What this study is
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.
What's being tested
- EMS
Intervention · DEVICE
The 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
Intervention · OTHER
Standard physical therapy exercises
Study details
- 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
- Sponsor
- Northwell Health
- Conditions
- Patellofemoral Pain Syndrome
- Enrolling
- 92 people
- Starts
- 2017-07-24
- Est. completion
- 2029-06
- Design
- Single-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 40 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNew York Bone and Joint Specialists
New York, New York, United States
- Leon Popovitz, MD · Contact2127594553orthodoc205@gmail.com
- Rupesh Tarwala, MD · Contact2127594553dr.rupesh@gmail.com
Recruiting
Study team
Sponsor
Northwell Health
Study ID 16-726
Principal investigator
Leon Popovitz, MD
Northwell Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.