Journal
BONE & JOINT OPEN
Volume 4, Issue 11, Pages 873-880Publisher
BRITISH EDITORIAL SOC BONE & JOINT SURGERY
DOI: 10.1302/2633-1462.411.BJO
Keywords
Randomised controlled trial; Adolescent idiopathic scoliosis; Bracing
Categories
Ask authors/readers for more resources
Scoliosis is a lateral curvature of the spine that can cause distress due to appearance. A randomized controlled trial is being conducted to compare the effectiveness of full-time bracing and night-time bracing in adolescent idiopathic scoliosis patients. The study aims to assess treatment outcomes and quality of life measures.
Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night- time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of 'full- time bracing' versus 'night- time bracing' in adolescent idiopathic scoliosis (AIS). UK paediatric spine clinics will recruit 780 participants aged ten to 15 years- old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20 degrees to 40 degrees with apex at or below T7. Patients are randomly allocated 1:1, to either full- time or night- time bracing. A qualitative sub- study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination. Discussion The primary outcome is 'treatment failure' (Cobb angle progression to 50 degrees or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or 'treatment success' (Cobb angle less than 50 degrees at skeletal maturity). The comparison is on a noninferiority basis (non- inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available