Spine (Phila Pa 1976) 2003 (Oct 1); 28 (19): 2185–2191 ~ FULL TEXT
Niemistö, Leena, MD; Lahtinen-Suopanki, Tiina, PT; Rissanen, Pekka, PhD; Lindgren,
Karl-August, MD, PhD; Sarna, Seppo, PhD; Hurri, Heikki, MD, PhD
Rehabilitation Unit of the Orthopaedic Hospital Orton,
Study design: A prospective randomized controlled trial.
Objectives: To examine the effectiveness of combined manipulative treatment, stabilizing exercises, and physician consultation compared with physician consultation alone for chronic low back pain.
Summary of background data: Strong evidence exists that manual therapy provides more effective short-term pain relief than does placebo treatment in the management of chronic low back pain. The evidence for long-term effect is lacking.
Methods: Two hundred four chronic low back pain patients, whose Oswestry disability index was at least 16%, were randomly assigned to either a manipulative-treatment group or a consultation group. All were clinically examined, informed about their back pain, provided with an educational booklet, and were given specific instructions based on the clinical evaluation. The treatment included four sessions of manipulation and stabilizing exercises aiming to correct the lumbopelvic rhythm. Questionnaires inquired about pain intensity, self-rated disability, mental depression, health-related quality of life, health care costs, and production costs.
Results: At the baseline, the groups were comparable, except for the percentage of employees (P = 0.01). At the 5- and 12-month follow-ups, the manipulative-treatment group showed more significant reductions in pain intensity (P < 0.001) and in self-rated disability (P = 0.002) than the consultation group. However, we detected no significant difference between the groups in health-related quality of life or in costs.
Conclusions: The manipulative treatment with stabilizing exercises was more effective in reducing pain intensity and disability than the physician consultation alone. The present study showed that short, specific treatment programs with proper patient information may alter the course of chronic low back pain.
KEYWORDS: low back pain, randomized controlled trial, spinal manipulation
From the FULL TEXT Article:
Chronic low back pain (CLBP) is the most common complaint
of the working-age population. In addition to human
suffering, it causes a substantial economic burden
due to the wide use of medical services and absence from
work.  Although in most patients acute LBP resolves
with conservative treatment or without any treatment,
the back pain appears to recur and become chronic more
often than expected. [2, 3]
According to the latest extensive systematic literature
review of the management of CLBP, strong evidence exists
that manual therapy provides more effective shortterm
pain relief than does placebo treatment.  Moderate
evidence indicates that manual therapy is more effective
than the usual care prescribed by the general practitioner,
including bed rest, analgesics, and massage, for
short-term pain relief.  However, the evidence for longterm
effects is lacking. [4, 5]
A recent focus in the management of CLBP patients
has been the specific training of the deep abdominal (internal
oblique and transversus abdominis) and lumbar
multifidus muscles. The primary role of these muscles is
considered to be the provision of dynamic stability and
segmental control of the spine.  A randomized controlled
trial (RCT) of specific stabilizing exercises in the
treatment of CLBP with radiologic diagnosis of spondylolysis
or spondylolisthesis showed significant reduction
in pain intensity and functional disability levels
compared with that of other commonly prescribed conservative
treatment programs. The results were maintained
during a 30–month follow-up. 
It has also been shown that subchronic LBP can be
treated successfully with an approach that includes a
clinical examination and information to patients about
the nature of the problem to reduce fear and motivate
them to resume light activity. 
The hypothesis of the present study was that manipulative
treatment with stabilizing exercises and physician
consultation would provide more effective pain relief and
alleviation of disability than physician consultation
alone. We wished to compare manipulative treatment
with an approach expected to be the most cost-effective
method.  The clinical objectives were to examine the
one-year effectiveness and cost-effectiveness of combined
manipulative treatment, stabilizing exercises, and physician
consultation compared with those from physician
consultation and patient education alone.
Patients and Methods
Study Sample and Design.
The present study was conducted
in the Rehabilitation Unit of the Orthopedic Hospital ORTON,
Invalid Foundation, Helsinki, Finland. The study was
initiated in March 1999 and completed in September 2000.
Chronic LBP patients were recruited voluntarily by a widely
circulated newspaper advertisement in February 1999. The patients
had 1 week to register for the study by phone, fax, mail,
or e-mail. The research nurse then contacted the patients by
telephone or e-mail to ensure that the candidate met the inclusion
We included 24– to 46–year-old employed (including students
and temporary housewives) patients who had LBP (with
or without sciatica) of at least 3 months’ duration. The selfrated
disability index (Oswestry Low Back Pain Disability
Questionnaire)  score had to be at least 16%. We excluded
patients with malignancies, ankylosing spondylitis, severe osteoporosis,
severe osteoarthritis, paralysis, progressive neurologic
disease, hemophilia, spinal infection, previous spinal operation,
vertebral fracture during the previous 6 months, severe
psychiatric disease, or severe sciatica with a straight leg raising
test less than 35° or with at least 1 recent motor deficit. Other
exclusion criteria included pregnancy, severe overweight (body
mass index [BMI] >32), or simultaneous spinal rehabilitation
or other spinal study.
We invited eligible patients to attend the baseline trial for
further evaluation. The clinical examination was performed
before randomization to confirm the admission criteria. The
Hospital Medical Ethics Review Board approved the study.
Patients were provided written and oral information on the
study as required by the Declaration of Helsinki  before they
were asked to sign a document signifying informed consent.
Patients in the manipulative-
treatment group attended 60–minute evaluation, treatment,
and exercise sessions 4 times in the course of 4 weeks. An
experienced manual therapist conducted the treatment sessions.
The therapy included manipulation using a muscleenergy
technique and stabilizing exercises aiming to correct the
lumbopelvic rhythm. [11, 12] Manipulation with a muscle-energy
technique was used to correct any biomechanical dysfunctions
in the lumbar or pelvic segments.  Muscle-energy technique is
a manipulative treatment procedure that uses a voluntary contraction
of the patient’s muscles against a distinctly controlled
counterforce from a precise position and in a specific direction.
Any muscular tension in either biceps femoris, rectus femoris, 
iliopsoas, or gluteus was treated by passively stretching the
muscles and teaching autostretching techniques. 
Muscle strain/tension was diagnosed by testing the range of motion of
the hip and knee joints. The restriction was measured with a
goniometer. The stabilizing exercises were taught by asking the
patients to draw in the stomach while giving them verbal, visual,
and tactile feedback and measuring the pressure change
with a biofeedback meter. In a prone position with the pressure
cushion under the lower abdomen, a pressure decrease of 4mm
Hg was considered to be the lower limit for actual independent
activation of the transversus abdominis muscle. Gradually the
patients were instructed to perform the stabilizing exercises in a
more functional manner.  Finally, the patients learned to do
these isometric exercises during their daily activities. All exercise
was by definition pain-free.
Physician’s Consultation Group.
Both the manipulative treatment group and the consultation group received a 25–page
educational booklet on basic anatomy and physiology of the
spine, principles of ergonomics for LBP patients, and instructions
on how to exercise and to cope with the acute phase of
LBP.  The clinical findings were explained with the aid of a
human skeleton, and the radiograph findings and possible
causes of pain were clarified. The patients were told that LBP
generally has a benign, self-limiting natural course. They could
hasten the process by simple regular exercises and by avoiding
The patients received individual instructions regarding
posture and three to four exercises aiming to increase
spinal mobility, muscle stretch, and/or trunk muscle stability
based on the clinical evaluation. They were also advised to
avoid long-standing static work by performing several countermovements.
When lifting heavy objects, they were told to avoid
bending and twisting and instead to use their legs. The main
principle was to encourage the patients to treat themselves instead
of undergoing passive treatments. At the 5–month followup,
this information was reinforced. Both appointments lasted
an average of 1 hour. During the follow-up, the patients were
free to use other health care services for LBP, use of which they
were asked to record.
The primary outcomes were pain intensity
and back-specific disability. Degree of experienced pain
and disability was quantified by: 1) a visual analogue scale
(VAS; from 0–100); 2) frequency of LBP experienced; and 3)
the Oswestry Low Back Pain Disability Questionnaire (ODI;
from 0–100). [10, 18]
The secondary outcomes were the degree of mental depression,
which was assessed by a Finnish Depression Questionnaire
(DEPS) ; health-related quality of life (HRQoL)
(15D),  days on sick leave, costs of health care consumption,
and productivity costs. The questionnaires were presented at
the initial examination before randomization and at follow-up
examinations 5 and 12 months after randomization.
Costs were assessed from a societal point of view. Use of
health services, direct drug and traveling costs to the patients,
and productivity costs due to absence from work were measured
by a questionnaire in the study sample before randomization
and at the 12–month follow-up.
The service fees to the
patients were not included in the cost analysis. In monetary
valuation of health services, we applied Finnish standard cost
information at the year 2000 price level.  Standard costs are
average costs for various specified procedures or diagnostic
tests by representative Finnish health care providers. Productivity
costs were valued by the average year 2000 wage level in
Finland. Because of theoretical and methodologic controversy
surrounding such valuation, we tested the effect of the valuing
algorithm on total costs by using a 50% lower estimate of the
average wage level. Costs were converted into dollars ($1 = 1.06 euros, June 2002).
Power calculations were carried out before
the study to attain a power of at least 0.80 at a significance
level of 0.05. NQuery 4.0 2-group, univariate, repeated measures
analysis of variance (ANOVA) (Greenhouse-Geisser correction)
were used.  A clinically significant difference between
the groups in the primary outcome pain intensity (VAS 0–100),
was considered to be 7 in the second phase and 5 in the third
phase, with a standard deviation of 22. Thus, the levels for the
study group were 55, 35, and 40, and for the control group 55,
42, and 45, respectively. Accordingly, this required 94 patients
per group for a total of 188 patients. Considering an expected
dropout rate of 8%, we increased the group size to 102. Patients
were included in the analysis as part of the group allocation
by randomization. Missing values in questionnaires were
not substituted for.
Baseline data were presented as means, medians, percentages,
and standard deviations. Categorical baseline variables
were analyzed by the χ2 test. Continuous baseline variables
were analyzed by an independent sample t test or in the case of
skewed distribution of the data, the Mann-Whitney U test.
Continuous outcomes were analyzed according to the intention-
to-treat principle, with repeated measures ANOVA
(group x time of assessment). In case of skewed distribution of
the data, the logarithmic or square root transformation was
used. Categorical variables (frequency of LBP experienced)
were analyzed by the likelihood ratio test for the difference in
change between time points and study groups. The heterogeneity
of the changes within the groups were tested with the
McNemar χ2 test. The data were analyzed with SYSTAT 10 for
Windows software.  Significance was accepted at the 5%
level. All P values were two-tailed.
After the patients had agreed to participate in the
study, and the anamnestic inclusion criteria were confirmed,
they were asked to complete baseline questionnaires (Table 1)
and then underwent medical examination to check the clinical
inclusion criteria. Once this was done, the research nurse randomized
the patients to either a manipulative-treatment or a
consultation group. The fixed allocation randomization procedure
was performed to guarantee an equal number of patients
in both groups. The assignments were presented in sealed, sequentially
numbered envelopes. No stratification was based on
prognostic factors. The research nurse was not responsible for
determining patient eligibility.
Patients could not be blinded in this study,  but a
blinded clinical assessment was performed before randomization
and at the 5–month follow-up. In addition, all the primary
outcomes were completed by the patients themselves.
Participant Flow and Follow-up
A patient sample of 210 was selected on the basis of
anamnestic criteria for 900 volunteers. The clear majority
of 900 volunteers were disqualified by virtue of a low
(<16%) Oswestry score. Other reasons for exclusion
were prior spinal surgery, inflammatory diseases (i.e.,
colitis ulcerosa, Mb Bechterew, rheumatoid arthritis,
etc.), simultaneous spinal rehabilitation, and unemployment
status. After the physician’s examination, 204 patients
were included in the trial: 102 assigned to the manipulative-
treatment and 102 to the consultation group.
