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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Pulsed Radiofrequency
Physical Therapy
Sponsored by
VA Long Beach Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring focus: pulsed radiofrequency (E02.779.468.599)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Long Beach Veterans HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulsed Radiofrequency

Physical Therapy

Arm Description

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.

This group will receive standard of care outpatient physical therapy weekly for 3-4 weeks with therapist instructions to reduce knee pain.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety of pulsed radiofrequency for knee pain treatment
The study will measure and document any adverse effects that occur in the study arms.

Full Information

First Posted
November 12, 2014
Last Updated
December 22, 2015
Sponsor
VA Long Beach Healthcare System
Collaborators
Southern California Institute for Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02294864
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Long Beach Healthcare System
Collaborators
Southern California Institute for Research and Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
focus: pulsed radiofrequency (E02.779.468.599)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Radiofrequency
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
This group will receive standard of care outpatient physical therapy weekly for 3-4 weeks with therapist instructions to reduce knee pain.
Intervention Type
Device
Intervention Name(s)
Percutaneous Pulsed Radiofrequency
Other Intervention Name(s)
Pulsed Radiofrequency
Intervention Description
Pulsed Radiofrequency
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Other Intervention Name(s)
Physical Therapy for 4 weeks
Primary Outcome Measure Information:
Title
VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy
Description
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 Outcome Measure Information:
Title
Safety of pulsed radiofrequency for knee pain treatment
Description
The study will measure and document any adverse effects that occur in the study arms.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Takemoto, M.D.
Phone
562-826-5554
Email
ronald.takemoto@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Takemoto, M.D.
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ravi Mirpuri, D.O.
Organizational Affiliation
Long Beach VA resident
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Beach Veterans Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Takemoto, M.D.
Phone
562-826-5554
First Name & Middle Initial & Last Name & Degree
Ronald Takemoto, MD
First Name & Middle Initial & Last Name & Degree
Ravi Mirpuri, D.O.

12. IPD Sharing Statement

Citations:
PubMed Identifier
18163497
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.
Results Reference
background
PubMed Identifier
22301609
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.
Results Reference
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PubMed Identifier
18211593
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.
Results Reference
background
PubMed Identifier
21872812
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.
Results Reference
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A Controlled Comparison of Pulsed Radiofrequency Vs Physical Therapy on Treating Chronic Knee Osteoarthritis

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