Novel Stretching Device Versus Night Splints

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

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.

Study Overview

• Status: Recruiting
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Device: Night splints; Device: Triceps Surae Stretching and Flexibility Assessment Device (TESS)

Detailed Description

The attached recruitment flyers 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 AcuFlex™ device for 5 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.

We 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 a United Ortho fitted night splint. Those with an even number will be provided with an AcuFlex™ unit to be used at home a minimum of 5 minutes 2-3 times per day. If at any point the number generator fills maximum participants (50) for either AcuFlex™ or night splints, the remaining participants will automatically be assigned the remaining method of home therapy.

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. We will not be using patient identifiable information such as name, date of birth, medical record number, or other personal information for the record.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mike Davis, MD; Phone Number: 618-525-3505; Email: mdavis1060@gmail.com
• Study Contact Backup: Name: Corey Hopkins, BS; Phone Number: 618-335-2804; Email: chopkin24@gmail.com

Study Locations

• United States
  • Illinois
    • Carterville, Illinois, United States, 62918
      • Recruiting
      • SAE Orthopedics
      • Contact: Mike Davis, MD; Phone Number: 6185253505; Email: mdavis1060@gmail.com
      • Contact: Corey Hopkins, BS; Phone Number: 6183352804; Email: corey.hopkins@saeorthopedics.com
      • Sub-Investigator: Aren Abell, BS
      • Sub-Investigator: Billy Braid, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• significant balance impairment which would prohibit safe use of the AcuFlex device
• corticosteroid injection within last 60 days
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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 AcuFlex device to treat their plantar fasciitis symptoms.

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.; Device: Triceps Surae Stretching and Flexibility Assessment Device (TESS); The AcuFlex 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. Measurements will be taken and recorded by sensors beneath the participants heels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 AcuFlex device to night splints in symptom relief.	6 weeks

Collaborators and Investigators

• Sponsor: SAE Orthopedics
• Investigators: Principal Investigator: Mike Davis, MD, SAE Orthopedics

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: AcuFlex

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data that underlie a publication will be shared.
• IPD Sharing Time Frame: Data will become available 6 months after study publication. Data will remain available indefinitely.
• IPD Sharing Access Criteria: Dr. Davis will review requests to access study data on a case by case basis. All deidentified data from this study has potential to be shared with other researchers. Requests can be made via email to james.m.davis1@siu.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No