Actively Recruiting
Novel Stretching Device Versus Night Splints a Prospective, Randomized Study in the Effectiveness of Treating Plantar Fasciitis
Led by SAE Orthopedics · Updated on 2026-04-28
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a novel calf stretching device called AcuFlex compared to traditional night splints in treating plantar fasciitis. This prospective, randomized study aims to understand how these two devices impact symptoms and pain levels over a six-week period in patients diagnosed with plantar fasciitis. The study is sponsored by SAE Orthopedics and involves 100 participants. Participants will be randomly assigned to use either a United Ortho fitted night splint worn during sleep or the AcuFlex device, a slant board with a balance bar used at home for calf stretching. Each participant will use their assigned device for six weeks, with the AcuFlex group standing on the device for 5 minutes several times daily. A check-in phone call occurs at the three-week mark, and participants will keep daily logs of pain levels and device usage. During the initial visit, participants complete medical history and symptom questionnaires and undergo flexibility assessment using the AcuFlex device with sensors measuring heel distance. Follow-up questionnaires at six weeks will evaluate symptoms and pain using a standard 0-10 pain scale. The study collects data anonymously linked by random numbers, and participants have contact support throughout. The main outcome is attendance at follow-up and reported pain changes after six weeks of device use.
CONDITIONS
Brief Title
Novel Stretching Device Versus Night Splints
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Diagnosis of plantar fasciitis
- Ability to understand the purpose of the study
- Ability to safely use the assigned device after education and return demonstration
You will not qualify if you...
- Patients with ankle fusion
- Significant balance impairment preventing safe use of the AcuFlex device
- Corticosteroid injection within the last 60 days
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants are assigned to use either a night splint or the AcuFlex stretching device at home to treat plantar fasciitis symptoms.
Participants use their assigned device at home for 6 weeks with a check-in phone call at 3 weeks
Duration - At 6 weeks
Participants attend a follow-up appointment to describe their symptoms and pain using a standard 0-10 pain chart.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
SAE Orthopedics
Carterville, Illinois, United States, 62918
Actively Recruiting
Research Team
M
Mike Davis, MD
C
Corey Hopkins, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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