FORENSIC-UK Fusion versus Best Conservative Care
Research type
Research Study
Full title
FORENSIC-UK: The clinical and cost-effectiveness of lumbar fusion surgery for patients with persistent, severe low back pain.
IRAS ID
343826
Contact name
David Beard
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
CTU0375, Clinical Trials Unit (CTU) Reference
Duration of Study in the UK
4 years, 8 months, 30 days
Research summary
Low back pain is common and can improve using pain medication and physiotherapy, but it is not always successful. People who suffer with persistent, severe low back pain often find it impacts their health, daily activities and ability to go to work.
The main cause of persistent low back pain is thought to be ‘wear-and-tear’ (degeneration) of the spinal joints in the lower back and an operation called spinal fusion, that surgically fixes the spinal bones together in the lower spine area may help.
Fusion surgery has been used successfully for degenerative conditions in the ankle and wrist, but it is not clear if Spinal Fusion Surgery can help patients with persistent lower back pain.
To find out if Spinal Fusion Surgery can help, we want to carefully select a group of patients with persistent low back pain, who have already undergone non-surgical treatment of pain medication and physiotherapy and make a comparison of fusion surgery versus a package of personalised non-surgery treatment to help with their pain. We also want to find out if the surgery is better value for money for the NHS instead of the non-surgery treatment.
We aim to carefully recruit 270 individuals with persistent lower back pain and allocate them equally into two groups, (135 in each group). One group will receive Spinal Fusion Surgery and the other will receive the non-surgery treatment called Best Conservative Care, (Best Conservative Care is an agreed patient focused treatment plan combining the use of medication, exercise, and pain control methods plus ‘tailoring’ of their care to make it the best possible).
Over 2 years we will ask participants about their physical function, pain, mental health, general health, quality of life, days off work and healthcare use. We also plan longer-term follow-up from Registry data(at 5 years) with additional funding .REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0040
Date of REC Opinion
20 Mar 2025
REC opinion
Further Information Favourable Opinion