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临床试验/NCT02185508
NCT02185508Unknown不适用

Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Radiculopathy Associated to Lumbar Disk Disease. Two Years Follow-up

American British Cowdray Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Electrophysiological changes measured through intraoperative neurophysiological monitoring.

研究概览

简要总结

The purpose of this study is to determine the relation among: (1) changes in voltage and amplitude of trans-operatory records obtained through the use of Intra-operative Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1 or 2 levels surgical decompression at lumbar spine.

IONM is the use of real time neurophysiological techniques during spinal surgeries. The modalities included in this study are:

  • Somatosensory evoked potentials (SSEPs).
  • Trans-cranial electric motor evoked potentials (tceMEPs).
  • Spontaneous electromyography (EMG).

Clinical outcome of the patients will be assessed through a careful evaluation of clinical data, as well as the application of three outcome scales:

  • Oswestry Disability Index 2.1a
  • Visual Analogue Scale for Pain
  • Patient's Overall Impression of Change

详细描述

Radiculopathy associated to lumbar disk disease is one of the most common reasons for a spine surgeon to be consulted. The pathophysiology of degenerative spine disease is acknowledged as complex, involving a wide array of risk factors ranging from genetic polymorphisms, to behavioural characteristics. While conflicting opinions exist with regard the direction of treatment for lumbar disk disease, de-compressive surgery is currently the gold standard for patients in which protocols of physiotherapy and analgesics have failed to comply.

Intraoperative neurophysiological monitoring (IONM) is widely used in the practice of spine surgery as a mean of preventing and reducing severe complications inherent to surgical techniques like paraparesis, paraplegia and quadriplegia. Indeed, a great deal of funding and work have been devoted to research projects seeking to determine the impact of IONM in reducing these risks. The results of such projects have been notoriously interesting, and frequently opposing to each other. This has lead to an open debate on weather the use of IONM may or not be justified by better outcomes in patients who undergo such procedure. To our knowledge there is no study in the literature that has addressed the potential role of the IOM to predict the long-term outcome of the patient in therms of radicular symptoms improvement.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Lumbar Disk Disease
  • Clinical Signs of Radiculopathy
  • Undergoing neurological surgery of the spine

排除标准

  • Previous neurological surgery of the lumbar spine
  • More than 2 levels intervened at the surgery
  • Serious post-operatory complications

结局指标

主要结局

Electrophysiological changes measured through intraoperative neurophysiological monitoring.

时间窗: Trans-operative

Standard register electrodes where placed from L1 to L5 myotomes and dermatomes. Through trans-operative real time modalities (trans-cranial electric motor evoked potentials, somatosensory evoked potentials, and spontaneous electromyography) measurements on amplitude and voltage were recorded at the beginning and at the end of the spinal decompression. This change will be studied to determine its predictive power in the clinical long-term outcome of the patients.

次要结局

  • Visual analogue scale for pain(In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Visual Analogue Scale for Pain)
  • Patient's Global Impression of Change Survey(In the follow-up visits up to two years after the completion of the neurological surgery, the patient will be asked to complete the Patient's Global Impression of Change Survey)
  • Oswestry Disability Index 2.1a(In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Oswestry Disability Index 2.1a)

研究者

发起方
American British Cowdray Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Galvan Ernesto Eduardo

MD

American British Cowdray Medical Center

研究点 (1)

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