Study Summary
This trial is testing whether electrical muscle stimulation can help treat patellofemoral pain syndrome, a type of anterior knee pain.
Eligible Conditions
- Patellofemoral Pain Syndrome
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: 2 years
2 years
At what point of time they returned to their sports activity
Isometric strength measurement of knee
Visual analog pain scale (VAS) pain scale during activities of life
measure would be how many return to sports activity.
Year 2
Kujala patellofemoral score.
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Lidocaine Injection
5%Hematomas
2%Bleeding
Trial Design
2 Treatment Groups
Only PT
1 of 2
EMS and PT
1 of 2
Active Control
Experimental Treatment
92 Total Participants · 2 Treatment Groups
Primary Treatment: Physical therapy · No Placebo Group · Phase 3
EMS and PTExperimental Group · 2 Interventions: EMS, Physical therapy · Intervention Types: Device, Other
Only PT
Other
ActiveComparator Group · 1 Intervention: Physical therapy · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EMS
2015
N/A
~210
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Northwell HealthLead Sponsor
425 Previous Clinical Trials
493,438 Total Patients Enrolled
Leon Popovitz, MD4.6221 ReviewsPrincipal Investigator - Northwell Health
Lenox Hill Hospital
Medical School - New York Medical College, Doctor of Medicine
Lenox Hill Hospital, Residency in Orthopedic Surgery
4Patient Review
The staff are all nice, but you can expect long waits.
Eligibility Criteria
Age 18 - 40 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The person has been having pain in their knees for more than three months
The individual experiences pain associated with prolonged sitting with their knees bent, pain with going downstairs, kneeling and squatting, or sports activities.
There was no history of injury.
There is no history of surgery to the knee.
References
- Giles, Lachlan S., Kate E. Webster, Jodie A. McClelland, and Jill Cook. 2013. “Does Quadriceps Atrophy Exist in Individuals with Patellofemoral Pain? A Systematic Literature Review with Meta-analysis”. Journal of Orthopaedic & Sports Physical Therapy. Journal of Orthopaedic & Sports Physical Therapy (JOSPT). doi:10.2519/jospt.2013.4833.
- Witvrouw, Erik, S. Werner, C. Mikkelsen, D. Van Tiggelen, L. Vanden Berghe, and G. Cerulli. 2005. “Clinical Classification of Patellofemoral Pain Syndrome: Guidelines for Non-operative Treatment”. Knee Surgery, Sports Traumatology, Arthroscopy. Springer Science and Business Media LLC. doi:10.1007/s00167-004-0577-6.
- Fagan, V, and E Delahunt. 2008. “Patellofemoral Pain Syndrome: A Review on the Associated Neuromuscular Deficits and Current Treatment Options”. British Journal of Sports Medicine. BMJ. doi:10.1136/bjsm.2008.046623.
- Avraham, Feazadeh, Saposhnik Aviv, Pnina Ya'akobi, Hava Faran, Zilla Fisher, Yael Goldman, Guy Neeman, and Eli Carmeli. 2007. “The Efficacy of Treatment of Different Intervention Programs for Patellofemoral Pain Syndrome–a Single Blinded Randomized Clinical Trial. Pilot Study”. The Scientific World JOURNAL. Hindawi Limited. doi:10.1100/tsw.2007.167.
- Rixe, Jeffrey A., Joshua E. Glick, Jodi Brady, and Robert P. Olympia. 2013. “A Review of the Management of Patellofemoral Pain Syndrome”. The Physician and Sportsmedicine. Informa UK Limited. doi:10.3810/psm.2013.09.2023.
- Hott, Alexandra, Sigurd Liavaag, Niels Gunnar Juel, and Jens Ivar Brox. 2015. “Study Protocol: A Randomised Controlled Trial Comparing the Long Term Effects of Isolated Hip Strengthening, Quadriceps-based Training and Free Physical Activity for Patellofemoral Pain Syndrome (anterior Knee Pain)”. BMC Musculoskeletal Disorders. Springer Science and Business Media LLC. doi:10.1186/s12891-015-0493-6.
- Alba-Martín, Pablo, T Gallego-Izquierdo, Gustavo Plaza-Manzano, Natalia Romero-Franco, Susana Núñez-Nagy, and Daniel Pecos-Martín. 2015. “Effectiveness of Therapeutic Physical Exercise in the Treatment of Patellofemoral Pain Syndrome: A Systematic Review”. Journal of Physical Therapy Science. Society of Physical Therapy Science. doi:10.1589/jpts.27.2387.
- Hott, Alexandra, Sigurd Liavaag, Niels Gunnar Juel, and Jens Ivar Brox. 2015. “Study Protocol: A Randomised Controlled Trial Comparing the Long Term Effects of Isolated Hip Strengthening, Quadriceps-based Training and Free Physical Activity for Patellofemoral Pain Syndrome (anterior Knee Pain)”. BMC Musculoskeletal Disorders. Springer Science and Business Media LLC. doi:10.1186/s12891-015-0493-6.
- 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. Review.
- Giles, Lachlan S., Kate E. Webster, Jodie A. McClelland, and Jill Cook. 2015. “Atrophy of the Quadriceps Is Not Isolated to the Vastus Medialis Oblique in Individuals with Patellofemoral Pain”. Journal of Orthopaedic & Sports Physical Therapy. Journal of Orthopaedic & Sports Physical Therapy (JOSPT). doi:10.2519/jospt.2015.5852.
- Chang, Wen-Dien, Wei-Syuan Huang, and Ping-Tung Lai. 2015. “Muscle Activation of Vastus Medialis Oblique and Vastus Lateralis in Sling-based Exercises in Patients with Patellofemoral Pain Syndrome: A Cross-over Study”. Evidence-based Complementary and Alternative Medicine. Hindawi Limited. doi:10.1155/2015/740315.
- Cowan, Sallie M., Kim L. Bennell, Paul W. Hodges, Kay M. Crossley, and Jenny McConnell. 2001. “Delayed Onset of Electromyographic Activity of Vastus Medialis Obliquus Relative to Vastus Lateralis in Subjects with Patellofemoral Pain Syndrome”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1053/apmr.2001.19022.
- Peng, Hsien-Te, and Chen-Yi Song. 2015. “Predictors of Treatment Response to Strengthening and Stretching Exercises for Patellofemoral Pain: An Examination of Patellar Alignment”. The Knee. Elsevier BV. doi:10.1016/j.knee.2014.10.012.
- Bily, Walter, Lukas Trimmel, Michaela Mödlin, Alexandra Kaider, and Helmut Kern. 2008. “Training Program and Additional Electric Muscle Stimulation for Patellofemoral Pain Syndrome: A Pilot Study”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2007.10.048.
- Callaghan, Michael J, and Jacqueline A Oldham. 2004. “Electric Muscle Stimulation of the Quadriceps in the Treatment of Patellofemoral Pain11a Commercial Party with a Direct Financial Interest in the Results of the Research Supporting This Article Has Conferred or Will Confer a Financial Benefit on the Author or 1 or More of the Authors.”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2003.07.021.
- Chiu, Joseph K.W., Yiu-ming Wong, Patrick S.H. Yung, and Gabriel Y.F. Ng. 2012. “The Effects of Quadriceps Strengthening on Pain, Function, and Patellofemoral Joint Contact Area in Persons with Patellofemoral Pain”. American Journal of Physical Medicine & Rehabilitation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/phm.0b013e318228c505.
- Fukuda, Thiago Yukio, Flavio Marcondes Rossetto, Eduardo Magalhães, Flavio Fernandes Bryk, Paulo Roberto Garcia Lucareli, and Nilza Aparecida De Almeida Carvalho. 2010. “Short-term Effects of Hip Abductors and Lateral Rotators Strengthening in Females with Patellofemoral Pain Syndrome: A Randomized Controlled Clinical Trial”. Journal of Orthopaedic & Sports Physical Therapy. Journal of Orthopaedic & Sports Physical Therapy (JOSPT). doi:10.2519/jospt.2010.3246.
- Kuru, Tugba. 2012. “Comparison of Efficiency of Kinesio® Taping and Electrical Stimulation in Patients with Patellofemoral Pain Syndrome”. Acta Orthopaedica Et Traumatologica Turcica. AVES Publishing Co.. doi:10.3944/aott.2012.2682.
- Servodio Iammarrone, Clemente, Matteo Cadossi, Andrea Sambri, Eugenio Grosso, Bruno Corrado, and Fernanda Servodio Iammarrone. 2016. “Is There a Role of Pulsed Electromagnetic Fields in Management of Patellofemoral Pain Syndrome? Randomized Controlled Study at One Year Follow-up”. Bioelectromagnetics. Wiley. doi:10.1002/bem.21953.
- Crossley, Kay M, Michael J Callaghan, and Robbart van Linschoten. 2015. “Patellofemoral Pain”. Bmj. BMJ. doi:10.1136/bmj.h3939.
- Callaghan, Michael J, Jacqueline A Oldham, and Julie Winstanley. 2001. “A Comparison of Two Types of Electrical Stimulation of the Quadriceps in the Treatment of Patellofemoral Pain Syndrome. A Pilot Study”. Clinical Rehabilitation. SAGE Publications. doi:10.1191/0269215501cr457oa.
- Avramidis, Kyriakos, Paul W Strike, Paul N Taylor, and Ian D Swain. 2003. “Effectiveness of Electric Stimulation of the Vastus Medialis Muscle in the Rehabilitation of Patients After Total Knee Arthroplasty11no Commercial Party Having a Direct Financial Interest in the Results of the Research Supporting This Article Has or Will Confer a Benefit on the Author(s) or on Any Organization with Which the Author(s) Is/are Associated.”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/s0003-9993(03)00429-5.
- 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.
- 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.
- 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.
- Fagan V, Delahunt E. Patellofemoral pain syndrome: a review on the associated neuromuscular deficits and current treatment options. Br J Sports Med. 2008 Oct;42(10):789-95. doi: 10.1136/bjsm.2008.046623. Epub 2008 Apr 18. Erratum In: Br J Sports Med. 2009 Apr;43(4):310-1.
- 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.
- 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.
- 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.
- Giles LS, Webster KE, McClelland JA, Cook J. Does quadriceps atrophy exist in individuals with patellofemoral pain? A systematic literature review with meta-analysis. J Orthop Sports Phys Ther. 2013 Nov;43(11):766-76. doi: 10.2519/jospt.2013.4833. Epub 2013 Sep 9.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Clin Rehabil 2002 May;16(3):345.
- Crossley KM, Callaghan MJ, van Linschoten R. Patellofemoral pain. BMJ. 2015 Nov 4;351:h3939. doi: 10.1136/bmj.h3939. No abstract available.
- Leon Popovitz 2017. "Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03184545.
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