Status:
NOT_YET_RECRUITING
Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
Lead Sponsor:
Japet Medical Devices
Collaborating Sponsors:
University Hospital, Clermont-Ferrand
Hôpital Cochin
Conditions:
Low Back Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain. This study aims to asses...
Eligibility Criteria
Inclusion
- Non-specific chronic low back pain with active discopathy OR Non-specific chronic low back pain without active discopathy,
- 18 years ≤ Age \< 80 years,
- Average pain intensity (VAS) over the last week ≥ 40/100,
- 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
- Specific low back pain (infectious, inflammatory, tumorous, or traumatic in origin).
- Motor neurological deficits (peripheral or central).
- Extrapyramidal syndrome.
- Treatment with implanted neurostimulation.
- Severe heart or circulatory disease or respiratory problems.
- Arthrodesis or disc replacement.
- Surgery for herniated disc (\<3 months).
- Spinal fracture or floating ribs (\<3 months).
- Skin lesions on the trunk, history of contusions or skin lesions following traction of the trunk.
- Pregnancy.
- Patients who cannot tolerate the JAPET.W+ device during an initial trial.
- Patients under guardianship, curatorship, or legal protection.
- Participation in another clinical trial.
- Patients who have worn a device designed to reduce lower back pain regularly during the 2 weeks prior to inclusion (lumbar belt, corset, exoskeleton).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT07195422
Start Date
September 1 2025
End Date
June 1 2028
Last Update
September 26 2025
Active Locations (1)
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1
Hôpital de Cochin, APHP
Paris, France, 75014