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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Tao Zhang, Guiling Wang, Bin Li, Linpeng Wang, Jing Guo, Junxia Hu, Xin Du, Qiuyang Hong, Jingqing Sun, Cunzhi Liu
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2750-0) contains supplementary material, which is available to authorized users.
Jingqing Sun and Cunzhi Liu contributed equally to this work.

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.
Zusatzmaterial
Additional File 1: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. (DOC 122 kb)
13063_2018_2750_MOESM1_ESM.doc
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