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Observational Study of Basivertebral Nerve Ablation for Low Back Pain

This study is looking at how well a procedure called basivertebral nerve ablation (BVNA) using the Intracept® System helps people with chronic low back pain caused by changes in their spine (vertebrogenic pain). Doctors want to understand how pain relief and daily function improve over time after this procedure. They also want to find out what factors might predict who will respond best to the treatment. You might be able to join if you are an adult with chronic low back pain, are scheduled for BVNA, and can participate in regular follow-up appointments for up to two years. The main goal is to see what percentage of participants achieve a significant reduction in their pain or improvement in their daily activities after two years.

Study design
This is an observational study involving 200 participants. It is not a randomized trial, meaning participants are not assigned to different treatment groups.
What's involved
You would have a baseline visit, followed by 8 weekly virtual/phone visits, and then virtual or in-person visits at 3, 6, 12, and 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years after the procedure to assess their clinical response.

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NCT07433634

Time to BBVNA Relief

Recruiting
Not specifiedAges 18+Observational
Yale University
~200 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:Basivertebral nerve ablation

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants achieving clinical response
Measured over 2 years

Conditions

Low Back Pain
Vertebrogenic Pain Syndrome
Basivertebral Nerve Ablation

Explore related trials

Lower Back PainVertebrogenic pain syndrome

Where it's being run

3 sites across 1 states
Connecticut3

Study leadership

  • Charles A Odonkor, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Charles A Odonkor, MD
[email protected]
203-767-1555
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of participants achieving clinical response2 years

    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