Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration

Not Applicable

• Conditions: Knee Pain Chronic
• Interventions: Device: pulsed radiofrequency modulation

• Registration Number: NCT04940832
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-28
• Study Start: 2022-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-09
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiofrequency without corticosteroids	pulsed radiofrequency modulation	Pulsed radiofrequency to 42 derees celsius for 6 minutes
radiofrequency with corticosteroids	pulsed radiofrequency modulation	corticosteroids- 80mg depo-medrol Pulsed radiofrequency to 42 derees celsius for 6 minutes

Primary Outcome Measures

Name	Time	Method
Improvement in chronic knee pain	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).

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel