Interventional procedure consultation document - percutaneous disc decompression using coblation for lower back pain
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Percutaneous disc decompression using coblation for lower back pain
The National Institute for Clinical Excellence is examining percutaneous disc decompression using coblation for lower back pain and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about percutaneous disc decompression using coblation for lower back pain.
This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.
The process that the Institute will follow after the consultation period ends is as follows:
For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).
Closing date for comments: 22 June 2004
Target date for publication of guidance: August 2004
Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.
Current evidence on the safety and efficacy of percutaneous disc decompression using coblation for lower back pain does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research.
Clinicians wishing to undertake percutaneous intradiscal electrothermal therapy for lower back pain should take the following actions.
Further research will be useful in reducing the current uncertainty and clinicians are encouraged to collect longer term follow-up data. The Institute may review the procedure upon publication of further evidence.
Chronic back pain is a common condition. In most individuals, the pain resolves spontaneously within several months. However, for some people the pain persists, despite specific causes of back pain - such as herniated discs, osteoporosis and fractures - being excluded. Increasingly this pain is being attributed to degeneration of the intervertebral disc, and referred to as discogenic back pain.
Typically, first-line treatment for chronic discogenic back pain is conservative, consisting of pharmacotherapy and/or a multidisciplinary programme which may include exercises, education and behavioural therapy. If the pain does not improve, patients can choose whether to continue with conservative management or to undergo surgery (spinal fusion). Potential candidates for percutaneous disc decompression using coblation are those patients with back and leg pain caused by contained herniated discs.
|2.2||Outline of the procedure|
Percutaneous disc decompression using coblation is usually performed on an outpatient basis under local anaesthesia and sedation. Under fluoroscopic guidance, a needle is inserted into the affected disc. A probe-like device is then introduced into the disc. The device is heated up to 40-70°C, ablating the centre part of the disc and creating a channel. After stopping at a pre-determined depth, the probe is then withdrawn, coagulating the tissue as it is removed. Around six channels are created during the procedure, the number of channels depending on the desired amount of tissue reduction.
The evidence was based on a small number of patients from three case series studies. Twelve-month follow-up data were available for only 82 patients. In the largest case series, 75% (52/69) of patients indicated a decrease in their pain scores at 12 months, with 54% (37/69) of patients indicating pain relief of 50% or more at final follow-up. Improvement in sitting (37/69), standing (30/69) and walking (34/69) was also reported by a number of patients at 12 months following the procedure. For more details, refer to the sources of evidence (see Appendix).
The lack of data makes it difficult to draw conclusions regarding the efficacy of the procedure. The lack of long-term and comparative data also makes it difficult to distinguish between the treatment effect and the natural history of the disease, as well as determine whether the benefits of this procedure are sustained beyond 12 months.
The Specialist Advisors expressed uncertainty regarding the efficacy of this procedure.
In two of the three studies the authors stated that no complications were observed during or after the procedure. It is difficult to know, however, whether this is because complications are uncommon or whether complications were not systematically detected and reported. For more details, refer to the sources of evidence (see Appendix).
The Specialist Advisors did not report any particular safety concerns, although nerve root damage, infection, haemorrhage or worsening pain were listed as potential complications.
There is a lack of long-term efficacy data.
The Institute has recently consulted on percutaneous intradiscal electrothermal therapy (www.nice.org.uk/ip_73) and percutaneous intradiscal radiofrequency thermocoagulation for lower back pain (www.nice.org.uk/ip_181) and is planning to publish guidance in Autumn 2004.
Chairman, Interventional Procedures Advisory Committee
|Appendix:||Sources of evidence|
The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.
Available from: www.nice.org.uk/ip235overview
This page was last updated: 05 February 2011