Clinical Trials in the UK / NCT06827262
Recruiting
Observational
Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
NCT06827262 · tracked via the Priya Life Science UK tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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| North Idaho Day Surgery, LLC | Post Falls | Idaho | Withdrawn |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 |
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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