Comparing Electrical Stimulation and Physical Therapy for Knee Pain
This study is looking at whether adding electrical muscle stimulation (EMS) to standard physical therapy can help people with patellofemoral pain syndrome (anterior knee pain) recover faster and have better results. EMS uses a device called Flex MT Plus, which is approved by the FDA, to stimulate a specific muscle in the thigh. Half of the participants will receive EMS and physical therapy, while the other half will only receive physical therapy. The study aims to enroll 92 people between 18 and 40 years old who have had knee pain for more than three months and meet other specific criteria. Researchers will measure pain levels, knee strength, and a specific knee function score over two years to see if EMS makes a difference.
- Study design
- This interventional study plans to enroll 92 participants, with half receiving EMS plus physical therapy and the other half receiving only physical therapy.
- What's involved
- Participants will receive electrical muscle stimulation for 20 minutes, 3 times daily, 5 times a week for 12 weeks, in addition to physical therapy exercises.
- Compensation
- Not stated in the trial record.
- Follow-up
- Each patient will be followed for a total of 12 months after enrollment, with measurements taken at 2 years from the study's start.
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Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
At a glance
Conditions
NCT03184545
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
New York Bone and Joint Specialists
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Leon Popovitz, MD · PRINCIPAL_INVESTIGATOR · Northwell Health
Who to contact
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Inclusion
Exclusion
What this trial measures
- Kujala patellofemoral score.2 years. Total duration of study is two years. But each patient will be followed for total 12 months after enrollment. If any patient enrolled at 1 year mark after start of study , he will be followed for one year. So total duration of study is 2 years.
Assessment will be done at each visit (pre-treatment, post-start treatment 3 weeks,, 6 weeks, 12 weeks, 6 months and 12 months) based on Kujala patellofemoral score. The Kujala score assesses following points: Limp, support, walking, stairs, squatting,running, jumping, prolong sitting with knee flexed,pain,swelling,abnormal painful kneecap movements, atrophy of thigh and flexion deficiency. Repeated measures linear regression models will be used to compare the two treatment arms with respect to knee function, pain score, and muscle strength from baseline to 12 months. Total duration of study is two years. We intend finish enrolling 92 patients by the end of one year after start of study. But each patient will be followed for total 12 months period. If any patient enrolled at 1 year mark after start of study , he will be followed for one year.
- Visual analog pain scale (VAS) pain scale during activities of life2 years
VAS scale of 1-10 will be used to evaluate knee pain. 1 being mild and 10 being worst.
- Isometric strength measurement of knee2 years
Isometric strength will be measured using dynamo-meter.