The National Institute for Health and Clinical Excellence is examining non-rigid stabilisation procedures for the treatment of low back pain and will publish guidance on their 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 procedures. The Advisory Committee has made provisional recommendations about non-rigid stabilisation procedures for the treatment of low back pain.
This document summarises the procedures 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 preliminary recommendations
  
• the identification of factual inaccuracies
  
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on these procedures. The recommendations are provisional and may change after consultation.

The process that the Institute 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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedures in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 20 December 2005
Target date for publication of guidance: March 2006

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Limited evidence suggests that non-rigid stabilisation procedures for the treatment of low back pain provide clinical benefit for a proportion of patients with intractable back pain. Current evidence on the safety of these procedures is unclear and involves a variety of different devices and outcome measures. Therefore, these procedures should not be used without special arrangements for consent and for audit or research.

Clinicians wishing to undertake non-rigid stabilisation techniques for the treatment of low back pain should take the following actions.

• Inform the clinical governance leads in their Trusts.
  
• Ensure that patients understand the uncertainty about the benefits of these procedures and the alternative treatment options, and provide them with clear written information. In addition, use of the Institute's Information for the public is recommended (available from www.nice.org.uk/IPGXXXpublicinfo [details to be available at publication]).
  
• Audit and review clinical outcomes of all patients undergoing non-rigid stabilisation procedures for the treatment of low back pain.
  

Publication of further research will be useful provided that the outcome measures and comparators are well defined. The Institute may review the procedure upon publication of further evidence.

Surgery may be appropriate for severe life-limiting chronic low back pain refractory to conservative interventions. There are a number of operations designed to immobilise painful segments by bony fusion. Solid spinal fusion cannot be reversed and abnormal load patterns may cause later problems in adjacent parts of the spine. Insertion of a prosthetic intervertebral disc is an alternative that attempts to create comfort while preserving lumbar mobility and reducing long-term adjacent degenerative change.

In non-rigid (otherwise known as flexible or dynamic) stabilisation of the lumbar spine, movement and load bearing of a spinal motion segment are supported without fusing the segment in question. The systems intend to restrict motion in the direction that produces pain but allow for a full range of motion in other directions. These procedures may have a role as treatment between medical symptom control and the more invasive procedure of spinal fusion.

In a case series of 83 patients (the majority with spinal stenosis) who received an implant, 48% (35/73) were totally incapacitated at baseline but only 3% (2/73) remained so at a mean follow-up of 38 months. Disability scores fell from a baseline of 55% to 23% at the same follow-up point. In a smaller series of 31 cases followed up to at least 2 years, 67% of patients reported that back symptoms had resolved or improved; but 3% reported that their symptoms had worsened.

The Specialist Advisors noted that the procedures may be undertaken concurrently with disc decompression or discectomy. It is therefore difficult to determine what clinical benefit is derived from the implants themselves.

In one case study, 3% (7/280) of screws implanted as part of dynamic stabilisation systems loosened during 38 months of follow-up; 13% (11/83) of patients required further surgery, with eight having the implant removed. In another series, 10% (3/31) of patients had malpositioned screws and 3% (1/31) had loosening of a screw. In the same study there was one case each of plural effusion, cardiac insufficiency and dural tear.

The Institute is also producing guidance on interspinous distraction procedures for spinal stenosis causing neurogenic claudication of the lumbar spine (www.nice.org.uk/ip_191).

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Interventional procedure overview of non-rigid stabilisation procedures for the treatment of low back pain, July 2005

Available from: www.nice.org.uk/ip306overview