Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03178175|
Recruitment Status : Terminated (This study will be terminated due to poor patient recruitments.)
First Posted : June 6, 2017
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Acupuncture||Procedure: Acupuncture Procedure: Needle Insertion||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease: A Single Blinded Randomised Controlled Study|
|Actual Study Start Date :||December 29, 2016|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||December 11, 2018|
Experimental: acupuncture with "De Qi"
all participants in this group will receive the standard procedure of acupuncture.
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.
Sham Comparator: Sham acupuncture
In this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth.
Procedure: Needle Insertion
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.
- Balance function evaluation [ Time Frame: 15-20 minutes ]check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)
- Motor function evaluation [ Time Frame: 15-20 minutes ]check participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178175
|Chang Bing Show Chwan Memorial Hospital|
|Principal Investigator:||Chao Hsien Hung, M.D.||Chang Bing Show Chang Memorial Hospital|