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

VA Long Beach Healthcare System50 enrolled

Overview

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: 1. Provide a controlled study to determine the effectiveness of PRF for intra-articular pain 2. Determine how effective PRF is 1 month and 3 months after treatment for articular pain. 3. Further scientific evidence on the overall effectiveness of PRF 4. Provide evidence that PRF likely has other mechanism of action besides direct nerve stimulation of inhibitory pain pathways. 5. Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee osteoarthritis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

Safety of pulsed radiofrequency for knee pain treatment

The study will measure and document any adverse effects that occur in the study arms.