Evaluating the Safety and Effectiveness of Monopolar Basivertebral Nerve Ablation for Treating Axial Low Back Pain with Method Improvements

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Monopolar Basivertebral Nerve Ablation BVNA for treating axial low back pain, focusing also on optimizing the method. This condition involves pain transmitted by a small nerve within the vertebral bodies, which BVNA aims to disrupt. The procedure is minimally invasive and targets pain from degenerated discs. The BVNA procedure is performed under sterile conditions with X-ray guidance by an experienced physician. After local anesthesia, a cannula is inserted into the affected vertebra, guided by MRI planning. A radiofrequency electrode then applies controlled thermal energy to interrupt pain signals. Patients remain awake or lightly sedated and monitored during the procedure. Afterward, patients usually go home following a short observation. Follow-up includes questionnaires assessing pain, function, and quality of life at 6 weeks, 3, 6, 12 months, and possibly beyond 24 months. An MRI scan is also done about 6 months after treatment. Participants will complete various standardized questionnaires measuring pain intensity, disability, enjoyment of life, and overall health quality. These assessments occur at multiple intervals up to one year and potentially longer. The study also includes a control MRI to observe changes after the procedure. The total participation may extend beyond two years, allowing researchers to monitor long-term outcomes and safety.

Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain