The effects of lever positioning manipulation versus schorth exercise in idiopathic scoliosis: a protocol for a randomized clinical trial (RCT)

Abstract

Abstract Background: Idiopathic scoliosis is a prevalent clinical condition within the bone and joint system, commonly manifested in adolescents, significantly impacting their physical and mental well-being. Presently, conservative interventions constitute the primary therapeutic approach, encompassing modalities such as brace therapy, manipulation therapy, and exercise therapy. Nonetheless, challenges persist in the realm of conservative treatment, marked by issues of inconvenience and suboptimal adherence. This study endeavors to identify a manipulation technique that can potentially substitute or augment the efficacy of brace therapy or exercise therapy. The primary objective of this protocol is to delineate a randomized controlled trial aimed at scrutinizing and contrasting the outcomes resulting from a specific manipulation method (lever positioning manipulation) and a widely employed exercise therapy (Schroth exercise) in the management of idiopathic scoliosis. Methods：This is a randomized clinical trial, employing both assessor-blinding and analyst-blinding methodologies. This study is proposed to include 102 patients with idiopathic scoliosis. The 102 patients were divided into 2 groups of 51 cases each by randomized number table method. The groups consist of a traditional massage combined with lever positioning manipulation group and a traditional massage combined with Schroth exercise group. Each exercise regimen is administered thrice weekly over an 8-week duration. Outcome measures encompass the assessment of Cobb angle, apical vertebral translation (AVT), muscle tone, pressure pain threshold (PPT), quality of life (SF-36), Oswestry disability index (ODI) and clinical efficiency. Evaluations are conducted at baseline, the conclusion of the treatment program, and during follow-up sessions. It will be observed whether the manipulation is superior compared to the schorth exercise and whether it can be used as an alternative treatment for scoliosis. Discussion: The results of this study will tell clinicians what conservative therapy regimen will produce better clinical outcomes for patients with AIS. Trial registration: This project is registered with the Chinese Clinical Trial Registry，Registration number: ChiCTR2300077604.