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

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)

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 Overview

• Status: Terminated
• Conditions: Lumbar Disc Disease
• Intervention / Treatment: Other: Visual analog scale; Other: Mac Gill Pain Questionnaire; Other: Roland and Morris Disability Questionnaire; Other: Quebec questionnaire

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Hôpital Privé Le Bois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATLAS; Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.	Other: Visual analog scale; to measure the lumbar and radicular pain felt by the patient.; Other: Mac Gill Pain Questionnaire; self-questionnaire that allows a qualitative assessment of chronic pain; Other: Roland and Morris Disability Questionnaire; functional disability scale for assessing low back pain; Other: Quebec questionnaire; To access the patient's perception of incapacity
Active Comparator: Standard lumbar support belt; Standard lumbar support belt : LombaSkin® or Lombogib®	Other: Visual analog scale; to measure the lumbar and radicular pain felt by the patient.; Other: Mac Gill Pain Questionnaire; self-questionnaire that allows a qualitative assessment of chronic pain; Other: Roland and Morris Disability Questionnaire; functional disability scale for assessing low back pain; Other: Quebec questionnaire; To access the patient's perception of incapacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the lumbar pain	The primary outcome measure is the change in lumbar pain assessed by the patient using an VAS from 0 to 100 mm.	1 hour after the start of the port

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerance of the devices	Analysis of all adverse events collected during the study	Between Day 0 and Day 8
Satisfaction of the patient	Percentage of patients with an overall assessment of the device	After a period of 8 days of wearing the medical device

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): October 7, 2021
• Study Completion (Actual): October 7, 2021

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: 2020-A01625-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No