FusiOn veRsus bEst coNServatIve Care (the FORENSIC-Australia trial)

Not Applicable

• Conditions: Persistent, severe low back pain; Lumbar spine degeneration (with imaging evidence) deemed suitable for lumbar fusion surgery at 1 or 2 levels; Musculoskeletal - Other muscular and skeletal disorders; Physical Medicine / Rehabilitation - Physiotherapy; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Surgery - Surgical techniques

• Registration Number: ACTRN12624001062516
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-03
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

A patient will be eligible for inclusion if ALL of the following criteria apply:
•Adults aged 18-65 years old. Patients over 65 years old are excluded given the increasing prevalence of spinal stenosis seen in older adults i.e. a change in pathology involving neurological compression requiring a different surgery.
•Episode of low back pain (lasting 6 months or longer)
•Low back pain severity is more than or equal to 6 on a 0-10 numeric rating scale (NRS)
•With or without previous discectomy/decompression
•Have undergone one or more of the following previous treatment for LBP recommended in guidelines/standards:
ostructured and supervised exercise therapy with or without manual therapy, with a healthcare professional
ostructured and supervised psychological programme
ostructured and supervised combined physical and psychological programme (CPPP)
ostructured and supervised programme of treatment led by a pain service
oradiofrequency denervation
(Previous recommended treatment(s) may have been delivered virtually, face to face, individually or in a group.)
•Recent evidence of lumbar spine degenerative changes using appropriate imaging (Magnetic Resonance Imaging (within the last 12 months) [MRI] +/- Single Photon Emission Computed Tomography-Computed Tomography [SPECT-CT]).
•Assessed as suitable for both LFS at 1 or 2 lumbar spine levels and BCC by a participating surgeon
•Able to give full informed consent

Exclusion Criteria

A patient will not be eligible for the study if ANY of the following apply:
•Has low back-related leg pain more severe than their low back pain
•Has pain in other body regions that is more severe than their low back pain
•Radiculopathy or claudication or clinical signs of nerve compression where the treatment plan includes offering direct or indirect spinal decompression along with the fusion
•Other reasons indicated for LFS (e.g. lumbar spine deformity, infection, tumours, instability due to spondylolisthesis of grade 2 or above, spinal fracture, systemic inflammatory disease)
•Previous (or attempted) LFS
•Psychiatric conditions (e.g., diagnosed personality disorders, post-traumatic stress disorder, drug or alcohol abuse/addictions, diagnosis of severe depression)
•Is pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified