Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Wishful thinking?
- Richard Bartley (28 May 2009)
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NICE guideline on low back pain are flawed
- Rajesh Munglani (31 May 2009)
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NICE Misguidance
- Michael Vagg (1 June 2009)
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NICE guidelines for the early management of persistent low back pain
- Martin R Underwood, Professor Peter Littlejohns, Clinical and Public Health Director , NICE, Professor of Public Health, St Georges University of London (3 June 2009)
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Missing reference
- Martin R Underwood, Professor P Littlejohns (4 June 2009)
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Re: NICE guidelines for the early management of persistent low back pain
- Stephen P Ward (4 June 2009)
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The NICE guideline - the real issues
- Michael H Basler (6 June 2009)
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A "landmark" indeed
- David Colquhoun (10 June 2009)
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The right stitch at the right time saves more than nine!
- Paul O. Ola (28 June 2009)
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Richard Bartley, Physiotherapist Wales
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I am struggling to see how the latest NICE guidelines for back pain can justify proposing eight sessions of exercise therapy and/or nine session of manual therapy and/or twelve session of acupuncture, when each of these modalities lack robust clinical evidence to support their use. Are these dosages reached at arbitrarily? Whatever happened to the principal that clinicians should treat what they see rather than following a prescription menu? Is clinical reasoning when it comes to back pain management now redundant? Competing interests: I am a physiotherapist with an interest in spinal pain and disability |
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Rajesh Munglani, Consultant in Pain Medicne West Suffolk Hospital IP33 2QZ
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Dear Sir We, as a group of Consultants in Pain Medicine received with incredulity and dismay the new NICE (National Institute of Health and Clinical Excellence) guidelines on the treatment of early persistent low back pain. NICE has decided that for back pain lasting between 6 weeks and one year that the following options be considered; osteopathy, acupuncture, psychological therapy and surgery. The NICE Committee consisted of, amongst others , a psychologist, a chiropractor, an acupuncturist and a spinal surgeon, but there was no one on the committee who was an experienced Pain Physician. It appears that the NICE committee’s conclusion on early low back pain reflect the personal bias of the committee members. An example of this is that NICE specifically dismiss the role of spinal injections in treatment of early low back pain, preferring instead to recommend spinal fusion surgery before spinal injections. Whilst we accept that fusion surgery has a limited role in some patients, to exclude less invasive and less risky procedures such as spinal injections, which can benefit patients and avoid the risk of major surgery, seems idiosyncratic and distorted at best and deeply disturbing at the worst. We believe that a consequence of these NICE guidelines is a grave risk that many thousands of patients will undergo unnecessary spinal fusion operations, when much less invasive injections would have been helpful We as a group of Consultants in Pain Medicine including previous and current presidents of the specialist association were alerted to the draft NICE guidelines and we urgently wrote presenting the wealth of data supporting the role of spinal injection and other therapy in helping people with low back pain. We were rebuffed and told we had to submit our concerns about the guidelines through a ‘registered Stakeholder’. Notwithstanding the bureaucratic hurdles that were in place , we submitted our concerns about what we felt was a distorted opinion of the evidence and in particular emphasised the positive outcomes of the randomised controlled trials of injection therapy. To our dismay, our submission and this data has been utterly ignored. Yet acupuncture and spinal fusion, which have far less reliable data to support them, have been included. We draw attention the past record of NICE's decision making in the respect of the drug treatment of early Alzheimer's’ and some cancer treatments which have provoked public and professional outrage and note the serious questions which have been raised about the lack of transparency in the decision making process of NICE. Because of these new guidelines patients will continue to experience unnecessary pain and suffering and their rights to appropriately individually tailored treatment have been removed on the basis of a flawed analysis of available evidence. We believe the guidelines do not reflect best practice, remove patient choice and are not in our patients’ best interests. Dr Rajesh Munglani, Dr Sanjeeva Gupta, Dr Jonathan Richardson, Dr Chris Wells, Dr Charles Gauci, Dr Glynn Towlerton, Dr Andrew Lawson, Dr AR Cooper, Dr Manohar Lal Sharma. Dr Tony Hammond, Dr Stephen Ward, Dr Wisam Ali, Dr Daniel W Wheeler, Dr Mark Abrahams, Dr Mark Sanders, Dr Dalvina E Hanu-Cernat, Dr.F.D.O. Babatola, Dr M. Murali-Krishnan, Dr Yadi Jayran-Nejad, Dr Thomas Smith, Dr Andrea M R Harvey, Dr Jones Kurian, Dr Andrew StClair Logan, Dr. Liz Garthwaite, Dr. Don Jones, Dr J C Burnell, Dr P.N.Colling, Dr. Marcia Schofield, Dr Dimitri Leschinskiy, Dr K E Tighe, Dr Ian Wilson, Dr Vanessa Hodgkinson, Dr. S. Kanakarajan, Dr Wisam Ali, Dr. Zahid Waheed, Dr Adam Masters., Dr Rokas Tamosauskas, Dr Raju Bhadresha, Dr M. Murali-Krishnan, Dr Nick Roberts, Dr Sujann Singh, Dr Simon Tordoff. Dr.Sridevi Ramachandran, Dr Mark Dale, Dr Nick Padfield. Dr R Iyer, Dr Andrew Ravenscroft, Dr Joseph Azzopardi . Dr Ilan Leiberman. Dr David Conn. Dr Amgad Ragheb, Dr FE LuscombeAll Consultants in Pain Medicine through out the United Kingdom. Competing interests: None declared |
