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

Knee Pain Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04940832
• Other study ID #: Knee_pain_radiofrequency
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Sheba Medical Center
• Contact: Matthew Medwick, Doctor
• Phone: 03-5303106
• Email: matt.medwick[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Pain Chronic

Intervention

Device:
• pulsed radiofrequency modulation
a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in chronic knee pain	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).	2nd and 6th week