Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial

Yan Cao, Xuan Yin, Francisca Soto-Aguilar, Yiping Liu, Ping Yin, Junyi Wu, Bochang Zhu, Wentao Li, Lixing Lao, Shifen Xu, Yan Cao, Xuan Yin, Francisca Soto-Aguilar, Yiping Liu, Ping Yin, Junyi Wu, Bochang Zhu, Wentao Li, Lixing Lao, Shifen Xu

Abstract

Background: The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke.

Methods: This proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up.

Discussion: This proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke.

Trial registration: Chinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382 . Registered on 28 April 2016.

Keywords: Acupuncture; Insomnia; Randomized controlled trial; Stroke.

Figures

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Fig. 1
Study process

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Source: PubMed

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