 2000 and Ditunno & Ditunno 2001
articles.
Clinical Summary: The WISCI II is a SCI specific measure developed to assess functional
walking capacity, including the amount of physical assistance and/or braces required. It would
be a useful to incorporate the WISCI II in clinical practice and to evaluate new SCI therapies.
Additional tests may be necessary to assess endurance (e.g. 6MWT) and/or walking speed
(10MWT), especially for individuals with greater walking capacity.
+++ Inter O +++ +++ Construct – WISCI II ++ ++ ++
WISCI I/II a) ++* (at 1 month )
+* (at 3,6, 12 months)
b) +++**
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; Inter O=interobserver; varied (re.
floor/ceiling effects; mixed results).
* Compared to timed walking tests
** Compared to functional measures (e.g. FIM, SCIM, BI).
Note: for the tables – the Morganti paper used the WISCI II, but results were classified as WISCI I.
22-49
22.3.1 Mobility
22.3.1.9 Wheelchair Circuit (WC)

The WC assesses manual wheelchair mobility (i.e. skill and performance). This test was
developed to overcome limitations in existing observational tests such as the Functional
Independence Measure which assess wheelchair mobility but do not provide information on
physical strain and are not able to detect change (Kilkens et al. 2002). Other wheelchair tests
have limitations such as not being clinically feasible or are not comprehensive enough to assess
functional wheelchair skills. The WC was adapted based on tasks from existing measures
(Janssen et al. 1996; Harvey et al. 1998; Dallmeijer et al. 1999). It consists of 8 tasks and 3
aspects of mobility: 1) tempo; 2) technical skill; and 3) physical capacity. Tasks assessing
tempo include figure-of-8 shape and sprint; tasks assessing skill include crossing a doorstep,
mounting a platform, and transferring; and tasks assessing physical capacity include wheelchair
driving and ascending slopes. An original an item on walking has been removed.
Procedure: Three scores can be obtained from this performance based test including:
1) Ability score (primary score of the measure) provides information about the ability of the
individual to perform each of the 8 test items within the allotted time. Assigned scores range
from 1 (anchor such as individual can perform the task) to 0 (anchor if not). Three items also
can receive a partial (i.e. ½ point) score. Total scores range from 0-8 on an ordinal scale.
2) Performance time score is the sum of the performance times on the figure-of-8 and the 15 m
sprint. Scores are reported in seconds.
3) Physical strain score consists of the strain experience in performing the 3% and 6% slope
items. Scores are reported as either the mean peak heart rate (beats/min) reached for the 2
tasks or as mean the peak heart rates reached during the 2 slope items (% heart rate reserve).
Advantages: The WC includes functional tasks developed specifically for the SCI population. It
was designed and tested on individuals with ASIA A-D and individuals with tetra and paraplegia.
Limitations: To date, this test has been primarily used in in-patient rehab settings in the
Netherlands for research (Kilkens et al. 2002; 2004). The tasks are only relevant to manual
wheelchair users. The ability and performance time score could be obtained in the clinical
setting if the equipment is available but the strain score requires a formula using HR values.
Interpretability: No normative data is available however the results can be compared to
published data. Separate scores for ability (ordinal scale); performance time (seconds); and
physical strain (formula using HR data) are calculated. The performance time and physical
strain are useful to monitor progress once the individual achieves a maximal score on the ability
score or if they have not demonstrated any change over repeated administrations.
Acceptability: Some tasks may be too difficult / not suitable if individuals have medical
complications or are older. Meaningfulness of time taken is questionable. Practice test is
recommended.
Feasibility: Space and equipment are required for the WC and include: an adjustable mat;
treadmill (with 3% and 6% grade); HR monitor; stop watch; 0.10 m platform on floor; wood
doorstep height 0.4 m; open space; and 15 m corridor. There was no mention of time required
to administer the test. Clinicians require specialized training to perform exercise testing. A copy
of the tool is available in the Kilkens et al. 2004 article.
Clinical Summary: The WC is a promising test for individuals with SCI as preliminary results
support its validity, reliability and responsiveness. It is primarily useful as a research measure
and the equipment required for exercise testing may limit its usefulness in the clinical setting.
++ Inter O +++ ++ Construct ++ ++ +++ ++**
++ Intra O +++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; IntraO=intraobserver;
InterO=interobserver; varied (re. floor/ceiling effects; mixed results).
22-50
22.3.1 Mobility
22.3.1.10 Wheelchair Skills Test

The Wheelchair Skills Test (WST) is a comprehensive measure used to objectively evaluate
manual wheelchair skills (Kirby et al. 2002). Existing wheelchair tests (Harvey et al. 1998) do
not include the level of wheelchair skills required for daily functioning. Version 1.0 of the WST
includes 33 skills of varying difficulty (e.g. using the brakes, performing a wheelie) and the
revised WST 2.4 (Kirby et al. 2004) includes 50 skills in 10 areas (brakes, armrests, footrests,
rolling, turning, reaching, transfers, fold/open, obstacles, and wheelie). The individual is required
to use a manual wheelchair and two attempts, with a rest, are permitted to complete the task.
Procedure: Scoring is on a pass-fail basis (pass=1, fail=0, N/A=not applicable) with an
additional goal attainment score (GAS), for which the clinician indicates whether or not the skill
is a reasonable goal for the individual case (N/G=not a goal). The following scores are reported:
1) total score, 2) total percentage (total score/total score possible [excluding N/A items] * 100),
3) asymmetry ratio (L:R) for skills with L and R scores, and 4) GAS ((total score – #N/G)/(total
score possible – #N/G) * 100).
Advantages: The tasks cover a wide range of difficulty while remaining functional. It is a
generic tool that can be used for several populations (e.g. SCI, amputees, stroke,
musculoskeletal disorders, able-bodied) and it was developed using both inpatient and
community dwelling samples.
Limitations: To date, there has been insufficient testing with SCI populations (n=34) and more
extensive research in community and long-term care settings is advisable.
Interpretability: The total WST score for individuals with SCI was 68.4+15.1%, indicating that
these individuals were able to complete approximately 70% of the tasks deemed suitable (Kirby
et al. 2004). Since the WST is still being piloted and revised it is difficult to compare results and
another version of the test is expected (i.e. WST 3.0).
Acceptability: Although no adverse events occurred during testing and feedback was mainly
positive, frustrations were noted for certain tasks. Clinicians rated the usefulness of the tool as
56.2±25.0% (range 2-93%), in which 0=not useful at all and 100=extremely useful. Translation
into French version is in progress.
Feasibility: The WST 2.4 was designed to require a minimal amount of equipment, set-up time
and space. On average, it took 27.0+9.3mins (range 12–70mins) to complete and therefore, it
can be conducted in one session. The clinician requires test familiarization and a spotter is
mandatory. The user manual and tool is available in pdf format on line at
http://www.wheelchairskillsprogram.ca.
Clinical Summary: The WST is a promising new measure to assess manual wheelchair
mobility that can be used in both the clinical and research setting. Information on
responsiveness is required before it should be used to evaluate interventions. Based on patient
and clinician feedback, there likely will be content changes and version WST 3.0 is expected in
the near future.
++ WST 2.4 WST 2.4 N/A N/A WST 2.4
TR +++ ++ Construct +++ ++
Inter O +++
Intra O +++ ++ Criterion ++
Intra O=intraobserver; varied (re. floor/ceiling effects; mixed results).
22-51
22.3.2 Self-Care
22.3.2.1 The Barthel Index

The 10 item Barthel Index (BI) is one of the oldest developed measures of activities of daily
living (ADL). It was developed to assess the severity of disability or independence in personal
care and mobility in stroke patients (Mahoney & Barthel 1965). Scoring of the 10 items reflects
the burden on nursing care and social acceptability of the activity and are weighted to give a
maximum score of 100 (Mahoney & Barthel 1965).
Item Scoring
Bathing 0=dependent; 5=independent
Grooming
Feeding 0=dependent; 5=needs help; 10=independent
Dressing
Toilet use
Ascend/descend stairs
Bowel management 0=dependent; 5=occasional accident; 10=independent
Bladder management
Bed/wheelchair transfer 0=unable, 5=major help needed; 10= minor help; 15=independent
Mobility (level surface) 0=unable; 5=wheelchair >50yards; 10=walks >50 yards; 15=independent
Procedure: Scores are obtained using direct observation, self-report, or responses from family
or friends. Scores based on information from the past 24-48 hours preferred. Total scores are
calculated by adding the items 0 (dependence) to 100 (independence).
Advantages: One of the best researched ADL tools. It has been used with a number of
diagnoses including: amputation, burns, cardiac problems, stroke and MS. Use of adaptive aids
are permitted with a score of ‘independent’.
Limitations: While research on responsiveness has been done for other populations only the
modified BI has published properties for the SCI population. Floor (tetraplegics) and ceiling
(paraplegics) effects makes the scale less useful for the SCI population.
Interpretability: Cut scores to categorize dependency of patients have been established on the
stroke population and are not necessarily representative for the SCI population. These scores
range from 0 (dependence) to 100 (independence). Scores of 0-20 indicate total dependence;
21-60 as severe dependence; 61-90 moderate dependence and 91-99 slight dependence
(Granger et al. 1977; 1979).
Acceptability: Minimum patient burden unless the entire is scored by observation. Several
modified versions exist including a 15 item (Granger et al. 1979) and a 17 item version
(McGinnis et al. 1986) designed to increase the sensitivity. The BI exists in English, Japanese
and a Turkish which has been assessed on the SCI population (Kucukdeveci et al. 2000). Only
the 10 item English version has been assessed for the SCI population. Items are deemed
important to society but may not reflect activities that are of importance to individuals with SCI.
Feasibility: The BI requires 2-10 minutes to complete (more if by observation) and it is easy to
score. No specific equipment or training is required although clinical experience and practice will
benefit the user. The scale is public domain. An online version of the BI can be obtained at:
http://www.strokecenter.org/trials/scales/barthel.pdf#search=%22barthel%20index%22.
Clinical Summary: The BI covers very basic functional abilities and while a score of 100
suggests independence assistance may still be required with other higher order tasks such as
cooking and cleaning and therefore other measures would be needed to assess these areas.
The floor and ceiling effects suggest that the sensitivity to detect subtle but important changes
for individuals with very high and low lesion levels may not be good. Therefore the BI may
provide valuable descriptive level. The BI is not a clinically useful tool for clients with SCI.
++ IC +++ +++ Concurrent +++ ++ +++ Floor ++
TR +++ Construct ++ Ceiling +
Inter O ++
consistency; Inter O=interobserver
22-52
22.3.2 Self-Care
22.3.2.2 Functional Independence Measure (FIM)

The Functional Independence Measure (FIM) was developed in 1983 as part of the Uniform
Data System for Medical Rehabilitation for the assessment of burden of care and functional
impairment (Granger et al. 1986). Consensus for the items was arrived by a national advisory
committee (McDowell & Newell 1996). The FIM assesses physical and cognitive disability. It
consists of 18 items with two subscales; motor and socio-cognitive. The motor subscale
includes 13 items: eating, grooming bathing, dressing upper extremity, dressing lower extremity,
bowel management, bladder management, transfers to bed, chair or wheelchair, transfer to tub,
toilet and shower, walking or wheelchair propulsion and stair climbing. The socio-cognitive
subscale includes 5 items: comprehension, expression, social interaction, problem solving and
memory. Each item is scored on a 7 point ordinal scale ranging from 1 (total dependence) to a
score of 7 (total independence). The scoring considers the use of adaptive equipment and/or
the extent of personal assistance or supervision required to complete the task.
Procedure: The tool is completed by trained health professionals who observe patient
performance. FIM Motor, cognitive and/or total scores can be derived by summing items.
Advantages: The FIM is internationally known/accepted measure that has been used for
clinical and research purposes. Substantial evidence supports its use. Reliability and validity are
well established (Dodds et al. 1993; Hamilton et al. 1994). Motor scores reflect the functional
status of individuals with spinal cord injuries (SCI) (Hall et al. 1999). It predicts the amount of
assistance needed indicating the cost of living in the community with SCI (Hamilton et al. 1999).
Limitations: The FIM is not SCI specific. It has limitations in sensitivity to component abilities
within tasks for people with SCI. The FIM is not able to discriminate between the subtle, yet
important changes in functional skills between paraplegics and tetraplegics (Dodds et al. 1993).
There is a ceiling effect with the socio-cognitive subscale for individuals with SCI (Davidoff et al.
1990) and it does not measure the social, psychological or vocational impact of disability (Dodds
et al. 1993) or the quality of life or patient satisfaction of living with SCI.
Interpretability: Total FIM scores range from 18 (totally dependent) to 126 (totally independent)
motor scores range from 13 (total dependence) to 91 (total independence) and cognitive scores
range from 5 (total dependence) to 35 (total independence). Higher scores reflect fewer care
hours required upon discharge (Heinemann et al. 1997; Hamilton et al. 1999). The FIM motor
score is a better predictor of discharge functional ability than the cognitive score with a SCI
population (Graves 2005). Individuals with a diagnosis of ASIA A or B upon admission, have the
most change in Motor scores from admission to discharge. Total scores are misleading for SCI
due to ceiling effects of the cognitive subscale (Hall et al. 1999).
Acceptability: Requires approximately 45 minutes to complete. The items are not necessarily
SCI specific. It has been translated into 10 languages (Ottenbacher et al. 1996). There is a
WeeFIM exists for children (McCabe et al. 1990). Short and phone versions also exist.
Feasibility: Certification for FIM administration is required. Information on training can be
obtained from http://www.udsmr.org/. See McDowell & Newell (1996) for a copy of the FIM.
Clinical Summary: The FIM is often considered the gold standard for assessing activities of
daily living. It is routinely used to collect data for administrative purposes in databases such as
the Canadian Institute for Health Information National Rehabilitation Reporting System and the
Uniform Data Set for Medical Rehabilitation. It is the best researched measure of function but it
is not thorough in its evaluation and is not sensitive to the subtle important changes in function
for SCI individuals. The cognitive subscale should only be used as a screen due to ceiling
effects. Despite its limitations, the FIM, has well established psychometric properties and is
accepted by fee users as a predictor of function and potential care hours required for discharge.
22-53
22.3.2 Self-Care
+++ IC ++ +++ Construct +++ +++ + Floor ++*, +**
TR +++ Concurrent ++ Ceiling +, ++**
Inter O +++ Predictive +++
consistency
*Hall et al. (1999) reports poor floor scores on motor scales with high tetraplegics.
** Hall et al. (1999) reports adequate floor /ceiling scores on motor scales with low tetraplegics.
22-54
22.3.2 Self-Care
22.3.2.3 Quadriplegia Index of Function (QIF)

The QIF was developed in 1980 to provide a functional assessment that would be useful in
documenting the small but clinically significant gains made by quadriplegics throughout in-
patient rehabilitation (Gresham et al. 1986). This index is comprised of 10 areas including:
transfers, grooming, bathing, feeding, dressing, wheelchair mobility, bed activities, bowel
program, bladder program and understanding of personal care. The first 9 areas represent
functional performance activities and the final area consists of a questionnaire designed to
assess the client’s understanding of skin care, nutrition, equipment medications and infections.
The functional performance categories are scored on a 5 point scale from 0 (dependent) to 4
(independent).
Procedure: Information is collected in an interview format. Scores are provided to give credit for
being able to complete a portion of the task rather than the entire task. Each category of
functional performance is calculated according to weighted scores. Functional performance
categories: /180 Understanding of personal care: /20 Total: 200 /2 = /100
Advantages: The QIF was designed for SCI population, specifically for those individuals with
tetraplegia. It measures improvement from admission to discharge for the in-patient
rehabilitation population. Studies have shown that the ASIA motor scores are strongly correlated
to performance improvement on QIF scores (Yavuz et al. 1998) and the scores are not
dependent on age or length of stay in rehabilitation facility. Studies of the responsiveness or
sensitivity to change indicate that the QIF reflects was better at detecting small gains in function
than the Barthel Index or the Kenny Self-care Evaluation (Gresham et al. 1986).
Limitations: The scoring criteria is highly specific due to the weighted calculations. Not all
activities are relevant to all individuals and not all items are relevant or applicable to the in-
patient rehabilitation setting. Given this it remains unclear how to score items that are not
missed. There is some redundancy within the QIF.
Interpretability: The scores represent functional performance in activities rather than
performance in component parts. No information regarding interpretability of the scores (eg:
norms or cut points) is provided.
Acceptability: Tested on a total of 59 SCI subjects in two separate studies (Gresham et al.
1986; Yavuz et al. 1998). These studies reported good client co-operation and lack of
expressed concern by the raters.
Feasibility: Takes less than 30 minutes to administer when the assessor is familiar with the
measure. It is easy to administer, requiring no special equipment or training. It is difficult to
score due to the weighted scale of the functional performance activities. Copies of the scale and
scoring instructions are available by contacting the authors of the Gresham et al. (1986) article.
Clinical Summary: The QIF is a functional measure designed specifically for clients with spinal
cord injury. It is sensitive to change, representing small gains in functional performance, which
is important for both clinicians and clients. It provides a meaningful assessment of participation
of functional self-care activities. This tool would be particularly useful for evaluating change and
assessing rehab effectiveness for the tetraplegic population.
+++ Inter O ++ +++ Construct +++ + + N/A
22-55
22.3.2 Self-Care
22.3.2.4 Self Care Assessment Tool (SCAT)

The Self Care Assessment Tool (SCAT) was developed by experienced clinicians to assess
cognitive and functional skills required by individuals with an SCI below C7 to perform self-care
(McFarland et al. 1992). C7 and below was selected because the individuals have the required
skills to perform self-care activities. When this article was published, none of the existing
measures were pertinent to the specific needs of individuals with SCI. It contains 81 items: 41
cognitive and 40 functional. Cognitive and functional skills are measured in eight self-care
areas: bathing/grooming; nutritional management; medications; mobility/transfers/safety; skin
management; bladder management; and bowel management. For each area the clinician
assesses the cognitive and functional skills. The items in the SCAT consider the use of physical
assistance as well as assistive devices. The scale for each item is yes/no/not applicable.
Procedure: The SCAT is an interviewer administered test. A cognitive and a functional
subscale score can be calculated as well as an overall score, although no details are provided
on how to calculate the scores.
Advantages: The SCAT was developed specifically for the SCI patient population whereas
many self-care measures such as FIM have been developed for a broad range of health
conditions. It assesses both cognitive and functional skill, which may be important as the
incidence of SCI increases in older individuals. The items assess performance rather than what
they are capable of doing. It has been used in both the rehabilitation and community setting.
Some preliminary results indicate that results at 6 weeks prior to discharge from rehabilitation
can predict self care performance at 6 months post discharge (McFarland et al. 1992).
Limitations: The SCAT is designed for individuals with SCI below C7 and it is likely that high
functioning individuals with thoracic and lumbar lesions may obtain a ceiling effect, but this
needs to be confirmed in future research studies. The ordinal scale may not make the test
suitable for assessing change. Since publication of the SCAT in 1992, the SCIM is now
commonly used to assess self care for individuals with SCI and it would be important to
compare these tests in future studies (McFarland et al. 1992).
Interpretability: The SCAT provides information on the functional and cognitive skills required
to perform self-care. The SCAT does not appear to be widely used in either the clinical setting
or in research. No standardized norms are available and no results were reported so it is difficult
to make any comparisons.
Acceptability: The content of the SCAT appears to be clinically relevant based on the sample
questions provided in the article. The test is designed for individuals with SCI lesion below C7.
Feasibility: There is no information is available on the time it takes to complete the SCAT.
However, considering it contains 81 items, it may not be feasible to administer in the clinical
setting. It does not require special training and the test developers produced a manual. For a
copy of the tool contact the authors of the McFarland et al. (1992) article.
Clinical Summary: The SCAT was designed to assess the cognitive and functional skills
required to perform self-care for individuals with a motor level below C7. It is relevant for
individuals who require assistance or devices for self-care but more information is required to
determine if it would be feasible to use it in the clinical setting.
++ TR ++* ++ Predictive +++** N/A N/A N/A
Inter O +++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test; Inter O=interobserver
* TR was assessed using Pearson correlation coefficients
** Validity was predictive validity (construct as no gold standard exists) and it was assessed by comparing pre-
discharge score with 6 months post discharge score.
22-56
22.3.2 Self-Care
22.3.2.5 Skin Management Needs Assessment Checklist (SMNAC)

The Skin Management Needs Assessment Checklist (SMNAC) (Berry et al. 2004) was
extracted from the Needs Assessment Checklist (Kennedy & Hamilton 1999), and was
developed as a post discharge measure to assess client knowledge and ability to perform skin
checks, pressure relief and prevention of skin breakdown. It is based on the individual’s
perception his/her ability to independently perform skin management activities. The checklist
was developed in accordance with Treatment Theory (identifying the need for assessments that
measure the processes between input and output, define issues for specific populations and
outline the required step to produce the expected outcome (Keith & Lipsey 1993). Each item on
the SMNAC receives a score ranging from 0-3 (0-complete dependence; 1-mostly dependent;
2-moderately dependent; 3-complete independence) or N/A (not applicable, representing no
rehabilitation need or goal to be identified).
Procedure: The self-report measure requires individuals to demonstrate or, for an individual
with a high lesion, instruct their personal care attendant to perform the activities. The items are
summed to generate a total score out of 36. The value reported is a proportion (client score/36).
Higher scores reflect greater independence.
Advantages: In addition to measuring physical and/or verbal independence, it considers
specific attributes such as clients’ attitudinal and behavioural factors towards skin management.
As a result, the SMNAC identifies the complex variables which impact an individuals’ actual
performance in skin protection activities. The test includes a measure of verbal abilities for
individuals with a high lesion SCI, enabling it to be sensitive to the subtle, yet significant gains
for these individuals and encourages independence and control over skin protection activities.
Data from the study suggest there is strong internal consistency (α = 0.85) and responsiveness.
Limitations: Most raters tend to score in either category 0 or 3 leading to floor/ceiling effects.
The ambiguity with the middle scores may reflect bias in interpreting or poorly defined
categories for the other scores. There is limited research using this tool.
Interpretability: No risk specific scores or normative data is available at this time.
Acceptability: There is minimal patient burden however some embarrassment may be evident.
Item wording and scoring options provided do not clearly correspond in all cases. This may lead
to rater ambiguity for the middle response categories. For example, when asking “Are you
aware of the danger of zips, seams, calipers, etc?” the response categories may cause the
patient confusion, who may want to answer ‘yes’ or ‘no’ rather than rate their independence.
Feasibility: It requires approximately 20 minutes to administer and score. No special equipment
or training is required, however, experience with wound care may enhance tool use. A copy can
be obtained from the author.
Clinical Summary: The SMNAC provides SCI specific information related to skin management
needs. The SMNAC score may be used to identify the problems for individuals living in the
community to establish priorities and goal setting or to inform community health care
professionals about a clients’ ability to manage skin management activities. In addition, the tool
could be used preventatively at discharge, to identify individuals at risk for skin breakdown,
enabling education prior to discharge. Additional research, particularly responsive and validity in
general, is necessary before recommending the use of the SMNAC to evaluate the
effectiveness of interventions targeting maintenance of skin integrity.
++ IC +++ ++ SS + ++ + N/A
SS=sensitivity/specificity
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22.3.2 Self-Care
22.3.2.6 Spinal Cord Injury Lifestyle Scale (SCILS)

