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

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ClinicalTrials.gov Identifier: NCT03178175
Recruitment Status : Terminated (This study will be terminated due to poor patient recruitments.)
First Posted : June 6, 2017
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Bing Show Chwan Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Acupuncture Procedure: Acupuncture Procedure: Needle Insertion Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease: A Single Blinded Randomised Controlled Study
Actual Study Start Date : December 29, 2016
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: acupuncture with "De Qi"
all participants in this group will receive the standard procedure of acupuncture.
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.

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




Primary Outcome Measures :
  1. Balance function evaluation [ Time Frame: 15-20 minutes ]
    check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)


Secondary Outcome Measures :
  1. Motor function evaluation [ Time Frame: 15-20 minutes ]
    check participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178175


Locations
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Taiwan
Chang Bing Show Chwan Memorial Hospital
Chang-hua, Taiwan
Sponsors and Collaborators
Chang Bing Show Chwan Memorial Hospital
Investigators
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Principal Investigator: Chao Hsien Hung, M.D. Chang Bing Show Chang Memorial Hospital

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Responsible Party: Chang Bing Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT03178175     History of Changes
Other Study ID Numbers: 1051004
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang Bing Show Chwan Memorial Hospital:
Scalp acupuncture
Parkinson's disease
Balance

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases