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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
3
to measure the lumbar and radicular pain felt by the patient.
self-questionnaire that allows a qualitative assessment of chronic pain
functional disability scale for assessing low back pain
Hôpital Privé Le Bois
Lille, France
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.
Time frame: 1 hour after the start of the port
To assess the safety and tolerance of the devices
Analysis of all adverse events collected during the study
Time frame: Between Day 0 and Day 8
Satisfaction of the patient
Percentage of patients with an overall assessment of the device
Time frame: After a period of 8 days of wearing the medical device
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To access the patient's perception of incapacity