CLBP Single-Arm Long-Term Follow-up Study

NCT05207813 | Completed Results FDA Device

• 1 other identifier: CP0015
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Low Back Pain

Keywords

Vertebrogenic chronic low back pain; Intraosseous basivertebral nerve ablation; Low back pain; Axial low back pain

Outcome Measures

Primary Outcomes (1)

• Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure

  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.

  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 (2)

• 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.

• 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.

Study Arms (1)

Basivertebral nerve ablation treatment

Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study.

Device: Intracept Procedure

Interventions

Intracept Procedure DEVICE

Intraosseous Basivertebral Nerve (BVN) Ablation

Basivertebral nerve ablation treatment

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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)"

You may not qualify if:

• \- None

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Seton Healthcare Family

Austin, Texas, 78731, United States

Location

Related Publications (2)

• 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.

  PMID: 31115683 RESULT

• 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.

  PMID: 35141598 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Boston Scientific Corporation

BSNClinicalTrials@bsci.com

855-213-9890

Study Officials

• Natalie Bloom Lyons

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 26, 2022
• Study Start: February 16, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)