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

Not Applicable

Completed

• Conditions: Idiopathic Parkinson's Disease
• Interventions: Device: sham acupuncture and normal saline injections; Device: acupuncture and bee venom acupuncture point injection

• Registration Number: NCT01970813
• Lead Sponsor: Kyunghee University Medical Center

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-06
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	sham acupuncture and normal saline injections	sham acupuncture and normal saline injections
Study group	acupuncture and bee venom acupuncture point injection	acupuncture and bee venom acupuncture point injection

Primary Outcome Measures

Name	Time	Method
Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III	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.

Trial Locations

Locations (1)

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of