Efficacy of the ATLAS Medical Device on Pain in Patients With Low Back Pain Due to Lumbar Disc Disease
TerminatedNot applicableNCT04585386
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Pilot Study to Assess the Efficacy of the ATLAS Medical Device on Pain in Patients With Subacute or Chronic Low Back Pain With Lumbar Disc Disease: Prospective, Randomized Trial (AmbuTract)
- Conditions
- Lumbar Disc Disease
- Interventions
- Other: Visual analog scale
- Other: Mac Gill Pain Questionnaire
- Other: Roland and Morris Disability Questionnaire
- Other: Quebec questionnaire
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Start date
- 2021-08-18
- Primary completion
- 2021-10-07
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04585386