Comparison of Braces for Treatment of Sever's Disease

Comparison of Braces for Treatment of Sever's Disease in Barefoot Athletes

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.

Study Overview

• Status: Completed
• Conditions: Sever's Disease
• Intervention / Treatment: Device: Cheetah Heel Cup; Device: The X Brace

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cheetah Heel Cup; Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.	Device: 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.
ACTIVE_COMPARATOR: The X Brace; Subjects randomly assigned to this group will receive the X Brace at their initial visit.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) Scores	The OxAFQ-C is used to measure subjective well-being for child patients (aged 5-16) affected by foot and ankle conditions using issues that are considered important to children. There are three domains to the OxAFQ-C: physical, school and play, and emotional well-being. The investigators will calculate the difference in OxAFQ-C Scores which range from 0 to 100 with higher scores indicating better functioning and higher well-being.	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Visual Analog Scale Pain Score	The Visual Analog Scale pain score is on a scale from 0 (no pain) to 100 (most severe pain). The investigators will calculate the difference in Visual Analog Scale Pain Scores.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Emily A Stuart, MD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2018
• Primary Completion (ACTUAL): November 21, 2021
• Study Completion (ACTUAL): November 21, 2021

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (ACTUAL): April 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 17-0611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing. Data is stored in RedCAP and will only be available for listed authors.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes