An observational study in Low Back Pain, Vertebrogenic Pain Syndrome and Basivertebral Nerve Ablation, sponsored by Yale University. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Yale University · Observational
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.
Primary Objective:
Secondary Objectives:
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 475 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will compromise all healthy adults presenting to the outpatient orthopedic and rehabilitation clinic with symptoms of vertebrogenic low back pain.
Exclusion Criteria:
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.
Also known as: Basivertebral Nerve Radiofrequency Ablation
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
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Incidence of spine-related interventions
Incidence of further spine-related interventions (e.g., epidural steroid injections, radiofrequency ablation, or spine surgery) post-BVN ablation.
Time frame: 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.
Time frame: 2 years
Plan to share: No
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