Calf-stretching device versus night splints for plantar fasciitis
Official title: Novel Stretching Device Versus Night Splints a Prospective, Randomized Study in the Effectiveness of Treating Plantar Fasciitis
Run by SAE Orthopedics · NCT05216679 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | SAE Orthopedics Industry-sponsored |
| Locations | 1 site (Carterville, Illinois) |
| Status | Recruiting |
| Started | April 15, 2026 |
| Main results expected | July 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT05216679 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous trials have shown benefit from stretching exercises and night splints for plantar fasciitis, but the AcuFlex device itself has not been widely tested.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Extracorporeal Shock Wave Therapy With or Without Kinesio Taping for Plantar Fasciitis
This study tests whether adding kinesio taping to shock wave therapy helps reduce pain and improve foot function in people with plantar fasciitis.
-
Transverse Friction Massage vs Instrument-Assisted Soft-Tissue Mobilization for Plantar Fasciitis
This study tests whether transverse friction massage or instrument-assisted soft-tissue mobilization helps people with plantar fasciitis feel better.
-
Ice packs vs cold baths with standard exercise for heel pain from plantar fasciitis
This trial tests whether ice packs or cold baths, when added to a standard exercise plan, better reduce pain for adults with plantar fasciitis.
-
Do Myofascial Release or Instrument-Assisted Soft Tissue Mobilization Help Pregnant Women with Plantar Fasciitis
This study tests whether two manual therapy techniques, MFR and IASTM, can reduce heel pain and improve foot function in pregnant women with plantar fasciitis.
-
Relationship between central sensitization and clinical features in plantar fasciitis
This study tests how brain-sensitivity, pain intensity, and psychological factors relate to ultrasound findings and how patients function with plantar fasciitis.
-
Barefoot Walking vs Standardised Conservative Care for Plantar Fasciopathy
This trial tests whether a barefoot walking program can reduce heel pain and improve foot function in adults with plantar fasciopathy compared with a standard stretching and strengthening program.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.