Comparison of Braces for Treatment of Sever's Disease

NCT ID: NCT03494647

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2021-11-21

Brief 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.

Conditions

Sever's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cheetah Heel Cup

Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.

Group Type: ACTIVE_COMPARATOR

Cheetah Heel Cup

Intervention Type: DEVICE

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

Subjects randomly assigned to this group will receive the X Brace at their initial visit.

Group Type: ACTIVE_COMPARATOR

The X Brace

Intervention Type: DEVICE

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.

Interventions

Cheetah Heel Cup

The Cheetah Heel Cup is composed of a rubber waffle that cups the athlete's heel, secured in place by a neoprene sleeve.

Intervention Type: DEVICE

The X Brace

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 8-14 years

2. Participate in barefoot sports including: martial arts, dance, gymnastics, or acrobatics

3. Clinical diagnosis of Sever's or calcaneal apophysitis

Exclusion Criteria

1. History of foot/ankle surgery

2. History of rheumatologic diagnoses

3. Prisoners,

4. pregnant females,

5. Individuals with limited decision-making capacity

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily A Stuart, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-0611

Identifier Type: -

Identifier Source: org_study_id