Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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All outcomes are not equal
- Randall H. Rosenthal (24 May 2005)
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All outcomes are not equal: a response
- Richard Bartley (24 May 2005)
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reducing knife crime
- Richard V Harrington (27 May 2005)
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Better informed patients will not mean the end for spinal fusion
- Jon norman (28 May 2005)
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Osteoporosis
- milind m deshpande (28 May 2005)
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Do lower back problem sufferers need doctors at all?
- Frank J Leavitt (1 June 2005)
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Re: Do lower back problem sufferers need doctors at all?
- Ian P stevens (2 June 2005)
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Surgical responses to Back Pain
- Fenella Lemonsky (3 June 2005)
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Indications for Surgery in Low Back Pain Still Unclear
- Gerson T. Lesser, MD (11 June 2005)
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Spinal Surgery or Intensive Rehabilitation: Patient selection is key
- Clare J Harris, Alexander Mirnezami (13 June 2005)
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Rehabilitation programme must precede spinal stabilisation
- Nicholas Vyner Todd (22 June 2005)
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Concerned about conclusions
- Brian R. Subach, MD, FACS, Thomas C. Schuler, MD (29 June 2005)
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Statistical analysis for one way cross over
- David W. Polly (5 July 2005)
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SF36 scores
- Gnanie Panch (7 September 2005)
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Randall H. Rosenthal, Computer Consultant 115 Hiram College Dr., Northfield, Ohio 44067, United States
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I was a chronic back pain sufferer due to sports and other influences. I was treated at a leading hospital for back related therapy and surgery. My disk herniated and similar data was given to me by my physical therapists, the doctor treating my back and later by the surgeon performing the surgery. I probed further asking how many cases as serious as mine they had seen or heard of going through therapy, both in reference to the studies and in reference to personal experience. Understand that at the time, I had evolved, while in therapy, to radiating pain and numbness as well as minor loss of strength in one leg. None had seen cases as serious as mine go any route other than surgery. Still the studies continued to be sited. I could go either way with equal probability of success. I pointed out that if there were no cases as serious as mine going down the path of therapy, this wasn't an apples to apples comparison and that no conclusion could be reached. Each time this was greeted first with surprise, then with the reality that this was true. From the date my disk herniated, and I was unable to stand from the pain, it was a month to my surgery, all the while I was in physical therapy. When the pain subsided, again from all the professional levels, the physical therapy was touted. When I pointed out that I had limited sensation in the areas that the pain had been in, there was no quick acceptance that I wasn't getting better but worse. I had no also developed a slight drop foot. The surgery took longer than expected as there was much swelling in the spinal cord and the nerves branching from that area. I still have some numbness in my foot and a slight weakness in my leg. While I wish to limit myself to the article, I also wish to point out that the facilities were not prepared to deal with a back problem of my severity. I had to sit in a standard waiting area, but I couldn't sit. I mostly lay on the floor. There was no urgency. I come to two possible conclusions: 1) that cases such as mine must be very rare (but I have heard of other serious cases just from family and friends with similar problems) 2) the studies, such as this one, are blinding Medical Professionals (not intentionally) to the problems related to severe back pain. I shocked each Medical Professional with the fact that I didn't fit the studies. These were leaders in their fields. These studies are very important, but it is also very important that the more severe cases receive special attention, especially in these studies. I don't feel it is the fault of the studies; it is the fault of the blanket conclusions that are drawn after reading them. Two questions should always be asked: First, does the study fit, and how well? Second, what is the possibility and probability of a negative outcome for specific cases and does the study address that? Competing interests: None declared |
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Richard Bartley, Chartered Physiotherapist Wales, UK
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Randomised control trials in the clinical setting, as with this study, relate to patient populations rather than individuals. Qualitative research on the other hand aims to represent the actual experiences of individuals. It is the attention to both types of research that best serves the interests of patients. Competing interests: None declared |
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Richard V Harrington, GP Thame Health Centre OX9 3JF
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In looking for the editorial relating to this paper, I turned first to 'Reducing Knife Crime' [and I'm not joking]. From the perspective of a GP [moreso this one with spondylolisthesis] the emphasis is on surgical referral as a last resort. It's not often that I laugh whilst reading the BMJ... Competing interests: None declared |
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Jon norman, pain fellow South Manchester University Hospital, Manchester, M23 9LT
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EDITOR-This excellent trial mirrors clinical practice far better than most. Patients with pain are often offered treatments without clear knowledge of their pain generator, with operative treatments selected on the basis of local expertise. The authors should also be congratulated for comparing surgery with a real alternative therapy, rather than a placebo purporting to be a treatment. Comparative trials of real treatments are the exception rather than the rule. So if we must first do no harm, then spinal fusion with a 14% complication rate and no clear outcome advantage does not make a good first line treatment. However we live in a quick fix society, therapies that promise cure today with a passive role for the patient pervade, no matter what the added cost. This trial does not mean the end for spinal fusion.But it will help clinicians to give a more balanced view when they present therapeutic options to patients, so that patients are empowered and informed to make their own choice. Although the technology of scans and surgery has advanced, this only defines structure and corrects its abnormalities. To assume that any abnormal structure is painful with the level of pain equating with magnitude of the structural abnormality is Pre Cartesian. Unfortunately the general public and many clinicians, both in medical and allied medical professions, still subscribe to this model. It can’t be stressed enough that scans show structure and patients report pain, they are not the same. We are treating the patient not the scan aren’t we? Jon Norman pain fellow South Manchester University Hospital, Manchester, M23 9LT. 1. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial Jeremy Fairbank, Helen Frost, James Wilson-MacDonald, Ly-Mee Yu, Karen Barker, Rory Collins for the Spine Stabilisation Trial Group BMJ 2005 330: 1233. Competing interests: None declared |
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milind m deshpande, consultant orthosurgeon hubli,India,580031
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Were patients above 35yrs subjected to assesment and treatment of osteoporosis before assigning them to either group in the study undertaken?If not,they should have been since it might have resolved some of the chronic low back pains! Best Wishes Milind. Competing interests: None declared |
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Frank J Leavitt, Chairman, Centre for Asian and International Bioethics, Faculty of Health Sciences, Faculty of Health Sciences, Ben Gurion University, Beer Sheva, Israel
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I am a veteran of two excruciating bouts with lower back problems, and the husband and father of two others who have had similar experiences, I was most interested by the fact that the intensive rehabilitation programme outlined in Fairbank and colleagues' excellent article did not seem to require any significant medical or other professional knowledge. Any intelligent person with some awareness of one's own body and with the ability to keep an optimistic mind, should be able to design and carry out an "intensive rehabilitation programme" on one's own. In our family experience, all three of us solved the problem by walking, walking and more walking. (Bicycling was not so effective, perhaps because it exercises much fewer parts of the body.) A little amateur back massage was also helpful in one incident. And as preventive medicine, my wife and I threw the mattress and bedsprings away more than fifteen years ago. A thin camping mat, no more than a centimeter in thickness, on top of a hard wooden bed, is all we use. After some getting used to, it is perfectly comfortable. Since sleeping on such a bed, the problem has not returned except for one very brief and quickly cured incident. None of us is a medical professional. Rather than investing in surgery or rehabilitation programmes, perhaps the NHS, sick funds, etc, should consider putting out a pamphlet on how to keep your back healthy,to be distributed for free to the public. Competing interests: None declared |
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Ian P stevens, Physiotherapist Forth Valley Stirling Royal Infirmary FK17
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You raise some interesting points . I gather you are not an 'orthopaedic' bed salesman! This link might be of interest to you (Instinctive and anthropological approach to back pain which you and your family seem to have worked out for yourself) http://bmj.bmjjournals.com/cgi/content/full/321/7276/1616 A pamphlet called the back book publised by HMSO is available in most health centres and has advice by Professor Wadell (Orthopaedic Surgeon and author of the Back Pain Revolution and a Dr of Psychlogy Chris Main) There is also a back pamphlet published by ARC (arhritis research council) which is available on line or from most health centres which has the kind of advice that you propose . The overmedicalisation of back pain is a big issue that Gordon Wadell has addressed over many years . If it were as simple as graded restoration of function and home massage (which I think are along the right lines) most chronic disability would be a thing of the past . For most people this approach is correct but many people simply will not follow this schema and there is a huge 'care' industry to turn to if coping strategies are stretched. Another author mentioned dualistic interpretations of pain and suffering . Any spell working in a pain clinic will expose you to numerous cases where pain is 'seen' and interpreted using the 'evidence' of the scanner or xray . Repeated back operations are still being performed when the factors either perpetuating sensitvity or hugely influencing it are not being addressed (fear avoidance and the issues of prior adverse life events ) Positively, there is evidence that education utilising up to date pain physiology and motor re-education has helped small numbers of intractable cases -- perhaps this work may expand in other clinics too . Ian Stevens Competing interests: None declared |
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Fenella Lemonsky, Mental Health Trainer London Borough of Barnet
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As a pain patient with severe LBP I have fared better in a pain clinic where the appraoch was more holistic-medication (minimal), exercise, manipulation, diet advice, trigger point injections occassionally and cognitive behavioural therapy. I was previously under a pain clinic inn London in a big teaching hospital and I was just given medication,, lectured about diet and exercise and treated as if I was thick and told " I'll be the one who makes the decisions" (pain consultant) and also when p[ain got worse and I didn't wish to increase my MST consultant asked "what is wrong with MST?". I went in search of a more holistic approach and 15 months later, my medication has been reduced by 65%, pain levels much so reduced and far more importantly this was in an NHS pain clinic with a consultant who genuinely believed that I could and would get better without all the medical interventions the previous consultant kept throwing at me. From a primary care perspective I was not impressed that medication was the best that could be offerred initially and no more-the knowledge was lacking, my bck was not examined properly until I hit the second pain consultant and I have huge concerns about doctors basic diagnostic skills in musculo skeletal pain. All doctors should be able to do a proper back examination-there is no excuse except sloppiness or lack of interest in the presenting patient. Proper examination leads to proper diagnosis and better outcomes in pain management. Competing interests: None declared |
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Gerson T. Lesser, MD, Assistant Professor, Dept. of Geriatrics & Adult Development, Mount. Sinai School of Medicine The Jewish Home and Hospital, 120 West 106th Street, New York, NY 10025
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Fairbank and co-workers (1) are to be congratulated for carrying out a difficult investigation of a sizeable cohort that helps to clarify issues faced by most practitioners. Given the paucity of well-controlled studies on surgery for low back pain and the authority of the Spine Stabilisation Trial Group, one would expect their conclusions to influence professional standards of care and clinical practice. However, this could be a mixed blessing, as several limitations of the study point up the need for expanded information on a broader range of low back sufferers. Subjects in this cohort were adults with >12 month history of chronic low back pain who were eligible only “… if the clinician and patient were uncertain which of the study treatment strategies was best.” Given such vague criteria, one must assume that large numbers of low back sufferers were not included, such as those with mild pain and, almost surely, the preponderance of those with important or progressive neurological abnormalities. It is these latter, high-risk patients for whom most practitioners find surgical referral to be indicated, and their exclusion from the study leaves us with no new information to assess surgical (vs. non-surgical) choices (1). In the accompanying editorial comment, Koes (2) properly suggests that an untreated control group should have been included, particularly since such untreated low-back sufferers might have improved as well. Similarly, another group should have been treated with both surgery and physiotherapy, since elements of each modality might be beneficial in different ways and thus might be additive. Although such studies are difficult to carry out, this type of supplementary information is essential to the clinician’s ability to make informed judgments. We are, at this time, not able to discard surgery as a potential therapeutic option for specific patients. References: 1. Fairbank J, Frost H, Wilson-MacDonald J, Yu L-M, Barker K, Collins R for the Spine Stabilisation Trial Group. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ 2005; 330:1233-9. 2. Koes BW. Surgery versus intensive rehabilitation programmes for chronic low back pain. BMJ 2005;330:1220-1. Competing interests: None declared |
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Clare J Harris, GP Hampshire SO52 9EP, Alexander Mirnezami
