Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial.
Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial.
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DOI：
10.1155/2017/2349794
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
Lin ZX
中科院分区：
文献类型：
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作者：
Chan YT;Zhang HW;Guo YQ;Lin ZX
背景吞咽困难是脑卒中最常见的并发症之一。在东亚，针灸被广泛用于治疗中风后吞咽困难。没有证据支持这种治疗方法。本研究旨在评价针刺治疗脑卒中后吞咽困难的有效性和安全性。方法和设计。这是一项多中心、务实、单盲、非随机对照的临床试验。共有140例合格患者将入组本研究。将符合研究条件但拒绝接受针灸治疗的受试者纳入非针灸对照组，两组患者均接受标准常规护理，干预组患者在此基础上接受标准针灸治疗。干预组的每位参与者将接受总共24次针灸治疗（每周三次）。主要结局指标是皇家布里斯班医院吞咽结局指标（RBHOMS）。次要观察指标包括功能性口服摄入量表、吞咽生活质量问卷中文版、受试者的BMI和不良事件。所有结果指标将在基线、针灸治疗结束时（第2个月）和治疗后2个月（第4个月）进行评估。道德与传播。临床研究的伦理批准由香港新界东及新界西联网的研究伦理委员会授予。将获得所有受试者的书面知情同意书，并将根据ICH-GCP指南开展研究。试验注册。本试验在chictr.org注册（注册号：ChiCTR-TRC-12002621，注册日期：2012-10-26）。
Background. Dysphagia is one of the most common complications of stroke. Acupuncture is widely employed to treat poststroke dysphagia in East Asia. No evidence is established to support such treatment approach. This proposed study aims to evaluate the effectiveness and safety of acupuncture for the treatment of poststroke dysphagia. Methods and Design. This is a multicenter, pragmatic, single-blinded, nonrandomized controlled clinical trial. A total of 140 eligible patients will be enrolled in the study. Subjects who are eligible in study but refuse to have acupuncture treatment will be put on the no-acupuncture control arm. Both groups of patients will receive standard routine care, while the patients of intervention group will receive add-on standardized acupuncture treatment. Each participant in intervention group will receive a total of 24 sessions of acupuncture treatment (three times per week). The primary outcome measure is the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS). Secondary outcome measures include functional oral intake scale, swallow quality-of-life questionnaire in Chinese version, BMI of the participant, and adverse events. All outcome measures will be assessed at baseline, at the end of acupuncture treatment (month 2), and at two months after treatment (month 4). Ethics and Dissemination. The ethics approval of clinical research study was granted by the Research Ethics Committee of both New Territories East and West Cluster of Hong Kong. Written informed consent will be obtained from all participants and the study will be undertaken according to the ICH-GCP Guidelines. Trial Registration. This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002621 and registration date: 2012-10-26).