scholarly journals Trial Protocol: The use of mindfulness-based intervention for improving bracing compliance for adolescent idiopathic scoliosis patients: protocol for a randomised, controlled trial

2018 ◽  
Vol 64 (3) ◽  
pp. 193
Author(s):  
Benjamin Hon Kei Yip ◽  
Xue Li ◽  
Christine Hiu Yan Leung ◽  
Ting Gao ◽  
Vincent Chi Ho Chung ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis ◽  
Controlled Trial ◽  
Trial Protocol ◽  
Randomised Controlled

scholarly journals 3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038373
Author(s):  
Youyu Zhang ◽  
Junyang Liang ◽  
Nanfang Xu ◽  
Lin Zeng ◽  
Chaojun Du ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis ◽  
Cobb Angle ◽  
Sample Size ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Three Dimensional ◽  
3D Printed ◽  
Randomised Controlled

IntroductionAdolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS.Methods and analysisPatients with AIS (age 10–16 years) with Risser sign 0-II, Cobb angle of main curve of 20°−40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen’s design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula.Ethics and disseminationThis study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.Trial registration numberChiCTR1900027379, pre-results.

Sign in / Sign up

Export Citation Format

Share Document