Clinical Research Directory
Browse clinical research sites, groups, and studies.
Summary
Basivertebral nerve ablation (BVNA) is a minimally invasive procedure approved for vertebrogenic low back pain. While early studies support its efficacy, real-world evidence is still evolving, particularly regarding the trajectory of pain relief and functional improvement over time, and predictors of clinical response. This study aims to evaluate clinical outcomes longitudinally following BVNA and identify baseline predictors of response.
Official title: Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2024-04-19
Completion Date
2026-10
Last Updated
2026-03-03
Healthy Volunteers
No
Interventions
Basivertebral nerve ablation
Participants underwent fluoroscopically guided intraosseous basivertebral nerve ablation (BVNA) using the Intracept® System (Boston Scientific, MA, USA) targeting MRI-confirmed Modic type 1 or 2 vertebral endplate changes. Procedures were performed under general anesthesia via a transpedicular or parapedicular approach with biplanar fluoroscopic confirmation of probe placement at the basivertebral foramen (30-50% vertebral body depth, midline AP position). Thermal radiofrequency ablation was delivered using either 75°C for 7 minutes (targeted lesion) or 85°C for 15 minutes (expanded lesion), selected based on intraoperative probe proximity to the intended target to optimize nerve capture. Only levels with imaging-confirmed Modic changes were treated. Weekly patient-reported outcomes were collected for 8, 12, 24 , 48 through 98 weeks.
Locations (3)
Yale Spine and Pain Center - Guilford
Guilford, Connecticut, United States
Yale Pain Management Center - New Haven
New Haven, Connecticut, United States
Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook
Old Saybrook, Connecticut, United States