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[ research report ]

JOSHUA A. CLELAND, PT, PhD1 • PAUL MINTKEN, DPT2,3 • AMY MCDEVITT, DPT2 • MELANIE BIENIEK, DPT4
KRISTIN CARPENTER, DPT5 • KATHERINE KULP, DPT6 • JULIE M. WHITMAN, PT, DSc7

Manual Physical Therapy and Exercise


Versus Supervised Home Exercise
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in the Management of Patients With


Inversion Ankle Sprain: A Multicenter
Randomized Clinical Trial
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

TTSTUDY DESIGN: Randomized clinical trial. TTRESULTS: Seventy-four patients (mean 


TTOBJECTIVE: To compare the effectiveness of SD age, 35.1  11.0 years; 48.6% female) were
manual therapy and exercise (MTEX) to a home randomized into the MTEX group (n = 37) or the
exercise program (HEP) in the management of HEP group (n = 37). The overall group-by-time in-
individuals with an inversion ankle sprain. teraction for the mixed-model analysis of variance

I
TTBACKGROUND: An in-clinic exercise program was statistically significant for the FAAM activities
nversion ankle sprains are
Journal of Orthopaedic & Sports Physical Therapy®

has been found to yield similar outcomes as an of daily living subscale (P<.001), FAAM sports sub-
HEP for individuals with an inversion ankle sprain. scale (P<.001), Lower Extremity Functional Scale common among physically
However, no studies have compared an MTEX ap- (P<.001), and pain (P.001). Improvements in all active people, with an annual
proach to an HEP. functional outcome measures and pain were sig- incidence of 7 ankle sprain in­
TTMETHODS: Patients with an inversion ankle nificantly greater at both the 4-week and 6-month
sprain completed the Foot and Ankle Ability follow-up periods in favor of the MTEX group.
juries per 1000 people.1,10,23,42,49,55,63
TTCONCLUSION: The results suggest that an
Measure (FAAM) activities of daily living subscale, These injuries often occur as a result of
the FAAM sports subscale, the Lower Extremity
MTEX approach is superior to an HEP in the landing on a plantar flexed and inverted
Functional Scale, and the numeric pain rating
scale. Patients were randomly assigned to either treatment of inversion ankle sprains. Registered at foot.33 The foot twists medially in rela-
an MTEX or an HEP treatment group. Outcomes clinicaltrials.gov (NCT00797368). tion to the externally rotated tibia, often
were collected at baseline, 4 weeks, and 6 months. TTLEVEL OF EVIDENCE: Therapy, level 1b–. causing injury to the lateral ligaments of
The primary aim (effects of treatment on pain the ankle.1 This injury can occur during
J Orthop Sports Phys Ther 2013;43(7):443-455.
and disability) was examined with a mixed-model
Epub 29 April 2013. doi:10.2519/jospt.2013.4792 sports, running on uneven surfaces, and
analysis of variance. The hypothesis of interest was
the 2-way interaction (group by time). TTKEY WORDS: manipulation, mobilization landing on an unbalanced foot after jump-
ing.33 Most patients who have sustained

1
Department of Physical Therapy, Franklin Pierce University, Concord, NH; Rehabilitation Services, Concord Hospital, Concord, NH; Manual Physical Therapy Fellowship
Program, Regis University, Denver, CO. 2Physical Therapy Program, School of Medicine, University of Colorado-Denver, Aurora, CO. 3Wardenburg Health Center, University of
Colorado-Boulder, Boulder, CO. 4Rehabilitation Services, Concord Hospital, Epsom, NH. 5Waldron’s Peak Physical Therapy, Boulder, CO. 6Children’s Hospital Colorado, Aurora,
CO; Functional Physical Therapy, Denver, CO. 7Orthopedic Manual Physical Therapy Program and Musculoskeletal Management Program, Evidence in Motion, Louisville, KY. This
study was approved by the following Institutional Review Boards: Concord Hospital, Concord, NH; the Colorado Multiple Institutional Review Board, Aurora, CO; and the University
of Colorado-Boulder, Boulder, CO. The American Academy of Orthopaedic Manual Physical Therapists Orthopaedic Physical Therapy Products Grant provided funding for this
project. This organization played no role in the design, conduct, or reporting of the study or in the decision to submit the manuscript for publication. The authors certify that they
have no affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in the article. Address
correspondence to Dr Joshua A. Cleland, Department of Physical Therapy, Franklin Pierce University, 5 Chenell Drive, Concord, NH 03301. E-mail: joshcleland@comcast.net t
Copyright ©2013 Journal of Orthopaedic & Sports Physical Therapy ®

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[ research report ]
an inversion ankle sprain respond well ing long-term outcomes. solely of exercise. Hence, data are insuf-
to conservative management; however, In a recent study,62 a clinical prediction ficient to determine if a combined MTEX
some individuals continue to experience rule was developed to identify patients program is superior to a home exercise
pain and persistent disability at long-term who had sustained an inversion ankle program (HEP) in the management of
follow-up.18,28 In a general population of sprain and were likely to benefit from inversion ankle sprains both in the short
patients with an inversion ankle sprain manual therapy and exercise (MTEX) and long term. The purpose of this mul-
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presenting to primary care, Braun9 found directed at the distal lower extremity. ticenter randomized clinical trial was to
that 72% reported persistent symptoms Consecutive patients with inversion ankle investigate the effects of MTEX com-
at the 6-month follow-up. Additionally, it sprain underwent a standardized exami- pared to an HEP for the management of
has been estimated that the reinjury rate nation, followed by an intervention con- patients with inversion ankle sprain.
following an inversion ankle sprain may sisting of manual therapy, which included
be as high as 80%, suggesting the need both thrust and nonthrust manipulation METHODS
to identify the most effective management and general mobility exercises. In that

O
strategies for this condition.56 study, 64 of 85 patients (75%) met the ver a 30-month period (January
It has been suggested that patients threshold for successful outcome.62 It has 2010-June 2012), consecutive pa-
with recurrent inversion ankle sprains been suggested that with a high pretreat- tients with inversion ankle sprain
frequently demonstrate dysfunction at ment probability of success (75%) and a presenting at any of 4 physical therapy
the proximal tibiofibular,3,31 distal tibio- low chance of harm, therapists should clinics (Rehabilitation Services, Concord
fibular,34 talocrural,17 or subtalar joint.30 consider utilizing the respective treat- Hospital, Concord, NH; Wardenburg
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

In addition, individuals with a history ment approach, and a clinical prediction Health Center, University of Colorado-
of an inversion ankle sprain may exhibit rule is not needed to guide clinical deci- Boulder, Boulder, CO; Anschutz Medical
deficits in strength of the ankle inverters sion making.27 Campus, University of Colorado-Denver,
and increased sway with single-leg stance In the previously published clinical Aurora, CO; and Waldron’s Peak Physi-
tested on a stable (eyes closed) or unsta- prediction rule derivation study,62 only cal Therapy, Boulder, CO) were screened
ble surface.32 Addressing impairments gentle ankle mobility exercises were for eligibility criteria to participate in this
of the foot and ankle region in patients used. Although evidence supports the multicenter clinical trial. To be eligible to
with inversion ankle sprains may lead to use of general range-of-motion exer- participate, patients had to present with
improved pain and function. It has been cises in patients with an inversion ankle current symptoms (the number of days
Journal of Orthopaedic & Sports Physical Therapy®

demonstrated that following an inversion sprain,18,19,22,40 a more comprehensive since injury was not restricted) associ-
ankle sprain, manual therapy techniques exercise program that includes strength- ated with a grade 1 or grade 2 inversion
(both thrust and nonthrust mobiliza- ening and proprioceptive retraining ankle sprain, as defined by the West Point
tion/manipulation) may be beneficial in may further enhance the treatment Ankle Sprain Grading System,28,33 to be
restoring or improving ankle dorsiflex- effect.61 The authors of a recent sys- between the ages of 16 and 60 years, to
ion,3,13,15,29,51,59 posterior talar glide,59 stride tematic review52 reported a significant have a numeric pain rating scale (NPRS)
speed and step length,29 distribution of improvement in functional outcomes score greater than 3/10 in the last week,
forces through the foot,41 and pain.14 Only and reductions in the subjective report of and to have a negative result from the
a few clinical trials have investigated the instability following proprioceptive train- Ottawa ankle rules.57 Patients were ex-
impact of manual therapy on improving ing in patients with ankle ligament injury. cluded if they exhibited contraindica-
function in a population of patients with Other systematic reviews have concluded tions to manual therapy, as noted in the
inversion ankle sprain.3,14,51 Among them, that there is moderate evidence that neu- patient’s medical screening questionnaire
Pellow and Brantingham51 demonstrated romuscular training results in improved (eg, tumor, fracture, rheumatoid arthri-
that 8 sessions of thrust manipulation function and decreased reinjury rates in tis, osteoporosis, prolonged history of
resulted in greater improvements in patients with inversion ankle sprains.7,20 steroid use, or severe vascular disease).
function, as measured with a functional In a randomized clinical trial utilizing a Other exclusions included prior surgery
evaluation scoring scale, at a 1-month progressive exercise regimen, Bassett and to the distal tibia, fibula, ankle joint, or
follow-up compared to placebo ultra- Prapavessis2 concluded that a supervised rearfoot region (proximal to the base of
sound. In a recent systematic review, home-based exercise program resulted in the metatarsals); fracture; other absolute
Brantingham et al8 concluded that lim- outcomes similar to those of 8 sessions contraindications to manual therapy;
ited evidence exists for manual therapy of in-clinic management. However, the insufficient English-language skills to
plus exercise to improve outcomes in the authors did not incorporate any form complete all questionnaires; or inability
short term in this population. However, of manual therapy into their in-clinic to comply with the treatment and follow-
we were unable to identify studies report- management approach, which consisted up schedule. The study was approved by

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the Institutional Review Boards of the pleted a number of self-report measures FAAM sports subscales have been shown
following institutions: Concord Hospi- at baseline. The historical items includ- to exhibit excellent test-retest reliabil-
tal, Concord, NH; the Colorado Multiple ed questions pertaining to the onset of ity and validity when compared to the
Institutional Review Board, Aurora, CO; symptoms, the distribution of symptoms, Medical Outcomes Study 36-Item Short
and the University of Colorado-Boulder, aggravating and easing postures, mecha- Form Health Survey physical functioning
Boulder, CO. All patients provided in- nism of injury, prior treatments, and subscale in individuals with leg, ankle,
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formed consent prior to their enrollment prior history of ankle pain. The physical and foot disorders.45 The minimal clini-
in the study. This trial was registered at examination consisted of items routinely cally important difference (MCID) for
clinicaltrials.gov (NCT00797368). used in the physical therapy examina- the FAAM ADL subscale is 8 percent-
tion of the lower extremity and included age points (0%-100% scale) and for the
Therapists observation of posture, range-of-motion sports subscale is 9 percentage points
Seven physical therapists (mean  SD and joint mobility assessment, and the (0%-100% scale).45
age, 42.7  15.4 years) participated in performance of provocation tests. The The LEFS consists of 20 questions,
the recruitment, examination, and treat- physical examination items were used to and the highest possible score is 80.6
ment of the patients in this study. All par- further determine if any contraindica- Higher scores indicate greater levels of
ticipating therapists were provided with tions to manual therapy were present and function. The LEFS has been shown to
a detailed manual of standard operations to determine the rigor with which manu- have excellent validity, test-retest reli-
and procedures that outlined all the study al therapy techniques would be delivered. ability, and responsiveness to change
procedures, and were trained in the study The primary outcome measure was in patients with lower extremity dis-
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

