Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-06-14
2022-12-01
Brief Summary
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Detailed Description
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The investigators will then use a random number generator program from www.random.org to generate a number between 1 and 100. Participants with an odd number will be assigned home use of standard night splints. Those with an even number will be provided with a TESS unit to be used at home a minimum of 5 minutes twice per day.
The participants will use their device for 6 weeks. They will receive a check in phone call at the 3 week mark of their participation.
Contact numbers will be given to each participant should they have any questions or concerns during the six-week interval. Each participant will be asked to maintain a daily log of their pain level on a visual analog scale and of their estimated time using each device.
Participant's random number will be used to link data in the study to the participant. The investigators will not be using patient identifiable information such as name, date of birth, medical record number, or other personal information for the record.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Main study
This is the only arm of the study. It is a 6 week period where the participants will either be using night splints or the TESS device to treat their plantar fasciitis symptoms.
Night splints
A night splint is a brace the patient wears on their foot to keep it in a dorsiflexed position while they sleep. It is the first line treatment for plantar fasciitis.
Triceps Surae Stretching and Flexibility Assessment Device (TESS)
The TESS device is a slant board with a bar added for balance that the participant will stand on in 5 minute intervals throughout the day to stretch their calves, and potentially treat their plantar fasciitis symptoms.
Interventions
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Night splints
A night splint is a brace the patient wears on their foot to keep it in a dorsiflexed position while they sleep. It is the first line treatment for plantar fasciitis.
Triceps Surae Stretching and Flexibility Assessment Device (TESS)
The TESS device is a slant board with a bar added for balance that the participant will stand on in 5 minute intervals throughout the day to stretch their calves, and potentially treat their plantar fasciitis symptoms.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of plantar fasciitis
* ability to understand the purpose of the study
* ability to safely use the device they are assigned after education and return demonstration.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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SAE Orthopedics
INDUSTRY
Responsible Party
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Principal Investigators
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Mike Davis', MD
Role: PRINCIPAL_INVESTIGATOR
SAE Orthopedics
Locations
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SAE Orthopedics
Carterville, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Tssfad1
Identifier Type: -
Identifier Source: org_study_id
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