Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06718348

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6060, Belgium

Location status: Recruiting

Location contact

Aline Gillain, MSc

CONTACT

[email protected]

Serge TROUSSEL, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of the Exoskeleton JAPET.W

Other

Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W

Primary outcomes

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

    Time frame: 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

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

    Time frame: Up to six months

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

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

    Time frame: Up to six months

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

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Assessment of the safety of the JAPET.W

    Time frame: Up to six months

    Rate of patients who had at least one device related adverse event during the clinical investigation.

Study contacts

Contact information is provided by the study sponsor or research team.

Serge TROUSSEL, MD

CONTACT

[email protected]

0032 71 10 ext. 3638

Sponsors and collaborators

Lead sponsor

Grand Hôpital de Charleroi

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.