Motorized versus standard lumbar support for non-specific low back pain
Effectiveness of a Motorized Lumbar Support for Non-specific Low Back Pain: A Randomized Controlled Trial
This test will see if a motorized, battery-powered lumbar support reduces pain and improves daily function more than a standard semi-rigid support in adults with non-specific low back pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT07366827 on ClinicalTrials.gov |
What this trial studies
This single-blind, parallel-group randomized study will enroll seventy adults with non-specific low back pain to compare a motorized lumbar orthosis that provides adjustable decompressive forces with a conventional semi-rigid lumbar support. Participants will be randomized to one of the two supports and wear them while continuing usual care as needed. Primary outcomes—daily pain intensity and daily physical functioning—will be collected every day, while secondary outcomes such as weekly average pain and pain-related disability (ODI) will be assessed at baseline, 3 weeks, and 9 weeks. Eligibility requires adults aged 18–65 with average pain ≥3/10, ODI ≥10%, and demonstrable pain relief with manual traction; multiple specific spinal and medical conditions are exclusions.
Who should consider this trial
Good fit: Adults 18–65 with non-specific low back pain who report average pain of at least 3/10, have at least 10% disability on the ODI, and experience noticeable pain relief during manual traction are the ideal candidates.
Not a fit: People with specific spinal pathology (e.g., fracture, cancer, spinal stenosis), neuropathic pain, BMI over 32, pregnancy, recent rib or pelvic fractures, osteoporosis, implanted electronic medical devices, or other major medical contraindications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the motorized support could provide greater pain relief and improved day-to-day function by delivering adjustable decompression while allowing movement.
How similar studies have performed: Direct evidence for motorized lumbar supports is limited and largely novel, while studies of static lumbar belts and spinal traction have shown mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Adults between 18 and 65 years old with non-specific low back pain. * Average pain level of ≥3 out of 10 during the previous week. * Pain-related disability ≥10% at ODI. * Pain relief must be present during manual traction, measured by a moderate improvement (+3) on a global rating of change scale (anchors: -7 to +7). Exclusion Criteria: * Specific cause of low back pain (e.g., fracture, cancer, spinal stenosis, severe spondylolisthesis) * Presence of neuropathic pain (leg or back of 4 at the DN4). * Pregnancy. * Body mass index \> 32. * Waist size between 74 and 115 cm. * Respiratory and circulatory conditions. * Osteoporosis. * Paraplegia and hemiplegia. * Abdominal wounds at the site of the orthosis. * Rib or pelvic fractures less than 3 months. * Presence of electronic medical device.
Where this trial is running
Québec, Quebec
- Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS) — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Hugo Massé-Alarie, PhD — Laval University
- Study coordinator: Hugo Massé-Alarie, PhD
- Email: hugo.masse-alarie@fmed.ulaval.ca
- Phone: +1 (418) 529 9141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.