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

NCT ID: NCT06718348

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2025-12-31

Brief Summary

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

Detailed 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.

Conditions

Low Back Pain, Mechanical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group CTRL

Participants will undergo 30 sessions of conventional physiotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group EXP

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

Group Type: EXPERIMENTAL

Use of the Exoskeleton JAPET.W

Intervention Type: OTHER

Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W

Interventions

Use of the Exoskeleton JAPET.W

Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grand Hôpital de Charleroi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Serge TROUSSEL, MD

Role: PRINCIPAL_INVESTIGATOR

Grand Hôpital de Charleroi

Locations

Grand Hôpital de Charleroi

Charleroi, Hainaut, Belgium

Countries

Belgium

Central Contacts

Serge TROUSSEL, MD

Role: CONTACT

Serge.TROUSSEL@ghdc.be

0032 71 10 ext. 3638

Facility Contacts

Serge TROUSSEL, MD

Role: primary

serge.troussel@ghdc.be

Aline Gillain, MSc

Role: backup

aline.gillain@ghdc.be

Other Identifiers

EXO-Exoskeleton Japet.W

Identifier Type: -

Identifier Source: org_study_id