Zhao Luopeng, Liu Lu, Zhang Claire Shuiqing, Zeng Lin, Zhao Jingxia, Wang Linpeng, Jing Xianghong, Wang Kelun, Li Bin
Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.
Beijing Key Laboratory of Clinic and Basic Research with Traditional Chinese Medicine on Psoriasis, Beijing Institute of Traditional Chinese Medicine, Beijing, China.
Evid Based Complement Alternat Med. 2018 Aug 14;2018:6126410. doi: 10.1155/2018/6126410. eCollection 2018.
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 needling method on dysphagia after stroke.
Sixty eligible participants will be recruited and randomly assigned into treatment group (He's 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.
吞咽困难是中风的常见并发症，影响多达78%的中风患者。中风后吞咽困难的存在与肺部并发症甚至死亡率的增加有关。先前的研究表明，针灸可能是治疗中风后吞咽困难的潜在治疗方法。一项前瞻性随机对照试验旨在评估贺氏针法对中风后吞咽困难的疗效。
将招募60名符合条件的参与者，并按1:1的比例随机分为治疗组（贺氏针法和吞咽康复训练）和对照组（吞咽康复训练）。所有治疗将在工作日每天进行，周末间隔两天，总疗程为四周。在基线和终点（第4周）使用带有吞咽功能纤维内镜检查的渗透-误吸量表进行评估作为主要结局。在基线和终点评估Saitoh分类评分、吞咽相关生活质量评分、改良曼恩吞咽能力评估评分和表面肌电图作为次要结局。
该试验方案已于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：2017BL-013-02）。将向每位参与者告知研究方案。将从每位参与者处获得书面知情同意书。
国际标准随机对照试验编号：ISRCTN68981054；于2017年9月25日注册。
