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

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 Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Physical Therapy; Device: Percutaneous Pulsed Radiofrequency

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronald Takemoto, M.D.; Phone Number: 562-826-5554; Email: ronald.takemoto@va.gov

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Recruiting
      • Long Beach Veterans Hospital
      • Contact: Ronald Takemoto, M.D.; Phone Number: 562-826-5554
      • Principal Investigator: Ronald Takemoto, MD
      • Sub-Investigator: Ravi Mirpuri, D.O.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed Radiofrequency; 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; Pulsed Radiofrequency; Other Names: Pulsed Radiofrequency
Active Comparator: Physical Therapy; 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; 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

Collaborators and Investigators

• Sponsor: VA Long Beach Healthcare System
• Collaborators: Southern California Institute for Research and Education
• Investigators: Principal Investigator: Ronald Takemoto, M.D., Principal Investigator; Principal Investigator: Ravi Mirpuri, D.O., Long Beach VA resident

Publications and helpful links

General Publications

• Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
• Guo L, Kubat NJ, Nelson TR, Isenberg RA. Meta-analysis of clinical efficacy of pulsed radio frequency energy treatment. Ann Surg. 2012 Mar;255(3):457-67. doi: 10.1097/SLA.0b013e3182447b5d.
• Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.
• Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: November 15, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: focus: pulsed radiofrequency (E02.779.468.599)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IRB #1283