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

February 2, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group with additional back insert of a lumbar belt
Additional back insert of a lumbar belt
Device: MRI evening 1
MRI in the evening after wearing the lumbar belt with additional back insert for one day
Active Comparator: Control group with lumbar belt
a lumbar belt
Device: MRI evening 2
MRI in the evening after wearing the lumbar belt for one day
Sham Comparator: Control group without lumbar belt
without lumbar belt
Device: MRI
MRI in the evening without lumbar belt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: Day1
Comfort is measuring with a scale : 0 = uncomfortable, 10 = extremely comfortable
Day1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Lohmann & Rauscher

Investigators

  • Principal Investigator: Hubert MAROTTE, MD PhD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25CH171
  • ANSM (Other Identifier: 2025-A02921-48)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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