NICE recommends early intensive management of persistent low back pain
BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b2115 (Published 27 May 2009) Cite this as: BMJ 2009;338:b2115All rapid responses
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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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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.
Competing interests: No competing interests
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
There are several hundred published randomised controlled trials of
treatments for low back pain. The guideline development group, therefore,
decided that it would only consider randomised controlled trial evidence
when making its treatment recommendations. The evidence for the
effectiveness of injections or nerve blocks compared with usual care or
sham is summarised in the full guideline document
http://guidance.nice.org.uk/index.jsp?action=folder&o=44335. In summary,
the two randomised controlled trials and one systematic review of three
studies did not provide evidence of effectiveness. On the other hand,
there are two systematic reviews reporting that spinal fusion is
effective. The data do not support the effectiveness of any other surgical
interventions. It is thus appropriate that the option to refer selected
patients to a specialist spinal surgical service to discuss pro and cons
of spinal fusion is included in the guideline and that injections of
therapeutic substances for into the back for non-specific low back pain
are excluded. We note that a recent guideline from the American Pain
Society has reviewed the evidence and come to similar conclusions(1)
2. Conclusions reflect committee member’s personal biases.
These are serious and unfounded allegations which NICE totally refutes on
behalf of the independent group of experts which formed the guideline
development group, itself and the national collaborating centre which
oversaw the guideline production. NICE has a rigorous policy for
declaring potential conflicts on interest. This GDG’s declarations of
interest are available to inspect. Where a significant conflict exists the
committee member withdraws when the decision is made, this is recorded in
the minutes of the meeting.
3. Attempts to submit evidence rebuffed and ignored
All submissions to NICE, following publication of the draft guidance have
been fully considered in producing this landmark guideline. None of the
submissions on injections into the back identified any relevant additional
randomised controlled trials. The submissions and the responses are
available at
(http://www.nice.org.uk/guidance/index.jsp?action=download&o=44314)
4. NICE’s processes are not transparent
We consider that inspection of the detailed information available on the
NICE website makes the process for developing this guideline and the
evidence underpinning the guideline accessible to all.
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
The right stitch at the right time saves more than nine!
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
Competing interests: No competing interests