Recruiting

Basivertebral Nerve Ablation

Sponsor:

Yale University

Code:

NCT07433634

Conditions

Low Back Pain

Vertebrogenic Pain Syndrome

Basivertebral Nerve Ablation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Basivertebral nerve ablation

Study Details

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.

Conditions

Low Back Pain

Vertebrogenic Pain Syndrome

Basivertebral Nerve Ablation

Study ID

NCT07433634

Start date

Apr 19, 2024

Status verified date

Feb, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Basivertebral nerve ablation

Participants 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.

Primary outcome measure

  • Percentage of participants achieving clinical response [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Charles A Odonkor, MD

203-767-1555kcodonkor@aya.yale.edu

Muhammad U Siddique, MD

203-668-2772muhammad.siddique@yale.edu

Locations

Yale Spine and Pain Center - Guilford

Recruiting

Guilford, Connecticut, United States, 06437

Yale Pain Management Center - New Haven

Recruiting

New Haven, Connecticut, United States, 06519

Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook

Recruiting

Old Saybrook, Connecticut, United States, 06475

More Information

Sponsor

Yale University

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • Pain relief trajectory
  • Basivertebral nerve ablation
  • Vertebrogenic low back pain,
  • Responder phenotypes
  • Clinical Outcomes
  • Radiofrequency Ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-03-03.