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

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

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain, Mechanical
• Intervention / Treatment: Other: Use of 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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serge TROUSSEL, MD; Phone Number: 3638 0032 71 10; Email: Serge.TROUSSEL@ghdc.be

Study Locations

• Belgium
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6060
      • Recruiting
      • Grand Hopital De Charleroi
      • Contact: Serge TROUSSEL, MD; Email: serge.troussel@ghdc.be
      • Contact: Aline Gillain, MSc; Email: aline.gillain@ghdc.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group CTRL; Participants will undergo 30 sessions of conventional physiotherapy
Experimental: Group EXP; Participants will undergo 30 sessions of physiotherapy with the use of the Japet.W+ Exoskeleton	Other: Use of the Exoskeleton JAPET.W; Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 - 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 - 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Grand Hôpital de Charleroi
• Investigators: Principal Investigator: Serge TROUSSEL, MD, Grand Hopital De Charleroi

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: EXO-Exoskeleton Japet.W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No