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Completed

NCT Number: NCT01970813

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyung Hee University Hospital at Gangdong

Seoul, 134-727, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture and bee venom acupuncture point injection

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.

sham acupuncture and normal saline injections

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2013
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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