NCT07355790

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

Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt "Cellacare Lumbal Classic - Lohmann & Rauscher" and Its Biophysical Impact

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed description

Back orthosis permits temporary support and stress reduction (in terms of load) of the concerned structures and first of all intervertebral disks. The aim of this study is to evaluate the comfort variation with and without the additional back insert, with the hypothesis that a more comfortable lumbar belt would improve the care observance. This study also aims to verify the relevancy of objective indicators such as pressure measurement and disk hydration for the added benefice of the back insert.

Conditions

• Low Back Pain
• Healthy Volunteer

Interventions

Type	Name	Description
DEVICE	MRI	MRI in the evening without lumbar belt
DEVICE	MRI evening 2	MRI in the evening after wearing the lumbar belt for one day
DEVICE	MRI evening 1	MRI in the evening after wearing the lumbar belt with additional back insert for one day

Timeline

• Start date: 2025-12-09
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2026-01-21
• Last updated: 2026-02-04

Locations

1 site across 1 country: France