Acupuncture as a Symptomatic Treatment for Anxiety in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Change in the Hamilton Anxiety Scale (HAM-A) between the treatment group.
研究概览
简要总结
This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safely and effectively manage anxiety in Parkinson's Disease. Eligible subjects will receive either real or sham acupuncture THREE times weekly for a total of 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, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Parkinson's Disease by authorized Neurologist.
- •Patients 40-75 years of age
- •Patients who have significant anxiety symptom
- •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 with dementia, depression, or sleep disorder
- •Patients who are currently taking medications known to affect anxiety
结局指标
主要结局
Change in the Hamilton Anxiety Scale (HAM-A) between the treatment group.
时间窗: SIX weeks
The primary outcome measure will be the change between the baseline visit and the SIX-week time point in the Hamilton Anxiety Scale (HAM-A) between the treatment group. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.
Change in the Generalized Anxiety Disorder 7-Item (GAD-7) scale between the treatment group.
时间窗: SIX Weeks
The primary outcome measure will be the change between the baseline visit and the SIX-week time point in the Generalized Anxiety Disorder 7-Item (GAD-7) scale between the treatment group. Each item is scored on a scale of 0 (not at all) to 3 (Nearly Every Day), with a total score range of 0-56, where \<4 indicates Minimal Anxiety, 5-9 Mild Anxiety, 10-14 Moderate Anxiety, and 15-21 Severe Anxiety.
次要结局
- Change in the Unified Parkinson's Disease Rating Scale between the treatment group.(THREE months)
研究者
Kim Yun Jin
Associate Professor
Xiamen University Malaysia