The 25 item Spinal Cord Injury Lifestyle Scale (SCILS) is a self-report measure of the frequency
of health-related behaviour performance in individuals with spinal cord injury (SCI). The tool was
designed to enable examination of the effectiveness of clinical and educational efforts for health
maintenance and prevention of secondary impairments (Pruitt et al. 1998). The items were
developed from a review of the literature on secondary impairments related to SCI. In addition,
expert clinicians (physician assistants, nurses and physiotherapists) generated items describing
health related behaviours. Each item describes different health behaviours. The 5 subscales
include: cardiovascular (4 items), genitourinary (4 items), neuromuscular (8 items), skin (6
items) and psychosocial (2 items). Its’ purpose is to evaluate the effectiveness of clinical and
educational efforts for health maintenance and the prevention of secondary impairments
following SCI. The frequency with which each behaviour has been performed over the past 3
months is rated using an ordinal scale where 4=‘almost always’, 3=‘frequently’, 2=‘sometimes’,
1=‘rarely’ and 0=‘never’. One item (genitourinary) is reverse scored.
Procedure: Data can be collected by pen and paper or through interview if the individual is
unable to write. A score is generated for each scale by totaling scores of each item using a 0-4
point scale. A total score is calculated by summing the 5 scale scores. Sub-scale scores may be
used to identify/address specific areas of concern.
Advantages: This is an SCI specific tool designed to address the concerns surrounding
secondary conditions that they experience. Data from the study suggest that the SCILS has
strong internal consistency (alpha=0.81) for the total score however the subsections range from
alpha=.31 to .86 indicating some item revision may be useful (Pruitt et al. 1998).
Limitations: Due to the nature of the small sample size (N=49) and the fact that the sample
consisted of males only, the generalizability of the results is limited. Current research is for
young adults (19-50 years old). Although the authors identified a comprehensive list of
secondary impairments, only some of these impairments have been included in the tool. For
example, items missed include autonomic dysreflexia, deep vein thrombosis, pressure relief in
bed, adjustment to disability, to mention a few. The evidence did not identify an association
between the SCILS and a decrease in secondary health impairments. The SCILS requires
retrospective recall and personal diagnoses, which is not as accurate as a health record review
or clinical assessment. Studies on responsiveness are not available.
Interpretability: Higher total scores are intended to indicate better performance of behaviours
which in turn promote health in individuals with SCI. The scores could be used for each sub-
scale or as a tool for general overall health. There are no norms or reported cut scores.
Acceptability: Individuals with SCI participated in item elimination during tool development
therefore the included items should resonate with the population.
Feasibility: Administration and scoring takes 10-15 minutes for each.The SCILS is not available
in any other languages. A copy is available from the authors.
Clinical Summary: The SCILS requires further testing and development of the measure before
recommending it for clinical use. Specifically responsiveness studies are required if the tools is
to be used to evaluate clinical or education interventions. At present there is no evidence to
suggest that it is able to predict and therefore prevent secondary impairment. Studies of the
utility of the SCILS with women and retest reliability are necessary.
++ IC ++ ++ Construct + N/A N/A N/A
Concurrent +
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22.3.2 Self-Care
22.3.2.7 The Spinal Cord Independence Measure (SCIM)

The SCIM is a new disability scale developed (Catz et al. 1997) that specifically addresses
patients with spinal cord lesions (SCL) in order to describe their ability to accomplish activities of
daily living. Actually 3 versions of the SCIM (I-III) have been consecutively developed (Catz et
al. 1997; 2001a; 2006). The SCIM scores 16 items in three subscales; 1) self-care (feeding,
grooming, bathing, and dressing); 2) respiration and sphincter management and 3) mobility (bed
and transfers and indoor/outdoor). The item scores are weighted related to the assumed clinical
relevance.
Procedure: Clinical staff scores the items based on the activities the patient is performing
during the regular daily activities or as the patient reports in an interview. Scores are derived by
adding up the items producing a total score (0 to 100) and/or subscale scores (self care 0-20;
respiration and sphincter management 0-40; mobility 0-40). Higher scores reflect higher levels
of independence.
Advantages: This is an SCI specific measure of basic functional independence. Validity (face
and construct) is supported by several studies including a recent multicentre (13 centers in 6
countries). The results suggest strong validity and reliability (Catz et al. 2006) and better
sensitivity to change compared to the Functional Independence Measure (Catz et al. 1997). The
SCIM is quickly becoming one of the best research tools within the SCI population (Catz et al.
1997; 2001a; 2001b; 2002; 2004; 2004; 2006; Grijalva et al. 2003; Itzkovich et al. 2002; 2003;
2006; Jackson et al. 2004; McKinley et al. 2001; Popovic et al. 2006; Ronen et al. 2004;
Scivoletto et al. 2003; Morganti et al. 2005). The SCIM III, the most recent version, has been
revised based on statistical analyses using Rasch analysis (Catz et al. in submission).
Limitations: The weighting of the items may require revision to account for the assumed clinical
relevance.
Interpretability: The scores have shown to be of clinical relevance and are able to monitor
improvements of independence during rehabilitation and represent typical rehabilitation goals.
The SCIM has been found to be more sensitive to chance in SCI rehabilitation than the FIM.
Acceptability: The items reflect basic areas of patient concern. There is minimal patient
burden. The multicentre study showed no difficulties related to languages.
Feasibility: The SCIM takes 30-45 minutes conduct and score. Minimal additional staff burden
is required as the variables collected are important to patient care. No special equipment is
necessary however knowledge of areas of function is beneficial and experience using the test is
likely an asset. A copy of the tool can be obtained from the article by Catz et al. (1997).
Clinical Summary: The SCIM has high clinical relevance for the rehabilitation for individuals
with either traumatic/non-traumatic and complete/incomplete SCI. Research supporting the use
of the tool is accumulating and the results suggest the SCIM is reliable and valid and may
become the gold standard of basic function. Ceiling and floor effects (especially floor) may be
an issue for individuals at either who have very high or low level lesions.
+++ Inter O +++ +++ Construct+++ ++ ++ ++
22-59
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22.4 Participation
Conceptualization and Definition of Participation:
There has been tremendous progress in understanding how individuals resume participating in
life activities following a health condition. In 2001, when International Classification of
Functioning, Disability and Health (ICF) (Gray & Hendershot 2000) replaced the International
Classification of Impairments, Disability and Handicap (ICIDH) there was a change from concept
handicap to participation. Participation is defined in the ICF as involvement in a life situation and
participation restriction is defined as problems an individual may experience while involved in
life situations (World Health Organization 2001). This is a significant shift because handicap
focused on the disadvantages for an individual in life roles considered normal (i.e. based on
age, sex, and social and cultural factors), which was also referred to as a societal perspective.
It is important to note that the World Health Organization’s ICIDH and ICF models are just one
way to conceptualize measuring life roles/activities. Other disciplines have proposed measuring
similar concepts but have used alternate terms, which are conceptually quite similar, and
include: social health; social adjustment; social or community re-integration; independent living;
instrumental activities of daily living; and quality of life (Dijkers et al. 2000).
Since the concept of measuring involvement in life situations is very broad, there will likely never
be consensus, as to what life dimensions should be included and what construct should be
addressed (Dijkers et al. 2000). In the ICF, activity and participation domains are listed together
and the user of the model decides which ones to consider activity versus participation. Jette et
al. (2003) analyzed items based on the ICF concepts activity and participation and
demonstrated that they are distinct concepts, with the former assessing basic tasks (e.g. the
ability to climb stairs) and the latter assessing more complex life tasks (e.g. preparing meals). It
has been recommended that in future revisions of the ICF that these two concepts are better
defined (Dijkers et al. 2000; Whiteneck 2006).
The perspective of how to assess participation has also evolved over time. Measures of
handicap primarily captured observable information, such as the frequency which an individual
performed roles (e.g. hours of paid work) and in this review are called measures assessing
objective participation. However, measures of objective participation do not capture the
individual’s perspective about the impact of the health condition and the problems they
experience when carrying out everyday activities or fulfilling social roles. As a result,
developers incorporated the perspective of participation as perceived by the individual which
has been termed subjective or person-perceived participation (i.e. cognitive, emotional and
motivational aspects of participation) (Noreau et al. 2005). Although the ICF model does not
explicitly include a subjective dimension, the replacement of the term handicap with the term
participation and the inclusion of a broader range of life roles provide the opportunity to capture
subjective information. In this review, the term objective participation will be used to describe
handicap and the term subjective participation will describe person perceived participation.
Recommendations:
For the purpose of this review, the measures included in this section had questions related to
most ICF dimensions of participation, particularly, interpersonal
relations/interactions/relationships, major life areas (e.g. education, employment), and/or
community/ social/civic life. All of the measures have been tested, to varying degrees on
individuals with SCI.
The measurement of participation has been termed the most meaningful outcome of
rehabilitation (Cicerone 2004); however, it is probably also the most challenging to measure
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since there are many things that contribute to a person’s level of participation. It is important not
to select an outcome measure just because it is commonly used, but rather consider whether it
provides information about the outcome of interest (Backman 2005). In this review consideration
was given to the domains (i.e. content) which is frequently determined from the conceptual
model, the perspective (i.e. objective versus subjective participation) of a particular measure,
the psychometric properties as well as logistical issues (e.g. number of questions, patient
burden etc.).
The measures included in this review were based on various conceptual models. Some of the
measures have been developed based on the ICIDH model (i.e. CHART, PHQ) or the ICF
model (IPAQ, PARTS/M). While other measures have used other models such as the
occupational performance model (COPM) and the Disability Creation Process model (Life-H).
The RNL and the PARA-SCI did not use a specific model, but were developed based on the
concepts re-integration and physical activity, respectively. All of the measures included multiple
domains (i.e. are generic) with the exception of the PARA-SCI, which just focused on physical
activity. The domains included vary depending on how participation was defined. Most
measures (except PARA-SCI) included some items on self-care, mobility, family/social relations
and work/education a few measures included details on items such as parenting, attending
religious services or conducting economic transactions. The COPM is the only participation
measure that has been used in an in-patient rehabilitation setting for individuals with SCI, which
is likely due to its individualized approach thereby allowing the individual to select relevant goals
that will ultimately result in them being able to participate in the community. The content and the
measurement properties of the other participation measures are designed to be used in the
community setting.
The participation perspective varies among the measures. Some measures primarily assess
objective participation (CHART, PARA-SCI) while other assess subjective participation (IPAQ,
Life-H, RNL, PHQ, COPM); one measure (PARTS/M) included both. Objective participation
measures such as the CHART are primarily useful for research purposes to describe from a
societal point of view, how individuals with SCI differ from other patient populations and healthy
controls. The CHART is probably the most widely used participation measure for individuals with
SCI. However, information provided in the CHART does not include the individual’s perspective
and so information about how the person performs the tasks as well as what tasks are important
to them is not captured, which is a significant limitation. In contrast, the subjective measures of
participation (IPAQ, PARTS/M, Life-H, RNL, PHQ, COPM) offer tremendous potential to
clinicians and researches working in the area of SCI.
Most of the participation measures have established some aspects of reliability and validity.
The IPAQ and the PARTS/M are relatively new measures and so not much has been published
specifically on individuals with SCI. To date, very little has been published on responsiveness
for any of the measures, with the exception of the IPAQ. In terms of logistical issues, the time
required to complete the measures will vary, the PHQ has only 5 questions and the PARTS/M is
the most comprehensive, containing 135 questions and this will likely be a contributing factor in
which measure to select. In Canada, data using the RNL in individuals with SCI will become
available since it is part of the NRS, although little work has been done to establish its
psychometric properties in this population. Finally, measures such as the LIFE-H, the COPM
and the PARTS/M include information on satisfaction with participation and clinicians and
researchers can use this information to identify areas or target interventions to those life
activities that are most important to the individual.
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Conclusion:
Participation measures, particularly ones that measure subjective participation, provide

important information for individuals working in the field of rehabilitation since they assess how
the individual is doing in the community, which some would argue is the ultimate rehabilitation
outcome. Future work establishing the psychometric properties of participation instruments will
be essential to ensure the measures are reliable, valid and responsive for assessing
participation in individuals with SCI thereby enabling clinicians and researchers to select
appropriate measures.
22.4.1 Assessment of Life Habits Scale (LIFE-H)................................................................22-67

22.4.2 Canadian Occupational Performance Measure (COPM) ..........................................22-68
22.4.3 The Craig Handicap Assessment & Reporting Technique (CHART) ........................22-69
22.4.4 Impact on Participation and Autonomy Questionnaire (IPAQ) ..................................22-70
22.4.5 Participation Survey/Mobility (PARTS/M...................................................................22-71
22.4.6 Perceived Handicap Questionnaire (PHQ) ...............................................................22-72
22.4.7 The Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI)
...............................................................................................................................................22-73
22.4.8 Reintegration to Normal Living (RNL) Index .............................................................22-74
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22.4 Participation
22.4.1 Assessment of Life Habits Scale (LIFE-H)

The LIFE-H was developed using the Disability Creation Process Model (DCP) to assess life
habits and handicap situations, which are concepts related to social participation (Noreau et al.
2002; Dumont et al. 2003). Life habits are defined as “those habits that ensure the survival and
development of a person in society throughout his or her life” and they include activities ranging
from ADL’s to social roles (Fougeyrollas et al. 1998). A handicap situation is “a disruption in the
accomplishment of a person’s life habits, taking into account age, sex and socio-cultural identity,
resulting from impairments, disabilities or environmental factors” (Fougeyrollas et al. 1998). The
LIFE-H includes 12 categories: nutrition, fitness, personal care, communication, housing,
mobility, responsibilities, interpersonal relationships, community life, education, employment,
and recreation. The long form (Version 3.0, June 2003) contains 240 items, whereas the short
form contains 77 items (Version 3.1, June 2003) (Noreau et al. 2002). The long form can be
used as a whole or as sub-sections and the short form is a general measure of handicap. The
response categories consider the level of difficulty (5 point ordinal scale) and the type of
assistance (4 point ordinal scale) required to do each life habit. Satisfaction for each item is
reported using a 5-point scale (1=very dissatisfied to 5=very satisfied).
Procedure: Self- or therapist-administered. The level of difficulty and the types of assistance
are combined and weighted to derive an accomplishment score: (Σ Scores x 10)/(number of
applicable life habits x 9). Total scores for each life habit category range from 0-10.
Advantages: The LIFE-H is a conceptually strong tool that incorporates the interaction of the
individual and their environment, and thus, overlaps with the ICF (Fougeyrollas et al. 1998;
Noreau et al. 1998; 2000). Input was obtained from rehabilitation experts and individuals with
SCI (children and adults). Participation is based on the individual’s perspective of performance
rather than describing it from a societal perspective. Rasch modeling applied to the short form
support its measurement model (Dumont et al. 2003).
Limitations: Satisfaction data is not incorporated into the accomplishment score and it is
unclear if this information was used in the cited research. There is no responsiveness data.
Interpretability: Information from the accomplishment score describes an individual’s
performance for each life habit (i.e. social participation). Satisfaction information may guide
clinical interventions. There are no published norms; however, data from various SCI studies
provide some basis for comparison (Fougeyrollas et al. 1998; Noreau et al. 2000).
Acceptability: The long form requires 20 to 120 minutes to complete (depending on which
sections are used) and the short form takes between 30 to 60 minutes.
Feasibility: No special training is required to administer or score the LIFE-H. It was originally
developed in French and translated into English.
Clinical Summary: Social participation is a meaningful rehabilitation outcome. Performance
and satisfaction measures provide relevant community based information which can be used to
guide clinical interventions.
++ *Adults: Convergent ++** N/A N/A N/A
(S) TR +++ +++
(L) TR ++
++ *Children:
(S) TR ++
(L) TR ++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test; S=Short Version;
L=Long Version
*: TR values were based on the overall values for the short and long version of the LIFE-H for adults.
**: Note the LIFE-H was compared to the CHART and the CIQ which assess objective handicap/participation and so
a high correlation is not expected.
22-67
22.4 Participation
22.4.2 Canadian Occupational Performance Measure (COPM)

The Canadian Occupational Performance Measure (COPM 1991) is a client-centered
individualized measure of function (Donnelly et al. 2004). It was developed to measure change
in an individual’s self-perception of occupational performance, where occupational performance
is defined as “activities an individual performs in the areas of self-care, productivity and leisure,
in the context of their environment” (Pollock 1993). The individual identifies areas of difficulties,
rates the importance of the issues (0 to 10, where 10 is the most important) and chooses up to 5
problems that they would like to make goals of their treatment. They rate their current level of
performance and satisfaction with their performance for each of the 5 goals on a scale of 0 to 10
(1= with great difficulty or not satisfied and 10=no difficulty or completely satisfied). Upon re-
assessment, the goals initially defined are reviewed and the individual’s performance and
satisfaction are compared to the first assessment (Donnelly et al. 2004).
Procedure: Information is administered in a semi-structured interview. Mean scores (range 1-
10) are calculated for satisfaction and performance, along with change scores (i.e. post-
treatment score – initial score).
Advantages: The COPM provides a unique perspective on occupational performance areas as
identified and rated by the individual. It is frequently used by occupational therapists for clinical
practice and research purposes. The areas covered are relevant for all patient populations.
Limitations: There is no evidence to support the reliability and responsiveness of the COPM in
individuals with SCI. The study by Donnelly et al. (2004) had a small sample (n=41) including
mostly males (n=29) from one centre. Furthermore, there is no information for differing SCI
groups (e.g. levels and severities of injury). It has been suggested (Donnelly et al. 2004) that a
mid-point evaluation using the COPM would be useful to determine if there are any new
problems identified during the rehabilitation process.
Interpretability: The COPM provides a self-assessment of occupational performance. A
change score of 2 has been demonstrated to be a meaningful difference, but it has not been
confirmed for the SCI patient population. No published norms are available for the COPM since
it is an individualized assessment. It is possible to compare results from the literature for other
patient populations. Donnelly et al. (2004) reported that the most common goals in the SCI
sample were self-care (79%), productivity (12%), and leisure (9%) and the most common
problems were functional mobility, dressing, and grooming.
Acceptability: The COPM is not suitable for very young children (under age of 8 years) or
individuals with cognitive deficits. It can be completed by the individual or by a family
member/care giver. The COPM has been demonstrated to work well in most cultures; however,
there may be difficulties in cultures in which the health care professional is expected to set the
individual’s rehabilitation goals.
Feasibility: The COPM takes approximately 20 to 40 minutes to administer. Further
information is located on the Canadian Association of Occupational Therapists website:
http://www.caot.ca/copm/. The cost the DVD kit is $225.45, which provides information on
administering and scoring the COPM. In addition, a summary of the research conducted on the
COPM is available for $63.86. The COPM is copyrighted.
Clinical Summary: The COPM provides important client-centered information that is not
captured in other standardized measures and is well suited to be used as part of clinical
practice. Initial research findings suggest that the COPM may be a very useful measure for
individuals with SCI. Future research studies should test the COPM with larger samples of
individuals with SCI to further establish its psychometric properties.
N/A N/A ++ Construct ++* N/A N/A N/A
* - the COPM was compared to the FIM and so high correlations between the scales are not expected since the
COPM is an individualized test and the FIM is a standardized performance test.
22-68
22.4 Participation
22.4.3 The Craig Handicap Assessment & Reporting Technique (CHART)

CHART was designed to measure the level of handicap in a community setting and was
modeled on the ICIDH-1 (WHO 1980). The handicap dimension assessed initially the degree of
disadvantage in 5 out of 6 handicap dimensions (physical independence, mobility, occupation,
social integration, economic self-sufficiency) of people living in the community (Hall et al. 1998).
Basically, CHART collects information on the degree to which the respondent fulfills the roles
typically expected from people without disabilities. The original CHART consisted of 27
questions, 2 to 7 questions per subscale (Whiteneck et al. 1992). In 1995, some items were
added to the instrument to cover the domain of cognitive independence (5 additional questions)
(Cusick et al. 2001). A short form (CHART-SF) has been developed (19 questions) (Whiteneck
et al. 1992).
Procedure: The questions can be answered in a quantifiable, behavioral terms (e.g.: hours of
physical assistance, how much time is someone with you to assist you, how many relatives do
you visit, etc.). For each CHART dimension, a scoring procedure allows to compute a score
from 0 to 100 points, the latter being the maximum attainable corresponding to a role fulfillment
equivalent to that of most individuals without disabilities
Advantages:
- Relatively simple procedures, wording with few ambiguity and a development based on
strong methodological studies that showed a good level of reliability and validity.
- Has been tested with proxies (Cusick et al. 2001)
Limitations:
- Potential ceiling effects in thoracic lesions for physical and cognitive independence,
mobility and social integration (Hall et al. 1998).
- Its conceptual base differs from the new approach of participation as defined by the
International Classification of Functioning (WHO 2001)
- Given its quantitative base, one should be cautious in assessing the quality of social
participation with CHART. For instance, counting the number of people contacted by the
respondent is not necessarily an indicator of the quality of social relationships (social
integration dimension), and fewer positive relationships is probably a more valuable
asset for any individual than numerous negative relationships (Whiteneck et al. 1992).
Interpretability: Total score is potentially a misleading assessment of handicap and the use of
subscales is recommended. Norms and profiles of handicap have been widely published.
Acceptability: Wording and clarity of questions make CHART easy to complete. Questions on
cognitive independence might be seen as irrelevant in SCI population.
Feasibility: No specific training is required to administer the CHART. An online pdf version of
the CHART can be obtained from http://www.tbims.org/combi/chart/CHART.pdf.
Clinical Summary: The CHART provides useful information mostly for research purposes to
establish profile in SCI population. It is widely used and particularly in the U.S. National Spinal
Cord Injury Database. Clinical utility remains to be demonstrated as no report informs on
clinical use of the CHART.
++ TR +++ ++ Discriminant ++ N/A N/A N/A
IR +++
PR +++, except
SI (+, ++)
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test; IR: Inter-rater
reliability; PR= Proxy-subject reliability; SI= Social integration
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22.4 Participation
22.4.4 Impact on Participation and Autonomy Questionnaire (IPAQ)

The Impact on Participation and Autonomy Questionnaire (IPAQ) is a self-administered
questionnaire developed using the ICF model of human functioning and disability (Cardol et al.
1999). It was developed after a review of the literature revealed that there were no instruments
available which obtained information about participation from the perspective of the individual.
The IPAQ assesses autonomy and participation as perceived by the individual. It was
developed using input from experienced clinicians and individuals attending an out-patient
rehabilitation unit (e.g. stroke, SCI, rheumatoid arthritis, and neuromuscular conditions) (Cardol
et al. 1999; 2001; 2002a; 2002b).
The IPAQ measures two different aspects of participation: 1) perceived participation and 2) the
experience of problems for each aspect of participation. The participation domains include:
autonomy outdoors (e.g. visiting friends, leisure time); autonomy indoors (e.g. self-care); family
role (e.g. housework); social relations; paid work; and education. The perceived participation
scale consists of 31 items which are assessed using a 5 point rating scale (1=very good and
5=very poor). The problem scale contains 8 items which are assessed using a 3 point rating
scale (0=no problem and 2=severe problem).
Procedure: The questionnaire is completed by self-report or by interviewer. A participation
score and a problem score are produced by summing items in each scale. The participation
score range from 30-155 (higher score = lower participation) and a problem score ranges from
0-16 (higher score = more problems).
Advantages: The IPAQ is a relatively short questionnaire that has been used in various patient
populations (e.g. stroke, SCI, fibromyalgia, etc.).
Limitations: The IPAQ is a relatively new measure and as a result there has been limited
information on its psychometric properties for individuals with SCI.
Interpretability: The IPAQ provides a measure of the individual’s perceived autonomy and
problems in life activities (i.e. participation). Although no normative data exists, published data
is available to compare results for individuals with SCI. A study published by Larsson Lund et
al. (2005) reported that approximately 50% of individuals with SCI did not complete the
questions on work and education stating that it was not applicable to them.
Acceptability: The IPAQ appears to be easy to understand and takes approximately 20
minutes to complete.
Feasibility: The IPAQ questions are included in the published articles. It does not require any
special training to administer or score. The IPAQ was originally published in Dutch and has
been translated into English and Swedish.
Clinical Summary: The IPAQ is a new generic measure which assesses participation from the
perspective of the individual. It conceptually compatible with the WHO’s ICF model. The IPAQ
can be used to discriminate between individuals with different health conditions. More research
assessing the responsiveness of the IPAQ will determine if it can be used to evaluate
community interventions targeted at improving participation in life activities.
+* TR domains +* Convergent ++ +* +++ N/A
+++
TR items ++
IC +++
consistency; IO=interobserver; varied (re. floor/ceiling effects; mixed results).
Note: * no SCI specific data reported and sample included a mix of individuals receiving out-patient rehabilitation.
22-70
22.4 Participation
22.4.5 Participation Survey/Mobility (PARTS/M)

