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

Japet Medical Devices

Status: Not yet enrolling

Conditions: Low Back Pain

Treatments: Device: Control (Standard treatment); Device: Japet.W+

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07195422

2024-A01665-42

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Group A

Active Comparator group

Description:

Period 1 (week 1-8): Current care / Washout period (week 9-10) / Period 2 (week 11-18): Current care + Japet.W+

Treatment:

Device: Japet.W+

Device: Control (Standard treatment)

Group B

Active Comparator group

Description:

Period 1 (week 1-8): Current care + Japet.W+ / Washout period (week 9-10) / Period 2 (week 11-18): Current care

Treatment:

Device: Japet.W+

Device: Control (Standard treatment)