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

NCT ID: NCT02731677

Last Updated: 2016-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-02-29

Brief Summary

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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 PrĂ³-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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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.

Control

The control group no suffered intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

38 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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NADJA MARIA JORGE ASANO

PRINCIPAL INVESTIGATOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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NADJA ASANO, PHD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Pernambuco

Other Identifiers

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CAAE 49662915.4.0000.5208

Identifier Type: -

Identifier Source: org_study_id

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