Retrospective-Prospective Clinical Trial Investigating the Treatment of Chronic Pain with the Freedom Peripheral Nerve Stimulation System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Curonix LLC
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain scores
研究概览
简要总结
This is a retrospective-prospective study in which 40 patients have received a permanent Freedom PNS System. Subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and/or surgical treatment.
A retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the Freedom PNS system for at least 12 months. Missing data might be collected after informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Subject is ≥ 18 years of age at time permanent implant; B. Subject has been implanted with the Freedom PNS system; C. Subject is willing to attend visit as scheduled, and comply with the study requirements (if prospective); D. Patient is capable of giving informed consent.
排除标准
- •A. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study (if prospective); B. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom PNS system.
研究组 & 干预措施
Observational
observational
干预措施: PNS device, observational study, no intervention during study (Device)
结局指标
主要结局
Pain scores
时间窗: 12 months
A text description of the subject's pain location(s) and severity will be recorded to correlate with subject feedback. The VRS will be used to measure severity.
次要结局
- EQ-5D-5L(12 months)
- Opioids(12 months)
- Work status(12 months)
- GPES(12 months)
- Amount of sleep(12 months)
- Sleep disturbances(12 months)
- Claims data(12 months)