Clinical trial NCT03184545: Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
Official title: A Prospective Randomized Study Comparing the Outcome of Electrical Stimulation of Vastus Medialis Obliquus Muscle and Physical Therapy Vs Only Physical Therapy but No Electrical Stimulation in Patients with Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Patellofemoral Pain Syndrome
Keywords: anterior knee pain
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It's a phase III study. A randomized, observer blinded, single center study. Patients will be divided in two groups based on randomization. One group will receive electrical muscle stimulation and Physical therapy and other group will receive only physical therapy. Electrical muscle stimulation device is The Flex MT Plus (Electrostim Medical Services Inc. Tampa, FL) is a neuromuscular stimulator. It is approved by the Food and Drug Administration (FDA). Assessment and follow up will be performed before start of treatment, at 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months post-start of treatment . Assessment will be done at each visit based on Kujala patellofemoral score, pain visual analog scale (VAS) during activities of daily life and isometric strength measurement.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The patellofemoral pain syndrome also known as anterior knee pain is a common entity in young athletic population. In patellofemoral knee syndrome, one of the theory is that the vastus medialis obliquus muscle is weak. To strengthen the muscle, physical therapy exercises are commonly used. This study evaluates addition of the electrical muscle stimulation device.The electrical muscle stimulation device "Flex MT Plus" (Electrostim Medical Services Inc. Tampa, FL) is a FDA approved device and has been used in knee for other conditions like treating for weakness associated with knee injuries or after knee surgeries. It has shown to improve the outcomes in above mentioned conditions. Its efficacy has been tested in patellofemoral pain syndrome but in smaller sample size. We intend to test it in larger sample size patient population.

Bily et al (2008) (reference #1) published their results on patellofemoral pain syndrome comparing EMS +PT to PT only and found that overall significant improvement in outcome score in all patients but when compared between the groups there was no difference. But there sample size was 19 patients in each group. Small sample size was one of the limitation of their study. We intend to collect 46 patients in each group to find significant difference based on power analysis.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Kujala patellofemoral score.
timeFrame: 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.
measure: Visual analog pain scale (VAS) pain scale during activities of life
timeFrame: 2 years
measure: Isometric strength measurement of knee
timeFrame: 2 years
Secondary outcomes:
measure: Secondary outcome measure would be how many return to sports activity.
timeFrame: 2 years
measure: At what point of time they returned to their sports activity
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Bone and Joint Specialists
state: New York
Study officials:
affiliation: Northwell Health
name: Leon Popovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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