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

Lumbar Disc Disease Clinical Trial

— AmbuTract  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04585386
• Other study ID #: 2020-A01625-34
• Status: Terminated
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: October 7, 2021

Study information

• Verified date: June 2022
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Low Back Pain
• Lumbar Disc Disease
• Spinal Diseases

Intervention

Other:
• Visual analog scale
to measure the lumbar and radicular pain felt by the patient.
• Mac Gill Pain Questionnaire
self-questionnaire that allows a qualitative assessment of chronic pain
• Roland and Morris Disability Questionnaire
functional disability scale for assessing low back pain
• Quebec questionnaire
To access the patient's perception of incapacity

Locations

Country	Name	City	State
France	Hôpital Privé Le Bois	Lille

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the safety and tolerance of the devices	Analysis of all adverse events collected during the study	Between Day 0 and Day 8
Secondary	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