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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Kyunghee University Medical Center
Sponsor:
Information provided by (Responsible Party):
Seong-Uk Park, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01970813
First received: October 17, 2013
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Idiopathic Parkinson's Disease
Procedure: acupuncture and bee venom acupuncture point injection
Procedure: sham acupuncture and normal saline injections

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The UPDRS part II is evaluation of the activities of daily living (ADL) and part III is the motor examination.


Estimated Enrollment: 90
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study group
acupuncture and bee venom acupuncture point injection
Procedure: 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
Procedure: 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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970813

Contacts
Contact: Seung-Yeon Cho, Ph.D +82 2 440 6209 sycho83@gmail.com
Contact: Seong-Uk Park, Ph.D +82 2 440 6217 seonguk.kr@gmail.com

Locations
Korea, Republic of
Kyung Hee University Hospital at Gangdong Recruiting
Seoul, Korea, Republic of, 134-727
Contact: Seung-Yeon Cho, Ph.D       sycho83@gmail.com   
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Seong-Uk Park, Ph.D Kyung Hee University
  More Information

No publications provided

Responsible Party: Seong-Uk Park, Associate professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01970813     History of Changes
Other Study ID Numbers: NRF-2011-0021389
Study First Received: October 17, 2013
Last Updated: November 5, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyunghee University Medical Center:
Parkinson's disease
Idiopathic Parkinson's disease
acupuncture
bee venom acupuncture

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 16, 2014