Efficacy of Tuina for Myopia in Children: Protocol for a Randomized Controlled Trial

BACKGROUND: Myopia has emerged as a major threat to the visual health of adolescents worldwide. Early intervention can effectively slow down the progression of myopia in adolescents. Tuina, a significant therapeutic method in traditional Chinese medicine, has shown promising clinical efficacy in delaying the progression of myopia; however, it lacks robust, large-scale, and standardized randomized controlled trials. OBJECTIVE: This study aims to explore the efficacy and safety of Tuina therapy in managing myopia in adolescents, thereby providing solid evidence for the application of Tuina in the clinical treatment of myopia. METHODS: The design of this study is a multicenter, randomized controlled clinical trial. We will include 62 myopic children from four hospitals, who will be randomly assigned in a 1:1 ratio to a Tuina experimental group and a drug-positive control group (tropicamide eye drops). Treatments in each group will be three times a week, for a total of 8 weeks. The Tuina therapy experimental group will receive 20 minutes of Tuina therapy per session, while the drug-positive control group will use tropicamide eye drops, administered every other day, with two drops per session. The primary outcome measures include uncorrected visual acuity and axial length, with secondary measures including refractive power and accommodative amplitude. Data will be collected on the day of enrollment and treatment (week 0), on the day of completion of the 4th and 8th weeks of treatment, and at the end of the 10-week follow-up. Adverse events will be monitored and recorded throughout the study, and statisticians will be blinded. Data will be analyzed using SPSS 28.0. RESULTS: This study has been funded, and recruitment began in June 2025; so far, there have been 29 participants, divided into the Tuina group of 16, and the drug-positive control group group of 13. The recruitment process will last until October 2026. Final manuscript submission should happen by December 2026. CONCLUSIONS: This study aims to evaluate the efficacy and safety of Tuina therapy in the treatment of myopic adolescents. We hypothesize that the therapeutic effect of Tuina therapy is non-inferior to that of tropicamide eye drops, with the added advantages of fewer side effects and stable long-term efficacy, thereby providing reliable evidence and support for the application of Tuina therapy in the management of myopia in adolescents. CLINICALTRIAL: Chinese Clinical Trial Registry: ChiCTR2600116606.