Study to Demonstrate the Value of Multiple Modalities and Combining Mechanisms Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 15
- 主要终点
- Overall Pain Responder Rate
研究概览
简要总结
To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
详细描述
To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
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 pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
- •22 years of age or older at time of enrollment
- •Able to independently read and complete all questionnaires and assessments provided in English
- •Signed a valid, IRB-approved informed consent form (ICF) provided in English
排除标准
- •Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
- •Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- •Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
- •Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
研究组 & 干预措施
WaveWriter Settings
WaveWriter Programming
干预措施: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System (Device)
Conventional Settings
Conventional Programming
干预措施: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System (Device)
结局指标
主要结局
Overall Pain Responder Rate
时间窗: 3 months post-randomization
Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications
次要结局
未报告次要终点