All patients visited the physician at least once before
randomization and received a back booklet, information
on the etiology of their back pain, and instructions on
how to cope with low back trouble. Of the subjects in the
manipulative-treatment group, 94% and 92% in the
control group visited the physician for the second
checkup. All subjects assigned to the manipulative treatment
group visited the manual therapist at least
once. The mean number of therapy sessions was 4.
Five patients had a lumbar discectomy during the 12–month follow-up: 3 in the manipulative-treatment group
and 2 in the consultation group.
A total of 8 out of 204 (3.9%) patients dropped out of
the study at the 12–month follow-up. Three subjects
could not be reached after moving to an unknown address,
and five other subjects did not return the questionnaires
for unknown reasons. The trial profile is summarized
in Figure 1.
The manipulative-treatment group and the consultation
group were comparable in age, gender, duration and localization
of LBP, pain intensity, self-rated disability, depression,
and HRQoL (Table 1). The level of education
and vocational training in both groups was comparable
to that of the Finnish working-age population. The study
sample differed from the metropolitan working-age population
of Helsinki in that the proportion of white-collar
workers was larger (45% vs. 28%) and blue-collar
workers smaller (7% vs. 25%).  There was no difference
between the groups in the use of analgesics for LBP.
The percentage of employees were higher in the manipulative-treatment group (99%) than in the consultation
group (91%) (P = 0.01). The number of days on sick
leave during the previous year was slightly higher in the
consultation group (P = 0.07, Mann-Whitney U test).
The previous use of health care services (medical services,
physiotherapy, chiropractic, massage) was similar
in both groups. Tobacco use was equally common in
both groups (32% vs. 36%).
The logarithmic transformation to adjust for the nonnormal
distribution was made for the VAS, ODI, and DEPS.
The square-root transformation was made for HRQoL.
Significant improvement occurred in both groups on every
self-rated outcome measure. In the follow-up, significant
differences emerged between the groups in pain
intensity (P < 0.001, ANOVA) and in self-rated disability
(P = 0.002, ANOVA), in favor of the manipulative treatment
group. The difference between the groups in
self-rated depression was nonsignificant (P = 0.10,
At baseline, 58% of the subjects in the manipulative treatment
group and 62% in the consultation group reported
daily LBP. At the 12–month follow-up, the percentage
of daily LBP reported decreased to 37% (P = 0.001, McNemar Symmetry χ2) in the manipulative treatment
group and to 39% (P < 0.001) in the consultation
group. There were no statistically significant differences
in change between the groups. The proportion
of the patients using analgesics for their back pain decreased
from 32% to 23% in the manipulative-treatment
group and from 36% to 26% in the consultation group.
Both groups showed clinically and statistically significant
increases in HRQoL (P < 0.001, ANOVA). However,
the groups did not differ at the 12–month follow-up
(P = 0.93, ANOVA) (Table 2).
In both groups, the number of visits to physicians or
use of physiotherapy or manual therapy decreased during
the 12–month follow-up, but no significant difference
existed between the groups. Use of other health services,
such as hospital services, was minor in both groups, and
changes in these were also very small and nonsignificant
Absence from work during the previous 12 months
already differed slightly between the groups at baseline,
but this difference was not statistically significant (P = 0.07, Mann-Whitney U test). The difference was not explained
by the employment status. In the consultation
group, the number of sick leave days decreased an average of 2 days during the 12–month follow-up, whereas in
the manipulative-treatment group, the decrease was
smaller. The variance in productivity costs was large, and
consequently the difference between the groups was not
statistically significant (mean change P = 0.46, Mann-
Whitney U test). Nevertheless, the total costs decreased
$154 in the manipulative-treatment group and $450 in the
consultation group at the 12–month follow-up compared to
baseline costs (Table 3). Incremental analysis showed that a
one-point change in VAS scale cost $23 with manipulative
treatment compared to the physician consultation.
