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Clinical Trials in France / NCT07195422
Recruiting Not applicable

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

NCT07195422 · tracked via the Priya Life Science France tracker
Sponsor
Japet Medical Devices
Phase
Not applicable
Started
2025-09-01
Last updated
2026-06-25

Condition(s) studied

Low Back Pain

Investigational drug(s) / intervention(s)

Japet.W+Control (Standard treatment)

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

Control (Standard treatment): Current care of low back pain

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Non-specific chronic low back pain with active discopathy OR Non-specific chronic low back pain without active discopathy, * 18 years ≤ Age \< 80 years, * Average pain intensity (VAS) over the last week ≥ 40/100, * Patient affiliated to the health social security system, * Patient able to understand the information relating to the study and to sign the informed consent form. Exclusion Criteria: * Specific low back pain (infectious, inflammatory, tumorous, or traumatic in origin). * Motor neurological deficits (peripheral or central). * Extrapyramidal syndrome. * Treatment with implanted neurostimulation. * Severe heart or circulatory disease or respiratory problems. * Arthrodesis or disc replacement. * Surgery for herniated disc (\<3 months). * Spinal fracture or floating ribs (\<3 months). * Skin lesions on the trunk, history of contusions or skin lesions following traction of the trunk. * Pregnancy. * Patients who cannot tolerate the JAPET.W+ device during an initial trial. * Patients under guardianship, curatorship, or legal protection. * Participation in another clinical trial. * Patients who have worn a device designed to reduce lower back pain regularly during the 2 weeks prior to inclusion (lumbar belt, corset, exoskeleton).

Primary outcome measure(s)

  • Visual Analogue Scale (VAS) — Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11.
    Pain VAS is a unidimensional measure of pain intensity (from 0: no pain to 100: severe pain), used to record the progression of pain in patients or to compare the severity of pain between patients with similar conditions. The VAS has been widely used in various adult populations, for example people suffering from chronic low back pain.

Trial sites (2)

FacilityCityRegionStatus
CHU Clermont-Ferrand Clermont-Ferrand France Recruiting
Hôpital de Cochin, APHP Paris France Recruiting

Other trials for the same condition

Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic and at Risk of Chronic Low Back Pain in Primary Care Active, not recruiting
Three CT Signs of Nerve-root Suffering in Low-back Sciatica: a Study of Their Frequency in Patients Referred for CT-guided Nerve-root Infiltration. Recruiting
Efficacy on Anxiety of the Digital Music Application Versus Equimolar Mixture of Oxygen and Nitrous Oxide in Patients Receiving CT-guided Lumbar Infiltration Recruiting
Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care Active, not recruiting
Assessment of the Evolution of Lumbar Spine Movement Fluidity Using Xsens Inertial Sensors in Subjects With Chronic Low Back Pain Before and After Rehabilitation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07195422 on ClinicalTrials.gov ↗ ← All trials in France