Bracing Adolescent Idiopathic Scoliosis (BASIS) study – night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial

Swaby, Lizzie; Perry, Daniel C.; Walker, Kerry; Hind, Daniel; Mills, Andrew; Jayasuriya, Raveen; Totton, Nikki; Desoysa, Lauren; Chatters, Robin; Young, Bridget; Sherratt, Frances; Latimer, Nick; Keetharuth, Anju; Kenison, Laura; Walters, Stephen; Gardner, Adrian; Ahuja, Sashin; Campbell, Laura; Greenwood, Sarah; Cole, Ashley; Turtle, Chris; Waterhouse, Simon; Davidson, Neil; Shafafy, Masood; Marjoram, Tom; Oxborrow, Neil; Sedra, Fady; Harris, Mark; Leong, Julian; Lucas, Jonathan; Lui, Darren; Isaacson, Antonia; Bowey, Andy; Harding, Ian; Davies, Evan; Jasani, Vinay; Khan, Almas; Thorpe, Paul; Tsirikos, Thanos; Sloan, Sam; Walker, Kerry; Kenison, Laura; Greenwood, Sarah

Abstract

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.

Citation

Swaby, L., Perry, D. C., Walker, K., Hind, D., Mills, A., Jayasuriya, R., Totton, N., Desoysa, L., Chatters, R., Young, B., Sherratt, F., Latimer, N., Keetharuth, A., Kenison, L., Walters, S., Gardner, A., Ahuja, S., Campbell, L., Greenwood, S., Cole, A., …Greenwood, S. (2023). Bracing Adolescent Idiopathic Scoliosis (BASIS) study – night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial. Bone & Joint Open, 4(11), 873-880. https://doi.org/10.1302/2633-1462.411.bjo-2023-0128

• Journal Article Type: Article
• Acceptance Date: Nov 1, 2023
• Online Publication Date: Nov 17, 2023
• Publication Date: Nov 1, 2023
• Deposit Date: Dec 4, 2023
• Publicly Available Date: Dec 4, 2023
• Journal: Bone & Joint Open
• Print ISSN: 2633-1462
• Electronic ISSN: 2633-1462
• Publisher: British Editorial Society of Bone and Joint Surgery
• Peer Reviewed: Peer Reviewed
• Volume: 4
• Issue: 11
• Pages: 873-880
• DOI: https://doi.org/10.1302/2633-1462.411.bjo-2023-0128
• Keywords: Surgery, Orthopedics and Sports Medicine
• Public URL: https://keele-repository.worktribe.com/output/654924