Novel Stretching Device Versus Night Splints

Not Applicable

• Conditions: Plantar Fasciitis
• Interventions: Device: Night splints; Device: Triceps Surae Stretching and Flexibility Assessment Device (TESS)

• Registration Number: NCT05216679
• Lead Sponsor: SAE Orthopedics

Brief Summary

A set of 100 patients previously diagnosed with plantar fasciitis will be given initial questionnaires about their symptoms and randomly assigned either night splints or the novel calf stretching device. The participants will use each device for 6 weeks. At the end of those 6 weeks, they will return for a follow up questionnaire. The answers in the questionnaire will be analyzed to compare the effectiveness of night splints to calf stretching.

Detailed Description

The attached recruitment brochure will be distributed to physician's offices, and possibly placed as an ad in the newspaper. Potential participants will call the enclosed number and an appointment will be arranged to be evaluated at our research facility in Carterville, IL. During their initial evaluation which will take 30 minutes to 1 hour, each participant will complete medical history pertinent to plantar fasciitis and questionnaires regarding symptoms and physical activity. The research participants will then stand on the tssfad1 device for 5 to 10 minutes during which time their triceps surae flexibility will be assessed by measuring the distance from their heel to the platform at the 30-degree setting. Measurements for each foot will be taken with a distance sensor every 5 seconds for a 5 minute period.

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-31
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-31
• Study Start: 2022-06-14
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age 18 years and older
• 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

• patients with ankle fusion or significant balance impairment which would prohibit safe use of the TESS device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main study	Night splints	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.
Main study	Triceps Surae Stretching and Flexibility Assessment Device (TESS)	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart.	6 weeks	The participant will return their device and fill out a questionnaire (the same as the original questionnaire from the first visit) that will ask them to describe their symptoms and pain levels using a standard 0-10 pain scale chart. The investigators will then use a Mixed ANCOVA statistical test to compare the effectiveness of the TESS device to night splints in symptom relief.

Trial Locations

Locations (1)

SAE Orthopedics; 🇺🇸 Carterville, Illinois, United States