Extra foam pad for a more comfortable lumbar belt
Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt "Cellacare Lumbal Classic - Lohmann & Rauscher" and Its Biophysical Impact
This study will test whether adding a foam pad to a lumbar belt makes it more comfortable and changes pressure on the back and disc hydration in healthy adults aged 18–50.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT07355790 on ClinicalTrials.gov |
What this trial studies
Healthy adult volunteers without lumbar pathology will wear a lumbar belt with and without an additional foam insert to compare comfort and biophysical effects. Comfort will be captured with subjective ratings while objective measures include pressure mapping and multiple MRI scans to measure intervertebral disc hydration and related changes. The protocol includes MRI sessions at specified evening times to compare baseline and post-wear states. The goal is to link any change in perceived comfort to measurable pressure and hydration differences.
Who should consider this trial
Good fit: Ideal participants are healthy men or women aged 18–50 without lumbar pathology who are eligible for MRI and can give informed consent.
Not a fit: People with recent or ongoing lumbar pain, scoliosis, pregnancy or breastfeeding, implanted electronic devices, MRI contraindications, or those unable to consent are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the foam pad could make lumbar belts noticeably more comfortable and improve patients' willingness to wear them, potentially reducing mechanical load on spinal structures.
How similar studies have performed: Some prior work shows that padding can improve orthosis comfort, but combining pressure measurement with MRI-based disc hydration analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint-Etienne
- Chu Saint Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Hubert MAROTTE, MD PhD — CHU de Saint-Etienne
- Study coordinator: Hubert MAROTTE, MD PhD
- Email: hubert.marotte@chu-st-etienne.fr
- Phone: (0)477127639
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.