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

Not Applicable

Not yet recruiting

• Conditions: Low Back Pain, Mechanical

• Registration Number: NCT06718348
• Lead Sponsor: Grand Hôpital de Charleroi

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.

Study Timeline

• Study First Submitted: 2024-11-17
• Study First Submitted QC: 2024-12-01
• Study First Posted: 2024-12-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Study Start: 2025-02-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of the efficacy of the JAPET.W - Assessment of the kinesiophobia	Up to six months	Comparison of the difference in TAMPA scale. This scale goes to 1-strongly disagree to 4-strongly agree with the proposal
Assessment of the efficacy of the JAPET.W - Assessment in quality of life	Up to six months	Assessment in quality of life with EQ-5D-5L. The scale goes to 1-totally able to carry out the activity up to 5-totally unable to do so.
Assessment of the efficacy of the JAPET.W - Assessment of the Anxiety level	Up to six months	Assessment of the Anxiety level with Hospital Anxiety Depression Scale. This scale ranges from 0-no anxiety to 3-totally anxious.
Assessment of the efficacy of the JAPET.W - measurement of pain	Up to six months	VAS scale for pain (o -no pain to 10 - pain as bad as it could possibly be) : rate of the patients who had at least -20 points/100 on the VAS for pain
Assessment of the efficacy of the JAPET.W - consumption of analgesic	Up to six months	Assessment of analgesic use in the two groups at the first and last session
Assessment of the efficacy of the JAPET.W - functional assessment	Up to six months	Mobility assessment with the french version of Oswestry Disablility Index. The scale goes from 0 - no pain to 5 - worse.

Secondary Outcome Measures

Name	Time	Method
Assessment of the safety of the JAPET.W	Up to six months	Rate of patients who had at least one device related adverse event during the clinical investigation.

Trial Locations

Locations (1)

Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Hainaut, Belgium