Comparing two types of braces for treating scoliosis in adolescents
Effectiveness of Three Dimensional Correction During in Bracing in Adolescent Idiopathic Scoliosis: a Prospective Randomised Clinical Trial of Rigo Chêneau Versus Boston-style Orthoses
This study is testing whether a new type of brace can work better than a traditional brace for treating scoliosis in teenagers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 10 Years to 15 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04382638 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Rigo Chêneau orthoses (RCO) versus traditional Boston-style thoracolumbosacral orthoses (TLSO) in correcting three-dimensional scoliosis in adolescents diagnosed with idiopathic scoliosis. The research follows guidelines from the Scoliosis Research Society and the International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment to ensure high-quality evidence is gathered. By focusing on patients at risk for curve progression, the study aims to enhance non-operative treatment strategies and potentially reduce the need for surgical interventions. The trial will involve adolescents aged 10 to 15 with specific criteria related to their scoliosis severity and skeletal maturity.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10 to 15 with a diagnosis of adolescent idiopathic scoliosis and specific curve characteristics.
Not a fit: Patients with underlying causes of scoliosis, previous spinal surgery, or those receiving other treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective non-surgical treatment options for adolescents with scoliosis, potentially reducing the need for surgery.
How similar studies have performed: Previous studies have shown that bracing can be effective in preventing curve progression in scoliosis, but this specific comparison of brace types is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of AIS * Male or female from 10 to 15 year-old, inclusive, at the time of consent provided * Skeletal immaturity, defined as a Risser grade (amount of ossification and eventual fusion of the iliac apophysis) of 0, 1, or 2 * Cobb angle of 25-40 * No prior conservative or surgical treatment for AIS Exclusion Criteria: * An underlying cause or association that may cause scoliosis * Leg length discrepancies or lower limb deformities that may interfere with spinal posture * Previous spinal surgery * Cognitive impairment * Those receiving any other forms of treatment including alternative medicine for the treatment of their scoliosis * Those who are unable to return for follow-up to complete the trial
Where this trial is running
Hong Kong
- Duchess of Kent Children's Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Dr Kenny Kwan, BMBCh (Oxon) — The University of Hong Kong
- Study coordinator: Dr Kenny Kwan, BMBCh (Oxon)
- Email: kyhkwan@hku.hk
- Phone: +852 22554654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.