PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace.

<h4>Introduction</h4>Idiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Patients are treated mainly with thoracolumbosacral orthosis (TLSO) if indicated. This form of brace treatment has been shown to be cumber...

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Autores principales: Elias Diarbakerli, Anastasios Charalampidis, Allan Abbott, Paul Gerdhem
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Publicado: Public Library of Science (PLoS) 2021
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spelling oai:doaj.org-article:1099786dc80e4b5a842ed0075f2316cb2021-12-02T20:18:31ZPReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace.1932-620310.1371/journal.pone.0255264https://doaj.org/article/1099786dc80e4b5a842ed0075f2316cb2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0255264https://doaj.org/toc/1932-6203<h4>Introduction</h4>Idiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Patients are treated mainly with thoracolumbosacral orthosis (TLSO) if indicated. This form of brace treatment has been shown to be cumbersome and tough on growing individuals. However, computer aided design and manufactured (CAD/CAM) braces might increase comfortability and ultimately outcome if compliance is improved. In a multicenter, randomized controlled trial, we aim to compare CAD/CAM designed Boston 3D-brace to standard Boston brace.<h4>Methods</h4>Subjects: 170 previously untreated and skeletally immature children diagnosed with idiopathic scoliosis, aged 9-17 years of age (curve magnitude Cobb 25-40 degrees) will be included. Interventions: Both groups will receive a physical activity prescription according to the World Health Organization recommendations. Randomization will be performed 1:1 to a 3D CAD/CAM designed Boston 3D-brace or a standard Boston brace, both with prescribed daily wear time of 20 hours. Outcome: The subjects will participate in the study until curve progression or until skeletal maturity. The primary outcome variable is failure of treatment, defined as progression of the Cobb angle more than 6 degrees compared to the baseline x-ray. The progression is confirmed if seen on two consecutive standing spinal x-rays. Radiographs will be taken at each six-month follow-up. Secondary outcome measures include patient and clinical reported outcomes, including number of individuals requiring surgical intervention.<h4>Discussion</h4>This study will show if efficacy in brace treatment can be improved with new brace designs.<h4>Trial registration</h4>The protocol has been registered on ClinicalTrials.gov, identifier: NCT04805437.Elias DiarbakerliAnastasios CharalampidisAllan AbbottPaul GerdhemPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 8, p e0255264 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Elias Diarbakerli
Anastasios Charalampidis
Allan Abbott
Paul Gerdhem
PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace.
description <h4>Introduction</h4>Idiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Patients are treated mainly with thoracolumbosacral orthosis (TLSO) if indicated. This form of brace treatment has been shown to be cumbersome and tough on growing individuals. However, computer aided design and manufactured (CAD/CAM) braces might increase comfortability and ultimately outcome if compliance is improved. In a multicenter, randomized controlled trial, we aim to compare CAD/CAM designed Boston 3D-brace to standard Boston brace.<h4>Methods</h4>Subjects: 170 previously untreated and skeletally immature children diagnosed with idiopathic scoliosis, aged 9-17 years of age (curve magnitude Cobb 25-40 degrees) will be included. Interventions: Both groups will receive a physical activity prescription according to the World Health Organization recommendations. Randomization will be performed 1:1 to a 3D CAD/CAM designed Boston 3D-brace or a standard Boston brace, both with prescribed daily wear time of 20 hours. Outcome: The subjects will participate in the study until curve progression or until skeletal maturity. The primary outcome variable is failure of treatment, defined as progression of the Cobb angle more than 6 degrees compared to the baseline x-ray. The progression is confirmed if seen on two consecutive standing spinal x-rays. Radiographs will be taken at each six-month follow-up. Secondary outcome measures include patient and clinical reported outcomes, including number of individuals requiring surgical intervention.<h4>Discussion</h4>This study will show if efficacy in brace treatment can be improved with new brace designs.<h4>Trial registration</h4>The protocol has been registered on ClinicalTrials.gov, identifier: NCT04805437.
format article
author Elias Diarbakerli
Anastasios Charalampidis
Allan Abbott
Paul Gerdhem
author_facet Elias Diarbakerli
Anastasios Charalampidis
Allan Abbott
Paul Gerdhem
author_sort Elias Diarbakerli
title PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace.
title_short PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace.
title_full PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace.
title_fullStr PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace.
title_full_unstemmed PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace.
title_sort preventing idiopathic scoliosis progression (priscopro): a protocol for a quadruple-blinded, randomized controlled trial comparing 3d designed boston brace to standard boston brace.
publisher Public Library of Science (PLoS)
publishDate 2021
url https://doaj.org/article/1099786dc80e4b5a842ed0075f2316cb
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