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Michael Vagg, Pain Clinic, Geelong Hospital Geelong 3220
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I am incredulous and very gravely concerned at the level of misunderstanding of current models of back care management propounded in this document. I would be grateful if any of the experts who prepared could answer my 3 biggest concerns. (1) I agree with the statement that back pain sufferers should be encouraged and empowered to 'self-manage' their condition. How is this to be achieved by recommending that they seek passive, hands-on treatment such as manual therapy, or even more mystifyingly, acupuncture ? (2)How can the committee of experts (all of them honourable men, as Mark Anthony might have said) recommend with a straight face non-evidence-based treatments like manual therapy, acupuncture and spinal fusion whilst ignoring the weight of evidence which supports interventional pain management and CBT as more than valid treatments of first resort ? The committee's statements about interventional pain management are frankly ignorant and embarrassing to NICE. (3) Where is the evidence-based advice to reassure and encourage back pain sufferers to think of their condition as time-limited and likely to settle without the need for complicated interventions or passive treatment ? It seems to me that this guideline has been used as a propaganda vehicle to allow cherry-picked evidence to be enshrined as doctrine. This is an abuse of the guideline development process, as we should remember that medicine is not just evidence-based but science-based as well. Competing interests: Specialist in Rehabilitation and Pain Medicine |
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Martin R Underwood, Professor of primary care research, Chair of back pain guideline development group Warwick Medical School, University of Warwick, CV4 7AL, Professor Peter Littlejohns, Clinical and Public Health Director , NICE, Professor of Public Health, St Georges University of London
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Dr Rajesh Munglania and his consultant colleagues are concerned about the new NICE guideline for the early management of persistent non-specific low back pain. They consider that the recommendation on spinal fusion is “ idiosyncratic and distorted at best and deeply disturbing at the worst”, They question the evidence used to inform the guidelines, and claim that the recommendations “reflect the personal bias of the committee members”. They suggest that attempts to submit evidence were “rebuffed” and “utterly ignored”, and then question NICE’s “transparency”. We will deal with these concerns in turn 1. The comparative strength of the evidence for spinal injections and
spinal fusion
2. Conclusions reflect committee member’s personal biases.
3. Attempts to submit evidence rebuffed and ignored
4. NICE’s processes are not transparent
The real issue here is the limited evidence base for injections into the spine. In 10 years NICE has established robust processes for collating, interpreting and distilling evidence into guidance. This task is obviously more difficult when the evidence base is weak. The most productive way forward is to improve the evidence base and that is why there are research recommendations in the guideline. A previous written response to the pain consultants concerns included an invitation to participate in the efforts to design appropriate research studies to reduce the uncertainty around how best to manage this common and disabling condition. Competing interests: MU’s research includes one completed RCT of exercise and manipulation for low back pain which informed the development of this guideline [1] and an ongoing study testing a cognitive behavioural intervention [2] 1. UK BEAM Trial Team. UK Back pain Exercise And Manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care. BMJ 2004;229:1377-81 2. Lamb SE, Lall R, Hansen Z, Withers EJ, Griffiths FE, Szczepura A, et al on Behalf Of The Back Skills Training Trial Best Team. Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial. BMC Musculoskeletal Disorders 2007, 8:14. PL is an employee of NICE |
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Martin R Underwood, Professor of primary care research, Chair of back pain guideline development group Warwick Medical School, University of Warwick, CV4 7AL, Professor P Littlejohns
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The following reference was accidentally omitted from the main text of our previous response. 1. Chou R, Loeser JD, Owens DK, Rosenquist RW, Atlas SJ, Baisden J, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine 2009;34(10):1066-77. Competing interests: MU’s research includes one completed RCT of exercise and manipulation for low back pain which informed the development of this guideline [1] and an ongoing study testing a cognitive behavioural intervention [2] 1. UK BEAM Trial Team. UK Back pain Exercise And Manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care. BMJ 2004;229:1377-81 2. Lamb SE, Lall R, Hansen Z, Withers EJ, Griffiths FE, Szczepura A, et al on Behalf Of The Back Skills Training Trial Best Team. Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial. BMC Musculoskeletal Disorders 2007, 8:14. |
