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Time to BBVNA Relief

Time to BBVNA Relief

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

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

Study details
    Low Back Pain
    Vertebrogenic Pain Syndrome
    Basivertebral Nerve Ablation

NCT07433634

Yale University

15 May 2026

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