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New treatment option for Low Back Pain
Official title Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
ClinicalTrials.gov ID: NCT07195422
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join 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.
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.