Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis
- Conditions
- Scoliosis
- Interventions
- Procedure: Brace therapy
- Registration Number
- NCT05424419
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between 25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and nighttime braces (=double brace) yields superior results compared to the standard treatment (single brace for day and night). These two treatment regimens were investigated in the study.
- Detailed Description
One-hundred-fifteen patients with adolescent idiopathic scoliosis (AIS) were assessed before initiation of bracing treatment and at the final follow-up 2 years after deposition of the brace. They were divided into two groups: double-brace group and single-brace group. Each patient underwent clinical and radiological examinations and Cobb angles were measured.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- AIS
- age between 10 and 15 years (y)
- Risser's sign of 0-2
- Cobb curvature angle of 25-40°
- no previous treatment
- compliance (at least 23 h wearing time)
- non-idiopathic scoliosis
- Cobb curvature angle >40°
- <10 years and >15 years for initial treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description single-brace group Brace therapy AIS patients with a single brace for day and night double-brace group Brace therapy AIS patients with daytime and nighttime braces
- Primary Outcome Measures
Name Time Method primary correction At study inclusion with initiation of brace therapy Primary correction (%) of brace therapy (Cobb angle measurement)
- Secondary Outcome Measures
Name Time Method Cobb angle reduction 2 years after deposition of the brace Follow-up Cobb angle (degree) in relation to the initial Cobb angle