A Controlled Comparison of Pulsed Radiofrequency Vs Physical Therapy on Treating Chronic Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
It is estimated that nearly 27 million US adults have osteoarthritis (OA) and suffer from pain . Pulsed Radio Frequency (PRF) is one method that has been successfully used in treatment of various etiologies of pain. However there are limited studies and research that prove its effectiveness in treating articular pain. The proposed study's primary aim is determining if PRF is an effective treatment for chronic osteoarthritic knee pain. This study hypothesizes that PRF has analgesic properties immediately after treatment and at least 3 months afterwards compared to control treatment with physical therapy. Additionally this research project addresses several other objectives including: Provide a controlled study to determine the effectiveness of PRF for intra-articular pain Determine how effective PRF is 1 month and 3 months after treatment for articular pain. Further scientific evidence on the overall effectiveness of PRF Provide evidence that PRF likely has other mechanism of action besides direct nerve stimulation of inhibitory pain pathways. Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee osteoarthritis.

Official Title
-----------------
A Controlled Comparison of Pulsed Radiofrequency Vs Physical Therapy on Treating Chronic Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Percutaneous Pulsed Radiofrequency
* Procedure: Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 Radiologic evidence of Kellgren-Lawrence knee arthritis between levels 1-3 Satisfy the American College of Rheumatology criteria for knee osteoarthritis. Exclusion Criteria: Failure to satisfy inclusion criteria Existence of general contraindications against percutaneous knee intervention including (e.g. infection, hemorrhagic diathesis, anticoagulated patients) Patients with pacemaker or stimulator implants Metallic hardware located in the treatment knee of choice High clinical suspicion for alternative diagnosis other than Knee Osteoarthritis VA defined vulnerable populations (e.g. adults with cognitive impairments, mentally retarded, non-english speaking, severe psychiatric disorders, prisoners, terminally ill patient, employees, homeless, pregnant). Any patient that would not be able to follow up at 1 and 3 months after intervention. Any patient unwilling to receive physical therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed Radiofrequency<br>Pulsed Radiofrequency This group will receive one dose of intra-articular PRF in the affected knee using previous literature standards. This includes standard blood pressure monitoring, sterile preparation, and needle insertion of the PRF probe directed at the site of maximal pain. The RFG-3C Plus radiofrequency generator will be activated at 42C, pulse width 10ms, and 2Hz frequency for 15 min. | Device: Percutaneous Pulsed Radiofrequency<br>* Pulsed Radiofrequency<br>* Other names: Pulsed Radiofrequency;|
| Active Comparator: Physical Therapy<br>This group will receive standard of care outpatient physical therapy weekly for 3-4 weeks with therapist instructions to reduce knee pain. | Procedure: Physical Therapy<br> <br> * Other names: Physical Therapy for 4 weeks;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy | The Study will measure VAS pain scores (0-10) at initial consult, 1 month, and 3 months. Additionally the study will document functional changes using the WOMAC questionnaire at initial evaluation and 3 months. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of pulsed radiofrequency for knee pain treatment | The study will measure and document any adverse effects that occur in the study arms. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
focus: pulsed radiofrequency (E02.779.468.599)