Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III
研究概览
简要总结
The aim of this study is to evaluate the efficacy of acupuncture and bee venom acupuncture (BVA) for idiopathic Parkinson's disease (IPD) through a sham-controlled trial and investigate whether there is sustainability of treatments effects by follow-up assessments after the end of the treatment.
详细描述
A total of 90 patients with idiopathic Parkinson's disease (IPD) who have been on a stable dose of anti-parkinsonian medication for at least one month with two or more symptoms among tremor, rigidity, postural instability, and bradykinesia will be included in this study. Participants will be randomly assigned to the study, the control, or the waiting group (2:2:1).
Initial assessment will be performed with the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III, the Parkinson's Disease Quality of Life Questionnaire (PDQL), the Beck Depression Inventory (BDI), and evaluation of the 20-m walking time and the steps to walk 20-m, as well as postural instability.
Acupuncture and BVA treatments will then be performed on the study group, and sham acupuncture and normal saline injections will be performed on the control group twice a week for 12 weeks. The waiting group does not receive any added treatment during the 12 weeks.
The initial assessment will be repeated after 12 weeks in all groups. In the study and the control groups, an additional assessment will be repeated after 16 and 20 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with IPD who have been on a stable dose of anti-parkinsonian medication for at least one month.
- •Hoehn & Yahr scale I-IV
- •More than one point in two or more items (tremor, rigidity, postural instability, and bradykinesia) in the UPDRS Part III, etc.
排除标准
- •Severe psychiatric or organic brain disorders other than PD, previous or current
- •Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc.
- •Atypical Parkinsonian or Parkinson plus syndrome
结局指标
主要结局
Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III
时间窗: baseline, up to 12 weeks, 16 weeks, and 20 weeks
The UPDRS part II is evaluation of the activities of daily living (ADL) and part III is the motor examination.
次要结局
未报告次要终点
研究者
Seong-Uk Park
Associate professor
Kyunghee University Medical Center