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Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain

Recruiting
Conditions
Chronic Low-back Pain
Vertebrogenic 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
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in Disability (Oswestry Disability Index (ODI) from Baseline60-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
NameTimeMethod

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 States
Boston Scientific Clinical Research
Contact
855-213-9890
BSNClinicalTrials@bsci.com
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