针刺治疗中风后失眠的疗效：一项随机对照试验的研究方案。
Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.
机构信息
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.
出版信息
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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