Healthy Volunteer, Low Back Pain
Conditions
Keywords
Lumbar belt, back insert, confort
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.
Interventions
DEVICEMRI
MRI in the evening without lumbar belt
DEVICEMRI evening 2
MRI in the evening after wearing the lumbar belt for one day
DEVICEMRI evening 1
MRI in the evening after wearing the lumbar belt with additional back insert for one day
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Lohmann & Rauscher
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | Day1 | Comfort is measuring with a scale : 0 = uncomfortable, 10 = extremely comfortable |
Countries
France
Contacts
CONTACTHubert MAROTTE, MD PhD
CONTACTFlorence RANCON, CDP
PRINCIPAL_INVESTIGATORHubert MAROTTE, MD PhD
CHU de Saint-Etienne
Outcome results
None listed