针灸治疗粘连性肩关节囊炎临床研究核心结局指标集的构建方法  

Construction of a core outcome set in clinical research of acupuncture and moxibustion for treatment of adhesive capsulitis

作　　者：白杨 宏亚丽 陈波 秦懿囡 杜元灏[5] BAI Yang;HONG Ya-li;CHEN Bo;QIN Yi-nan;DU Yuan-hao(Qibo Medical School,Longdong College,Qingyang 745000,Gansu Province,China;Department of Acupuncture-Moxibustion and Tuina,Qingyang Hospital of TCM,Qingyang 745000,Gansu Province;College of Acupuncture-Moxibusiton and Tuina,Tianjin University of TCM;College of Acupuncture-Moxibustion and Tuina,Shaanxi University of CM;Second Ward of Acupuncture and Moxibustion,First Teaching Hospital of Tianjin University of TCM,Tianjin 300073)

机构地区：[1]陇东学院岐伯医学院,甘肃庆阳745000 [2]庆阳市中医医院针灸推拿科,甘肃庆阳745000 [3]天津中医药大学针灸推拿学院 [4]陕西中医药大学针灸推拿学院 [5]天津中医药大学第一附属医院针灸二病区,天津300073

出　　处：《中国针灸》2023年第6期701-705,共5页Chinese Acupuncture & Moxibustion

基　　金：甘肃省青年科技基金项目:20JR10QA808。

摘　　要：构建针灸治疗粘连性肩关节囊炎(AC)临床研究的核心结局指标集。采用系统评价、半结构化访谈、德尔菲问卷调查、层次分析法、专家共识会议的研究方法,得到的主要结局指标为肩关节局部压痛、肩关节活动时疼痛程度、肩关节活动度、肩关节活动度的变化程度、肩关节功能评分、肩关节局部症状评分,次要结局指标为肌筋膜厚度、关节囊下壁的厚度、健康情况、日常生活能力、不良事件发生率、实验室指标、生命体征、成本-效益、总有效率、患者满意度,以期为针灸治疗AC临床研究结局指标的选择和循证医学证据的产生提供参考。This study aims to construct the core outcome set for the clinical trials of adhesive capsulitis treated with acupuncture and moxibustion.Using systematic review,semi-structured interview,Delphi questionnaire survey,analytic hierarchy process and expert consensus meeting,the primary outcomes are obtained,i.e.local tenderness,pain degree during movement,range of motion,changes in range of motion,function score,and score of local symptoms of shoulder joint.The secondary outcomes are myofascial thickness,thickness of the inferior wall of the joint capsule,health status,activity of daily living,incidence of adverse events,laboratory indexes,vital signs,cost-effectiveness,total effective rate,and patient satisfaction.It is expected to provide a reference for the outcome selection in clinical trials and the generation of medical evidences in the treatment of adhesive capsulitis with acupuncture and moxibustion.

关 键 词：粘连性肩关节囊炎 针灸 临床研究 结局指标 核心结局指标集 

分 类 号：R246.2[医药卫生—针灸推拿学]