NCT04730700招募中不适用
Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The mean visual analog scale (VAS) between the two group
研究概览
简要总结
The purpose of this study is to better understand how people feel after a radiofrequency ablation standard of care surgery using a different type of needle (multi-tined expandable electrode/MEE) in comparison to receiving conventional medical management (CMM) techniques.
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
- •Age > 18 years old.
- •Patients with pain lasting at least 6 months.
- •Patients with history of non-radiating low back pain.
- •Patient who had two diagnostic medial branch blocks (MBB) with significant (>50%) improvement on both injections.
- •Patient has signed study-specific informed consent.
- •Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.
排除标准
- •Patient with low back pain with radiation or involvement of pain going into their legs below their knees.
- •Patient did not receive satisfactory relief from diagnostic MBB (<50% relief).
- •Patient is unable to receive radiation exposure.
- •Patient is currently pregnant.
- •Patient has a current local overlying low back or systemic infection.
- •Patient currently receiving or seeking workers compensation, disability remuneration, and/or involved in injury litigation.
- •Known or suspected drug or alcohol abuse.
- •Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
- •Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation.
- •Patient has an implanted intrathecal pump or spinal neuromodulation device.
- •Patient currently on daily oral morphine equivalent (OME) of 50.
结局指标
主要结局
The mean visual analog scale (VAS) between the two group
时间窗: 12 months
will be compared using an independent samples t-test
次要结局
- Observe the incidence of complications associated with MEE while utilizing this device(12 months)
研究者
Dawood Sayed, MD
Study Principal Investigator
University of Kansas Medical Center
研究点 (2)
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