Background and Rationale: 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 [1-4] with some large trials leading to the National Institute for Clinical Excellence (NICE) [5] 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: 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) and lumbar degenerative disease as measured by a validated LBP disability score (Oswestry Disability Index) at 24 months follow-up.
Study Design: 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.
- Sample Size: 270 patients recruited from approx. 20 centres (to achieve 90% power).
- 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.
All patients will be suitable for both LFS and BCC. Patients with neurological symptoms, deformity, infection, tumours, spondylolisthesis, spinal fracture, systemic inflammatory disease and wider MSK (musculoskeletal) pain or previous fusion surgery, will be excluded.
- Intervention and Comparator: Lumbar Fusion Surgery [LFS] (& post-operative care) versus Best Conservative Care (BCC).
After identification participants will be assessed by a spinal surgeon to ensure they are eligible for surgery and hence randomisation. Participants will be randomised to either LFS or BCC. Patients randomised to LFS will be listed and undergo spinal fusion surgery according to protocol. Any standard accepted fusion method/graft option (except BMP) is allowed to maximise external validity.
BCC commences with a review by a senior spinal practitioner (usually an MSK physiotherapist) experienced in assessing and treating LBP with links to a wider multidisciplinary team. Following this review, participants will be offered a package of personalised BCC, based on the participant’s individual goals, abilities, and expectations. The content of BCC includes non-surgical interventions recommended by NICE [5] the National Low Back and Radicular Pain Pathway (NLBRPP) [6], and approved by our expert Clinical Advisory Group (CAG).
- Outcome: The primary outcome is a validated LBP physical disability score (Oswestry Disability Index, ODI), at 24 months follow-up.
Secondary outcomes include LBP intensity (Numerical Rating Scale), Global rating of change (NRS), Quality of life (EQ-5D-5L), Pain Health Questionnaire (PHQ-8)Fear avoidance beliefs (TSK), Pain Self-efficacy beliefs (PSEQ), Global Perceived Effects (GPE), Work outcomes (days-off-work), Treatment and outcome satisfaction at 24months, Adverse events, revision/further surgery, fusion failure rate, Healthcare use (NHS and non-NHS) including surgery, conservative care, concurrent treatments (including analgesia).
What is needed from sites? A local Lead PI (spinal surgeon) and a 2nd PI ( Lead MSK physiotherapist or similar expertise in non-surgery treatment for LBP) based at the participating Hospital Trust, and a clinical and research team to support the recruitment, delivery of interventions and data collection will be required.
Sites will need to identify suitable participants, consent, complete baseline data collection & randomise patients, complete delivery & data collection for the assigned interventions (including data on any adverse events) in line with the trial protocol. For participants who have undergone lumbar fusion surgery an appointment for a follow-up CT scan will be planned at 24 months follow-up as part of the fidelity assessment of the LSF.
What is provided by the trial? We will provide training on all the trial processes, including delivery of the trial interventions and trial related materials. Follow-up questionnaires at 6, 12 and 24 months to participants will be delivered centrally from the Oxford team.
Sites will receive a per patient randomised payment to offset costs incurred including, recruiting to the trial and capturing trial data. The study is on the UK RDN portfolio and NIHR Associate PI scheme, so that sites will also be able to access RDN support for recruiting participants and data collection.
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. Should LFS show no significant benefit over BCC then fusion surgery should remain a non-commissioned treatment option. Should LFS be shown to be superior to BCC then this option should then be offered under NICE guidelines for appropriate patients. There is also a parallel Australian trial conducted to the same protocol will be led by Professor Nadine Foster and an Australian team of clinicians and methodologists (the FORENSIC-AUS trial).
References
1. Ibrahim T, et al. Surgical versus non-surgical treatment of chronic low back pain:. Int Orthop 2008;32(1):107-13.
2. Chou R, et al. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine (Phila Pa 1976) 2009;34(10):1094-109.
3. Rihn JA, et al. Comparative Effectiveness of Treatments for Chronic Low Back Pain. Clin Spine Surg 2017;30(5):204-25.
4. Harris IA, et al. Lumbar spine fusion: what is the evidence? Intern Med J 2018;48(12):1430-34.
5. National Institute of Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management (Clinical Guideline [NG59]) London2016 [Available from: https://www.nice.org.uk/guidance/ng59.
6. UKSSB. National Low Back & Radicular Pain Pathway 2017. [Available: http://docs.wixstatic.com/ugd/dd7c8a_caf17c305a5f4321a6fca249dea75ebe.pdf
