N/A
Completed N=43
Comparison of Braces for Treatment of Sever's Disease
Sever's Disease
Source: ClinicalTrials.gov NCT03494647 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) Scores — 0.27; 0.22; 0.19; 0.18 score on a scale
Summary
This study is to learn more about braces that may help young athletes diagnosed with Sever's disease. Young athletes with this diagnosis who are seen by a Sports Medicine doctor will be asked it they want to be a part of the study. Patients who want to be in the study will be randomly assigned to wear one of two kinds of braces to treat their foot pain via randomization scheme independently created by a statistician. The subjects will be given the brace for free. The subjects will also answer survey questions about the brace when they first see the doctor, then at one, two, and three months after their first visit. Data collected in this study will help doctors gain a better understanding of how to treat young athletes who do sports without shoes who are diagnosed with Sever's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) Scores |
0.27; 0.22; 0.19; 0.18; 0.13; 0.05 | — |
| SECONDARY Changes in the Visual Analog Scale Pain Score |
-9.5; -7.4; -25.4; -23.6; -42.4; -36.1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 8-14 years
- Participate in barefoot sports including: martial arts, dance, gymnastics, or acrobatics
- Clinical diagnosis of Sever's or calcaneal apophysitis
Exclusion Criteria
- History of foot/ankle surgery
- History of rheumatologic diagnoses
- Prisoners,
- pregnant females,
- Individuals with limited decision-making capacity
Data sourced from ClinicalTrials.gov (NCT03494647). 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. Informational only — not medical advice.