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Electrical Stimulation vs Physical Therapy for Knee Pain

Phase 3
Recruiting
Led By Leon Popovitz, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 3 of the 4 following criteria present: pain associated with prolonged sitting with knees bent, pain with going downstairs, kneeling and squatting, or sports activities
No history of surgery to the knee
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing whether electrical muscle stimulation can help treat patellofemoral pain syndrome, a type of anterior knee pain.

Who is the study for?
This trial is for individuals aged 18-40 with patellofemoral pain syndrome, which includes knee pain from sitting, stairs, or exercise. Candidates shouldn't have a history of knee injuries or surgery and can't be pregnant or have used steroids recently.Check my eligibility
What is being tested?
The study compares the effectiveness of electrical muscle stimulation (EMS) combined with physical therapy (PT) versus PT alone in improving knee pain outcomes in patients with anterior knee pain.See study design
What are the potential side effects?
Potential side effects may include discomfort at the EMS application site, skin irritation, muscle twitching during use, and unusual sensations like tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience pain in at least 3 activities: sitting, going downstairs, kneeling/squatting, or during sports.
Select...
I have never had knee surgery.
Select...
I am between 18 and 40 years old.
Select...
I have had knee pain for over 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Isometric strength measurement of knee
Kujala patellofemoral score.
Visual analog pain scale (VAS) pain scale during activities of life
Secondary outcome measures
At what point of time they returned to their sports activity
measure would be how many return to sports activity.

Side effects data

From 2011 Phase 4 trial • 127 Patients • NCT01250184
10%
Hematomas
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lidocaine Injection + Physical Therapy
Physical Therapy
Lidocaine Injection

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EMS and PTExperimental Treatment2 Interventions
Group 1: Electrical Muscle stimulation (EMS) and Physical therapy (PT).
Group II: Only PTActive Control1 Intervention
Group 2: Only Physical therapy (PT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EMS
2023
N/A
~230

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
457 Previous Clinical Trials
470,167 Total Patients Enrolled
Leon Popovitz, MD4.6221 ReviewsPrincipal Investigator - Northwell Health
Lenox Hill Hospital
Medical School - New York Medical College, Doctor of Medicine
Lenox Hill Hospital, Residency in Orthopedic Surgery
4Patient Review
The staff are all nice, but you can expect long waits.

Media Library

Physical therapy Clinical Trial Eligibility Overview. Trial Name: NCT03184545 — Phase 3
Patellofemoral Pain Syndrome Research Study Groups: EMS and PT, Only PT
Patellofemoral Pain Syndrome Clinical Trial 2023: Physical therapy Highlights & Side Effects. Trial Name: NCT03184545 — Phase 3
Physical therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03184545 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given their official opinion on physical therapy?

"There is some preexisting data supporting the efficacy of physical therapy, as well as multiple rounds of safety testing. Consequently, our team at Power gave it a score of 3."

Answered by AI

Are middle-aged adults eligible to enroll in this clinical research?

"As this study's inclusion criteria specifies, only individuals aged 18-40 may enroll."

Answered by AI

Are there any vacancies in this research program for new test subjects?

"Yes, this information can be found on clinicaltrials.gov. This particular trial was originally posted on July 24th, 2017 and was last edited on October 1st, 2020."

Answered by AI

How can I sign up for the clinical trial?

"This study requires 92 individuals, all aged 18 to 40, who suffer from patellofemoral pain. Other requirements for participants include: Bilateral/unilateral anterior knee pain for more than 3 moths, Age of patient 18 to 40 years, No h/o injury, No h/o surgery to the knee."

Answered by AI

How many people are being welcomed into this research project?

"That is correct, the listing on clinicaltrials.gov currently says that this trial is recruiting patients. This particular study was first advertised on July 24th, 2017 and was updated October 1st, 2020. They are looking for a total of 92 participants across 1 location."

Answered by AI
Recent research and studies
~14 spots leftby Jun 2025