NCT04676022已完成不适用
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 45
- 主要终点
- Responder Rate
研究概览
简要总结
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Chronic low back pain, with or without leg pain, for at least 6 months
- •Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
- •If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
- •Subject signed a valid, IRB-approved informed consent form (ICF) provided in English
排除标准
- •Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
- •Require implantation of lead(s) in the cervical epidural space
- •Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
- •Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
结局指标
主要结局
Responder Rate
时间窗: 3 months post-activation
Proportion of subjects with 50% or greater reduction in overall pain relief
次要结局
- Change in Disability (Oswestry Disability Index)(3-Months post activation)
研究者
研究点 (45)
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