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NCT Number: NCT07433634

Time to BBVNA Relief

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.

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Key information

Conditions

Low Back Pain Back Pain Basivertebral Nerve Ablation Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertebrogenic Pain Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale Spine and Pain Center - Guilford, Guilford, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basivertebral nerve ablation

Procedure

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 delivered using either 75°C for 7 minutes (targeted lesion) or 85°C for 15 minutes (expanded lesion), selected based on intraoperative probe proximity to the intended target to optimize nerve capture. Only levels with imaging-confirmed Modic changes were treated. Weekly patient-reported outcomes were collected for 8, 12, 24 , 48 through 98 weeks.

Other names: Basivertebral Nerve Radiofrequency Ablation

Primary outcomes

  1. Percentage of participants achieving clinical response

    Time frame: 2 years

    Clinical response defined as a ≥50% reduction in pain intensity from baseline as measured by the Visual Analog Scale (VAS) or a ≥15-point improvement in the Oswestry Disability Index (ODI) score

Secondary outcomes

  1. Change in PROMIS-7 Global Health Score

    Time frame: 2 years

    7-item, self-report, or parent-proxy tool designed to assess overall physical, mental, and social health using a 5-point Likert scale., score range 20-80. It generates a T-score, where 50 is the U.S. population average and 10 is the standard deviation. Higher scores indicate better overall health.

  2. Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS)

    Time frame: 2 years

    2-question screening tool used in clinical settings to assess if adults meet the recommended 150+ minutes of weekly moderate-to-vigorous physical activity. Calculate the total weekly minutes of exercise by multiplying #1 times #2.

  3. Incidence of spine-related interventions

    Time frame: 2 years

    Incidence of further spine-related interventions (e.g., epidural steroid injections, radiofrequency ablation, or spine surgery) post-BVN ablation.

  4. Patient Global Impression of Change (PGIC) score

    Time frame: 2 years

    Self-report 7-point scale measuring a patient's belief regarding the effectiveness of a treatment with higher scores indicating a better outcome. Score range 1-7.

Study contacts

Contact information is provided by the study sponsor or research team.

Charles A Odonkor, MD

CONTACT

[email protected]

203-767-1555

Muhammad U Siddique, MD

CONTACT

[email protected]

203-668-2772

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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