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Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
April 19, 2024
Primary Completion Date
October 1, 2026
Completion Date
October 1, 2026
Last Updated
March 3, 2026
200
ESTIMATED participants
Basivertebral nerve ablation
PROCEDURE
Lead Sponsor
Yale University
NCT06661850
NCT03836248
NCT06702189
Data Source & Attribution
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