Comparing electrical stimulation and physical therapy for knee pain
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
PHASE3 · Northwell Health · NCT03184545
This study is testing if using an electrical stimulation device along with physical therapy can help people with knee pain recover faster and feel better compared to just physical therapy alone.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Northwell Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03184545 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an electrical muscle stimulation (EMS) device in conjunction with physical therapy for patients suffering from patellofemoral pain syndrome, commonly known as anterior knee pain. Participants will be divided into two groups: one receiving EMS along with physical therapy, and the other receiving physical therapy alone. The goal is to determine if the addition of EMS accelerates recovery and improves outcomes compared to standard physical therapy. The EMS device used is FDA approved and has shown promise in treating knee-related conditions. This study aims to include a larger patient population to validate previous findings that were limited by small sample sizes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 40 with bilateral or unilateral anterior knee pain lasting more than three months and specific pain-related criteria.
Not a fit: Patients with a history of knee surgery, patellar dislocation, or other significant knee pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with patellofemoral pain syndrome, potentially leading to faster recovery times.
How similar studies have performed: Previous studies have shown mixed results with similar approaches, indicating the need for further investigation with larger sample sizes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- New York Bone and Joint Specialists — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Leon Popovitz, MD — Northwell Health
- Study coordinator: Leon Popovitz, MD
- Email: orthodoc205@gmail.com
- Phone: 2127594553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patellofemoral Pain Syndrome, anterior knee pain