Acupuncture as a Symptomatic Treatment for Anxiety in Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Xiamen University
- Enrollment
- 30
- Primary Endpoint
- Change in the Hamilton Anxiety Scale (HAM-A) between the treatment group.
- Last Updated
- 5 years ago
Overview
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.
Investigators
Kim Yun Jin
Associate Professor
Xiamen University Malaysia
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in the Hamilton Anxiety Scale (HAM-A) between the treatment group.
Time Frame: 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.
Time Frame: 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 Outcomes
- Change in the Unified Parkinson's Disease Rating Scale between the treatment group.(THREE months)