Clinical Trial

Evaluation of the Japet.W+ Medical Device for Low Back Pain Management

Study acronym: EXODOMICILE
Recruiting
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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 assess the effectiveness of this device among the two targeted populations during daily use. Each patient will be asked to estimate the intensity of their low back pain several times during the clinical investigation. Our main hypothesis is a reduction in low back pain while wearing the device. The secondary hypothesis is a decrease in activity limitations, an increase in participation, an improvement in quality of life, and a reduction in healthcare product and medication consumption.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-09-19; most recent amendment 2026-06-24.
Status change: Not Yet Recruiting → Recruiting 2026-06-09
Trial Details
NCT Number NCT07195422
Lead Sponsor Japet Medical Devices
Collaborators: University Hospital, Clermont-Ferrand, Hôpital Cochin
Conditions Low Back Pain
Enrollment 102 participants
Start Date 2025-09-01
Primary Completion 2028-03 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-25