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
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
Research Team
L
Leon Popovitz, MD
R
Rupesh Tarwala, MD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
EMS plus Physical Therapy
Physical Therapy Alone
What it is
Regular electrical muscle stimulation (EMS) to the thigh muscle (vastus medialis obliquus), delivered using an FDA-approved device (Flex MT Plus), combined with standard physical therapy exercises.
A program of standard physical therapy exercises delivered without electrical stimulation.
Primary use
To determine if EMS combined with physical therapy improves knee function and reduces pain for adults with patellofemoral pain syndrome.
To improve knee function and decrease pain symptoms through supervised physical therapy alone.
How it is given or performed
EMS is applied to the vastus medialis obliquus muscle for 20 minutes, three times daily, five days per week, for 12 weeks at 40 Hz, using specified pulse and duty cycle; this is combined with standard physical therapy exercises.
Participants complete standard physical therapy exercises according to a supervised protocol, without EMS device use.
Evidence status
Limited published evidence from small studies suggests EMS plus physical therapy may improve pain and function, but high-quality large trials are lacking; results from this study have not yet been posted.
Physical therapy has strong evidence from systematic reviews and is recognized as effective for most people with patellofemoral pain syndrome.
Important limitations
Requires access to EMS device and adherence to frequent stimulation sessions. Uncertain long-term benefits compared to standard care. Potential discomfort or contraindications for patients with pacemakers or electrical implants.
Requires regular participation in exercise sessions. May not provide sufficient improvement for all patients, especially if adherence is low. Optimal exercise type and program remain under discussion.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 40Years
All Genders
Eligibility Criteria
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
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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive physical therapy exercises. One group also receives electrical muscle stimulation applied to the vastus medialis obliquus muscle for 20 minutes, 3 times daily, 5 days a week for 12 weeks.
Weekly visits for up to 12 weeks
Follow-up
Duration - 12 months
Participants are followed for 12 months after enrollment to assess outcomes such as pain, knee strength, and return to sports activities.
Periodic follow-up visits over 12 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Study protocol: a randomised controlled trial comparing the long term effects of isolated hip strengthening, quadriceps-based training and free physical activity for patellofemoral pain syndrome (anterior knee pain).
Alexandra Hott, Sigurd Liavaag, Niels Gunnar Juel...
Muscle Activation of Vastus Medialis Oblique and Vastus Lateralis in Sling-Based Exercises in Patients with Patellofemoral Pain Syndrome: A Cross-Over Study.