0895-4356/92 S5.00 + 0.

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Copyright Q 1992 PcrSamon Prw pk

J Uin E#wnbl Vol. 45, No. 3, pp. 301-311, 1992

Rinted in Great Britain. All ri&8 reserved

ACUTE LOW BACK PAIN AND ECONOMICS OF

THERAPY: THE ITERATIVE LOOP APPROACH
VALERIEA. LAWRENCE,* PETER TUGWELL, AWEXRACHAIKOSUWON~and WALTER0.

GAFNI,~
SPITZ&

Division of General Medicine, Department of Medicine, University of Texas Health Science

Center at San Antonio and Am-lie L. Murphy Memorial Veterans Hospital, %epartment of Clinical
Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario and %epartment of
Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada
(Received in revised form 16 April 1991; received for publication 13 November 1991)

Abstract-We
use the measurement iterative loop as a conceptual framework to
examine the economics of common therapies for acute non-specific low back pain.
The measurement iterative loop systematically assesses the interlocking facets of an
illness from the community health perspective, including quantifying burden of illness,
etiology, assessment of therapeutic effectiveness, and economic evaluation of therapies.
The iterative loop reveals that: (1) burden of illness, although known to be substantial,
is so far inaccurately measured, (2) little is known about such factors as provider
and patient compliance; and (3) the economics of therapy can guide us in this time of
clinical uncertainty when no therapy appears clearly superior. For therapies with at least
some support from randomized controlled trials, bedrest appears to be economically
superior. Resides burden of illness, compliance, and current therapies, future research
should address such therapeutic options as early return to work and patient
self-management.
Acute non-specific low-back pain
Measurement
perspective
Economic evaluation

INTRODUCDON
low back pain is a complex illness.
It is common and associated with a substantial
burden of illness but in only a small minority is
an identifiable pathophysiological cause found.
For the great majority it is a self-limited illness
with a good prognosis. Despite its good prognosis, acute low pack pain consumes considerable
resources in medical care, absence from work,
and workers compensation.
Finally, recent
critical reviews have determined that therapy for
acute low back pain is far from being definitive
or of proven efficacy.

Acute

*AU~rmpondence should be addressed to: Dr Lawrence,

Division of General Medicine, Department of Medicine,
UTHSC-SA, 7703 Floyd Curl Drive, San Antonio, TX
782847879, U.S.A.

iterative loop

Community

health

In this setting, careful and systematic evaluation and linkage of the numerous facets of a
health care issue are important to determine its
full impact, assess the state of the art for clinical
decision-making and rational use of health care
services and identify important avenues for
research and policy formulation. One model
for such evaluation is the measurement iterative
loop [l]. The iterative loop model uses the
community heahh perspective to systematically
integrate current knowledge of a health -problem
into a conceptual framework to demonstrate the
interaction of different aspects of disease and
treatment (Fig. 1). Steps in the loop include
quantification of burden of illness, determination of etiology, assessment of therapeutic
effectiveness, economic evaluation of therapies,
monitoring interventions and, coming full circle,
301

302

VALERIEA. LAWRENCE
et al.
1
BURDEN OF ILLNESS
Accurate and relevant
quantification of compromised
health status, morbidity,
and mortality

7
REASSESSMENT
Measurement of achieved reduction
in burden of illness
and ongoing health needs

2
ETIOLOGY OR CAUSATION
Identify and assess causes of illness
and factors contributing
to overall burden of illness

/
Efficacy

1 coverage

6
MONITORING OF PROGRAM
Ongoing monitoring of patient
outcomes and quality of care with
markers of disease or disability

SYNTHESIS &
IMPLEMENTATION
Integration of feasibility,
impact and efficiency to make recommendations

Diagnostic
Accuracy

COMMUNITY E;FECTIENESS
Assess efficacy of feasible
interventions and potential
when implemented in the community

Provider
Compliance

/
Patient
Compliance

ECONOMIC EVALUATION
Determine relationships
between costs and effects
of options within and
across programs

Fig. 1. The measurement iterative loop: a framework for the critical appraisal of need, benefits, and costs
of health interventions. (Adapted from Tugwell et al. [I].)

assessment of achieved reduction in the burden

of illness.
This study uses the measurement iterative
loop to examine acute non-specific low back
pain. We define this entity as the syndrome of
pain in the lumbar region, acute (6 7 days) or
subacute (l-7 weeks), without evidence of nerve
root compression, without radiation below the
knee (sciatica), and without identifiable anatomical, mechanical, or infectious cause or known
risk factors for such. Our purpose is: (1) to
systematically link the interrelated facets of this
health care issue and (2) to see how economic
evaluation might guide therapeutic decisions
until effective therapies are more clearly defined.

