NCT03184545 · Northwell Health
Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
What this study is about
The purpose of study is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
DEVICE
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.
OTHER
Physical therapy
Standard physical therapy exercises
Primary outcome measures
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.
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.
Visual analog pain scale (VAS) pain scale during activities of life
Time frame: 2 years
VAS scale of 1-10 will be used to evaluate knee pain. 1 being mild and 10 being worst.
Isometric strength measurement of knee
Time frame: 2 years
Isometric strength will be measured using dynamo-meter.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 3, 2024 · Source of record for eligibility and locations