Low Back Pain
Conditions
Brief summary
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.
Interventions
DEVICELumbarBelt SOFT 300
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.
OTHERControl group LumbarBelt SOFT 300
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.
DEVICELumbarBelt MID 500
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.
OTHERControl group LumbarBelt MID 500
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.
Sponsors
EFOR, France
Decathlon SE
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Subject is aged ≥18 years old * Subject has a medically-confirmed common subacute or chronic low back pain * Subject performs regular physical activity * The current condition of his/her back allows the subject to pursue a usual physical activity * Subject has been informed and is willing to sign an informed consent form * Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks) * Subject is affiliated to the French social security regime
Exclusion criteria
* Subject has undergone a surgical treatment for his/her back * Subject presents associated neurologic signs (equina syndrome, radiculopathy, sciatica…) * Subject presents signs of specific low back pain (i.e. low back pain is a symptom of an underlying condition): presence of red flags * Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent * Subject has worn a support (lumbar or sacroiliac hip belt) during sports sessions in the last month * Subject has any medical condition that could impact the study at investigator's discretion * Subject has a known hypersensitivity or allergy to the components of the devices (elastodiene, elastane, polyamide, polyethersulfone \[PES\]) * Adult subject to a legal protection measure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functionnal score | Change from Baseline functionnal score at 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confidence level (confidence questionnaire related to physical activity) | Change from Baseline confidence level at 12 weeks | 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 |
| Low back pain | Change from Baseline low back pain at 12 weeks | 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 |
| Safety (adverse events) | 12 weeks of follow-up | Comparison of adverse events rates between the groups (orthosis vs control), for each device model |
Countries
France
Contacts
Primary ContactJean HEE
Backup ContactSophie TALLON
Outcome results
None listed