NCT07692737尚未招募不适用
A Randomized Controlled Trial Comparing Intra-Periarticular Lumbar Facet Platelet-Rich Plasma Injection Versus Medial Branch Radiofrequency Ablation for Chronic Lumbar Facet-Mediated Pain
The New England Baptist Hospital0 个研究点目标入组 30 人开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Numeric Rating Scale on Pain Level
研究概览
简要总结
The first clinical research effort under this initiative is a pilot randomized controlled trial comparing intra-periarticular lumbar facet platelet-rich plasma (PRP) injection to standard-of-care medial branch radiofrequency ablation (RFA) for chronic lumbar facet-mediated pain.
The study is designed to:
- Use contemporary best-practice techniques for both treatment arms
- Minimize incremental risk beyond standard care
- Generate feasibility, safety, and preliminary comparative effectiveness data
- Inform future definitive trials and potential program expansion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults with chronic lumbar back pain suspected to be facet-mediated
- •≥80% pain relief following two diagnostic medial branch blocks
- •Ability to provide informed consent
- •Ability to complete patient-reported outcome measures
排除标准
- •Active radiculopathy or alternate dominant spinal pain generator
- •Prior lumbar fusion at target level
- •Active systemic infection or local infection at injection site
- •Thrombocytopenia, less than 100,000/uL
- •Anemia, Hemoglobin less than 10 g/dL
- •Pregnancy
- •Inability to complete follow-up assessments
结局指标
主要结局
Numeric Rating Scale on Pain Level
时间窗: 4 months post-treatment
Range: 0-10 Higher score means more painful.
次要结局
- Numeric Rating Scale on Pain Level(1 month post-treatment)
- Oswestry Disability Index(1 Month post-procedure)
- Patient Global Impression of Change(1 month post-procedure)
- Oswestry Disability Index(4 months post-procedure)
- Patient Global Impression of Change(4 months post-procedure)
- Numeric Rating Scale on Pain Level(6 months post-treatment)
- Oswestry Disability Index(6 months post-procedure)
- Patient Global Impression of Change(6 months post-procedure)
- Numeric Rating Scale on Pain Level(12 months post-treatment)
- Oswestry Disability Index(12 months post-procedure)
- Patient Global Impression of Change(12 months post-procedure)
研究者
Andrew Lederman
Chief of Physiatry and Interventional Pain Physician
The New England Baptist Hospital
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