Recruitment

Recruitment Status
Completed
Estimated Enrollment
90

Inclusion Criterias

More than one point in two or more items (tremor, rigidity, postural instability, and bradykinesia) in the UPDRS Part III, etc.
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.
Patients with IPD who have been on a stable dose of anti-parkinsonian medication for at least one month.
Hoehn & Yahr scale I-IV

Exclusion Criterias

Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc.
Severe psychiatric or organic brain disorders other than PD, previous or current
Atypical Parkinsonian or Parkinson plus syndrome
Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc.
Severe psychiatric or organic brain disorders other than PD, previous or current
Atypical Parkinsonian or Parkinson plus syndrome

Summary

Conditions
Idiopathic Parkinson's Disease
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

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 randoml...

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.

Inclusion Criterias

More than one point in two or more items (tremor, rigidity, postural instability, and bradykinesia) in the UPDRS Part III, etc.
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.
Patients with IPD who have been on a stable dose of anti-parkinsonian medication for at least one month.
Hoehn & Yahr scale I-IV

Exclusion Criterias

Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc.
Severe psychiatric or organic brain disorders other than PD, previous or current
Atypical Parkinsonian or Parkinson plus syndrome
Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc.
Severe psychiatric or organic brain disorders other than PD, previous or current
Atypical Parkinsonian or Parkinson plus syndrome

Locations

Seoul, 134-727
Seoul, 134-727

Tracking Information

NCT #
NCT01970813
Collaborators
Not Provided
Investigators
  • Principal Investigator: Seong-Uk Park, Ph.D Kyunghee University
  • Seong-Uk Park, Ph.D Kyunghee University