NCT04073446已完成不适用
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
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
- Double (Participant, Outcomes Assessor)
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
- •Average unilateral foot, or knee or groin pain intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score
- •Subject signed a valid, EC-approved informed consent form (ICF)
- •Willing and able to comply with all protocol-required procedures and assessments/evaluations
- •18 years of age or older when written informed consent is obtained
排除标准
- •Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
- •Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
结局指标
主要结局
Change in Pain Intensity
时间窗: up to 6 weeks
Change in pain intensity from Baseline to end of each Period (knee/foot). Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible.
次要结局
未报告次要终点
研究者
研究点 (1)
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