Recruiting

Night Splints vs. Calf Stretching

Sponsor:

SAE Orthopedics

Code:

NCT05216679

Conditions

Plantar Fasciitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Night splints

Triceps Surae Stretching and Flexibility Assessment Device (TESS)

Study Details

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.

Conditions

Plantar Fasciitis

Study ID

NCT05216679

Start date

Apr 15, 2026

Status verified date

Apr, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 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.

Primary outcome measure

  • Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart. [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Mike Davis, MD

618-525-3505mdavis1060@gmail.com

Corey Hopkins, BS

618-335-2804chopkin24@gmail.com

Locations

SAE Orthopedics

Recruiting

Carterville, Illinois, United States, 62918

Contacts

Mike Davis, MD

6185253505mdavis1060@gmail.com

Corey Hopkins, BS

6183352804corey.hopkins@saeorthopedics.com

More Information

Sponsor

SAE Orthopedics

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SAE Orthopedics on 2026-04-28.