Heart Rate Variability Assessment in Dialysis Patients by Acupuncture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change from Baseline International restless legs syndrome rating scale(IRLSRS) at 4 weeks,5weeks
研究概览
简要总结
Title of the study:Heart Rate Variability Assessment in Dialysis Patients by Acupuncture
Study period: 08/2019 - 07/2021
Institution: the Graduate Institute of Chinese Medical Science, China Medical University/ Changhua Christian Hospital,Taiwan
Aim of the study: To investigate the effect of medical acupuncture in comparison to placebo acupuncture by heart rate variability(HRV)
Design: Prospective randomized trial
Intervention: Experiment group using indwelling fixed needles, N=30 ; Control group using placebo needles, N=30
Outcome measures: International RLS Rating Scale, HRV
详细描述
RLS occurs in 3-15% of the general population and in 10-30% of patients on maintenance dialysis. End-stage renal disease, a decrease in HRV is typically found, with abnormal HRV being considered an independent risk factor for mortality.While the majority of studies show an initial improvement in symptoms, longer studies and clinical experience show that either treatment efficacy decreases with time, and/or augmentation develops: dopaminergic augmentation has been reported to be the main reason for treatment discontinuation and treatment failure in RLS/WED.
The study randomly assigned to either true acupuncture treatment or placebo/sham acupuncture treatment. Each participant will undergo 12 treatments third-weekly, for a period of 4 weeks. At the end of the eighth treatment session, each participant will again fill out a IRLSRS questionnaire ,ISI and HRV test. At the end of the treatment regimen and 5weeks, participants will again fill out a IRLSRS questionnaire ,ISI and HRV test.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dialysis patients with RLS
- •The symptoms expressed ≧ 3 months and more than twice per week.
- •A score of at least 20 corresponding to severe RLS ( International Restless Legs Syndrome Rating Scale, IRLSRS).Dialysis patients with RLS
排除标准
- •Idiopathic RLS
- •Other movement disorders, various psychiatric and organic disorders, cognitive impairment, or bleeding disorders, on anticoagulant therapy, or cardiac pacemaker.
结局指标
主要结局
Change from Baseline International restless legs syndrome rating scale(IRLSRS) at 4 weeks,5weeks
时间窗: Baseline, 4 weeks, 5weeks
IRLSRS are scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). All items are scored. The sum of the item scores serves as the scale score.
次要结局
- Change from Baseline ISI and HRV(LF,HF, RMSSD, PNN50) at 4 weeks, 5weeks(Baseline, 4 weeks, 5weeks)
研究者
Jia-Ming Chen
Principal Investigator
China Medical University, Taiwan