Recruiting
Phase 3

Electrical Stimulation & Physical Therapy

Sponsor:

Northwell Health

Code:

NCT03184545

Conditions

Patellofemoral Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

EMS

Physical therapy

Study Details

Brief summary:

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.

Conditions

Patellofemoral Pain Syndrome

Study ID

NCT03184545

Start date

Jul 24, 2017

Status verified date

Nov, 2024

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EMS and PT

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

active comparator: Only PT

Group 2: Only Physical therapy (PT).

Interventions

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.

Physical therapy

Standard physical therapy exercises

Primary outcome measure

  • 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. ]
  • Visual analog pain scale (VAS) pain scale during activities of life [ Time Frame: 2 years ]
  • Isometric strength measurement of knee [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Leon Popovitz, MD

2127594553orthodoc205@gmail.com

Rupesh Tarwala, MD

2132915282dr.rupesh@gmail.com

Locations

New York Bone and Joint Specialists

Recruiting

New York, New York, United States, 10019

Contacts

Leon Popovitz, MD

2127594553orthodoc205@gmail.com

Rupesh Tarwala, MD

2127594553dr.rupesh@gmail.com

More Information

Sponsor

Northwell Health

Last update posted

Dec 3, 2024

Last verified

Nov, 2024

Keywords

  • anterior knee pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2024-12-03.