Bracing in Adolescent Idiopathic Scoliosis (BrAIST)

University Of Iowa, Iowa City IA

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): Several studies have examined the effect of thoracolumbosacral orthoses on adolescent idiopathic scoliosis (AIS), however, neither the positive nor the negative studies meet current standards for scientific evidence. This lack of evidence was highlighted by the United States Preventive Services Task Force, when they concluded there is not sufficient evidence for bracing to endorse mandatory screening for AIS. A randomized, prospective, controlled study is proposed to quantify the risk associated with TLSO use relative to observation alone. If results of this study show that bracing has no benefit over watchful waiting, the public health impact will be enormous. States will need to re-evaluate the usefulness of screening for AIS and physicians will need to re-evaluate their treatment practices. The resources spent on AIS could be used for other evidence-based initiatives. If the results of this study show an improvement of outcome with bracing in AIS, it will provide additional impetus to endorse screening programs across the nation. The results of this study will also provide physicians and patients with definitive information about the improvement that can be expected with bracing, and for whom bracing will provide the most benefit. Despite the growing realization within the healthcare community that we do our patients and our profession a disservice by continuing to practice based on tradition, personal experience and anecdotal accounts, many barriers still exist to the critical review of current practice. This grant will serve to address several of these barriers, including the extensive planning, review and organizational logistics of a multicenter trial. This proposal seeks resources to plan and initiate the first prospective, randomized controlled trial of bracing in adolescent idiopathic scoliosis. To this end, the aims of our proposed planning grant are to further refine and operationalize aspects of the trial. Major areas of activity include: developing the organizational structure of the trial, establishing major work centers, estimating sample sizes through simulated patient recruitment, mapping the model of psychosocial reaction to the condition and its treatment, modeling psychological models of treatment adherence and the development of objective measures of adherence, validating radiographic measurement software, establishing quality control standards and reporting mechanisms, and completing the Manual of Operations and Procedures.