NCT07433634

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Apr 2024Oct 2026

Study Start

First participant enrolled

April 19, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

February 19, 2026

Last Update Submit

February 27, 2026

Conditions

Low Back PainVertebrogenic Pain SyndromeBasivertebral Nerve Ablation

Keywords

Pain relief trajectoryBasivertebral nerve ablationVertebrogenic low back pain,Responder phenotypesClinical OutcomesRadiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in PROMIS-7 Global Health Score

    2 years

  • Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS)

    2 years

  • Incidence of spine-related interventions

    2 years

  • Patient Global Impression of Change (PGIC) score

    2 years

Interventions

Basivertebral nerve ablationPROCEDURE

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.

Also known as: Basivertebral Nerve Radiofrequency Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will compromise all healthy adults presenting to the outpatient orthopedic and rehabilitation clinic with symptoms of vertebrogenic low back pain.

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

MeSH Terms

Conditions

Low Back PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Charles A Odonkor, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles A Odonkor, MD

CONTACT

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

Muhammad U Siddique, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

April 19, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)