procedures by 1 of the investigators (J.A.C. the Foot and Ankle Ability Measure orders,6,44,60 and to have an MCID of 9
and P.M.) who were orthopaedic clinical (FAAM) activities of daily living (ADL) points.6
specialists and fellows of the American subscale.45 Secondary outcome measures An 11-point NPRS was used to mea-
Academy of Orthopaedic Manual Physical included the FAAM sports subscale,45 sure pain intensity. The scale is anchored
Therapists. The training session included the Lower Extremity Functional Scale on the left by 0 as “no pain” and on the
instruction in the administrative aspects (LEFS),6 and the NPRS.38 Patients com- right by 10 as “worst imaginable pain.”
of the study (informed consent, subject pleted all outcome measures at baseline The NPRS has been shown to be reliable
recruitment, etc) and specific training and at 4-week and 6-month follow-up and valid.21,36-39,53 Patients rated their cur-
in the performance of the examination periods. The FAAM45 is a region-specific, rent level of pain and their worst and least
Journal of Orthopaedic & Sports Physical Therapy®

and treatment procedures, including the self-report questionnaire with 2 sub- amount of pain in the previous 24 hours.
manual physical therapy techniques and scales. The ADL subscale consists of 21 The average of the 3 ratings was used to
the exercise program. The purpose of the questions, each with a Likert response represent the patient’s level of pain. The
training was to ensure that the examina- scale ranging from 4 (no difficulty) to 0 NPRS has been shown to be reliable and
tion and treatment procedures were per- (unable to do the activity). Individuals valid in patients with low back pain11 and
formed in a standardized fashion across can also mark “N/A” in response to any neck pain.12 However, this has yet to be
the 4 data-collection sites. Participating of the activities listed. Items marked N/A examined in a population with inversion
therapists had a mean  SD of 17  15 are not scored. The scores for all items ankle sprains. The MCID for the NPRS
years (range, 1-40 years) of clinical ex- are added together. The number of ques- has been reported to be 2 points.24
perience in the outpatient orthopaedic tions with a response is multiplied by In addition to the aforementioned
physical therapy setting. Of the 7 physical 4 to get the highest potential score. If self-report measures, patients also com-
therapists, 4 (57%) were orthopaedic cer- all questions are answered, the highest pleted a 15-point global rating of change
tified specialists and 3 (43%) were fellows possible score is 84; if 1 question is not (GRC) scale at the 4-week and 6-month
of the American Academy of Orthopaedic answered, the highest possible score is follow-up periods. The GRC scale, origi-
Manual Physical Therapists. It was not 80; if 2 questions are not answered, the nally described by Jaeschke et al,35 was
possible to blind the treating therapists highest possible score is 76, etc. The to- completed by each patient to rate their
to the patients’ treatment group assign- tal score for the items is divided by the own perception of improved ankle func-
ment due to the nature of the interven- highest possible score and multiplied by tion. The scale ranges from –7 (“a very
tions provided. 100 to obtain a percentage. Higher scores great deal worse”) to 0 (“about the same”)
indicate higher levels of function.45 The to +7 (“a very great deal better”). Inter-
Outcome Measures sports subscale is scored separately (high- mittent descriptors of worsening or im-
After signing informed consent forms, est possible number of points is 28) using proving are assigned values from –1 to –6
all patients provided a history, under- the same method as that described for the and +1 to +6, respectively. At the 6-month
went a physical examination, and com- ADL subscale. Both the FAAM ADL and follow-up, patients were also asked if they

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[ research report ]
experienced a recurrence of their inver- the patient and clinical decision making velocity, end-range longitudinal trac-
sion ankle sprain since the time of their of the therapist. Patients returned to the tion force to the dorsum of the foot
enrollment in the study. In an attempt clinic once a week for the next 3 weeks on the lower leg in a supine position,
to ascertain adherence to their HEP, pa- for instruction on exercise progression. with ankle dorsiflexion and eversion.
tients were also asked, “What percentage On the first day of treatment, the pa- Low-velocity, mid- to end-range an-
of the time did you complete your home tient began mobilizing and strengthen- terior-to-posterior oscillatory force
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exercise program?” ing exercises based on patient status and to the talus on the distal tibiofibular
tolerance, as described by Bassett and joint in a supine position, with varying
Randomization Prapavessis,2 which included the follow- amounts of ankle dorsiflexion. Low-
Once the baseline assessment was com- ing: mobilizing exercises for the foot and velocity, mid- to end-range medial-to-
pleted, patients were randomly assigned ankle, gentle strengthening exercises, lateral oscillatory force to the medial
to receive either MTEX or an HEP. Con- resistive-band exercises, body-weight side of the talus (or calcaneus) on the
cealed allocation to treatment group was resistance exercises, 1-leg standing ac- lower leg in a left sidelying position.
performed by an individual not involved tivities, standing on balance board, and Low-velocity, end-range anterior-to-
in subject recruitment, using a computer- weight-bearing functional activities. posterior sustained glide to the talus
generated randomized table of numbers Specific details regarding exercises and in a weight-bearing position, with ac-
created for each participating site prior to indicators for progression are provided tive ankle dorsiflexion and knee flex-
the beginning of the study. The group as- in APPENDIX A. ion in an on/off fashion.
signment was recorded on an index card. The exercise progression was based on These techniques are described in
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

This card was folded in half such that the feedback from the patient and the clinical detail in APPENDIX B. The goal of the low-
label with the patient’s group assignment decision making of the therapist. Patients velocity manual physical therapy inter-
was on the inside of the fold. The folded in this group were asked to perform the ventions was for the clinician to perform
index card was then placed inside the above exercise regimen at home once dai- grades III to IV, as described by Maitland
envelope, and the envelope was sealed. ly for the duration of the study. Patients et al,43 for five 30-second bouts. However,
A second therapist, blinded to the base- were also instructed to continue normal the therapist was allowed to modify the
line examination findings, opened the activities that do not increase symptoms, grade of manual therapy (I-IV) to maxi-
envelope and proceeded with treatment and to avoid activities that aggravate mize patient comfort with the technique.
according to the group assignment. All symptoms. At each visit with a physical On the first day of treatment, the pa-
Journal of Orthopaedic & Sports Physical Therapy®

patients received treatment on the day of therapist, patients were asked if they had tients began the exact same mobilizing
the collection of baseline measurements experienced any adverse events from the and strengthening exercises, as described
and enrollment in the study. exercise program. At the fourth and final by Bassett and Prapavessis,2 that the HEP
visit (week 4), patients were instructed to group received (APPENDIX A). The exercise
Interventions continue with strengthening and balance progression was based on feedback from
Patients in the HEP group were seen activities. the patient and the clinical decision mak-
by a physical therapist for 4 sessions (1 MTEX Group At each session, the physical ing of the therapist. Patients in this group
per week) focusing on progression of the therapist delivered manual physical thera- were asked to perform the above exercise
exercise regimen. Patients in the MTEX py interventions that were originally used regimen at home once daily for the dura-
group were treated by a physical therapist in a prospective cohort study by Whitman tion of the study. Patients in this group
twice weekly for 4 weeks, for a total of 8 et al.62 The following descriptions of the were also instructed to perform 2 self-
therapy sessions. Each treatment session manipulations are consistent with the mobilization techniques at home (ankle
lasted 30 minutes for both treatment model proposed by Mintken et al48: eversion self-mobilization and weight-
groups. Both groups received advice to • Proximal tibiofibular joint: high-ve- bearing dorsiflexion self-mobilization),
stay active, as well as education on ice, locity, end-range anterior force to the as described by Whitman et al.62 Patients
compression, and elevation. Due to the head of the fibula on the tibia through were also instructed to do all activities
nature of the interventions, it was not end-range flexion and external rota- that did not increase symptoms and to
possible to blind the patients to group tion of the knee in a supine position. avoid activities that aggravated symp-
assignment. • Distal tibiofibular joint: low-velocity, toms. At each therapy session with a
HEP Group Patients attended physical mid- to end-range anterior-to-posteri- physical therapist, patients were asked if
therapy for 4 sessions for instruction and or oscillatory force to the distal fibula they had experienced any adverse events
progression of exercise. The first instruc- and/or tibia in a supine position, with from the exercise program or manual
tion occurred on the day of enrollment in slight ankle plantar flexion. physical therapy interventions. Upon
the trial and was based on the status of • Talocrural and subtalar joints: high- discharge from therapy, all patients were

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instructed to continue with strengthen-
ing and balance activities. Consecutive patients with an inversion
ankle sprain screened for eligibility,
Follow-up n = 157
At the final physical therapy session (4-
week follow-up) and at the 6-month Not eligible, n = 67
• Presented with
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follow-up, patients in both groups com-


contraindications, n = 17
pleted the FAAM ADL, FAAM sports,
• Previous surgery, n = 2
LEFS, NPRS, and GRC. Self-report • NPRS score <3, n = 31
questionnaires were administered at the • Unable to follow treatment
4-week follow-up by an individual who schedule, n = 11
was blind to group assignment, and were • Did not satisfy age
mailed to the subjects at the 6-month requirements, n = 6
follow-up.
Eligible, n = 90
Sample Size
The calculations were based on detecting Declined, n = 16
an 8% difference in the FAAM ADL at
the 4-week follow-up, assuming a stan- Agreed to participate and signed
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

dard deviation of 11%, a 2-tailed test, informed consent, n = 74


and an alpha level equal to .05 and 80%
power. This generated a sample size of 32 Random assignment
patients per group. Allowing for a conser-
vative dropout rate of approximately 15%,
we recruited 74 patients into the study.
MTEX group, n = 37 HEP group, n = 37
Data Analysis
Descriptive statistics, including measures
4-wk follow-up, n = 34 4-wk follow-up, n = 35
Journal of Orthopaedic & Sports Physical Therapy®

of central tendency and dispersion, were


Dropout, n = 3 Dropout, n = 2
calculated for baseline demographic data.
• Moved, n = 1 • Did not return, n = 1
Frequency distributions were estimated • Cost of care too high, n = 1 • Unable to make time
for categorical data. Baseline demograph- • Unable to make time commitments, n = 1
ic data were compared between treat- commitments, n = 1
ment groups using independent t tests for
continuous data and chi-square tests of
independence for categorical data to as- 6-mo follow-up, n = 33 6-mo follow-up, n = 32
sess the adequacy of the randomization. Dropout, n = 1 Dropout, n = 3
• Did not return follow-up • Did not return follow-up
Patients were also categorized according
questionnaires, n = 1 questionnaires, n = 3
to their stages of injury as follows: acute,
less than 6 weeks’ duration; subacute, 6
to 12 weeks’ duration; chronic, greater FIGURE 1. Flow diagram of patient recruitment and retention. Abbreviations: HEP, home exercise program; MTEX,
manual therapy and exercise; NPRS, numeric pain rating scale.
than 12 weeks’ duration.
The primary aim, the effects of treat-
ment on disability and pain, was exam- the dependent variable. For each ANO- maximization, whereby missing data are
ined with a 2-by-3 mixed-model analysis VA, the hypothesis of interest was the computed using regression equations.54
of variance (ANOVA), with treatment 2-way group-by-time interaction. To de- Planned pairwise comparisons were per-
group (MTEX versus HEP) as the be- termine if missing data points associated formed examining the difference between
tween-subject factor and time (baseline, with dropouts were missing at random or baseline and follow-up periods, using the
4-week follow-up, 6-month follow-up) missing for systematic reasons, we per- Bonferroni equality at an alpha level of
as the within-subject factor. Separate formed the Little missing completely at .05. A Mann-Whitney U test was used to
ANOVAs were performed with the FAAM random test.54 Intention-to-treat analy- determine a difference in the GRC be-
ADL, FAAM sports, LEFS, and NPRS as sis was performed by using expectation tween groups at the 4-week and 6-month

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[ research report ]
follow-up periods. An independent t test
was used to determine if a difference ex- Demographics and Outcome  
TABLE 1
isted between groups for adherence to the Measures at Baseline
exercise regimen, and a chi-square analy-
sis was used to examine the number of Variable HEP (n = 37)* MTEX (n = 37)* P Value
recurrences between groups. The alpha Age, y 33.2  9.8 37.1  11.8 .12†
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level for all analyses was a priori estab- Gender (female), n (%) 19 (51) 17 (46) .81‡
lished at .05 using a 2-tailed test. Data Duration of symptoms, d 59.9  31.3 72.1  67.7 .32†
analyses were performed using the SPSS Acute (<6 wk), n 11 12
Version 20.0 statistical software package Subacute (6-12 wk), n 22 17 .37‡
(SPSS Inc, Chicago, IL). Chronic (>12 wk), n 4 8
NPRS (0-10)§ 3.9  0.9 3.9  0.7 .99†
RESULTS LEFS (0-80) 53.8  7.2 51.1  8.7 .16†
FAAM ADL (0%-100%) 63.5  12.5 65.8  9.7 .39†

O
ne hundred fifty-seven pa- FAAM sports (0%-100%) 49.9  9.4 49.3  8.0 .76†
tients with inversion ankle sprain Taking medications at the start 7 (18.9) 5 (13.5) .75‡
of the study, n (%)
were screened for eligibility to par-
ticipate in this clinical trial. Seventy-four Abbreviations: ADL, activities of daily living; FAAM, Foot and Ankle Ability Measure; HEP, home
exercise program; LEFS, Lower Extremity Functional Scale; MTEX, manual therapy and exercise;
patients (mean  SD age, 35.1  11.0 NPRS, numeric pain rating scale.
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

years; 48.6% female) met the eligibility *Values are mean  SD unless otherwise indicated.
criteria, agreed to participate, and signed

Independent-samples t tests.

Chi-square tests.
informed consent. Of these 74 patients, §
Lower score is better. In all other scales, higher score is better.
37 were randomized to the HEP group
and 37 were randomized to the MTEX
group. FIGURE 1 shows a flow diagram of 100 * 100 *
90 *
patient recruitment and retention for 80
90 *
80
this trial. All baseline demographics were 70 70
FAAM, %
FAAM, %

60 60
similar between groups (P>.05) (TABLE 1). 50 50
Journal of Orthopaedic & Sports Physical Therapy®

Of the 74 patients enrolled, 69 (93.2%) 40 40


30 30
completed the 4-week follow-up and 65 20 20
10 10
(87.8%) completed the 6-month follow- 0 0
up (FIGURE 1). The percentages of dropouts Initial 4 wk 6 mo Initial 4 wk 6 mo

at 4 weeks and at 6 months were not sta-


MTEX HEP MTEX HEP
tistically different between treatment
groups.
FIGURE 2. Mean  SD FAAM activities of daily living FIGURE 3. Mean  SD FAAM sports subscale scores
The overall group-by-time interac- subscale scores at each assessment point. The at each assessment point. The scale ranges from 0%
tion for the mixed-model ANOVA was scale ranges from 0% to 100%, with higher scores to 100%, with higher scores indicating better function.
statistically significant for the FAAM indicating better function. *Significant difference *Significant difference between groups (P<.05).
ADL (P.001), FAAM sports (P<.001), between groups (P<.05). Abbreviations: FAAM, Abbreviations: FAAM, Foot and Ankle Ability Measure;
Foot and Ankle Ability Measure; HEP, home exercise HEP, home exercise program; MTEX, manual therapy
LEFS (P.001), and pain (P.001). Be-
program; MTEX, manual therapy and exercise. and exercise.
tween-group differences revealed that the
MTEX group experienced statistically
significantly greater improvement in the nificant between-group differences for in favor of greater improvements in pain
FAAM ADL and FAAM sports subscales improvement existed for the LEFS at 4 for the MTEX group at both the 4-week
at both the 4-week (FAAM ADL mean weeks (mean difference, 12.8; 95% CI: (mean difference, –1.2; 95% CI: –1.5,
difference, 11.7; 95% confidence interval 9.1, 16.5) and at 6 months (mean differ- –0.90) and 6-month (mean difference,
[CI]: 7.4, 16.1; FAAM sports mean dif- ence, 8.1; 95% CI: 4.1, 12.1), both favor- –0.47; 95% CI: –0.90, –0.05) follow-
ference, 13.3; 95% CI: 8.0, 18.6, respec- ing the MTEX group. FIGURES 2 through up periods (TABLE 2). FIGURE 5 shows the
tively) and 6-month (FAAM ADL mean 4 show the scores at each time frame scores at each time frame for the NPRS.
difference, 6.2; 95% CI: 0.98, 11.5; FAAM for the FAAM ADL, FAAM sports, and The Mann-Whitney U test revealed a sig-
sports mean difference, 7.2; 95% CI: 2.6, LEFS, respectively. nificant difference in favor of the MTEX
11.8) follow-up periods. Similarly, sig- There was also a significant difference group for the GRC at both the 4-week

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43-07 Cleland.indd 448 6/19/2013 12:30:47 PM


90 Changes in Pain and Function
80 * TABLE 2
70
* for the 2 Interventions
60
LEFS

50
40 Manual Therapy Between-Group
30 Variable* Home Exercise Program† and Exercise† Differences‡
20
FAAM ADL (0%-100%)
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10
0 Baseline to 4 wk 9.6 (6.5, 12.6) 21.3 (18.2, 24.5) 11.7 (7.4, 16.1)§
Initial 4 wk 6 mo
Baseline to 6 mo 24.6 (20.5, 28.7) 30.8 (27.4, 34.2) 6.2 (0.98, 11.5)║
MTEX HEP FAAM sports (0%-100%)
Baseline to 4 wk 13.8 (10.9, 16.8) 27.1 (22.7, 31.6) 13.3 (8.0, 18.6)§
FIGURE 4. Mean  SD LEFS scores at each Baseline to 6 mo 33.5 (30.7, 36.3) 40.7 (37.0, 44.4) 7.2 (2.6, 11.8)¶
assessment point. The scale ranges from 0 to 80, with LEFS (0-80)
higher scores indicating better function. *Significant Baseline to 4 wk 5.6 (3.1, 8.1) 18.4 (15.5, 21.2) 12.8 (9.1, 16.5)§
difference between groups (P<.05). Abbreviations:
Baseline to 6 mo 17.3 (14.5, 20.0) 25.3 (22.3, 28.3) 8.1 (4.1, 12.1)§
LEFS, Lower Extremity Functional Scale; HEP, home
exercise program; MTEX, manual therapy and exercise. NPRS (0-10)
Baseline to 4 wk –1.5 (–1.8, –1.3) –2.7 (–2.9, –2.5) –1.2 (–1.5, –0.90)§
Baseline to 6 mo –3.1 (–3.5, –2.8) –3.6 (–3.9, –3.4) –0.47 (–0.90, –0.05)#
(MTEX group mean, 4.1; median, 4.0;
Abbreviations: ADL, activities of daily living; FAAM, Foot and Ankle Ability Measure; LEFS, Lower
mode, 4.0; and HEP group mean, 3.0;
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

Extremity Functional Scale; NPRS, numeric pain rating scale.


median, 3.0; mode, 3.0; P<.001) and *Higher scores on the functional scales indicate improvement, and lower scores on the pain scale
6-month (MTEX group mean, 6.3; medi- indicate less pain.

Values are within-group mean (95% confidence interval) differences over time.
an, 6.0; mode, 7.0; and HEP group mean, ‡
Values are mean (95% confidence interval) differences in within-group changes between groups at
4.4; median, 4.6; mode, 5.0; P<.001) fol- each time occasion.
low-up periods. §
P<.001.

P = .02.
No adverse events were reported for ¶
P = .002.
either group during the study period. #
P = .03.
There was no statistically significant dif-
ference in the recurrence of ankle sprain
Journal of Orthopaedic & Sports Physical Therapy®

rate (P = .48) between the MTEX (3/33, CIs around these estimates (with the ex-
9.1%) and HEP (5/32, 15.6%) groups. ception of the LEFS at 4 weeks) fail to 6
5
Furthermore, there was no statistically provide completely convincing evidence
4
significant difference (P = .56) for the for a clinically meaningful advantage *
3
NPRS

percentage of patients who reported com- (greater than MCID) for MTEX in the 2 *
pleting their home exercises between the target population. Though the between- 1
MTEX group (mean, 69.3% completion group differences did not surpass the 0
rate) and the HEP group (mean, 65.5% MCIDs at 6 months, we believe that clini- Initial 4 wk 6 mo

completion rate). cians should consider using a multimodal


MTEX HEP
approach incorporating manual physical
DISCUSSION therapy interventions and exercise for
the management of patients with inver- FIGURE 5. Mean  SD NPRS scores at each

T
he results of the current study sion ankle sprain, based on the fact that assessment point. The scale ranges from 0 to 10,
with lower scores indicating less pain. *Significant
demonstrate that both groups expe- the within-group average improvements
difference between groups (P<.05). Abbreviations:
rienced improvements in pain and (as well as the lower bound of their 95% HEP, home exercise program; MTEX, manual therapy
function during the study period. Howev- CIs) for the patients in the MTEX group and exercise; NPRS, numeric pain rating scale.
er, the patients in the MTEX group exhib- exceeded the MCIDs at both the 4-week
ited significantly greater improvements and 6-month follow-ups. Furthermore, The findings from the current study
in pain and function at both 4 weeks and although the difference between groups differ from those reported by Bassett and
6 months as compared to those in the for recurrence rates was not statistically Prapavessis,2 who compared a mean of
HEP group. Although point estimates of significant, the HEP group experienced 7.6 sessions of supervised in-clinic exer-
between-group effect sizes for treatment almost double the rate of recurrence com- cise with a physical therapist to 4.6 ses-
benefit suggest clinically meaningful ben- pared to the MTEX group (15.6% versus sions of supervised HEP progression. In
efits of MTEX over an HEP, widths of the 9.1%), which may be clinically relevant. contrast to our results, showing superior

journal of orthopaedic & sports physical therapy  |  volume 43  |  number 7  |  july 2013  |  449

43-07 Cleland.indd 449 6/19/2013 12:30:49 PM


[ research report ]
results with an MTEX approach over who exhibited improvements within our tors and thereby assist the improvement
an HEP, the results in the Bassett and trial, suggesting that the current study’s of neural feedback, which may aid in
Prapavessis2 trial revealed no statisti- MTEX approach might be beneficial for dynamic stability and maximize the ben-
cally significant difference between the individuals with ankle inversion sprain, efits of therapeutic exercise. Addition-
groups at the completion of treatment. regardless of the time since injury. Simi- ally, it is plausible that manual therapy
It is possible that the inclusion of man- larly, the authors of a recent study14 that interventions could result in a reduction
Downloaded from www.jospt.org at California State University Fresno on June 2, 2014. For personal use only. No other uses without permission.

ual physical therapy interventions in the examined the impact of a 30-second of inflammatory cytokines,58 an increase
treatment approach in our trial was the bout of grade III anterior/posterior talo- in beta endorphins,16 and hypoalgesia.25,26
primary reason for the different findings crural joint mobilization in patients with These hypotheses require further scien-
between studies. However, Bassett and acute inversion ankle sprains reported tific investigation.
Prapavessis2 also included strategies to no better improvements in dorsiflexion There are a number of limitations to
enhance adherence to the HEP, which in- or function at a 24-hour follow-up as the current study that should be consid-
cluded educational materials, a treatment compared to a control group. As only 1 ered. First, the study did not include a
booklet, and cognitive-behavioral inter- manual therapy technique was used for a comparison group that received either
ventions. These strategies were not used single session, this suggests that multiple no treatment (control) or a placebo inter-
in the current study and could have led to treatment sessions utilizing a variety of vention. Therefore, we cannot determine
greater improvements in the HEP group manual therapy techniques may be nec- what percentage of the improvements
in their study. Bassett and Prapavessis2 essary to significantly improve function, made by the patients enrolled in the cur-
reported adherence to the HEP using a or that a combination of manual therapy rent trial was a result of the interven-
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

1-to-5 scale (1 is no, 5 is all), whereas we and exercises may increase the potential tions they received, placebo, or simply
asked the patients to report their per- to maximize patient outcomes. the natural history of the disorder. Ad-
centage of adherence. Therefore, direct The exact mechanism by which manu- ditionally, the physical therapists spent
comparisons regarding exercise adher- al therapy achieves its effects is unknown, twice as much time with the patients in
ence between studies cannot be made. but there are possible explanations worth the MTEX group as they did with those
Although it is expected that increased considering. It has been reported that in the HEP group. This in itself could
adherence to home exercise would result patients with an inversion ankle sprain have contributed to the differences be-
in better clinical outcomes, very few stud- often exhibit impairments at joints that tween groups. It should also be recog-
ies have examined this potential associa- contribute to ankle mobility, including nized that the therapists had no physical
Journal of Orthopaedic & Sports Physical Therapy®

tion.46 Future studies should examine the proximal tibiofibular, distal tibiofib- contact with the patients in the HEP
whether exercise adherence contributes ular,34 talocrural,17 and subtalar joints.30 group and that the power of touch might
to better outcomes. Perhaps manual therapy is helpful in re- also have contributed to the differences
The results of the current study fur- storing motion at these joints, leading to in outcomes between groups. Smoking
ther support the conclusions of a system- improved foot and ankle mechanics, less was not captured as a baseline variable,
atic review by Brantingham et al8 that pain, and improved function. It is also hence it is not known if this contributed
MTEX is effective in the short term for possible that the effects of manual ther- to a poorer prognosis for some individu-
reducing pain and improving function in apy are neurophysiological in nature.4,5 als. Future studies should include a com-
patients with an inversion ankle sprain. For example, it has been demonstrated parison group receiving no intervention
This is in contrast to the findings of Bea- that the soleus and peroneal muscles ex- and, potentially, a placebo group, and
zell and colleagues.3 They examined the hibit arthrogenous muscle inhibition in should ensure that equal time is spent
benefits of a joint manipulation applied to patients with ankle instability.47,50 The with individuals in each treatment group.
either the proximal or distal tibiofibular authors of these studies have suggested
joint versus no treatment in patients with that this might be the result of altered CONCLUSION
chronic ankle instability, and their results mechanoreceptors following the ankle

I
revealed that all 3 groups showed similar sprain, leading to a disrupted neural n this randomized clinical trial, a
improvement in dorsiflexion range of mo- feedback system to the dynamic stabi- management approach incorporating
tion and function. Perhaps the difference lizers of the ankle. Interestingly, Grind- MTEX for individuals with inversion
between the current study and that of staff et al31 demonstrated that patients ankle sprain resulted in greater improve-
Beazell et al3 is the fact that their popula- with chronic ankle instability who were ments in pain and function in both the
tion had chronic symptoms and received treated with manipulation to the distal short and long term as compared to the
only 1 intervention technique. However, tibiofibular joint exhibited increased so- use of an HEP. Although both groups ex-
our sample included 12 patients in the leus activation. Perhaps manual therapy hibited improvement, the MTEX group
chronic stage (greater than 12 weeks) interventions stimulate mechanorecep- experienced greater changes over time

450  |  july 2013  |  volume 43  |  number 7  |  journal of orthopaedic & sports physical therapy

43-07 Cleland.indd 450 6/19/2013 12:30:50 PM


that were not only statistically signifi- prehensive model. Man Ther. 2009;14:531-538. Mil Med. 1994;159:20-24.
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FINDINGS: In this randomized clinical L, van Dijk CN. Interventions for treating
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Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

clinic population 6 to 18 months after medical 11-point numerical pain rating scale. Pain.
partially or fully responsible for the dif- evaluation. Arch Fam Med. 1999;8:143-148. 2001;94:149-158.
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ACKNOWLEDGEMENTS: The American Academy intramural rugby at the United States Military tor effects after a single cervical spine manipu-
Academy [abstract]. J Athl Train. 2001;36:S-56. lation in subjects with lateral epicondylalgia.
of Orthopaedic Manual Physical Therapists 11. Childs JD, Piva SR, Fritz JM. Responsiveness J Manipulative Physiol Ther. 2008;31:675-681.
Orthopaedic Physical Therapy Products of the numeric pain rating scale in patients http://dx.doi.org/10.1016/j.jmpt.2008.10.005
Grant provided funding for this project. This with low back pain. Spine (Phila Pa 1976). 26. Fernández-de-las-Peñas C, Alonso-Blanco C,
organization played no role in the design, 2005;30:1331-1334. Cleland JA, Rodríguez-Blanco C, Alburquerque-
12. Cleland JA, Childs JD, Whitman JM. Psycho- Sendín F. Changes in pressure pain thresh-
conduct, or reporting of the study, or in the metric properties of the Neck Disability Index olds over C5-C6 zygapophyseal joint after
Journal of Orthopaedic & Sports Physical Therapy®

decision to submit the manuscript for pub- and Numeric Pain Rating Scale in patients with a cervicothoracic junction manipulation in
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@ MORE INFORMATION
outcome instruments for the foot and ankle. J 2007;5:A71-A77.
Orthop Sports Phys Ther. 2007;37:72-84. http:// 55. Shaffer RA, Brodine SK, Ito SI, Le AT. Epidemiol-
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452  |  july 2013  |  volume 43  |  number 7  |  journal of orthopaedic & sports physical therapy

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APPENDIX A

GUIDELINES FOR EXERCISE PROGRESSION


Physical Therapy Progression
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Education: refrain from activity detrimental to recovery, elevate the ankle As swelling and bruising decrease, reduce the time spent elevating the
and apply ice, use elastic compression to assist with edema control. ankle and decrease frequency of ice application.
Mobility: active range of motion and mobilizing exercises for the foot Progress to greater range of movement, adding holds at the end range
and ankle: plantar flexion, dorsiflexion, inversion, and eversion. and increasing the duration of holds.
Target: 3 sets of 15 repetitions.
Strength: gentle strengthening exercises initially consisting of isometrics: Strengthening exercises progress to isotonic exercises using elastic band
pushing foot against the wall for inversion, eversion, and plantar flex- for resistance. Three sets of 15 repetitions to be performed in
ion, using the other foot for resistance of dorsiflexion (5-second holds all directions, with the goal of achieving muscle fatigue at the end of 3
for 5 repetitions in all directions), and scrunching a towel under the sets. Increase range of movement, duration of holds at the end range,
sole of the foot for intrinsic muscles. and strength level of the elastic band over time. Progress strength of
elastic band when 3 sets of 15 repetitions are completed in the full
range.
Body-weight resistance: heel raises and mini-squats in bilateral standing. Progress to heel raises and mini-squats standing on the injured limb.
Increase time spent in the weight-bearing position.
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

Stretching: calf and heel cord stretches, starting in long sitting, using Progress to standing stretches for gastrocnemius and soleus;
a towel to manually provide the stretch; 3 stretches of 30 seconds’ 3 stretches of 30 seconds’ duration.
duration.
Balance: 1-legged standing on the injured limb, with arms abducted Progress from arms abducted to arms across chest when able to stand
and eyes open; 3 sets of 30 seconds’ duration. without losing balance, 3 × 30 seconds. Progress eyes open to eyes
closed when able to stand without losing balance, 3 × 30 seconds with
eyes open, arms across chest.
Dynamic balance: standing on balance/wobble board (or pillow) with eyes Options for progression: eyes open to eyes closed, decrease the standing
open; 3 sets of 60 seconds’ duration. base, throwing and catching a ball, and standing on the injured limb
only.
Journal of Orthopaedic & Sports Physical Therapy®

Functional weight-bearing activities: walking, running, skipping, and Progress from walking to running/hopping when strength, range of
hopping, according to patient’s activities and participation. motion, and balance exercises have been progressed fully as above.

Adapted from Bassett SF, Prapavessis H. Home-based physical therapy intervention with adherence-enhancing strategies versus clinic-based
management for patients with ankle sprains. Phys Ther. 2007;87:1132-1143, with permission of the American Physical Therapy Association. This material
is copyrighted, and any further reproduction or distribution requires written permission from APTA.

APPENDIX B

DESCRIPTION OF THRUST/NONTHRUST MANIPULATION TECHNIQUES


Technique Description of Technique Illustration*
Rearfoot: distraction The therapist grasped the dorsum of the patient’s foot
high-velocity with interlaced fingers. Firm pressure with both
manual physical thumbs was applied in the middle of the plantar
therapy intervention surface of the forefoot. The therapist engaged the
restrictive barrier by passively dorsiflexing the ankle
and applying a long-axis distraction. The therapist
pronated and dorsiflexed the foot to fine tune the
barrier. The therapist applied a high-velocity, low-
amplitude force in a caudal direction.

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[ research report ]
APPENDIX B

Technique Description of Technique Illustration*


Talocrural joint: The therapist used the left hand to firmly stabilize
anterior-to-posterior the lower leg at the malleoli. The therapist grasped
Downloaded from www.jospt.org at California State University Fresno on June 2, 2014. For personal use only. No other uses without permission.

low-velocity manual the anterior, medial, and lateral talus with the right
physical therapy hand. The therapist applied a low-velocity, anterior-
intervention to-posterior oscillatory force to the talus. Tip: the
therapist used the thigh to help stabilize the foot and
to progressively increase the amount of ankle dorsi-
flexion. The therapist may need to adjust the amount
of supination/pronation to optimize the technique.

Weight-bearing The therapist supported the arch of the foot and ap-
talocrural joint: plied a stabilizing force (anterior-to-posterior-direct-
anterior-to-posterior ed force) over the anterior talus. A belt (padded) was
low-velocity manual placed over the patient’s distal posterior tibia and
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

physical therapy fibula and around the therapist’s buttock region. The
intervention patient was guided into dorsiflexion of the involved
ankle while, simultaneously, the therapist applied
a posterior-to-anterior-directed force to the distal
leg by leaning backward/pulling on the belt. As the
patient dorsiflexes more, the therapist should squat
down while leaning back to keep a direct posterior-
to-anterior force at the talocrural joint (therefore
following the plane of the joint).
Lateral glides and Talocrural joint lateral glide: the therapist grasped the
eversion: low- malleoli just proximal to the talocrural joint with
Journal of Orthopaedic & Sports Physical Therapy®

velocity manual the left index finger/thumb and used the forearm
intervention to stabilize the patient’s left leg against the table.
The therapist placed the right thenar eminence on
the talus just distal to the malleoli and grasped the
rearfoot. The therapist used his body to impart a
low-velocity oscillatory force to the talus through the
right arm and thenar eminence.
Subtalar joint lateral glide: the therapist shifted the left
hand/forearm distally and grasped the talus with
the left index finger/thumb. The therapist placed
his right thenar eminence on the patient’s medial
aspect of the calcaneus and grasped the rearfoot.
The therapist used his body to impart a low-velocity
oscillatory force to the calcaneus through the right
arm and thenar eminence.
Proximal tibiofibular The therapist placed his second MCP in the popliteal
joint: high-velocity fossa, then pulled the soft tissue laterally until the
manual intervention MCP was firmly stabilized behind the patient’s fibu-
lar head. The therapist used the left hand to grasp
the foot and ankle. The therapist externally rotated
the leg and flexed the knee to the restrictive barrier.
Once the restrictive barrier was met, the therapist
applied a high-velocity, low-amplitude force through
the tibia (directing the patient’s heel toward his ipsi-
lateral buttock).

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APPENDIX B

Technique Description of Technique Illustration*


Distal tibiofibular joint: The therapist grasped and stabilized the distal tibia
low-velocity manual with 1 hand. The therapist placed the thenar emi-
Downloaded from www.jospt.org at California State University Fresno on June 2, 2014. For personal use only. No other uses without permission.

intervention nence over the lateral malleolus and used his body
to impart a low-velocity, oscillatory, anterior-to-
posterior force to the fibula on the tibia.

Abbreviation: MCP, metacarpophalangeal joint.


*Images reproduced with kind permission of Evidence in Motion (http://www.evidenceinmotion.com/).
Copyright © 2013 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Journal of Orthopaedic & Sports Physical Therapy®

BROWSE Collections of Articles on JOSPT’s Website


The Journal’s website (www.jospt.org) sorts published articles into more
than 50 distinct clinical collections, which can be used as convenient entry
points to clinical content by region of the body, sport, and other categories
such as differential diagnosis and exercise or muscle physiology. In each
collection, articles are cited in reverse chronological order, with the most
recent first.

In addition, JOSPT offers easy online access to special issues and features,
including a series on clinical practice guidelines that are linked to the
International Classification of Functioning, Disability and Health. Please
see “Special Issues & Features” in the right-hand column of the Journal
website’s home page.

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