Low Back PainEXODOMICILENCT07195422
Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
A study testing Japet.W+ in people with Low Back Pain, run by Japet Medical Devices at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Japet.W+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Emmanuel COUDEYRE, +33 4 73 75 09 49, ecoudeyre@chu-clermontferrand.fr
- Recruiting
Hôpital de Cochin, APHP
Paris, 75014
Alexandra Rören, +33158412541, alexandra.roren@aphp.fr
About this study
Official title: Evaluation of the Japet.W+ Medical Device for Low Back Pain Management: Performance and Safety Analysis Across Two Patients' Groups
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
- Being tested
- Japet.W+, Control (Standard treatment)
- Keywords
- Low back pain, Active discopathy, Japet.W+, Medical device, Pain assessment, Quality of life
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japet.W+Device
Also called Experimental
Current care of low back pain and wearing the Japet.W+
Control (Standard treatment)Device
Current care of low back pain
| Study group | Role | What they receive |
|---|---|---|
| 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+ Receives: 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 Receives: Device: Japet.W+; Device: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11.
Secondary outcomes (6)
Adverse events
Measured: Week 4 day 7, Week 8 day 7, Week 14 day 7 and Week 18 day 7
Rate of device failure
Measured: Group B: Week 4 day 7, Week 8 day 7 / Group A: Week 14 day 7 and Week 18 day 7
Functional disability
Measurement of specific activity limitation using the Roland-Morris score
Measured: 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
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.
Measured: 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.
Measured: 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.)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Sep 2025
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japet Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Clermont-Ferrand, Hôpital Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195422
- Sponsor's protocol ID
- 2024-A01665-42
- Acronym
- EXODOMICILE
- Status last verified
- Jun 2026
- First submitted
- 3 Jan 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Japet.W+ Medical Device for Low Back Pain Management: Performance and Safety Analysis Across Two Patients' Groups
- ClinicalTrials.gov ID
- NCT07195422
- Acronym / sponsor ID
- EXODOMICILE / 2024-A01665-42
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Active discopathy, Japet.W+, Medical device, Pain assessment, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Japet Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Clermont-Ferrand, Hôpital Cochin
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Japet.W+, Device: Control (Standard treatment)Period 1 (week 1-8): Current care / Washout period (week 9-10) / Period 2 (week 11-18): Current care + Japet.W+ |
| Group B | Active comparator | Device: Japet.W+, Device: Control (Standard treatment)Period 1 (week 1-8): Current care + Japet.W+ / Washout period (week 9-10) / Period 2 (week 11-18): Current care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Japet.W+Also: ExperimentalCurrent care of low back pain and wearing the Japet.W+ | Device | Group A, Group B |
| Control (Standard treatment)Current care of low back pain | Device | Group A, Group B |
Primary outcome
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.
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Japet.W+ in people with Low Back Pain, run by Japet Medical Devices at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélissa Moulart, PhD (+33671307712, melissa.moulart@japet.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.