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| Methodological reflections on the implementation and evaluation of blinding in clinical trials of Tiuna manipulation |
| Hits 216 Download times 43 Received:January 30, 2026 |
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| DOI
10.11656/j.issn.1672-1519.2026.06.09 |
| Key Words
Tuina;clinical trials;blinding;methodology;DITTO framework;blinding quality assessment |
| Author Name | Affiliation | E-mail | | ZHANG Mengmeng | First Clinical Medical College, Beijing University of Chinese Medicine, Beijing 100700, China | | | WANG Xiyou | Department of Tuina and Pain Management, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China | | | WANG Yuhan | First Clinical Medical College, Beijing University of Chinese Medicine, Beijing 100700, China | | | YU Changhe | Department of Tuina and Pain Management, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China | yakno2@163.com |
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| Abstract
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| As a vital component of non-pharmacological therapies in traditional Chinese medicine，the high-quality clinical research on Tiuna manipulation is crucial for its modernization and international acceptance. However，the inherent characteristics of Tuina，such as its individualized application and reliance on somatic sensation，pose significant challenges to the successful implementation and assessment of blinding in clinical trials，directly compromising the reliability of findings and the hierarchy of evidence. This article aims to provide a systematic review of the status，core difficulties，and methodological advancements in blinding within Tuina clinical trials. It thoroughly analyzes the pivotal role of blinding in controlling measurement and performance biases，while highlighting the severe realities within the field，including low rates of blinding reporting，insufficient scientific design of sham interventions，and simplistic，non-standardized assessment methods. To address these challenges，the article introduces the DITTO framework，suitable for procedural interventions，offering a structured approach for the systematic design of sham Tuina protocols. Furthermore，it discusses the value and limitations of quantitative tools like the James Blinding Index（JBI）and Bang Blinding Index（BBI）for assessing blinding quality，advocating for the establishment of a multi-role，multi-dimensional evaluation system. Finally，the article foresees future directions，such as integrating modern technologies like Virtual Reality（VR）/Augmented Reality（AR）to optimize blinding design， conducting large-scale methodological studies to establish Tuina-specific standards，and strengthening academic transparency. This review concludes that only through methodological innovation and standardization can the scientific rigor of Tuina clinical research be fundamentally enhanced，thereby generating compelling high-level evidence for its efficacy. |
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