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Spinal manipulation compared with back school and with individually delivered physiotherapy for the treatment of chronic low back pain: A randomized trial with one-year follow-up

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To compare spinal manipulation, back school and individual physiotherapy in the treatment of chronic low back pain. Randomized trial, 12-month follow-up. Outpatient rehabilitation department. 210 patients with chronic, non-specific low back pain, 140/210 women, age 59 +/- 14 years. Back school and individual physiotherapy scheduled 15 1-hour-sessions for 3 weeks. Back school included: group exercise, education/ ergonomics; individual physiotherapy: exercise, passive mobilization and soft-tissue treatment. Spinal manipulation, given according to Manual Medicine, scheduled 4 to 6 20'-sessions once-a-week. Roland Morris Disability Questionnaire (scoring 0-24) and Pain Rating Scale (scoring 0-6) were assessed at baseline, discharge 3, 6, and 12 months. 205 patients completed the study. At discharge, disability score decreased by 3.7 +/- 4.1 for back school, 4.4 +/- 3.7 for individual physiotherapy, 6.7 +/- 3.9 for manipulation; pain score reduction was 0.9 +/- 1.1, 1.1 +/- 1.0, 1.0 +/- 1.1, respectively. At 12 months, disability score reduction was 4.2 +/- 4.8 for back school, 4.0 +/- 5.1 for individual physiotherapy, 5.9 +/- 4.6 for manipulation; pain score reduction was 0.7 +/- 1.2, 0.4 +/- 1.3, and 1.5 +/- 1.1, respectively. Spinal manipulation was associated with higher functional improvement and long-term pain relief than back school or individual physiotherapy, but received more further treatment at follow-ups (P < 0.001); pain recurrences and drug intake were also reduced compared to back school (P < 0.05) or individual physiotherapy (P < 0.001). Spinal manipulation provided better short and long-term functional improvement, and more pain relief in the follow-up than either back school or individual physiotherapy.
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Clinical Rehabilitation
http://cre.sagepub.com/content/24/1/26
The online version of this article can be found at:
DOI: 10.1177/0269215509342328
2010 24: 26Clin Rehabil
and Claudio Macchi
Francesca Cecchi, Raffaello Molino-Lova, Massimiliano Chiti, Guido Pasquini, Anita Paperini, Andrea A Conti
follow-up
physiotherapy for the treatment of chronic low back pain: a randomized trial with one-year
Spinal manipulation compared with back school and with individually delivered
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Clinical Rehabilitation 2010; 24: 26–36
Spinal manipulation compared with back school
and with individually delivered physiotherapy for
the treatment of chronic low back pain: a randomized
trial with one-year follow-up
Francesca Cecchi,Raffaello Molino-Lova,Massimiliano Chiti,Guido Pasquini,Anita Paperini Fondazione Don Carlo
Gnocchi, Scientific Institute, Florence, Andrea A Conti and Claudio Macchi Fondazione Don Carlo Gnocchi, Scientific
Institute, Florence and Department of Medical and Surgical Critical Care, University of Florence, Italy
Received 10th April 2009; returned for revisions 24th May 2009; revised manuscript accepted 13th June 2009.
Objective: To compare spinal manipulation, back school and individual
physiotherapy in the treatment of chronic low back pain.
Design: Randomized trial, 12-month follow-up.
Setting: Outpatient rehabilitation department.
Participants: 210 patients with chronic, non-specific low back pain, 140/210
women, age 59 14 years.
Interventions: Back school and individual physiotherapy scheduled 15
1-hour-sessions for 3 weeks. Back school included: group exercise, education/
ergonomics; individual physiotherapy: exercise, passive mobilization and soft-tissue
treatment. Spinal manipulation, given according to Manual Medicine, scheduled 4
to 6 20’-sessions once-a-week.
Outcome: Roland Morris Disability Questionnaire (scoring 0-24) and Pain Rating
Scale (scoring 0-6) were assessed at baseline, discharge 3, 6, and 12 months.
Results: 205 patients completed the study. At discharge, disability score decreased
by 3.7 4.1 for back school, 4.4 3.7 for individual physiotherapy, 6.7 3.9
for manipulation; pain score reduction was 0.9 1.1, 1.1 1.0, 1.0 1.1,
respectively. At 12 months, disability score reduction was 4.2 4.8 for back
school, 4.0 5.1 for individual physiotherapy, 5.9 4.6 for manipulation; pain
score reduction was 0.7 1.2, 0.4 1.3, and 1.5 1.1, respectively. Spinal
manipulation was associated with higher functional improvement and long-term
pain relief than back school or individual physiotherapy, but received more further
treatment at follow-ups (P50.001); pain recurrences and drug intake were also
reduced compared to back school (P50.05) or individual physiotherapy (P50.001).
Conclusions: Spinal manipulation provided better short and long-term functional
improvement, and more pain relief in the follow-up than either back school or
individual physiotherapy.
Address for correspondence: Francesca Cecchi, Fondazione
Don Carlo Gnocchi, IRCCS, Outpatient Rehabilitation
Department, V. Caccini 18, 50141 Florence, Italy.
e-mail: francescacecchi2002@libero.it
ßThe Author(s), 2010.
Reprints and permissions: http://www.sagepub.co.uk/journalsPermissions.nav 10.1177/0269215509342328
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Introduction
The treatment for chronic low back pain is still
very controversial. Many interventions, including
back school, education, specific exercise and spinal
manipulation are claimed to be effective in the
short term, but there is insufficient evidence that
these approaches provide long-term effects on pain
and function.
1
Exercise therapy is a generally recommended
treatment for chronic low back pain, but the
most effective exercise approach is still under dis-
cussion; a recent review suggests that individually
designed supervised exercise programmes, includ-
ing stretching or strengthening, may provide more
functional improvement and pain relief than home
exercise in chronic non-specific low back pain.
2
Back school was first developed in Sweden in
1969,
3
conveying group back exercises with patient
information/education and ergonomic training
aimed at optimizing functional recovery. Since
then, many different models of back school have
been proposed and a recent Cochrane review con-
cludes that there is moderate evidence that back
school has better effects on pain and functional
status than other treatments for patients with
recurrent and chronic low back pain in the short
and intermediate term.
4
Individually delivered physiotherapy sometimes
combined with individually tailored, active exer-
cise, with passive or assisted mobilization or with
manual treatment, is another widely adopted
approach to the treatment of chronic low back
pain. Different protocols and types of exercise
may be involved in the delivery of such treatment,
but the overall effectiveness and cost-effectiveness
of this one-to-one approach are under
question.
2,5,6
Spinal manipulation and vertebral mobilization
are also widely used in clinical practice, and there
is evidence of the effectiveness of spinal manipu-
lation both in the acute and in the subacute or
chronic phase of low back pain.
7,8
Nevertheless,
it is not clear whether this intervention is more
effective than anti-inflammatory drugs in reducing
low back pain,
9
and there is no evidence that
spinal manipulation therapy is superior to other
standard treatments for patients with acute or
chronic low back pain.
10
Many experts agree
that there are more similarities than differences
in the package of techniques used by professionals
who deliver spinal manipulation.
11
Manual medi-
cine
12
is a relatively recent discipline, based on a
reproducible semiotics and a defined protocol of
interventions. Although it is widely diffused in
Europe, published evidence is scant.
13
This paper presents a pragmatic clinical study
conducted on patients with chronic non-specific
low back pain. Our objective was to compare
the short- and long-term effects of back school,
individual physiotherapy and spinal manipulation,
delivered according to manual medicine, with low
back pain-related disability as our primary
outcome.
Subjects and methods
Home-dwelling patients examined for a complaint
of low back pain in our rehabilitation outpatient
department were consecutively recruited by the two
physiatrists involved in the study. Non-specific low
back pain, reported ‘often’ to ‘always’ at least for
the past six months, determined eligibility.
14
Exclusion criteria were: neurological signs or symp-
toms, spondylolisthesis4second degree, spinal ste-
nosis, lumbar scoliosis 420 degrees, rheumatoid
arthritis or spondylitis, previous vertebral frac-
tures, psychiatric disease, cognitive impairment
or pain-related litigation. Eligible patients were
invited to participate in the trial and were asked
for their written consent. All recruited patients pro-
vided standard radiographs of the lumbar spine
and 99 also provided CT or MR scans.
Once enrolled, each patient was given a progres-
sive number and the secretary of the outpatient
department assigned patients to their treatment
group based upon a three-column series (one for
each treatment) of randomly generated numbers,
without any restriction. The enrolling physician
was blind as to which number corresponded to
which treatment.
All patients received a booklet with evidence-
based, standardized educational information on
basic back anatomy and biomechanics, optimal
postures, ergonomics and the advice to stay active.
Therapists with a university degree in physio-
therapy and at least five years’ experience were
Spinal manipulation versus exercise therapy for chronic low back pain 27
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involved in giving either back school or individual
physiotherapy according to standard protocols,
which they had been trained to apply under super-
vision when they first started working in our
department. The back school protocol was
designed referring to the original Swedish model
3
to include 15 one-hour sessions, 5 days a week.
The first five were devoted to information and
group discussions on back physiology and pathol-
ogy, with reassurance on the benign character of
common low back pain, and with education in
ergonomics at home and in different occupational
settings by slides and demonstrations. The next 10
sessions included relaxation techniques, postural
and respiratory group exercises, and individually
tailored back exercises. Back school groups
included eight patients each; two therapists
together ran all 15 sessions for each group.
Individual physiotherapy included passive and
assisted mobilization, active exercise,
2
massage/
treatment of the soft tissues,
15
and proprioceptive
neuromuscular facilitation,
16
with emphasis on
patient education and active treatment. The pro-
tocol presented a range of exercises
2–4
from which
the therapists were allowed to select in order to
adapt the interventions to specific patient charac-
teristics. The patients assigned to either interven-
tion were treated for 15 sessions lasting 60 minutes
each, five times a week, for three consecutive
weeks (15 hours of treatment altogether).
Spinal manipulation was performed according
to the manual medicine approach described by
Maigne.
12
The whole spine was examined by
static and dynamic assessment. Treatment was
aimed at restoring the physiological movement in
the dysfunctional vertebral segment(s) and con-
sisted in vertebral direct and indirect mobilization
and manipulation, with associated soft tissue
manipulation, as needed. Patients assigned to the
this group received 4–6 (as needed) weekly sessions
of 20 minutes each for a total of 4–6 weeks of
treatment (80–120 minutes of treatment alto-
gether). Two physicians specializing in physical
medicine and rehabilitation, who had received
similar training and had been practising manual
medicine for 9 and 12 years respectively, per-
formed manipulations; the same physician deliv-
ered the whole cycle of treatment to the patient,
once assigned. Discharge was the physician’s clin-
ical decision, when desired results were obtained
or there was no indication of prosecute manipula-
tion (i.e. no more dysfunctional vertebral segments
to be manipulated).
Baseline and follow-up questionnaires were
administered by three independent interviewers
at the outpatient department. The examiners
were blinded to group assignment. The primary
outcome measure was low back pain-related func-
tional disability, assessed by the Roland Morris
Disability Questionnaire,
17
a self-report measure
considered by many authors to be the ‘gold stan-
dard’ in low back pain trials.
18
The questionnaire
scores from 0, representing no low back pain-
related disability, to 24, representing maximum
low back pain-related disability. We regarded as
clinically important a difference of the Roland
Morris Disability score among groups equal or
greater than 2 points, reported by many authors
as clinically relevant in low back pain trials.
19
Pain
intensity, measured by the Roland Morris Pain
Rating Scale,
16
an ordinal scale varying from 0
(no pain), to 6 (almost unbearable pain), was
also reported.
Assessments were performed at baseline, on dis-
charge and at three, six and twelve months after
discharge. Baseline assessment also included
demographics, household, weight, height, occupa-
tion and work satisfaction (rated on a 0–4 scale,
from unsatisfied to highly satisfied). Retirement
related to low back pain was also recorded and,
in those working, sick leave (‘did you lose any
working days because of low back pain in the
past six months?’) or change of job.
Follow-up assessment also included the report
of low back pain recurrences, low back pain-
related use of drugs (‘Are you currently taking
any medication for low back pain?’) and request
of further treatment for low back pain (‘Did you
receive any further treatment for low back pain in
the time between follow-ups?’) at each follow-up.
Further information included, for those who were
working at baseline, low back pain-related days of
sick leave, change of job or retirement in the time
between follow-ups
The sample size was estimated based on our pri-
mary outcome (Roland Morris Disability score).
Routine administration of Roland Morris
Disability Questionnaire before/after treatment in
all low back pain patients treated by physiother-
apy in our department showed an average
28 F Cecchi et al.
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after-treatment score of 8.1 3.4. Thus, we esti-
mated that a sample of around 60 patients per
group would have been able to detect a difference
among groups of at least 2 points in the disability
score after the treatment,
19
with a 0.8 power at the
two-sided 0.05 level. Accordingly, we enrolled 60
participants per group; however, because simple
(non-restricted) randomization led to some imbal-
ances in patient’s baseline characteristics, we
decided to enlarge the sample and continued enrol-
ment up to 70 patients per group.
Analysis
Data were analysed using the STATA 7.0 soft-
ware, from Stata Corporation (College Station,
TX, USA).
20
Baseline differences across groups
were compared using the ANOVA, the chi-
square test or the Kruskal–Wallis rank test for
continuous, categorical or ordinal variables,
respectively. Changes in disability score and pain
intensity from baseline to discharge and to follow-
ups were tested using the Wilcoxon rank test.
