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Recruiting NCT07433634

Time to BBVNA Relief

— Observational Low Back Pain Vertebrogenic Pain Syndrome Basivertebral Nerve Ablation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Basivertebral nerve ablation.
Who it may be relevant to
Registry conditions: Low Back Pain, Vertebrogenic Pain Syndrome, Basivertebral Nerve Ablation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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.

Interventions

  • Procedure Basivertebral 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 del

Primary outcome measures

  • Percentage of participants achieving clinical response [Time frame: 2 years]
Secondary outcome measures (4)
  • Change in PROMIS-7 Global Health Score [Time frame: 2 years]
  • Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS) [Time frame: 2 years]
  • Incidence of spine-related interventions [Time frame: 2 years]
  • Patient Global Impression of Change (PGIC) score [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • Yale Spine and Pain Center - Guilford — Guilford
  • Yale Pain Management Center - New Haven — New Haven
  • Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook — Old Saybrook

Identifiers

NCT: NCT07433634 · 2000040858

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