Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease, Acupuncture
Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Needle Insertion
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Scalp acupuncture, Parkinson's disease, Balance
Eligibility Criteria
Inclusion Criteria:
- age 50-75
- Meet the diagnostic criteria of Parkinson's disease: UK (United Kingdom) Parkinson's disease society brain bank clinical diagnostic criteria
- Disease severity of Hoehn-Yahr stage: stage I to III
- clinical condition stable, not adjusting medicine in recent 3 months
- no falling episode in recent 1 year
- live independently
Exclusion Criteria:
- already enrolled in another studies
- can't cooperate this evaluation examinations due to poor visual acuity, impaired cognitive function, musculoskeletal system disorder, or psychiatric illness
- any other condition would make participants not to cooperative this study
- can't tolerate acupuncture procedure
Sites / Locations
- Chang Bing Show Chwan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
acupuncture with "De Qi"
Sham acupuncture
Arm Description
all participants in this group will receive the standard procedure of acupuncture.
In this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth.
Outcomes
Primary Outcome Measures
Balance function evaluation
check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)
Secondary Outcome Measures
Motor function evaluation
check participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score)
Full Information
NCT ID
NCT03178175
First Posted
May 31, 2017
Last Updated
February 27, 2019
Sponsor
Chang Bing Show Chwan Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03178175
Brief Title
Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease
Official Title
Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease: A Single Blinded Randomised Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
This study will be terminated due to poor patient recruitments.
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Bing Show Chwan Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This plan is to evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for PD patients. This is a randomized, controlled, single-blind clinical trial.
Detailed Description
BACKGROUND: Parkinson's disease (PD) is an age-related progressive neurodegenerative disease. The etiology and pathogenetic mechanisms that cause PD are still not fully understood. Scalp acupuncture (SA), a common treatment modality within complementary and alternative medicine, has been widely used for PD.
OBJECTIVE: To evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for PD patients.
DESIGN: Randomized, controlled, single-blind clinical trial. SETTING: Department of Neurology, Chang Bing Show Chwan Memorial Hospital in Changhua County.
PARTICIPANTS: Patients with PD of grade 1 to 3 of Hoehn & Yahr (H&Y) scale (N = 26).
INTERVENTIONS: SA group (Si Shen Cong and Baihui) or control group. The techniques were administered by traditional chinese medicine trained in SA and evaluated at baseline and at 20 and 30 minutes.
MAIN OUTCOME MEASURE: Motor score subscale of Unified Parkinson's Disease Rating Scale (UPDRS) was used to measure the motor performances. Balance ability in each patient was assessed as follows: subjects were placed on a force platform (SPS, SYNAPSYS posturography system) to assess the displacement area from the centre of gravity, either with eyes open or closed, in a standing posture. The mini balance evaluation systems test (the mini-BESTest) was used to measure the performance of balance and walking speed. The test was repeated twice each in baseline period, SA period and post-SA period. The Mann-Whitney U test, Chi-square test, and Fisher's exact test were used to compare the baseline characteristics of the 2 groups. One-way repeated measures ANOVA was used to examine the differences among different time points (before, during, and after acupuncture treatment) within a group. Association between continuous variables was evaluated with Spearman's rank correlation coefficient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Acupuncture
Keywords
Scalp acupuncture, Parkinson's disease, Balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acupuncture with "De Qi"
Arm Type
Experimental
Arm Description
all participants in this group will receive the standard procedure of acupuncture.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
In this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
In the acupuncture with "De Qi" group, using stainless tiny needles is inserted to the specific acupoints over the scalp (Si Shen Cong and Baihui) until the "De Qi" phenomenon occurs. The duration is about 30 minutes, and all patients will receive the procedure 16 times within 2 months.
Intervention Type
Procedure
Intervention Name(s)
Needle Insertion
Intervention Description
In the Sham acupuncture group, using stainless tiny needles is inserted to the specific acupoints over the scalp (Si Shen Cong and Baihui) but the needle doesn't reach the exact depth and "De Qi" phenomena doesn't occur. The duration is about 30 minutes, and all patients will receive this procedure 16 times within 2 months.
Primary Outcome Measure Information:
Title
Balance function evaluation
Description
check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)
Time Frame
15-20 minutes
Secondary Outcome Measure Information:
Title
Motor function evaluation
Description
check participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score)
Time Frame
15-20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 50-75
Meet the diagnostic criteria of Parkinson's disease: UK (United Kingdom) Parkinson's disease society brain bank clinical diagnostic criteria
Disease severity of Hoehn-Yahr stage: stage I to III
clinical condition stable, not adjusting medicine in recent 3 months
no falling episode in recent 1 year
live independently
Exclusion Criteria:
already enrolled in another studies
can't cooperate this evaluation examinations due to poor visual acuity, impaired cognitive function, musculoskeletal system disorder, or psychiatric illness
any other condition would make participants not to cooperative this study
can't tolerate acupuncture procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao Hsien Hung, M.D.
Organizational Affiliation
Chang Bing Show Chang Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Bing Show Chwan Memorial Hospital
City
Chang-hua
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease
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