Low Back Pain, MechanicalNCT06718348
Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain
A study testing Use of the Exoskeleton JAPET.W in people with Low Back Pain, Mechanical, run by Grand Hôpital de Charleroi at 1 site in Belgium.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Use of the Exoskeleton JAPET.W
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Dec 2025to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060
Serge TROUSSEL, MD, serge.troussel@ghdc.be
Aline Gillain, MSc, aline.gillain@ghdc.be
About this study
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
Read the detailed description
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.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Use of the Exoskeleton JAPET.W
- 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.
Use of the Exoskeleton JAPET.WOther
Phsysiotherapy sessions with the support of the Exoskeleton JAPET.W
| Study group | Role | What they receive |
|---|---|---|
| Group CTRL | No intervention | Participants will undergo 30 sessions of conventional physiotherapy |
| Group EXP | Experimental | Participants will undergo 30 sessions of physiotherapy with the use of the Japet.W+ Exoskeleton Receives: Other: Use of the Exoskeleton JAPET.W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the efficacy of the JAPET.W - measurement of pain
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
Measured: Up to six months
Assessment of the efficacy of the JAPET.W - consumption of analgesic
Assessment of analgesic use in the two groups at the first and last session
Measured: Up to six months
Assessment of the efficacy of the JAPET.W - functional assessment
Mobility assessment with the french version of Oswestry Disablility Index. The scale goes from 0 - no pain to 5 - worse.
Measured: Up to six months
Assessment of the efficacy of the JAPET.W - Assessment of the kinesiophobia
Comparison of the difference in TAMPA scale. This scale goes to 1-strongly disagree to 4-strongly agree with the proposal
Measured: Up to six months
Assessment of the efficacy of the JAPET.W - Assessment in quality of life
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.
Measured: Up to six months
Assessment of the efficacy of the JAPET.W - Assessment of the Anxiety level
Assessment of the Anxiety level with Hospital Anxiety Depression Scale. This scale ranges from 0-no anxiety to 3-totally anxious.
Measured: Up to six months
Secondary outcomes (1)
Assessment of the safety of the JAPET.W
Rate of patients who had at least one device related adverse event during the clinical investigation.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start20 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grand Hôpital de Charleroi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge TROUSSEL, MD, Principal investigator, Grand Hôpital de Charleroi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718348
- Sponsor's protocol ID
- EXO-Exoskeleton Japet.W
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06718348
- Acronym / sponsor ID
- EXO-Exoskeleton Japet.W
- Conditions
- Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Grand Hôpital de CharleroiUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (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 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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CTRL | No intervention | –Participants will undergo 30 sessions of conventional physiotherapy |
| Group EXP | Experimental | Other: Use of the Exoskeleton JAPET.WParticipants will undergo 30 sessions of physiotherapy with the use of the Japet.W+ Exoskeleton |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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,
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 |
|---|---|---|
| Use of the Exoskeleton JAPET.WPhsysiotherapy sessions with the support of the Exoskeleton JAPET.W | Other | Group EXP |
Primary outcome
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
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
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.
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
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.
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.
1 secondary outcome
Assessment of the safety of the JAPET.W
Time frame: Up to six months
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 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Serge TROUSSEL, MD principal investigator
Grand Hôpital de Charleroi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Exoskeleton JAPET.W in people with Low Back Pain, Mechanical, run by Grand Hôpital de Charleroi at 1 site in Belgium.
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 4 inclusion and 12 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 Serge TROUSSEL, MD (0032 71 10 ext. 3638, Serge.TROUSSEL@ghdc.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the efficacy of the JAPET.W - measurement of pain (time frame: Up to six months). The study lists 6 primary outcomes in all. 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 17 Apr 2026.