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,...
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| Format: | Article |
| Language: | English |
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The British Editorial Society of Bone & Joint Surgery
2023-11-01
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| Series: | Bone & Joint Open |
| Subjects: | |
| Online Access: | https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.411.BJO-2023-0128 |
| _version_ | 1797403182704361472 |
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| author | Lizzie Swaby Daniel C. Perry Kerry Walker Daniel Hind Andrew Mills Raveen Jayasuriya Nikki Totton Lauren Desoysa Robin Chatters Bridget Young Frances Sherratt Nick Latimer Anju Keetharuth Laura Kenison Stephen Walters Adrian Gardner Sashin Ahuja Laura Campbell Sarah Greenwood Ashley Cole on behalf of the BASIS study group |
| author_facet | Lizzie Swaby Daniel C. Perry Kerry Walker Daniel Hind Andrew Mills Raveen Jayasuriya Nikki Totton Lauren Desoysa Robin Chatters Bridget Young Frances Sherratt Nick Latimer Anju Keetharuth Laura Kenison Stephen Walters Adrian Gardner Sashin Ahuja Laura Campbell Sarah Greenwood Ashley Cole on behalf of the BASIS study group |
| author_sort | Lizzie Swaby |
| collection | DOAJ |
| description | 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. Cite this article: Bone Jt Open 2023;4(11):873–880. |
| first_indexed | 2024-03-09T02:35:47Z |
| format | Article |
| id | doaj.art-bc90f47c24394db589a8ef2f2780e6a3 |
| institution | Directory Open Access Journal |
| issn | 2633-1462 |
| language | English |
| last_indexed | 2024-03-09T02:35:47Z |
| publishDate | 2023-11-01 |
| publisher | The British Editorial Society of Bone & Joint Surgery |
| record_format | Article |
| series | Bone & Joint Open |
| spelling | doaj.art-bc90f47c24394db589a8ef2f2780e6a32023-12-06T10:42:31ZengThe British Editorial Society of Bone & Joint SurgeryBone & Joint Open2633-14622023-11-0141187388010.1302/2633-1462.411.BJO-2023-0128Bracing Adolescent Idiopathic Scoliosis (BASIS) study – night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trialLizzie Swaby0https://orcid.org/0000-0001-9443-7681Daniel C. Perry1https://orcid.org/0000-0001-8420-8252Kerry Walker2Daniel Hind3https://orcid.org/0000-0002-6409-4793Andrew Mills4https://orcid.org/0000-0002-6997-4327Raveen Jayasuriya5https://orcid.org/0000-0002-0798-9128Nikki Totton6https://orcid.org/0000-0002-1900-2773Lauren Desoysa7https://orcid.org/0000-0002-6151-836XRobin Chatters8https://orcid.org/0000-0002-1945-6011Bridget Young9https://orcid.org/0000-0001-6041-9901Frances Sherratt10https://orcid.org/0000-0003-4147-9305Nick Latimer11https://orcid.org/0000-0001-5304-5585Anju Keetharuth12https://orcid.org/0000-0001-8889-6806Laura Kenison13Stephen Walters14https://orcid.org/0000-0001-9000-8126Adrian Gardner15https://orcid.org/0000-0001-6532-7950Sashin Ahuja16https://orcid.org/0000-0001-8676-6100Laura Campbell17https://orcid.org/0009-0003-2002-590XSarah Greenwood18Ashley Cole19https://orcid.org/0000-0003-2504-2402on behalf of the BASIS study groupSCHARR, Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UKAlder Hey Children’s Hospital, Liverpool, UKSCHARR, Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UKSCHARR, Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UKSheffield Children’s Hospital, Sheffield, UKSheffield Children’s Hospital, Sheffield, UKSCHARR, Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UKSCHARR, Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UKSCHARR, Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UKDepartment of Public Health, Policy and Systems, University of Liverpool, Liverpool, UKDepartment of Public Health, Policy and Systems, University of Liverpool, Liverpool, UKSCHARR, Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UKSCHARR, Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UKEvelina London Children’s Hospital, London, UKSCHARR, Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UKRoyal Orthopaedic Hospital, Birmingham, UKNoah’s Ark Children’s Hospital for Wales, Cardiff, UKSchool of Medicine, Keele University, Keele, UKManchester University NHS Foundation Trust, Manchester, UKSheffield Children’s Hospital, Sheffield, UKAims: 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. Cite this article: Bone Jt Open 2023;4(11):873–880.https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.411.BJO-2023-0128randomised controlled trialadolescent idiopathic scoliosisbracingadolescent idiopathic scoliosisrandomized controlled trialscoliosiscobb anglespinedepressionanxietyspinal bracingspine registrybracing treatment |
| spellingShingle | Lizzie Swaby Daniel C. Perry Kerry Walker Daniel Hind Andrew Mills Raveen Jayasuriya Nikki Totton Lauren Desoysa Robin Chatters Bridget Young Frances Sherratt Nick Latimer Anju Keetharuth Laura Kenison Stephen Walters Adrian Gardner Sashin Ahuja Laura Campbell Sarah Greenwood Ashley Cole on behalf of the BASIS study group 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 randomised controlled trial adolescent idiopathic scoliosis bracing adolescent idiopathic scoliosis randomized controlled trial scoliosis cobb angle spine depression anxiety spinal bracing spine registry bracing treatment |
| title | Bracing Adolescent Idiopathic Scoliosis (BASIS) study – night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial |
| title_full | Bracing Adolescent Idiopathic Scoliosis (BASIS) study – night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial |
| title_fullStr | Bracing Adolescent Idiopathic Scoliosis (BASIS) study – night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial |
| title_full_unstemmed | Bracing Adolescent Idiopathic Scoliosis (BASIS) study – night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial |
| title_short | Bracing Adolescent Idiopathic Scoliosis (BASIS) study – night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial |
| title_sort | bracing adolescent idiopathic scoliosis basis study night time versus full time bracing in adolescent idiopathic scoliosis study protocol for a multicentre randomized controlled trial |
| topic | randomised controlled trial adolescent idiopathic scoliosis bracing adolescent idiopathic scoliosis randomized controlled trial scoliosis cobb angle spine depression anxiety spinal bracing spine registry bracing treatment |
| url | https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.411.BJO-2023-0128 |
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