Novel Stretching Device Versus Night Splints

Plantar Fasciitis Clinical Trial

Official title:

Novel Stretching Device Versus Night Splints a Prospective, Randomized Study in the Effectiveness of Treating Plantar Fasciitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05216679
• Other study ID #: Tssfad1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2022
• Source: SAE Orthopedics
• Contact: Mike Davis, MD
• Phone: 618-525-3505
• Email: mdavis1060[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	SAE Orthopedics	Carterville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
SAE Orthopedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart.	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.	6 weeks