Actively Recruiting
Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain
Led by Grand Hôpital de Charleroi · Updated on 2026-04-17
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with nonspecific mechanical low back pain lasting more than six weeks to evaluate the use of the Japet.W+ lumbar traction device in rehabilitation. The study compares two groups: one receiving conventional physiotherapy and another receiving physiotherapy with the support of the Japet.W+ exoskeleton. Participants are also categorized based on work status: those on temporary work leave and those unable to work after exhausting other treatments. The trial involves two groups: a control group undergoing 30 sessions of conventional physiotherapy, and an experimental group receiving 30 physiotherapy sessions assisted by the Japet.W+ exoskeleton. Evaluations occur at session 1, session 15, session 30, and a follow-up three months after completing physiotherapy. The study monitors various outcomes over six months, including pain levels, analgesic use, functional ability, fear of movement, quality of life, and anxiety. Participants will attend physiotherapy sessions and undergo assessments at specified points to measure pain, function, medication use, and psychological factors. Safety of the Japet.W+ device is also assessed. Data collection continues for up to six months to observe changes and longer-term effects. The study duration includes the physiotherapy sessions and a post-treatment follow-up period, with monitoring throughout.
CONDITIONS
Brief Title
Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Nonspecific mechanical low back pain for more than 6 weeks
- Age between 18 and less than 80 years
- Affiliated to the health social security system
- Able to understand study information and sign informed consent
You will not qualify if you...
- Specific low back pain caused by infection, inflammation, tumor, or trauma
- Motor neurological deficits (peripheral or central)
- Extrapyramidal syndrome
- Treatment with implanted neurostimulation device
- Cardiac, circulatory, or serious respiratory diseases
- Recent arthrodesis or lumbar prosthesis surgery
- Surgery for herniated disc within past 3 months
- Fracture of dorsolumbar spine or ribs within past 3 months
- Skin lesions, contusions, or stretching injuries of the trunk
- Pregnancy
- Unable to tolerate the Japet.W+ device during initial trial
- Under guardianship, curatorship, or legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 30 physiotherapy sessions
Participants undergo 30 physiotherapy sessions either with or without the use of the Japet.W+ exoskeleton device.
Evaluations at sessions 1, 15, and 30
Duration - 3 months after completion of treatment
Participants are evaluated 3 months after the end of physiotherapy sessions to assess long-term outcomes.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium, 6060
Actively Recruiting
Research Team
S
Serge TROUSSEL, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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