Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
- Conditions
- Chronic Low-back PainVertebrogenic Pain Syndrome
- Registration Number
- NCT06827262
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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.
- Meets any contraindications per locally applicable Instructions for Use (IFU).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (5)
North Idaho Day Surgery, LLC
🇺🇸Post Falls, Idaho, United States
MarinHealth Spine Institute
🇺🇸Larkspur, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Pacific Sports and Spine
🇺🇸Eugene, Oregon, United States
University of Utah Orthopaedic Center
🇺🇸Salt Lake City, Utah, United States
North Idaho Day Surgery, LLC🇺🇸Post Falls, Idaho, United StatesBoston Scientific Clinical ResearchContact855-213-9890BSNClinicalTrials@bsci.com