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

NCT ID: NCT03184545

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-24

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patellofemoral Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The examiner who will be evaluating and assessing the outcome scores on each visit will be blinded to the patient's group.

Study Groups

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EMS and PT

Group 1: Electrical Muscle stimulation (EMS) and Physical therapy (PT).

Group Type EXPERIMENTAL

EMS

Intervention Type 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 Type OTHER

Standard physical therapy exercises

Only PT

Group 2: Only Physical therapy (PT).

Group Type ACTIVE_COMPARATOR

Physical therapy

Intervention Type OTHER

Standard physical therapy exercises

Interventions

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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.

Intervention Type DEVICE

Physical therapy

Standard physical therapy exercises

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Leon Popovitz

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leon Popovitz, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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New York Bone and Joint Specialists

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Leon Popovitz, MD

Role: CONTACT

[email protected]
2127594553

Rupesh Tarwala, MD

Role: CONTACT

[email protected]
2132915282

Facility Contacts

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Leon Popovitz, MD

Role: primary

[email protected]
2127594553

Rupesh Tarwala, MD

Role: backup

[email protected]
2127594553

References

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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.

Reference Type BACKGROUND
PMID: 18586125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11777094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14669193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15179650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23268824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21340241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15703965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17721640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22248804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24113699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26254693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26158920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25883866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26311988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26110547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24175596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26756278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27104322 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26504480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18424487 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26537829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25879452 (View on PubMed)

Other Identifiers

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16-726

Identifier Type: -

Identifier Source: org_study_id