Spine

© Lippincott-Raven Publishers.

Volume 21(24)             15 December 1996             pp 2860-2871
Spinal Manipulation for Low Back Pain: An Updated Systematic Review of Randomized Clinical Trials
[Keynote Address for Primary Care Forum]

Koes, Bart W. PhD*; Assendelft, Willem J. J. MD*; Van der Heijden, Geert J. M. G. MSc; Bouter, Lex M. PhD*

From the *Institute for Research in Extramural Medicine, Vrije Universiteit Amsterdam, Amsterdam, and the Department of Epidemiology, Maastricht University, Limburg, The Netherlands.
Presented at the International Forum for Primary Care Research on Low Back Pain, Seattle, Washington, October 13-14, 1995.
Supported by grants from The Group Health Foundation, The Prudential Center for Health Care Research, and Wyeth-Ayerst Laboratories; and by a grant from the Health Insurance Executive Board.
Acknowledgment date: January 21, 1996.
First revision date: May 8, 1996.
Acceptance date: May 22, 1996.
Device status category: 1.
Address reprint requests to: Bart W. Koes, PhD; EMGO Institute; Van der Boechorststraat 7; 1081 BT Amsterdam; The Netherlands


Outline


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Abstract^

Study Design: Systematic review of randomized clinical trials.

Objectives: To assess the efficacy of spinal manipulation for patients with low back pain.

Summary of Background Data: The management of low back pain remains controversial. Spinal manipulation is a widely used treatment option for low back pain. Recently issued clinical guidelines suggest that spinal manipulation may be effective for patients with acute low back pain.

Methods: A computer-aided search for published papers was conducted, and the methods of the studies identified were assessed. Scores were assigned for quality of methods (based on four main categories: study population, interventions, measurement of effect, and data presentation and analysis), the conclusion of authors regarding spinal manipulation, and the results based on the main outcome measure.

Results: Thirty-six randomized clinical trials comparing spinal manipulation with other treatments were identified. The highest score of a trial was 60 points (maximum score was set at 100 points), indicating that most were of poor quality. Nineteen studies (53%) showed favorable results for manipulation. In addition, five studies (14%) reported positive results in one or more subgroups only. Among the five studies with 50-60 points, three were positive, and two were positive only for a subgroup of the study population. Eleven trials compared manipulation with some placebo therapy, with inconsistent results. There appeared to be no clear relation between the methodologic score and the overall outcome of the studies. Twelve trials included patients with acute low back pain only. Of these, five reported positive results, four reported negative results, and three reported positive results in a subgroup of the study population only. There were eight trials comparing manipulation with other conservative treatment modalities, focusing on patients with subacute or chronic low back pain. Of these, five reported positive results, two reported negative results, and in one study no conclusion was presented. There were only 16 studies that included an effect measurement of at least 3 months. In only six of these do the authors report positive effects of manipulation.

Conclusions: The efficacy of spinal manipulation for patients with acute or chronic low back pain has not been demonstrated with sound randomized clinical trials. There certainly are indications that manipulation might be effective in some subgroups of patients with low back pain. These impressions justify additional research efforts on this topic. Methodologic quality remains a critical aspect that should be dealt with in future studies.



About 80% of the people in Western societies will endure one or more episodes of low back pain during their lives.32,68 Fortunately, these episodes usually are self-limiting, and most of the patients (90%) seem to recover from an attack of back pain within 6 weeks, regardless of the type of treatment given.20,68 The recurrence rate, however, is high.20,68 Despite its frequent occurrence, the management of back pain remains controversial. There is a wide variety of therapeutic interventions available, but no single treatment modality seems to be superior to others.14 Spinal manipulation is a widely used treatment option for low back pain, and its efficacy has been studied frequently in randomized clinical trials (RCTs).2,35,59,64 The differences between the several manipulative techniques available are not always clear.3 However, there seems to be agreement that spinal manipulation involves a high-velocity thrust to a joint beyond its restricted range of movement. Spinal mobilization involves low-velocity, passive movements within or at the limit of joint range.52 Throughout this article, we use the word “manipulation” to cover spinal manipulation and spinal mobilization.

The rationale given for manipulation in the management of back pain ranges from reduction of a bulging disc, correction of the internal displacement of disc fragments, freeing of adhesions around a prolapsed disc or facet joints, inhibition of transmission of nociceptive impulses, relaxation of entrapped synovial folds or plica, to relaxation of hypertonic muscles by sudden stretching, unbuckling motion segments that have undergone disproportionate displacements.21,31,60 Whether the manipulation is effective on a clinical level can be evaluated only in outcome studies, preferably in RCTs.