Differences in Roland Morris Disability score
and pain rating score on discharge and at the
three follow-ups were analysed using the
Kruskal–Wallis rank test. Differences in the pro-
portion of participants reporting pain recurrences,
low back pain-related use of drugs and further
treatment for low back pain were analysed using
the chi-square test.
Results
Patients were consecutively recruited between April
2002 and October 2006. Follow-up data collection
was completed by January 2008. Figure 1 shows the
flow diagram of the study. Seventy patients were
randomly assigned to each treatment group.
Among those assigned to back school, two patients
discontinued the treatment, one because of concur-
rent illness and one because of family problems.
Among those assigned to individual physiotherapy,
two patients discontinued the treatment, both
because of concurrent illness and among those
assigned to manipulation, one patient discontinued
the treatment because of concurrent illness.
Drop-outs were all women, aged 55–77 years.
Sixty-eight back school patients, 68 individual
physiotherapy patients and 69 spinal manipulation
patients completed the study protocol. Since 205
patients were analysed, our ‘per protocol’ analysis
was substantially similar to the ‘intention to treat’
analysis commonly adopted in reporting rando-
mized trials because of the minimal drop-out
(5/210, 2.4%). All participants who completed
back school and individual physiotherapy attended
at least 12 of the 15 sessions. The 69 participants
who completed spinal manipulations attended 4–6
once-a-week sessions (mean 4.2 SD 0.6).
The demographic and clinical characteristics of
the study sample according to intervention are
shown in Table 1. No significant difference
across the groups was found with regard to age,
gender, household, weight, height, disability score,
pain intensity, low back pain-related use of drugs,
retirement and change of job because of low back
pain. The number of those currently working was
significantly higher in the spinal manipulation
group. Among those working, the number report-
ing sick leave in the past six months was signifi-
cantly higher in the back school group.
Table 2 shows low back pain-related disability
and pain intensity on discharge and at the three
follow-ups, according to the received treatment.
No significant difference in Roland Morris
Disability score was found between back school
and individual physiotherapy on discharge and
at the three follow-ups. On the contrary, spinal
manipulation showed a significantly lower disabil-
ity score on discharge and at the three follow-ups
when compared with either other intervention. No
significant difference in pain rating scale was
found between back school and individual physio-
therapy on discharge and at the three follow-ups.
When compared with either back school or indi-
vidual physiotherapy, spinal manipulation did not
show any significant difference in pain relief on
discharge, while at the three follow-ups pain inten-
sity was significantly lower in the spinal manipu-
lation group.
At the end of the treatment all three groups
reported a significant improvement in disability
score (mean reduction 3.7 4.1 for back school,
4.4 3.7 for individual physiotherapy and
6.7 3.9 for spinal manipulation, P50.001 for
the three groups) and in pain rating scale (mean
reduction 0.9 1.1 for back school, 1.1 1.0 for
Spinal manipulation versus exercise therapy for chronic low back pain 29
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Assessed for eligibility
LBP primary complaint
(n = 443)
Excluded (n = 233)
– Did not meet inclusion
criteria (n = 184)
– Refused to participate
(n = 49)
Randomly allocated (n = 210)
Back school
Allocated to intervention
(n = 70)
Allocated to intervention
(n = 70)
Allocated to intervention
(n = 70)
– Received complete
intervention (n = 68)
– Received complete
intervention (n = 68)
– Received complete
intervention (n = 69)
– Discontinued
intervention (n = 2)
1 concurrent illness
1 family problems
– Discontinued
intervention (n = 2)
2 concurrent illness
– Discontinued
intervention (n = 1)
1 concurrent illness
Individual physiotherapy: Spinal manipulation:
Lost to follow-up (n = 0) Lost to follow-up (n = 0) Lost to follow-up (n = 0)
Followed up at
– discharge n = 68
– 3 months n = 68
– 6 months n = 68
– 12 months n = 68
Followed up at
– discharge n = 68
– 3 months n = 68
– 6 months n = 68
– 12 months n = 68
Followed up at
– discharge n = 69
– 3 months n = 69
– 6 months n = 69
– 12 months n = 69
Analysed (n = 68) Analysed (n = 68) Analysed (n = 69)
Excluded from analysis
(n = 2)
Excluded from analysis
(n = 2)
Excluded from analysis
(n = 1)
Figure 1 Flowchart of the study. LBP, low back pain.
30 F Cecchi et al.
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individual physiotherapy and 1.0 1.1 for spinal
manipulation, P50.001 for the three groups)
when compared with baseline data. Specifically,
the reduction in disability score was significantly
greater in the spinal manipulation group when
compared with both back school and individual
physiotherapy groups (P50.001 for both), while
there was no significant difference among groups
with regard to the reduction in pain rating scale.
One year later, compared to baseline, all three
groups maintained a significant improvement in
Roland Morris Disability score (mean reduction
4.2 4.8 for back school, 4.0 5.1 for individual
physiotherapy and 5.9 4.6 for spinal manipula-
tion, P50.001 for the three groups) and in pain
rating scale (mean reduction 0.7 1.2 for back
Table 2 Low back pain-related disability and pain intensity according to the received treatment
Back school
(n¼68)
Individual
physiotherapy
(n¼68)
Spinal
manipulation
(n¼69)
Differences
across groups
P-value*
BS vs. IP
P-value*
BS vs. SM
P-value*
IP vs. SM
P-value*
Roland Morris Disability score
Discharge (mean, SD) 5.9 4.8 5.3 5.2 1.6 2.6 50.001 0.270 50.001 50.001
Three-month follow-up
(mean, SD)
5.3 4.7 5.4 4.7 2.2 3.3 50.001 0.903 50.001 50.001
Six-month follow-up
(mean, SD)
5.4 4.7 5.8 5.0 2.7 3.4 50.001 0.717 50.001 50.001
Twelve-month follow-up
(mean, SD)
5.3 4.6 5.7 5.0 2.5 3.6 50.001 0.742 50.001 50.001
Pain rating scale
Discharge (mean, SD) 1.0 0.8 0.9 0.8 1.2 1.2 0.401 0.225 0.747 0.259
Three-month follow-up
(mean, SD)
1.4 1.2 1.5 1.2 0.5 0.7 50.001 0.739 50.001 50.001
Six-month follow-up
(mean, SD)
1.4 1.0 1.4 1.1 0.8 0.7 50.001 0.856 50.001 50.001
Twelve-month follow-up
(mean, SD)
1.3 0.9 1.6 0.9 0.7 0.8 50.001 0.128 50.001 50.001
*From Kruskaal-Wallis rank test.
BS, back school; IP, individual physiotherapy; SM, spinal manipulation.
Table 1 Baseline patient characteristics according to the assigned treatment
Back school
(n¼70)
Individual
physiotherapy
(n¼70)
Spinal
manipulation
(n¼70)
Differences
across groups
P-value*
General characteristics
Age (years) (mean SD) 57.9 15.1 60.5 15.8 58.1 12.2 0.517
Women (n) 49 43 48 0.515
Living alone (n) 15 14 13 0.915
Weight (kg) (mean SD) 71.7 12.1 71.9 11.6 68.0 11.2 0.085
Height (cm) (mean SD) 167 9 166 9 166 8 0.878
Pain characteristics
Roland Morris Disability score (meanSD) 9.5 4.7 9.7 5.6 8.4 4.3 0.226
Pain rating scale (mean SD) 2.0 1.0 2.0 0.9 2.2 0.8 0.283
Low back pain-related use of drugs (n) 36 32 43 0.169
Working activity
Retired because of low back pain (n) 1 3 0 0.168
Working (n) 25 31 40 0.038
Sick leave because of low back pain (n) 16 10 7 0.001
Change of job because of low back pain (n) 1 1 0 0.472
*From ANOVA, chi-square test or Kruskal–Wallis rank test, as appropriate.
Spinal manipulation versus exercise therapy for chronic low back pain 31
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school, P50.001, 0.4 1.3 for individual phy-
siotherapy, P¼0.021 and 1.5 1.1 for spinal
manipulation, P50.001). Specifically, the reduc-
tion in the Roland Morris Disability score was
significantly greater in the spinal manipulation
group when compared with both back school
(P¼0.029) and individual physiotherapy groups
(P¼0.010), and also the reduction in pain rating
scale was significantly greater in the spinal manip-
ulation group when compared with both back
school and individual physiotherapy groups
(P50.001 for both).
Table 3 shows low back pain recurrences, low
back pain-related use of drugs and request of fur-
ther treatment for low back pain at the three
scheduled follow-ups, according to the received
treatment. When compared with back school, indi-
vidual physiotherapy showed significantly higher
reports of frequent low back pain at 3- and 6-
month follow-ups but not at 12-month follow-
up, while low back pain-related use of drugs and
further treatment for low back pain were similar
across all follow-ups. When compared with back
school, spinal manipulation showed a significantly
less frequent report of low back pain at 3- and 12-
month follow-ups, but not at 6-month follow-up,
while when compared with individual physiother-
apy, reports of low back pain were significantly
less frequent in spinal manipulation at all
follow-ups. When compared with either other
intervention, spinal manipulation showed a signif-
icantly less frequent report of low back pain-
related use of drugs at all three follow-ups.
Reports of further treatment for low back pain
were significantly more frequent in the spinal
manipulation group when compared with either
back school or individual physiotherapy at 6-
and 12-month follow-ups, while at 3-month
follow-up reports of further treatment for low
back pain were significantly more frequent only
when compared with individual physiotherapy.
For 33 of the 40 patients seeking further care in
the spinal manipulation group, treatment con-
sisted in a short cycle of spinal manipulations
(data not shown).
Working patients were 25 for back school, 31
for individual physiotherapy and 40 for spinal
manipulation. In the one-year follow-up, no
patient retired from work because of low back
pain, while four patients reported to have changed
their job because of low back pain (one back
school and one individual physiotherapy at three
months, one back school and one individual phys-
iotherapy at six months). People reporting low
back pain-related sick leave in the time between
follow-up were five at three months (two back
school, two individual physiotherapy, one spinal
manipulation), four at six months (two back
school, one individual physiotherapy, one spi-
nal manipulation) and one at 12 months
Table 3 Reports of frequent low back pain, low back pain-related use of drugs and further treatment for low back pain
according to the received treatment
Back
school
(n¼68)
Individual
physiotherapy
(n¼68)
Spinal
manipulation
(n¼69)
Differences
across
groups
P-value*
BS vs. IP
P-value*
BS vs. SM
P-value*
IP vs. SM
P-value*
Reports of frequent low back pain
Three- month follow-up (n)21 34 6 50.001 0.024 0.001 50.001
Six-month follow-up (n)16 30 850.001 0.012 0.073 50.001
Twelve-month follow-up (n)24 34 9 50.001 0.086 0.003 50.001
Low back pain-related use of drugs
Three-month follow-up (n) 17 20 8 0.037 0.565 0.047 0.011
Six-month follow-up (n) 18 22 8 0.015 0.454 0.031 0.004
Twelve-month follow-up (n) 19 22 8 0.013 0.577 0.018 0.004
Further treatment for low back pain
Three-month follow-up (n) 11 6 20 0.007 0.196 0.067 0.002
Six-month follow-up (n)8 9 3650.001 0.796 50.001 50.001
Twelve-month follow-up (n)14 8 40 50.001 0.164 50.001 50.001
*From
2
test.
BS, back school; IP, individual physiotherapy; SM, spinal manipulation.
32 F Cecchi et al.
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(spinal manipulation), for a total number of 35
days at three months (30 back school, 2 individual
physiotherapy, 3 spinal manipulation), 23 at six
months (17 individual physiotherapy, 3 back
school, 3 spinal manipulation) and 4 at 12
months (4 spinal manipulation) – data not
shown. None of the drop-outs interrupted treat-
ment because of adverse events or worsening of
symptoms. None of those who completed the
treatment reported adverse events during the
observation period.
Discussion
In this pragmatic clinical study we compared the
short- and long-term effects of three recommended
treatments for chronic, non-specific low back pain
in a selected outpatient population. Spinal manip-
ulation provided more functional improvement
than either physiotherapy intervention, at dis-
charge and all across follow-ups. Further, pain
relief at follow-ups was also significantly more rel-
evant in spinal manipulation patients. Low back
pain recurrences and reduction of pain-related use
of drugs were also most striking for the spinal
manipulation group.
On the other hand, patients who underwent
spinal manipulation were more prone to receive
further care in the follow-up, even in the case of
rare recurrences of low back pain. Treatment in
most cases consisted of a short cycle of spinal
manipulation. Though all patients received stan-
dardized education and advice to stay active,
these results suggest that spinal manipulation
may have been less effective than physiotherapy
in promoting self-management of recurrences,
21
while the better pain control in this group com-
pared with either back school or individual phys-
iotherapy seemed to be obtained by more than
occasional return to treatment in the long term.
However, reasons for seeking and getting further
care may be different, such as the requirement for
a medical prescription, prompt availability of the
required treatment, direct or indirect cost of the
treatment, and the patient’s characteristics, includ-
ing outdoor mobility and transport availability,
which we did not investigate in detail.
The individual physiotherapy approach pro-
vided a similar outcome in the short term to the
group physiotherapy approach represented by
back school, but more individually treated patients
reported recurrence of frequent-constant low back
pain in the follow-up, and this difference from the
back school group reached significance at 3 and 6
months from baseline. Thus back school provided
a similar and, for some results, even better out-
come than individual physiotherapy. Indeed,
though emphasis on active self-treatment was
given in both interventions, as well as a discharge
home exercise programme, we hypothesize that the
educational, more function-centred approach of
back school was more effective in actually promot-
ing self-treatment and compliance to a home pro-
gramme.
