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临床试验/NCT03744260
NCT03744260已完成不适用

The Effect of Medial Branch Radiofrequency Ablation on Functional Spinal Stability and Lumbar Multifidi Muscle Architecture Assessed by Magnetic Resonance Imaging and Ultrasound Imaging

Columbia University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
1
主要终点
Percentage Change in Volume of multifidus muscle on MRI

研究概览

简要总结

The purpose of this study is to evaluate the effects of lumbar medial branch radiofrequency ablation (RFA) on lumbar multifidi muscle size and clinical spinal stability. Specifically, this study is designed to highlight the comparison of multifidi muscle architecture using ultrasound imaging (USI) and MRI before and after lumbar medial branch RFA. This study will also include a commonly utilized functional assessment of the lumbar spine to evaluate the effects of RFA on lumbar spinal stability.

详细描述

Radiofrequency ablation (RFA) for the lumbar spine (lower back) is a procedure used to treat lower back pain secondary to facet arthritis. The procedure ablates (burns) a small nerve that goes to the arthritic joint in the back. This nerve also innervates a muscle called the multifidus, thought to be important for lumbar stability. The investigators are conducting a study to evaluate if RFA has any impact on multifidi size, spinal stability, and overall function. The tools the investigators will be using to assess the multifidi muscles are musculoskeletal ultrasound, MRI, physical therapy assessment, and functional questionnaires. The goal of the study is to determine if RFA impacts the multifidi in a clinically significant fashion, causing atrophy, spinal instability, and/or functional decline.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage Change in Volume of multifidus muscle on MRI

时间窗: Up to 3 months after radiofrequency ablation procedure

Analysis will include volumetric measurements of the multifidi as well as volumetric assessments of the muscle with fat subtracted.

Percentage Change in Cross Sectional Area of Multifidi

时间窗: Up to 3 months after radiofrequency ablation procedure

Area will be measured by MRI scan.

次要结局

  • Score on Numeric Pain Rating Scale (NPRS)(Up to 3 months after radiofrequency ablation procedure)
  • Percentage Score on the Modified Oswestry Disability Index(Up to 3 months after radiofrequency ablation procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Clark Smith

Associate Professor of Rehabilitation and Regenerative Medicine

Columbia University

研究点 (1)

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