Effect of He's Santong Needling Method on Dysphagia after Stroke: A Study Protocol for a Prospective Randomized Controlled Pilot Trial.
Effect of He's Santong Needling Method on Dysphagia after Stroke: A Study Protocol for a Prospective Randomized Controlled Pilot Trial.
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DOI：
10.1155/2018/6126410
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发表时间：
2018
期刊：
影响因子：
--
通讯作者：
Li B
中科院分区：
文献类型：
--
作者：
Zhao L;Liu L;Zhang CS;Zeng L;Zhao J;Wang L;Jing X;Wang K;Li B
吞咽困难是中风的常见并发症，影响高达78%的中风患者。卒中后吞咽困难的存在与肺部并发症甚至死亡率的风险增加有关。以往的研究表明，针刺可能是治疗脑卒中后吞咽障碍的一种潜在的治疗方法。目的：采用前瞻性随机对照研究方法，观察何氏三通刺法治疗脑卒中后吞咽障碍的临床疗效。 将60名符合条件的受试者按1：1的比例随机分为治疗组（何氏三通刺法配合吞咽康复训练）和对照组（吞咽康复训练）。所有治疗将在工作日每天提供，周末间隔两天，总疗程为4周。将在基线和终点（第4周）评估吞咽纤维内镜检查的穿透-抽吸量表，作为主要结局。将在基线和终点评价Saitoh分类评分、吞咽相关生活质量评分、改良Mann吞咽能力评估评分和表面肌电图，作为次要结局。 本试验方案已于2017年5月9日获得首都医科大学附属北京中医医院研究伦理委员会批准（伦理批号：2017 BL-013-02）。将通知每名受试者研究方案。将获得每名受试者的书面知情同意书。 ISRCTN登记：ISRCTN 68981054;于2017年9月25日注册。
Dysphagia is a common complication of stroke, affecting up to 78% of stroke patients. The existence of dysphagia after stroke has been associated with an increased risk for pulmonary complications and even mortality. Previous studies have shown that acupuncture could be potential therapeutic method for treatment of dysphagia after stroke. A prospective randomized controlled pilot trial is designed to evaluate the effect of He's Santong needling method on dysphagia after stroke. Sixty eligible participants will be recruited and randomly assigned into treatment group (He's Santong needling method and swallowing rehabilitation training) and control group (swallowing rehabilitation training) in a 1:1 ratio. All treatments will be provided everyday on weekdays with a two-day interval at the weekend, during a total treatment course of four weeks. The Penetration-Aspiration Scale with Fiberoptic Endoscopic Examination of Swallowing will be assessed at baseline and endpoint (Week 4) as primary outcomes. The Saitoh's classification score, Swallowing-Related Quality of Life score, the Modified Mann Assessment of Swallowing Ability score, and Surface Electromyography will be evaluated at baseline and endpoint as secondary outcomes. The trial protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University on 9 May 2017 (ethical batch number: 2017BL-013-02). Each participant will be notified regarding the study protocol. Written informed consent will be obtained from each participant. ISRCTN registry: ISRCTN68981054; Registered on 25 September 2017.
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影响因子：
1
作者：
Nacci, Andrea;Matteucci, Jacopo;Fattori, Bruno
通讯作者：
Fattori, Bruno
影响因子：
2.6
作者：
Colodny, N
通讯作者：
Colodny, N
影响因子：
6.7
作者：
Smithard, D. G.;Smeeton, N. C.;Wolfe, C. D. A.
通讯作者：
Wolfe, C. D. A.
DOI：
10.1155/2017/2349794
发表时间：
2017
期刊：
Evidence-based complementary and alternative medicine : eCAM
影响因子：
--
作者：
Chan YT;Zhang HW;Guo YQ;Lin ZX
通讯作者：
Lin ZX
影响因子：
5.7
作者：
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通讯作者：
Liu, HW