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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-40
SponsorNorthwell Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

H/o patellar dislocation or subluxation

Associated bursitis, tendinitis in periarticular area

Ligamentous problems

Intra-articular pathology

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Standard physical therapy exercises

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: EMS and PTExperimental treatment 2 interventions
Group B: Only PTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.
2

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.

Time frame
2 years
3

Isometric strength measurement of knee

Isometric strength will be measured using dynamo-meter.

Time frame
2 years

Secondary outcomes

1

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.

Time frame
2 years
2

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.

Time frame
2 years

Other outcomes

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