Assessment of the Safety and Performance of a Lumbar Belt
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functionnal score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Functionnal score
时间窗: 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
次要结局
- Safety (adverse events)(12 weeks of follow-up)
- Confidence level (confidence questionnaire related to physical activity)(Change from Baseline confidence level at 12 weeks)
- Low back pain(Change from Baseline low back pain at 12 weeks)