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

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ClinicalTrials.gov Identifier: NCT03184545
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Leon Popovitz, Northwell Health

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.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Device: EMS Other: Physical therapy Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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. 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.
Masking: Single (Outcomes Assessor)
Masking Description: The examiner who will be evaluating and assessing the outcome scores on each visit will be blinded to the patient's group.
Primary Purpose: Treatment
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
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: EMS and PT
Group 1: Electrical Muscle stimulation (EMS) and Physical therapy (PT).
Device: EMS
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.

Other: Physical therapy
Standard physical therapy exercises

Active Comparator: Only PT
Group 2: Only Physical therapy (PT).
Other: Physical therapy
Standard physical therapy exercises




Primary Outcome Measures :
  1. Kujala patellofemoral score. [ Time Frame: 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.


  2. Visual analog pain scale (VAS) pain scale during activities of life [ Time Frame: 2 years ]
    VAS scale of 1-10 will be used to evaluate knee pain. 1 being mild and 10 being worst.

  3. Isometric strength measurement of knee [ Time Frame: 2 years ]
    Isometric strength will be measured using dynamo-meter.


Secondary Outcome Measures :
  1. Secondary outcome measure would be how many return to sports activity. [ Time Frame: 2 years ]
    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.

  2. At what point of time they returned to their sports activity [ Time Frame: 2 years ]
    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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184545


Contacts
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Contact: Leon Popovitz, MD 2127594553 orthodoc205@gmail.com
Contact: Rupesh Tarwala, MD 2132915282 dr.rupesh@gmail.com

Locations
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United States, New York
New York Bone and Joint Specialists Recruiting
New York, New York, United States, 10019
Contact: Leon Popovitz, MD    212-759-4553    orthodoc205@gmail.com   
Contact: Rupesh Tarwala, MD    2127594553    dr.rupesh@gmail.com   
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Leon Popovitz, MD Northwell Health

Publications:

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Responsible Party: Leon Popovitz, Orthopaedic Surgeon, Northwell Health
ClinicalTrials.gov Identifier: NCT03184545     History of Changes
Other Study ID Numbers: 16-726
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No patient data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Leon Popovitz, Northwell Health:
anterior knee pain

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases