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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Efficacy and safety of electroacupuncture for post stroke depression: study protocol for a randomized controlled trial

Authors: Wa Cai, Wen Ma, Guan-Tao Wang, Wei-Dong Shen

Published in: Trials | Issue 1/2018

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Abstract

Background

Poststroke depression is closely related to increased mortality in stroke patients. Compared with antidepressants, electroacupuncture (EA) treatment for poststroke depression (PSD) has relatively more stable effectiveness and can reduce side effects. This trial is designed to provide solid evidence for the efficacy and safety of EA treatment for patients with PSD.

Methods/design

This ongoing study is a single-blind, single-center, parallel group, randomized controlled trial. Sixty-two participants will be recruited from Shanghai Shuguang Hospital and randomized into either the EA group or the sham EA group. Baihui, Sishencong, Ganshu, Sanyinjiao, and Taichong are selected as the treatment acupoints in both groups. The EA group will receive the traditional EA treatment with de-qi sensation, and the sham EA group will receive sham EA treatment without needle penetration and electrostimulation. Participants will receive treatment 3 times per week for a total of 12 sessions over 4 weeks. The primary outcome is Hamilton Rating Scale for Depression score, and the secondary outcomes are scores on the Zung Self-Rating Depression Scale, National Institutes of Health Stroke Scale, Barthel Index of Activities of Daily Living, and Depression Scale of traditional Chinese medicine. All of the outcome measures will be assessed at baseline, 2 weeks after EA treatment onset, 4 weeks after treatment onset, and at 8-week follow-up. Safety assessments will be done at each visit.

Discussion

The results of this trial will demonstrate the efficacy and safety of EA treatment for PSD with credible and important clinical evidence, thus supporting EA treatment as an ideal choice for PSD treatment.

Trial registration

Chinese Clinical Trial Registry, ChiCTR-IOR-17012610. Registered on 7 September 2017. http://​www.​chictr.​org.​cn/​edit.​aspx?​pid=​21494&​htm=​4
Appendix
Available only for authorised users
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Metadata
Title
Efficacy and safety of electroacupuncture for post stroke depression: study protocol for a randomized controlled trial
Authors
Wa Cai
Wen Ma
Guan-Tao Wang
Wei-Dong Shen
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2548-0

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