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NCT07433634Recruiting

Time to BBVNA Relief

Yale University

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

Inclusion Criteria: * 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 Criteria: * 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

Interventions

PROCEDURE

Basivertebral nerve ablation

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Conditions

Low Back PainVertebrogenic Pain SyndromeBasivertebral Nerve Ablation

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