Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain (IMPROVE)

June 3, 2026 updated by: Boston Scientific Corporation
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Recruiting
        • Flagstaff Bone & Joint
        • Contact:
      • Phoenix, Arizona, United States, 85014
        • Recruiting
        • Innovative Pain and Wellness
        • Contact:
    • California
      • Larkspur, California, United States, 94939
        • Recruiting
        • MarinHealth Spine Institute
        • Contact:
    • Connecticut
      • Westport, Connecticut, United States, 06880
        • Recruiting
        • The Spine Wellness Center in Westport
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Washington Hospital Center
        • Contact:
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • North Idaho Day Surgery, LLC
        • Contact:
    • Illinois
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Illinois Bone and Joint Institute
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • Commonwealth Pain and Spine
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • iSpine Clinics
        • Contact:
    • New York
      • Port Jefferson Station, New York, United States, 11776
        • Recruiting
        • New York Spine and Pain Specialists
        • Contact:
      • Rochester, New York, United States, 14618
        • Recruiting
        • University of Rochester
        • Contact:
    • North Carolina
      • Bermuda Run, North Carolina, United States, 27106
        • Recruiting
        • Novant Health Spine Specialists
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Active, not recruiting
        • Pacific Sports and Spine
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
    • Texas
      • Houston, Texas, United States, 77065
        • Recruiting
        • Cy-Pain and Spine
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah Orthopaedic Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects are established patients in a medical practice who will receive intraosseous nerve ablation to treat vertebrogenic pain utilizing a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use according to standard of care.

Description

Inclusion Criteria:

  • Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
  • Signed a valid, IRB/EC-approved informed consent form.

Exclusion Criteria:

  • Meets any contraindications per locally applicable Instructions for Use (IFU).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intracept™ Intraosseous Nerve Ablation Systems
Subjects with pain treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System
Device: Intracept™ Intraosseous Nerve Ablation
Intracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Disability (Oswestry Disability Index (ODI) from Baseline
Time Frame: 60-months post-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.
60-months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, M.A., Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2025

Primary Completion (Estimated)

July 1, 2034

Study Completion (Estimated)

July 1, 2034

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REL025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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