DITTO框架在膝骨关节炎临床试验模拟假推拿方案设置中的应用  

Application of the DITTO framework in designing simulated sham Tuina protocols for clinical trials of knee osteoarthritis

作　　者：刘春雪 王锡友[1] 孙亚男[2] 于长禾[1] LIU Chunxue;WANG Xiyou;SUN Yanan;YU Changhe(Tuina and Pain Management Department,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Department of Traditional Chinese Medicine,Xuanwu Hospital,Capital Medical University,Beijing 100053)

机构地区：[1]北京中医药大学东直门医院推拿疼痛科,北京100700 [2]首都医科大学宣武医院中医科,北京100053

出　　处：《北京中医药》2025年第3期269-274,共6页Beijing Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金面上项目(82374617);国家自然科学基金青年科学基金项目(81803956);北京市卫健委首都卫生发展科研专项青年优才项目(首发2020-4-4195);2024年北京中医药大学双一流学科建设项目。

摘　　要：推拿作为一种重要的中医非药物干预手段,被广泛应用于治疗肌肉骨骼疼痛,临床疗效显著。但因缺乏有效的推拿安慰剂设计,临床试验研究发展较为缓慢。DITTO框架是英国国家卫生研究所和医学研究所共同开发的,旨在规范侵入性安慰干预设置的标准化框架,由5五个核心步骤(解构、识别、移除、考量和优化)组成。参考DITTO框架,在推拿临床试验中,为保证患者维持盲态,将推拿组和假推拿组的患者分开进行操作;假推拿组的操作部位距离治疗穴位1 cm左右;操作手法为弱刺激或无刺激、低频率、稍施加力,将按揉手法替换为轻度的摩法,使患者不产生酸、麻、胀、痛等感觉,确保无得气感;在进行运动类手法操作时,不主动拉伸膝关节;其余操作条件应保持一致。虽然DITTO框架并非专为推拿设计,但其为推拿临床研究提供了重要指导,推动了推拿研究的国际化发展。As an important non-drug intervention method in traditional Chinese medicine(TCM),Tuina is widely used in the treatment of musculoskeletal pain,with remarkable clinical efficacy.However,due to the lack of effective Tuina placebo design,clinical trial research has developed relatively slowly.The DITTO framework,developed jointly by the UK's National Institutes of Health and the Institute of Medicine,is a standardized framework aimed at regulating the setting of invasive comfort interventions.It consists of five core steps,i.e.,deconstruction,identification,removal,thinking,and optimization.Referring to the DITTO framework,in clinical trials of Tuina,to ensure that patients maintain blinding,the patients in the Tuina group and the sham Tuina group were operated separately.The operation site for the sham Tuina group was approximately 1 cm away from the treatment point.The manipulation technique involved weak stimulation or no stimulation,low frequency,and slight applied force,replacing the kneading technique with mild rubbing manipulation,ensuring that the patient did not experience sensations of soreness,numbness,distension,pain,or other discomforts,thereby ensuring no therapeutic sensation.When performing physical manipulation,the operator did not actively stretch the knee joint.The remaining operating conditions were consistent.Although the DITTO framework was not specifically designed for Tuina,it provides important guidance for clinical Tuina research and promotes the international development of Tuina studies.

关 键 词：DITTO框架 膝骨关节炎 推拿 安慰剂 模拟推拿方案 

分 类 号：R244.1[医药卫生—针灸推拿学]