None listed
Conditions
Brief summary
FORENSIC-Australia aims to find out: 1) if lumbar fusion surgery (an operation that fixes spinal bones together) for a carefully selected group of patients with on-going, severe low back pain and spine degeneration, and who have already tried non-surgical treatment, is better than best conservative care (personalised spinal care) at improving back-related disability. Best conservative care is a personalised, patient-focused treatment plan with evidence-based options including advice and education, exercise, combined physical and psychological treatment, and other pain control strategies; 2) if the surgery is good value for money.
Interventions
Lumbar Fusion Surgery (LFS): 1 or 2 level LFS, either intertransverse or interbody. LFS is used routinely in Australia. All commonly accepted fusion methods and graft options within Australia will be permitted. The exceptions are mixed fusion procedures (i.e., fusion with decompression, fusion with disc replacement at the same or different levels).
Other than the above mixed fusion procedures, there are no limitations (within accepted methods) for implants, bone grafts or surgical approach, give
Lumbar Fusion Surgery (LFS): 1 or 2 level LFS, either intertransverse or interbody. LFS is used routinely in Australia. All commonly accepted fusion methods and graft options within Australia will be permitted. The exceptions are mixed fusion procedures (i.e., fusion with decompression, fusion with disc replacement at the same or different levels). Other than the above mixed fusion procedures, there are no limitations (within accepted methods) for implants, bone grafts or surgical approach, given the evidence that none are superior. The LFS will be performed by skilled Neurosurgeons or Orthopaedic surgeons in the FORENSIC-Australia trial. The LFS intervention includes usual practice of the participating surgeon at the site (i.e., usual pre-/postoperative imaging, usual review appointment(s) and usual post-operative care). There is low-quality evidence of the effectiveness of physiotherapy following LFS and therefore usual post-operative care at participating sites will be offered and recorded. Intervention details will be recorded on the treatment case report form.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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: o structured and supervised exercise therapy with or without manual therapy, with a healthcare professional o structured and supervised psychological programme, with a healthcare professional o structured and supervised combined physical and psychological programme (CPPP), with a healthcare professional o structured and supervised programme of treatment led by a pain service o radiofrequency 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
Outcome results
None listed