Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
NCT ID: NCT07195422
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
102 participants
INTERVENTIONAL
2025-09-30
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Group A
Period 1 (week 1-8): Current care / Washout period (week 9-10) / Period 2 (week 11-18): Current care + Japet.W+
Japet.W+
Current care of low back pain and wearing the Japet.W+
Control (Standard treatment)
Current care of low back pain
Group B
Period 1 (week 1-8): Current care + Japet.W+ / Washout period (week 9-10) / Period 2 (week 11-18): Current care
Japet.W+
Current care of low back pain and wearing the Japet.W+
Control (Standard treatment)
Current care of low back pain
Interventions
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Japet.W+
Current care of low back pain and wearing the Japet.W+
Control (Standard treatment)
Current care of low back pain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Hôpital Cochin
OTHER
Japet Medical Devices
INDUSTRY
Responsible Party
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Locations
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Hôpital de Cochin, APHP
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A01665-42
Identifier Type: -
Identifier Source: org_study_id
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