Annals of Internal Medicine 2014 (Sep 16); 161 (6): 381—391 ~ FULL TEXT
Gert Bronfort, DC, PhD; Maria A. Hondras, DC, MPH; Craig A. Schulz, DC, MS;
Roni L. Evans, DC, PhD; Cynthia R. Long, PhD; and Richard Grimm, MD, PhD
University of Minnesota,
Northwestern Health Sciences University, and
Berman Center for Outcomes and Clinical Research at
the Minneapolis Medical Research Foundation,
Minneapolis, Minnesota, and
Palmer Center for Chiropractic Research,
BACKGROUND: Back-related leg pain (BRLP) is often disabling and costly, and there is a paucity of research to guide its management.
OBJECTIVE: To determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with BRLP.
DESIGN: Controlled pragmatic trial with allocation by minimization conducted from 2007 to 2011.
SETTING: 2 research centers (Minnesota and Iowa).
PATIENTS: Persons aged 21 years or older with BRLP for least 4 weeks.
INTERVENTION: 12 weeks of SMT plus HEA or HEA alone.
MEASUREMENTS: The primary outcome was patient-rated BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks. Blinded objective tests were done at 12 weeks.
RESULTS: Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over home exercise and advice (HEA) (difference, 10 percentage points [95% CI, 2 to 19]; P=0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P=0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.
LIMITATION: Patients and providers could not be blinded.
CONCLUSION: For patients with back-related leg pain (BRLP), SMT plus home exercise and advice (HEA) was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.
From the FULL TEXT Article:
Back-related leg pain (BRLP) is an important symptom
commonly associated with pervasive low back pain
(LBP) conditions and, despite its socioeconomic effect, has
been generally understudied. With poorer prognosis and
quality of life, persons with BRLP have greater pain severity
and incur more work loss, medication use, surgery, and
health-related costs than those with uncomplicated LBP. [1–6]
Most patients with BRLP are treated with prescription
medications and injections, although little to no evidence
supports their use. [7, 8] Surgical approaches are also commonly
applied, although there is only some evidence for
short-term effectiveness compared with less invasive treatments.  Concerns are mounting about the overuse,
costs, and safety of these conventional medical treatments [10–18], warranting identification of more conservative
treatment options. Spinal manipulative therapy (SMT), exercise,
and education promoting self-management are increasingly
recommended as low-risk strategies for BRLP.  Although limited, evidence shows that these conservative
approaches can be effective. [20–26] A recent systematic
review by our group showed that SMT is superior
to sham SMT for acute BRLP in the short and long term;
however, the evidence for subacute and chronic BRLP is
inconclusive, and high-quality research is needed to inform
clinical and health policy decisions.  The underlying
mechanisms of SMT seem to be multifactorial, including
improvement in spinal stiffness, muscle recruitment, and
synaptic efficacy of central neurons. [27, 28]
The purpose of this study was to test the hypothesis
that the addition of SMT to home exercise and advice
(HEA) would be more effective than HEA alone for patients
with subacute and chronic BRLP.
This pragmatic trial used a parallel design with allocation
by minimization and has been described previously.  Patients were recruited between 2007 and 2010, and
follow-up was completed in 2011. Institutional review
boards approved the study protocol, and all patients provided
written consent. The primary outcomes and most
secondary outcomes were self-reported; objective measures
were obtained by blinded examiners. There were no important
changes to methods after trial commencement.
Settings and Patients
The trial was conducted at institution-affiliated research
clinics at Northwestern Health Sciences University
(Minneapolis, Minnesota) and Palmer College of Chiropractic
(Davenport, Iowa). Patients were recruited through
newspaper advertisements, direct mail, and community
posters. Interested patients were initially screened by telephone
interviews, followed by 2 in-person baseline evaluation
visits. Inclusion criteria were age 21 years or older;
BRLP based on Quebec Task Force on Spinal Disorders
classifications 2, 3, 4, or 6 (radiating pain into the proximal
or distal part of the lower extremity, with or without neurologic
signs) (30); BRLP severity of 3 or greater (scale of 0
to 10); a current episode of 4 weeks or more; and a stable
prescription medication plan in the previous month. Exclusion
criteria were Quebec Task Force on Spinal Disorders
classifications of 1, 5, 7, 8, 9, 10, and 11 (pain without
radiation into the lower extremities, progressive
neurologic deficits, the cauda equina syndrome, spinal fracture,
spinal stenosis, surgical lumbar spine fusion, several
incidents of lumbar spine surgery, chronic pain syndrome,
visceral diseases, compression fractures or metastases, blood
clotting disorders, severe osteoporosis, and inflammatory
or destructive tissue changes of the spine). Patients could
not be receiving ongoing treatment of leg pain or LBP; be
pregnant or nursing; have current or pending litigation for
worker’s compensation, disability, or personal injury; be
unable to read or comprehend English; or have evidence of
A Web-based program assigned patients to treatment
after the second baseline visit using a minimization algorithm
based on the Taves method , balancing on 7
baseline characteristics previously shown to influence
outcomes. [32–34] Baseline characteristics included age,
BRLP duration, neurologic signs, distress, positive straight
leg raise, time spent driving a vehicle, and pain aggravation
with coughing or sneezing. Patients were assigned in a 1:1
ratio, stratified by site. The allocation algorithm was prepared
by the study statistician before enrollment, and its
administration was concealed from study personnel.
The intervention protocols were developed and tested
in previous pilot studies. [32, 33] Both interventions were
intended to be pragmatic in nature (for example, modified
to patient presentation and needs) and were informed by
commonly recommended clinical practices, patient preferences,
and promising research evidence. [19, 35–38]
Eleven chiropractors with a minimum of 5 years of
practice experience delivered SMT in the SMT plus HEA
group. Thirteen providers (7 chiropractors, 5 exercise therapists,
and 1 personal trainer) delivered the HEA intervention.
When possible, patients worked with the same providers
during the 12–week course of care; however, to
accommodate patient and provider schedules during the
intervention period, providers were trained to comanage
patients. Treatment fidelity was facilitated through standardized
training, manuals of operation, and clinical documentation
forms that were monitored weekly by research
SMT Plus HEA Group
As many as 20 SMT visits were allowed, each lasting
10 to 20 minutes, including a brief history and examination.
Patients assigned to SMT plus HEA also attended 4
HEA visits, as described in the HEA Group section. For
SMT visits, the primary focus of treatment was on manual
techniques (including high-velocity, low amplitude thrust
procedures or low-velocity, variable amplitude mobilization
maneuvers to the lumbar vertebral or sacroiliac joints).
The specific spinal level treated and the number and frequency
of SMT visits were determined by the clinician on
the basis of patient-reported symptoms, palpation, and
pain provocation tests.  Adjunct therapies to facilitate
SMT were used as needed and included light soft-tissue
techniques (that is, active and passive muscle stretching
and ischemic compression of tender points) and hot or
cold packs. To facilitate adherence to HEA, chiropractors
asked about patients’ adherence, reaffirmed main HEA
messages, and answered questions as needed.
Home exercise and advice were delivered in four
1–hour, one-on-one visits during the 12–week intervention.
The main program goals were to provide patients with the
tools to manage existing pain, prevent pain recurrences,
and facilitate engagement in daily activities.
Instruction and practice were provided for positioning
and stabilization exercises to enhance mobility and increase
trunk endurance. These were individualized to patients’
lifestyles, clinical characteristics (including positional sensitivities),
and fitness levels. Positioning exercises included
extension and flexion motion cycles (patients were encouraged
to perform 25 repetitions 3 times per day in the
lying, standing, or seated position). [33, 40] Stabilization
exercises included pelvic tilt, quadruped, bridging, abdominal
curl-ups, and side bridging with positional variations
appropriate to patients’ tolerance and abilities.  Patients
were instructed to do 8 to 12 repetitions of each
stabilization exercise every other day.
Patients were also instructed in methods for developing
spine posture awareness related to their activities of
daily living, such as lifting, pushing and pulling, sitting,
and getting out of bed.  Information about simple
pain-management techniques, including cold, heat, and
movement, was also provided.
Printed materials were distributed to take home and
review. They included instructions of exercises with photos
and a modification of the Back in Action book , emphasizing
movement and restoration of normal function
and fitness. [35, 44]
To facilitate adherence to HEA, providers called or
e-mailed patients 3 times (at 1, 4, and 9 weeks) to reaffirm
main messages and answer exercise-related questions.
Outcomes and Measurements
Patients’ demographic and clinical characteristics were
collected at their first baseline visit through self-report
questionnaires, histories, and physical examinations. Selfreported
outcomes were collected at the baseline visit and
at 3, 12, 26, and 52 weeks via questionnaires independent
of study personnel influence. Patients were queried in each
questionnaire about attempts to influence their responses.
The primary outcome measure was patient-rated typical
level of leg pain during the past week using an 11–
point numerical rating scale, a reliable, valid, and important
patient-centered outcome. [36, 45–47] The primary
end points were 12 weeks, which was the end of the intervention
phase, and the 52–week follow-up.
A complete description of all secondary outcome measures
is provided elsewhere.  The measures reported in
this article include LBP, disability measured with the modified
Roland–Morris Disability Questionnaire [48–50],
physical and mental health status using the Short Form-36
Health Survey (SF–36) [51, 52], patient satisfaction ,
global improvement , and frequency of medication use
for back and leg pain in the past week. 
Patient expectations about treatment were measured
using an 11–box numerical rating scale (0 meaning treatment
was not at all helpful and 10 meaning it was extremely
helpful) at baseline. Expected side effects were
measured using a self-report questionnaire by indicating
presence or absence of 7 symptoms as well as bothersomeness
on an 11–box numerical rating scale (0 meaning symptoms
were not at all bothersome and 10 meaning they were
Secondary, biomechanical, and clinical objective outcomes
were straight leg raise and muscle endurance tests at
baseline and 12 weeks collected by examiners who were
independent of treatment delivery and masked to group
assignment. Three-dimensional lumbar motion, standing
postural sway, sudden load response, self-reported fear
avoidance, self-efficacy, and qualitative data about patient
perceptions of care were also collected and will be reported
Sample size was calculated to ensure 85% power to
detect an 8–percentage point mean difference between
groups in patient-rated leg pain; 8 to 11 percentage points
have been recommended as a minimally important group
difference in pain and disability for LBP studies.  We
assumed an SD of 17 percentage points and 17% loss to
follow-up on the basis of our latest pilot study  and a
0.05 level of significance for a 2–tailed test at one end point
to calculate a target sample size of 96 patients per group,
We used an intention-to-treat approach in which patients
were analyzed according to their original treatment
assignment. All observed data were used in the analyses.
Data analyses were done using SAS, version 9.3 (SAS Institute).
All regression models included terms for site and
the variables used in the minimization algorithm for treatment
allocation. Dependent on the outcome variable, adjusted
mean differences or odds ratios and 95% CIs between
groups at weeks 12 and 52 were presented.
The primary outcome variable, patient-rated leg pain,
was modeled with mixed-effects regression over baseline
(the average value obtained at the 2 baseline visits) and 3,
12, 26, and 52 weeks. After assuming that group means
were the same at baseline, the additional terms in the
model were time (as a categorical variable) and site-bygroup
and time-by-group interactions. The site-by-group
interaction was removed if it was not significant at the 0.05
level. Because we tested between-group differences at 2
primary end points, we used the Bonferroni method to
control for 2 tests.
Responder analyses were done for pain reduction of
50%, 75%, and 100% at the end of treatment at 12 weeks
and at the 52–week follow-up. [55–57] The differences in
proportions between groups were calculated for patients
with data at each end point based on each criterion, and
95% CIs were based on the Wilson score method. 
The secondary outcome variables, patient-rated LBP
scores, disability scores, SF-36 physical and mental
health component scores, global improvement scores, and
satisfaction scores, were analyzed with the same methods as
patient-rated leg pain but without controlling for multiple
testing. Two approaches were used for sensitivity analyses
to examine the possible effects of missing data on the results
(Appendix and Appendix Tables 1 and 2, available at
www.annals.org). The ordinal categorical variable representing the number of days that patients used any medications over the past week for leg pain or LBP was analyzed
at baseline and at 3, 12, 26, and 52 weeks with a proportional
odds model. Generalized estimating equations using
all observed data with an independent covariance structure
were used to fit the model. The change in the biomechanical
variables from baseline to end of treatment were evaluated
by analysis of covariance.
Role of the Funding Source
This trial was funded by the U.S. Department of
Health and Human Services. The funding source did not
participate in the study design, data collection, analysis and
interpretation of the data, or writing of this article.
A total of 1132 patients were initially screened by
phone, and 658 attended 1 or 2 clinic baseline visits. We
enrolled 192 patients: 70 at the Iowa site and 122 at the
Minnesota site (Figure 1). Allocation resulted in baseline
comparability between groups. Table 1 summarizes the demographic
and clinical characteristics of enrolled patients.
Approximately 90% of the patients in both groups had
Study flow diagram.
Of the 192 enrolled patients, 191 (99%) provided
follow-up data at 12 weeks and 179 (93%) at 52 weeks.
Overall, 94% of study patients attended their prescribed
treatment visits: 98% in the SMT plus HEA group and
91% in the HEA group. The mean number of HEA visits
was 3.8 (SD, 0.6; median, 4.0) in the SMT plus HEA
group and 3.6 (SD, 1.0; median, 4.0) in the HEA group.
The mean number of SMT visits was 14.6 (SD, 3.8; median,
16) in the SMT plus HEA group. Each HEA provider
delivered care to approximately the same number of
patients in each treatment group (range for SMT plus
HEA group, 1 to 38; range for HEA group, 2 to 47); 7
chiropractors who delivered SMT plus HEA also delivered
at least 1 HEA session. Patients receiving SMT plus HEA
had slightly greater expectations of improvement (scale of 0
to 10) from their assigned treatment (mean, 9.0 [SD, 1.8]
than the HEA group (mean, 7.6 [SD, 2.0]). One patient
reported being influenced on how he answered the questionnaire
at 12 weeks and indicated that it was by a person
who was not involved with the study. There were no crossovers
of treatment assignments during the trial. Group differences
have been standardized into percentage points for
all outcomes to facilitate interpretation of effect magnitude.
The adjusted and unadjusted results were very similar
and did not affect the conclusions.
On the basis of the adjusted means of the primary
outcome measure, patient-rated leg pain, there was an advantage
of SMT plus HEA over HEA alone after 12 weeks
(10 percentage points [95% CI, 2 to 19]; P = 0.008) but
not at the 52–week follow-up (7 percentage points [CI, –2 to 15]; P = 0.146) (Table 2). Figure 2 shows the adjusted
group means of patient-rated leg pain over time. At 12
weeks, 37% of patients receiving SMT plus HEA had at
least a 75% reduction in leg pain, compared with 19% in
the HEA group. Twenty percent of patients receiving SMT
plus HEA had a 100% reduction, compared with 5% in
the HEA group (Table 2).
At 12 weeks, the adjusted means in the SMT plus
HEA group were better than those in the HEA group for
LBP (difference, 9 percentage points [CI, 3 to 16];
P = 0.005) (Table 2), disability (difference, 11 percentage
points [CI, 5 to 17]; P < 0.001) (Table 3), SF-36 physical
component score (difference, 3.4 percentage points [CI,
1.0 to 5.8]; P = 0.006) (Appendix Table 3, available at
www.annals.org), global improvement (difference, 10 percentage
points [CI, 14 to 5]; P = 0.02) (Table 3), and
satisfaction (difference, 13 percentage points [CI, 17 to 9];
P < 0.001) (Table 3). There were no significant between-group
differences for the SF-36 mental health component
score at 12 weeks (Appendix Table 3).
At 52 weeks, the SMT plus HEA group sustained better
global improvement (difference, 6 percentage points
[CI, 11 to 1]; P = 0.02) (Table 3) and satisfaction (difference,
10 percentage points [CI, 16 to 6]; P < 0.001) (Table 3) than did the HEA group. However, no significant
long-term differences were seen for LBP, disability, and
SF-36 mental health and physical component scores (Tables 2 and 3 and Appendix Table 3).
The proportions of patients still using medication for
leg or back pain at 12 weeks was 56% for SMT plus HEA
versus 63% for HEA and 42% versus 66% at week 52,
respectively. The odds of the SMT plus HEA group having
fewer versus more medication days was 1.8 (CI, 1.0 to 3.1)
times that for the HEA group at 12 weeks and 2.6 (CI, 1.4
to 4.7) at 52 weeks.
Adjusted group means in patient-rated LBP, disability,
and global improvement over time are shown in Figure 2.
The sensitivity analyses for the assumptions that data were
missing at random and were not missing at random
showed estimated model coefficients of consistent magnitude
and in the same direction as the results reported here.
All statistically significant between-group differences remained
the same (Appendix).
The SMT plus HEA group had better extension trunk
endurance (14.2 seconds; P = 0.001) (Appendix Table 4,
available at www.annals.org) and performed better in the
straight leg raise test, although it was of borderline significance
(left, P = 0.054; right, P = 0.051) (Appendix Table 4). There were no between-group differences in flexion
and side bridge endurance.
During the 12–week intervention, 10 patients reported
visits to nonstudy health care providers for their leg pain or
LBP: 3 in the SMT plus HEA group (2 chiropractic visits
and 1 massage therapy visit) and 7 in the HEA group (3
multiple provider visits, 2 medical physician visits, 1 chiropractic
visit, and 1 massage therapy visit). By 52 weeks,
81 patients had sought additional health care since the end
of the study treatment phase: 38 in the SMT plus HEA
group and 43 in the HEA group.
Five serious adverse events occurred during the trial,
all unrelated to study interventions (1 due to bowel obstruction
in the HEA group and 4 due to anaphylaxis,
sports-related trauma, heart condition, and menorrhagia in
the SMT plus HEA group). No deaths occurred among the
enrolled patients. Expected adverse events were mild to
moderate, self-limiting, and reported by 30% of patients in
the SMT plus HEA group and 42% in the HEA group
To our knowledge, this is one of the first adequately
powered pragmatic trials to focus on patients with subacute
and chronic BRLP. Both groups demonstrated improvement
during the 12–week intervention. Similar patterns
were seen for all outcome measures, showing that SMT
plus HEA was more effective than HEA alone on all selfreport
outcomes except SF-36 mental health status after 12
weeks of treatment. This short-term advantage for the
SMT plus HEA group was sustained only for global improvement,
medication use, and satisfaction at the
Determination of the clinical importance of betweengroup
mean differences has not been well-standardized;
however, we facilitated interpretation by considering many
factors in aggregate, including the magnitude of group differences
(54), consistency of results, durability of treatment
effect, intervention safety and tolerance, and patients’ ability
to adhere to treatment. 
The magnitude of 10 percentage points for the group
differences of the primary outcome, leg pain, translates to a
medium effect size of 0.6  in favor of SMT plus HEA,
which is considered clinically important. Further, we saw
consistent statistically significant and clinically important
group differences for nearly all other outcomes in the short
term and for some secondary outcomes in the long term in
favor of SMT plus HEA, including global improvement,
an important and recommended patient-centered outcome. [45, 61] Group differences in the responder analyses for
patient-rated leg pain consistently favored SMT plus HEA.
The SMT plus HEA group had less aggravation of leg
pain. Of importance, patients receiving SMT plus HEA
used less medication during the treatment phase and at the
52–week follow-up. On the basis of these factors, we consider
the group differences in aggregate in this trial to be
clinically important, consistently favoring SMT plus HEA
over HEA alone, especially in the short term.
