Low back pain and sciatica in over 16s: assessment and management

Assessing the evidence

The purpose of this exceptional review was to examine the effectiveness of spinal fusion as a management option for low back pain and sciatica. NICE guideline NG59 currently states do not offer spinal fusion for people with low back pain unless as part of a randomised controlled trial (RCT). All other areas covered in the guideline scope were not considered by this exceptional review.

We decided to undertake an exceptional review of this area following publication of NICE's interventional procedures guidance on transaxial interbody lumbosacral fusion for severe chronic low back pain (IPG620). The recommendations in this interventional procedures guidance state that the evidence on efficacy is adequate in quality and quantity and this procedure may be used provided that standard arrangements are in place for clinical governance, consent and audit. There is also related NICE interventional procedures guidance on lateral interbody fusion in the lumbar spine for low back pain (IPG574) that is recommended for use. Because the populations in NICE guideline NG59 and NICE interventional procedures guidance 574 and 620 overlap, and the procedures covered (transaxial interbody lumbosacral fusion and lateral interbody fusion) are forms of spinal fusion (an intervention considered in NICE guideline NG59), we decided to review the area again and consider the impact on NICE's guideline on low back pain and sciatica.

See appendix A: summary of evidence from surveillance for details of all evidence considered, and references.

Guideline development

Transaxial interbody lumbosacral fusion and lateral interbody fusion were excluded from the scope of NICE guideline NG59 because they are covered in NICE interventional procedures guidance. However, the guideline did consider the clinical and cost effectiveness of spinal fusion in people with non-specific low back pain. Overall the guideline committee considered that there was no consistent benefit of spinal fusion over comparator treatments and evidence of potential harm. Given this and the limited number of studies from which data could be evaluated, the committee agreed that there was a lack of evidence of clinical effectiveness to recommend spinal fusion for people with low back pain other than in the context of a RCT.

Views of topic experts

We sent questionnaires to 5 topic experts and received 2 responses. The topic experts either:

The responses from the topic experts suggested that the recommendation on spinal fusion in NICE guideline NG59 did not need to be updated and no further relevant new evidence was highlighted.

Impact

To develop NICE's interventional procedures recommendation on transaxial interbody lumbosacral fusion, the committee considered 2 systematic reviews, 1 non-randomised comparative study, 3 case series and 2 case reports. Most studies were retrospective, none were UK based and there was a lack of long term data. The only comparative data that was discussed by the Interventional Procedures Advisory Committee compared transaxial interbody lumbosacral fusion with other approaches for spinal fusion. The scope of the interventional procedure focused on severe, lifestyle limiting, chronic low back pain that has not responded to conservative treatment. In terms of lateral interbody fusion, the interventional procedures recommendation was based on 3 systematic reviews, 1 RCT, 2 non-RCTs, 3 case series and 6 case reports.

As interventional procedures focus on safety and efficacy of an intervention, we considered new evidence to determine the clinical and cost effectiveness of the procedure. No evidence directly assessing the effectiveness of transaxial interbody lumbosacral fusion or lateral interbody fusion for low back pain was identified, therefore studies focusing on conventional spinal fusion were considered. The effectiveness of spinal fusion appears inconclusive from the results of the new evidence. There is some indication that spinal fusion shows similar clinical outcomes to other surgical procedures for patient reported pain and disability. However, the studies also highlight increased risks of safety and complications associated with spinal fusion. There is also a lack of data in the new evidence on the effectiveness of individual types of spinal fusion and there is a limited number of comparisons with other types of intervention. The new evidence is unlikely to affect the recommendation in NICE guideline NG59 which advises not to offer spinal fusion for people with low back pain unless as part of a RCT.

After taking into account the evidence base and views of topic experts, we acknowledge that this is an area of research showing promising results for some outcomes. However, the findings from this exceptional review have demonstrated a lack of data on the clinical and cost effectiveness of transaxial interbody lumbosacral fusion or lateral interbody fusion whilst the effectiveness of spinal fusion remains inconclusive and there is still uncertainty around the safety and risk of complications in this population. For this reason, we will not update the guideline at this time.