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 个研究点目标入组 60 人开始时间: 2022年3月29日最近更新: 2023年4月24日

试验速览

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

•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

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