Various terms describe radiating leg pain associated
with back pain (such as radiculopathy, sciatica, and
BRLP). There is a need for consensus on the classification
and definition of radiating leg pain to facilitate comparison
between studies.  We used the term BRLP to be consistent
with the Quebec Task Force on Spinal Disorders
Classification Taxonomy.  Back-related leg pain was
defined by a constellation of symptoms characterized by
radiating pain originating from the lumbar spine and traveling
into the proximal or distal lower extremity with or
without neurologic signs.
There is currently no first-line therapy for BRLP that
is clearly supported by a strong evidence base. This is illustrated
by recent systematic reviews that found insufficient
evidence to confidently guide the use of prescription medication
for the effective management of BRLP.  Further,
epidural corticosteroid injections have been shown to provide
only short-term relief of leg pain and disability for
patients with BRLP.  Surgery for BRLP associated with
image-verified disc herniation has been shown to be superior
to conservative interventions only in the short term. [9, 63] The lack of evidence is further compounded by growing
concerns about the safety of these commonly used interventions. [10–18]
Before this study, there was moderate-quality evidence
that SMT is superior to sham SMT for acute BRLP in the
short and long term; however, the evidence for subacute
and chronic BRLP was inconclusive because of poor study
quality. This evidence was based on conclusions from an
earlier systematic review by our group , which searched
MEDLINE, EMBASE, CINAHL, Index to Chiropractic
Literature, Mantis, PEDro, and the Cochrane Library for
all randomized trials published through July 2010. Eleven
trials were identified, 8 of which included patients with
subacute or chronic BLRP and none of which were considered
to be at low risk of bias (for example, high-quality).
We did an updated search through April 2014, using the
same search strategies described previously. We identified a
small randomized study of surgical candidates for chronic
sciatica that found similar outcomes for spinal manipulation
and surgery.  Because of the small sample size and
lack of baseline comparability, we consider that study to be
at high risk of bias. Thus, our current trial adds to the
much-needed evidence base about SMT for subacute and
The trial has several strengths, including a rigorous
design and interventions intended to be pragmatic in nature
and reflect clinical practice, patient needs, and the best
available research. Also, patients older than 65 years were
included, resulting in a greater mean age than in similar
studies (but with similar clinical characteristics to other
trials, including primary care settings), enhancing generalizability. [64–66] The study is limited by the inability to
blind patients and providers to the nature of the treatments
and differentiate between the specific treatment effects and
contextual (nonspecific) effects (such as patient–provider
interactions). Qualitative data collection examining patients’
perspectives will shed more light on these issues and
are planned for future publications. This study was not
designed to assess the effectiveness of SMT alone. Although
that is a worthwhile question, this trial was intentionally
pragmatic in nature, comparing the relative clinical
effectiveness of commonly used treatment approaches by
approximating how they are delivered in practice. 
Given the dearth of high-quality research investigating
conservative interventions for BRLP, there are several opportunities
for future research, including those that directly
compare manual therapy with commonly used medical
treatments and address cost-effectiveness. Further qualitative
studies would be useful in identifying potential mediators
and moderators of outcome to aid in individualizing
treatments to best meet the preferences and abilities of
patients with BRLP.
For patients with subacute and chronic BRLP, SMT
in addition to HEA is a safe and effective conservative
treatment approach, resulting in better short-term outcomes
than HEA alone.
The authors thank the coinvestigators at both sites
for their collaboration to develop and analyze the biomechanical objective
outcome measures and qualitative data, which will be reported elsewhere.
The authors also thank the research patients, clinicians, therapists,
and staff for the successful conduct of this trial.
By the Health Resources and Services Administration,
U.S. Department of Health and Human Services (grant R18HP07638).
Reproducible Research Statement:
Study protocol: Available at http://chiromt.com/content/19/1/8. Statistical code: Available from Dr. Long
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