MEASUREMENT

LTERATIVE LOOP

Burden of illness

Quantification of morbidity and mortality

should be accurate and relevant. Available evidence indicates that acute non-specific low back
pain causes substantial burden of illness but
accuracy and precision are lacking (see Table 1)
[2-221. Although precise estimation is difficult, it
is important for health care planning, policy
decisions, and resource allocation for research
[5,6]. Discrepancies in prevalence and incidence
figures among studies are largely due to methodological differences, especially in survey tech-

niques, patients studied, and definition of pain.

Accuracy is additionally hampered by difficulty
in obtaining specific diagnoses in most cases.
Data from the National Ambulatory Medical
Care Survey (1977-1978) indicated that sprains
and strains of the sacroiliac region and other
unspecified parts of the back were the single
largest diagnostic category and comprised
38% of diagnoses [16]. Data from the earlier
NHANES I survey (1971-1975) also indicated
that the majority of cases (81.5%) were not
given a specific diagnosis by physicians [4].
Incidence and prevalence do not provide a
complete picture of burden of illness. Impaired
functional ability and disability due to back pain
are substantial (Table 1). Further, estimates of
economic impact are necessary for accurately
quantifying burden of illness. Estimates of total
annual costs of back pain in the U.S. range from
$5 billion for direct medical costs to $25 billion
for overall costs (Table 1) [7,8]. Back injuries
have been estimated to account for 19-26% of
compensation claims in industrial settings in the
U.S. and Canada [21,22]. However, data are
from diverse sources which are not necessarily
comparable (e.g. different states in the U.S.,
insurance companies, countries with nationalized health insurance, industrialized settings).
Although these data clearly demonstrate a
substantial financial impact, they may underestimate total costs for several reasons [21]:

Acute Low Back Pain and

(1) compensation programs do not usnally

cover federal employees, farmers, railroad
workers, harbor workers, and housewives; (2)
even with a work-related spinal injury, some
employees likely are not absent from work
su!Xciently long to qualify for compensation;
(3) workers with a job-related spinal injury
may be assigned to other work they can perform
while recuperating, so productivity losses are
more difficult to quantitate; (4) many estimates
are for.direct costs (direct medical costs) and do
not include indirect costs such as productivity
loss, replacement training and retraining. In
summary, accurate and relevant quantification
of burden of illness due to acute pack pain is
lacking, but is necessary for assessment of
therapeutic effectiveness and informed resource
allocation and policy formulation. Ways to

Economicsof Therapy

303

improve the precision and validity of future data

might include a speci6c diagnostic entity of
acute non-specific low back pain defined by
explicit criteria, use of new measures recently
developed to objectify impairment in functional
status and quality of life, and a valid, reliable,
standardized plan for assessing costs which is
formulated and agreed on by experts in this
area.
Etiology
The etiology of back pain comprises three
broad categories: mechanical, non-mechanical,
and visceral [23]. Mechanical pain is the
most common. Its causes include degenerative
disease, herniated disc, spinal stenosis, osteoporosis, fractures, spondylolisthesis, congenital
kyphosis or scoliosis. These and injury to any of

Table 1. Estimates of burden of illness for acute/subacute non-specific low back pain
Prevalence
On+year incidence

Point prevalence

Cumulative lifetime prevalence

1.37% [2,3] (spinal disorders with work absence)

31% [15]
17.0% [4] (NHANES I)
6.8% [5] (IJHANES II)
4.4% [6] (serious back trouble, Canadian Health Survey)
13.8% [S] (LBP lasting at least 2 weeks)
5080% [9-151

Phyiician visits

National Ambulatory Medical Care Surveys, 1977-1978: [16]

Back discomfort was the second leading symptom prompting visits to physicians by patients of all ages. For men
25-44 years old and women 35-64 years old, back discomfort was the primary presenting complaint. Back symptoms
accounted for 32 million visits (3% of all physician visits). Two thirds of patients with first episode of back
symptoms saw a physician within 3 weeks.
NHANES II [5]:
Of patients reporting back pain of at least two weeks duration, 85% had visited a health care professional.
Disability impact

U.S. National Health Survey [17]:

Disorders of the spine and back accounted for 42% of chronic physical impairment due to musculoskeletal conditions
in men and women. Among chronic conditions, impairments of the back and spine were the most frequent cause of
limited activity in persons < 45 years old and third. most frequent in 45-60 year olds.
NHANES I [4]:
Of those reporting symptoms only in the back/neck, 17.8,16.3 and 14.2% reported moderate/severe activity restriction,
change in job status, and 5 or more days lost from work, respectively.
Canadian Health Survey [6]:
An 11% sample of those with serious back trouble revealed an average of 21.4 disability days/person/year.
Rowe [18]:
Low back pain was the second most common cause of work absence (4 hours/man/year) after upper respiratory
infection (8 hours/man/year)
Nachemson [19]:
In the U.S., an estimated 1400 workdays/l000 workers are lost annually.
Financial impact
In 1976, an estimated $14 billion was spent in the U.S. on treatment and compensation for low back pain [ZO].
Estimated total (direct + indirect) cost of back pain in 1984 approached $16 billion but a projected total cost for 1983
was $25 billion [8].
Estimates for annual direct cost of medical care alone, not including disability and indirect costs, range from more
than $8 billion [5] to $13 billion [8].
Study of workmens compensation claims in 26 states in the U.S. in 1979 [21]:
of 1.7 million claims, 19.3% were for back injuries, of which 87% were strains/sprains; average cost per case was $3533
and total direct cost of compensation was more than Sl billion.
Study of a large U.S. industrial manufacturer [22]:
Back injuries comprised 19% of work-related injuries and accounted for 41% of total costs of W.5 million.
Study of Quebec, Canada workmens compensation claims, 1981 [2]:
10% of compensated claims were for lumbar spinal disorders; compensation cost was $150 million for spinal disorders
(28% of total compensation costs).

304

VALERIEA. LAWRENCEet al.

the numerous innervated spinal components

can cause pain. However, the majority of these
entities are clinically indistinguishable and fall
in the loose diagnostic category of lumbar
strain, without an exact known cause, in as
many as 85% of cases. Visceral diseases (e.g.
pyelonephritis, prostatitis, endometriosis, aortic
aneurysm, pancreatitis) cause secondary back
pain. Non-mechanical causes are usually neoplastic, infectious or inflammatory. The triad of
malignancy, inflammatory disease and infections are rare causes of back pain, with prevalence from 0.6% for malignancy to 2% for all
three causes combined.
Mechanical acute back pain may be associated with certain clinical risk factors such as
physical activity, (e.g. lifting, pulling, pushing,
twisting, overexertion) [19,24], occupation (e.g.
truck driving, heavy labor, nursing) [19,24-251,
ergonomic factors [22], industry (e.g. forestry,
mining, manufacturing)
[2]. However, the
specific pathophysiology is not understood and
exact clinical cause is not often known. No
specific diagnosis is made in the majority,
ergonomic studies have provided little insight
into significant prevention in the work place,
and we cannot as yet predict which few patients
will become chronically disabled. These issues
become more significant when one examines the
current status of therapeutic effectiveness for
acute non-specific low back pain.
Community efectiveness
The potential for any therapy to reduce
burdon of illness in a community of patients has
several components (see Fig. 1) [l]. These include: (1) efficacy (the extent to which an intervention does more good than harm, given the
setting of optimal diagnostic accuracy, appropriate management, and patient compliance);
(2) diagnostic accuracy (the extent to which
patients are correctly diagnosed); (3) health
provider compliance with standards of appropriate management; (4) patient compliance; and
(5) coverage (availability and acceptability of
health care services). The cornerstone of these
is efficacy but, theoretically, all should be
assessed to accurately predict the magnitude of
therapeutic effectiveness. The nature of possible
interrelationships or interactions among these
factors is not known. Therefore, the iterative
loop assumes that these factors function
independently and that a simple multiplicative
probabilistic model is acceptable for estimating
community effectiveness.