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Stephen P Ward, Consultant in Pain Medicine Brighton and Sussex Unversity Hospitals NHS Trust RH16 1UL
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Underwood and Littlejohns tell us 'there are two systematic reviews reporting that spinal fusion is effective' and that these reviews informed the NICE low back pain guideline development group (GDG) who propose referral for consideration of spinal fusion as an appropriate step in the management of low back pain of less than 12 months duration. Reading the first systematic review (T. Ibrahim, I. M. Tleyjeh, and O. Gabbar)it is difficult to see how the GDG reached this conclusion - the authors showing that: 'Surgical fusion for chronic low back pain favoured a marginal improvement in the ODI (4.13)compared to non-surgical intervention.This difference in ODI was not statistically significant and is of minimal clinical importance. Surgery was found to be associated with a significant risk of complications (16%). Therefore, the cumulative evidence at the present time does not support routine surgical fusion for the treatment of chronic low back pain.' An erratum has since been published : (http://www.springerlink.com/content/4m44771517342781/fulltext.pdf). The GDG feel that the results of this revised meta-analysis are so different to the original that a referral for surgery recommendation is now warranted. This was not the view of the author however. The conclusion reached was that the improvement in the ODI compared to the original article (−4.87 compared to −4.13) was statistically significant but of minimal clinical importance and that: 'Further long-term follow-ups of the studies reviewed in this meta- analysis are required to provide more conclusive evidence in favour of either treatment.' The second review by Mirza of 4 RCTs reached similar conclusions, the authors concluding that: 'One study suggested greater improvement in back-specific disability for fusion compared to unstructured nonoperative care at 2 years, but the trial did not report data according to intent-to-treat principles. Three trials suggested no substantial difference in disability scores at 1-year and 2-years when fusion was compared to a 3-week cognitive-behavior treatment addressing fears about back injury' For Underwood and Littlejohns to state that the reviews considered by the NICE GDG report spinal fusion to be 'effective' is disappointing and suggests a misreading of the evidence. Unfortunately the rather haphazard interpretation of the evidence pervades this 'landmark' document and I echo calls from others in the medical community to withdraw the guideline and start again. Competing interests: None declared |
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Michael H Basler, Consultant Glasgow Royal Infirmary G4 0SF
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Professor Underwood writes “the real issue here is the limited evidence base for injections into the spine”. This is not the case. The real issue is the fact that the evidence base for any intervention is poor and that back pain is hugely complex. The fact that there are several hundred published randomised controlled trials of treatments for low back pain should have meant that the guideline development group(GDG) realised that no one stakeholder would have the answers and that NICE should temper its conclusions. It did neither. No one is making comments on the integrity of the GDG group but it is naive to think in such a complex area with a poor evidence base that personal opinions may not count. Some of the data from the original “spinal injection” trials used patients who had back pain greater than 12 months. Someone decided to include this data to show these injections were ineffective. This was out with the guidelines remit and grade 4 evidence i.e. opinion was used to admit this data. More importantly NICE has done nothing to counter the widespread misinformation of the guidelines in the media, even in its publication. Consider its website which says – “This guideline is about the care and treatment that people who have persistent non-specific low back pain can expect from the NHS in England and Wales to help them manage their pain." This is also not the case. The guideline has specific limitations and to most individuals “patients with persistent low back pain” are a much wider cohort. In its economic analysis it makes the conclusion that by stopping injection therapy various developments will be funded. Is it limiting this analysis on patients with less than 12 months of back pain or has it included a much larger cohort of patients which were out with the guidelines remit? The sad thing is that one of the key features of the guideline, which is to give regular exercise therapy, has been lost in the coverage. As expected chiropracters, acupuncturist and equipment companies will race to promote their service and products on the back of this. Indeed this has already occurred. As a consultant with 10yrs experience of managing people in pain, predominantly musculoskeletal, my job to get people more mobile and improve their physical functioning will now be much harder. They will likely now be concerned about the “curvatures of their spine” ( on the back of something “collectively called manual therapy”), may ask for access to longterm acupuncure ( which may encourage passivity) and I may see a considerable number patients on the back of failed spinal surgery who should never have gone near an operating table. That is the real world but that is only my grade 4 opinion. There are another 2000 people in pain management units up and down the country, who dare I say it, may hold similar views. The trouble is that they seem to have been ignored. A small amount of poor grade 1 evidence, in a contentious area, has held forth and been given fairly strong backing. Complex problems need widespread consultations, tempered conclusions and clear messages to prevent misinterpretaion. None of that has occurrred here. Lets hope NICE learns some lessons. A good start would be to admit its flaws. Competing interests: Consultant in Pain Medicine |
