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Patellofemoral Pain SyndromePhase 3NCT03184545

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

A Phase 3 study testing EMS and Physical therapy in people with Patellofemoral Pain Syndrome, run by Northwell Health at 1 site in United States.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Patellofemoral Pain Syndrome
What is being tested?
EMS and Physical therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteUnited States
Study dates
24 Jul 2017to Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Leon Popovitz, MD contact

2127594553

orthodoc205@gmail.com

Rupesh Tarwala, MD contact

2132915282

dr.rupesh@gmail.com

United States1 site, 1 recruiting
  • New York Bone and Joint Specialists

    New York, New York, 10019

    Leon Popovitz, MD, 2127594553, orthodoc205@gmail.com

    Rupesh Tarwala, MD, 2127594553, dr.rupesh@gmail.com

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
EMS, Physical therapy
Keywords
anterior knee pain
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMSDevice

    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 therapyOther

    Standard physical therapy exercises

Study groups in NCT03184545
Study groupRoleWhat they receive
EMS and PTExperimentalGroup 1: Electrical Muscle stimulation (EMS) and Physical therapy (PT).
Receives: Device: EMS; Other: Physical therapy
Only PTActive comparatorGroup 2: Only Physical therapy (PT).
Receives: Other: Physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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. 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.

    Measured: 2 years

  3. Isometric strength measurement of knee

    Isometric strength will be measured using dynamo-meter.

    Measured: 2 years

Secondary outcomes (2)
  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2017
  2. Study start24 Jul 2017
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03184545
Sponsor's protocol ID
16-726
Status last verified
Oct 2026
First submitted
4 Jun 2017
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No patient data will be shared.

Publications

  • Bily W, Trimmel L, Modlin M, Kaider A, Kern H. Training program and additional electric muscle stimulation for patellofemoral pain syndrome: a pilot study. Arch Phys Med Rehabil. 2008 Jul;89(7):1230-6. doi: 10.1016/j.apmr.2007.10.048.

    PubMed 18586125
  • Callaghan MJ, Oldham JA, Winstanley J. A comparison of two types of electrical stimulation of the quadriceps in the treatment of patellofemoral pain syndrome. A pilot study. Clin Rehabil. 2001 Dec;15(6):637-46. doi: 10.1191/0269215501cr457oa.

    PubMed 11777094
  • Avramidis K, Strike PW, Taylor PN, Swain ID. Effectiveness of electric stimulation of the vastus medialis muscle in the rehabilitation of patients after total knee arthroplasty. Arch Phys Med Rehabil. 2003 Dec;84(12):1850-3. doi: 10.1016/s0003-9993(03)00429-5.

    PubMed 14669193
  • Callaghan MJ, Oldham JA. Electric muscle stimulation of the quadriceps in the treatment of patellofemoral pain. Arch Phys Med Rehabil. 2004 Jun;85(6):956-62. doi: 10.1016/j.apmr.2003.07.021.

    PubMed 15179650
  • Kuru T, Yaliman A, Dereli EE. Comparison of efficiency of Kinesio(R) taping and electrical stimulation in patients with patellofemoral pain syndrome. Acta Orthop Traumatol Turc. 2012;46(5):385-92. doi: 10.3944/aott.2012.2682.

    PubMed 23268824
  • Garcia FR, Azevedo FM, Alves N, Carvalho AC, Padovani CR, Negrao Filho RF. Effects of electrical stimulation of vastus medialis obliquus muscle in patients with patellofemoral pain syndrome: an electromyographic analysis. Rev Bras Fisioter. 2010 Nov-Dec;14(6):477-82. English, Portuguese.

    PubMed 21340241
  • Witvrouw E, Werner S, Mikkelsen C, Van Tiggelen D, Vanden Berghe L, Cerulli G. Clinical classification of patellofemoral pain syndrome: guidelines for non-operative treatment. Knee Surg Sports Traumatol Arthrosc. 2005 Mar;13(2):122-30. doi: 10.1007/s00167-004-0577-6. Epub 2005 Feb 10.

    PubMed 15703965
  • Avraham F, Aviv S, Ya'akobi P, Faran H, Fisher Z, Goldman Y, Neeman G, Carmeli E. The efficacy of treatment of different intervention programs for patellofemoral pain syndrome--a single blinded randomized clinical trial. Pilot study. ScientificWorldJournal. 2007 Aug 24;7:1256-62. doi: 10.1100/tsw.2007.167.

    PubMed 17721640
  • Chiu JK, Wong YM, Yung PS, Ng GY. The effects of quadriceps strengthening on pain, function, and patellofemoral joint contact area in persons with patellofemoral pain. Am J Phys Med Rehabil. 2012 Feb;91(2):98-106. doi: 10.1097/PHM.0b013e318228c505.

    PubMed 22248804
  • Rixe JA, Glick JE, Brady J, Olympia RP. A review of the management of patellofemoral pain syndrome. Phys Sportsmed. 2013 Sep;41(3):19-28. doi: 10.3810/psm.2013.09.2023.

    PubMed 24113699
  • Peng HT, Song CY. Predictors of treatment response to strengthening and stretching exercises for patellofemoral pain: An examination of patellar alignment. Knee. 2015 Dec;22(6):494-8. doi: 10.1016/j.knee.2014.10.012. Epub 2014 Nov 10.

    PubMed 26254693
  • Van Der Heijden RA, Lankhorst NE, Van Linschoten R, Bierma-Zeinstra SM, Van Middelkoop M. Exercise for treating patellofemoral pain syndrome: an abridged version of Cochrane systematic review. Eur J Phys Rehabil Med. 2016 Feb;52(1):110-33. Epub 2015 Jul 9.

    PubMed 26158920
  • Selhorst M, Rice W, Degenhart T, Jackowski M, Tatman M. Evaluation of a treatment algorithm for patients with patellofemoral pain syndrome: a pilot study. Int J Sports Phys Ther. 2015 Apr;10(2):178-88.

    PubMed 25883866
  • Alba-Martin P, Gallego-Izquierdo T, Plaza-Manzano G, Romero-Franco N, Nunez-Nagy S, Pecos-Martin D. Effectiveness of therapeutic physical exercise in the treatment of patellofemoral pain syndrome: a systematic review. J Phys Ther Sci. 2015 Jul;27(7):2387-90. doi: 10.1589/jpts.27.2387. Epub 2015 Jul 22.

    PubMed 26311988
  • Giles LS, Webster KE, McClelland JA, Cook J. Atrophy of the Quadriceps Is Not Isolated to the Vastus Medialis Oblique in Individuals With Patellofemoral Pain. J Orthop Sports Phys Ther. 2015 Aug;45(8):613-9. doi: 10.2519/jospt.2015.5852. Epub 2015 Jun 25.

    PubMed 26110547

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EMS and Physical therapy in people with Patellofemoral Pain Syndrome, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leon Popovitz, MD (2127594553, orthodoc205@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03184545, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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