Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJapet Medical Devices
About this trial
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 criteria
Qualifiers
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,
Disqualifiers
Specific low back pain (infectious, inflammatory, tumorous, or traumatic in origin).
Motor neurological deficits (peripheral or central).
Extrapyramidal syndrome.
Treatment with implanted neurostimulation.
Trial design
Treatments tested in this trial
- Japet.W+
- Control (Standard treatment)
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
Japet Medical Devices
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborator
Hôpital Cochin
Collaborator
Source ClinicalTrials.gov