Assessment of the Safety and Performance of a Lumbar Belt
- Conditions
- Low Back Pain
- Interventions
- Other: Control group LumbarBelt MID 500Device: LumbarBelt SOFT 300Device: LumbarBelt MID 500Other: Control group LumbarBelt SOFT 300
- Registration Number
- NCT05552248
- Lead Sponsor
- Decathlon SE
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group 2 Control group LumbarBelt MID 500 Control group of the LumbarBelt Mid 500 group - no medical device used during sport practice (for 12 weeks) Orthosis group 1 LumbarBelt SOFT 300 Use of LumbarBelt Soft 300 device during sport practice (for 12 weeks) Orthosis group 2 LumbarBelt MID 500 Use of LumbarBelt Mid 500 device during sport practice (for 12 weeks) Control group 1 Control group LumbarBelt SOFT 300 Control group of the LumbarBelt Soft 300 group - no medical device used during sport practice (for 12 weeks)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Safety (adverse events) 12 weeks of follow-up Comparison of adverse events rates between the groups (orthosis vs control), for each device model
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
Trial Locations
- Locations (2)
Centre Hospitalier de Boulogne-sur-Mer
🇫🇷Boulogne-sur-Mer, France
Centre de rééducation et de balnéothérapie Kinés Faches
🇫🇷Faches-Thumesnil, France