A Prospective Randomized Study Comparing Electrical Stimulation of Vastus Medialis Obliquus Muscle Plus Physical Therapy Versus Physical Therapy Alone in Patellofemoral Pain Syndrome

What this Trial Is About

Researchers are evaluating the effectiveness of an electrical muscle stimulation (EMS) device in patients with patellofemoral pain syndrome, also known as anterior knee pain. This condition is common among young athletes and is believed to involve weakness in the vastus medialis obliquus muscle. The study aims to determine if adding EMS to standard physical therapy (PT) can speed recovery and improve outcomes compared to PT alone. This is a phase 3 randomized study with a larger sample size than previous research to better assess the device's impact. Participants are assigned to one of two groups: one receiving both EMS and physical therapy, and the other receiving only physical therapy. The EMS device used is the Flex MT Plus, an FDA-approved neuromuscular stimulator applied to the vastus medialis obliquus muscle for 20 minutes, three times daily, five days a week, over 12 weeks at 40 Hz with specific pulse settings. Physical therapy consists of standard exercises for strengthening. During the study, participants will be followed for up to 12 months after enrollment, with a total study duration of two years. Researchers will assess outcomes including the Kujala patellofemoral score, visual analog pain scale during daily activities, and isometric knee strength. Secondary outcomes include the rate and timing of return to sports activities. Safety and progress will be monitored regularly throughout the study.

Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome