Low back pain relief with the Japet.W+ device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests the Japet.W+ dynamic distraction support system against standard care for chronic low back pain. Participants will wear the device and report pain levels multiple times during the study, with outcomes including pain reduction, improved daily functioning, better participation, and quality of life. The trial includes adults 18 to under 80 with average pain ≥40/100 in the prior week and excludes specific spinal conditions, neurological deficits, recent spine surgery, and other medical risks. Lead sponsor is Japet Medical Devices, with collaboration from University Hospital Clermont-Ferrand and Hôpital Cochin, conducted at CHU Clermont-Ferrand and APHP sites in Paris. The goal is to determine if the device provides meaningful relief and reduced healthcare use compared with standard treatment.

Why it matters

Who can join: the full rules

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).

Where it's running

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

Study contacts

• Study coordinator: Mélissa Moulart, PhD
• Email: melissa.moulart@japet.eu
• Phone: +33671307712

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.