Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
Primary Purpose
Idiopathic Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
acupuncture and bee venom acupuncture point injection
sham acupuncture and normal saline injections
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease, Idiopathic Parkinson's disease, acupuncture, bee venom acupuncture
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
Sites / Locations
- Kyung Hee University Hospital at Gangdong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
No Intervention
Arm Label
Study group
Control group
Waiting group
Arm Description
acupuncture and bee venom acupuncture point injection
sham acupuncture and normal saline injections
no additional intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01970813
First Posted
October 17, 2013
Last Updated
September 6, 2015
Sponsor
Kyunghee University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01970813
Brief Title
Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
Official Title
Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Parkinson's disease, Idiopathic Parkinson's disease, acupuncture, bee venom acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
acupuncture and bee venom acupuncture point injection
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
sham acupuncture and normal saline injections
Arm Title
Waiting group
Arm Type
No Intervention
Arm Description
no additional intervention
Intervention Type
Device
Intervention Name(s)
acupuncture and bee venom acupuncture point injection
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham acupuncture and normal saline injections
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III
Description
The UPDRS part II is evaluation of the activities of daily living (ADL) and part III is the motor examination.
Time Frame
baseline, up to 12 weeks, 16 weeks, and 20 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Uk Park, Ph.D
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
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