Knee Osteoarthritis
Conditions
Keywords
focus: pulsed radiofrequency (E02.779.468.599)
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: 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.
Interventions
DEVICEPercutaneous Pulsed Radiofrequency
Pulsed Radiofrequency
PROCEDUREPhysical Therapy
Sponsors
Southern California Institute for Research and Education
VA Long Beach Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of pulsed radiofrequency for knee pain treatment | 3 months | The study will measure and document any adverse effects that occur in the study arms. |
Countries
United States
Contacts
Primary ContactRonald Takemoto, M.D.
Outcome results
None listed