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

NCT ID: NCT01970813

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Idiopathic Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study group

acupuncture and bee venom acupuncture point injection

Group Type ACTIVE_COMPARATOR

acupuncture and bee venom acupuncture point injection

Intervention Type DEVICE

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.

Control group

sham acupuncture and normal saline injections

Group Type SHAM_COMPARATOR

sham acupuncture and normal saline injections

Intervention Type DEVICE

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.

Waiting group

no additional intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seong-Uk Park

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seong-Uk Park, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University

Locations

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Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NRF-2011-0021389

Identifier Type: -

Identifier Source: org_study_id

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