Time to BBVNA Relief
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population will compromise all healthy adults presenting to the outpatient orthopedic and rehabilitation clinic with symptoms of vertebrogenic low back pain.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Basivertebral nerve ablation
Procedure/SurgeryParticipants 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov