A Single Blinded Randomized Controlled Clinical Trial Comparing Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration

Sheba Medical Center1 site in 1 country40 target enrollmentApril 1, 2022

ConditionsKnee Pain Chronic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Pain Chronic
Sponsor: Sheba Medical Center
Enrollment: 40
Locations: 1
Primary Endpoint: Improvement in chronic knee pain
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.

Registry

clinicaltrials.gov

Start Date

April 1, 2022

End Date

December 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sheba Medical Center

Responsible Party

Principal Investigator

Dr. Itay GoorAryeh

Doctor Head of Pain Clinics, Sheba Medical Center

Sheba Medical Center

Eligibility Criteria

Inclusion Criteria

•Men and women with pain secondary to osteoarthritis of the knee
•Age of 18 years and up
•Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation

Exclusion Criteria

•Patients who are incapable of judgment and/or to give informed consent
•Patients who are pregnant
•Patients who are under 18 years old
•Patients who have allergies to local anesthetic
•Patients with platelet dysfunction or bleeding disorders
•Patients who are currently mentally unstable
•Patients who have a diagnosis of fibromyalgia

Outcomes

Primary Outcomes

Improvement in chronic knee pain

Time Frame: 2nd and 6th week

Measured by the Knee injury and Osteoarthritis Outcome Score; higher scores indicating that the patients experiences more impairment (All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale; 0 representing extreme knee problems and 100 representing no knee problems).