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Recruiting NCT07195422

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

No phase Interventional Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Japet.W+, Control (Standard treatment).
Who it may be relevant to
Registry conditions: Low Back Pain. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Japet.W+
    Current care of low back pain and wearing the Japet.W+
  • Device Control (Standard treatment)
    Current care of low back pain

Primary outcome measures

  • Visual Analogue Scale (VAS) [Time frame: Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11.]
Secondary outcome measures (6)
  • Adverse events [Time frame: Week 4 day 7, Week 8 day 7, Week 14 day 7 and Week 18 day 7]
  • 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]
  • 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).]
  • 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).]
  • 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.]
  • 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

France · 2 centers
  • CHU Clermont-Ferrand — Clermont-Ferrand
  • Hôpital de Cochin, APHP — Paris

Identifiers

NCT: NCT07195422 · 2024-A01665-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