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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Другое Physical therapy
  Standard physical therapy exercises

Первичные конечные точки

• Kujala patellofemoral score. [Срок оценки: 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.]
• Visual analog pain scale (VAS) pain scale during activities of life [Срок оценки: 2 years]
• Isometric strength measurement of knee [Срок оценки: 2 years]

Вторичные конечные точки (2)

• Secondary outcome measure would be how many return to sports activity. [Срок оценки: 2 years]
• At what point of time they returned to their sports activity [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• New York Bone and Joint Specialists — New York

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 17721640

Идентификаторы

NCT: NCT03184545 · 16-726

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