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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Acupuncture

• Registration Number: NCT02731677
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-03-22
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-01
• Last Update Submitted: 2016-04-01
• Study First Posted: 2016-04-07
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Scale for Parkinson's disease (PDSS)	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).