Efficacy of the ATLAS Medical Device on Pain in Patients With Low Back Pain Due to Lumbar Disc Disease

Not Applicable

Terminated

• Conditions: Lumbar Disc Disease
• Interventions: Other: Visual analog scale; Other: Mac Gill Pain Questionnaire; Other: Roland and Morris Disability Questionnaire; Other: Quebec questionnaire

• Registration Number: NCT04585386
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Study Start: 2021-08-18
• Primary Completion: 2021-10-07
• Study Completion: 2021-10-07
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard lumbar support belt	Visual analog scale	Standard lumbar support belt : LombaSkin® or Lombogib®
ATLAS	Mac Gill Pain Questionnaire	Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
ATLAS	Visual analog scale	Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
Standard lumbar support belt	Roland and Morris Disability Questionnaire	Standard lumbar support belt : LombaSkin® or Lombogib®
Standard lumbar support belt	Quebec questionnaire	Standard lumbar support belt : LombaSkin® or Lombogib®
ATLAS	Roland and Morris Disability Questionnaire	Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
ATLAS	Quebec questionnaire	Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
Standard lumbar support belt	Mac Gill Pain Questionnaire	Standard lumbar support belt : LombaSkin® or Lombogib®

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Privé Le Bois; 🇫🇷 Lille, France