Cooled radiofrequency ablation versus cryoneurolysis for the symptomatic management of pain in knee osteoarthritis: a prospective, randomized, sham-controlled, double-blind trial

General University Hospital of Patras0 sites60 target enrollmentMarch 29, 2022

Overview

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37041607/ (added 12/04/2023)

Registry

who.int

Start Date

March 29, 2022

End Date

April 15, 2023

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•Patients of either sex will participate in the clinical trial as long as they have:
•1\. The NICE clinical criteria of primary knee OA for one or both knees:
•1\.1\. Age \>45 years
•1\.2\. Activity\-related joint pain
•1\.3\. No morning joint stiffness or morning stiffness that lasts no longer than 30 minutes
•2\. Radiological confirmation of knee arthritis (grade \=2\) according to the Kellgren and Lawrence classification
•3\. Chronic knee pain for a minimum duration of 6 months
•4\. Pain intensity \=4 on the (NRPS)
•5\. A decrease of \=50% in NRPS scores with diagnostic genicular nerve block
•6\. The ability to communicate in Greek

•1\. inflammatory or post\-traumatic knee arthritis
•2\. Patients who have received CRYON or CRFA treatment in the past
•3\. Injection of hyaluronic acid or corticosteroid within the previous 3 months
•4\. Significant structural deformities affecting locomotion and knee function aside from osteoarthritis and which might cause chronic knee pain
•5\. Body mass index \=40 kg/m²
•6\. Uncontrolled serious disease (cancer, diabetes, end\-stage heart disease etc)
•7\. Unstable psychiatric illness
•8\. Coagulopathy or bleeding disorders
•9\. Active systemic or local infection
•10\. Disease\-associated with reactions to cold, such as cryoglobulinemia