Using the JAPET.W+ lumbar exoskeleton to help rehabilitate non-specific mechanical low back pain
Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain
This trial will test whether adding the JAPET.W+ lumbar exoskeleton to physiotherapy helps adults with non-specific mechanical low back pain lasting more than six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Grand Hôpital de Charleroi Academic / other |
| Locations | 1 site (Charleroi, Hainaut) |
| Trial ID | NCT06718348 on ClinicalTrials.gov |
What this trial studies
Adults with nonspecific mechanical low back pain lasting more than six weeks are assigned to either a control group receiving standard physiotherapy or an experimental group that uses the JAPET.W+ exoskeleton during rehabilitation. The program comprises 30 physiotherapy sessions with evaluations at sessions 1, 15, and 30 and a follow-up visit three months after completion. Participants are categorized as "workers" (on temporary work leave) or "non-workers" (unable to work after exhausting treatments) to capture occupational outcomes. The single-center trial at Grand Hôpital de Charleroi excludes patients with specific spinal pathology, neurological deficits, recent spine surgery, serious cardiopulmonary disease, pregnancy, or inability to tolerate the device.
Who should consider this trial
Good fit: Adults aged 18–79 with nonspecific mechanical low back pain for more than six weeks who can give informed consent, are covered by the health social security system, and can attend in-person physiotherapy sessions are ideal candidates.
Not a fit: Patients with specific causes of back pain, motor neurological deficits, recent lumbar surgery, serious cardiac or respiratory disease, pregnancy, or those unable to tolerate the JAPET.W+ device are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the device could reduce pain and improve function, potentially shortening work absence and speeding rehabilitation.
How similar studies have performed: Early pilot studies and small trials of lumbar exoskeletons and assisted traction have shown mixed but promising results for pain and function, though larger high-quality trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nonspecific mechanical low back pain for more than 6 weeks, * 18 years ≤ Age \< 80 years, * Patient affiliated to the health social security system, * Patient able to understand the information relating to the study and to sign the informed consent form Exclusion Criteria: * Specific low back pain (infectious, inflammatory, tumorous, or traumatic origin), * Motor neurological deficits (peripheral or central), * Extrapyramidal syndrome, * Treatment with implanted neurostimulation, * Cardiac or circulatory diseases or serious respiratory problems, * Previous recent arthrodesis or recent lumbar prosthesis surgery, * Surgery for herniated disc (\<3 months), * Fracture of the dorsolumbar spine or rib (\<3 months), * Skin lesions, contusions and stretching injuries of the trunk, * Pregnancy, * Individuals not tolerating the JAPET.W+ device during an initial trial, * Under guardianship, curatorship or legal protection
Where this trial is running
Charleroi, Hainaut
- Grand Hôpital de Charleroi — Charleroi, Hainaut, Belgium (Recruiting)
Study contacts
- Principal investigator: Serge TROUSSEL, MD — Grand Hôpital de Charleroi
- Study coordinator: Serge TROUSSEL, MD
- Email: Serge.TROUSSEL@ghdc.be
- Phone: 0032 71 10
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.