An interventional study of Acupuncture and Needle Insertion in Parkinson Disease and Acupuncture, sponsored by Chang Bing Show Chwan Memorial Hospital. Terminated at 1 site in Taiwan. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-01.
Sponsored by Chang Bing Show Chwan Memorial Hospital · Not applicable, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 4 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Chang Bing Show Chwan Memorial Hospital is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Exclusion Criteria:
all participants in this group will receive the standard procedure of acupuncture.
Procedure: Acupuncture
In this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth.
Procedure: Needle Insertion
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.
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
check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)
Time frame: 15-20 minutes
Motor function evaluation
check participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score)
Time frame: 15-20 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Chang Bing Show Chwan Memorial Hospital