Trial Status: In Set-Up
The clinical and cost-effectiveness of lumbar fusion surgery for patients with persistent, severe low back pain: Short: FusiOn veRsus bEst coNServatIve Care.
For people with persistent Low Back Pain (LBP) and lumbar degenerative disease, is Lumbar Fusion Surgery (LFS) more clinically, and cost, effective than continued Best Conservative Care (BCC), as measured by a validated back pain disability score (Oswestry Disability Index), at 24 months follow-up? We also include a Quintet Recruitment Intervention (QRI) and health economic analysis.
Lumbar fusion is an operation in which vertebrae are fixed together to reduce or alleviate chronic low back pain (LBP). Uncertainty exists over its effectiveness, especially compared to conservative care with some large trials leading to the National Institute for Clinical Excellence (NICE) stating that it should only be used in a randomised controlled trial (RCT). Because of these guidelines the frequency of surgery has reduced substantially in the UK. However, there is a concern that in specific situations, i.e., when patients have failed non-surgical treatments, spinal fusion may still be useful and provide a beneficial option in appropriate patients.
Aims and Objectives:
1) To test for superiority of lumbar fusion surgery versus continued best conservative (non-surgical) care on disability (physical function) in patients with severe persistent LBP and lumbar degenerative disease.
2) To investigate the cost-effectiveness of lumbar fusion surgery compared with continued best conservative care.
A multicentre, two parallel arm (surgery versus best conservative care [control]), superiority RCT with an internal pilot, integrated Quintet Recruitment Intervention (QRI) & health economic analysis.
The study will be conducted in 270 patients who will be allocated to either Lumbar Fusion Surgery (LFS) or Best Conservative Care (BCC) from at least 20 NHS musculoskeletal / spinal clinics.