Ireland
--:--IST
Recruiting Observational

Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain

NCT06827262 · tracked via the Priya Life Science UK tracker
Phase
Observational
Started
2025-03-26
Last updated
2026-11-13

Condition(s) studied

Chronic Low-back PainVertebrogenic Pain Syndrome

Investigational drug(s) / intervention(s)

Intracept™ Intraosseous Nerve Ablation

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Change in Disability (Oswestry Disability Index (ODI) from Baseline — 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.

Trial sites (23)

FacilityCityRegionStatus
Flagstaff Bone & Joint Flagstaff Arizona Recruiting
Innovative Pain and Wellness Phoenix Arizona Recruiting
MarinHealth Spine Institute Larkspur California Recruiting
Stanford University Medical Center Stanford California Recruiting
The Spine Wellness Center in Westport Westport Connecticut Recruiting
Washington Hospital Center Washington D.C. District of Columbia Recruiting
Orlando Regional Medical Center Orlando Florida Recruiting
Horizon Clinical Research, LLC Jasper Georgia Recruiting
North Idaho Day Surgery, LLC Post Falls Idaho Withdrawn
Illinois Bone and Joint Institute Barrington Illinois Recruiting
Commonwealth Pain and Spine Lexington Kentucky Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Recruiting
iSpine Clinics Maple Grove Minnesota Recruiting
CentraCare Health System Saint Cloud Minnesota Recruiting
New York Spine and Pain Specialists Port Jefferson Station New York Recruiting
University of Rochester Rochester New York Active Not Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Novant Health Spine Specialists Bermuda Run North Carolina Recruiting
Pacific Sports and Spine Eugene Oregon Active Not Recruiting
Allegheny General Hospital Pittsburgh Pennsylvania Recruiting
Cy-Pain and Spine Houston Texas Recruiting
University of Utah Orthopaedic Center Salt Lake City Utah Recruiting
Buckinghamshire Healthcare NHS Trust Aylesbury United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06827262 on ClinicalTrials.gov ↗ ← All trials in the UK