Biomechanical characteristics and therapeutic effects of Traditional Chinese Medicine manual therapy in adolescent idiopathic scoliosis: study protocol for a randomized controlled trial

BACKGROUND: Adolescent idiopathic scoliosis (AIS) is a three‐dimensional spinal deformity that progresses with age, making effective early intervention crucial to avoid surgical treatment. Traditional Chinese Medicine (TCM) Manual therapy (MT) offers the advantage of relaxing muscles and correcting biomechanical imbalances, thereby assisting patients in performing postural correction exercises under proper biomechanical alignment. However, evidence supporting the use of TCMMT for AIS remains limited. OBJECTIVE: This study aims to elucidate the biomechanical changes in AIS patients by comparing with healthy individuals, and investigate the clinical efficacy and biomechanical mechanisms of combining TCMMT with Schroth method in the treatment of AIS. METHODS: This study is a randomized controlled trial. Sixty eligible AIS patients will be randomly allocated in a 1:1 ratio to either the experimental group (EG) or the control group. All patients will undergo Schroth method for 60 min, five times per week. The EG will additionally receive TCMMT for 20 min, three times per week. The treatment course will be 8 weeks. Furthermore, fifteen age‐matched healthy volunteers will be included. The primary outcome measure is the Cobb angle assessed before and after treatment. Secondary outcome measures include plantar pressure and 3D gait parameters, surface electromyography and muscular temperature. Adverse events will be recorded throughout the trial. All patients randomly allocated in this study will be included in the intention‐to‐treat analysis. CONCLUSION: This study will provide multi‐dimensional evidence for the efficacy of TCMMT as an adjunctive treatment for AIS, advance the development of manual therapy within the field of rehabilitation, and facilitate its application in clinical decision which making by both physicians and patients. STUDY PROTOCOL REGISTRATION: http://itmctr.ccebtcm.org.cn, identifier ITMCTR2025002392.