N/A
Completed N=42
CLBP Single-Arm Long-Term Follow-up Study
Source: ClinicalTrials.gov NCT05207813 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure — 34.63 units on a scale
Summary
This is a prospective, noninterventional, observational post market data collection of long-term effectiveness and satisfaction outcomes for "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Study)" population at three (3), four (4), and five (5) years post Intracept Procedure. The working hypothesis is that data collected in this study will demonstrate safety, efficacy, durability and reproducibility of BVN ablation treatment outcomes out to 3, 4, and 5-years post-procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure |
34.63 | — |
| SECONDARY Mean Change in Oswestry Disability Index (ODI) From Baseline to 3 Years Post Intracept Procedure |
33.25 | — |
| SECONDARY Mean Change in ODI From Baseline to 4 Years Post Intracept Procedure |
34.50 | — |
Eligibility Criteria
Inclusion Criteria
- Patient received the Intracept procedure while participating in "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Long-Term Study)"
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT05207813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.