Eflcacy. Therapy for acute low back pain

is uncertain. Therapies are myriad but several
reviews [2, 12,26-301 have recently critically
appraised these modalities and found no
evidence of efficacy for many. What then
constitutes appropriate
therapy? The usual
prescription is bed rest, analgesics, sometimes
back school or physical therapy, and possibly
muscle relaxants. Does evidence support this
regimen?
The Quebec Task Force, using formal critical
appraisal guidelines, recently reviewed the evidence regarding therapy through mid-1985 [2].
Because randomized controlled trials are the
gold standard of experimental design [31],
we independently recritiqued the randomized
controlled trials identified by the Quebec Task
force, using one trained physician-reviewer
(VAL). We found some evidence of benefit
from randomized controlled trials for the
following modalities: bed rest, back school,
physical therapy, non-steroidal anti-inflammatory drugs, and muscle relaxants. We did not
find sufficient evidence of benefit for the
other therapeutic modalities including spinal
manipulation. We then updated the critical
appraisal of randomized controlled trials for
bedrest, back school, physical therapy, nonsteroidal anti-inflammatory drugs and muscle
relaxants through March 1989 using the same
single reviewer. We used Medline and the search
terms of backache, not chronic disease, bed rest,
patient education, anti-inflammatory
agents
(non-steroidal,
exploded), muscle relaxants
(central, exploded), physical therapy (exploded),
and manipulation (orthopedic, exploded). In
addition, we used text word searches for the
terms back, ache and school.
Bedrest has been shown to result in earlier
return to active duty in young military recruits
[32], but two recent studies have reassessed this
therapy from different perspectives. Deyo et al.
[33] found that 2 days of bedrest was equal
to 7 days in terms of functional, physiologic,
and self-reported outcomes. Gilbert et al. [34]
found no differences in a randomized trial of
four regimens: (1) physical therapy plus education plus bedrest, (2) physical therapy plus
education, (3) bedrest only, and (4) a control
regimen of none of these modalities. It is not
clear that bedrest for any period is beneficial,
and in light of increasing interest in early return
to work plus the complexities of workers compensation [2,35], bedrest should be evaluated
further.

Acute Low Back Pain and Economics of Therapy

For acute back pain, four randomized controlled trials evaluated various forms of education and counselling about spinal physiology
and anatomy formalized into a program known
as back school [12,34,36,371. The landmark
study [12], of workers in an automotive plant
in Sweden, found that subjects randomized to
back school lost significantly fewer days from
work (median of 20.5 days) compared to subjects randomized to physiotherapy or to a
placebo regimen of shortwave heat therapy
(median of 26.5 days for both groups). Two
important problems limit interpretation of these
results: (1) data are presented as median values
only, rather than means with estimates of variance; (2) there was no clear difference between
back school and physiotherapy in duration of
symptoms (14.8 and 15.8 days) although both
treatments appeared better than placebo (28.7
days). Gilbert gt al. [34] found no difference in
efficacy in a randomized trial of four regimens
for acute low back pain: (1) physical therapy
plus education plus bedrest; (2) physical therapy
plus education; (3) bedrest only; and (4) no
therapy (control). All groups were given the
same analgesic regimen. This study found no
beneficial effect of a back school program but
did not document that patients had mastered
the programs techniques.
Two other randomized trials [36,37] tested
the back school approach but their design flaws
preclude valid conclusions about the efficacy of
this modality. The critical review by Linton [30]
delineates most of the evidence and methodological issues in published evaluations of
back school. In summary, the two best studies
of back school [12,34] come to conflicting
conclusions about its efficacy.
Five randomized controlled trials evaluated
physical therapy [38-421. However, none used
sufli&ntly
sound methodology
to generate
valid conclusions about this modality for acute
nonspecific low back pain. Physiotherapy
maneuvers varied widely among the studies
(e.g. isometrics, mobilization, traction, flexion
exercises, massage, hot packs, moist heat).
Methodological problems included: inconsistencies in types of pain studied; no description of
inclusion and exclusion criteria; no control for
placebo and Hawthorne effects; and possible
Type II error.
Three randomized controlled trials found
a nonsteroidal anti-inflammatory drug to be
beneficial for acute musculoskeletal pain when
compared with placebo [43-451. Six randomized

305

controlled trials have compared non-steroidal

anti-inflammatory
drugs to other analgesics
for acute pain [46-511. The non-steroidal antiinflammatory drugs were as benefleial as, but
not unequivocally superior to, aspirin or the
other analgesics (meptazinol, acetaminophen,
acetaminophen plus codeine, chlormezanon*
acetaminophen) in relieving pain.
Six placebo-controlled clinical trials evaluated muscle relaxants [52-57] and the earlier
trials [52-541 suggested benefit. A recent trial
[Sq found baclofen to be significantly better
than placebo in functional, physiologic, and
self-reported outcomes, especially for patients
with severe pain. However, it was associated
with significantly more side effects, most commonly affecting the central nervous system,
and a significantly higher withdrawal rate.
Most recently, results of double-blind, placebo
controlled trials suggest that tizanidine, alone or
combined with ibuprofen may be effective early
in short term therapy (7 days) for moderate
and severe pain associated with paravertebral
muscle spasm [56,571. However, it appears
to be associated with drowsiness and other
central nervous system effects. Additionally,
carisoprodol, when compared to diazepam in a
blinded study, appeared to be effective [26].
In summary, evidence from controlled clinical
trials suggests that bedrest, backschool, and
physical therapy may be beneficial but does not
demonstrate clear superiority of any of these
modalities. Analgesics, including non-steroidal
anti-inflammatory
drugs, appear efficacious.
Muscle relaxants may be beneficial for some
patients with severe pain,. but adverse effects
on the central nervous system might prevent
a patient with mild to moderate pain from
returning to normal activities or work as early
as possible. Although spinal manipulation is
also often recommended we did not find
sufficient evidence in our initial critique of
randomized controlled trials to indicate therapeutic effect. Our conclusion agreed with that
of two other critical reviews [26,27J. Two
additional reviews, directed at spinal manipulation only, concluded that properly controlled trials demonstrate an immediate effect
(minutes to hours) but equivocal results in
terms of longer range outcomes such as return
to work or resumption of activities [28,29].
Two controlled trials published subsequently
suggest that manipulation may be effective for
specific subgroups of patients so further study is
necessary [58,59].

306

VALERIE
A. LAWRENCE
et al.

Proven efficacy is the cornerstone

of
community effectiveness for any therapy. At this
point, no measures other than analgesics for
acute non-specific low back pain appear to be
clearly beneficial. Further study is necessary to
test efficacy of bedrest, back school, physical
therapy, plus spinal manipulation. Given the
lack of clear evidence for efficacy beyond antiinflammatory analgesics, early return to work or
normal activities also should be evaluated as a
therapeutic option. Further, in the absence of
certain warning signs, it is possible that patients
should be educated to not even seek medical
care for back pain.
Diagnostic accuracy. For most patients, no
specific cause for acute low back pain is found.
The goal of diagnosis is to correctly and
efficiently identify the majority who have no
significant pathology (e.g. malignancy, infection). Current recommendations
are for a
directed history and physical examination,
followed by conservative therapy and observation for the majority [2,23,27,60].
For
patients without risk factors for a specific diagnosis (e.g. younger than 20 or older than 50,
evidence of trauma, neoplasm, fever, neurological deficit, or recurrent pain), X-rays and
laboratory
work are not routinely recommended initially [2,23,27,60]. However, the
diagnostic accuracy of this approach has not
been systematically tested.
Health provider compliance. We are unaware
of any studies which evaluate the extent of
provider compliance with current recommendations for conservative management of acute
and subacute lumbar pain. One study examined
compliance with recommendations for limited
use of lumbosacral spine films for patients with
acute back pain, Deyo and Diehl published
criteria intended to reduce overutilization of
roentgenograms
while selecting for patients
likely to have important abnormalities on films
[61]. Frazier et al. then retrospectively compared hypothetical roentgenography use based
on these criteria with actual use in their walkin clinic population [62]. They found low
compliance with the published criteria; full
compliance would have more than doubled
ordering of films without apparent significant
gain in diagnosis. This study was retrospective
with limitations in completeness of the pertinent
medical record but found few serious causes
of pain (1.5%). The results may be site
specific and not generalizable to all patient
care settings but the study is important in its

systematic evaluation of the yield of physician

compliance.
Patient compliance. Patient compliance with
conservative management has been examined
to some extent. In a recent study of 2 days vs
7 days bedrest for patients with non-specific
acute low back pain [33], compliance was about
25% for the 7-day regimen. Patients randomized to 2 days bedrest had a mean of 2.3 days
at bedrest, but inspection of the data indicate
that approximately 25% reported 1 day of
bedrest or less. Recent evidence indicates that
in the setting of acute low back pain, patient
satisfaction with minimal diagnostic workup
and compliance with conservative management is highly tied to adequate explanation and
reassurance [63,64].
Coverage. Coverage is the extent to which
health care services are appropriately utilized by
those who could benefit from it. It is distinct
from patient compliance in that it is the extent
to which individuals make contact with health
professionals. It includes availability and awareness of services and their expected benefits.
Clearly, for acute non-specific low back pain,
coverage will vary widely among health care
settings. Variations in community effectiveness
among therapies may therefore be site-specific.
Economic evaluation

Given the unanswered questions described

above, it appears that we have little grasp of
community effectiveness for any therapy for
acute and subacute non-specific low back pain.
Considerable time and resources are being spent
on therapies of unclear efficacy for uncertain
yield in overall effectiveness and potential
reduction in burden of illness. In this setting, the
iterative loop can be an analytical springboard.
We performed modified economic evaluations
for the three therapeutic strategies for which
there is some evidence of efficacy from randomized controlled clinical trials (2 days of bedrest,
back school, physiotherapy) plus the program
recommended by the Quebec Task Force on
Spinal Disorders for initial management of
acute non-specific low back pain [2]. We assumed consistent use of analgesics and muscle
relaxants among the four strategies. We predicated all four modalities on a directed history
and physical examination and risk stratification.
Our full definitions of the four strategies are
given in the Appendix. Briefly, by bedrest we
mean absolute bedrest at home. Back school is
primarily an educational program in spinal

Acute Low Back Pain and Economics of Therapy

rneehanics and postural techniques to reduce

mechanical stress to the spine. Physical therapy
foeuses on exercises done with a therapist. The
management recommended by the Quebec Task
Force on Spinal Disorders [2] combines a short
period of bedrest with physical therapy and
instruction in spine mechanics and posture.
Classically, an economic evaluation is a
comparison of alternatives after clinical effectiveness has been established [65j. Theoretically,
an economic evaluation is unnecessary in the
situation of unproven efficacy, but for a health
issue with the economic impact of low back
pain, it can be helpful for several reasons. If a
practice has no clinical value, it is important to
define how much we are paying for no return.
If a practice has limited clinical value, it is
useful to examine the extent to which it
competes with other health interventions for
health care dollars. An estimate of economic
efficiency can guide clinical practice during
times of uncertainty and demonstrate the potential value of research to adequately define
efficacy and effectiveness.
We performed a modified cost-benefit
analysis for the four therapies of bedrest, back
school, physiotherapy, and the initial (first step)
management program recommended by the
Quebec report [2]. To measure costs for 2 days
bedrest, back school and physical therapy, we
used data from published literature which gave
sufhciently detailed descriptions of the interventions and measured outcome in terms of absence
from work (see the Appendix) [12,33]. Average
duration of work absence for the Quebec program was obtained directly from Task Force
data [66]. Back school and physical therapy
programs vary from site to site. We used the
Swedish automative plant study to measure
costs of these two interventions because it gave
detailed descriptions of both, although we realize that duration of work absence may not be

307

comparable between the U.S. and Sweden [12].

We assumed equal community e%ctiveness for
all four therapies.
We performed modified analyses because
data are inadequate for complete economic
analyses. For example, data are strikingly lacking on the number of recurrences of acute low
back pain over a predetermined period of time
and measurement of disability other than days
away from work. For our calculations, the
following assumptions were made:
(1) Components of cost were direct medical
costs plus indirect costs of lost earnings.
(2) We assumed only one episode of acute
low back pain per year, occurring at the
beginning of the year [3];
(3) For the modified cost-benefit analysis,
benefit was the difference in cost among
the four programs, which included direct
medical costs and indirect costs of lost
productivity, or lost earnings. This
method underestimates the benefits of
any program because lost earnings, or
reduced productivity, does not represent
the full effect of illness. Inability to
work due to illness has two components:
(1) reduced productivity, which we
measured by lost earnings, and (2) other
social, emotional, clinical factors in
disability and loss of well-being. Our
analysis takes into account only the 8rst
component. Costs arereported in 1985
Canadian dollars. The resulting costs
given in Table 2 may appear low to
readers in the U.S. but they reflect a
system which is less costly compared to
the U.S.
Estimates for costs of the therapies were
obtained as follows:
(i) Physicians fees: Ontario Health Insurance Plan Fee Schedule, 1985;

Table 2. Summary of modified cost-benefit analysis (CBA)*

CBA assuming equal community effectiveness
for all four therapies

Physiotherapy
Back School
zzE!!t

Direct
medical
wst

Days lost
from work

Indirect
cost of lost
earnings

Total cost

$1084
1313
1340
256

26.5 [12]
20.5 [12]
8.4f661
3.1[33]

s2533
1960
803
2%

33617
3273
2143
552

cost
averted with
bedWt

Threshold values for

recumnarates
compared to bedrest:
reduced rate of
reWrmna nee&d to
equal bedrest in cost

DO65
2721
1591

6.6
5.9
3.8

*Figures in 1985 Canadian dollars. Conversion factor to 1985 U.S. dollars is 0.7. homes equal use of analgesics z&d mus@e
relaxants among the fbur therapies.
tFirst step management recommended by the Quebec Task Force on Spinal Disorders [2].
CE &,3-H

VALERIE
A. LAWRENCE
et al.

308

(ii) Organizational and operating costs for

back school and physiotherapy: outpatient department costs were calculated
by the simultaneous allocation method
1651; therapists salaries were based on
average salaries, Chedoke-McMaster
Hospital, McMaster University, Hamilton, Ontario; oranization costs were
estimated by the hospital. For none of
the four therapies is the cost of a spousecaretaker included.
(iii) Days lost from work: number of days
was estimated from the published
literature or obtained directly from the
Quebec Task Force on Spinal Disorders
[12,33,66]; lost earnings were calculated
using workers paid hourly wage in
Canadian manufacturing [67].
Table 2 shows the results of analyses of
cost-benefit, or difference in cost among the
four therapies, assuming equal community
effectiveness. This analysis indicates that the
lowest cost per case of acute non-specific back
pain is incurred when 2 days of bedrest is
prescribed. The combined management program recommended by the Quebec Task Force
on Spinal Disorders appears less expensive than
physical therapy or back school, even though it
contains elements of both, because the available
data suggest it may be associated with less work
absence. The results suggest that until more
information is available regarding efficacy, compliance coverage and recurrence rates, restricted
bedrest at home is the most economically
efficient therapy. However, if recurrence rates
differ among treatments, this superiority may
not hold. To explore the issue of recurrences
further we calculated recurrence rate threshold
values for the different treatment strategies
compared to bedrest. Threshold values were
calculated with the formula:
Cost of treatment other than bedrest
Cost of treatment with bedrest
= number of episodes treated with bedrest (initial
+ recurrences) needed to equal other treatment in cost

This ratio assumes that the only important

variables are medical costs and lost productivity
or earnings.
Table 2 shows the results of these calculations. In a 1 year period, physiotherapy and
back school would have to be associated
with approximately six times fewer episodes to
approach bedrest in cost-benefit. The manage-

ment program recommended by the Quebec

Task Force would have to be associated with
3.8-fold fewer episodes than bed rest for equivalent cost-benefit. In light of recent evidence
suggesting therapeutic effectiveness [58,59],
spinal manipulation would have to be associated with work absence equal to that for bedrest
to approach it as a lower cost modality. However, more precise information is needed on the
true recurrence rate of acute low back pain in
both treated and untreated patients and on the
length and nature of disability associated with
each treatment.
In summary, given the current evidence of
efficacy for these therapies, bedrest plus analgesics and possibly muscle relaxants is the most
efficient management of acute/subacute low
back pain. In addition, the management program recommended by the Quebec Task Force
on Spinal Disorders [2] consistently performs
better than back school and physical therapy.
Although this program has components of back
school and physiotherapy, it appears to be less
costly because the little data available suggest it
may be associated with less absence from work.
Synthesis, implementation and program
toring

moni-

The purpose of these steps in the iterative

loop is to integrate feasibility with estimates
of effectiveness and efficiency in order to
make recommendations for implementating and
monitoring a health care intervention from
the community perspective. Feasibility rests
on identification of possible constraints on
implementation in specific settings, which may
be social, cultural, political, or logistic. For
example, the program recommended by the
Quebec Task Force on Spinal Disorders actively
moves the patient through a protocol designed
to facilitate early return to work and maximize
reassurance to the patient. In contrast, a simple
bedrest regimen may be perceived as less
attractive to the patient due to its relative
provider inaction. Another important component is definition of realistic objectives, or
targets, by which to monitor outcomes. Full
assessment of the impact of a health care issue,
its management, and evaluation of reduction in
burden of illness requires accurate ongoing
monitoring of patient outcomes and quality of
care. The fulcrum of these steps is clear evidence
of efficacy for any therapeutic or prophylactic
intervention. For acute non-specific low back
pain, the occupational perspective may be the

Acute Low Back Pain and E&mmica of Therapy

most e&ctive approach for implementation and

monitoring because of the burden of illness that
residues in the workplace.
SUMMARY

We have applied the iterative loop model

to the complex illness of acute/subacute nonspecific low back pain in order to systematically
examine the various facets of this health care
problem and to evaluate the economic implications of several widely used therapies. This
model uses two assumptions which may not be
accurate. First, flow around the loop is in one
direction, without second order interactions
among the components of the model. Although
such interactions may exist, insufhcient data
exist to incorporate them into the analysis.
Second, in the absence of data that provide
conditional probabilities, the iterative loop
model assumes the components of therapeutic
effectiveness (e.g. diagnostic accuracy, efficacy,
provider and patient compliance) are probabilistically independent and can be combined in
a simple multiplicative model. The loops value
is in utilizing a global conceptual framework for
the fnst time to integrate the various facets of a
health problem associated with a large burden
of illness for which therapy is not yet definitive.
We performed modified cost-benefit analyses
of the three therapeutic modalities for which
there was some evidence of efficacy from randomized controlled trials: bedrest, physical
therapy, backschool, plus combined management as recommended by the Quebec Task
Force on Spinal Disorders [2]. The analysis
indicated that bedrest is the most economically
efficient therapy and the management program
recommended
by the Quebec Task Force
ranked second. However, because of lack of
data we could not address the factor of possible differences in frequency of recurrence
with the different therapies. We recognize that
inadequate and inaccurate data from published literature may have resulted in spurious
quantification in our analyses. Specifically, comparisons of outcomes between the study of
bedrest by Deyo et al. [33] and the study of back
school in Sweden [12] are especially problematic. Back school may be more applicable to
prophylaxis rather than treatment of a single
episode of .back pain and the philosophy about
work disability may be very different between
the two countries. The fact that these were the
only data available for our analysis underscores

309

how little clear and valid information on useful

therapy is available to practitioners; managing
this complex clinical problem. We consider
these dif&ulties to be a strength rather than a
weakness of this evaluation, as they emphasize
that accurate relevant information is needed for
every facet of the community health issue of
acute back pain. The results of our evaluation
are to be explored and tested.
We think the greatest potential for reducing
burden of illness rests in several specific areas of
research. For burden of illness, the most cogent
questions now are: (1) accurate determination
of both direct and indirect costs of acute
non-specific low back pain; (2) improved characterization of length and type of disability and
impaired quality of life associated with this
syndrome; (3) accurate data about recurrence
rates. The most important issues in etiology
appear to be (1) ascertainment of any clinical
subtypes of acute non-specific low back pain
which may respond to spe&c therapy (e.g.
physical therapy, back school), and (2) definition of the determinants of chronic functional
impairment.
Determination of effective therapy for acute
non-specific low back pain needs research attention on several fronts: (1) formal evaluation of
the accuracy of conservative diagnostic strategy;
(2) assessment of the comparative. e&ctiveness
of 2 days bedrest, early. return to usual activities, a monitored combination therapy program
and spinal manipulation in terms of pain relief,
successful return to usual activities, timely
identification of other pathology (e.g. neoplasm,
infection), prevention of recurrence, and early
identification of potential chronic disability; (3)
evaluation of programs to ,educate patients in
effective self-management of acute non-specific
low pack pain; (4) assessment of back schools
prophylactic potential for recurrence of pain; (5)
testing of interventions to prevent chronic disability once the predisposed patient is identified.
Once progress has been made toward resolution of these issues of diagnosis and therapy,
we will need to address questions of maximixing
patient and provider compliance. It is feasible
that relatively small inexpensive clinical trials
would answer questions about diagnostic accuracy, compliance and coverage. It is clear from
the wide range of estimates found in our survey
that. tamrate quantif%ation of these variables
is necessary, followed by well designed trials
of interventions to improve these components
of community effectiveness.

VALERIEA. LAWRENCEet al.

310

Economic evaluation can be an effective tool

at any juncture in our level of knowledge about
acute non-specific low back pain. As we have
shown, it is helpful in identifying unanswered
questions and potential avenues for research.
Combined with information about burden of
illness and possible reductions in that burden, it
can also be a powerful adjunct in determining
economic feasibility of proposed investigations.
In addition, when armed with adequate data
about the true nature of disability, recurrence
rate and effective therapy, we will be poised to
use economic evaluation to clearly delineate
cost-effective strategies in various clinical settings. Then it will be reasonable to integrate
issues of feasibility, implementation and health
program monitoring. As the last step, it will be
possible to close the loop for the first round
and measure outcome, or achieved reduction in
burden of illness.
Acknowledgement-This
study was supported by a training grant from the National Center for Health Services
Research and Health Care Technology Assessment, U.S.
Public Health Service.

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APPENDIX
Therapies
Two airys bedrest: absolute bedrest (except for bathroom
privileges) at home [33].
Back School: four instructional sessions, 45 minutes each,
given by a trained therapist, which concentrate on instruction in spinal mechanics, spinal stress, correct posture, and
correct lifting and moving techniques to reduce mechanical
stress to the spine. In addition, this therapy includes one
30-minute swimming instruction, and two work site visits to
assess incorporation of the instructional material into work
activities [12].
Physiotherapy: four l-hour visits to a physiotherapist
which include information (l-2 minutes), physical examination (5-15 minutes), and exercises (45-55 minutes). In this
therapy, the emphasis is on exercises done with the physiotherapist, although brief instruction in spinal mechanics and
posture is included [12].
The management recommended by the Report of the
Quebec Task Force on Spinal Disorders comprises components of the former three: bedrest, limited course of
physiotherapy, and instruction in proper posture and spine
mechanics [2]. After consultation with members of the
Task Force, we interpret this program as 2 days bedrest (as
above) followed by physiotherapy, if needed, as described
above. Visits to the physiotherapist would be in an ambulatory setting and would include postural instructions as given
in Back School.