TcPRF for Knee Osteoarthritis

Objectives * Primary Objective: To evaluate the efficacy of transcutaneous PRF treatment in reducing knee pain compared to a sham intervention * Secondary Objectives: To assess the improvement in functional outcomes and patient satisfaction following PRF treatment. Study Design * Type: Randomized, double-blind, sham-controlled study. * Duration: 6 months * Study Population: Adults aged 40-75 years with chronic knee pain (lasting ≥ 6 months) due to osteoarthritis (OA). * How many patients in each group: 25 patients in each group (according to Janssens et al, 2024) Inclusion Criteria * Diagnosed with knee osteoarthritis according to NICE criteria. * Chronic knee pain (Visual Analogue Scale \[VAS\] ≥ 4). * Failure to respond adequately to conventional treatments (e.g., NSAIDs, physical therapy). * Willingness to comply with study procedures. Exclusion Criteria * Previous PRF/RF treatment for knee pain. * Hyaluronic acid injection for knee pain in the past 6 months * Knee surgery within the last 6 months. * Severe cardiovascular, neurological, or psychiatric conditions. * Active systemic infections or local skin infections at the knee. * Pregnancy or lactation.

NCT Number	NCT07351981
Lead Sponsor	National and Kapodistrian University of Athens
Conditions	Knee OA, Knee Osteoarthristis
Enrollment	50 participants
Start Date	2026-01-15
Primary Completion	2026-03-01 (estimated)
Study Completion	2026-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-20