2,22
Furthermore, it is possible that the
manual treatment and personal assistance received
in individual treatment were actually more valued
by individual physiotherapy patients than active
exercise. This hypothesis would also explain why
outcome differences developed in the follow-up,
since the effects of motivation tend to become
more evident in the long term.
23
Unfortunately,
our observer-blind study design precluded the pos-
sibility of investigating compliance to home exer-
cise in either physiotherapy group.
Because our patients could not be blinded and
the spinal manipulation was given by a physician
while the other interventions by a physiotherapist,
a patient’s different attitude to the two clinical
categories may have influenced the results. While
pointing out this possible bias, we should also
mention that since manual medicine can only be
medically delivered by definition,
12
this should not
change the pragmatic evaluation of the treatment
package ‘as it is’.
18
The same considerations apply
for the difference in duration of the first treatment
(3 weeks for back school and individual, 4.3 weeks
for spinal manipulation on average), although,
since patients in our spinal manipulation group
received a 1.2 week longer treatment than individ-
ual physiotherapy and back school, this must be
acknowledged as a major limitation in the
between-group comparisons in the short term.
On the other hand, spinal manipulation would
indeed be delivered across a wider timeframe,
but the total amount of time devoted to treatment
would be much less than either physiotherapy
Spinal manipulation versus exercise therapy for chronic low back pain 33
at Fondazione Don Carlo Gnocchi on October 29, 2012cre.sagepub.comDownloaded from
intervention (80–120 minutes vs. 15 hours
altogether).
Our study design did not include a formal cost
analysis and straightforward recommendations
cannot be drawn from our data. However, we
may be confident that individual physiotherapy’s
costs were altogether higher than back school’s,
since duration, frequency and number of sessions
were the same, but the therapist:patient ratio was
1:4 in back school and 1:1 in individual phy-
siotherapy. Thus, since back school appeared to
provide a similar short-term and similar or better
long-term outcome compared with individual
physiotherapy at lower costs, our results seem in
line with health policies promoting back school,
and in general group physiotherapy with indivi-
dualized exercise programmes,
2
rather than indi-
vidual physiotherapy for most patients with
chronic low back pain.
5,24
Such direct comparison is not possible for spinal
manipulation versus physiotherapy. Spinal manip-
ulation was associated with best results both in
terms of pain and function, but long-term results
were obtained at the price of returning more often
for further treatment in the follow-up. Thus spinal
manipulation seemed to be less effective than
physiotherapy in promoting self-treatment.
Furthermore, at least as far as manual medicine
is concerned, spinal manipulation requires avail-
ability of specialized trained physicians in the
ambulatory setting.
Observing changes within group, we found that,
on discharge, patients assigned to all three groups
reported on average a significant improvement in
the primary functional outcome measure (Roland
Morris Disability score) greater than 2.5 points.
19
Pain also improved significantly in all three
groups. Compliance was very high: of the 210 par-
ticipants recruited, only five interrupted treatment,
evenly spread across groups, and none because of
any adverse reaction or worsening of symptoms.
In the long term, all interventions were signifi-
cantly associated with maintained improvements
in disability reports. Pain scores at one year
remained significantly lower than baseline scores
for back school and spinal manipulation, but not
for individual physiotherapy. Working variables
also improved in time across groups, but our
home-dwelling Italian sample, mostly composed
of women and also including elderly patients,
had relatively few working participants, thus our
numbers were too small to detect meaningful
changes regarding working outcome.
Since our purpose was to compare already
recommended interventions for chronic, non-speci-
fic low back pain,
25
at this stage we did not select a
control group, so strictly we cannot claim effective-
ness for either intervention considered.
Furthermore, it should be mentioned that although
we selected only patients who reported constant or
almost constant low back pain in the past six
months, recruitment actually followed a specialist’s
consultation for the complaint of low back pain.
It is reasonable to suppose that chronic patients
required consultation when the symptoms exacer-
bated,
26,27
and this may have added to the positive
effects of all three interventions.
28
On the other
hand, patients assigned to all three groups reported
improvements in Roland Morris Disability score
more than the 2.5-point difference that is regarded
by many authors as clinically relevant in low back
pain trials,
19
while pain improved in all three
groups by 0.9–2.9 points out of 6. These results
were better than the pooled mean improvement
of 13.3 points (5.5–21.1) out of 100 for pain, 6.9
(2.2–11.7) out of 10 for function found in studies
investigating the effects of exercise therapy on
health care samples.
