Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt and Its Biophysical Impact
CONFORT
2 other identifiers
interventional
15
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Dec 2025
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2025
CompletedStudy Start
First participant enrolled
December 9, 2025
CompletedFirst Posted
Study publicly available on registry
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
February 4, 2026
February 1, 2026
1.9 years
November 27, 2025
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comfort
Comfort is measuring with a scale : 0 = uncomfortable, 10 = extremely comfortable
Day1
Study Arms (3)
Experimental group with additional back insert of a lumbar belt
EXPERIMENTALAdditional back insert of a lumbar belt
Control group with lumbar belt
ACTIVE COMPARATORa lumbar belt
Control group without lumbar belt
SHAM COMPARATORwithout lumbar belt
Interventions
MRI in the evening after wearing the lumbar belt for one day
MRI in the evening after wearing the lumbar belt with additional back insert for one day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Saint Etienne
Saint-Etienne, 42100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hubert MAROTTE, MD PhD
CHU de Saint-Etienne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2025
First Posted
January 21, 2026
Study Start
December 9, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
February 4, 2026
Record last verified: 2026-02