Clinical trial NCT04585386: Efficacy of the ATLAS Medical Device on Pain in Patients With Low Back Pain Due to Lumbar Disc Disease
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Disc Disease
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of the lumbar pain
timeFrame: 1 hour after the start of the port
Secondary outcomes:
measure: To assess the safety and tolerance of the devices
timeFrame: Between Day 0 and Day 8
measure: Satisfaction of the patient
timeFrame: After a period of 8 days of wearing the medical device
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Privé Le Bois
Study officials:
References: