Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Braces for Treatment of Sever's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494647
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Sever's Disease Device: Cheetah Heel Cup Device: The X Brace Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Braces for Treatment of Sever's Disease in Barefoot Athletes
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

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
At 1, 2, and 3 months, a study team member will email the subject's parent the OxAFQ-C and Visual Analog Scale (VAS). A reminder phone call will be made if the questionnaires have not been completed within 5 days.

Active Comparator: The X Brace
Subjects randomly assigned to this group will receive the X Brace at their initial visit.
Device: The X Brace
At 1, 2, and 3 months, a study team member will email the subject's parent the OxAFQ-C and Visual Analog Scale (VAS). A reminder phone call will be made if the questionnaires have not been completed within 5 days.




Primary Outcome Measures :
  1. Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) Scores [ Time Frame: Baseline and 3 months ]
    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.


Secondary Outcome Measures :
  1. Changes in the Visual Analog Scale Pain Score [ Time Frame: Baseline and 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494647


Contacts
Layout table for location contacts
Contact: Corrine N Seehusen, BA 720-777-0109 corrine.seehusen@childrenscolorado.org
Contact: Emily A Stuart, MD 720-777-6600 emily.sweeney@childrenscolorado.org

Locations
Layout table for location information
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Corrine N Seehusen, BA    720-777-0109      
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Emily A Stuart, MD Children's Hospital Colorado
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03494647    
Other Study ID Numbers: 17-0611
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing. Data is stored in RedCAP and will only be available for listed authors.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes