NCT04231409终止不适用
Study to Demonstrate the Value of Fast-Acting Subperception (FAST) Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain (COMBO Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 12
- 主要终点
- Overall Pain Responder Rate
研究概览
简要总结
Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
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
结局指标
主要结局
Overall Pain Responder Rate
时间窗: 3 months post-randomization
Proportion of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization
次要结局
未报告次要终点
研究者
研究点 (12)
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