RecruitingNot Applicable

Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt and Its Biophysical Impact

France15 participantsStarted 2025-12-09

Plain-language summary

The spine is the central musculoskeletal system of the back. It carries and supports a major part of the body weight and ensures simultaneously the trunk's mobility, particularly the mobility of the lumbar spine and the head's mobility by moving the cervical spine. Back pain in the lumbar spine area is the most common kind of pain with a prevalence of 60 to 70 per cent in industrialized countries (Jellema2001).

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy volunteer, men or women, aged 18 to 50 years old without lumbar pathology. * Volunteer beneficiary of a social security scheme. * Volunteer informed about the study and having co-signed a consent form to participate to the study with the investigator Exclusion Criteria: * Protected persons * Pregnant or breastfeeding women * Persons deprived of freedom, hospitalised without consent, hospitalised with other ends then research. * Adults under legal protection (protection of vulnerable adults) or not able to express consent. * Persons showing gait difficulties (test on treadmill) or with neurological/joint pathologies promoting falls (Parkinson, hemiplegia, …) * Patient seen by a doctor for lumbar pain in the 2 months prior to the inclusion. * Patient suffering from scoliosis * Refusal of consent * Contraindication to MRI * Patient carrying an internal electronic device (pacemaker, neurostimulator, insulin pump…) * Patient with known allergies to one of the product components (e.g. latex) * During the first MRI, volunteers showing prior signs of lower back pain or discopathy will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comfort

Timeframe: Day1

Trial details

NCT IDNCT07355790

SponsorCentre Hospitalier Universitaire de Saint Etienne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Hubert MAROTTE, MD PhD

(0)477127639 hubert.marotte@chu-st-etienne.fr

View on ClinicalTrials.gov More Low Back Pain trials