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

NCT03178175 | Terminated

• 1 other identifier: 1051004
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Acupuncture

Keywords

Scalp acupuncture; Parkinson's disease; Balance

Outcome Measures

Primary Outcomes (1)

• Balance function evaluation

  check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)

  15-20 minutes

Secondary Outcomes (1)

• Motor function evaluation

  15-20 minutes

Study Arms (2)

acupuncture with "De Qi"

EXPERIMENTAL

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

Procedure: Acupuncture

Sham acupuncture

SHAM COMPARATOR

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

Procedure: Needle Insertion

Interventions

Acupuncture 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.

acupuncture with "De Qi"

Needle Insertion 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.

Sham acupuncture

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Bing Show Chwan Memorial Hospital: lead

Study Sites (1)

Chang Bing Show Chwan Memorial Hospital

Chang-hua, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Chao Hsien Hung, M.D.

  Chang Bing Show Chang Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 6, 2017
• Study Start: December 29, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 11, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)