About this trial
The purpose of study is to evaluate the efficacy of the electrical muscle stimulation (EMS) device in patients with patellofemoral pain known as anterior knee pain. Usual treatment for it is physical therapy (PT). We want to evaluate and see if adding the electrical muscle stimulation will fasten the recovery and improved outcome in patellofemoral pain syndrome. Half of participants will receive EMS and PT while other half will receive PT only.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
H/o patellar dislocation or subluxation
Associated bursitis, tendinitis in periarticular area
Ligamentous problems
Intra-articular pathology
Trial design
Parallel
Treatments tested in this trial
EMS
DeviceThe EMS device Flex MT Plus (Electrostim Medical Services Inc. Tampa, FL) is a neuromuscular stimulator. It is approved by the FDA. The Electrical muscle stimulation (EMS) applied to vastus medialis obliquus (VMO) muscle for 20 minutes, 3 times daily and it would be 5 times a week for 12 weeks at 40 Hz. The pulse duration will be 0.26ms, at 5 seconds on and 10 seconds off.
Physical therapy
Other interventionStandard physical therapy exercises
Treatment groups
Trial outcomes
Primary outcomes
Kujala patellofemoral score.
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 life
VAS scale of 1-10 will be used to evaluate knee pain. 1 being mild and 10 being worst.
Isometric strength measurement of knee
Isometric strength will be measured using dynamo-meter.
Secondary outcomes
Secondary outcome measure would be how many return to sports activity.
Secondary outcome assessment will be to see how many in EMS+PT group and how many in PT group returned to their previous activity level of sports without any pain after completion of treatment.
At what point of time they returned to their sports activity
It will be also noted and compared between the groups at what time period after the start of treatment they returned to their regular sports activities. We hypothesize that EMS group might return early.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.