Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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UK BEAM Trial Team
- HC Faure (23 November 2004)
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Which treatment for whom?
- Dr Chris McCarthy (3 December 2004)
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Comments on the BEAM Trial
- Edzard Ernst (6 December 2004)
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Re: Comments on the BEAM Trial
- richard tillett MSc MCSP (6 December 2004)
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Manipulation the panacea?
- Philip Hope (16 December 2004)
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Got back pain? Gravity could be your best friend!
- Donald J. Stout (29 December 2004)
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Does the UK BEAM trial really support the use of manipulation?
- Francisco M Kovacs, Pablo Lazaro, Alfonso Muriel, Victor Abraira, Javier Zamora, Carmen Fernandez, Ignacio Mendez, Jose Luis Martin, Francisco Martinez, Luis González Lujan, Sergio Luna, and Bartolome Leal, for the Spanish Back Pain Research Network (12 January 2005)
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An opportunity missed
- John A Mathews (31 January 2005)
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Is manipulation the most cost effective addition to “best care”?
- Torill H. Tveito, Hege R. Eriksen (9 February 2005)
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Non-manipulative Relief for Chronic Back Pain
- Arunachalam Kumar, Jairaj Kumar.C, and Garvit Chitkara (23 March 2005)
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HC Faure, Editorial Project Manager 34-42 Cleveland Street, London W1T 4LB, UK
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Dear Sir, I have read with interest the recent article in the BMJ in which the results of the UK Beam Trial are presented (http://bmj.bmjjournals.com/cgi/rapidpdf/bmj.38282.669225.AEv1?etoc.). As you may be aware, this trial is publicly registered with an International Standard Randomised Controlled Trial Number: ISRCTN32683578 (1). It is an important part of the unique numbering scheme that trials quote their ISRCTN in all publications arising from the trial. This is to ensure that all papers resulting from a trial can be easily identified. We hope that you and your colleagues will agree to quote your ISRCTN in the title and/or abstract of any future papers arising out of the UK Beam Trial. Yours sincerely, Helene Faure PS: You may also be interested in the recent article (2) published in the BMJ about making trial registration a condition of publication. (1) http://www.controlled- trials.com/isrctn/trial/ISRCTN32683578/0/32683578.html (2) Abbasi K: Compulsory registration of clinical trials. BMJ 2004, 329:637-638 (18 September 2004). [ Full text <http://bmj.bmjjournals.com/cgi/data/329/7466/DC1/1> ] Competing interests: Employed by Current Controlled Trials, who developed the International Standard Randomised Controlled Trial Number (ISRCTN) scheme. |
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Dr Chris McCarthy, Research physiotherapist / Chair of the Manipulation Association of Chartered Physiotherapists University of Manchester
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Dear Sir, It is encouraging to see that a package of manipulation and or a back to fitness exercise approach to the treatment of non-specific low back pain (NSLBP) has some clinical effectiveness. It is also encouraging that the provision of these treatment packages was cost effective and considerably below recommended thresholds of "willingness to pay". The UKBEAM team are to be congratulated on running an excellent trial, it is however disappointing that the results, although positive, are only marginally sized and of questionable clinical significance. Those of us involved in the treatment of NSLBP will recognise that "back to fitness" programmes and manual therapy approaches are appropriate and clinically beneficial in particular subgroups of NSLBP and not appropriate in others. The decisions used by clinicians in deciding what therapy is likely to be beneficial in certain "types" patients are complex and grounded in our clinical reasoning abilities. Within the complexities of our diagnostic reasoning process only one thing is clear, the vast majority of clinicians do not provide “non-specific” treatment for non- specific low back pain. Unfortunately, whilst our reasoning processes are infinitely adaptable to all patient presentations the diagnostic labelling that results from this process can be as diverse. In the face of this diversity the challenge of diagnosing valid “types” of NSLBP has been unmet and indeed has been all too often forgotten. It has been recognised that the greatest priority facing the NSLBP community is the need to develop valid subcategories of NSLBP(1). This recommendation, developed during the international forum for primary care research in low back pain (1995) has been in the public domain since the mid nineties with little change in diagnostic practice being evident as a result. It is possible that if that recommendation had been addressed and subcategories of NSLBP had been established prior to the commencement of this seminal study, we would be viewing data of an all-together more convincing nature. It is entirely reasonable to believe that certain sub- groups of patients are more suited to manual therapy approaches than "back to fitness" exercise classes however until we establish a valid mechanism of sub-classifying NSLBP we can only hypothesize. It is time we addressed our own recommendations and developed trial designs that will have greater chance of demonstrating clinically significant differences between interventions in subgroups of this heterogeneous syndrome. Reference (1)Borkan J, Koes B, Reis S, Cherkin D. A report from the second international forum for primary care research on low back pain. Spine 1998; 23(18):1992-1996. Competing interests: None declared |
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Edzard Ernst, Director, Complementary Medicine, Peninsula Medical School 25 Victoria Park Road, Exeter, EX2 4NT
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Dear Sir Three brief comments on the excellent BEAM Trial (1). My reading of the results is that the data are compatible with a non-specific effect caused by touch: exercise has a significantly positive effect on back pain which can be enhanced by touch. If this “devil’s advocate” view is correct, the effects have little to do with spinal manipulation per se. It would be relevant to know which of the three professional groups (chiropractors, osteopaths, physiotherapists) generated the largest effect size. This might significantly influence the referral pattern. A post-hoc analysis might answer this question. It is regrettable that the study only monitored serious adverse effects. There is compelling data to demonstrate that minor adverse effects occur in about 50% of patients after spinal manipulation (2). If that is the case, such adverse events might also influence GP’s referrals. E Ernst, Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth References 1. UK BEAM Trial Team. United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care. BMJ, doi:10.1136/bmj.38282.669225.AE. BMJ 2004;19 November:1-8. 2. Stevinson C, Ernst E. Risks associated with spinal manipulation. Am J Med 2002;112:566-70. Competing interests: None declared |
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richard tillett MSc MCSP, senior primary care physiotherapist. Mid Devon Primary Care Trust. The Blackdown Practice, Station Rd, Hemyock. Devon EX15 3SF
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Any attempt to shine a light into the dark corners of chronic back pain management is to be applauded and the UK BEAM team have produced a broad piece of research that has attempted to answer many questions all at the same time. However, I find it difficult to understand how any conclusions can be drawn from the published results if 25% of the study population were not included in the analysis (23% at three months and 26% at 12 months) It would be more than helpful to know what happened to these participants as any conclusions drawn from the remaining datum without an intention to treat analysis severely weaken what is a brave piece of research. Competing interests: None declared |
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Philip Hope, Physiotherapy Extended Scope Practitioner Chesterfield Royal Hospial
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Dear sir I would like to raise one or two points in relation to the UK BEAM trials report into the effectiveness of manipulation versus exercise and general practitioner advice in the management of low back pain (1). The results from the trial of course will lead to the conclusion that manipulation is a ‘cure’ for low back pain, and that if you receive other interventions you are being short changed, I can see the tabloid headlines now. I can also see the requests on patient referral letters from my medical colleagues. It is important, however, to consider whether it was a manipulation that made the difference. Though what difference there was in relation the main outcome measure the Roland and Morris Disability Questionnaire (RMQ), the only outcome measure used where there were stated values of clinical significance, seems marginal at best. It is also interesting to note that though a difference of 2.5 was originally taken as the level indicating a clinically significant difference on the RMQ, then seemingly lowered to 1.67 by some wonder of statistical analysis, other authors have suggested that a difference of 4 points is needed to detect a clinically meaningful difference (2). In any case in the results and discussion section the notion of clinical significance is ignored in favour statistical significance. There seems a tacit assumption that the interaction between a therapist and patient in a one to one situation i.e. the manipulation groups is the same as that in a group situation i.e. the exercise groups. The difference in outcome is assumed to be due to the supposed active element of the treatment, the magical laying on of hands. Deyo (3) however suggests that it is the bedside manner of the manipulator that is effective and not the manipulation per se, there is after all no biological rational for the use of manipulative therapy (4). The ‘bedside manner’ effect is totally different in the group verses individual situation and this is not controlled for in the BEAM trial. Could it be the manipulator instilled a confidence in the patient such that they felt ‘fixed’ which meant the they challenged their back problem to a higher degree than the patients in the exercise group. Or were they just happy to have physical contact with the therapist. These would of course be reasons for employing manipulation, but it is important to know how