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Document: 12
Spinal manipulation for low back pain: an updated systematic review of
randomized clinical trials.
Koes B W, Assendelft W J, van der Heijden G J, Bouter L M..
Spinal manipulation for low back pain: an updated systematic review of
randomized clinical trials.
Spine,
1996,
21(24),
pp.2860-2871
Record status
This record is a structured abstract written by CRD reviewers. The original
has met a set of quality criteria. Since September 1996 abstracts have been
sent to authors for comment. Additional factual information is incorporated
into the record. Noted as [A:....].
Author's objective
To assess the efficacy of spinal manipulation for patients with low back pain.
Type of intervention
Treatment.
Specific interventions included in the review
Spinal manipulations studied included both high velocity thrust to a joint
beyond its restricted range of movement and spinal mobilisations consisting of
low velocity, passive movements within or at the limit of joint range.
Manipulations were of the following types: osteopathic, chiropractic,
rotational, Cyriax, Kaltenborn, Lewitt, Janda, Stoddard and Maitland.
Comparison treatments included exercises and advice, spinal mobilisation, back
school, analgesics, infrared heat, shortwave diathermy, ultrasound,
nonsteroidal anti-inflammatory drugs, massage, electrical stimulation and
physiotherapy.
Participants included in the review
Participants were patients with both acute back pain usually defined as having
a duration of less than 6 weeks and chronic low back pain usually defined as
having a duration beyond 6 weeks.
Outcomes assessed in the review
A study outcome was determined to be positive if the authors concluded that
manipulation was more effective than the reference treatment. Outcomes
assessed included pain intensity measured with a visual analogue scale, mean
number of days until recovery, score on Oswestry Disability Scale, improvement
in spinal flexion and straight leg raising, improvement in symptoms and number
of patients assessing treatment as effective.
Study designs of evaluations included in the review
Randomised controlled trials (RCTs) where the treatment regime included
manipulation or mobilization of the spine (additional interventions were
allowed) and the subjects suffered from low back pain.
What sources were searched to identify primary studies?
MEDLINE was searched from 1966 to June 1995 for English language articles
using the following key words: backache, musculoskeletal diseases, joint
diseases, manipulation, osteopathy, chiropractic, evaluation studies, outcome
and process assessment. References given in relevant publications were
further examined. Abstracts and unpublished studies were not selected.
Criteria on which the validity (or quality) of studies was assessed
The validity of the primary studies was assessed using the following criteria:
homogeneity of study population, similarity of baseline characteristics,
adequacy of randomisation, details of drop-outs according to treatment group,
loss to follow-up, sample size, descriptions of interventions included,
pragmatic study, co-interventions avoided, placebo controlled, qualification
of therapist, blinding of patients, relevant outcome measure, blinded outcome
assessment, adequate follow-up period, intention-to-treat analysis and
frequencies of most important outcomes presented for each treatment group.
How were the judgements of validity (or quality) made?
All studies were scored on the stated criteria by two reviewers independently
of each other. Disagreement were resolved by consensus or by a third
reviewer.
How were decisions on the relevence of primary studies made?
Not stated.
How was the data extracted from primary studies?
Not stated.
Number of studies included
36 RCT were used to assess the efficacy of manipulation in low back pain.
12 RCT were used to assess the efficacy of manipulation vs other treatment
modality in acute low back pain (N = 899 patients).
8 RCT were used to assess the efficacy of manipulation vs other treatment
modality in chronic back pain (N = 611 patients approximately, number not
stated for one study).
12 RCT were used to assess the efficacy of manipulation vs other treatment
modality in acute, subacute and chronic low back pain (N = 2240 patients
approximately, number not stated for one study).
11 RCT were used to assess the efficacy of manipulation vs some kind of
placebo in acute and chronic low back pain (N = 876 patients approximately,
number not given for 2 studies).
How were the studies combined?
The studies were combined in a narrative review.
How were differences between studies investigated?
Studies were grouped according to the score obtained for the methodological
quality of the study and results reported for this grouping of studies.
Results of the review
Only five studies had a methodological score of 50 points or more (out of a
possible score of 100). Only 16 studies included an effect measure of at
least three months. There appeared to be no clear relation between the
methodological score and the overall outcome of the studies.
Acute low back pain: manipulation vs other modalities 5 studies reported
positive effects of manipulation, 4 reported negative effects and 3 reported
positive effects in a sub-group.
Chronic low back pain: manipulation vs other modalities 5 studies reported
positive results, 2 reported negative results, 1 reported no conclusion.
Subacute and chronic: manipulation vs other modalities in mixed acute,
subacute and chronic low back pain 8 reported positive results, 1 reported
positive results in a subgroup only, 2 reported negative results, 1 reported
no conclusion.
Manipulation vs some kind of placebo in mixed acute and chronic: 7 positive
reports, 1 positive in a subgroup only, 3 negative.
Was any cost information reported?
No.
Author's conclusions
The efficacy of spinal manipulation for patients with acute or chronic low
back pain has not been demonstrated with sound randomised clinical trials.
There are indications that manipulation might be effective in some sub-groups
of patients and further research is required on this topic. Future studies
should be of sound methodological quality and should consider developing
relevant prognostic indicators and a diagnostic classification system to help
identify sub-groups which could be studied.
CRD commentary
This review includes a rigorous scoring of primary studies on 17 stated
methodological criteria and reports the most common methodological flaws
found. These include lack of baseline comparison of treatment groups,
inadequate description of randomisation method, incomplete details of
drop-outs, small sample size, lack of blinding of patients, variable effect
measures and inadequate analysis and presentation of data. The authors
acknowledge that by limiting the literature search they may have omitted some
relevant studies. No details are given of the methods used to select studies
or to extract data from the included studies. A definition of low back pain
which was used as an inclusion criteria for participants would have been
helpful and some indication of patient characteristics would have been useful
in assessing generalisability of the results. It is stated that manipulation
could be given separately or with other therapeutic modalities but the
reporting of results does not appear to take this into account. Positive and
negative outcomes are reported without reference to the sample size of the
studies. Despite the considerable heterogeneity among trials there is little
exploration or discussion as to possible sources of this heterogeneity.
Consideration of definition of inclusion criteria, characteristics of
participants, duration of therapy, duration of follow-up, intention-to-treat
analysis from raw data where possible, more rigorous evaluation of outcome
measures used, weighted effects measures and accounting for specific aspects
of quality assessment may have revealed possible sources of heterogeneity.
The authors suggest there may be evidence that manipulation is more
efficacious in certain subgroups of patients with acute or chronic low back
pain. This albeit tentative suggestion does not appear to be supported by the
evidence offered.
The authors have rigorously assessed the quality of the primary studies of
spinal manipulation in patients with low back pain and found no conclusive
evidence of efficacy of this therapy. The methodological flaws reported in
the primary studies would appear to preclude any other conclusion.
What are the implications of the review?
Future research should include the development of a classification of low back
pain and relevant outcome measures to be used in well designed randomised
trials of defined spinal manipulation.
Subject index terms
Subject indexing assigned by NLM: Chiropractic-; Low-Back-Pain/rh
[rehabilitation]; Manipulation,-Orthopedic; Spinal-Diseases/rh
[rehabilitation] Randomized-Controlled-Trials; Treatment-Outcome
Correspondence address
Dr. B W Koes, EMGO Institute, Van der Boechorststratt 7, 1081 BT Amsterdam,
The Netherlands.
Copyright
University of York, 1998
Database no.: DARE-970192
