CLBP Single-Arm Long-Term Follow-up Study

Completed

Conditions: Chronic Low Back Pain

Interventions: Device: Intracept Procedure

Registration Number: NCT05207813

Lead Sponsor: Boston Scientific Corporation

Brief 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.

Detailed Description: Patients were originally enrolled under NCT03266107 and followed through 12-months post Intracept Procedure. This study approached patients from NCT03266107 to collect additional long-term effectiveness and satisfaction outcomes at three (3), four (4), and five (5) years post Intracept Procedure.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Basivertebral nerve ablation treatment	Intracept Procedure	Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study.

Primary Outcome Measures

Name	Time	Method
Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure	Difference between baseline and 5-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 5-years post Intracept Procedure data collected through this NCT record/study.	The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Oswestry Disability Index (ODI) From Baseline to 3 Years Post Intracept Procedure	Difference between baseline and 3-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 3-years post Intracept Procedure data collected through this NCT record/study.	The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
Mean Change in ODI From Baseline to 4 Years Post Intracept Procedure	Difference between baseline and 4-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 4-years post Intracept Procedure data collected through this NCT record/study.	The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.