Effect of Ultrasound-Guided Genicular Nerve Neurolysis vs Sham Procedure on Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial.

Abstract

Background: Knee osteoarthritis (OA) is a leading cause of chronic pain and disability, particularly in patients with symptomatic disease. While total knee arthroplasty (TKA) remains the standard treatment for advanced OA, many patients, especially older adults, are not suitable surgical candidates due to comorbidities or limited access to care. Minimally invasive options, such as chemical neurolysis of the superomedial genicular nerve (SMGN), superolateral genicular nerve (SLGN), recurrent tibial genicular nerve (RTGN), and inferomedial genicular nerve (IMGN), may offer meaningful pain relief and improved quality of life for this population.

Objectives: To evaluate the efficacy and safety of ultrasound-guided chemical neurolysis using 95% ethanol targeting the four genicular nerves in patients with symptomatic knee OA who failed conservative treatment.

Methods: In this double-blind, randomized, sham-controlled trial (NCT06087601), 100 patients with symptomatic knee OA were assigned to either ultrasound-guided genicular nerve neurolysis with 95% ethanol or a sham procedure. The primary outcome was pain intensity measured by the Numerical Rating Scale (NRS) at 7 days, 30 days, 3 months, and 6 months post-procedure. Secondary outcomes included opioid consumption and health-related quality of life, assessed via the EQ-5D-5L questionnaire. Safety outcomes included the occurrence of neurological complications. Analyses followed an intention-to-treat protocol, with appropriate handling of missing data.

Results: Patients treated with ethanol neurolysis showed significantly greater reductions in NRS scores at all follow-up points compared to the sham group (p < 0.0001). Opioid consumption was also significantly lower in the neurolysis group throughout the study period (p < 0.0001). EQ-5D-5L scores indicated a significant improvement in quality of life (p < 0.0001). No neurological deficits or serious adverse events were reported.

Conclusions: Ultrasound-guided chemical neurolysis of the SMGN, SLGN, RTGN, and IMGN using 95% ethanol is a safe, effective, and cost-efficient treatment for refractory knee pain in patients with symptomatic knee OA. This technique significantly reduces pain, lowers opioid reliance, and enhances quality of life, offering a valuable alternative for patients who are not candidates for surgical intervention.