Time to BBVNA Relief
Start Date
4/19/2024
Completion Date
10/1/2026
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.
Detailed Description
Primary Objective: • To determine the proportion of patients achieving clinical response (defined as ≥50% reduction in VAS or ≥15-point improvement in ODI) following BVNA. Secondary Objectives: * To assess changes in PROMIS-7, PAVS, and other patient-reported outcomes. * To determine the incidence of further interventions such as epidural steroid injections (ESIs) or surgeries. * To evaluate temporal trends in response and adverse events. A total of 11 visits inclusive of follow up visits with schedule for study intervals. 1 baseline visit, 8 virtual/ phone weekly visits, 1 3-month virtual visit , 1 6-month , 1 12-month and 1 24-month visit.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Basivertebral nerve ablation
Conditions
Locations
Yale Spine and Pain Center - Guilford
Guilford, Connecticut 06437
United States
Yale Pain Management Center - New Haven
New Haven, Connecticut 06519
United States
Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook
Old Saybrook, Connecticut 06475
United States