Effect of ultrasound-guided genicular nerve neurolysis versus sham procedure on pain in patients with knee osteoarthritis: a randomized clinical trial.

IMPORTANCE

Knee osteoarthritis (OA) is a prevalent and disabling condition, especially in older adults. For patients who are not candidates for total knee arthroplasty (TKA) due to comorbidities or limited access to care, minimally invasive pain-relief options are critically needed.

OBJECTIVE

To assess the efficacy and safety of ultrasound-guided chemical neurolysis using 95% ethanol targeting four genicular nerves in patients with symptomatic knee OA who have not responded to conservative management.

DESIGN

Double-blind, randomized, sham-controlled clinical trial.

PARTICIPANTS

A total of 100 adults with symptomatic knee OA, confirmed radiographically and unresponsive to conservative treatment, were enrolled and randomized.

INTERVENTIONS: Patients were randomized to receive ultrasound-guided chemical neurolysis of the superomedial, superolateral, recurrent tibial, and inferomedial genicular nerves with 95% ethanol (treatment group) or a sham procedure (control group).

MAIN OUTCOMES AND MEASURES: 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 measured by the EQ-5D-5L questionnaire. Safety outcomes focused on the occurrence of neurological complications. Analyses were conducted using an intention-to-treat approach with appropriate handling of missing data.

RESULTS

Patients in the ethanol neurolysis group experienced significantly greater reductions in NRS scores at all follow-up points compared to the sham group (P < .0001). Opioid consumption was also significantly reduced in the neurolysis group throughout the 6-month period (P < .0001). Quality of life, as assessed by EQ-5D-5L, improved significantly in the treatment group (P < .0001). No neurological deficits or serious adverse events were reported in either group.

CONCLUSIONS AND RELEVANCE: Ultrasound-guided chemical neurolysis of the SMGN, SLGN, RTGN, and IMGN with 95% ethanol is a safe and effective minimally invasive treatment for patients with refractory knee OA pain. It significantly reduces pain and opioid use while improving quality of life, making it a valuable therapeutic option for individuals ineligible for surgical intervention.