Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
University of Maryland School of Medicine, Baltimore, MD, 21201, USA.
Trials. 2016 Nov 16;17(1):546. doi: 10.1186/s13063-016-1670-0.
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.
背景:中国的中风发病率、死亡率和患病率都很高。中风常伴有失眠;失眠和中风都可以通过长期针灸得到有效治疗。本试验旨在评估针灸治疗中风后失眠的疗效。
方法:本研究为单中心、单盲(患者评估者盲法)、平行组随机对照试验。我们将以 1:1 的比例将 60 名中风后失眠患者随机分为两组。干预组将接受能达到“得气”感的传统针灸治疗,对照组将接受不插针的假针灸治疗。两组均使用相同的穴位(DU20、DU24、EX-HN3、EX-HN22、HT7 和 SP6)。所有患者每周接受 3 次治疗,共 4 周。主要结局指标为匹兹堡睡眠质量指数。次要结局指标包括:失眠严重程度指数;通过活动记录仪记录的睡眠效率、睡眠觉醒和总睡眠时间;国立卫生研究院中风量表;中风特异性生活质量评分;医院焦虑抑郁量表。在某些条件下允许并规范使用艾司唑仑。在基线、治疗开始后 2 周、治疗开始后 4 周和 8 周随访时评估结局。
讨论:本研究将有助于扩大对针灸治疗中风后失眠的认识。这将是一项高质量的随机对照试验,方法严格,设计缺陷较少。它将研究针灸作为中风后失眠替代治疗的有效性。
试验注册:中国临床试验注册中心标识符:ChiCTR-IIC-16008382。于 2016 年 4 月 28 日注册。
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