Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt and Its Biophysical Impact
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI, MRI evening 2, MRI evening 1.
- Who it may be relevant to
- Registry conditions: Low Back Pain, Healthy Volunteer. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt "Cellacare Lumbal Classic - Lohmann & Rauscher" and Its Biophysical Impact
Overview
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.
Interventions
- 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
Primary outcome measures
- Comfort [Time frame: Day1]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Chu Saint Etienne — Saint-Etienne
Identifiers
NCT: NCT07355790 · 25CH171 · ANSM