Pediatric Tuina in children with autism spectrum disorder: A study protocol for a randomized controlled trial

Abstract Background Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterised by repetitive stereotypical behaviour and communication disorders. Currently, it lacks a specific clinical treatment method. Pediatric Tuina is a recent therapy in traditional Chinese medicine; however, there have been studies on the treatment of children with ASD by Tuina. Nonetheless, it remains uncommon given the lack of large-scale evidence-based medical studies. This study aims to compare the efficacy of Tuina and conventional treatment in children with ASD. Methods Eligible children will be randomly divided into the pediatric Tuina plus conventional treatment group or conventional treatment group based on a random table at a ratio of 1:1. Effectiveness will be evaluated using a scale; moreover, the primary outcome will be the Childhood Autism Rating Scale. The secondary outcome will be the Autism Treatment Evaluation Checklist. All participants will be assessed on the scale by a third party not involved in the study. Baseline values of the participants will be determined at the registration time. Outcomes will be evaluated after the 30th treatment session. The follow-up period will last for 6 post-treatment months. Discussion This study will evaluate the effectiveness and safety of Tuina in ASD treatment, which could provide reliable evidence-based findings to improve clinical treatment. Trial registration: Chinese Clinical Trial Registry (CHICTR), ChiCTR2000040452. Registered on 28 November 2020