the method of treatment you are using is effecting its benefit, its more than possible that other approaches could achieve the same benefit. It then is relevant to point out that in normal physiotherapy clinical practice one to one therapist patient treatment is the norm whether applying manipulative techniques or prescribing a programme of exercise, and in normal practice they are combined. This normal practice is not the regime employed in the BEAM trial. Manipulation may or may not be employed in any one patient presentation but of course ‘bedside manner’ will be. A recent trial of what I would consider to be standard physiotherapy (5) in a similar cohort of patients to those in the BEAM trial reported that there was little difference in outcome between the physiotherapy and simple advice groups, what in the BEAM trial was called best practice. Physiotherapy included possibilities of exercise, manipulation etc at the therapists discretion and was over only 5 sessions not eight with the possibility of an exercise program afterwards as in the BEAM trial. At the follow up at one year the RMQ score for the physiotherapy group was 4.76, in the BEAM trial the RMQ score at one year for the most improved group, the manipulation and exercise group, was 4.72. I therefore still have no idea how much difference manipulation will make to my patients, as the BEAM trial has not evaluated my and many other therapists approach to the patients I see. I will therefore continue to manipulate the minds and bodies of my patients the best way I see fit, but will wait before I bestow upon myself the gift of healing hands. Phil Hope MSc (Manipulative Therapy) MCSP SRP Physiotherapy Extended Scope Practitioner 1 UK BEAM Trial Team. United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care. BMJ 2004; 329: doi:10.1136/bmj.38282.607859.AE 2 Stratford P, Binkley J, Solomon P, Finch E, Gill C and Moreland J. Defining the Minimum Level of Detectable Change for the Roland and Morris Questionnaire. Physical Therapy 1996; 76(4): 359-365. 3 Deyo R, Cherkin D, Conrad D and Volinn E. Cost, Controversy, Crisis: Low Back Pain and the Health of the Public. Annual Review of Public Health 1991; 12: 141-156. 4 Deyo R. Conservative Therapy for Low Back Pain. JAMA 1983 ; 250 (8): 1057-1062. 5 Frost H, Lamb S, Doll H, Taffe Carver P and Stewart-Brown S. Randomised Controlled Trial of Physiotherapy Compared with Advice for Low Back Pain. BMJ 2004;329;doi:10.1136?bmj.38216.868808.7C Competing interests: None declared |
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Donald J. Stout, Doctor of Chiropractic Simply Chiropractic / Ridgefield,Wa 98642
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In grad school I volunteered for a now published work of Dr. Bill Ruck that dissected spines for mirror image studies. I noticed the latent effects of "Wolf's Law" on the contorted spinal bones yet when we removed all of the muscle attachments they seemed to resume some resemblance of an "S"shaped curve. After nine months in the lab I concluded for myself that if we can make "Arnold" then we could at least reestablish our basic balancing mechanisms. I read up on how children transform from "C" curve to "S" curve and as fascinated to find that "Wolf's Law" was a major player. After 5 years of practice and personal research I adopted a results based format of treating patients. Since then, I have found it necessary to exercise the patient both before and after the adjustment using gravity based, posturally correct, alternating repetitive exercise for neurological integrative movements. Then I found it necessary to retrain the reflexes to sense the natural path of gravitational forces in the body by completing a minimal 12 week course of weight assisted neurological reintegration movements concentrating on the reestablishment of full pelvic ranges of motion. Additionally I found it necessary to do dietary counseling and nutritional supplementation. Then I started getting 100% recovery. This approach has been effective in healing from old injuries as well as new. This has been a blessing for post operative patients as well. The most dramatic demonstration of this is when, the patient achieves the ability to coordinate the proper path of gravity, there is a notable increase in range of motion throughout the entire body. All patients experience an increased vitality. There is also a dramatic economy of movement. This is accompanied by regeneration of damaged muscle, reabsorption of scar tissue, and disc stabilization. Basically the kind of stuff I only dreamed about when I was first studying Biomechanics. This type of practice takes a tremendous amount of time and effort on the part of the patient and the doctor. The patients must learn a tremendous amount about the body and how to manage it. Every new patient seems to have a unique adaptation of their body mechanics. Because of this fact there can be no standardized methodology to similar symptoms. However, it should be noted the baseline weight assisted gravity training has proven to work 100% with every patient for every condition. It maximizes the effect of the adjustment and naturally speeds healing process. I believe that if we restore our body's natural balance and coordination and its ranges of motion we allow nature to express its full genetic potential. Every year I am fortunate to have many new good reasons to substantiate this belief. Good luck and thanks for the opportunity to share. Donald J. Stout D. C.
