Efficacy and Safety of Massage Therapy for Cognitive Impairment in Patients With Autism Spectrum Disorder: Protocol...

Autism spectrum disorder (ASD) is a neurodevelopmental condition marked by social communication deficits and cognitive impairment. As pharmacological and behavioral treatments often show inconsistent efficacy, massage therapy-a low-risk complementary approach including tuina and acupressure-is used to improve cognitive symptoms, yet its systematic efficacy and safety remain unevaluated.

This systematic review and meta-analysis aims to evaluate the efficacy and safety of massage therapy (categorized into traditional Chinese medicine-based and Western-based approaches) for improving specific cognitive domains (eg, executive function, attention, and memory) in individuals with ASD.

Randomized controlled trials (RCTs) and cluster RCTs will be identified across 9 English and Chinese databases (including PubMed, Cochrane Library, and China National Knowledge Infrastructure) through September 2025. Two reviewers will independently perform study selection, data extraction, and risk-of-bias assessment using version 2 of the Cochrane risk-of-bias tool. A random-effects model will be primarily applied due to anticipated clinical diversity, with fixed-effects models reserved for sensitivity analyses of homogeneous data (I2=0%). Subgroup analyses will explore age, intervention context, and massage type. Evidence for primary outcomes-including checklist scores and specialized cognitive scales-will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Selection results will be summarized in a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram. This review will synthesize evidence on massage therapy's effects on cognitive outcomes measured using scales such as the Autism Behavior Checklist, Childhood Autism Rating Scale, and Autism Treatment Evaluation Checklist, as well as safety profiles. This study was funded in 2024. Following the September 2025 search, analysis will be completed by June 2026, with final results expected for submission in December 2026.

This study will evaluate massage therapy's role in managing cognitive impairment in ASD. By synthesizing available evidence from RCTs, the findings will provide an evidence-based foundation for clinical decision-making and clarify whether manual therapies serve as safe, effective nonpharmacological adjuncts to existing ASD interventions.