Lumbar Disc Disease
Conditions
Brief summary
Monocentric, comparative, randomized, controlled interventionnal study in 2 parallel groups, aiming to compare the efficacy of the ATLAS device with that of a standard lumbar belt on the reduction of pain felt in patients with subacute or chronic low back pain with lumbar disc disease.
Detailed description
The main expected benefit is a reduction in pain experienced in patients with subacute or chronic low back pain during and after wear. Consequently, an improvement in the quality of daily life is expected with a less significant impact of low back pain. The main objective of the study is to compare the efficacy of the ATLAS medical device with a standard lumbar support belt in terms of immediate reduction of low back pain experienced in patients with subacute or chronic low back pain.
Interventions
OTHERVisual analog scale
to measure the lumbar and radicular pain felt by the patient.
OTHERMac Gill Pain Questionnaire
self-questionnaire that allows a qualitative assessment of chronic pain
OTHERRoland and Morris Disability Questionnaire
functional disability scale for assessing low back pain
OTHERQuebec questionnaire
To access the patient's perception of incapacity
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient suffering from subacute (for 6 to 12 weeks) or chronic (\> 3 months) lumbar pain; * Lumbar disc disease confirmed by Magnetic Resonance Imaging (MRI) less than 3 months old; * Patient with lumbar pain ≥ 40mm on the visual analogue scale (VAS) at inclusion; * Patient in whom a lumbar belt / restraint is considered for a short period to help resumption of activity; * Patient with internet and a camera (by phone or computer) and agreeing to use them as part of the study's teleconsultations; * Patient capable of understanding the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), of reading the information leaflet, of completing questionnaires and agreeing to sign the consent form.
Exclusion criteria
* Patient with neurological radicular or medullary deficits; * Patient presenting a postural problem with lateralized contracture; * Skin pathology in the trunk region and / or contusions and injuries by stretching the trunk; * History of spinal arthrodesis surgery; * History of cauda equina syndrome; * Patient treated by implanted neurostimulation; * Scoliosis with Cobb angle\> 30 °; * History of recent fracture of the dorsolumbar spine (\<3 months); * History of recent rib fracture (\<3 months); * History of recent herniated disc surgery (\<3 months); * Patient with diagnosed fracture osteoporosis; * Patient with heart or circulatory disease or respiratory failure; * Patient presenting with a tumor or infectious process of the vertebrae; * Pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding; * Patient participating in another clinical trial, or in a period of exclusion from another clinical trial; * Patient not beneficiary of a social security scheme.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the lumbar pain | 1 hour after the start of the port | The primary outcome measure is the change in lumbar pain assessed by the patient using an VAS from 0 to 100 mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerance of the devices | Between Day 0 and Day 8 | Analysis of all adverse events collected during the study |
| Satisfaction of the patient | After a period of 8 days of wearing the medical device | Percentage of patients with an overall assessment of the device |
Countries
France
Outcome results
None listed