RecruitingNot Applicable

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

France102 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analogue Scale (VAS)

Timeframe: Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11.

Trial details

NCT IDNCT07195422

SponsorJapet Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

Mélissa Moulart, PhD

+33671307712 melissa.moulart@japet.eu

View on ClinicalTrials.gov More Low Back Pain trials