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
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Visual analog pain scale (VAS) pain scale during activities of life
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The examiner who will be evaluating and assessing the outcome scores on each visit will be blinded to the patient's group.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Visual analog pain scale (VAS) pain scale during activities of life
时间窗: 2 years
VAS scale of 1-10 will be used to evaluate knee pain. 1 being mild and 10 being worst.
Isometric strength measurement of knee
时间窗: 2 years
Isometric strength will be measured using dynamo-meter.
Kujala patellofemoral score.
时间窗: 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.
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.
次要结局
- Secondary outcome measure would be how many return to sports activity.(2 years)
- At what point of time they returned to their sports activity(2 years)
研究者
Leon Popovitz
Orthopaedic Surgeon
Northwell Health