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Editor- Fairbank and colleagues (1) suggest that there is little difference in outcome for patients with chronic back pain whether given intensive rehabilitation or spinal fusion. The key limitation to this study however is that the best candidates for surgery were excluded. In this study, patients in the surgical group had a mean Oswestry Disability Score of 46.5 and in the intensive rehabilitation group of 44.8. In clinical practice there is a group of patients with higher disability scores than this (2,3) which in itself makes attendance at a daily intensive rehabilitation programme difficult and at worst impossible. I (CH) can speak from personal experience having suffered from chronic back pain for two and a half years. Despite being highly motivated, well informed and otherwise fit and healthy my symptoms did not settle after the acute episode. I was left with an Oswestry Disability Score of 63. At this level of disability attending a regular rehabilitation programme is practically impossible. For me, after months of various analgesics, physiotherapy, rehabilitation and a self directed CBT approach to pain management - none of which gave me a significant improvement in quality of life - surgery was the only option. Certainly the operative risks were far outweighed by the potential benefits. We need to be aware that there is a group of patients for which surgery is the answer. If we do not recognise this we run the risk of condemning patients with potentially curative problems to years of pain and suffering. Worse still, these patients can become pigeonholed as having a large psychological component to their problem. As human beings could any of us live with years of debilitating pain without any psychological effect? In summary, although intensive rehabilitation looks promising for some patients perhaps we should be looking at better means of selecting those who will benefit from rehabilitation and those for whom surgery really is the only option. 1 Fairbank J, Frost H, Wilson-MacDonald J, Yu L, Barker K, Collins R. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehab programme for patients with chronic low back pain; the MRC spine stabilisation trial. BMJ 2005; 330:1233-1238. 2 Guyer RD, McAfee PC, Hchschuler SH, Blumenthal SL, Fedder IL, Ohnmeiss DD, Cunningham BW. Prospective randomized study of the Charite artificial disc: Data from two investigative centres. Spine J. 2004; 4(6 suppl):252s-259s. 3 McAfee PC, Fedder IL, Saidy S, Shucosky EM, Cunningham BW. SB Charite Disc Replacement; report of 60 prospective randomised cases in a US centre. Spine Disorders Tech. 2003; 16 (4) 424-33. Competing interests: None declared |
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Nicholas Vyner Todd, Neurosurgeon Newcastle General Hospital, Westgate Road, Newcastle Upon Tyne, NE4 6BE
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Fairbank et al(1) reported a randomised control led trial of surgical stabilisation of the lumbar spine compared to intensive rehabilitation programme in patients with chronic low back pain(1). The principle of randomisation was based on a “grey zone” of uncertainty (on behalf of the treating clinician) as to whether surgical stabilisation or an intensive rehabilitation programme was the appropriate management i.e. that there was clinical equipoise as to whether the patient should have surgery or non-surgical treatment. Many spinal surgeons including myself would not feel that this is an area where clinical equipoise is possible. If a patient is thought to be appropriate for an intensive rehabilitation programme then that is what should occur. Surgery is contraindicated until all conservative treatments have been exhausted, including an intensive rehabilitation programme. A number of spinal surgeons were unwilling to joint this trial because of that. If a spinal surgeon is apparently in clinical equipoise as to surgical/non-surgical management, then it is likely that a patient has either (i) not had a full course of medical management or (ii) has less severe disease. Either of these would bias the trial in favour of the intensive rehabilitation programme. Another noteworthy point is that despite the likelihood that the trial is biased in favour of non-surgical treatment 28% of patients randomised for rehabilitation eventually had a surgical procedure. Koes(2) correctly concludes that there is limited evidence that confirms the benefit of surgical stabilisation and that appropriate patient selection is difficult. However the primary position is that until a patient has had a full course of non-surgical treatment surgical stabilisation is not an appropriate option. Mr N V Todd MD FRCS Consultant Neurosurgeon & Spinal Surgeon Newcastle General Hospitals NHS Trust 1. Katz. J. Lumbar spinal fusion: surgical rates, costs, and complications. Spine 1995;20:78S-83S 2. Koes BW. Surgery versus intensive rehabilitation programmes for chronic low back pain Competing interests: None declared |
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Brian R. Subach, MD, FACS, Spinal Surgeon/ Neurosurgeon The Virginia Spine Institute, 1831 Wiehle Avenue, Reston, VA, USA, Thomas C. Schuler, MD
