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Actively Recruiting

Phase 3
Age: 18Years - 40Years
All Genders
ID03184545

Studying Electrical Muscle Stimulation Plus Physical Therapy Versus Physical Therapy Alone for Adults Ages 18 to 40 With Patellofemoral Pain Syndrome

Led by Northwell Health · Updated on 2024-12-03

92

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

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 devices 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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Bilateral or unilateral anterior knee pain lasting more than 3 months
  • Age between 18 and 40 years
  • At least 3 of the following: pain with prolonged sitting with knees bent, pain going downstairs, pain with kneeling or squatting, or pain during sports activities
  • No history of injury
  • No history of knee surgery
Not Eligible

You will not qualify if you...

  • History of patellar dislocation or subluxation
  • Associated bursitis or tendinitis near the knee
  • Ligament problems
  • Intra-articular knee pathology
  • Pregnancy
  • History of knee surgery
  • Steroid medication taken orally or injected in the knee within the last 3 months
  • Presence of implanted devices like pacemakers

Research Team

L

Leon Popovitz, MD

R

Rupesh Tarwala, MD

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