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NCT Number: NCT07195422

Evaluation of the Japet.W+ Medical Device for Low Back Pain Management

The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain. This study aims to assess the effectiveness of this device among the two targeted populations during daily use. Each patient will be asked to estimate the intensity of their low back pain several times during the clinical investigation. Our main hypothesis is a reduction in low back pain while wearing the device. The secondary hypothesis is a decrease in activity limitations, an increase in participation, an improvement in quality of life, and a reduction in healthcare product and medication consumption.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-specific chronic low back pain with active discopathy OR Non-specific chronic low back pain without active discopathy,
  • 18 years ≤ Age < 80 years,
  • Average pain intensity (VAS) over the last week ≥ 40/100,
  • 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 in origin).
  • Motor neurological deficits (peripheral or central).
  • Extrapyramidal syndrome.
  • Treatment with implanted neurostimulation.
  • Severe heart or circulatory disease or respiratory problems.
  • Arthrodesis or disc replacement.
  • Surgery for herniated disc (<3 months).
  • Spinal fracture or floating ribs (<3 months).
  • Skin lesions on the trunk, history of contusions or skin lesions following traction of the trunk.
  • Pregnancy.
  • Patients who cannot tolerate the JAPET.W+ device during an initial trial.
  • Patients under guardianship, curatorship, or legal protection.
  • Participation in another clinical trial.
  • Patients who have worn a device designed to reduce lower back pain regularly during the 2 weeks prior to inclusion (lumbar belt, corset, exoskeleton).

Treatment and study plan

Japet.W+

Device

Current care of low back pain and wearing the Japet.W+

Other names: Experimental

Control (Standard treatment)

Device

Current care of low back pain

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11.

    Pain VAS is a unidimensional measure of pain intensity (from 0: no pain to 100: severe pain), used to record the progression of pain in patients or to compare the severity of pain between patients with similar conditions. The VAS has been widely used in various adult populations, for example people suffering from chronic low back pain.

Secondary outcomes

  1. Adverse events

    Time frame: Week 4 day 7, Week 8 day 7, Week 14 day 7 and Week 18 day 7

  2. Rate of device failure

    Time frame: Group B: Week 4 day 7, Week 8 day 7 / Group A: Week 14 day 7 and Week 18 day 7

  3. Functional disability

    Time frame: Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7).

    Measurement of specific activity limitation using the Roland-Morris score

  4. Quality of life

    Time frame: Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7).

    The SF-12 physical (PCS-12) and mental (MCS-12) component summary scales are scored using norm-based methods. Physical and mental regression weights and a constant for both measures come from the general U.S. population. Both the PCS-12 and MCS-12 scales are transformed to have a mean of 50 and a standard deviation of 10 in the general U.S. population.

    The minimum possible PCS score (standard version of the SF-12) is 9.9 points and the maximum is 76.0 points. For the MCS, the minimum is 3.2 and the maximum is 77.9. In both cases, the higher the score, the better the patient's health status.

  5. Adherence to Japet.W+

    Time frame: Recovery of Japet.W+ usage time after 28 days and 56 days of use. Group A (using the device during the second period): Week 14, day 7, and Week 18, day 7. Group B (using the device during the first period): Week 4, day 7, and Week 8, day 7.

    Recovery of Japet.W+ usage time.

  6. Number of healthcare products consumed (drugs, medical appointments, physiotherapy sessions, etc.)

    Time frame: Information retrieved 3 times per period (D+7, D+28, D+56). Period 1: Week 1 day 7, Week 4 day 7, Week 8 day 7. Period 2: Week 11 day 7, Week 14 day 7, and Week 18 day 7.

Study contacts

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

Mélissa Moulart, PhD

CONTACT

[email protected]

+33671307712

Sponsors and collaborators

Lead sponsor

Japet Medical Devices

Industry

Collaborators

  • Hôpital Cochin
  • University Hospital, Clermont-Ferrand

Registry information

Official study title

Evaluation of the Japet.W+ Medical Device for Low Back Pain Management: Performance and Safety Analysis Across Two Patients' Groups

Acronym: EXODOMICILE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 26, 2025
Registry last updated
Jun 25, 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.

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