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

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Healthy Volunteer; Low Back Pain

Treatments: Device: MRI evening 1; Device: MRI evening 2; Device: MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07355790

ANSM (Other Identifier)

25CH171

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Experimental group with additional back insert of a lumbar belt

Experimental group

Description:

Additional back insert of a lumbar belt

Treatment:

Device: MRI evening 1

Control group with lumbar belt

Active Comparator group

Description:

a lumbar belt

Treatment:

Device: MRI evening 2

Control group without lumbar belt

Sham Comparator group

Description:

without lumbar belt

Treatment:

Device: MRI