PARTS/M has been designed to assess the concept of participation as defined by the
International Classification of Functioning (Gray et al. 2006). It addresses 20 major life activities
that are grouped into 6 domains (activity/participation) of the ICF: self-care, mobility, domestic
life interpersonal interactions and relationships, major life areas, community, social and civic life.
Its measurement scales focus on 6 components of participation: Frequency of the involvement,
health-related limitations, importance, choice, satisfaction, use of assistive technology or
personal assistance that are operationalised by 7 questions.
Procedure: PARTS/M has been tested by a mail survey and in-home interview. The 20 life
activities (and the 7 questions) can generate 135 different scores that can be grouped into more
global scores: 24 scores for the 6 participation domains and each of the 4 participation
components (temporal, evaluative, health-related, and supportive); 6 scores if only 1 score is
generated for each participation domains. Finally an overall participation score can be
generated.
Advantages: PARTS/M addressed concepts that are fully compatible with the construct of
participation as defined by the ICF. It can provide a guide for changes in participation based on
one’s aspiration without comparing him/her with ‘normal’ (non-disabled) people (Gray et al.
2006).
Limitations: PARTS/M might be seen a lengthy instrument. It might take as many as 60-90
minutes to complete the instrument. So far the scoring system has not been fully described in
publications and more information is available from the developer (David Gray).
Interpretability: The information provided by PARTS/M is compatible with the construct of
person-perceived participation and fits into the participation construct of ICF. However, the
scoring system has to be described more in-depth before we can comment on its usefulness.
(Gray et al. 2006).
Acceptability / Feasibility: No complaint was received from respondents but the amount of
time needed to complete the instrument (WEB-based version 25-40 minutes; hard copy version
60-90 minutes) might be prohibitive in some settings. No special equipment or training seems to
be required to administer PARTS/M. The scoring procedure is available via the developer
(David Gray, see contact information below)
Clinical Summary: PARTS/M is a promising instrument to be used after rehabilitation
discharge but need more testing. It has the ability of providing information that can be used by
clinicians to propose interventions (on the person or his/her environment) based on the person’s
importance or satisfaction regarding a specific participation activity.
++ IC Part-D = +++ ++ Convergent +++ N/A N/A N/A
IC Part-I = ++
IC Part-C = +++
TR Part-D = +++
TR Part-I = +++
TR Part-C = +++
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; IC=internal consistency; Part-D=
participation domains; Part-I= Participation items; Part-C = Participation Component; TR=Test re-test;
Contact information: David B. Gray, Washington University School of Medicine, Campus Box 8505, 4444 Forest Park, St.
Louis, MO 63108 USA. E-mail: grayda@msnotes.wustl.edu
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22.4 Participation
22.4.6 Perceived Handicap Questionnaire (PHQ)

The Perceived Handicap Questionnaire (PHQ) was developed using Whiteneck’s proposed
model of quality of life based on an expanded version of the WHO’s ICIDH model of disability.
This model includes: impairment, disability and handicap as well as perceived outcomes
(perceived impairments, perceived disability, perceived handicap), which affect subjective well
being (i.e. contribute to quality of life). At the time this questionnaire was developed most of the
research assessed objective measures of handicap/participation (i.e. CHART which asked
about hours of paid employment, number of friends contacted monthly, etc.) but very little work
had been done to measure perceived handicap, which assesses subjective handicap that
considers value judgments of the individual. The PHQ contains 5 subscales (same as CHART):
physical independence; mobility; occupation; social integration; and economic self-sufficiency.
The individual rates their ability in each domain on a scale of 1 (low ability) to 5 (completely in
control). The PHQ was developed and tested using the SCI patient population (Whiteneck et al.
1994).
Procedure: The questionnaire is administered by interviewer but is also well-suited to being
self-administered. A score of 1 to 5 for each of the 5 domains can be calculated as well as an
aggregate score for the 5 domains (ranging from 5 to 25) to measure overall perception of
handicap.
Advantages: The PHQ measures a unique perspective of handicap that is not captured in the
CHART. Research indicates that information obtained in the PHQ account for more of an
individual’s rating of their life satisfaction compared to objective measures of handicap such as
the CHART (Hansen et al. 1998).
Limitations: Since the publication of this questionnaire the ICIDH has been replaced by the ICF
and the concept handicap has been replaced by the concept participation and so it may be
preferable to use a measure assessing subjective participation rather than subjective handicap.
There was evidence of floor/ceiling effects based on the range of scores reported in the article
(note: actual percentages of floor/ceiling were not reported). The psychometric evidence is
limited and more work is needed.
Interpretability: Results from the PHQ provide an assessment of an individual’s perception of
their handicap. No norms are available for comparison. The questionnaire does not appear to
be widely used and so it would be difficult to compare results. The PHQ would be a useful as a
“sister questionnaire” to the CHART and is suited for understanding how handicap changes over
time once an individual is living in the community and what factors are associated with a
person’s perceived handicap.
Acceptability: The questions in the PHQ appears to be appropriate and easily understood.
Feasibility: The PHQ is short (5 items total) and the items are listed in the article.
Clinical Summary: The PHQ is a potentially useful measure of subjective handicap that can be
used in conjunction with the CHART to assess community re-integration, but more research is
required on its psychometric properties. Due to the change from the ICIDH to the ICF model it
may be preferable to use a measure of subjective participation rather than assessing subjective
handicap.
N/A N/A ++ Construct +++* N/A N/A N/A
* For validity the PHQ was compared to subscales of the CHART, but difficulty in interpreting this result since it is
expected that they would assess different constructs.
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22.4 Participation
22.4.7 The Physical Activity Recall Assessment for People with Spinal Cord injury
(PARA-SCI)
The PARA-SCI has been designed to capture information on the type, frequency, duration and
intensity of physical activity carried out by people with SCI using a wheelchair as their primary
mode of mobility (Martin Ginis et al. 2005; Latimer et al. 2006).
Interview protocol: An interview format was developed to capture activities performed over the
last 3 days which are divided into 8 periods from morning routine to evening routine. The 2
routine periods are subdivided to capture activity related to daily living (transfer, bowel and
bladder management, dressing, etc.). The interviewer asks the respondent about general
activities performed during each period. The number of minutes spent on each specific activity
is recorded and the activity is coded into 2 dimensions: Leisure-time physical activity or lifestyle
activity (Martin Ginis et al. 2005).
Intensity Classification system: This system was developed from empirical data collected during
maximal exercise testing (VO2max and 1RM muscle workload for chest press and bicep curl).
From a list of adjectives, participants of the experiment identified words that described how they
felt during exercise. Based on their responses, definitions were created for mild, moderate and
heavy intensity exercise (Martin Ginis et al. 2005).
Procedure: Data are reported as an average number of minutes of activity per day (mild,
moderate, heavy, total) for the two dimensions (Leisure-time physical activity or lifestyle activity)
and a cumulative index.
Advantages:
- Provide a quantitative measure of physical activity that takes into account the intensity of
exercise.
- Specifically developed for SCI population and takes into account the activities of daily
living.
Limitations:
- The 3 days recall period (capture the activities that are actually performed) enhanced the
accuracy of the data but might lead to an underestimation of the overall physical activity
if leisure-time activities are not performed on a regular basis (3-4x /week).
- Construct validity has been only partially demonstrated and has to be proven by
comparing the measure with another measure of physical activity (Latimer et al. 2006).
Interpretability: A relatively new instrument but the design seems to be consistent with the
usual dimension of physical activity.
Acceptability: On average, the interview can be completed within 20-30 minutes.
Feasibility: No specific training is required to administer the PARA-SCI. Flowcharts are used to
guide the interviewer and provides prompts to help respondents recall the different types of
physical activities.
Clinical Summary: PARA-SCI is a promising instrument that provides information on the
intensity-based type of physical activities. It has to be used more extensively before a final
assessment is completed.
++ TR ++, +++ + Concurrent ++ N/A N/A N/A
Convergent +
Construct +
22-73
22.4 Participation
22.4.8 Reintegration to Normal Living (RNL) Index

