Application of the DITTO framework in designing simulated sham <italic style="font-style: italic">Tuina</italic> protocols for clinical trials of knee osteoarthritis

LIU Chunxue; WANG Xiyou; SUN Yanan; YU Changhe

doi:10.16025/j.1674-1307.2025.03.002

您当前的位置：

首页 >

文章列表页 >

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

更新时间：2025-04-29

- Application of the DITTO framework in designing simulated sham Tuina protocols for clinical trials of knee osteoarthritis
- Beijing Journal of Traditional Chinese Medicine Vol. 44, Issue 3, Pages: 269-274(2025)
- 作者机构：
  
  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
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2025.03.002
  CLC：
- Received：20 December 2024，
  
  Published：25 March 2025
- 稿件说明：
移动端阅览
刘春雪，王锡友，孙亚男，等.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［J］.北京中医药，2025，44（3）：269-274.

LIU Chunxue,WANG Xiyou,SUN Yanan,et al.Application of the DITTO framework in designing simulated sham Tuina protocols for clinical trials of knee osteoarthritis[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(03):269-274.
刘春雪，王锡友，孙亚男，等.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［J］.北京中医药，2025，44（3）：269-274. DOI： 10.16025/j.1674-1307.2025.03.002.

LIU Chunxue,WANG Xiyou,SUN Yanan,et al.Application of the DITTO framework in designing simulated sham Tuina protocols for clinical trials of knee osteoarthritis[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(03):269-274. DOI： 10.16025/j.1674-1307.2025.03.002.

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。

Abstract

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

Keywords

references

王毓婷 , 张培铭 , 董昱 , 等 . 针刺安慰剂效应剖析 [J ] . 针刺研究， 2024 , 49 （ 8 ）: 875 - 879 .

王晓涛 , 崔学军 , 王拥军 , 等 . 安慰剂效应与安慰剂组学的研究与思考 [J ] . 世界科学技术-中医药现代化 , 2016 , 18 ( 12 ): 2043 - 2048 .

曾莹 , 施慧 , 彭剑飞 , 等 . 临床研究中中医护理适宜技术安慰剂效应控制的范围综述 [J ] . 军事护理 , 2023 , 40 ( 11 ): 79 - 82,108 .

LIU Z , YAN S , WU J , et al . Acupuncture for chronic severe functional constipation: a randomized trial [J ] . Ann Intern Med , 2016 , 165 ( 11 ): 761 - 769 .

ZHAO L , CHEN J , LI Y , et al . The long-term effect of acupuncture for migraine prophylaxis: a randomized clinical trial [J ] . JAMA Intern Med , 2017 , 177 ( 4 ): 508 - 515 .

商强强 , 姚俊杰 , 王宇峰 , 等 . 基于核心期刊传统中医推拿研究热点趋势及展望的CiteSpace可视化分析 [J ] . 实用临床医药杂志 , 2023 , 27 ( 1 ): 9 - 15 .

COUSINS S , BLENCOWE NS , TSANG C , et al . Optimizing the design of invasive placebo interventions in randomized controlled trials [J ] . Br J Surg , 2020 , 107 ( 9 ): 1114 - 1122 .

付阳阳 , 梁红广 , 朱清广 , 等 . “以痛为腧”推拿对膝骨关节炎患者步态及足底压力的影响研究 [J ] . 北京中医药 , 2025 , 44 ( 1 ): 36 - 40 .

范希然 , 李多多 , 王双双 , 等 . 推拿手法治疗骨骼肌肉疼痛影响因素的质性研究 [J ] . 中国全科医学 , 2023 , 26 ( 2 ): 219 - 224 .

ZHANG X , LIANG F , LAU CT , et al . Standards for reporting interventions in clinical trials of tuina/massage (STRICTOTM): Extending the CONSORT statement [J ] . J Evid Based Med , 2023 , 16 ( 1 ): 68 - 81 .

李思娜 , 王锡友 , 唐镜全 , 等 . 推拿治疗膝骨关节炎临床试验中不同手法干预方案的标准化研究 [J ] . 中华中医药杂志 , 2020 , 35 ( 3 ): 1422 - 1427 .

付春雨 , 叶佳锋 , 姚斌彬 . 手法节奏变化在推拿治疗腰肌劳损中的临床价值分析 [J ] . 北京中医药 , 2023 , 42 ( 12 ): 1379 - 1381 .

MUKOKA G , OLIVIER B , RAVAT S . Level of knowledge, attitudes and beliefs towards patients with chronic low back pain among final year School of Therapeutic Sciences students at the University of the Witwatersrand ——A cross-sectional study [J ] . S Afr J Physiother , 2019 , 75 ( 1 ): 683 .

BASTEMEIJER CM , VAN EWIJK JP , HAZELZET JA , VOOGT LP . Patient values in physiotherapy practice, a qualitative study [J ] . Physiother Res Int , 2021 , 26 ( 1 ): e1877 .

CARLINO E , BENEDETTI F . Different contexts, different pains, different experiences [J ] . Neuroscience , 2016 （ 338 ）: 19 - 26 .

TESTA M , ROSSETTINI G . Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes [J ] . Man Ther , 2016 （ 24 ）: 65 - 74 .

GROENEWEG R , HAANSTRA T , BOLMAN CAW , et al . Treatment success in neck pain: The added predictive value of psychosocial variables in addition to clinical variables [J ] . Scand J Pain , 2017 （ 14 ）: 44 - 52 .

MOLINA-ÁLVAREZ M , ARRIBAS-ROMANO A , RODRÍGUEZ-RIVERA C , et al . Manual therapy effect in placebo-controlled trials: a systematic review and meta-analysis [J ] . Int J Environ Res Public Health , 2022 , 19 ( 21 ): 14021 .

CHAIBI A , ŠALTYTĖ BENTH J , BJØRN RUSSELL M . Validation of placebo in a manual therapy randomized controlled trial [J ] . Sci Rep , 2015 （ 5 ）: 11774 .

WALKER BF , HEBERT JJ , STOMSKI NJ , LOSCO B , FRENCH SD . Short-term usual chiropractic care for spinal pain: a randomized controlled trial [J ] . Spine (Phila Pa 1976) , 2013 , 38 ( 24 ): 2071 - 2078 .

HAWK C , LONG CR , ROWELL RM , et al . A randomized trial investigating a chiropractic manual placebo: a novel design using standardized forces in the delivery of active and control treatments [J ] . J Altern Complement Med , 2005 , 11 ( 1 ): 109 - 117 .

TORO-VELASCO C , ARROYO-MORALES M , FERNÁNDEZ-DE-LAS-PEÑAS C , et al . Short-term effects of manual therapy on heart rate variability, mood state, and pressure pain sensitivity in patients with chronic tension-type headache: a pilot study [J ] . J Manipulative Physiol Ther , 2009 , 32 ( 7 ): 527 - 535 .

HOWICK J , WEBSTER RK , REES JL , et al . TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls [J ] . PLoS Med , 2020 , 17 ( 9 ): e1003294 .

GÖDDE D , NÖHL S , WOLF C , et al . A SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis of ChatGPT in the medical literature: concise review [J ] . J Med Internet Res , 2023 （ 25 ）: e49368 .

孙承颐 , 刘晓玉 , 孙重阳 , 等 . DITTO框架及其对针刺临床研究中模拟针刺设置的启示 [J ] . 针刺研究 , 2022 , 47 ( 12 ): 1118 - 1122 .

冯硕 , 李博 , 张会娜 , 等 . 针刺临床试验的安慰剂对照及其方法学问题 [J ] . 中国针灸 , 2022 , 42 ( 4 ): 437 - 441 .

GOOBERMAN-HILL R , JINKS C , BOUÇAS SB , et al . Designing a placebo device: involving service users in clinical trial design [J ] . Health Expect , 2013 , 16 ( 4 ): e100 - e110 .

MUÑOZ LAGUNA J , KURMANN A , HOFSTETTER L , et al . Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial [J ] . Pilot Feasibility Stud , 2024 , 10 ( 1 ): 70 .

王锡友 . 推拿治疗疼痛研究的机遇与挑战 [J ] . 北京中医药 , 2024 , 43 ( 7 ): 714 - 718 .

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Current status and challenges of clinical and mechanistic research on Tuina for knee osteoarthritis

Therapeutic effects and mechanisms of “tendons instead of bone” acupoint-pressing manipulation on knee osteoarthritis rats with chronic pain and depression

Epigenetic regulatory mechanism of Tuina in treatment of osteoarthritis

A clinical study of massage intervention in knee osteoarthritis gait and plantar pressure with "painful locality taken as acupoint"

Effect of acupuncture combined with orthopedics formentation on gait characteristics in knee osteoarthritis of cold-dampness obstruction syndrome

Related Author

WANG Xiyou

SUN Boao

ZHANG Mingyang

WANG Yanhua

LI Fenglin

ZHANG Yang

WANG Xiyou

YU Changhe

Related Institution

Tuina Department， China-Japan Friendship Hospital

Department of Massage， Yueyang Hospital of Integrated Traditional Chinese and Western Medicine， Shanghai University of Traditional Chinese Medicine

Department of Massage， Shanghai General Hospital

Institute of Traditional Chinese Massage， Shanghai Academy of Traditional Chinese Medicine

Department of Acupuncture and Moxibustion， Huguosi Hospital of Traditional Chinese Medicine Affiliated to the Beijing University of Chinese Medicine

⁰

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

DOI：10.16025/j.1674-1307.2025.03.002

摘要

Abstract

关键词

Keywords

references