Functional Restoration for Chronic Low Back Pain: Medico-economic Impact (NCT07472374) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Functional Restoration for Chronic Low Back Pain: Medico-economic Impact
France242 participantsStarted 2026-03-10
Plain-language summary
The hypothesis is that functional restoration is not only effective in term of activity limitation, but also efficient, in regard to its impact on this criterion, the use of healthcare services, return to work and job retention, in the context of chronic low back pain with occupational disability.
The main objective is the medico-economic evaluation of a functional restoration program for chronic low back pain, in order to determine its efficiency using a differential cost-utility approach from an insurance perspective at 24 months after inclusion.
Who can participate
Age range18 Years – 69 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Low back pain for at least 3 months
* Low back pain with an intensity greater than or equal to 40/100 on a visual analog scale
* Low back pain with a mechanical pattern (reduced by rest)
* Low back pain on mobilization or palpation of the lumbar spine
* Standard X-ray or MRI of the lumbar spine taken at the same time as the low back pain, showing normal or degenerative (arthritic) changes in the lumbar spine
* Patient on sick leave due to low back pain for at least 3 months and less than 2 years
* Patient who speaks and writes French
* Patient with social security coverage
Exclusion Criteria:
* Low back pain of inflammatory, infectious, tumorous, or fracture origin
* Radiculalgia in a lower limb greater than 40/100
* Radiculalgia in a lower limb with neurological complications (motor function less than or equal to 3/5 or cauda equina syndrome)
* Cortisone injection into the lumbar spine in the previous month
* Lumbar spine surgery in the previous 6 months
* Heart or respiratory failure
* Psychiatric condition preventing assessment of low back pain
* Pregnancy
* Refusal to participate in the study
* Individuals benefiting from judicial protection measures
What they're measuring
1
Incremental cost per quality-adjusted life year (QALY)