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

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.