Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve Ablation for Vertebrogenic Low Back Pain A Prospective Observational Cohort Study

What this Trial Is About

Researchers are studying the effects of basivertebral nerve ablation BVNA, a minimally invasive procedure used for vertebrogenic low back pain. This prospective observational study aims to track clinical outcomes over time after BVNA and identify factors at baseline that predict how well patients respond. The study focuses on measuring pain relief and functional improvement among patients with chronic axial low back pain. Participants undergo BVNA using the Intracept System, which involves a fluoroscopically guided thermal radiofrequency ablation targeting specific vertebral nerve areas confirmed by MRI. The procedure is performed under general anesthesia via a transpedicular or parapedicular approach with precise probe placement. Only vertebral levels with confirmed Modic type 1 or 2 changes are treated. Following the procedure, patient outcomes are monitored weekly through virtual or phone visits for 8 weeks, with additional follow-up visits at 3, 6, 12, and 24 months. During the study, participants will complete patient-reported outcome surveys such as PROMIS-7 and Physical Activity Vital Sign PAVS to assess health changes and activity levels. Researchers also track any additional spine-related interventions like epidural steroid injections or surgeries, and monitor adverse events. The main outcome is the percentage of patients achieving significant clinical response, defined by pain and disability improvements, over a two-year period. The study includes 11 visits in total to comprehensively evaluate participants progress and safety.

Time to BBVNA Relief