Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 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.
研究组 & 干预措施
Radiofrequency ablation (RFA) with MEE
Radiofrequency ablation involves a minimally invasive procedural technique. It uses radiofrequency waves to burn the nerve causing pain. This nerve will no longer be able to send pain signals to your brain. For this study, the multi-tined expandable electrode needle will be used. This needle will result in a larger treatment area. This may result in better pain relief and longer lasting pain relief. If you undergo the radiofrequency ablation procedure you will have pain medication injected where the ablation will be done. The procedure will take about 20 mins to complete. You will be allowed to go home afterward.
干预措施: Radiofrequency Ablation with MEE (Procedure)
Conventional Medical Management (CMM) Treatment Only
Your current standard of care treatment may already consist of some CMM therapies. Standard of care includes a variety of intervention types such as medication, physical therapy, home exercise programs, back brace, walking aid, and chiropractic care.
干预措施: Conventional Medical Management (Behavioral)
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