Time to BBVNA Relief

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Vertebrogenic Pain Syndrome; Basivertebral Nerve Ablation
• Intervention / Treatment: Procedure: Basivertebral nerve ablation

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Charles A Odonkor, MD; Phone Number: 203-767-1555; Email: kcodonkor@aya.yale.edu
• Study Contact Backup: Name: Muhammad U Siddique, MD; Phone Number: 203-668-2772; Email: muhammad.siddique@yale.edu

Study Locations

• United States
  • Connecticut
    • Guilford, Connecticut, United States, 06437
      • Recruiting
      • Yale Spine and Pain Center - Guilford
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale Pain Management Center - New Haven
    • Old Saybrook, Connecticut, United States, 06475
      • Recruiting
      • Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will compromise all healthy adults presenting to the outpatient orthopedic and rehabilitation clinic with symptoms of vertebrogenic low back pain.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving clinical response	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of spine-related interventions	Incidence of further spine-related interventions (e.g., epidural steroid injections, radiofrequency ablation, or spine surgery) post-BVN ablation.	2 years
Change in PROMIS-7 Global Health Score	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 years
Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS)	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.	2 years
Patient Global Impression of Change (PGIC) score	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.	2 years

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Charles A Odonkor, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; Clinical Outcomes; Pain relief trajectory; Basivertebral nerve ablation; Vertebrogenic low back pain,; Responder phenotypes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Low Back Pain
• Other Study ID Numbers: 2000040858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No