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| Name | Class |
|---|---|
| EFOR, France | INDUSTRY |
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Decathlon has developed the Lumbar belt Soft 300 and Mid 500 products which are medical devices designed to reduce pain and improve function during sport practice for athletes with a common subacute or chronic low back pain.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Lumbar belt range of products to demonstrate safety and performance of these devices in a real-world setting.
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon lumbar belt Soft 300/ Mid 500 devices and support peer-reviewed publications on products performance and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthosis group 1 | Use of LumbarBelt Soft 300 device during sport practice (for 12 weeks) |
| |
| Control group 1 | Control group of the LumbarBelt Soft 300 group - no medical device used during sport practice (for 12 weeks) |
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| Orthosis group 2 | Use of LumbarBelt Mid 500 device during sport practice (for 12 weeks) |
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| Control group 2 | Control group of the LumbarBelt Mid 500 group - no medical device used during sport practice (for 12 weeks) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LumbarBelt SOFT 300 | Device | 15 patients will be included in this group and will used the medical device LumbarBelt SOFT 300 during sport practice (at least 2 sport sessions per week), for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Functionnal score | Comparison of the Oswestry Disability Index (10-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model | Change from Baseline functionnal score at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Confidence level (confidence questionnaire related to physical activity) | Gap in the confidence level related to physical activity (scale from 0=worst outcome to 100=best outcome), between the baseline and last follow-up visit in each group (orthosis vs control), for each device model | Change from Baseline confidence level at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Subject with medically-confirmed common subacute or chronic low back pain whose current condition of his/her back allows the subject to pursue a usual physical activity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean HEE | Contact | 07 64 35 00 45 | +33 | jean.hee@btwin.com |
| Sophie TALLON | Contact | stallon@soladis.fr |
| Name | Affiliation | Role |
|---|---|---|
| Yoann MORVAN | Boulogne sur Mer Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Boulogne-sur-Mer | Recruiting | Boulogne-sur-Mer | 62200 | France |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Control group LumbarBelt SOFT 300 | Other | 15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device LumbarBelt SOFT 300), for at least 2 sport sessions per week during 12 weeks. |
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| LumbarBelt MID 500 | Device | 15 patients will be included in this group and will used the medical device LumbarBelt MID 500 during sport practice (at least 2 sport sessions per week), for 12 weeks. |
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| Control group LumbarBelt MID 500 | Other | 15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device LumbarBelt MID 500), for at least 2 sport sessions per week during 12 weeks. |
|
| Low back pain |
Comparison of low back pain, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control), for each device model |
| Change from Baseline low back pain at 12 weeks |
| Safety (adverse events) | Comparison of adverse events rates between the groups (orthosis vs control), for each device model | 12 weeks of follow-up |
| Centre de rééducation et de balnéothérapie Kinés Faches | Recruiting | Faches-Thumesnil | 59155 | France |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |