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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731677
• Other study ID #: CAAE 49662915.4.0000.5208
• Status: Completed
• Phase: N/A
• First received: March 22, 2016
• Last updated: April 1, 2016
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 38 Years to 78 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parasomnias
• Parkinson Disease
• Sleep Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale for Parkinson's disease (PDSS)	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).	8 weeks	Yes