Clinical trial NCT05207813: CLBP Single-Arm Long-Term Follow-up Study
Official title: A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain Long-term Follow Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Keywords: Vertebrogenic chronic low back pain
Intraosseous basivertebral nerve ablation
Low back pain
Axial low back pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 47 subjects treated in original CLBP Single-Arm Study will be given the option to participate in the study.

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.

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

Primary outcomes:
measure: Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure
timeFrame: 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.
Secondary outcomes:
measure: Mean Change in Oswestry Disability Index (ODI) From Baseline to 3 Years Post Intracept Procedure
timeFrame: 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.
measure: Mean Change in ODI From Baseline to 4 Years Post Intracept Procedure
timeFrame: 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.
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Austin
country: United States
facility: Seton Healthcare Family
state: Texas
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References:
citation: Truumees E, Macadaeg K, Pena E, Arbuckle J 2nd, Gentile J 2nd, Funk R, Singh D, Vinayek S. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Eur Spine J. 2019 Jul;28(7):1594-1602. doi: 10.1007/s00586-019-05995-2. Epub 2019 May 21.
citation: Macadaeg K, Truumees E, Boody B, Pena E, Arbuckle J 2nd, Gentile J, Funk R, Singh D, Vinayek S. A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. N Am Spine Soc J. 2020 Sep 18;3:100030. doi: 10.1016/j.xnsj.2020.100030. eCollection 2020 Oct.