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

NCT06718348 | Recruiting

• 1 other identifier: EXO-Exoskeleton Japet.W
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (6)

• Assessment of the efficacy of the JAPET.W - measurement of pain

  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

  Up to six months

• Assessment of the efficacy of the JAPET.W - consumption of analgesic

  Assessment of analgesic use in the two groups at the first and last session

  Up to six months

• Assessment of the efficacy of the JAPET.W - functional assessment

  Mobility assessment with the french version of Oswestry Disablility Index. The scale goes from 0 - no pain to 5 - worse.

  Up to six months

• Assessment of the efficacy of the JAPET.W - Assessment of the kinesiophobia

  Comparison of the difference in TAMPA scale. This scale goes to 1-strongly disagree to 4-strongly agree with the proposal

  Up to six months

• Assessment of the efficacy of the JAPET.W - Assessment in quality of life

  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.

  Up to six months

• Assessment of the efficacy of the JAPET.W - Assessment of the Anxiety level

  Assessment of the Anxiety level with Hospital Anxiety Depression Scale. This scale ranges from 0-no anxiety to 3-totally anxious.

  Up to six months

Secondary Outcomes (1)

• Assessment of the safety of the JAPET.W

  Up to six months

Study Arms (2)

Group CTRL

NO INTERVENTION

Participants will undergo 30 sessions of conventional physiotherapy

Group EXP

EXPERIMENTAL

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

Other: Use of the Exoskeleton JAPET.W

Interventions

Use of the Exoskeleton JAPET.W OTHER

Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W

Group EXP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonspecific mechanical low back pain for more than 6 weeks,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grand Hôpital de Charleroi: lead

Study Sites (1)

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6060, Belgium

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serge TROUSSEL, MD

  Grand Hôpital de Charleroi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serge TROUSSEL, MD

CONTACT

0032 71 10; Serge.TROUSSEL@ghdc.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: December 5, 2024
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)