Efficacy of Radiofrequency Ablation Using Multi-Tined Electrodes vs. Traditional Electrodes for Treatment of Lumbar Spondylosis

What this Trial Is About

Lumbar spondylosis is a condition affecting the small facet joints in the lower spine, often causing lower back pain due to wear and mechanical stress. This research evaluates two types of electrodes used in radiofrequency ablation (RFA) to treat lumbar spondylosis. The study compares the Stratus Nimbus multi-tined electrode, which creates a larger lesion, and the traditional Stryker Venom electrode to see if the larger lesion leads to better pain relief and improved daily functioning measured by the PROMIS-29 questionnaire. Patients diagnosed with lumbar facet-mediated lower back pain who have already undergone two diagnostic medial branch blocks with significant pain relief will be randomly assigned to receive RFA using either the Stratus Nimbus or the Stryker Venom electrode. The procedure uses radio waves to create a lesion that disrupts pain signals in the lumbar medial branch nerves. The study is double-blinded for patients and follows standard care protocols, with the physician aware of the electrode type used. Participants will complete the PROMIS-29 questionnaire before treatment and at 1, 3, 6, 9, and 12 months after the procedure to assess pain and impairment in daily activities. Researchers will compare these outcomes to baseline scores to evaluate the effects of each electrode type. The study includes ongoing follow-up over one year to monitor response to treatment and gather data to inform future care decisions.

RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for Lumbar Spondylosis