How quickly basivertebral nerve ablation relieves vertebrogenic low back pain
Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 3 sites (Guilford, Connecticut and 2 other locations) |
| Trial ID | NCT07433634 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guilford, Connecticut and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.