RecruitingNCT07433634

Time to BBVNA Relief

Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study

Sponsor

Yale University

Enrollment

200 participants

Start Date

Apr 19, 2024

Study Type

OBSERVATIONAL

Conditions

Low Back Pain Vertebrogenic Pain Syndrome Basivertebral Nerve Ablation

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Diagnosis of chronic axial low back pain with vertebrogenic features
Scheduled for BVN ablation
Able to provide informed consent
Capable of participating in weekly virtual/telephone follow-up for 8 weeks and in- person or remote follow-up at 3 and 6 months through 2 years

Exclusion Criteria5

Prior spinal neuromodulation therapy (e.g., spinal cord stimulation or intrathecal pump) within the past 6 months
Active substance use disorder or uncontrolled psychiatric illness that may interfere with participation
Cognitive impairment limiting ability to complete surveys or provide informed consent
Pregnancy
Incarceration or current status as a prisoner

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Interventions

PROCEDUREBasivertebral 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.