Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01970813|
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : September 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Parkinson's Disease||Device: acupuncture and bee venom acupuncture point injection Device: sham acupuncture and normal saline injections||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: Study group
acupuncture and bee venom acupuncture point injection
Device: acupuncture and bee venom acupuncture point injection
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.
Sham Comparator: Control group
sham acupuncture and normal saline injections
Device: sham acupuncture and normal saline injections
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.
No Intervention: Waiting group
no additional intervention
- Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III [ Time Frame: baseline, up to 12 weeks, 16 weeks, and 20 weeks ]The UPDRS part II is evaluation of the activities of daily living (ADL) and part III is the motor examination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970813
|Korea, Republic of|
|Kyung Hee University Hospital at Gangdong|
|Seoul, Korea, Republic of, 134-727|
|Principal Investigator:||Seong-Uk Park, Ph.D||Kyunghee University|