28
Furthermore, a recent sys-
tematic review of non-pharmacological therapies
for chronic low back pain for an American
Pain Society/American College of Physicians clini-
cal practice guideline reported evidence of the effec-
tiveness of cognitive-behavioural therapy, exercise,
spinal manipulation and interdisciplinary rehabili-
tation, with benefits over placebo, sham therapy
or no treatment that averaged 10–20 points on a
100-point visual analogue pain scale, 2–4 points
on the Roland Morris Disability Questionnaire.
25
Again, for any of the three interventions considered
in our study, short- and long–term pain relief and
functional improvement were more relevant than
those reported by this review.
Finally, considering that all our patients at
baseline had complained of constant low back
pain for at least six months, our 15–49% rate of
patients across groups reporting no or rare low
back pain recurrence over the last six months of
the follow-up suggested that the effects of the three
interventions were also clinically meaningful in the
long term.
26,29
34 F Cecchi et al.
at Fondazione Don Carlo Gnocchi on October 29, 2012cre.sagepub.comDownloaded from
Other study limitations include the single-site
study design, which reduces the generalizability
of the results, and the lack of a control group,
and of a structured baseline and follow-up assess-
ment of psychological well-being, which might
have added relevant information to our data. As
recent evidence suggests that clustering low back
pain patients with specific problems may predict
best outcome of different treatment,
30,31
it is pos-
sible that clustering our sample into subgroups
with specific clinical characteristics and comparing
a single intervention with a control group may
further optimize the results.
Clinical messages
In chronic non-specific low back pain, spinal
manipulation provided more functional
improvement and pain relief, and reduced
drug intake and recurrence rate than exercise
therapy, though with more treatment at
follow-up.
Compared with physiotherapy interventions,
back school had similar short-term and
better long-term outcome than individually
delivered treatment.
Competing interests
None declared.
Source of funding
The study was financed by current research
funds from the Fondazione Don Gnocchi
Foundation, Scientific Institute.
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To interpret meta-analysis results, we considered a 15-point difference in pain and a 10-point difference in functional limitations outcomes to be clinically important for the primary comparison of exercise versus no treatment, usual care or placebo. Main results: We included 249 trials of exercise treatment, including studies conducted in Europe (122 studies), Asia (38 studies), North America (33 studies), and the Middle East (24 studies). Sixty-one per cent of studies (151 trials) examined the effectiveness of two or more different types of exercise treatment, and 57% (142 trials) compared exercise treatment to a non-exercise comparison treatment. Study participants had a mean age of 43.7 years and, on average, 59% of study populations were female. Most of the trials were judged to be at risk of bias, including 79% at risk of performance bias due to difficulty blinding exercise treatments. We found moderate-certainty evidence that exercise treatment is more effective for treatment of chronic low back pain compared to no treatment, usual care or placebo comparisons for pain outcomes at earliest follow-up (MD -15.2, 95% CI -18.3 to -12.2), a clinically important difference. Certainty of evidence was downgraded mainly due to heterogeneity. For the same comparison, there was moderate-certainty evidence for functional limitations outcomes (MD -6.8 (95% CI -8.3 to -5.3); this finding did not meet our prespecified threshold for minimal clinically important difference. Certainty of evidence was downgraded mainly due to some evidence of publication bias. Compared to all other investigated conservative treatments, exercise treatment was found to have improved pain (MD -9.1, 95% CI -12.6 to -5.6) and functional limitations outcomes (MD -4.1, 95% CI -6.0 to -2.2). These effects did not meet our prespecified threshold for clinically important difference. Subgroup analysis of pain outcomes suggested that exercise treatment is probably more effective than education alone (MD -12.2, 95% CI -19.4 to -5.0) or non-exercise physical therapy (MD -10.4, 95% CI -15.2 to -5.6), but with no differences observed for manual therapy (MD 1.0, 95% CI -3.1 to 5.1). In studies that reported adverse effects (86 studies), one or more adverse effects were reported in 37 of 112 exercise groups (33%) and 12 of 42 comparison groups (29%). Twelve included studies reported measuring adverse effects in a systematic way, with a median of 0.14 (IQR 0.01 to 0.57) per participant in the exercise groups (mostly minor harms, e.g. muscle soreness), and 0.12 (IQR 0.02 to 0.32) in comparison groups. Authors' conclusions: We found moderate-certainty evidence that exercise is probably effective for treatment of chronic low back pain compared to no treatment, usual care or placebo for pain. 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