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

Not Applicable

Terminated

• Conditions: Parkinson Disease; Acupuncture
• Interventions: Procedure: Needle Insertion; Procedure: Acupuncture

• Registration Number: NCT03178175
• Lead Sponsor: Chang Bing Show Chwan Memorial Hospital

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.

Study Timeline

• Study Start: 2016-12-29
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-06
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham acupuncture	Needle Insertion	In this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth.
acupuncture with "De Qi"	Acupuncture	all participants in this group will receive the standard procedure of acupuncture.

Primary Outcome Measures

Name	Time	Method
Balance function evaluation	15-20 minutes	check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)

Secondary Outcome Measures

Name	Time	Method
Motor function evaluation	15-20 minutes	check participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score)

Trial Locations

Locations (1)

Chang Bing Show Chwan Memorial Hospital; 🇨🇳 Chang-hua, Taiwan