NCT07195422

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

Evaluation of the Japet.W+ Medical Device for Low Back Pain Management: Performance and Safety Analysis Across Two Patients' Groups

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Japet Medical Devices · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Japet.W+	Current care of low back pain and wearing the Japet.W+
DEVICE	Control (Standard treatment)	Current care of low back pain

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-03-01
• Completion: 2028-06-01
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: France