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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970813
First Posted: October 28, 2013
Last Update Posted: September 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seong-Uk Park, Kyunghee University Medical Center
  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 Device: acupuncture and bee venom acupuncture point injection Device: sham acupuncture and normal saline injections

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Seong-Uk Park, 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 ]
    The UPDRS part II is evaluation of the activities of daily living (ADL) and part III is the motor examination.


Enrollment: 74
Study Start Date: October 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
Korea, Republic of
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Seong-Uk Park, Ph.D Kyunghee University
  More Information

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
First Submitted: October 17, 2013
First Posted: October 28, 2013
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Seong-Uk Park, 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