Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Retrospektive Analyse Der Konservativen Skoliosetherapie - Doppelkorsettversorgung Mittels Tag- Und Nachtorthese Versus Ganztagesorthese

Conditions
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Scoliosis

Intervention / Treatment
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* Procedure: Brace therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: non-idiopathic scoliosis Cobb curvature angle >40° <10 years and >15 years for initial treatment

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| double-brace group<br>AIS patients with daytime and nighttime braces | Procedure: Brace therapy<br>* A Chêneau-type brace was made to be worn as a full-time brace or during daytime only (double-brace group), whereas the nighttime brace was produced according to the Charleston approach.<br>|
| single-brace group<br>AIS patients with a single brace for day and night | Procedure: Brace therapy<br>* A Chêneau-type brace was made to be worn as a full-time brace or during daytime only (double-brace group), whereas the nighttime brace was produced according to the Charleston approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary correction | Primary correction (%) of brace therapy (Cobb angle measurement) | At study inclusion with initiation of brace therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cobb angle reduction | Follow-up Cobb angle (degree) in relation to the initial Cobb angle | 2 years after deposition of the brace | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scoliosis, nighttime bracing, full-time bracing, Chêneau brace, Charleston brace