Competing interests: None declared |
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Francisco M Kovacs, Director. Spanish Back Pain Research Network. Fundacion Kovacs. Paseo Mallorca 36, 3º, 07012 Palma de Mallorca. Spain, Pablo Lazaro, Alfonso Muriel, Victor Abraira, Javier Zamora, Carmen Fernandez, Ignacio Mendez, Jose Luis Martin, Francisco Martinez, Luis González Lujan, Sergio Luna, and Bartolome Leal, for the Spanish Back Pain Research Network
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An interesting pragmatic clinical trial in patients with low back pain[1] concludes that spinal manipulation achieves better results at 3 and 12 months than general practitioner care, including advice to continue normal daily activities and to avoid rest. Spinal manipulation appears to be also superior to a light exercise programme with group classes incorporating cognitive behavioural principles. A total of 1,334 patients participated in the study, which involved 181 general practices and 63 community settings for physical treatment around 14 centres in the UK. Despite the impressive amount of data and the rigorous study design, planning, and execution, we believe that the conclusions are not properly supported by the results obtained. There are two important shortcomings that may jeopardise the findings presented. First, losses to follow-up in the different study groups varied between 22 and 31%. However, a sensitivity analysis was not performed and the potential effect of this problem on the interpretation of results is not discussed. Second, the size of the observed differences amongst groups is irrelevant from a clinical point of view. Disability, measured by the Roland Morris questionnaire, was the main outcome of the trial. The sample size was calculated to detect intergroup differences of 2.5 points on that scale. This is the lowest cut-off point for a clinically relevant effect,[2] although 3 or 4 points are considered the optimal thresholds.[3,4] Actual differences in favour of manipulation when compared to general practitioner care were only 1.6 and 1.0 points at 3 and 12 months, respectively. Therefore, relevant differences as claimed in the paper were in fact non-existent. This important consideration goes unnoticed in the discussion. Since differences in effectiveness are actually irrelevant, cost/effectiveness benefits of spinal manipulation, as shown in the accompanying paper,[5] are attributable to cost reduction. The study design prevents assessment of whether cost reduction and minimal differences in effectiveness are due to a potential biological effect of manipulation itself, which seems unlikely,[6] or to the influence of other factors.[7] These may well include acceptance by patients of the approach and explanations given by spinal manipulators, physical contact with the therapist or the longer time of individualised care in the manipulation group, when compared to a standard general practitioner consultation or a group exercise class. Losses to follow-up and the lack of a sensitivity analysis of the effect of this confounder on the results make it difficult to draw unequivocal conclusions from this study. On the other hand, although validity of results would have been assumed, a fair interpretation of the findings could be that the three treatment modalities achieve similar clinical results, in spite of longer time of individualised care in the spinal manipulation group, the fact that patients could not be blinded to assigned treatment, and that no attempt was made to mask the assessment of patients’ evolution or the statistical analysis of data. In our opinion, the results of this study do not support the use of spinal manipulation in the routine treatment of patients with low back pain and certainly do not suggest the convenience of implanting spinal manipulation in the different National Health Services in which, as is the case in our country, this therapeutic strategy is not currently being offered. 1. BMJ, doi:10.1136/bmj.38282.669225.AE (published 29 November 2004) 2. Bombardier C, Hayden J, Beaton DE. Minimal clinically important difference in low back pain outcome measures. J Rheumatol 2001;28:431-8. 3. Ostelo RW, de Vet HC, Knol DL, van den Brandt PA. 24-item Roland- Morris Disability Questionnaire was preferred of six functional status questionnaires for post-lumbar disc surgery. J Clin Epidemiol 2004;57:268- 76. 4. Stratford P, Binkley J, Solomon P, Finch E, Gill C and Moreland J. Defining the Minimum Level of Detectable Change for the Roland and Morris Questionnaire. Physical Therapy 1996; 76(4): 359-365. 5. BMJ, doi:10.1136/bmj.38282.607859.AE (published 29 November 2004) 6. Deyo R. Conservative Therapy for Low Back Pain. JAMA 1983 ; 250 (8): 1057-1062. 7. Deyo R, Cherkin D, Conrad D and Volinn E. Cost, Controversy, Crisis: Low Back Pain and the Health of the Public. Annual Review of Public Health 1991; 12: 141-156. of manipulative therapy (4). Competing interests: None declared |
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John A Mathews, Consultant Rheumatologist St Thomas' Hospital, London SE1 7EH
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In disorders whose natural history is towards recovery the rate of improvement is more important than the outcome. My own study demonstrated, for example ,that in selected patients the chance of being able to work one week after manipulation was doubled by manipulation compared with controls. This surely is an important outcome. The design of the UK BEAM study precluded such a finding. What a missed opportunity to help patients. The preliminary reading of the literature by the authors, the referees of the paper, and for that matter the leader writers in your issue of 8th January, 2005 obviously missed our paper. It is regrettable that more care was not taken in a literature search before awarding research funding, subsequent publication of results and eventual review in a leading article. J A Mathews et al 1987 Controlled trials of manipulation, traction and epidural injections. British Journal of Rheumatology 26 416 - 423 Competing interests: None declared |
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Torill H. Tveito, Research fellow Dept of Biological & Medical Psychology, University of Bergen, Jonas Liesv.91, N-5009 Bergen, Norway, Hege R. Eriksen
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Dear Sir, We find the conclusions from the two articles on the UK BEAM Trial (1, 2) surprising. The authors compared three interventions; manipulation, exercise, and the combination of manipulation and exercise. In the recently published European guidelines for treatment of chronic low back pain (www.backpaineurope.org) the trial is rated as of high quality. However, the treatment effects are small, and they are not clinically significant (3). Even more surprising to us, there are no comparisons between the treatments. As far as we can tell from the information given in the papers simple Student’s t-tests do not show any significant differences between exercise and manipulation on Roland Morris or the physical component scale of the SF-36. The only significant difference we find is on the mental component scale of the SF-36, manipulation being significantly better than exercise at three months. It is, therefore, difficult to follow why the authors claim that spinal manipulation is a cost effective addition to "best care" for back pain in general practice, and that manipulation alone may give better value for money than manipulation followed by exercise. As we understand the papers, manipulation and “best care” were of equal benefit regarding clinical significance (Roland Morris), and there was no significant difference between exercise and manipulation (Roland Morris and SF-36 physical component). Given that there is no clinical effect, we would expect that the least expensive treatment would be recommended. If any treatment should be added on to “best care”, in our opinion exercise would be the better choice because of all the other health benefits. Yours sincerely, Torill H. Tveito and Hege R. Eriksen References 1. UK BEAM Trial Team. United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care. BMJ 2004;329:1377, doi:10.1136/bmj.38282.669225.AE (published 19 November 2004). 2. UK BEAM Trial Team. United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care. BMJ 2004;329:1381, doi:10.1136/bmj.38282.607859.AE (published 19 November 2004). 3. Kovacs, FM et al. Does the UK BEAM trial really support the use of manipulation? Rapid response, bmj.com, 12 Jan 2005, http://bmj.bmjjournals.com/cgi/eletters/329/7479/1377#92349. Competing interests: None declared |
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Arunachalam Kumar, Professor of Anatomy KMC Mangalore 575001 India, Jairaj Kumar.C, and Garvit Chitkara
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One simple pre-manipulative relief for chronic low back pain is provided by sleeping on a cot(bed) whose foot end has been elevated by six inches through placement of bricks or wood blocks under its legs at foot end. Lying down and resting in this engineered cranially sloping posture, alleviates pain to a considerable degree, in less than four to six weeks. Though we have not quantified the range of relief through any study, this cost-effective and drugless method, is well worth a try - before more expensive or prolonged courses of therapeutics or physiotherapies become mandated or imperative. In parts of the third-world we come from, the services or ready availability of trained physiotherapists is expensive and premium; not to mention the total absence of chiropractors or their ilk in India. Competing interests: None declared |
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