Percutaneous intradiscal electrothermal therapy for low back pain (interventional procedures second consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Percutaneous intradiscal electrothermal therapy for low back pain
In some patients, low back pain is thought to occur when one or more of the tough discs that sit between the bones (vertebrae) in the spine become worn. This procedure involves inserting a needle into the affected disc (a video image similar to an X-ray is used to help find the correct position). A narrow tube is then passed through the needle into the disc. The tube is heated slowly and kept in place for a few minutes.
The National Institute for Health and Clinical Excellence (NICE) is examining percutaneous intradiscal electrothermal therapy for low back pain and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about percutaneous intradiscal electrothermal therapy for low 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:
- comments on the provisional recommendations
- the identification of factual inaccuracies
- additional relevant evidence, with bibliographic references where possible.
Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.
The process that NICE will follow after the consultation period ends is as follows.
- The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.
For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).
NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.
Closing date for comments: 28 July
Target date for publication of guidance: November 2009
1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of percutaneous intradiscal electrothermal therapy for low back pain is inconsistent. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake percutaneous intradiscal electrothermal therapy for low back pain should take the following actions.
- Inform the clinical governance leads in their Trusts.
- Ensure that patients and their carers understand the uncertainty about the procedure’s safety and efficacy and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
- Audit and review clinical outcomes of all patients having percutaneous intradiscal electrothermal therapy for low back pain (see section 3.1).
1.3 Further research into percutaneous intradiscal electrothermal therapy for low back pain would be useful. Research should describe patient selection, use validated measures of long-term pain relief and quality of life, address the role of the procedure in avoiding major surgery and measure long-term safety outcomes.
2 The procedure
2.1 Indications and current treatments
2.1.1 There are several causes of low back pain, some of which are attributed to degeneration of the intervertebral discs.
2.1.2 Conservative treatments for back pain include analgesics, non‑steroidal anti-inflammatory drugs and physical therapy. Surgery (including discectomy, fusion or disc replacement) may be considered for people with neurological complications or persistent symptoms that are unresponsive to conservative treatment.
2.2 Outline of the procedure
2.2.1 The aim of percutaneous intradiscal electrothermal therapy (IDET) is to relieve pain by heating the damaged or degenerate disc to destroy painful nerve fibres and alter its structure.
2.2.2 The procedure is usually performed with the patient under local anaesthesia and light sedation, and under fluoroscopic control. The targeted disc is identified by discography. If the patient feels pain when contrast is injected into the disc, it is taken as evidence that the disc is symptomatic. An introducer needle is inserted into the disc. An electrode is then passed into the disc adjacent to its posterior wall. Once in position, the electrode or catheter is heated to up to 90°C for up to 15 minutes.
| Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP73aoverview |
2.3 Efficacy
2.3.1 A meta-analysis of 17 studies including a total of 805 patients reported pain outcomes across 13 studies. The pooled mean pain score (measured on a 10-point visual analogue scale [VAS] from 0 [no pain] to 10 [worst possible pain]) after IDET improved by 2.9 points (95% confidence interval [CI] 2.5 to 3.4) (range of follow-up 6–34 months).
2.3.2 A non-randomised comparative study of 109 patients treated by IDET or pain-relieving disc injection reported that pain (measured on a 10-point VAS) improved significantly from baseline in both groups (significance not stated). Patients treated with injections reported greater pain relief (2.2 points) than those treated by IDET (1.3 points) at 7.7-month and 15.5-month follow-up, respectively (p = 0.01). A non-randomised comparative study of 42 patients treated with either IDET or disc radiofrequency ablation reported a greater improvement from baseline in pain scores (on a 10-point VAS) after IDET (7.4 to 1.4 points) than after radiofrequency ablation (6.6 to 4.4 points) at 1-year follow-up (significance not stated).
2.3.3 In the meta-analysis of 17 studies including a total of 805 patients, 3 studies evaluated functional ability using the Oswestry Disability Index (ODI), a 10-item questionnaire (on a scale from 0% to 100%, low scores better). The pooled mean reduction in the ODI score after IDET was 7.0 points (95% CI 2.0 to 11.9) (range of follow-up 6–34 months). A case series of 53 patients reported that ODI score had improved significantly from 24.8 points at baseline to 5.2 points at 1-year follow-up (p = 0.001).
2.3.4 In a case series of 53 patients narcotic analgesic medication was required by 51% of the patients at baseline and 13% at 1-year follow-up (absolute figures and significance not stated). In the same study, 6% (3/53) of patients had resumed full work duties, 17% (9/53) were working with restriction on heavy lifting and 25% (13/53) of patients had resumed light duties only, at 56-month follow-up.
2.3.5 The Specialist Advisers listed key efficacy outcomes as back pain scores, quality of life and functional status. They stated that the benefits the procedure might potentially produce are reduction in pain and analgesic use, improved movement and improved functional ability (SF-36 score).
2.4 Safety
2.4.1 The RCT of 57 patients reported that transient (defined as < 6 weeks) radiculopathy occurred in 11% (4/38) of patients treated by IDET and 5% (1/19) of patients in the sham group (significance not stated).
2.4.2 A case report of one patient described how three different catheters had to be used during the IDET procedure. One catheter tip broke off inside the disc space and was removed after 3 months. The patient had paraesthesia and dysaethesia in the left leg at 6-month follow-up.
2.4.3 A case report of one patient described worsening of pain after IDET. Magnetic resonance imaging at 3-month follow-up indicated L2 lesions consistent with osteonecrosis. A remnant lesion was apparent at 12-month follow-up.
2.4.4 The Specialist Advisers listed adverse events reported in the literature or anecdotally, as acute post-procedural pain, infection and vertebral osteonecrosis. The Specialist Advisers considered theoretical adverse events to include nerve root injury, bleeding, cerebrospinal fluid leak, catheter breakage and postprocedural disc herniation.
2.5 Other comments
2.5.1 The Committee noted that since the publication of the original guidance on this procedure there are now data to suggest limited efficacy in a small group of carefully selected patients.
3 Further information
3.1 This document is a review of the NICE interventional procedures guidance IPG81 published in 2004. For related NICE guidance see www.nice.org.uk.
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July 2009
Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.
It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 30 March 2010
