Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy of acupuncture and bee venom acupuncture (BVA) for idiopathic Parkinson's disease (IPD) through a sham-controlled trial and investigate whether there is sustainability of treatments effects by follow-up assessments after the end of the treatment.

Detailed Description
-----------------
A total of 90 patients with idiopathic Parkinson's disease (IPD) who have been on a stable dose of anti-parkinsonian medication for at least one month with two or more symptoms among tremor, rigidity, postural instability, and bradykinesia will be included in this study. Participants will be randomly assigned to the study, the control, or the waiting group (2:2:1). Initial assessment will be performed with the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III, the Parkinson's Disease Quality of Life Questionnaire (PDQL), the Beck Depression Inventory (BDI), and evaluation of the 20-m walking time and the steps to walk 20-m, as well as postural instability. Acupuncture and BVA treatments will then be performed on the study group, and sham acupuncture and normal saline injections will be performed on the control group twice a week for 12 weeks. The waiting group does not receive any added treatment during the 12 weeks. The initial assessment will be repeated after 12 weeks in all groups. In the study and the control groups, an additional assessment will be repeated after 16 and 20 weeks.

Official Title
-----------------
Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease

Conditions
-----------------
Idiopathic Parkinson's Disease

Intervention / Treatment
-----------------
* Device: acupuncture and bee venom acupuncture point injection
* Device: sham acupuncture and normal saline injections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with IPD who have been on a stable dose of anti-parkinsonian medication for at least one month. Hoehn & Yahr scale I-IV More than one point in two or more items (tremor, rigidity, postural instability, and bradykinesia) in the UPDRS Part III, etc. Exclusion Criteria: Severe psychiatric or organic brain disorders other than PD, previous or current Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc. Atypical Parkinsonian or Parkinson plus syndrome
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>acupuncture and bee venom acupuncture point injection | Device: acupuncture and bee venom acupuncture point injection<br>* acupuncture and bee venom acupuncture point injection at 10 acupuncture points twice a week for 12 weeks. This intervention is added on to the conventional antiparkinsonian drugs.<br>|
| Sham Comparator: Control group<br>sham acupuncture and normal saline injections | Device: sham acupuncture and normal saline injections<br>* sham acupuncture and normal saline injections at 10 sham acupuncture points twice a week for 12 weeks. This intervention is added on to the conventional antiparkinsonian drugs.<br>|
| No Intervention: Waiting group<br>no additional intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III | The UPDRS part II is evaluation of the activities of daily living (ADL) and part III is the motor examination. | baseline, up to 12 weeks, 16 weeks, and 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Idiopathic Parkinson's disease, acupuncture, bee venom acupuncture