Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:26 AM
Study NCT ID:
NCT07433634
Status:
RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time to BBVNA Relief
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 response and adverse events. A total of 11 visits inclusive of follow up visits with schedule for study intervals. 1 baseline visit, 8 virtual/ phone weekly visits, 1 3-month virtual visit , 1 6-month , 1 12-month and 1 24-month visit.
• 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 response and adverse events. A total of 11 visits inclusive of follow up visits with schedule for study intervals. 1 baseline visit, 8 virtual/ phone weekly visits, 1 3-month virtual visit , 1 6-month , 1 12-month and 1 24-month visit.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: