NCT05322798已完成不适用
High-frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia (HEAL-SCS): a Randomized Clinical Trial
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年8月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Visual analog scale (VAS) score
研究概览
简要总结
The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)
详细描述
Open-label, parallel-group, randomized study with a 1:1 allocation ratio to check the hypothesis of whether high-frequency-SCS (HF-SCS) is better than conventional low-frequency (LF-SCS) for pain relief in patients with chronic limb-threatening ischemia (CLTI).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-reconstructable critical limb-threatening ischemia (CLTI)
- •Fontaine stage IIB-IV
- •VAS score 5/10 or more
- •succesful SCS trial
排除标准
- •intractable acute infection
- •allergy to SCS component
- •ulcerations larger than 3 cm2
- •inadequate patient compliance
- •life expectancy less than 12 months
- •patient refuse to participate in any stage of the study
结局指标
主要结局
Visual analog scale (VAS) score
时间窗: 12 months
score by visual analog scale (0-10)
次要结局
- TcPO2 (rest)(12 months)
- Walking Impairment Questionnaire (WIQ) - walking distance(12 months)
- Walking Impairment Questionnaire (WIQ) - walking speed(12 months)
- SF-36 - mental component summary(12 months)
- Visual analog scale (VAS) score(3 months)
- Walking Impairment Questionnaire (WIQ) - calf pain severity(12 months)
- Walking Impairment Questionnaire (WIQ) - stair climbing(12 months)
- Short form 36 health survey (SF-36) - physical component summary(12 months)
- TcPO2 (orthostatic probe)(12 months)
研究者
研究点 (2)
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