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Recruiting Not applicable NCT06718348

Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain

No applicable phase (e.g. observational)
Conditions: Low Back Pain, Mechanical

Sponsor: Grand Hôpital de Charleroi

trial.available_in: БГ
Overview
The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. Two groups will be compared. A Control group and an Experimental group with the exoskeleton JAPET.W
Description
The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. The study will consist of two groups: a control group (Group CTRL) and an experimental group (Group EXP). Participants will be categorized into two categories: "workers," patients on temporary work leave due to low back pain, and "non-workers," patients unable to work due to this condition after exhausting all available therapeutic solutions. Monitoring period (30 physiotherapy sessions): evaluations will be conducted at sessions 1, 15 and 30, on the two groups. Evaluation session 3 months after the end of the physiotherapy sessions.
Who can participate
Inclusion Criteria: * Nonspecific mechanical low back pain for more than 6 weeks, * 18 years ≤ Age \< 80 years, * 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 origin), * Motor neurological deficits (peripheral or central), * Extrapyramidal syndrome, * Treatment with implanted neurostimulation, * Cardiac or circulatory diseases or serious respiratory problems, * Previous recent arthrodesis or recent lumbar prosthesis surgery, * Surgery for herniated disc (\<3 months), * Fracture of the dorsolumbar spine or rib (\<3 months), * Skin lesions, contusions and stretching injuries of the trunk, * Pregnancy, * Individuals not tolerating the JAPET.W+ device during an initial trial, * Under guardianship, curatorship or legal protection
Interventions
Use of the Exoskeleton JAPET.W
OTHER
Locations 1
Belgium (1)
Grand Hôpital de Charleroi
Charleroi , Hainaut
Serge TROUSSEL, MD
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.12.2025
Completion date
31.12.2026
Registry ID
NCT06718348
Source
clinicaltrials.gov
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