Comparison of Braces for Treatment of Sever's Disease
Condition: Sever's Disease
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Cheetah Heel Cup; The X Brace
Intervention type(s): Device; Device
Intervention description(s): The Cheetah Heel Cup is composed of a rubber waffle that cups the athlete's heel, secured in place by a neoprene sleeve.; The X Brace is composed of one thick elastic band that is wrapped around the athlete's arch of the foot. A second band is wrapped around the back of the heel, crossed under the foot, and secured to the thicker band on the bottom of the foot.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment