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Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial

INTRODUCTION: Spasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and sa...

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Autores principales: Cai, Yiyi, Zhang, Claire Shuiqing, Ouyang, Wenwei, Li, Jianmin, Nong, Wenheng, Zhang, Anthony Lin, Xue, Charlie Changli, Wen, Zehuai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5855476/
https://www.ncbi.nlm.nih.gov/pubmed/29487073
http://dx.doi.org/10.1136/bmjopen-2017-017912
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author Cai, Yiyi
Zhang, Claire Shuiqing
Ouyang, Wenwei
Li, Jianmin
Nong, Wenheng
Zhang, Anthony Lin
Xue, Charlie Changli
Wen, Zehuai
author_facet Cai, Yiyi
Zhang, Claire Shuiqing
Ouyang, Wenwei
Li, Jianmin
Nong, Wenheng
Zhang, Anthony Lin
Xue, Charlie Changli
Wen, Zehuai
author_sort Cai, Yiyi
collection PubMed
description INTRODUCTION: Spasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC). METHODS AND ANALYSIS: This study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored. ETHICS AND DISSEMINATION: Ethics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences. TRIAL REGISTRATION NUMBER: ChiCTR-IOR-16010283; Pre-results.
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spelling pubmed-58554762018-03-19 Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial Cai, Yiyi Zhang, Claire Shuiqing Ouyang, Wenwei Li, Jianmin Nong, Wenheng Zhang, Anthony Lin Xue, Charlie Changli Wen, Zehuai BMJ Open Complementary Medicine INTRODUCTION: Spasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC). METHODS AND ANALYSIS: This study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored. ETHICS AND DISSEMINATION: Ethics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences. TRIAL REGISTRATION NUMBER: ChiCTR-IOR-16010283; Pre-results. BMJ Publishing Group 2018-02-27 /pmc/articles/PMC5855476/ /pubmed/29487073 http://dx.doi.org/10.1136/bmjopen-2017-017912 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Complementary Medicine
Cai, Yiyi
Zhang, Claire Shuiqing
Ouyang, Wenwei
Li, Jianmin
Nong, Wenheng
Zhang, Anthony Lin
Xue, Charlie Changli
Wen, Zehuai
Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
title Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
title_full Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
title_fullStr Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
title_full_unstemmed Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
title_short Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
title_sort electroacupuncture for poststroke spasticity (eapss): protocol for a randomised controlled trial
topic Complementary Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5855476/
https://www.ncbi.nlm.nih.gov/pubmed/29487073
http://dx.doi.org/10.1136/bmjopen-2017-017912
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