Neither group reported adverse effects.
This study showed that manipulative treatment with stabilizing
exercises and physician consultation reduced
self-rated disability and pain more than did physician
guidance and an educational booklet alone. However,
both groups also showed significant improvement concerning
all primary and secondary outcome measures in
the follow-up. Visits to physicians, physiotherapy, or
other therapies decreased in both groups, which resulted
in decreased costs for health care and for the patients.
Previous studies comparing spinal manipulation and
physiotherapy [25–28] or standard medical care [29, 30] have
found no significant differences in pain intensity and disability.
In the study by Cherkin et al, manipulative therapy
and physiotherapy separately resulted in limited benefits
and higher costs than for the educational booklet. 
In the study by Koes et al, manipulative therapy and
physiotherapy showed better outcomes than continued
treatment by general practitioners.  Data on the effectiveness
of patient information from an educational
booklet on LBP are controversial. [31–33] The effect of an
educational booklet appears to increase with personal
contact with a medical professional.  Two Norwegian
studies showed that early intervention with examination,
information, and recommendations for remaining active
reduced sickness leaves. [8, 35–37]
All of the studies have focused on patients with acute
to subchronic pain, during which period the natural recovery
rate is considerable. In our study focused on
CLBP patients, to achieve longer-lasting effects, we combined
manipulative treatment and stabilizing exercises.
Our control group with educational information alone
might not totally reflect the natural course of the LBP
syndrome. Naturally, the outcomes may be explained by
regression to the mean. On the other hand, as the baseline
mean duration of low back pain was 8 years (the
median duration 6 years) in both groups and the follow-
up period was 1 year, the recurrences of the symptoms
might as well have been expected.  Our consultation
approach has also been shown to be effective
compared to general practice or usual care in other studies.
8 Besides, total placebo intervention would have been
almost impossible to implement, for practical and ethical
In our experience, this is the first randomized controlled
trial evaluating the combined effects of manipulation
and stabilizing exercises. The economic consequences
have been evaluated thus far in only a small
number of similar studies. [27, 30] Our patient sample was
adequate for statistical power. Randomization was successful
because there were no significant differences in
baseline characteristics. The dropout rate was very low
(3.9%), suggesting that compliance to the study in both
groups was good.
The patients were recruited voluntarily by a widely
circulated newspaper advertisement which may have
motivated them more than it would the usual CLBP population.
However, the study sample was, by and large,
comparable, regarding subjective pain and disability, to
the CLBP population needing inpatient rehabilitation in
Finland. We cannot specify the effect of manipulation,
the stabilizing exercises, or the information provided
Both groups received the same information
and encouragement by the physician. The manipulative treatment
group had four more contacts than did the
consultation group, which in itself can be beneficial. A
positive association can occur between the number of
contacts with providers and improvement of backrelated
symptoms.  Thus, the improvement in the manipulative-
treatment group may partly be due to nonspecific
effects such as general encouragement and
supporting guidance rather than to specific treatment
For patients with chronic low back pain (CLBP), the short, specific manipulative treatment
program with stabilizing exercises and a physician’s
clinical examination, information, encouragement,
and simple advice was more effective in reducing
pain and disability than was merely a physician’s consultation
and an educational booklet. Both treatment methods
enhanced HRQoL and reduced the use of health-care
services and costs. Results within these groups seem clinically
significant. Whether the difference in 1–year outcomes
between the groups is clinically significant remains
debatable. However, patients recovered with no
greater costs by the short manipulative-treatment
method. We believe that our treatment modality is effective
for most mechanical-origin CLBP patients.
This randomized controlled trial showed that a
short, specific manipulative-treatment program
with stabilizing exercises and physician’s clinical
examination, information, encouragement, and
simple advice was more effective than physician
consultation alone in reducing self-assessments of
pain and disability for patients with chronic low
back pain in a 1–year follow-up.
Further evaluations are needed to identify the
patient subgroups that particularly benefit from the
manipulative-treatment method and correspondingly
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