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 range
18 Years – 69 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incremental cost per quality-adjusted life year (QALY)