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