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Sponsor decision: no sufficient patient
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATLAS | Experimental | Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected. |
|
| Standard lumbar support belt | Active Comparator | Standard lumbar support belt : LombaSkin® or Lombogib® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual analog scale | Other | to measure the lumbar and radicular pain felt by the patient. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Le Bois | Lille | 59000 | France |
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| Mac Gill Pain Questionnaire | Other | self-questionnaire that allows a qualitative assessment of chronic pain |
|
| Roland and Morris Disability Questionnaire | Other | functional disability scale for assessing low back pain |
|
| Quebec questionnaire | Other | To access the patient's perception of incapacity |
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| After a period of 8 days of wearing the medical device |
| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
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