Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups
研究概览
简要总结
This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PD
- •Patients 40-99 years of age
- •Patients who have significant fatigue
- •Patients must be on a stable medication regimen for the treatment of PD
排除标准
- •Patients who have had previous acupuncture within the past six months
- •Patients who have had deep brain stimulation (DBS)
- •Patients with dementia, depression, or sleep disorder
- •Patients who are currently taking medications known to affect fatigue, such as stimulants
研究组 & 干预措施
Randomized Subjects receive a sham acupuncture.
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
干预措施: Acupuncture to treat fatigue in Parkinson disease (Other)
Randomized Subjects receive real acupuncture.
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups
时间窗: 6 weeks
The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue.
次要结局
未报告次要终点