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Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
Sponsor: Japet Medical Devices
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.
Official title: Evaluation of the Japet.W+ Medical Device for Low Back Pain Management: Performance and Safety Analysis Across Two Patients' Groups
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2025-09
Completion Date
2028-06
Last Updated
2025-09-26
Healthy Volunteers
No
Conditions
Interventions
Japet.W+
Current care of low back pain and wearing the Japet.W+
Control (Standard treatment)
Current care of low back pain
Locations (1)
Hôpital de Cochin, APHP
Paris, France