Comparing a New Calf Stretching Device to Night Splints for Treating Plantar Fasciitis A Randomized Study Evaluating Symptom Relief Over Six Weeks

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.

Novel Stretching Device Versus Night Splints