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

Aims: 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).
Methods: 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° to 40° 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° 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° at skeletal maturity). The comparison is on a non-inferiority 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.
Competing Interests: A. A. Cole, D. C. Perry, D. Hind, N. Totton, B. Young, N. Latimer, L. Kenison, S. Walters, A. Gardner, S. Ahuja, F. Sherratt, L. Campbell, R. Jayasuriya, A. J. Mills, S. Greenwood, and R. Chatters obtained grant funding for this project. This project was funded by the UK NIHR HTA Programme (project number NIHR131081). S. Walters reports book royalties from Wiley and Blackwell, unrelated to this study. A. Gardner also reports grants from Innovate UK, ORUK, and the Freda Ashmore Memorial Fund, payment for medicolegal services from A C Gardner Ltd, and support to attend the British Scoliosis Society meeting 2022 and BritSpine 2023, all of which are unrelated to this study. A. Gardner is also an unpaid research lead for the British Scoliosis Society. L. Campbell reports payment for online meetings, unrelated to this study. D. C. Perry is funded by a National Institute for Health Research Professorship Award, was a committee member on the NIHR Commissioning Board (2016-2021), and is a member of the editorial board of The Bone & Joint Journal. A. J. Mills is shareholder and director of the SpineCorporation Limited, which designs and supplies braces to a number of BASIS sites. A. J. Mills also holds a patent for TechnoSpine, and is an unpaid SOSORT Bracing Expert Advisor. The funder has not been involved in the design of the study. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. L. Swaby reports grants from the National Institute for Health and Care Research, unrelated to this study. D. Hind's salary was partly funded by a research grant from the NIHR HTA.
(© 2023 Swaby et al.)