Clinical trial NCT02294864: A Controlled Comparison of Pulsed Radiofrequency Vs Physical Therapy on Treating Chronic Knee Osteoarthritis
Official title: A Controlled Comparison of Pulsed Radiofrequency Vs Physical Therapy on Treating Chronic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: focus: pulsed radiofrequency (E02.779.468.599)
Lead sponsor: VA Long Beach Healthcare System
Sponsor class: FED
Collaborators: name: Southern California Institute for Research and Education
First posted: 2014-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy
timeFrame: 3 months
Secondary outcomes:
measure: Safety of pulsed radiofrequency for knee pain treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Veterans Hospital
state: California
Study officials:
affiliation: Principal Investigator
name: Ronald Takemoto, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Long Beach VA resident
name: Ravi Mirpuri, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. No abstract available.
citation: 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.