NCT07537335

Knee Osteoartritis Genicular Nerve RF Ablation vs Alcohol Neurolysis

Comparison of Genicular Nerve Radiofrequency Ablation and Neurolytic Alcohol Injection for Chronic Knee Osteoarthritis Pain: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sakarya University · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The GEN-AL-RF study is a randomized controlled trial designed to compare the clinical efficacy of two interventional techniques for managing chronic knee pain due to osteoarthritis. The study focuses on genicular nerve radiofrequency (RF) ablation versus neurolytic alcohol injection for pain blockade. Patients diagnosed with knee osteoarthritis are randomly assigned to either the RF ablation group or the neurolytic alcohol group. The primary objective is to evaluate the superiority and duration of analgesic effects between these two methods. Clinical outcomes are assessed at baseline and at 1, 3, and 6 months post-procedure using the Numeric Rating Scale (NRS) for pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for physical function, and the Short Form-12 (SF-12) for health-related quality of life. The results of this study aim to provide high-quality evidence regarding the comparative effectiveness and long-term outcomes of genicular nerve RF and alcohol neurolysis in the clinical management of chronic knee osteoarthritis pain.

Detailed description

The GEN-AL-RF study investigates the clinical outcomes of two ultrasound-guided genicular nerve procedures in patients with Grade 3-4 knee osteoarthritis according to Kellgren-Lawrence criteria. Patients who have failed conservative treatment options are enrolled and randomly assigned to one of two intervention groups. Under real-time ultrasound guidance, the superior medial, superior lateral, and inferior medial genicular nerves are targeted. In the Thermal Radiofrequency (RF) group, patients receive RF ablation at 75°C for 90 seconds per target nerve. In the Neurolytic Alcohol group, 1 mL of absolute ethanol is injected at each of the three anatomical targets. Both procedures are performed by experienced physicians using standardized needle placement techniques. Clinical assessments are conducted at baseline and at follow-up intervals of 1, 3, and 6 months. The primary outcome is pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes include physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and health-related quality of life measured by the Short Form-12 (SF-12) survey. Safety is monitored throughout the study period by documenting any procedure-related adverse events.

Conditions

• Knee Osteoarthristis
• Radiofrequency Ablation
• NEUROLYSIS

Interventions

Type	Name	Description
OTHER	genicular nerve block	Genicular nerve radiofrequency ablation : Patients will undergo ultrasound or fluoroscopy-guided radiofrequency ablation of the genicular nerves (superior medial, superior lateral, and inferior medial). The procedure involves placing RF cannulas at the target neural sites. Once the position is confirmed by sensory and motor stimulation, thermal radiofrequency lesioning will be performed to disrupt pain signal transmission. Genicular nerve chemichal neurolysis: Patients will receive ultrasound or fluoroscopy-guided chemical neurolysis of the genicular nerves (superior medial, superior lateral, and inferior medial). Following correct needle placement confirmed by contrast spread or local anesthetic test block, a specific volume (1 mL per nerve) of ethyl alcohol (95-96% concentration) will be injected to achieve long-term neurolytic blockade of the target nerves.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-01
• Completion: 2026-12-30
• First posted: 2026-04-17
• Last updated: 2026-04-17