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

Part of paid clinical trials in New York, New York.

Sponsor
Northwell Health
Study ID
NCT03184545
Phase
PHASE3
Status
Recruiting
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Conditions

  • Patellofemoral Pain Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jul 24, 2017
Status verified
Nov 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York Bone and Joint SpecialistsNew YorkNew York10019
Leon Popovitz, MD
[email protected]
2127594553
Rupesh Tarwala, MD
[email protected]
2127594553

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By research site
New York Bone and Joint Specialists· New York, NY

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