Neuropsychiatric disease and treatment · 2026
Acupuncture and Tuina Combined with Educational Rehabilitation for Children with Autism Spectrum Disorder: Study Protocol for a Single-Center, Three-Arm, Pragmatic Randomized Controlled Trial.
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Wang Xing, Dong Xiao-Qing, Tao Ya-Wen, Du Xiao-Gang, Zhao Ning-Xia, Song Hu-Jie
Аннотация
BACKGROUND: The prevalence of autism spectrum disorder (ASD) is increasing globally. While educational rehabilitation is the standard of care, Traditional Chinese Medicine (TCM) techniques like acupuncture and tuina are widely used in China as adjunctive therapies, but high-quality evidence from rigorous clinical trials remains limited. The objective of this study is to evaluate the efficacy of acupuncture and tuina, combined with educational rehabilitation, for ASD, and to compare the effects of different TCM intervention methods.
METHODS: A single-center, three-arm, pragmatic randomized controlled trial. A total of 120 children aged 2-12 with ASD will be randomized (1:1:1) to: (A) acupuncture + tuina + rehabilitation; (B) acupuncture + rehabilitation; or (C) rehabilitation alone. The intervention duration is 12 weeks with a 4-week follow-up. The primary outcome is the change in the Autism Treatment Evaluation Checklist (ATEC) total score from baseline to week 12. Secondary outcomes include core symptoms (CARS-2, ABC), comorbidities (sleep via CSHQ; constipation via BSFS/SBMs), and neurophysiological measures (EEG). The primary analysis will test the superiority of Groups A and B over Group C, and the non-inferiority of Group B to Group A using a repeated-measures mixed model.
CONCLUSION: This trial is designed to generate high-quality evidence regarding the efficacy of TCM techniques as adjunctive therapy for ASD. The findings will inform clinical practice and guide the formulation of integrative intervention strategies for ASD.
TRIAL REGISTRATION: This study was registered in the International Traditional Medicine Clinical Trial Registry (ITMCTR) with registration number ITMCTR2025002393.
METHODS: A single-center, three-arm, pragmatic randomized controlled trial. A total of 120 children aged 2-12 with ASD will be randomized (1:1:1) to: (A) acupuncture + tuina + rehabilitation; (B) acupuncture + rehabilitation; or (C) rehabilitation alone. The intervention duration is 12 weeks with a 4-week follow-up. The primary outcome is the change in the Autism Treatment Evaluation Checklist (ATEC) total score from baseline to week 12. Secondary outcomes include core symptoms (CARS-2, ABC), comorbidities (sleep via CSHQ; constipation via BSFS/SBMs), and neurophysiological measures (EEG). The primary analysis will test the superiority of Groups A and B over Group C, and the non-inferiority of Group B to Group A using a repeated-measures mixed model.
CONCLUSION: This trial is designed to generate high-quality evidence regarding the efficacy of TCM techniques as adjunctive therapy for ASD. The findings will inform clinical practice and guide the formulation of integrative intervention strategies for ASD.
TRIAL REGISTRATION: This study was registered in the International Traditional Medicine Clinical Trial Registry (ITMCTR) with registration number ITMCTR2025002393.