NCT04652687终止不适用
VIA Disc NP Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 83
- 试验地点
- 32
- 主要终点
- Patient self-reporting of daily function
研究概览
简要总结
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.
详细描述
The Registry is intended to collect data for patients having received treatment with VIA Disc NP.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Understand and sign the informed consent form (as applicable)
- •VIA Disc NP injection is scheduled for 1 or more levels
排除标准
- •VIA Disc NP injection is not performed
结局指标
主要结局
Patient self-reporting of daily function
时间窗: 1, 3, 6, 12, 24, & 36 months
Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain.
Patient self-reported back pain
时间窗: 1, 3, 6, 12, 24, & 36 months
Change in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).
次要结局
- Patient self-reported mental health(1, 3, 6, 12, 24, & 36 months)
- Resource Utilization(1, 3, 6, 12, 24, & 36 months)
研究者
研究点 (32)
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