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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02294864
• Other study ID #: IRB #1283
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2014
• Last updated: December 22, 2015
• Start date: April 2014

Study information

• Verified date: December 2015
• Source: VA Long Beach Healthcare System
• Contact: Ronald Takemoto, M.D.
• Phone: 562-826-5554
• Email: ronald.takemoto[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Percutaneous Pulsed Radiofrequency
Pulsed Radiofrequency

Procedure:
• Physical Therapy

Locations

Country	Name	City	State
United States	Long Beach Veterans Hospital	Long Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Long Beach Healthcare System	Southern California Institute for Research and Education

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Karaman H, Tüfek A, Kavak GÖ, 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes