Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03494647 |
Other study ID # |
17-0611 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 18, 2018 |
Est. completion date |
November 21, 2021 |
Study information
Verified date |
April 2022 |
Source |
University of Colorado, Denver |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
It is widely accepted and scientifically confirmed that physical activity improves child
health with positive effects on adiposity, musculoskeletal health and fitness, and
cardiovascular health. Beyond the health benefits of physical activity alone, participation
in sports at this crucial age enhances psychological and social health outcomes. Athletes
with Sever's symptoms are limited in their ability to participate in physical activity and
athletics, and it is suggested that active intervention in the management of Sever's is most
appropriate to improve quality of life and outcomes without substantial time lost from sport
or physical activity. Therefore, efficient and effective treatment is essential, especially
for active and competitive athletes.
Standard treatment for Sever's disease is placement of heel cups in shoes and stretching or
physical therapy. These interventions are effective in reducing Sever's patients' heel pain.
A retrospective study showed that with treatment with a heel cup or other foot orthoses,
symptoms improved within 2 months. However, there remains a distinct lack of randomized
control trials evaluating treatments for Sever's in the literature. For the many young
athletes with Sever's who participate in barefoot sports such as gymnastics, dance, or tae
kwan do, the standard treatment is inadequate. They cannot use the recommended heel cups,
which are placed in an athletic shoe. Currently, two braces are commonly used for barefoot
athletes with Sever's: Cheetah Heel Cups and The X Brace. Neither of these braces are
currently FDA approved as they are not considered medical devices and are marketed as an
insert. Health care providers often recommend barefoot athletes purchase these braces, but no
published studies evaluating their effectiveness exist in the established literature. This
study will compare these two braces in an investigator-blinded, randomized control trial in
order to contribute to the understanding of standard treatment for barefoot athletes with
Sever's disease and improve patient outcomes by affecting clinical practice. In light of the
paucity of information on and the importance of optimizing patient outcomes to improve
quality of life and maintain an active lifestyle for young barefoot athletes, this
prospective, randomized treatment study will compare the effectiveness of two braces in
decreasing pain severity in barefoot athletes diagnosed with Sever's disease.