NICE guidelines for the early management of persistent low back pain
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
03 June 2009
Martin R Underwood
Professor of primary care research, Chair of back pain guideline development group
Professor Peter Littlejohns, Clinical and Public Health Director , NICE, Professor of Public Health, St Georges University of London
Warwick Medical School, University of Warwick, CV4 7AL
Rapid Response:
NICE guidelines for the early management of persistent low back pain
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