A Randomized Controlled Trial to Compare Analgesia and Functional Improvement After Continuous Neuroablative and Pulsed Neuromodulative Radiofrequency Treatment of the Genicular Nerves in Patients with Knee Osteoarthritis up to One Year After the Intervention

研究概要

Two hundred and sixteen patients suffering from chronic pain due to advanced knee osteoarthritis (grade 3 and 4 according to the Kellgren-Lawrence Scale) were randomized to receive continuous neuroablative radiofrequency (CNARF; n=108) or pulsed neuromodulative radiofrequency (PNMRF; n=108). The primary outcome of interest is pain measured using the visual analogue scale (VAS) at 1, 6, and 12 months follow-up. Secondary outcomes of interest included Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index total score and its associated subscores (pain, function, and stiffness). Furthermore, other outcomes of interest included the 12-Item Short Form Health Survey (SF-12) mental and physical summary scores, patient's satisfaction using the Likert scale, consumption of medications using the Medication Quantification Scale version III (MQS III), incidence of adverse events (i.e. abnormal proprioception, numbness, paresthesia, neuralgia, and motor weakness), and effective analgesic duration evaluated using Kaplan-Meier survival plots. All secondary outcomes were evaluated at 1, 6, and 12 months follow-up. Results revealed that the primary outcome of interest, VAS pain scores, was statistically significantly lower at all timepoints in the CNARF group vs PNMRF group (p=0.014; p<0.001; p=0.016, respectively). In addition, WOMAC total, WOMAC pain and WOMAC physical function scores were statistically significantly in favour of the CNARF group at all timepoints compared to the PNMRF group (p<0.05 for all). SF-12 physical summary subscores were statistically significantly in favour of the CNARF group vs PNMRF group at 1 and 6 months follow-up (p>0.05 for both), but this did not last at 12 months follow-up (p=0.067). WOMAC stiffness and SF-12 mental summary scores were not statistically significantly different between the 2 groups at any of the timepoints (p>0.05). The incidence of adverse events were not statistically significantly different between the 2 groups; 15/93 patients in the CNARF group and 8/95 patients in the PNMRF group reported an adverse events (p=0.668).