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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03178175
Enrollment
4
Registered
2017-06-06
Start date
2016-12-29
Completion date
2018-12-11
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Acupuncture

Keywords

Scalp acupuncture, Parkinson's disease, Balance

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.

Interventions

PROCEDUREAcupuncture

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.

Sponsors

Chang Bing Show Chwan Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Balance function evaluation15-20 minutescheck participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)

Secondary

MeasureTime frameDescription
Motor function evaluation15-20 minutescheck participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026