Sever's DiseaseNCT03494647
Comparison of Braces for Treatment of Sever's Disease
A study testing Cheetah Heel Cup and The X Brace in people with Sever's Disease, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Sever's Disease
- What is being tested?
- Cheetah Heel Cup and The X Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2018to 21 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 8-14 years
- Participate in barefoot sports including: martial arts, dance, gymnastics, or acrobatics
- Clinical diagnosis of Sever's or calcaneal apophysitis
Who cannot join
- History of foot/ankle surgery
- History of rheumatologic diagnoses
- Prisoners,
- pregnant females,
- Individuals with limited decision-making capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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
- Being tested
- Cheetah Heel Cup, The X Brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheetah Heel CupDevice
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 BraceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cheetah Heel Cup | Active comparator | Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit. Receives: Device: Cheetah Heel Cup |
| The X Brace | Active comparator | Subjects randomly assigned to this group will receive the X Brace at their initial visit. Receives: Device: The X Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (1)
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start18 Apr 2018
- Primary completion21 Nov 2021
- Study completion21 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sever's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily A Stuart, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494647
- Sponsor's protocol ID
- 17-0611
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2018
- Last updated
- 25 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No sharing. Data is stored in RedCAP and will only be available for listed authors.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Braces for Treatment of Sever's Disease in Barefoot Athletes
- ClinicalTrials.gov ID
- NCT03494647
- Acronym / sponsor ID
- 17-0611
- Conditions
- Sever's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 21 Nov 2021 (actual)
- Study completion
- 21 Nov 2021 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Posted 25 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cheetah Heel Cup | Active comparator | Device: Cheetah Heel CupSubjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit. |
| The X Brace | Active comparator | Device: The X BraceSubjects randomly assigned to this group will receive the X Brace at their initial visit. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 8-14 years
- Participate in barefoot sports including: martial arts, dance, gymnastics, or acrobatics
- Clinical diagnosis of Sever's or calcaneal apophysitis
Key exclusion criteria (5 listed)
- History of foot/ankle surgery
- History of rheumatologic diagnoses
- Prisoners,
- pregnant females,
- Individuals with limited decision-making capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cheetah Heel CupThe Cheetah Heel Cup is composed of a rubber waffle that cups the athlete's heel, secured in place by a neoprene sleeve. | Device | Cheetah Heel Cup |
| The X BraceThe 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. | Device | The X Brace |
Primary outcome
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.
1 secondary outcome
Changes in the Visual Analog Scale Pain Score
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No sharing. Data is stored in RedCAP and will only be available for listed authors.
Related trials for Sever's Disease
Recruiting
Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Recruiting
Low-Level Laser Therapy for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily A Stuart, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cheetah Heel Cup and The X Brace in people with Sever's Disease, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) Scores (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.