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

NCT ID: NCT03178175

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-29
• Study Completion Date: 2018-12-11

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.

Conditions

Parkinson Disease; Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

acupuncture with "De Qi"

all participants in this group will receive the standard procedure of acupuncture.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

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 acupuncture

In this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth.

Group Type: SHAM_COMPARATOR

Needle Insertion

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Bing Show Chwan Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chao Hsien Hung, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Bing Show Chang Memorial Hospital

Locations

Chang Bing Show Chwan Memorial Hospital

Chang-hua, , Taiwan

Countries

Taiwan

Other Identifiers

1051004

Identifier Type: -

Identifier Source: org_study_id