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Clinical Trial NCT07433634 for Low Back Pain, Vertebrogenic Pain Syndrome, Basivertebral Nerve Ablation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Time to BBVNA Relief 200 Real-World Evidence

Recruiting
Clinical Trial NCT07433634 is an observational study for Low Back Pain, Vertebrogenic Pain Syndrome, Basivertebral Nerve Ablation that is recruiting. It started on 19 April 2024 with plans to enroll 200 participants. Led by Yale University, it is expected to complete by 1 October 2026. The latest data from ClinicalTrials.gov was last updated on 3 March 2026.
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 p...Show More
Detailed Description

Primary Objective:

• To determine the proportion of patients achieving clinical response (defined as ≥50% reduction in VAS or ≥15-point improvement in ODI) following BVNA.

Secondary Objectives:

  • To assess changes in PROMIS-7, PAVS, and other patient-reported outcomes.
  • To determine the incidence of further interventions such as epidural steroid injections (ESIs) or surgeries.
  • To evaluate temporal trends in res...
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Official Title

Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study

Conditions
Low Back PainVertebrogenic Pain SyndromeBasivertebral nerve ablation
Other Study IDs
  • 2000040858
NCT ID Number
NCT07433634
Start Date (Actual)
2024-04-19
Last Update Posted
2026-03-03
Completion Date (Estimated)
2026-10
Enrollment (Estimated)
200
Study Type
Observational
Status
Recruiting
Keywords
Pain relief trajectory
Basivertebral nerve ablation
Vertebrogenic low back pain,
Responder phenotypes
Clinical Outcomes
Radiofrequency Ablation
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
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% ver...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Percentage of participants achieving clinical response
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
2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in PROMIS-7 Global Health Score
7-item, self-report, or parent-proxy tool designed to assess overall physical, mental, and social health using a 5-point Likert scale., score range 20-80. It generates a T-score, where 50 is the U.S. population average and 10 is the standard deviation. Higher scores indicate better overall health.
2 years
Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS)
2-question screening tool used in clinical settings to assess if adults meet the recommended 150+ minutes of weekly moderate-to-vigorous physical activity. Calculate the total weekly minutes of exercise by multiplying #1 times #2.
2 years
Incidence of spine-related interventions
Incidence of further spine-related interventions (e.g., epidural steroid injections, radiofrequency ablation, or spine surgery) post-BVN ablation.
2 years
Patient Global Impression of Change (PGIC) score
Self-report 7-point scale measuring a patient's belief regarding the effectiveness of a treatment with higher scores indicating a better outcome. Score range 1-7.
2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Yale University logoYale University457 active studies to explore
Study Central Contact
Contact: Charles A Odonkor, MD, 203-767-1555, [email protected]
Contact: Muhammad U Siddique, MD, 203-668-2772, [email protected]
3 Study Locations in 1 Countries

Connecticut

Yale Spine and Pain Center - Guilford, Guilford, Connecticut, 06437, United States
Recruiting
Yale Pain Management Center - New Haven, New Haven, Connecticut, 06519, United States
Recruiting
Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook, Old Saybrook, Connecticut, 06475, United States
Recruiting