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

Grand Hôpital de Charleroi

Status: Begins enrollment this month

Conditions: Low Back Pain, Mechanical

Treatments: Other: Use of the Exoskeleton JAPET.W

Study type: Interventional

Funder types: Other

Identifiers

NCT06718348

EXO-Exoskeleton Japet.W

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group CTRL

No Intervention group

Description:

Participants will undergo 30 sessions of conventional physiotherapy

Group EXP

Experimental group

Description:

Participants will undergo 30 sessions of physiotherapy with the use of the Japet.W+ Exoskeleton

Treatment:

Other: Use of the Exoskeleton JAPET.W