N/A
N=245
Effect of Compliance Counseling on Brace Success in Patients With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT02412137 ↗Enrolled (actual)
245
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Brace Progress Report (i.e. Informing the Patient How Often They Were Wearing the Brace Versus Not Informing the Patient) — 93; 78; 26; 29 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Counseled cohort (Other)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Texas Scottish Rite Hospital for Children
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brace Progress Report (i.e. Informing the Patient How Often They Were Wearing the Brace Versus Not Informing the Patient) |
93; 78; 26; 29; 67; 49 | — |
Summary
To measure the effectiveness of counseling on brace-wear compliance and curve progression in patients with adolescent idiopathic scoliosis. The investigators hypothesize that compliance is increased when it is measured and used to counsel patients, and therefore those patients will have less curve progression and fewer would need surgery.
A second purpose is to evaluate whether there is a correlation between BMI and brace effectiveness. Proposed theories for decreased effectiveness in patients with elevated BMI have included decreased compliance due to discomfort and decreased force exerted on the curve due to the larger habitus.
Eligibility Criteria
Inclusion Criteria
- Male and female patients of all races and ethnic backgrounds between the ages of 10 and 16, who have been or who are being treated for idiopathic scoliosis with a Boston brace at Texas Scottish Rite Hospital for Children. These patients will not have worn braces before and have scoliosis curves measuring from 25-45 degrees and are Risser 0, 1, or 2. Female patients will be premenarchal or 45 degrees at the time of brace prescription, patients previously treated with spinal surgery or orthoses, girls who are greater than one year postmenarchal, and patients who are Risser 3, 4, or 5.
Furthermore, if during the course of treatment a diagnosis of non-idiopathic scoliosis, i.e. if a spinal cord abnormality such as a syrinx, becomes apparent, the previously enrolled patient will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT02412137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.