ClinicalTrials.gg
RecruitingNCT06827262IMPROVEUpdated Oct 9, 2026

Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain

An observational study in Chronic Low-back Pain and Vertebrogenic Pain Syndrome, sponsored by Boston Scientific Corporation. Recruiting at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Primary conditionLow Back PainRegistry: Back PainReclassifiedWhy we changed it
Registry
Back Pain — the first condition term the registry derived for this study.
ClinicalTrials.gg
Low Back Pain
Why
  1. The study's listed conditions name Low Back Pain, a narrower term within Back Pain.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Boston Scientific Corporation · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Updated Oct 9, 2026Site recruiting status changedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study summary

Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Read the 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.

02

Conditions studied

  • Chronic Low-back Pain
  • Vertebrogenic Pain Syndrome

Browse trials for

Keywords

  • Intraosseous basivertebral nerve ablation
  • Axial low back pain
  • Low Back Pain
03

In context

Low Back Pain Reclassified

2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 100 across 481 observational studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Compared within Low Back Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Back Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

Exclusion Criteria:

  • Meets any per locally applicable Instructions for Use (IFU).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
60 Months
Patient registry
Yes

Groups and cohorts

  • Intracept™ Intraosseous Nerve Ablation Systems

    Subjects with pain treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System

    Device: Intracept™ Intraosseous Nerve Ablation

Interventions

  • DeviceIntracept™ Intraosseous Nerve Ablation

    Intracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain

06

What researchers measure

Primary outcomes

  1. Change in Disability (Oswestry Disability Index (ODI) from Baseline

    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.

    Time frame: 60-months post-procedure

07

Study locations

19 of 22 sites recruiting
  • Flagstaff Bone & Joint
    Flagstaff, Arizona 86001, United States
    Recruiting
  • Innovative Pain and Wellness
    Phoenix, Arizona 85014, United States
    Recruiting
  • MarinHealth Spine Institute
    Larkspur, California 94939, United States
    Recruiting
  • Stanford University Medical Center
    Stanford, California 94305, United States
    Recruiting
  • The Spine Wellness Center in Westport
    Westport, Connecticut 06880, United States
    Recruiting
  • Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • Orlando Regional Medical Center
    Orlando, Florida 32806, United States
    Recruiting
  • Horizon Clinical Research, LLC
    Jasper, Georgia 30143, United States
    Recruiting
  • North Idaho Day Surgery, LLC
    Post Falls, Idaho 83854, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Illinois Bone and Joint Institute
    Barrington, Illinois 60010, United States
    Recruiting
  • Commonwealth Pain and Spine
    Lexington, Kentucky 40509, United States
    Recruiting
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70115, United States
    Recruiting
  • iSpine Clinics
    Maple Grove, Minnesota 55369, United States
    Recruiting
  • CentraCare Health System
    Saint Cloud, Minnesota 56303, United States
    Recruiting
  • New York Spine and Pain Specialists
    Port Jefferson Station, New York 11776, United States
    Recruiting
  • University of Rochester
    Rochester, New York 14618, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Montefiore Medical Center
    The Bronx, New York 10461, United States
    Recruiting
  • Novant Health Spine Specialists
    Bermuda Run, North Carolina 27106, United States
    Recruiting
  • Pacific Sports and Spine
    Eugene, Oregon 97404, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
    Recruiting
  • Cy-Pain and Spine
    Houston, Texas 77065, United States
    Recruiting
  • University of Utah Orthopaedic Center
    Salt Lake City, Utah 84108, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
University of Rochester is now Active, not recruiting
Oct 9, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • University of Rochester · Rochester, United StatesContact removed B•••@bsci.com · •••9890
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    University of Rochester is now Active, not recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • University of Rochester · Rochester, United StatesContact removed B•••@bsci.com · •••9890
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06827262
Responsible party
Sponsor
First posted
Feb 14, 2025
Start date
Mar 26, 2025
Primary completion
Jul 2034 (estimated)
Completion
Jul 2034 (estimated)
Last update
Oct 9, 2026

Study contacts

Ann Yamano
Contact
BSNClinicalTrials@bsci.com
855-213-9890
Diane Keesey
Contact
BSNClinicalTrials@bsci.com
855-213-9890
Natalie Bloom Lyons, M.A.
study director · Boston Scientific Corporation

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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