NCT05515341已完成不适用
A DirEct to PatieNt Study in Chronic Pain
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Change in pain post procedure
研究概览
简要总结
To compile real-world, direct from patient clinical outcomes and objective metrics in patients who have received or plan to receive a commercially approved interventional medical device therapy/procedure for chronic pain in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is planning to receive or has received a commercially approved interventional medical device therapy/procedure to treat chronic pain, ascertained from self-reporting
- •Age ≥ 22 years at time of eligibility screening, ascertained by self-reported age at time of eligibility screening
- •Proficient in written and spoken English, defined by self-reporting of comfort reading, writing and speaking English
排除标准
- •Requires a legal representative to sign the ICF ascertained from self-reporting
研究组 & 干预措施
Medical Device Therapy/Procedure for Chronic Pain
干预措施: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain (Device)
结局指标
主要结局
Change in pain post procedure
时间窗: up to 12 months
Change in patient-reported pain on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain
Targeted Pain Responder Rate
时间窗: up to 40 months post study enrollment
Percentage of subjects with a 50 percent or greater reduction in targeted pain intensity, based on self-reported percent pain relief
次要结局
未报告次要终点
研究者
研究点 (1)
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