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We read with great interest the recent contribution by Fairbank et al (May 2005) regarding the surgical versus rehabilitation interventions for chronic low back pain. As a center that successfully utilizes both operative and non-operative techniques in the management of our patients, we hoped to draw conclusions from the paper, which were similar to our own philosophy. Unfortunately, the study has a number of shortcomings that may lead to misinterpretation of the collected data and consequently conclusions, which are unsubstantiated. First, the entry criteria for the study essentially excluded all patients for whom surgery was the initial treatment recommendation. The exclusion of this subset of patients, likely having the highest pretreatment Oswestry scores, introduces an unacceptable bias. By removing these patients, who would conceivably benefit most from surgery and show the greatest benefit from each treatment dollar spent, the authors effectively predetermine the outcome of the study. It is not surprising that the post-operative Oswestry scores barely reached statistical significance. Second, by employing the intention to treat method of analysis, the study allows and fails to account for one-way crossover of patients. For example, the 48 patients (28%) in the non-operative group who crossed over to the surgical group should be considered failures of rehabilitation. Obviously, if these patients required surgery within the two years of study follow-up, they would have incurred the cumulative cost of both treatment regimens. This could hardly be considered an appropriate control group, nor a cost-effective means of patient care. Third, the authors admit to an extended period of time for patient accrual into the study (June 1996 to February 2002). In a study that requires a prolonged enrollment time (over 60 months) to enroll patients, we are concerned by the 20% loss to follow-up rate at 24 months. How can one possibly make decisions regarding cost-effectiveness and overall treatment efficacy, if one cannot verify adherence to the patient’s prescribed treatment regimen and follow up over the standard two years? Similarly, we are concerned about the length of enrollment. Could the techniques and costs associated with any intervention possibly be standardized over such a period of time? In conclusion, we applaud the significant effort put for by Fairbank et al, but also caution against drawing conclusions unsubstantiated by their data. Competing interests: None declared |
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David W. Polly, Professor and Chief of Spine Surgery University of Minnesota, MN, USA
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Re: Fairbank et al Dear Sir, Fairbank and colleagues have completed a noteworthy study. However, several study design and statistical issues warrant additional comment because they may bias the results against surgery. By virtue of the inclusion and exclusion criteria, the patients most likely to benefit from surgery were excluded. As such, the enrolled patients are not representative of the population as a whole, which limits the inferences that can be drawn from this trial. In addition, the investigation was conducted at centers only in the United Kingdom (U.K.), which, again, limits the generalizability of the findings to other countries, like the United States (U.S.), where clinical practice patterns and treatment regimens may differ from the U.K. Surgical studies with bone morphogenetic proteins or with minimal invasive surgery typically find ODI changes after intervention in excess of 20 points.2 This is more than double that reported by Fairbank for the surgical (change 12.5 pts) and rehab groups (change 8.7 pts). With more current spine technologies, it is possible that different conclusions might have been reached. In light of the intent-to-treat analysis (ITT) employed (data analyzed according to treatment assigned, not treatment undergone), the differential crossover rate is particularly troubling: 28% of PT patients underwent surgery, whereas only 4% of surgical patients had PT. With this level of noncompliance, Sheiner contends that an average causal effect analysis (ACE) is more relevant than an ITT, particularly with respect to therapeutic decision-making.3 An ACE would evaluate the effectiveness of surgery after “adjusting” for the observed level of crossover. For example, Robins et al., using an ACE, demonstrated that their ITT failed due to crossover rather than the lack of intrinsic efficacy.4 The validity and policy relevance of the Fairbank study warrants further consideration in light of these potential biases. Fairbank J, Frost H, Wilson-MacDonald J, et al. Randomised controlled trial to compare surgical stabilization of the lumber spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilization trial. BMJ, doi:10.1136/bmj.38441.620417.8F (published 23 May 2005). 2Burkus J.K., Heim S.E., Gornet M.F., and Zdeblick T.A. Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device. J. Spinal Disord. Tech. 16(2): 113-22, 2003. 3Sheiner LB. Is the intent-to-treat analysis always (ever) enough? Br J Clin Pharmacol 2002; 54:203-211. 4Robins JM, Finkelstein DM. Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics 2000; 56:779-788. Competing interests: Consultant Medtronic |
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Gnanie Panch, Consultant in anaesthesia and pain management Whittington hospital London N19 5NF
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I have been using SF36 in my pain clinic for initial assessment and to evaluate the effect of treatments which are multimodal and multidisciplinary. I have used norm based scores from the demo screen to score the results. It is not clear from the article whether the results reported for the domain scores PF,RP,BP,GH, VT, SF, RE and MH scores were direct scores or norm based scores. Please clarify. Will it be possible to obtain the Norm based scores of the above samples? Competing interests: None declared |
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