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

NCT07195422 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-09-26

No results posted yet for this study

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.

Conditions

  • Low Back Pain

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

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    collaborator OTHER

  • Hôpital Cochin

    collaborator OTHER

  • Japet Medical Devices

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-03-31
Completion
2028-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195422 on ClinicalTrials.gov