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

NCT07195422 | Not Yet Recruiting DMC

• 1 other identifier: 2024-A01665-42
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Low back pain; Active discopathy; Japet.W+; Medical device; Pain assessment; Quality of life

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  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.

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

Secondary Outcomes (6)

• Adverse events

  Week 4 day 7, Week 8 day 7, Week 14 day 7 and Week 18 day 7

• Rate of device failure

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

• Functional disability

  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

  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+

  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.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Period 1 (week 1-8): Current care / Washout period (week 9-10) / Period 2 (week 11-18): Current care + Japet.W+

Device: Japet.W+; Device: Control (Standard treatment)

Group B

ACTIVE COMPARATOR

Period 1 (week 1-8): Current care + Japet.W+ / Washout period (week 9-10) / Period 2 (week 11-18): Current care

Device: Japet.W+; Device: Control (Standard treatment)

Interventions

Japet.W+ DEVICE

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

Also known as: Experimental

Group A; Group B

Control (Standard treatment) DEVICE

Current care of low back pain

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-specific chronic low back pain with active discopathy OR Non-specific chronic low back pain without active discopathy,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Japet Medical Devices: lead
• University Hospital, Clermont-Ferrand: collaborator
• Hôpital Cochin: collaborator

Study Sites (1)

Hôpital de Cochin, APHP

Paris, 75014, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mélissa Moulart, PhD

CONTACT

+33671307712; melissa.moulart@japet.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: September 26, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-01

Locations

FR (1)