NCT04585386

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

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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Disc Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-08-18
• Primary completion: 2021-10-07
• Completion: 2021-10-07
• First posted: 2020-10-14
• Last updated: 2022-06-23

Locations

1 site across 1 country: France