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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Effect of acupuncture for constipation after ischemic stroke: study protocol for a randomized controlled trial

Authors: Tao Zhang, Guiling Wang, Bin Li, Linpeng Wang, Jing Guo, Junxia Hu, Xin Du, Qiuyang Hong, Jingqing Sun, Cunzhi Liu

Published in: Trials | Issue 1/2018

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Abstract

Background

Constipation is a common complication after stroke that can severely influence a patient’s quality of life and rehabilitation. Treatments for constipation after stroke vary. Acupuncture may improve spontaneous bowel movements, quality of life, and clinical symptoms. The study seeks to assess the preliminary effects of acupuncture on constipation after an ischemic stroke.

Methods/design

This is a prospective randomized controlled pilot trial design in which 120 eligible patients will be randomly allocated to one of three groups. The acupuncture group (n = 40) will receive acupuncture and routine care, the medication group (n = 40) will receive mosapride citrate and routine care, and the control group (n = 40) will receive only routine care for ischemic stroke. Patients will be recruited 2 weeks to 6 months after stroke onset and will receive the intervention continuously over 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of acupuncture for constipation after an ischemic stroke. The primary outcome will be the change in the weekly mean number of complete spontaneous bowel movements. Secondary outcomes will include any change in the weekly mean number of spontaneous bowel movements, mean stool consistency scores, mean straining scores during defecation, and frequency of laxative use. All outcome measures will be assessed at inception, after the intervention (4 weeks), and at the follow-up (8 weeks).

Discussion

This study will provide evidence of the preliminary effects and inform future sample size calculations for studies of acupuncture for constipation following an ischemic stroke. These findings will inform subsequent large-scale randomized controlled trials.

Trial registration

ISRCTN, 22214747. Registered on 17 August 2015.
Appendix
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Metadata
Title
Effect of acupuncture for constipation after ischemic stroke: study protocol for a randomized controlled trial
Authors
Tao Zhang
Guiling Wang
Bin Li
Linpeng Wang
Jing Guo
Junxia Hu
Xin Du
Qiuyang Hong
Jingqing Sun
Cunzhi Liu
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2750-0

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