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Comparison of Braces for Treatment of Sever's Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03494647
Enrollment
43
Registered
2018-04-11
Start date
2018-04-18
Completion date
2021-11-21
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sever's Disease

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.

Interventions

DEVICECheetah 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.

DEVICEThe 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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) ScoresBaseline and 3 monthsThe 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

MeasureTime frameDescription
Changes in the Visual Analog Scale Pain ScoreBaseline and 3 monthsThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Cheetah Heel Cup
Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit. 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.
16
The X Brace
Subjects randomly assigned to this group will receive the X Brace at their initial visit. 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.
16
Total32

Baseline characteristics

CharacteristicTotalCheetah Heel CupThe X Brace
Age, Continuous10.4 years
STANDARD_DEVIATION 1.6
10.6 years
STANDARD_DEVIATION 1.6
10.1 years
STANDARD_DEVIATION 1.6
Days from consent signed to beginning use of brace5.95 Days
STANDARD_DEVIATION 4.05
6.8 Days
STANDARD_DEVIATION 4.2
5.1 Days
STANDARD_DEVIATION 3.9
Diagnosed with Seber's disease8 Participants3 Participants5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants15 Participants15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Height138.4 cm
STANDARD_DEVIATION 10
138.2 cm
STANDARD_DEVIATION 10.7
138.6 cm
STANDARD_DEVIATION 9
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants2 Participants1 Participants
Race (NIH/OMB)
More than one race
4 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
22 Participants11 Participants11 Participants
Region of Enrollment
United States
32 participants16 participants16 participants
Sex: Female, Male
Female
29 Participants14 Participants15 Participants
Sex: Female, Male
Male
3 Participants2 Participants1 Participants
Weight32.05 kg
STANDARD_DEVIATION 6.4
32.7 kg
STANDARD_DEVIATION 7.6
31.4 kg
STANDARD_DEVIATION 5.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 22
other
Total, other adverse events
1 / 211 / 22
serious
Total, serious adverse events
0 / 210 / 22

Outcome results

Primary

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.

Time frame: Baseline and 3 months

ArmMeasureGroupValue (MEAN)Dispersion
Cheetah Heel CupChanges in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) ScoresPhysical0.27 score on a scaleStandard Deviation 0.22
Cheetah Heel CupChanges in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) ScoresSchool and play0.19 score on a scaleStandard Deviation 0.19
Cheetah Heel CupChanges in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) ScoresEmotional wellbeing0.13 score on a scaleStandard Deviation 0.08
The X BraceChanges in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) ScoresPhysical0.22 score on a scaleStandard Deviation 0.18
The X BraceChanges in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) ScoresSchool and play0.18 score on a scaleStandard Deviation 0.25
The X BraceChanges in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) ScoresEmotional wellbeing0.05 score on a scaleStandard Deviation 0.11
Secondary

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.

Time frame: Baseline and 3 months

ArmMeasureGroupValue (MEAN)Dispersion
Cheetah Heel CupChanges in the Visual Analog Scale Pain ScoreDaily living activities-25.4 score on a scaleStandard Deviation 30.3
Cheetah Heel CupChanges in the Visual Analog Scale Pain ScoreAt rest-9.5 score on a scaleStandard Deviation 23.1
Cheetah Heel CupChanges in the Visual Analog Scale Pain ScoreDuring sports-42.4 score on a scaleStandard Deviation 30.5
The X BraceChanges in the Visual Analog Scale Pain ScoreAt rest-7.4 score on a scaleStandard Deviation 14.5
The X BraceChanges in the Visual Analog Scale Pain ScoreDaily living activities-23.6 score on a scaleStandard Deviation 23.2
The X BraceChanges in the Visual Analog Scale Pain ScoreDuring sports-36.1 score on a scaleStandard Deviation 25.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026