| NCT ID | NCT07433634 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Low Back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-04-19 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-04-19 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Charles A Odonkor, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07433634 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07433634 currently recruiting?
Yes, NCT07433634 is actively recruiting participants. Contact the research team at kcodonkor@aya.yale.edu for enrollment information.
Where is the NCT07433634 trial being conducted?
This trial is being conducted at Guilford, United States, New Haven, United States, Old Saybrook, United States.
Who is sponsoring the NCT07433634 clinical trial?
NCT07433634 is sponsored by Yale University. The principal investigator is Charles A Odonkor, MD at Yale University. The trial plans to enroll 200 participants.