RESUMO
Medical treatments and less invasive surgical approaches for knee osteoarthritis are variably effective, and total knee arthroplasty (TKA) is generally reserved for the most severe cases. The care gap between more conservative treatments and TKA leaves many patients with unresolved pain and loss of function for long periods. We conducted a study to determine if incorporating the BioniCare stimulator into an unloading brace would produce more rapid improvement and result in increased adherence and efficacy. Two hundred eighty-nine patients treated only with BioniCare served as historical controls and were compared with 225 patients treated with BioniCare combined with an unloading brace. Means and standard deviations of the changes in scores for pain intensity in the past 48 hours, pain and associated symptoms, patient global assessment, pain on going up or down stairs, and pain on walking on a flat surface and the effect sizes at 1, 3, 6, and 12 months, as well as the percentages of patients achieving at least 20% improvement, and at least 50% improvement, demonstrated that treatment with stimulator and unloading brace combined was significantly superior to treatment with the stimulator alone.