Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 27
- 主要终点
- Change in Disability (Oswestry Disability Index (ODI) from Baseline
研究概览
简要总结
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Meets any contraindications per locally applicable Instructions for Use (IFU).
研究组 & 干预措施
Intracept™ Intraosseous Nerve Ablation Systems
Subjects with pain treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System
干预措施: Intracept™ Intraosseous Nerve Ablation (Device)
结局指标
主要结局
Change in Disability (Oswestry Disability Index (ODI) from Baseline
时间窗: 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.
次要结局
未报告次要终点