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David Colquhoun, Research professor UCL WC1E 6BT
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Underwood and Littlejohns describe their guidance as being a "landmark". I can only agree with that description. It is the first time that NICE has ever endorsed alternative medicine in the face of all the evidence. The guidance group could hardly have picked a worse moment to endorse chiropractic. Chiropractors are so sensitive about criticisms of their practices that, when one of our finest science writers, Simon Singh, queried the evidence-base for their therapeutic claims they sued him for defamation. I suggest that the guidance group should look at the formidable list of people who are supporting Singh, after his brave decision to appeal against an illiberal court ruling in this iniquitous persecution. One wonders whether this bizarre decision by NICE has anything to do with the presence on the guidance group of Peter Dixon, chair of the General Chiropractic Council. I am also curious to know why it is that when I telephoned two of the practices belonging to Peter Dixon Associates, I was told that chiropractic could be effective in the treatment of infantile colic and asthma. Similar claims about treating colic have just been condemned by the Advertising Standards Authority. The low back pain guidance stands a good chance of destroying NICE's previously excellent reputation for dispassionate assessment of benefits and costs. Yes, that is indeed a landmark of sorts. If NICE is ever to recover its reputation, I think that it will have to start again. Next time it will have to admit openly that none of the treatments works very well in most cases. And it will have to recognise properly the disastrous cultural consequences of giving endorsement to people who, instead of engaging in scientific debate, resort to legal intimidation. Competing interests: None declared |
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Paul O. Ola, Preventive Health Physiotherapist Physiohealth Services Ltd (23401)
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I support NICE’s recommendation that persistent non-specific low back pain should be managed earlier than is presently done, more actively to reduce the risk of long term pain and disability, with self-management starting with advice and information being a key focus of this management. Most low back pain persisting beyond 6 weeks result from the failure of doctors to refer early to manipulative physiotherapists who emphasize early restoration of the normal range of motion and correction of poor posture over pain management. The result of this is stiffness of the physiological and accessory joints of the spine, progressive deterioration of back structures,loss of back function and chronicity. NICE’s recommendation that low back pain be managed with structured exercise programme tailored to the individual patient, manual therapy which can accelerate the rate of healing of the damaged back tissues through improvement of blood supply to them which is complementary to mobilization exercises and postural correction is therefore clinically reasonable. Expert manipulative therapists know that only a few low back pain patients will benefit from spinal manipulation as most cases will only require appropriate mobilization exercises and postural correction without which there will be perpetuation of patients’ pain and therefore it is inappropriate to refer to practitioners who have no proper grounding in exercise and manual therapy and postural education like manipulative physiotherapists. Interventions like acupuncture needling, thermal modalities, electrical stimulation, bed rest, and medication that aim to reduce pain have not been proven to be effective in managing low back pain since this pain is only a symptom of musculoskeletal injuries and relief of pain without mobilization exercises, manual techniques and postural correction will definitely be nothing more than symptomatic and credit for any improvement without mechanical intervention should be given to nature. Remember the saying, “time heals wounds”. I hope Professor Underwood now knows that post-graduate training in Mechanical Diagnosis and Therapy (MDT) at the McKenzie Institute International is available not only to physiotherapists, but also to doctors.This makes it possible for practitioners concerned to acquire skills that will help them understand the importance of early back mobilization and postural correction so that we do not refer patients to surgeons when they can be conservatively managed. All over the world, doctors and physiotherapists with Mechanical Diagnosis and Therapy (MDT) training have been using non-invasive self treatment, mobilization exercises and postural correction prescriptions to save people from the side-effects and organ damage that could result from dependence on non-steroidal anti-inflammatory drugs, opioids, tricyclic antidepressants and the dangers of surgery. It is my hope that the National Collaborating Centre for Primary Care in the nearest future will make recommendations that emphasize prevention and conservative treatments that address the underlying cause of low back pain over invasive treatments that aim to alleviate symptoms. Competing interests: None declared |
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