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Novel Stretching Device Versus Night Splints

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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Night splints (device)
• Triceps Surae Stretching and Flexibility Assessment Device (TESS) (device)

Sponsor: SAE Orthopedics · Participants: 100 · Started: Apr 15, 2026

Contact the study team

• Mike Davis, MD · Phone: 618-525-3505
• Corey Hopkins, BS · Phone: 618-335-2804

Official record on ClinicalTrials.gov — NCT05216679

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.