In this article, we present an update of a previously published review (1991) of the available RCTs about the efficacy of spinal manipulation for low back pain.35 An update seems to be appropriate because eight new RCTs on manipulation for low back pain have been published since 1990.6-8,13,28,30,34,36,37,39,54,58,66,70 In addition, guidelines for the management of low back pain in different countries around the world have been issued recently. These guidelines, for example, those of the Agency for Health Care Policy and Research (United States)5 and the Clinical Standard Advisory Group (United Kingdom),11 support the use of spinal manipulation at least in patients with acute low back pain. This updated review assesses the available evidence regarding manipulation for low back pain and evaluates whether the recommendations in these guidelines are supported with results from sound RCTs. Because even the outcome of a RCT may be biased by flaws in the methodologic quality of the study, we also assess the validity of the studies included in the review.

[black small square] Methods^
Selection of Studies. A MEDLINE literature search was carried out from 1966 to June, 1995 (key words: backache, musculoskeletal diseases, joint diseases, manipulation, osteopathy, chiropractic, evaluation studies, outcome, and process assessment). In addition, the references given in relevant publications were further examined. Abstracts and unpublished studies were not selected. Studies had to meet the following criteria:

1. The (experimental) treatment regimen included manipulation or mobilization of the spine. Additional interventions were allowed.
2. The study subjects suffered from low back pain.
3. It concerned an RCT.
4. The article was written in English.
Assessment of Methodologic Quality of the Studies. All trials were scored according to the criteria listed in Table 1. The criteria are based on generally accepted principles of intervention research 18,49 and have been used in a number of systematic reviews of RCTs of management for low back pain.3,26,38,40-43 Shekelle et al also used this list of criteria in their meta-analysis of spinal manipulation for low back pain (published in 1992). They also validated this list by comparing the outcome of the quality assessment with the outcome when using the criteria of Chalmers et al, with similar results.59 To each criterion, a weight was attached. The maximum score was set at 100 points for each study. All studies were assessed by two reviewers (WJJA, GJMGvdH) independently of each other. In a subsequent meeting, they tried to reach consensus on each criterion over which they disagreed. Where disagreement persisted, a third reviewer (LMB) made the decision. The assessments resulted in a hierarchical list in which higher scores indicate studies with a better methodology. The outcomes of the studies are discussed in relation to their methodologic scores.



Table 1. Criteria List for the Methodologic Assessment of Randomized Clinical Trials of Manipulation for Back and Neck Pain

Outcome of the Studies. A study outcome was determined positive if the authors concluded that manipulation was more effective than the reference treatment. Sometimes the authors reported favorable outcomes for manipulation only in a subgroup of the study population. In a negative study, the authors reported no differences between the study treatments or even better results in favor of the reference treatment. In addition, we extracted the main result from each study based on the most important outcome measure according to the authors. In most patients, this outcome measure was pain intensity measured with a visual analog scale or a numeric rating scale or the number of patients who reported improvement or recovery.

Acute Versus Chronic Low Back Pain. To assess the efficacy of manipulation in subgroups of patients with low back pain, we separately present the results of the studies for acute low back pain (duration of complaints usually < 6 weeks) and chronic low back pain (including subacute; duration of complaints usually > 6 weeks). Furthermore, studies comparing manipulation with other conservative treatment modalities are presented separately from studies comparing manipulation with a placebo treatment.

[black small square] Results^
Forty-six articles met the inclusion criteria.1,4,6-10,12,13,15-17,22-25,27-30,33,34,36,37,39,44-48,50,51,54-58,61-63,65-67,69,70,72 However, these included a number of articles publishing data from the same trials. In these instances, we combined the information in the different articles to determine the quality and outcomes of the trials. We finally identified 36 different RCTs that met our inclusion criteria. These trials are presented in Table 2 in a hierarchical order according to their methodologic score.



