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Bracing in adolescent idiopathic scoliosis trial

Not Applicable
Completed
Conditions
Adolescent idiopathic scoliosis
Musculoskeletal Diseases
Scoliosis
Registration Number
ISRCTN81733841
Lead Sponsor
The Hospital for Sick Children (Canada)
Brief Summary

1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24026162 2. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/24047455 (added 11/04/2019)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
449
Inclusion Criteria

Amended as of 06/03/2009:
5. Primary Cobb angle 20 - 39 degrees

Initial information at the time of registration:
1. Diagnosis of adolescent idiopathic scoliosis
2. Aged 10 - 15 years, either sex
3. Risser 0 - 2
4. Menarche within 1 year
5. Primary Cobb angle 25 - 39 degrees
6. Curve Apex caudal to T7

Exclusion Criteria

1. Other musculoskeletal, neurological, or developmental illnesses possibly responsible for the curvature
2. Physical and mental disability precluding adherence to bracing protocol
3. History of previous surgical or orthotic treatment
4. Inability to read and understand English, Spanish, and/or French

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<br> Amended as of 06/03/2009:<br> Progression to 50 degrees as measured every 6 months.<br><br> Initial information at the time of registration:<br> Progression to greater than 45 degrees as measured every 6 months.<br>
Secondary Outcome Measures
NameTimeMethod
<br> 1. Child Health Questionnaire measured every 6 months<br> 2. Self-Image Questionnaire for Young Adolescents measured every 6 months<br> 3. Peds Quality of Life measured every 6 months<br> 4. Spinal Appearance Questionnaire measured every 6 months<br>
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