How quickly basivertebral nerve ablation relieves vertebrogenic low back pain
Official title: Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study
Run by Yale University · NCT07433634 · Data updated 2026-11-12
This study will follow people with vertebrogenic low back pain who are getting basivertebral nerve ablation to see how quickly and how much their pain and function improve over two years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 3 sites (Guilford, Connecticut and 2 other locations) |
| Status | Recruiting |
| Started | April 19, 2024 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | March 3, 2026 |
| Trial ID | NCT07433634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with chronic axial low back pain with vertebrogenic features who are scheduled to undergo BVNA and can complete weekly virtual follow-ups and longer-term remote or in-person visits.
✕Probably not a fit
Patients with recent spinal neuromodulation (within 6 months), active substance use disorder, uncontrolled psychiatric illness, cognitive impairment, pregnancy, or incarceration are excluded and likely would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a longitudinal observational study of patients scheduled for basivertebral nerve ablation (BVNA) at Yale-affiliated centers, with 11 visits including an initial baseline, eight weekly virtual/phone check-ins, and follow-up at 3, 6, 12, and 24 months. The primary outcome is the proportion of patients achieving clinical response, defined as ≥50% reduction in VAS pain or ≥15-point improvement in ODI. Secondary outcomes include changes in PROMIS-7, PAVS, incidence of additional interventions (e.g., ESIs or surgery), and adverse events. Baseline clinical and demographic factors will be analyzed to identify predictors of response and temporal patterns of pain relief.
Why it matters
Potential benefit: If successful, the results could help clinicians and patients set realistic expectations for timing and degree of pain relief after BVNA and identify who is most likely to benefit.
How similar studies have gone: Early randomized and prospective studies have shown BVNA can reduce pain in vertebrogenic low back pain, but long-term, real-world trajectories and predictors of response are less well established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Yale Spine and Pain Center - Guilford
Guilford, Connecticut, United States Recruiting -
Yale Pain Management Center - New Haven
New Haven, Connecticut, United States Recruiting -
Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook
Old Saybrook, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Charles A Odonkor, MD — Yale University
- Study coordinator: Charles A Odonkor, MD
- Email: kcodonkor@aya.yale.edu
- Phone: 203-767-1555
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.