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

Patellofemoral Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03184545
• Other study ID #: 16-726
• Status: Recruiting
• Phase: Phase 3
• Start date: July 24, 2017
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: Leon Popovitz, MD
• Phone: 2127594553
• Email: orthodoc205[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	New York Bone and Joint Specialists	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Chang WD, Huang WS, Lai PT. Muscle Activation of Vastus Medialis Oblique and Vastus Lateralis in Sling-Based Exercises in Patients with Patellofemoral Pain Syndrome: A Cross-Over Study. Evid Based Complement Alternat Med. 2015;2015:740315. doi: 10.1155/2015/740315. Epub 2015 Oct 4. — View Citation

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. — View Citation

Crossley KM, Callaghan MJ, van Linschoten R. Patellofemoral pain. BMJ. 2015 Nov 4;351:h3939. doi: 10.1136/bmj.h3939. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hott A, Liavaag S, Juel NG, Brox JI. 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 Musculoskelet Disord. 2015 Feb 25;16:40. doi: 10.1186/s12891-015-0493-6. — View Citation

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. — View Citation

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. — View Citation

Ramazzina I, Pogliacomi F, Bertuletti S, Costantino C. Long term effect of selective muscle strengthening in athletes with patellofemoral pain syndrome. Acta Biomed. 2016 Apr 15;87 Suppl 1:60-8. — View Citation

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. — View Citation

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. — View Citation

Servodio Iammarrone C, Cadossi M, Sambri A, Grosso E, Corrado B, Servodio Iammarrone F. Is there a role of pulsed electromagnetic fields in management of patellofemoral pain syndrome? Randomized controlled study at one year follow-up. Bioelectromagnetics. 2016 Feb;37(2):81-8. doi: 10.1002/bem.21953. Epub 2016 Jan 12. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	2 years
Primary	Isometric strength measurement of knee	Isometric strength will be measured using dynamo-meter.	2 years
Secondary	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.	2 years
Secondary	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.	2 years