PMID- 29487073
OWN - NLM
STAT- MEDLINE
DCOM- 20180906
LR  - 20190202
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 8
IP  - 2
DP  - 2018 Feb 27
TI  - Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised 
      controlled trial.
PG  - e017912
LID - 10.1136/bmjopen-2017-017912 [doi]
LID - e017912
AB  - 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.
CI  - (c) 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.
FAU - Cai, Yiyi
AU  - Cai Y
AD  - Guangdong Provincial Hospital of Chinese Medicine (The Second Affiliated Hospital 
      of Guangzhou University of Chinese Medicine), Guangdong Provincial Academy of 
      Chinese Medical Sciences and The Second Clinical College, Guangzhou University of 
      Chinese Medicine, Guangzhou, Guangdong, China.
AD  - China-Australia International Research Centre for Chinese Medicine, School of 
      Health and Biomedical Sciences, RMIT University, Melbourne, Victoria, Australia.
FAU - Zhang, Claire Shuiqing
AU  - Zhang CS
AUID- ORCID: 0000-0003-3866-602X
AD  - China-Australia International Research Centre for Chinese Medicine, School of 
      Health and Biomedical Sciences, RMIT University, Melbourne, Victoria, Australia.
FAU - Ouyang, Wenwei
AU  - Ouyang W
AD  - Guangdong Provincial Hospital of Chinese Medicine (The Second Affiliated Hospital 
      of Guangzhou University of Chinese Medicine), Guangdong Provincial Academy of 
      Chinese Medical Sciences and The Second Clinical College, Guangzhou University of 
      Chinese Medicine, Guangzhou, Guangdong, China.
FAU - Li, Jianmin
AU  - Li J
AD  - Guangdong Provincial Hospital of Chinese Medicine (The Second Affiliated Hospital 
      of Guangzhou University of Chinese Medicine), Guangdong Provincial Academy of 
      Chinese Medical Sciences and The Second Clinical College, Guangzhou University of 
      Chinese Medicine, Guangzhou, Guangdong, China.
FAU - Nong, Wenheng
AU  - Nong W
AD  - Guangdong Provincial Hospital of Chinese Medicine (The Second Affiliated Hospital 
      of Guangzhou University of Chinese Medicine), Guangdong Provincial Academy of 
      Chinese Medical Sciences and The Second Clinical College, Guangzhou University of 
      Chinese Medicine, Guangzhou, Guangdong, China.
FAU - Zhang, Anthony Lin
AU  - Zhang AL
AD  - China-Australia International Research Centre for Chinese Medicine, School of 
      Health and Biomedical Sciences, RMIT University, Melbourne, Victoria, Australia.
FAU - Xue, Charlie Changli
AU  - Xue CC
AD  - Guangdong Provincial Hospital of Chinese Medicine (The Second Affiliated Hospital 
      of Guangzhou University of Chinese Medicine), Guangdong Provincial Academy of 
      Chinese Medical Sciences and The Second Clinical College, Guangzhou University of 
      Chinese Medicine, Guangzhou, Guangdong, China.
AD  - China-Australia International Research Centre for Chinese Medicine, School of 
      Health and Biomedical Sciences, RMIT University, Melbourne, Victoria, Australia.
FAU - Wen, Zehuai
AU  - Wen Z
AD  - Guangdong Provincial Hospital of Chinese Medicine (The Second Affiliated Hospital 
      of Guangzhou University of Chinese Medicine), Guangdong Provincial Academy of 
      Chinese Medical Sciences and The Second Clinical College, Guangzhou University of 
      Chinese Medicine, Guangzhou, Guangdong, China.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180227
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - *Electroacupuncture
MH  - Humans
MH  - Muscle Spasticity/*therapy
MH  - Pilot Projects
MH  - Research Design
MH  - Safety
MH  - Severity of Illness Index
MH  - Stroke/*complications
MH  - Treatment Outcome
PMC - PMC5855476
OTO - NOTNLM
OT  - acupuncture
OT  - muscle spasticity
OT  - randomised controlled trial
OT  - stroke
COIS- Competing interests: None declared.
EDAT- 2018/03/01 06:00
MHDA- 2018/09/07 06:00
PMCR- 2018/02/27
CRDT- 2018/03/01 06:00
PHST- 2018/03/01 06:00 [entrez]
PHST- 2018/03/01 06:00 [pubmed]
PHST- 2018/09/07 06:00 [medline]
PHST- 2018/02/27 00:00 [pmc-release]
AID - bmjopen-2017-017912 [pii]
AID - 10.1136/bmjopen-2017-017912 [doi]
PST - epublish
SO  - BMJ Open. 2018 Feb 27;8(2):e017912. doi: 10.1136/bmjopen-2017-017912.