Effective Management of Low Back Pain:
It’s Time to Accept the EvidenceThis section is compiled by Frank M. Painter, D.C.
Send all comments or additions to: Frankp@chiro.org
FROM: J Can Chiropr Assoc. 1993 (Dec); 37 (4): 221–229 ~ FULL TEXT
Pran Manga, PhD, Douglas E Angus, MA, William R Swan, BComm
Low back pain is a ubiquitous and economically costly problem. Unfortunately, the clinical management of low back pain is not yet well understood. Chiropractic management of back pain, long the black sheep of back care, has undergone a transition and is now a more respected and understood alternative to conservative medical care, itself under increased scrutiny due to unsatisfactory outcomes and unacceptable iatrogenic side effects.
The substantial amount of clinical and related research on the effectiveness of manipulation for low back pain is summarized here from a larger study, divided into randomized control trials, case-control trials, meta-analyses and descriptive studies. The chiropractic management of low back pain is found to be a more effective way of dealing with this medical, social and economic problem. It is suggested that greater utilization of chiropractors be encouraged such that the “right people are doing the right things at the right time”.
From the FULL TEXT Article:
INTRODUCTION
Recent estimates indicate that about 10.5 percent of Canada's GNP is spent on health care services - a proportion second only to the United States, and the highest in the world for a publicly funded system. As such, cost containment has become the cornerstone of virtually all health care policy decisions.
One crucial area of concern - particularly in view of the pervasive medical, social and economic implications - is the search for effective management of acute and chronic low back pain (LBP). We have reviewed the extensive literature on the epidemiology, prevalence and incidence of LBP elsewhere, [1] and thus, offer only a synopsis of those findings here.
In its many manifestations, LBP afflicts at least 80 percent of the population at some time during their lives. Estimates of the number of people actually suffering from LBP at the time of a given survey range from 5 to 30 percent. While estimates of the incidence and prevalence of LBP may be wide ranging, there can be no doubt that LBP remains a ubiquitous health problem.
LBP is most common between the ages of 25 and 55, while the average age for filing a workers' compensation claim falls between 33 and 35 in both Canada and the United States. Although some studies have reported a substantial difference in the occurrence of back pain between males and females, still others have found little overall differences between sexes. This is, no doubt, due to an historical trend in gender incidence of LBP which has been most evident in workers' compensation statistics. Earlier analyses showed that the incidence and prevalence of LBP was much higher among men than women. However, with the continued increase in the labour force participation rate for females since World War II, the difference in rates between men and women has narrowed substantially.
Variations in the occurrence of LBP have also been found based on age, race, region and educational status. Further, prevalence has been shown to be higher for people who smoke, for people with lower levels of education and for people who have had previous back problems. Finally, there is some support for the inclusion of anxiety, stress, pregnancy, being separated, divorced or widowed, and sports activities as other potential correlates of LBP.
According to Frymoyer and Cats-Baril, "Low back disorders are extremely prevalent in all societies and probably have not increased substantially over the past two decades. What has increased is the rate of disability, the reasons for which are uncertain". [2] Obviously, the greater the incidence of disabling back injuries, the greater the social and economic burden.
An important and essential first step in the process of identifying cost-effective solutions is to establish scientific evidence of the effectiveness of alternative therapies for LBP. The purpose of this paper is to review the existing literature and experience regarding the efficacy and effectiveness of chiropractic, medical, and physiotherapeutic approaches for treating and managing LBP. Cost-effectiveness issues are dealt with in a larger, more comprehensive study. [1]
Effectiveness of chiropractic and other management of low back pain
To assess the effectiveness of a given therapeutic procedure, "the strongest and only conclusive evidence of effectiveness is the randomized controlled trial, which in the ordinary clinical situation is difficult to perform". [3] Other types of studies - case control or cohort, descriptive, and literature reviews or metaanalyses - carry a lower level of proof. Using a methodology previously employed by the Quebec Task Force on Spinal Disorders, [4] each study in this review is classified according to the type of research technique used.
Randomized controlled trials (RCTs)
Table 1 [5–36] presents a summary of 31 clinical trials which were conducted on spinal manipulation for back pain. While there have been many clinical trials done on the efficacy of manipulation and other treatment for LBP, there have been questions with respect to their validity. Hence, certain criteria should be considered and noted when interpreting the results of a given trial. These criteria are: randomization, patient attrition, outcome assessment, equivalent co-intervention, compliance, contamination, statistical power, demographic description of patients, clinical description of patients, description of intervention, and reporting of relevant outcomes.
While the first RCT of spinal manipulation on record was done in 1974, [5] the first true controlled efficacy study of chiropractic therapy for LBP was conducted in 1986 by Waagen et al. Prior to this study, the authors observed that "any efficacy of chiropractic therapy can only be inferred from the studies of manipulative therapy for the treatment of LBP which have been performed utilizing medical, osteopathic or physiotherapytrained practitioners of manipulation". [6] However, because chiropractors specialize in the delivery of specific spinal adjustments and receive a longer period of formal training than other practitioners of manipulation, the authors of this study believed that it was not possible to extrapolate the results of previous trials in manipulative therapy directly to chiropractic.
Nineteen patients undertook this trial which lasted two weeks. They were randomly allocated to one of two groups: one received a series of chiropractic adjustments (experimental), and the other (control) received a comparable series of manual interventions, both provided by trained chiropractors. Assessment of treatment effect was conducted prior to the first treatment and at the conclusion of the two-week treatment period by a group of chiropractors who were not involved in treating the patients. Eight objective tests of function and a subjective rating of pain on a Visual Analogue Scale were used. Results showed that the experimental group had significantly more relief from pain than control patients immediately after being treated. As well, after two weeks of treatments the experimental patients, as a group, exhibited significant overall pain relief whereas this was not the case in the control group. Experimental patients improved significantly in the objective measurements of spinal mobility as well, compared to the control patients. Thus, for the first time that chiropractic manipulation was properly assessed, it was found that both subjectively and objectively, chiropractic therapy was more effective at relieving LBP than a manual placebo treatment. However, a major drawback of this study was the small sample size.
In another highly-rated RCT, Ongley et al. [7] randomized 81 patients with chronic LBP into two groups: one group received forceful spinal manipulation and injections of a proliferant solution into soft-tissue structures in order to decrease pain and disability; the other group received less extensive manipulation and initial local anaesthesia, and substitution of saline for proliferant, both treatments carried out by physicians. Effectiveness of treatment was measured by the patients' subjective assessment of pain and disability, as well as by an independent objective evaluation of physical signs. Measurements were made upon entry to the trial and at ope, three and six months. Results showed that the experimental group had significantly greater improvement than the control group at all three points. Visual analogue pain scores and pain diagrams also showed significant advantages for the forcefully manipulated group. The authors concluded that the experimental regimen "is a safe and effective treatment for chronic LBP that has not responded to other conservative forms of treatment".
In a very recent Dutch study, Koes et al. [8] conducted a randomized controlled trial on the effectiveness of manual therapy, physiotherapy, and general practitioner treatment for nonspecific back and neck complaints. They also reported on the results in a one year follow-up of the trial. In total, 256 patients were allocated into one of the three treatment groups or a placebo group. They were pre-stratified and randomly allocated in blocks of eight to either their general practitioner, a physiotherapist or to a manual therapist. Manual therapy was limited to manipulation and mobilization of the spine. Physiotherapy consisted of exercises, massage and physical therapy modalities (not manipulative techniques). The general practitioner treatment included prescription medication, home exercises and bed rest among other modalities. The placebo treatment (provided by a physiotherapist) used detuned short-wave diathermy and detuned ultrasound. The principal outcome measures were severity of the main complaint, global perceived effect, pain and functional status. Assessments were carried out at three, six and twelve weeks after the onset of the trial. Results of this study indicated a more favourable outcome for treatment with manual therapy or physiotherapy as opposed to medical treatment. The former two treatments decreased the severity of complaints more and had a higher global perceived effect compared to continued treatment by the general practitioner. There were no differences between physiotherapy and manual therapy treatments. The basic trend showed that all four groups had increased improvements at all three follow-up periods. At the three and six week follow-up, the medical treatment was least effective, even more so than the placebo. By the twelve week follow-up, all four study groups showed a large improvement, while the differences among them had almost disappeared entirely. The authors concluded that "it seems useful to refer patients with nonspecific back (and neck) complaints lasting for at least six weeks for treatment with physiotherapy or manual therapy". [8] In the results of the one year follow-up of this study,9 it was concluded that manipulative therapy and physiotherapy were better than general practitioner and placebo treatment. Furthermore, manipulative therapy was found to be slightly better than physiotherapy after one year.
In 1977, the British Chiropractors' Association, citing the results and controversy over contemporary studies in the U.S., appealed to the Medical Research Council (MRC) in the U.K. to explore the question of chiropractic efficacy. In response to the pressure, the MRC set out plans for what became the longest and largest clinical trial of chiropractic effectiveness to date.
The Medical Research Council study published in the British Medical Journal in 1990, [10] is based on a prospective randomized controlled trial in which 741 patients aged 18-65 were tracked for two years after random assignment to chiropractic and hospital outpatient clinics in eleven centres. The treatment alternatives were discretionary, but chiropractors used manipulation on virtually all patients and the hospital staff (physiotherapists) used mostly Maitland mobilization and/or manipulation. The principal outcome measures were changes in the score on the Oswestry pain disability questionnaire and in the results of tests of straight leg raising and lumbar flexion. The characteristics of patients under hospital outpatient care and chiropractic care were very similar. Outcome measures were taken at weekly intervals for six weeks, at six months, and then at one and final at two years after entry. A notable feature of the study was its full and candid discussion of its design and possible weaknesses.
The results of this randomized clinical trial were that:(1) chiropractic care conferred significantly long-term benefit in comparison with hospital outpatient treatment;
(2) the advantages of chiropractic management started soon after treatment began;
(3) the effects of chiropractic treatment were long-term, whereas the effects for those treated by hospital staff deteriorated after six months to a year;
(4) the longer term benefits of chiropractic care were not due to further chiropractic treatment, since between year one and year two only 17 percent of those initially treated by chiropractors had further chiropractic care, while 24 percent of the hospital group had further hospital treatment; and
(5) the benefit was seen mainly in those patients with chronic or severe LBP,Inevitably, there were a number of criticisms as well as positive commentaries on this clinical trial. The criticisms were largely minor and included: the use of hospital physiotherapists who may have been restrained with respect to the number of treatments rendered; the limitation of the comparison to physiotherapists; the spontaneous disappearance of some LBP; the adequacy of the Oswestry scale as an outcome measure; and, that variables other than treatment modalities may have affected outcomes. Perhaps the warmest testimonial on the value of the MRC study came from a renowned researcher who declared the trial "to be one of the better trials in this field". [11]
Overall, of the 28 RCT's reviewed, more than two-thirds concluded that manual manipulation had significant beneficial outcomes in the treatment and management of LBP, and none of the studies found that chiropractic made the patient worse off. Perhaps most interestingly, the more recent - and better - studies tend to give greater credibility to the effectiveness of chiropractic manipulation in LBP.
Case-controlled/cohort studies
Table 2 [38–42] summarizes six significant case-control studies, all of which conclude that chiropractic treatment is a comparatively more effective treatment alternative. For brevity, we do not discuss each of the studies here, but focus on the best and most recent of the studies.
Arkuszewski [37] conducted a clinical trial to assess the efficacy of manual treatment in LBP. One hundred patients with sciatica or lumbosacral pain were divided into two groups. Both received a standard treatment of drugs, physiotherapy and physical examination twice a week. However, in one group manual treatment was also applied, in the form of traction, mobilization and manipulation. To assess efficacy of treatment, six outcomes were measured: posture, mobility of the spine, severity of pain, gait, manual and neurological examinations (after treatment and at six months). Results showed that after the first week of treatment, improvement was significantly greater in the experimental group, up to the day of discharge. Even at six months, improvement of all symptoms was significantly greater in the manipulated group. "A comparison of the two groups six months after discharge showed . . . a greater ability to continue professional employment in the group of patients given manual treatment. In this group, in addition, the percentage of those pensioned off for disability was lower". [37]
Descriptive studies
As early as 1930, there was evidence in the literature of the efficacy of manipulation for LBP. Riches [43] examined the clinical records of 113 patients who had undergone manipulation of the back reported over an eight-year period. In addition to examining clinical data, a questionnaire was sent to those patients requesting information on the condition of their backs, length of time taken from work, return of pain, and so on.
Results of the study indicated that in cases of chronic back and sacroiliac strain, manipulation was successful in about 90 percent of the cases, and success was seen in almost all cases where there was evidence of existing trauma. The study also concluded that manipulation did not permanently improve lumbo-sacral strain, manipulation improved about half the cases of spinal arthritis, cases of neurotic spine did not respond to manipulation unless there was an underlying strain, and finally, that manipulation of the back should not be confined to cases where mechanical displacement existed. [43]
Other relevant descriptive studies include those by Mensor, [44] Parsons and Cumming, [45] Potter, [46] Cassidy et al. [47, 48] and Mierau et al. [49] These studies corroborate the value of spinal manipulation for LBP. Mierau et al. [49] compared the effectiveness of spinal manipulative therapy for LBP patients with and without spondylolisthesis. Data collected from a previous study showed that the results of manipulative treatment were not significantly different in those patients with or without lumbar spondylolisthesis. As such, spondylolisthesis was found not to be a contraindication to 'skillful' manipulation.
Meta-analyses/literature reviews
Meta-analysis is a relatively recent approach to reviewing a vast amount of research and information and finds significant use in the area of health technology assessment. For example, Brunarski [50] reviewed nearly fifty trials to determine where there existed sufficient evidence to suggest that spinal manipulation was more effective than medical care in the management of "painful neuromuscular conditions". He found that in these trials, over 8,300 patients underwent spinal manipulation, and over 80 percent of the trials examined patients who were treated for LBP. Aggregatively, improvement in the manipulated groups averaged over 70 percent as compared to 50 percent in the non-manipulated patients, with acute patients responding comparatively better. However, both acute and chronic pain patients "appeared to do consistently better when treated with spinal manipulative therapy than with other more conventional treatment".
Very recently, Anderson et al. [51] undertook a meta-analysis of 23 randomized controlled clinical trials of spinal manipulation to evaluate its effectiveness in the treatment of LBP. The results demonstrated a consistent (and strong) trend favouring the greater efficacy of spinal manipulative treatment over other forms of treatment. The authors determined that "the average patient receiving spinal manipulation is better off than from 54-85 percent of the patients receiving the comparison treatment, depending upon the specific outcome variable and the follow-up time period. . . . Clearly, spinal manipulation was better than whatever treatment to which it was compared for a large majority (86%) of the outcomes.... We believe that the consistently positive small to medium effect sizes noted in this meta-analysis are real and indicative of clinically meaningful differences in favour of spinal manipulation for LBP patients". [51]
Other meta-analyses were also examined, including: Greenland et al. [52] Ottenbacher and Di Fabio; [53] Di Fabio; [54] the Quebec Task Force on Spinal Disorders; [4] Curtis; [55] Koes et al.; [56] Shekelle et al.; [57] and Assendelft et al. [58] 1n the report by Shekelle et al., [57] published by RAND, the medical literature was reviewed to gain knowledge about the efficacy of spinal manipulation for LBP. The authors concluded that "support is consistent for the use of spinal manipulation as a treatment for patients with acute LBP and an absence of other signs or symptoms of lower limb nerve-root involvement. Support is less clear for other indications, with the evidence for some insufficient, . . . while the evidence for others is conflicting". [57]
The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) conducted a review of controlled trials of manipulation for back pain disorders, with the purpose of assessing the effectiveness of chiropractic in the treatment of low back disorders. It concluded that "chiropractor applied manipulation, in all but one study, was at least as effective in treating back pain as the alternative treatments described in each study (these included physiotherapy, massage, electrostimulation, drug therapy, heat, exercise, education and bed-rest); and that based on the relatively small number of patients enrolled in these trials, chiropractor applied manipulation appears to be a safe treatment offering more immediate relief than other forms of conservative care". [59]
Reviews such as the prestigious RAND study, and the recent CCOHTA study, were also undertaken by medical organizations such as the North American Spine Society [60] which concluded that spinal manipulation and adjustment was an acceptable and effective treatment for most patients with lumbosacral disorders. All these reviews add measurably to the growing credence of spinal manipulation as the therapy of choice for most LBP.
Conclusions
LBP is pervasive and results in significant medical, social and economic implications. The approaches for dealing with LBP have been mainly medical, chiropractic, and physiotherapeutic. In this paper, we have reviewed the evidence on the effectiveness of these different alternatives for treating and managing LBP.
There are many clinical trials assessing alternative treatment of LBP. There are also several case-control studies, as well as meta-analysis and descriptive studies. Our review found many of the past studies wanting in terms of methodology and scientific validity. Nevertheless, we believe that despite the weaknesses and shortcomings, the studies do point to some likely results vis-a-vis the effectiveness of the alternative therapies for LBP. We hasten to add, however, that clinical trials with greater scientific validity need to be undertaken for further understanding of the effectiveness of alternative therapies for LBP.
In the bulk of the methodologically sound clinical studies, spinal manipulation applied by chiropractors is shown to be more effective than many alternative treatments for LBP. The clinical evidence is corroborated by meta-analysis, case-control studies and highly-respected clinical guidelines panels. It is noteworthy that there is no clinical or case-control study that demonstrates or even implies-that chiropractic spinal manipulation is unsafe in the treatment of LBP.
The evidence also shows that many traditional medical therapies for LBP have questionable efficacy, effectiveness and adequacy, sometimes resulting in severe iatrogenic complications for the patients. Our reading of the literature suggests that chiropractic manipulation is (at least) as safe and many times safer than medical management of LBP and resulted in one rather curious conclusion. While it is prudent to call for even further clinical evidence of the effectiveness and efficacy of chiropractic management of LBP, what the literature revealed to us is the equally significant need for clinical evidence of the validity of medical management of LBP. There is also some evidence in the literature to suggest that manipulation can be less safe and less effective when performed by non-chiropractic professionals.
It appears that the time is right for encouraging greater utilization of chiropractic services for the management of LBP, especially in view of the impressive body of evidence on the effectiveness of such services which we have reviewed in this paper. Finally, it also is apparent that greater collaboration amongst the key providers in this area - chiropractors, physicians, and physiotherapists - is required, particularly if we wish to ensure that the "right people are doing the right thing at the right time".
Acknowledgements
The authors gratefully acknowledge the significant contribution of Costa Papadopoulos. The material for this study was funded by the Ontario Ministry of Health.
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