Evaluation of the Comfort Increase Provided by an Additio... | NCT07355790

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

NCT07355790

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Recruiting

Last Update Posted

Feb 4, 2026Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Low Back Pain
Healthy Volunteer

Interventions

MRI
MRI evening 2
MRI evening 1

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ANSM	Other Identifier	2025-A01675-44

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2025Actual

Primary Completion Date

Nov 2027Estimated

Completion Date

Nov 2027Estimated

First Submitted Date

Nov 27, 2025

First Submission Date that Met QC Criteria

Jan 13, 2026

First Posted Date

Jan 21, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 4, 2026Actual

Name	Class
Lohmann & Rauscher	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group with additional back insert of a lumbar belt	Experimental	Additional back insert of a lumbar belt	Device: MRI evening 1
Control group with lumbar belt	Active Comparator	a lumbar belt	Device: MRI evening 2
Control group without lumbar belt	Sham Comparator	without lumbar belt	Device: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	MRI in the evening without lumbar belt	Control group without lumbar belt

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hubert MAROTTE, MD PhD	Contact	(0)477127639	33	hubert.marotte@chu-st-etienne.fr
Florence RANCON, CDP	Contact	(0)477829458	33	florence.rancon@chu-st-etienne.fr

Overall Officials

Name	Affiliation	Role
Hubert MAROTTE, MD PhD	CHU de Saint-Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Saint Etienne	Recruiting	Saint-Etienne		42100	France

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms