Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial

Joint Authors

Guo, Yuanqi
Chan, Yu Tat
Lin, Zhi-Xiu
Zhang, Hongwei

Source

Evidence-Based Complementary and Alternative Medicine

Issue

Vol. 2017, Issue 2017 (31 Dec. 2017), pp.1-8, 8 p.

Publisher

Hindawi Publishing Corporation

Publication Date

2017-01-29

Country of Publication

Egypt

No. of Pages

8

Main Subjects

Medicine

Abstract EN

Background.

Dysphagia is one of the most common complications of stroke.

Acupuncture is widely employed to treat poststroke dysphagia in East Asia.

No evidence is established to support such treatment approach.

This proposed study aims to evaluate the effectiveness and safety of acupuncture for the treatment of poststroke dysphagia.

Methods and Design.

This is a multicenter, pragmatic, single-blinded, nonrandomized controlled clinical trial.

A total of 140 eligible patients will be enrolled in the study.

Subjects who are eligible in study but refuse to have acupuncture treatment will be put on the no-acupuncture control arm.

Both groups of patients will receive standard routine care, while the patients of intervention group will receive add-on standardized acupuncture treatment.

Each participant in intervention group will receive a total of 24 sessions of acupuncture treatment (three times per week).

The primary outcome measure is the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS).

Secondary outcome measures include functional oral intake scale, swallow quality-of-life questionnaire in Chinese version, BMI of the participant, and adverse events.

All outcome measures will be assessed at baseline, at the end of acupuncture treatment (month 2), and at two months after treatment (month 4).

Ethics and Dissemination.

The ethics approval of clinical research study was granted by the Research Ethics Committee of both New Territories East and West Cluster of Hong Kong.

Written informed consent will be obtained from all participants and the study will be undertaken according to the ICH-GCP Guidelines.

Trial Registration.

This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002621 and registration date: 2012-10-26).

American Psychological Association (APA)

Chan, Yu Tat& Zhang, Hongwei& Guo, Yuanqi& Lin, Zhi-Xiu. 2017. Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial. Evidence-Based Complementary and Alternative Medicine،Vol. 2017, no. 2017, pp.1-8.
https://search.emarefa.net/detail/BIM-1153236

Modern Language Association (MLA)

Chan, Yu Tat…[et al.]. Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial. Evidence-Based Complementary and Alternative Medicine No. 2017 (2017), pp.1-8.
https://search.emarefa.net/detail/BIM-1153236

American Medical Association (AMA)

Chan, Yu Tat& Zhang, Hongwei& Guo, Yuanqi& Lin, Zhi-Xiu. Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial. Evidence-Based Complementary and Alternative Medicine. 2017. Vol. 2017, no. 2017, pp.1-8.
https://search.emarefa.net/detail/BIM-1153236

Data Type

Journal Articles

Language

English

Notes

Includes bibliographical references

Record ID

BIM-1153236