The Reintegration to Normal Living (RNL) Index is a self-report questionnaire that assesses an
individual’s satisfaction with performance in life activities (May & Warren 2002). The RNL
assesses mobility, self-care, daily activity, recreational activity, and family roles. It was
developed based on interviews with clinicians, patients and other their significant others. It
contains 11 items and each one is scored using a 10 cm visual analogue scale anchored with
phrases (0=no reintegration and 10=complete reintegration). Wheelchairs or other
assistive/adaptive aids may be used when considering how to answer the questions. The CIHI
National Rehabilitation Reporting System (NRS) uses a 3 point ordinal scale (0=does not
describe my situation; 1=partially describes my situation; and 3=fully describes my situation).
Procedure: The questionnaire is completed by self-report or by interviewer. The total score =
sum (points all 11 items) and the adjusted score = (total score)/110 * 100. A minimum adjusted
score is 0 and a maximum adjusted score is 100. No information was obtained on how the CIHI
NRS scores the RNL.
Advantages: The RNL is a short measure of participation that has been used in various patient
populations. It is currently part of the CIHI NRS and is collected at the time of follow-up. Since
the RNL is widely used with various patient populations it is possible to compare results.
Limitations: Although the RNL is commonly used as part of the NRS for individuals with SCI,
there has been very little research conducted on the psychometric properties for this patient
population. In the literature the concepts of participation and quality of life are not always clearly
defined and the RNL has been classified as a proxy measure of quality of life which may cause
some confusion regarding the construct being measured (May & Warren 2002).
Interpretability: The RNL provides a measure of the individual’s perceived re-integration to life
activities. Data is available on the CIHI website for individuals with SCI. Results can also be
compared to other research studies.
Acceptability: The RNL is easy to understand and does not take long to complete (i.e. 11
items).
Feasibility: A copy of the RNL is available at no cost and can be found on the internet. It does
not require any special training to administer or score.
Clinical Summary: The RNL evaluates the overall function of individuals who have received
rehabilitation by assessing the degree to which they are able to return to a normal life. The RNL
is currently part of the NRS and is being administered at follow-up to various patient
populations, including SCI.
22-74
Participation References
Backman CL. Outcomes and outcome measures: measuring what matters is in the eye of the
beholder. Can J Occup Ther 2005;72:259-264.
Cardol M, Beelen A, van den Bos GA, de Jong BA, de Groot IJ, de Haan RJ. Responsiveness
of the Impact on Participation and Autonomy Questionnaire. Arch Phys Med Rehabil 2002;
83:1524-1529.
Cardol M, de Haan RJ, van den Bos GA, de Jong BA, de Groot IJ. The development of a
handicap assessment questionnaire: the Impact on Participation and Autonomy (IPA). Clin
Rehabil 1999;13:411-419.
Cardol M, de Haan RJ, de Jong BA, van den Bos GA, de Groot IJ. Psychometric properties of
the Impact on Participation and Autonomy Questionnaire. Arch Phys Med Rehabil 2001;
82:210-216.
Cardol M, de Jong BA, van den Bos GA, Beelem A, de Groot IJ, de Haan RJ. Beyond disability:
perceived participation in people with a chronic disabling condition. Clin Rehabil 2002;16:27-
35.
Cicerone KD. Participation as an outcome of traumatic brain injury rehabilitation. J Head
Trauma Rehabil 2004;19:494-501.
Cusick C, Brook C, Whiteneck G. The Use of Proxies in Community Integration Research. Arch
Dijkers MP, Whiteneck G, El Jaroudi R. Measures of social outcomes in disability research.
Arch Phys Med Rehabil 2000;81:S63-S80.
Donnelly,C., Eng,J.J., Hall,J., Alford,L., Giachino,R., Norton,K., Kerr,D.S. Client-centred
assessment and the identification of meaningful treatment goals for individuals with a spinal
cord injury. Spinal Cord 2004; 42:302-307.
Dumont C, Bertrand R, Fougeyrollas P, Gervais M. Rasch modeling and the measurement of
social participation. J Appl Meas 2003;4:309-325.
Fougeyrollas P, Noreau L, Bergeron H, Cloutier R, Dion SA, St-Michel G. Social consequences
of long term impairments and disabilities: conceptual approach and assessment of
handicap. Int J of Rehab Res 1998;21:127-141.
Gray DB, Hendershot GE. The ICIDH-2: developments for a new era of outcomes research.
Arch Phys Med Rehabil 2000;81:S10-S14.
Gray D, Hollingworth H, Stark S, Morgan K. Participation Survey/Mobility: Psychometric
Properties of a Measure of participation for People with Mobility Impairments and
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Hall K, Dijkers M, Whiteneck G, Brooks C, Krause J. The Craig Handicap Assessment and
reporting technique (CHART): Metric properties and scoring. Topics in Spinal Cord Injury
Rehabilitation 1998;4:16-30.
Hansen NS, Forchheimer M, Tate DG, Luera G. Relationships among community re-integration,
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distinct? J Rehabil Med 2003;35:145-149.
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People with Spinal Cord Injury: Validity. Med Sci Sports Exerc 2006;38:208-216.
Lund M, Nordlund A, Nygard L, Lexell J, Bernspang B. Perceptions of participants and
predictors of perceived problems with participation in persons with spinal cord injury. J
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Measure for People with Spinal Cord Injury. Med Sci Sports Exerc 2005;37:1099-1111.
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May LA, Warren S. Measuring quality of life of persons with spinal cord injury: external and
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participation: The Occurrence of Handicap Situations. Disabil Rehabil 2000;22:170-180.
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addressing the concept of handicap:CHART and LIFE-H. J Spinal Cord Med 1998;21:151.
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22.5 Quality of Life
Conceptualization and definition of QOL
Although the term “goodness of life” (Baker & Intagliata 1982) seems appropriate to express the
overall concept of quality of life (QOL), its apparent simplicity hides a multidimensional concept
that is among the most difficult one to define and to translate into a functioning and operating
reality. Nonetheless, 2 main conceptualizations of QOL are well-accepted: (1) the subjective
approach whose focal point is the person’s emotional or cognitive assessment of the
congruence between his/her life expectations and achievement, usually associated with life
satisfaction or well-being and (2) the objective approach, based on one’s characteristics that
can be objectively measured by an external appraiser or outsider (Dijkers 2003). The latter
includes the concept of Health-related Quality of Life (HRQOL) that focuses mostly on physical
and mental health, social and role achievements, and thus it is more oriented toward functional
performance than is subjective QOL (Wood-Dauphinee et al. 2002).
As the HRQOL tends to address dimensions that influence subjective QOL (health status,
functioning), Post et al. proposed a superordinate construct of QOL that includes both HRQOL
and well-being which was operationalized from the International Classification Functioning,
Disability and Health (ICF) (Post et al. 1999; WHO 2001; Post & Noreau 2005). This approach is
quite useful for the rehabilitation community as it permits to integrate most of the dimensions
that might be measured to cover the construct of QOL in the field of disability and rehabilitation.
Thus QoL tools are either investigator-determined enabling statistical comparisons between an
experimental and control group or they are more individualized allowing the participating subject
to weight the value (importance) of any individual field in the self-assessment of their own QoL.
Measurement issues
On an operational basis, Dijkers (2003) nicely summarized that QOL measures focus on three
dimensions: 1) the person’s achievements (performance) or 2) expectations, or 3) the reaction
to the congruence between his/her life expectations and achievements. The HRQOL measures
mainly (but not exclusively) focus on achievement as the subjective QOL measures address the
reaction (or satisfaction) regarding the achievements.
The current review focuses on a number of HRQOL and subjective measures that were
previously reported in the field of SCI for which psychometric testing has been published and
assessed as adequate or excellent. Most of the measures are not disability-specific, meaning
that they have not been specifically developed for the context of people with disability in general
or specifically for individuals with SCI. As such, psychometric properties are usually stronger
with general population or groups having conditions other than SCI.
Recommendations (HRQOL)
Three generic instruments addressing the concept of HRQOL are recommended despite some
limitations: The short version of the World Health Organization Quality of Life Assessment
(WHOQOL-BREF), the Sickness Impact Profile (SIP-68), and the MOS 36-Item Short-Form
Health Survey (SF-36) or its shorter form (SF-12). The WHOQOL (BREF) is a promising
instrument with a strong conceptualization but its psychometric testing in SCI is limited. Despite
their wide use, SIP-68 and SF-36 should be used with caution as limitations were previously
reported (Andresen & Meyers 2000; Post & Noreau 2005). For example, the SF-36 physical
functioning scale has been found inappropriate in individuals with mobility impairments because
several items refer to climbing or walking. Post et al. (1996) found the SIP68 valid for use in
persons with SCI but had to develop a recoding procedure to deal with several questions about
22-77
walking difficulties that are not applicable to persons who cannot walk. Moreover, to answer the
questions ‘in the context of health’ can be problematic as some persons with SCI will distinguish
health from disability. People perceive themselves as healthy, defining SCI and its
consequences as a disability, and not as a disease.
A utility measure (Quality of Well-being) has been reviewed but little work has been done to
establish its psychometric properties in individuals with SCI. Moreover, the usefulness of the
concept (utility) in the field of rehabilitation might be limited in regards of clinical purposes.
Finally, the Qualiveen a SCI specific measure of urinary related QOL has been reviewed.
Despite excellent psychometric properties its scope is limited.
Recommendations (subjective QOL)
Four different instruments focusing on life satisfaction have been included in the current review:
The Satisfaction with Life Scale (SWLS), the Life Satisfaction Questionnaire (LISAT-11), The
Quality of Life Index (QLI) and the Quality of Life for Adults with Physical Disabilities (QOLP-PD)
With some pros and cons, they addresses the life satisfaction as a whole, or with a few
questions focusing on general life dimensions or with a more-in depth assessment of
importance and satisfaction regarding life domains. SWLS is quite brief, mostly useful in
research setting but does not bring about information that can be assessed as useful for clinical
interventions. At the opposite, QLI and QOLP-PD can inform a lot on some areas of life
dissatisfaction hut they might be seen as lengthy in some setting. QOLP-PD is a promising
instrument with a good conceptualization but it is at an early stage of development with a few
psychometric characteristics already tested. The LISAT-11 might be seen a good compromise
for research and clinical purposes as it contains items (life dimensions) that are relevant to SCI.
Some data has already been published in the field (Post et al. 1998; Schönherr et al. 2005;
Kennedy et al. 2006) and it has previously been recommended by an expert committee on QOL
(Wood-Dauphinee et al. 2002). Its main limitation remains the lack of psychometric information
relative to the field of SCI.
Conclusion
In the process of selecting tools to assess QOL, one should consider the purposefulness,
usefulness and psychometric properties of measures. For example, generic and global
outcomes measures might be useful for comparison across populations but might not bring
about information for needs related to community interventions. At the opposite, more specific or
detailed measures might be seen as too lengthy for some research or survey settings or as
having complex scoring procedures. In many situations, the choice might be driven by a ‘trade-
off’ between a measure that fully meets one’s needs and another one that will limit the
respondent’s burden. But in all cases, a careful evaluation of the psychometric characteristics is
mandatory before making the final choice.
22.5.1 Life Satisfaction Questionnaire (LISAT -9 -11) .........................................................22-79

22.5.2 Quality of Life Index (QLI, Ferrans & Powers) ..........................................................22-80
22.5.3 Quality of Life Profile for Adults with Physical Disabilities (QOLP-PD) .....................22-81
22.5.4 Quality of Well Being.................................................................................................22-82
22.5.5 Qualiveen..................................................................................................................22-83
22.5.6 Satisfaction with Life Scale (SWLS, Deiner Scale) ...................................................22-84
22.5.7 The Short Form 12 (SF-12) and Short Form 36 (SF-36) ..........................................22-85
22.5.8 The Sickness Impact Profile 68 (SIP 68) ..................................................................22-86
22.5.9 WHOQOL (BREF).....................................................................................................22-87
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22.5.1 Life Satisfaction Questionnaire (LISAT -9 -11)

The Life Satisfaction Questionnaire (LISAT) was originally developed as a checklist rather than
a measure of life satisfaction (Fugl-Meyer et al. 1991). The LISAT-9 is comprised of 1 general
question about satisfaction with life as a whole and 8 other questions targeting important life
domains: vocational, financial and leisure situations, contacts with friends, sexual life, self-care
management, family life, and partner relationships. More recently, physical and psychological
health were added (LISAT-11) (Melin et al. 2003).
Procedure: Each item (domain) is scored on a 6-point scale from 1, very dissatisfied, to 6, very
satisfied. Item scores can be summed and an average score is produced. It seems more
appropriate to use mean item scores rather than a total score in order to keep the information
on each domain available for clinical interventions.
Advantages: The LISAT is available in many languages, which makes it suitable for
international collaborations. Although it is a relatively short questionnaire, it assesses life
satisfaction in several domains, which can provide the information necessary for clinical
interventions. Its conciseness and simple coding system are also advantages for research and
surveys. It is generic and can be applied for comparisons between groups, as it holds no bias
due to specific disability (Post et al. 1998). It has already been used in the field of SCI (Post et
al. 1998, 1999; Kennedy et al. 2006).
Limitations: Depending on when the test is administered with respect to discharge, the
questions targeting vocational situation may or may not have missing data. Potential ceiling
effects can be expected, as mean scores of ~5 were reported for some life dimensions (e.g.
Post et al. 1998). Although the LISAT is beyond the first stages of development, its
psychometric testing in the field of SCI remains limited.
Interpretability: Scores can be seen as meaningful as they represent satisfaction in different
domains of life. Norms have not been developed per se, but a certain level of comparability
exists among the studies using the LISAT and amongst the various populations reported
(including SCI).
Acceptability: The LISAT can be completed in approximately 5 minutes; however, a few extra
minutes may be required to clarify the meaning of terms such as vocational and leisure
situation. It has been validated in 8 languages (Conway et al. 2000).
Feasibility: No equipment or training is necessary to use the LISAT. A copy of the tool can be
obtain in the Fugl-Meyer et al. (1991) article.
Clinical Summary: The LISAT provides meaningful information for clinical and research
purposes in the field of SCI. To date, it has been used in several studies involving a SCI
population. Its psychometric properties have been partially tested in different groups; however,
there is limited information for SCI populations (e.g. no data on test-retest reliability), which
remains its most important limitation.
++ IC* = ++ +++ Criterion* = ++ N/A N/A Ceiling effect* = +
IC**= ++ Criterion**= ++ Potential ceiling
Discriminant*= + effect in SCI
+ TR*= ++ Discriminant**= +
consistency
* (Other populations than SCI)
** (SCI population)
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22.5.2 Quality of Life Index (QLI, Ferrans & Powers)

The QLI was designed to measure subjective quality of life in terms of satisfaction within
different life domains. It originates from Flanagan’s perception of life satisfaction, which holds
that two aspects, importance and satisfaction, must be addressed when measuring QOL
(Ferrans & Powers 1998). Importance ratings are used to weight the satisfaction responses,
such that scores reflect the respondents’ satisfaction with the aspects of life they value. Items
that are rated as more important have a greater impact on scores than those of lesser
importance.
The original QLI (Ferrans & Powers 1985) is comprised of 32 items within 4 domains: health
and functioning, psychological/spiritual, social and economic, and family. A SCI version has
been developed with 37 items (May & Warren 2001).
Procedure: The scales (satisfaction and importance) are on a 6-point Likert scale, ranging from
1, very dissatisfied (very unimportant), to 6, very satisfied (very important). Five scores are
generated (i.e. total and 4 domains) on a 0 - 30 scale and scoring instructions are available on
the instrument website (Ferrans & Powers 1998).
Advantages: The QLI is a suitable tool when one aims at having information on various aspects
of life satisfaction. It has adequate psychometric properties for different populations and scores
can be compared across populations (Ferrans & Powers 1985; 1992).
Limitations: The same total score can reflect two very different QOL profiles. The scoring
information seems to be relatively complex and is greatly facilitated by computer assistance.
The domains of QOL that are addressed were pre-selected and a uniquely important life
dimension for a person may not be included. Psychometric properties for SCI populations
remain to be established, particularly with respect to test-retest reliability.
Interpretability: Scores represent the satisfaction with different aspects of life. Norms are
available for the general population, as well as different groups with disabilities (Ferrans &
Powers 1992).
Acceptability/ Feasibility: The QLI can be administered in an interview or by client self-report.
It takes about 10 minutes to complete and no special training is required. The QLI is a copyright
instrument that can be used (no charge) in non-profit research or clinical practice and copies
can be downloaded from the QLI website http://www.uic.edu/orgs/qli/.
Clinical Summary: The QLI can provide good information to guide interventions on an
individual basis. For that purpose, it may be advisable to use the two scales independently in
order to establish the precise importance and satisfaction of the specific life domains.
+ IC* = +++ ++ Construct*= +++ N/A N/A N/A
TR* = +++ Construct**=+++
TR**= N/A
Note: +++ = Excellent; ++ = Adequate; + = Poor; N/A=Insufficient information; TR=Test re-test ; IC=internal
consistency
** (SCI population)
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22.5.3 Quality of Life Profile for Adults with Physical Disabilities (QOLP-PD)
The QOLP-PD has been designed to offer a new approach to measuring QOL that is grounded
in and congruent with the perspective and experience of people with disabilities. It has been
based on the Center for Health Promotion (CHP) Quality of Life model that views QOL as
arising out of the ongoing relationship between the person and his/her environment (Renwick &
Brown 1996). In this sense, CHP addresses concepts similar to various disability models (e.g.
ICF, DCP). The QOLP-PD is comprised of 102 items classified into the 3 CHP domains: being,
belonging, and becoming.
Procedure: The items in the 3 domains are grouped into 9 sub-scores. All items are rated on a
5-point scale for satisfaction and importance, ranging from 1 (not at all satisfied/important) to 5
(extremely satisfied/important). Overall scores are made more comprehensible by subtracting
3, leading to a range of scores from negative 10 (not at all satisfied/extremely important issues)
to positive 10 (extremely satisfied/extremely important issues).
Advantages: The QOLP-PD comes from a strong conceptual model (CHP-QOL; see Renwick
& Brown 1996). It is applicable across a wide range of disabilities and it can provide information
for clinical interventions (Renwick et al. 2003).
Limitations: The major limitation is the fact that this instrument is in the early stages of
development with few documented psychometric characteristics. Other limitations may be
similar to those of the Quality of Life Index (QLI), as the measurement approaches are similar.
Interpretability: Being in the early stages of development, the meaningfulness of scores, the
definitions and classifications of the results and norm-based scores are undetermined.
Acceptability/ Feasibility: Owing to the 102 items that must be assessed on 2 scales, the
QOLP-PD is a lengthy instrument compared to some others already available. For a copy of the
tool, contact the author, Rebecca Renwick, at r.renwick@utoronto.ca. It is currently available in
English.
Clinical Summary: The QOLP-PD is a promising instrument that can provide good information
to support interventions on an individual basis. Further testing is necessary prior to appraising
its usefulness.
+ IC +++ + Construct= + , ++ N/A N/A N/A
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22.5.4 Quality of Well Being

Quality of Well Being (QWB) is a preference measure that was designed to measure health
related quality of life (Andresen et al. 1999). It was developed based on theory from the
General Health Policy Model which incorporates the concepts of mortality, morbidity, the
preference of an individual for a certain health state and the duration in that particular health
state. The QWB self-administered (QWB-SA) version combines three scales (mobility; physical
activity and social activity) with a measure of symptoms/problems. It contains 71 questions.
The self-administered version contains slightly different content and the recall period was
decreased from six days to three days to reduce recall bias.
Procedure: The original version of the QWB was designed to be interviewer administered and
there is now a self-administered version. The QWB-SA score is calculated by subtracting from
1.0 the combination of the maximum weighted symptom/problem item and the weights
associated with mobility, social activity and physical function. An overall utility score is
calculated between 0.0 and 1.0, where 0.0 represents death and 1.0 represent perfect health.
Advantages: The QWB-SA can produce utility values which can be used in economic analyses.
The utility is a generic measure and so it is easy to compare utilities of different health
conditions. The score combines multiple types of information into one summary score which
can be useful in statistical analyses. The QWB-SA correlates well with other health related tools.
Limitations: Since the QWB-SA combines all of the information into one score, the amount of
specific information is lost (i.e. it is not possible to obtain just information on mobility). It does
not also capture the unique needs of individuals with SCI since it was designed as a generic
measure. Research has also indicated that not all preference-based measures produce
equivalent utility values. There has been a considerable amount of research assessing the
psychometric properties of the QWB-SA in the general population and in many health states,
but very little work has been done to establish reliability, validity, and responsiveness in
individuals with SCI (Andresen et al. 1999).
Interpretability: The QWB-SA provides an overall utility value which represents the preference
an individual places on their specific health state, scored between 0.0 and 1.0. Data exists on
numerous health conditions for example community dwelling older adults have a utility value
between 0.70-0.75 and individuals with SCI were reported to be 0.55 (Andresen et al. 1999).
Acceptability: The QWB-SA is reported to be easier to complete compared to the original QWB
measure (Andresen et al. 1999). The QWB-SA is available in various languages. It is not
recommended to complete the QWB-SA by proxy.
Feasibility: Information on the QWB and the QWB-SA can be obtained from the UCSD Health
Outcomes Assessment Program, http://www.medicine.ucsd.edu/fpm/hoap/ . The QWB-SA is
reported to take approximately 10 minutes to complete. A copy of the User Manual can be
obtained on-line and a copyright agreement must be signed before a copy of the tool can be
obtained. Depending on the purpose for using the QWB-SA, a fee may be charged. A web-
based version of the QWB-SA was scheduled to be ready in 2004.
Clinical Summary: The QWB-SA is a preference-based measure that has been used in
individuals with SCI. It can provide information on health related quality of life and produces a
utility value which can be used to calculate quality adjusted life years required for economic
analyses. To date, very little research has been conducted on the use of preference based
measures in individuals with SCI and their validity still needs to be determined.
N/A N/A ++ Construct + N/A N/A N/A
22-82
22.5.5 Qualiveen
Qualiveen was developed as a disease specific quality of life measure for individuals with SCI
who have urinary disorders that could be used in international multi-centre trials (Costa et al.
2001). The tools were developed by a multi-disciplinary group of experts and the questions were
derived based on the literature and individuals with SCI. There are 30 items which are part of
four scales: limitations (9 items); constraints (8 items); fears (8 items); and feelings (5 items).
The Qualiveen was originally developed in French and translated in English.
Procedure: The Qualiveen can be administered by interviewer or be self-administered. The
questionnaire is based on a 5 point Likert scale. Each of the four scales are scored from 0 to
100, where lower scores indicated a better quality of life (i.e. no limitations, fears, constraints, or
negative feelings) and higher scores indicate poorer quality of life.
Advantages: The Qualiveen provides detailed information regarding the impact on urinary
disorders which was developed specifically for individuals with SCI (Costa et al. 2001). There
were no ceiling or floor effects in the initial study.
Limitations: The Qualiveen provides a disease specific perspective on measuring quality of life
which has traditionally measured more globally (Costa et al. 2001). A limitation of disease
specific measures is that it is not possible to compare results to other patient populations.
Quality of life is a very broad and complex concept and it may be difficult to attribute the urinary
disorders to an individual’s overall quality of life. No information was provided on how the
English version was translated from the French version. More research is needed to compare it
to other quality of life measures and to assess if it is responsive before being used in clinical
trials.
Interpretability: The four scales provide information on quality of life for individuals with urinary
disorders. Only data is provided from one study, so no normative data exists.
Acceptability: The Qualiveen was developed with input from individuals with SCI. Individuals
reported that it was easy to understand and was comprehensive (Costa et al. 2001).
Feasibility: The Qualiveen is easy to administer but no details are provided on the scoring.
Qualiveen is in the process of getting a pending registration trade mark of Coloplast and to
obtain a copy of the questionnaire the primary author Dr. Pierre Costa should be contacted at
Pierre.costa@chu-nimes.fr. Since it is still in the pilot phase it would be important to check to
see if there have been any modifications to the questions or the scoring.
Clinical Summary: The Qualiveen is a quality of life tool designed to assess issues pertaining
to urinary disorders specifically for individuals with SCI. It would be relevant to administer it to
individuals living in the community to understand the impact of urinary issues but it is likely not
measuring the same concept as in other quality of life measures which assess life satisfaction
and well-being.
++ TR +++ ++ Construct ++ N/A N/A ++
++ IC +++
consistency
22-83
22.5.6 Satisfaction with Life Scale (SWLS, Deiner Scale)

The SWLS was designed to address the concept of life satisfaction as a whole and thus, to
reflect a global perspective of the individual’s values rather than to assess satisfaction with sub-
dimensions of life (Diener et al. 1985). Conceptually, SWLS measures subjective QOL and in
particular, the reaction to the ‘discrepancy or balance’ between one’s life achievements and
expectations.
SWLS was developed using a classical test construction approach, in which an initial item pool
was subsequently reduced to a smaller collection of items. The current version consists of 5
statements, scored on a 7-point Likert scale, ranging from strongly disagree (1) to strongly
agree (7).
Procedure: A global score (5 – 35) is computed by summing the scores of each question. No
reports have been presented wherein the scores of a single question were used.
Advantages: SWLS is a suitable tool when one aims to evaluate subjective QOL specifically. It
is generic, in that it holds no bias due to particular disability (e.g. SCI). It has adequate
psychometric properties across various populations and scores can be compared between
these populations (see Pavot & Diener 1993 for review).
Limitations: SWLS lacks specificity regarding life domains and it does not provide any
information on the source of potential dissatisfaction. Furthermore, it may not be useful for
guiding clinical intervention and reliability with SCI groups is relatively weak compared to other
populations (Dijkers 1999).
Interpretability: Scores represent a global perspective of life satisfaction. Norms/profiles are
available for a SCI population, other disability populations and non-disabled populations. It is
available in multiple foreign languages.
Acceptability: The SWLS can be completed in less than 5 minutes. The items on the
questionnaire present no potential discomforts.
Feasibility: No equipment or specific training is required to administer the SWLS. An online pdf
version of the SWLS can be obtained from
http://www.ppc.sas.upenn.edu/lifesatisfactionscale.pdf.
Clinical Summary: Overall, the SWLS provides global information on life satisfaction. It is
useful for drawing general profiles in various populations and thus, it is an appropriate tool for
research purposes or epidemiological databases (e.g. the US National SCI Database). Its use in
clinical settings may be less useful, in that it does not establish appropriate interventions;
however, it does document the overall appreciation of one’s life.
++ IC = +++ +++ Criterion*= +++ N/A N/A N/A
TR*= +++ Construct**= ++
TR**= ++ Concurrent** = +++
consistency
** (SCI population)
22-84
22.5.7 The Short Form 12 (SF-12) and Short Form 36 (SF-36)

