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NCT Number: NCT03184545

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

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.

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Key information

Conditions

Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMS

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

Other

Standard physical therapy exercises

Primary outcomes

  1. Kujala patellofemoral score.

    Time frame: 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.

  2. Visual analog pain scale (VAS) pain scale during activities of life

    Time frame: 2 years

    VAS scale of 1-10 will be used to evaluate knee pain. 1 being mild and 10 being worst.

  3. Isometric strength measurement of knee

    Time frame: 2 years

    Isometric strength will be measured using dynamo-meter.

Secondary outcomes

  1. Secondary outcome measure would be how many return to sports activity.

    Time frame: 2 years

    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. At what point of time they returned to their sports activity

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leon Popovitz, MD

CONTACT

[email protected]

2127594553

Rupesh Tarwala, MD

CONTACT

[email protected]

2132915282

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Jun 12, 2017
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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