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.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03184545

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

Recruiting
PHASE3Ages 18–40InterventionalTreatment
Northwell Health
~92 participants
Updated 2024-12-03 on ClinicalTrials.gov
What's tested:EMSPhysical therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Kujala patellofemoral score.
Measured over 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.
+2 more outcomes measured
Patellofemoral Pain Syndrome

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.

  • Leon Popovitz, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

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Eligibility criteria

Inclusion

Bilateral/unilateral anterior knee pain for more than 3 moths
Age of patient 18 to 40 years
At least 3 of the 4 following criteria present: pain associated with prolonged sitting with knees bend, pain with going downstairs, kneeling and squatting or sports activities
No h/o injury
No h/o surgery to the knee

Exclusion

H/o patellar dislocation or subluxation
Associated bursitis, tendinitis in periarticular area
Ligamentous problems
Intra-articular pathology
Pregnancy (patient reported pregnancy, in case of doubt patient will be referred to their OBG/GYN physician to exclude the pregnancy)
H/o knee surgery
Oral or intraarticular administration of steroid medication with in last 3 months
Patients with implanted devices like pacemaker
  • 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.