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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03178175
• Other study ID #: 1051004
• Status: Terminated
• Phase: N/A
• Start date: December 29, 2016
• Est. completion date: December 11, 2018

Study information

• Verified date: February 2019
• Source: Chang Bing Show Chwan Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 11, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Parkinson Disease

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Bing Show Chwan Memorial Hospital	Chang-hua

Sponsors (1)

Lead Sponsor	Collaborator
Chang Bing Show Chwan Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance function evaluation	check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)	15-20 minutes
Secondary	Motor function evaluation	check participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score)	15-20 minutes