Acupuncture for Anxiety in Parkinson's Disease

Not Applicable

• Conditions: Anxiety; Parkinson Disease
• Interventions: Other: Acupuncture to treat anxiety in Parkinson disease

• Registration Number: NCT04729010
• Lead Sponsor: Xiamen University

Brief Summary

This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safely and effectively manage anxiety in Parkinson's Disease. Eligible subjects will receive either real or sham acupuncture THREE times weekly for a total of SIX weeks.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-28
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-02
• Study Start: 2021-10
• Primary Completion: 2023-09
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients diagnosed with Parkinson's Disease by authorized Neurologist.
• Patients 40-75 years of age
• Patients who have significant anxiety symptom
• Patients must be on a stable medication regimen for the treatment of PD

Exclusion Criteria

• Patients who have had previous acupuncture within the past SIX months
• Patients with dementia, depression, or sleep disorder
• Patients who are currently taking medications known to affect anxiety

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized Subjects receive a real acupuncture.	Acupuncture to treat anxiety in Parkinson disease	Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
Randomized Subjects receive a sham acupuncture.	Acupuncture to treat anxiety in Parkinson disease	Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.

Primary Outcome Measures

Name	Time	Method
Change in the Hamilton Anxiety Scale (HAM-A) between the treatment group.	SIX weeks	The primary outcome measure will be the change between the baseline visit and the SIX-week time point in the Hamilton Anxiety Scale (HAM-A) between the treatment group. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.
Change in the Generalized Anxiety Disorder 7-Item (GAD-7) scale between the treatment group.	SIX Weeks	The primary outcome measure will be the change between the baseline visit and the SIX-week time point in the Generalized Anxiety Disorder 7-Item (GAD-7) scale between the treatment group. Each item is scored on a scale of 0 (not at all) to 3 (Nearly Every Day), with a total score range of 0-56, where \<4 indicates Minimal Anxiety, 5-9 Mild Anxiety, 10-14 Moderate Anxiety, and 15-21 Severe Anxiety.

Secondary Outcome Measures

Name	Time	Method
Change in the Unified Parkinson's Disease Rating Scale between the treatment group.	THREE months	A comprehensive assessment of both motor and non-motor symptoms associated with Parkinson's. The Unified Parkinson's Disease Rating Scale is made up of 42 items. These items are divided into six sections which are separately "evaluation of mentation, behavior, and mood", "self-evaluation of the activities of daily life", "clinician-scored monitored motor evaluation", "complications of therapy", "Hoehn and Yahr staging of severity of Parkinson's disease" and "Schwab and England ADL scale". The evaluation score for the first item to the 39th item is 0 to 4 points. The evaluation score for the 40th to the 42th item is 0 to 1 points. The higher score means the worse condition. This scores indicate severe symptoms.