Time to BBVNA Relief

Part of paid clinical trials in Guilford, Connecticut.

Sponsor
Yale University
Study ID
NCT07433634
Status
Recruiting
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Conditions

  • Basivertebral Nerve Ablation
  • Low Back Pain
  • Vertebrogenic Pain Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Basivertebral nerve ablation — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Apr 19, 2024
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Yale Spine and Pain Center - GuilfordGuilfordConnecticut06437-
Yale Pain Management Center - New HavenNew HavenConnecticut06519-
Yale Interventional Spine and Musculoskeletal Medicine - Old SaybrookOld SaybrookConnecticut06475-

Find similar trials in Guilford, CT

By research site
Yale Spine and Pain Center - Guilford· Guilford, CTYale Pain Management Center - New Haven· New Haven, CTYale Interventional Spine and Musculoskeletal Medicine - Old Saybrook· Old Saybrook, CT

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