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临床试验/NCT02731677
NCT02731677已完成不适用

Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease

Universidade Federal de Pernambuco0 个研究点目标入组 22 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
主要终点
Scale for Parkinson's disease (PDSS)

研究概览

简要总结

Sleep disorders correspond to a non-motor symptom present in DP, being represented by daytime sleepiness and maintenance insomnia. This study aims to evaluate the effects of acupuncture on sleep disorders in patients with PD assisted by Pró-Parkinson Program at University Hospital of Pernambuco, Brazil. Its a randomized clinical trial approved by the Ethics Committee for Research with Human. It was included patients with diagnosed with Idiopathic Parkinson's disease, Mini Mental State Examination (MMEE) according to education, stages 1, 2 and 3 in the Hoehn-Yahr scale. It was used the sleep Scale for Parkinson's disease (PDSS), a self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Twenty-two subjects were allocated in two groups: experimental and control. Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE once a week, eight sessions in the experimental group. The control group no suffered intervention. The paired analyzes were performed using the Wilcoxon test and the independent analyzes using the Mann-Whitney test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
38 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Idiopathic Parkinson's disease
  • Mini Mental State Examination (MMSE) According to education
  • Stages 1, 2 and 3 in the Hoehn-Yahr scale.

排除标准

  • Patients who have another neurological disorder associated with Parkinson's disease
  • Cardiac with pacemaker (contraindicated the use of electrotherapy).

结局指标

主要结局

Scale for Parkinson's disease (PDSS)

时间窗: 8 weeks

A self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Consists of 15 items represented by a ruler (10 cm) where the patient indicates the frequency of the symptom from 0 (always)- 10 (never).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NADJA MARIA JORGE ASANO

PRINCIPAL INVESTIGATOR

Universidade Federal de Pernambuco

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