Table 2. Randomized Trials on the Efficacy of Manipulation for Back Pain and Neck Pain in Order of Methods Score

Initially, the two reviewers did not agree 269 (19%) of the 1440 times a criterion had to be applied. Usually, this turned out to be a result of errors in reading. After their consensus meeting, this number was reduced to four, for which the third reviewer made the final decision. A comparison of the quality ratings of the 23 RCTs that were included in the review by Shekelle et al and the current one showed more or less similar results, both in the actual scores and in the hierarchical order.59

In the current review, only five studies had a methodologic score of 50 points or more, with the highest score being 60 points, indicating the general poor quality of the trials. Table 2 shows that the most prevalent methodologic problems concern (B) similarity of relevant baseline characteristics, (C) adequate randomization procedure, (D) the proper description of dropouts, (F) size of the study population, (G) clear description of interventions, (J) inclusion of a placebo group, (L) the blinding of patients to treatment, (N) the blinded effect measurements, and (P) intention-to-treat analysis.

The quality of trials published within the past 5 years seems to improve only little. The median quality score of the trials published before 1990 was 37 (range, 20-56), whereas the median quality of trials published since 1990 was 44 (range, 25-60).

In general, there are 19 trials (53%) in which the authors report better results for manipulation compared with the reference treatment (e.g., short-wave diathermy [SWD], massage, exercises, analgesics, or a placebo treatment). In addition, five other trials report better results in a subgroup only. In 10 trials, manipulation seemed to be no better than the reference treatment. In two studies, the authors refrained from drawing a conclusion. There were only 16 studies that included an effect measurement of at least 3 months. In only six of these do the authors report long-term positive effects of manipulation.

Figure 1 presents the relation between the methodologic score and the outcome of the study. Included are the 19 positive studies and the 10 negative studies. The five trials reporting positive results of manipulation only in a subgroup of the study population were omitted because labeling as “positive” or “negative” would be ambiguous for these. The two studies in which the authors refrained from drawing a conclusion also were omitted from Figure 1.



Figure 1. Relation between methods score of trials and their outcomes.

There appeared to be no clear relation between the methodologic score and the overall outcome of the studies. For most of the trials (about 70%) with less than 46 points, the negative studies had higher methodologic scores; however, for the trials with scores greater than 46 points, the positive studies had higher methodologic scores.

Acute Low Back Pain^
Table 3 presents the comparison of manipulation with other conservative treatment modalities for patients with acute low back pain. Usually this meant that the duration of the complaints of the patients included in the study was less than 6 weeks. The main characteristics of the forms of manipulation included in the trials are presented in the second column. Manipulation could be given separately or combined with other therapeutic modalities. The reference treatments were mainly physiotherapeutic interventions (e.g., SWD, massage, exercises) and drug therapy (analgesics). There were 12 trials that included patients with acute low back pain only. Of these, five reported positive results, four reported negative results, and three reported positive results in a subgroup of the study population only (see legend to Table 2 for description of subgroups).



Table 3. Details of Trials Comparing Spinal Manipulation With Other Conservative Treatments in Acute Low Back Pain

Chronic Low Back Pain^
Table 4 presents the eight trials comparing manipulation with other conservative treatment modalities focusing on patients with chronic or subacute low back pain only. Usually this meant that the duration of the complaint at entry in the study exceeded 6 weeks. Again, manipulation was given separately or combined with other therapeutic modalities. The reference treatments varied from usual care by general practitioner, physiotherapeutic interventions (including SWD, massage, exercises), and back school, to drug therapy (analgesics). Of these, five reported positive results, two reported negative results, and in one study no conclusion was presented.



Table 4. Details of Trails Comparing Spinal Manipulation With Other Conservative Treatments Chronic or Subacute Low Back Pain

Subacute and Chronic^
Table 5 presents the 12 trials comparing manipulation with other conservative treatment modalities in mixed populations of patients with acute, subacute, or chronic low back pain. Of these, eight reported positive results, one reported positive results in a subgroup only, two reported negative results, and in one study no conclusion was presented. All studies scored less than 50 points. The study with the highest methodologic score (48 points) reported chiropractic manipulation to be better than physiotherapy (including Cyriax and Maitland) for patients with acute and chronic low back pain.47,48 The other study with a score between 40 and 50 points reported no differences in results of manipulation, physiotherapy, corset, or analgesics.15 There were nine studies with scores less than 40 points, eight of which reported favorable results of manipulation.



Table 5. Details of Trials Comparing Spinal Manipulation With Other Conservative Treatments in Mixed (Acute and Chronic, or Duration Not Mentioned) Populations With Low Back Pain

Placebo Comparisons^
Table 6 presents the 11 trials comparing manipulation with some kind of placebo therapy. In most studies, the placebo therapy consisted of detuned SWD or a sham manipulation. Overall, there were seven positive studies, one positive only in a subgroup, and three negative studies. The study populations included acute and chronic conditions.



Table 6. Details of Trials Comparing Manipulation With Placebo Therapy

All three studies with a score of 50 points or higher reported better results of manipulation compared with detuned SWD and detuned ultrasound in chronic low back pain,34,36,37,39 sham manipulation in acute low back pain,58 and nonforceful manipulation in chronic low back pain.51 However, Koes et al reported significant differences for global perceived effect only (not for other outcomes). Sanders et al reported on a follow-up period of only 30 minutes, and in the trial of Ongley et al, manipulation was only part of a treatment regimen that also included injections and exercises.

[black small square] Discussion^
The value of a review of the literature depends, among other features, on the success in obtaining the results of all available studies (in this case RCTs) that have been conducted on the subject at issue. Although we have put much effort into obtaining all the available published RCTs, it remains possible that we have missed (un)published trials, the results of which might differ from the ones we have presented here (because of publication bias).

We identified 36 different RCTs evaluating manipulation for low back pain. To our knowledge, of all available interventions for low back pain, manipulation is the most frequently studied intervention in RCTs. Unfortunately, this review shows that major methodologic flaws occur in most trials. It was disappointing to find that most of the trials scored less than 50 of the maximum of 100 points on our methodologic checklist and that the quality of the trials seems to improve little during the past 5 years. Although this finding is not unique for manipulation trials in low back pain,38 the large variation in the methods scores (20-60 points) indicates that there is much room for improvement. In the future, more attention should be given to comparability of relevant baseline characteristics, an adequate randomization procedure, a proper description of dropouts, sufficient size of the study population, the blinding of patients, effect measurements, and an adequate analysis and presentation of the data.

Efficacy of Manipulation^
The results of 19 of the 36 trials indicated that manipulation was more effective than a range of reference treatments. However, in a considerable number of trials (n = 10), no difference in effect could be determined between manipulation compared with control treatment, including placebo therapies. The overall results of the trials presented indicate that manipulation is not consistently better than other therapeutic approaches. It must be noted, however, that some negative results might be caused partly by relatively small study populations, thus making it difficult to detect existing treatment differences between manipulation and reference treatments.19 Most trials report short-term effects only. Long-term effects (i.e., more than 3 months after randomization) are seldom reported. Only two of the eight trials published since 1990 included such long-term outcomes, and although both reported favorable long-term results of manipulation, most (n = 10) studies that did include a long-term follow-up (n = 16) showed negative results, which indicates that the long-term efficacy of manipulation remains doubtful.

Acute Low Back Pain^
We could not find conclusive evidence in favor of manipulation in patients with acute low back pain. This finding may be somewhat surprising given the clinical guidelines for the management of acute low back pain in the United States and the United Kingdom.5,11 Compared with physiotherapeutic interventions (e.g., SWD, massage, exercises) and drug therapy (analgesics), manipulation was not consistently better. Of the 12 relevant RCTs, five reported positive results, four had negative results, and three were positive in a subgroup of the study population only (indicating overall negative results of the study). In addition, the methodologically better studies (> 50 points) could not demonstrate that manipulation was effective for patients with acute low back pain. In two of the best studies, similar recovery rates in the study groups were found, although the author reported positive results of manipulation in a subgroup with 2-4 weeks' duration of the current complaints.25,44 One other study with a score greater than 50 points was positive, but contained limited clinical relevance because of a follow-up period of 30 minutes only.58

In two of the three trials with methodologic quality scores between 40 and 50 points, manipulation was not better than back school or analgesics, and the third study reported favorable results of manipulation only in the subgroup of patients with a limited straight leg raising test. Even the methodologically weaker trials (40 points) showed inconsistent results of manipulation. These findings do not support the efficacy of manipulation for patients with acute low back pain, although it remains possible that manipulation is more efficacious than other approaches in certain subgroups of patients with acute low back pain. The reported positive finding in the subgroups mentioned earlier might be an indication for this suggestion. However, because the findings from subgroup analyses should be interpreted cautiously,53,71 further study is needed to confirm or refute these impressions.

Chronic Low Back Pain^
Most previous reviews on manipulation for low back pain report that there is insufficient evidence in favor of manipulation for patients with chronic low back pain. We identified eight trials comparing manipulation focusing on patients with chronic or subacute low back pain only. Of these, five reported positive results, two reported negative results, and in one study no conclusion was presented, indicating that manipulation may be effective for patients with chronic and subacute low back pain. These findings even suggest that there is more evidence in favor of manipulation for more chronic conditions than for acute conditions. However, for the more chronic conditions, the evidence for or against manipulation also is not conclusive. The study with the highest methodologic score (60 points) reported manipulation to be better than usual care by the general practitioner but equal to physiotherapy treatment, although the number of treatments given in the manual therapy group was much than in the physiotherapy group.34,36,37,39 Of the five trials with scores between 40 and 50 points, manipulation was not better than SWD,22 or massage, corset, or transcutaneous muscle stimulation,54 but in two others studies, manipulation was reported to be better than analgesics 16 or back education.66 Both studies with low scores reported favorable results of manipulation compared with massage (and sham manipulation)67 and bed rest, analgesics, and massage.1 As is the case in acute low back pain, these findings do not clearly support the efficacy of manipulation for patients with chronic low back pain, although there certainly are indications that manipulation might be beneficial for certain (subgroups of) patients.

Unfortunately, to date, we have not been able to identify the patients in whom manipulation might be most beneficial. Suggestions about promising subgroups might be derived from observations in clinical practice and from subgroup analysis in (randomized) studies, as indicated previously. Furthermore, studies on relevant prognostic indicators and diagnostic classification systems (possibly guided by the postulated mechanisms of action of manipulation) might help in identifying such subgroups relevant for treatment with manipulation. Consequently, future trials should limit their patient selection to those promising subgroups.

There have been many other reviews of the efficacy of manipulation. There even appear to be more reviews on manipulation than original RCTs.2 Drawbacks of many of these reviews are the partial inclusion of the available trials, possibly leading to selective citation; the narrative approach of the author because of which the methods used in the reviews are not clear; and, finally, little attention is paid to the methodologic quality of the trials included in the review. In a high-quality review, Shekelle et al 59 included 23 of the 36 trials that we included in our updated review. They concluded, based on a statistical pooling of a subset of trials including patients with acute low back pain, that spinal manipulation is of short-term benefit in some patients, particularly those with uncomplicated, acute low back pain. For the efficacy for chronic low back pain, the data were considered to be insufficient.

Our results are somewhat different (i.e., less positive) from the results of Shekelle et al, possibly because of the limited number of randomized trials on acute low back pain included in their quantitative analysis. Their quantitative analysis included six of the 12 RCTs listed in Table 3.

The methods used in the current review, however, also may show some limitations. The methodologic checklist contains items reflecting internal and external validity, precision, and quality of reporting at the same time. Although a gold standard for a methodologic checklist is lacking, it is possible that our checklist is too rigorous in some areas and too liberal in others. In addition, the weights attached to the methodologic criteria are arbitrarily chosen; readers may wish to assign their own weights, if any, and assess the quality of the trials by themselves.35

Because the purpose of this article was to update our previous review, we chose not to pool statistically the results of the available trials. The methods for statistical pooling of the results of RCTs, however, are developing rapidly, which might open the possibility for pooling the results of studies with homogeneous outcomes for subgroups of patients with similar patient characteristics, possibly limited to studies with higher methodologic quality. Within the framework of the Cochrane Collaboration, our group and the one from Rand (Shekelle et al) just initiated such a systematic review on spinal manipulation in which the methodologic quality of the trials and the quantitative pooling of the results will be considered.

In the meantime, we conclude that the efficacy of manipulation for patients with acute low back pain has not been convincingly demonstrated with sound RCTs. There is at least as much evidence in favor of manipulation for chronic low back pain as there is for acute low back pain. However, the efficacy of manipulation has not been established for chronic conditions, either. There certainly are indications that manipulation might be effective in some subgroups of patients with low back pain. These impressions justify additional research efforts on this topic. Methodologic quality remains a critical aspect that should be dealt with in future studies on manipulation for low back pain.

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Appendix^
Table



Appendix. Operationalization of the Criteria From Table 1*

Key words: efficacy; low back pain; spinal manipulation; systematic review

Section Description^
International Forum for Primary Care Research on Low Back Pain

Seattle, Washington

October 13-14, 1995

Spine offers a special thanks to Dr. Daniel C. Cherkin and the planning committee for their cooperation and hard work.

1995 Planning Committee; Daniel Cherkin, PhD, Chairman; Jeffrey Borkan, MD, PhD; Timothy Carey, MD, MPH; Richard Deyo, MD, MPH Bart Koes, PhD



Accession Number: 00007632-199612150-00013

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