The SF-36 (Ware & Sherbourne 1992) is a generic health status measure that has been
translated into various languages and is used world-wide. It was designed to be applied to all
health conditions and to assess general health concepts, such as functional status and well-
being. The SF-36 contains 36 items covering eight domains: physical functioning, role
limitations due to physical health problems, bodily pain, general health, vitality, social
functioning, role limitations due to emotional problems and mental health. The SF-12 was
introduced as a shorter alternative to the SF-36 for use in population studies (i.e. large sample
sizes) and includes one or two items from each of the eight domains.
Procedure: The SF-36 and SF-12 can be administered by the interviewer or the client. The
scoring is norm-based, with a general population mean score of 50 and a standard deviation of
10. Higher scores indicate higher levels of health. The SF-12 is scored using two summary
scores, a physical and a mental component score, which are norm based (the SF-36 can also
be scored in this manner).
Advantages: The SF-36 and SF-12 are the most widely used measures of health status and
allows the evaluation of various patient populations (McHorney et al. 1994). Economic methods
have been applied to the SF-36 and the data can be used to complete a new preference based
measure, the SF-6D, which has the advantage of being able to obtain utility values needed to
report quality adjusted life years (Brazier et al. 2002).
Limitations: Since the SF-36 and SF-12 were designed to be generic, some of the walking/stair
climbing questions are not applicable to individuals with SCI and thus, it has been suggested
that the wording of these questions be changed from “walking/climbing” to “going”. Another
limitation is the differing interpretations of health as distinct or equivalent to disability.
Interpretability: There is published data and norms available for most health conditions as well
as for the general population (in Canada and the United States). Further research is needed for
the establishment of psychometric properties of the SF-36 and SF-12 for SCI populations.
Acceptability: The SF-36 requires 5-10 mins to complete and the SF-12 requires 2-4 mins.
Feasibility: The SF-36 and SF-12 is easy to administer and the manuals are very informative.
Permission to use the tools must be obtained from Quality Metric at www.qualitymetric.com and
this incurs a cost. The SF-36 and SF-12 have been translated into various languages. Alternate
versions are available (e.g. 1- and 4-week recalls).
Clinical Summary: The SF-36 and SF-12 are the most widely used health surveys. These
tools have been used extensively to discriminate, evaluate and predict outcomes in various
health conditions; however, more work is required to study the validity of the questions and the
proposed modifications to the questions for a SCI patient population.
++ IC +++ +++ Construct ++** N/A N/A +*
(SF-36) (SF-36) (SF-36)
++ Construct
(SF-12) ++
* Note: ceiling / floor effects were noted in some scales in SF-36 V1 when reporting the scores using 0-100, however,
the scales on the role physical and role emotional items were changed from dichotomous to a Likert scale in V2
which should reduce the floor and ceiling effects. No floor and ceiling effects are evident using the MCS and PCS.
** Note: since there is no gold standard to compare the SF-36 and the authors tested convergent / divergent validity
using hypotheses, this was classified as construct validity as per the Stroke recommendations. The hypotheses were
also tested using ANOVA (F-test). Also results from Andresen 1999, comparing SF-36 to QWB, BFSS and IADL. I
used my judgment to derive an overall rating.
22-85
22.5.8 The Sickness Impact Profile 68 (SIP 68)

The Sickness Impact Profile is a generic health status measure. The original version contains
136 items (Bergner et al. 1981). The length of the measure is considered a barrier to using it
and thus, a modified version containing 68 items (SIP 68) was developed (de Bruin et al. 1994).
This measures physical, mental and social aspects of health-related functioning in 6 subscales:
somatic autonomy, mobility control, mobility range, social behavior, emotional stability, and
psychological autonomy/communication. The SIP 68 contains statements regarding behavior
“sickness impact” and the individual is asked to respond by checking items that describe their
health status.
Procedure: The SIP 68 can be administered by the interviewer or the client (i.e. self-report). All
items are scored dichotomously (no=0, yes=1). The items reported as “yes” are used to
calculate the scores and higher scores indicate more health-related behavioral problems (i.e.
worse health state). The SIP-68 can be reported as an overall total score, three dimension
scores (physical, psychological and social) or six sub-scale scores. The questions regarding
walking are not relevant to wheelchair-dependent individuals and a scoring modification is
proposed in such cases – for a “yes” response to the item “I cannot walk at all”, all 7 items
related to walking are scored positively (Post et al. 1996).
Advantages: The SIP 68 is a commonly used health status measure and it is possible to
compare results with various patient populations, including those with SCI (Post et al. 2001).
Limitations: Floor effects (i.e. reflecting poor health) have been reported for the mobility control
scale and ceiling effects (i.e. no reported problems) for the emotional stability and psychological
autonomy/communication scales. The evidence on the psychometric properties of the SIP 68
for a SCI population is limited and more research is needed to assess reliability and
responsiveness.
Interpretability: The scores provide an assessment of health behavior problems. There is
published data and norms available for a SCI population, as well as for individuals with other
disabilities (Post et al. 2001).
Acceptability: The SIP 68 requires approximately 15-20 minutes to complete.
Feasibility: The SIP 68 is easy to administer. It is available in English and Dutch, but the
administration guidelines are published in Dutch. The SIP 136 version can be obtained from the
Medical Outcomes Trust at: http://www.outcomes-trust.org/instruments.htm and the SIP 68 is
available in the literature (de Bruin 1994).
Clinical Summary: The SIP 68 has been used to assess health-related quality of life of
individuals living in the community. Modifications made to the scoring of the walking/mobility-
related items in the SIP 68 make it a suitable tool for this patient population.
+++ IC +++ +++ Construct ++ N/A N/A ++
++ Predictive +*
* Note: Predictive validity was assessed by determining that social functioning and psychological functioning from the
SIP 68 were significant predictors of life satisfaction.
22-86
22.5.9 WHOQOL (BREF)

The short version of the World Health Organization Quality of Life Assessment (WHOQOL-
BREF) has been developed using data from the field trial version of the WHOQOL-100
(WHOQOL Group 1998). It can be used in situations in which time is restricted or the burden
placed upon the respondent must be minimized (WHOQOL Group 1998). This is an instrument
that conceptually fits with the WHO definition of QOL and substantial effort has been put forth to
properly operationalize the sub-concepts (various aspects of life) included in the instrument
(WHOQOL Group 1998). WHOQOL-BREF is a self-report questionnaire that is comprised of 24
items grouped into 4 domains of QOL (physical health, psychological health, social
relationships, and environment) and 2 items which measure overall QOL and general health.
Procedure: The instrument uses a 5-point Likert scale (e.g. 1, Not at all – 5, Completely). The
respondents express how much they have experienced the items in the preceding 2 weeks. All
domain scores are reported between 4 and 20 (mean scores for each multiplied by 4).
Advantages: WHOQOL-BREF is a suitable tool when the goal is to acquire information on
various aspects of life satisfaction; however, it also includes 2 questions targeting overall QOL
and general health. Its conceptualization is strong and some psychometric properties were
tested with different populations (Skevington et al. 2004). Furthermore, it can be used to
compare results across populations (cross-cultural validity) (Skevington et al. 2004).
Limitations: Lack of information on concurrent validity, test-retest reliability, and
responsiveness.
Interpretability: Scores represent one’s personal experience and satisfaction regarding various
aspects of life. Norms are available for different groups of people.
Acceptability: The WHOQOL-BREF can be completed within a few minutes.
Feasibility: No equipment or specific training is required to administer it. Copies can be
downloaded from the WHO website.
Clinical Summary: WHOQOL-BREF is among the rare instruments that can provide data for
research and clinical purposes. Although it is a relatively brief instrument, its structure allows
one to acquire specific information covering many aspects of life. The adequate cross-cultural
validity makes it suitable for use in multinational collaborative research (Skevington et al. 2004).
++ IC*= +++ +++ Discriminant*= ++ N/A N/A Only 2 items
IC**= +++ Discriminant**= ++ reported a slight
N/A except for SR= Construct* **= +++ floor effect with
++ ++ Concurrent **= +++ SCI
TR*= N/A
TR**= N/A
consistency, SR= Social Relationships.
** (SCI population)
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Quality of Life References
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Spinal Cord Injury Rehabilitation Evidence

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Spinal Cord Injury Rehabilitation Evidence

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Janice Eng, PhD, Robert Teasell, MD, William Miller, PhD, Dalton Wolfe, PhD,

Andrea Townson, MD, Jo-Anne Aubut, BA, Caroline Abramson, MA,

Janice J. Eng, PhD, BSc (PT/OT), Robert Teasell, MD, FRCPC,

Executive Summary ................................................................................................iii viii

Chapter 1 Rehabilitation: From Bedside to Community Following

Chapter 2 Methods of the Systematic Reviews ................................................ 2-1 2-11

Chapter 3 Rehabilitation Practice and Associated Outcomes Following

Chapter 10 Depression Following Spinal Cord Injury .......................................... 10-1 10-19

Chapter 14 Pain Following Spinal Cord Injury .................................................... 14-1 14-32

Chapter 18 Heterotopic Ossification Following Spinal Cord ................................ 18-1 18-8

Chapter 21 Spasticity Following Spinal Cord Injury ............................................. 21-1 21-56

Chapter 22 Outcome Measures .......................................................................... 22- 1 22-89

The SCIRE Advisory Committee members:

1. SCIRE Project overview

Outcome measure assessment

3. Findings from the Systematic Review of SCI Rehabilitation

Upper Limb Rehabilitation

Lower Limb Rehabilitation

Cardiovascular Health and Exercise

4. Limitations in SCI Rehabilitation Literature

Pharmacological interventions were supported by the largest proportion of randomized

Janice J Eng, PhD, BSc (PT/OT), is Professor, School of Rehabilitation Sciences,

Robert Teasell, MD, FRCPC is Professor/Chair/Chief of the Department of Physical

William C Miller, PhD, OT, is Associate Professor, School of Rehabilitation Sciences,

Andrea F Townson, MD, FRCPC is Clinical Assistant Professor in the Division of

Jo-Anne Aubut, BA is a research assistant in the Department of Physical Medicine &

Sandra Connolly, BHScOT(C), OTReg. (Ont.) is an occupational therapist in the Spinal

Maureen Ashe, PhD, PT Chris Fraser, HBSc, RD

Najib Ayas, MD, MPH, FRCPC Tal Jarus, PhD, OT

Jeff Blackmer, MD, FRCPC Lyn Jongbloed, PhD, OT(C)

Sally Breen, RN, BSN, CRRN David Keast, MD, FRCPC

Geri Claxton, RN Andrei Krassioukov, MD, PhD

B. Cathy Craven, MD FRCPC Tania Lam, PhD, PT

Armin Curt, MD, FRCPC Kate McBride, RN

Stacy Elliot, MD William B Mortensen, BScOT, MSc

Susan J Forwell, PhD, OT(C) Stephanie Muir-Derbyshire, MSc, SLP(C),

Luc Noreau, PhD Jim Slivinski, MA

Steven Orenczuk, PsyD Shannon Sproule, PT

Emily Procter, BSc John Steeves, PhD

W Darlene Reid, PhD, PT Darren Warburton, PhD

Candice Rideout, PhD (Candidate) Maura Whittaker, PT

Bonita Sawatzky, PhD Shannon Wilkinson, BScOT

Keith Sequeira, MD, FRCPC

Rehabilitation: From Bedside To Community

1.1 Background ......................................................................................................................1-1

1.2 Epidmiology .....................................................................................................................1-2

1.4 Rehabilitation ...................................................................................................................1-6

1.5 Community Re-integration..............................................................................................1-7

Thoracic T1-11 Intercostals

1.2.1 Traumatic SCI

1.2.2 Non-traumatic SCI

1.3.2 Measures of Recovery

Functional recovery is often measured by the Functional Independence Measure (FIM), an 18

Methods of Systematic Reviews

2.1 Introduction ......................................................................................................................2-1

2.2 Article Assessment..........................................................................................................2-2

2.3 Determining Levels of Evidence and Formulating Conclusions .................................2-3

Appendix 1. Specific Search Terms .....................................................................................2-5

Appendix 2. The PEDro Scale...............................................................................................2-8

2.2.1 Literature Search Strategy

A systematic review was undertaken using multiple databases (MEDLINE/PubMed, CINAHL®,

2.2.2 Quality Assessment Tool and Data Extraction

2.3 Determining Levels of Evidence and Formulating Conclusions

Table 2.1 Five levels of evidence