WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 26
- 主要终点
- Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
研究概览
简要总结
To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude
详细描述
To demonstrate sustained clinically significant pain relief in patients when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Complaint of chronic pain of the trunk and/or limbs
- •Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English
- •Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English
排除标准
- •Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU)
- •Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
研究组 & 干预措施
SCS starting with supra-perception
Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS
干预措施: Precision or Precision Spectra Spinal Cord Stimulator System (Device)
SCS starting with sub-perception amplitude
Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS
干预措施: Precision or Precision Spectra Spinal Cord Stimulator System (Device)
结局指标
主要结局
Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
时间窗: 90 days post activation
Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain
次要结局
未报告次要终点