Calf-stretching device versus night splints for plantar fasciitis
Novel Stretching Device Versus Night Splints a Prospective, Randomized Study in the Effectiveness of Treating Plantar Fasciitis
This test compares a home calf-stretching device with night splints to see if one reduces heel pain in adults with plantar fasciitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SAE Orthopedics Industry-sponsored |
| Locations | 1 site (Carterville, Illinois) |
| Trial ID | NCT05216679 on ClinicalTrials.gov |
What this trial studies
One hundred adults previously diagnosed with plantar fasciitis will complete baseline questionnaires and have calf (triceps surae) flexibility measured using the AcuFlex device. Participants will be randomly assigned by a random number generator to use either a fitted night splint or the AcuFlex stretching unit at home for six weeks, with a 3-week check-in call. Flexibility measurements are captured during a five-minute standing assessment with distance sensors, and symptom questionnaires are repeated after six weeks. The questionnaire responses will be analyzed to compare symptom change between the two home therapies.
Who should consider this trial
Good fit: Adults aged 18 and older with a diagnosis of plantar fasciitis who can understand the study, safely use the assigned device after instruction, and attend visits at the Carterville, IL site are ideal candidates.
Not a fit: Patients with ankle fusion, significant balance impairment that prevents safe device use, recent corticosteroid injection within 60 days, pregnancy, or inability to attend the site visit are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the AcuFlex device could provide a convenient home-based stretching option that reduces plantar fasciitis pain and improves function comparable to or better than night splints.
How similar studies have performed: Previous trials have shown benefit from stretching exercises and night splints for plantar fasciitis, but the AcuFlex device itself has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Carterville, Illinois
- SAE Orthopedics — Carterville, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Mike Davis, MD — SAE Orthopedics
- Study coordinator: Mike Davis, MD
- Email: mdavis1060@gmail.com
- Phone: 618-525-3505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.