NCT02294864

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

November 12, 2014

Last Update Submit

December 22, 2015

Conditions

Knee Osteoarthritis

Keywords

focus: pulsed radiofrequency (E02.779.468.599)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety of pulsed radiofrequency for knee pain treatment

    3 months

Study Arms (2)

Pulsed Radiofrequency

EXPERIMENTAL

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

Physical Therapy

ACTIVE COMPARATOR

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

Interventions

Percutaneous Pulsed RadiofrequencyDEVICE

Pulsed Radiofrequency

Also known as: Pulsed Radiofrequency
Pulsed Radiofrequency
Physical TherapyPROCEDURE
Also known as: Physical Therapy for 4 weeks
Physical Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Beach Veterans Hospital

Long Beach, California, 90822, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18163497BACKGROUND

  • 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.

    PMID: 22301609BACKGROUND

  • 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.

    PMID: 18211593BACKGROUND

  • 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.

    PMID: 21872812BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Pulsed Radiofrequency TreatmentPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsRadiofrequency TherapyRehabilitation

Study Officials

  • Ronald Takemoto, M.D.

    Principal Investigator

    PRINCIPAL INVESTIGATOR

  • Ravi Mirpuri, D.O.

    Long Beach VA resident

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald Takemoto, M.D.

CONTACT

562-826-5554ronald.takemoto@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Of California Resident Physician

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 19, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2017

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

US(1)