Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease: A Single Blinded Randomised Controlled Study

Conditions
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Parkinson Disease, Acupuncture

Intervention / Treatment
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* Procedure: Acupuncture
* Procedure: Needle Insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture with De Qi<br>all participants in this group will receive the standard procedure of acupuncture. | Procedure: Acupuncture<br>* 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.<br>|
| Sham Comparator: Sham acupuncture<br>In this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth. | Procedure: Needle Insertion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance function evaluation | check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test) | 15-20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor function evaluation | check participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score) | 15-20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scalp acupuncture, Parkinson's disease, Balance