We are pleased to announce that FORENSIC-UK is now open to recruitment - details of this study below:
The aim of the FORENSIC-UK trial is to assess if lumber fusion surgery (LFS) is more clinically and cost effective than continued best conservative care (BCC) for people with persistent lower back pain (LBP) measured at 24m using the Oswestry Disability Index on mobility.
The study is a multi-centre superiority randomised controlled trial with a two-armed parallel group design and 1:1 allocation, with an internal pilot, integrated Qualitative Research Intervention (QRI) and health economic analysis.
The design is pragmatic and accounts for the main study purpose (to assess clinical and cost effectiveness of LFS in the contemporary NHS setting) whilst accounting for the current NICE guidance for persistent LBP.
Our Sample Size: 270 patients recruited from approx. 20 centres (to achieve 90% power).
Study Population: Patients will be adults aged 18 to 65 with persistent (duration ≥6 months), severe LBP with recent imaging evidence of lumbar degenerative disease. Prior to study enrolment, all potential participants will have undergone core conservative therapies recommended in national guidance, such as exercise therapy, analgesia, and/or a psychologically informed LBP programme. Core therapies may have been delivered virtually, face to face, individually or in a group.
Suitability: All participants must be suitable for both LFS and BCC.
Anticipated Impact and Dissemination: Wide dissemination of the results is planned on completion of the trial. The results will have high impact and substantially change or confirm current practice.
For further details please visit: FORENSIC-UK Study | OCTRU