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NOT YET RECRUITING
NCT07195422
NA

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

Sponsor: Japet Medical Devices

View on ClinicalTrials.gov

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

DEVICE

Japet.W+

Current care of low back pain and wearing the Japet.W+

DEVICE

Control (Standard treatment)

Current care of low back pain

Locations (1)

Hôpital de Cochin, APHP

Paris, France