Therapeutic endoscopic division of epidural adhesions: interventional procedures consultation

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Therapeutic endoscopic division of epidural adhesions

Back and leg pain can have many causes. In some people it is caused by scar tissue in the lower back pressing on nerves. This procedure involves finding and removing scar tissue around the nerves through a small cut near the lower backbone (‘keyhole surgery’) using special instruments. The aim of the procedure is to reduce pain.

 

The National Institute for Health and Clinical Excellence (NICE) is examining therapeutic endoscopic division of epidural adhesions 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 therapeutic endoscopic division of epidural adhesions.

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  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 18 November 2009

Target date for publication of guidance: February 2010

 

1       Provisional recommendations

1.1    Current evidence on therapeutic endoscopic division of epidural adhesions is limited to some evidence of short-term efficacy, and there are significant safety concerns. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2    Clinicians wishing to undertake therapeutic endoscopic division of epidural adhesions 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, in particular the risk of neural damage, dural puncture and visual disturbance, 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 therapeutic endoscopic division of epidural adhesions (see section 3.1).

1.3    Further research on this procedure should clearly describe case selection. Outcomes should include pain relief, duration of effectiveness and whether other treatments are subsequently required.

2       The procedure

2.1    Indications and current treatments

2.1.1 In some patients, it is thought that chronic back or leg pain may be caused by formation of abnormal scar tissue around the spinal nerve roots.

2.1.2 Conservative treatments may include analgesics, non-steroidal anti-inflammatory drugs and physical therapy. Surgery (including discectomy, artificial disc insertion and spinal fusion) may be considered for people with neurological or persistent symptoms that are unresponsive to conservative treatment.

2.2    Outline of the procedure

2.2.1 The aim of endoscopic division of epidural adhesions is to reduce or eliminate pain related to scar tissue formation around spinal nerves.

2.2.2 The procedure is carried out with the patient under local anaesthesia and mild sedation. The epidural space is accessed at the appropriate level using fluoroscopic guidance, and a guidewire and endoscope are inserted. The epidural space is distended by injection of saline, and endoscopic manipulation is used to identify painful nerve roots (by communication with the patient). Endoscopic instruments are used to divide epidural adhesions around the spinal nerve roots or the spinal cord.

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/IP86aoverview.

 

2.3    Efficacy

2.3.1 A randomised controlled trial (RCT) of 83 patients treated by endoscopic division of epidural adhesions or having a diagnostic endoscopy alone (control group), reported a significantly greater improvement in pain from baseline (using a 10-point visual analogue scale [VAS]; lower scores indicate less pain) in the treatment group (from 9.0 to 5.7) compared with the control group (from 8.9 to 8.6) at 12-month follow-up (p = 0.001 for both improvement from baseline and between group comparisons).

2.3.2 In a comparative case series of 183 patients treated by endoscopic division of epidural adhesions, patients with a history of previous nerve decompression had significantly less leg and low back pain at 3-month follow-up compared with those without such history (p < 0.05). VAS scores were significantly lower at 3-month follow-up in all patients (absolute figures not stated) (p < 0.05).

2.3.3 The RCT of 83 patients reported a significant improvement from baseline in mean Oswestry Disability Index (ODI) score (10-item functional ability questionnaire with scores from 0% to 100%; lower scores indicate greater functional ability) in the treatment group - from 36% at baseline to 25% at 12-month follow - compared with the control group - from 34% to 33% (p = 0.001 for both improvement from baseline in the treatment group and for between- group comparisons).

2.3..4 A prospective case series of 38 patients reported that patient satisfaction and subjective improvement did not change significantly after treatment at either 2- or 12-month follow-up (no further details provided).

2.3.5 The Specialist Advisers listed key efficacy outcomes as pain relief, improved function and disability score, quality of life, psychological status, return to work, and avoidance of spinal cord stimulation for chronic pain.

2.4    Safety

2.4.1 Visual disturbance (clinical significance and degree and speed of resolution not described) was recorded in a case report of 12 patients treated by either epidural injection, epiduroscopy or lysis of adhesions (denominator not stated). An additional case report described blurred vision and bilateral central scotomas immediately after the procedure (which resolved spontaneously within 2 months) in 1 patient.

2.4.2 In a case series of 120 patients, subarachnoid puncture and subarachnoid block (complications that can be associated with neural damage including paralysis) were reported in 12% (7/60) and 7% (4/60) of patients treated by endoscopic division of epidural adhesions and 7% (4/60) and 3% (2/60) of patients treated by non-endoscopic (radiologically-guided) division of adhesions (timing of events not stated). The RCT of 83 patients reported 1 case of postoperative subarachnoid block in the intervention group (treated with steroids and resolved without sequelae).

2.4.3 Dural puncture was reported in 3% (4/124) and 2% (1/58) of patients in the case series of 183 and 58 patients, and in 1 patient in a case report. Contrast medium leakage into the cerebrospinal fluid space was also reported in this case report (causing postoperative rhabdomyolysis and acute encephalopathy; patient recovered after 20 hours and was able to walk after 24 hours; recovered fully uneventfully). Intravascular appearance of radiopaque contrast material used in fluoroscopy was reported in a case report of 2 patients treated by epiduroscopy (no adverse reactions recorded).

2.4.4 Intraoperative transient headache or neck pain was reported in 45% (56/124) and intraoperative leg pain in 10% (13/124) of patients in the case series of 183 patients.

2.4.5 Non-persistent lower limb paraesthesia was reported in 2 patients in the case series of 38 patients (timing of event and resolution of the event not stated).

2.4.6 The Specialist Advisers considered theoretical adverse events to include catheter shearing, nerve root avulsion, nerve palsy, meningitis, arachnoiditis, paralysis, epidural infection or abscess and excessive epidural hydrostatic pressure associated with injection of fluid which could cause events such as spinal compression and haematoma. They listed anecdotal adverse events as numbness in the lower limbs and blindness.

3     Further information

3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

3.2 For related NICE guidance see www.nice.org.uk.

 

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
October 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