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临床试验/NCT03890315
NCT03890315已完成不适用

Evaluation of Patients With Neuropathic Pain in the Context of Clinical Symptoms, Quantitative Sensory Tests and Imaging With FMRI

Ege University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月26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
40
试验地点
1
主要终点
Functional MRI BOLD responses

研究概览

简要总结

This study is planned to evaluate patients with upper extremity neuropathic pain due to cervical radiculopathy with clinical symptoms, Quantitative Sensory Testing(QST) and Functional Magnetic Resonance Imaging(fMRI). Patients with similar charactheristics will be grouped and comparisons will be conducted in fMRI results, as well as QST.

详细描述

Neuropathic pain is a type of pain which usually accompanies injuries or conduction defects in the central or peripheral nervous system, as well as receptors. Unlike the other types of pain, neuropathic ones are more resistant to therapy and prone to be chronic.

In recent years, there are many novel techiques to assess the neurological status and create standardized test protocols. One of these techiques is QST(Quantitative Sensory Testing). QST is a specific type of sensory examination, usually done through computerized stimuli of heat, cold or vibration, or specific test equipment. There are many types of QST protocols around the world, and their results can also be expressed as phenotypes through statistics. While there are 3 types of pain phenotypes with the 13 item QST protocol suggested by German Neuropathic Pain Research group(DFNS), all patient groups can be classified differently as well, according to the common findings they express. These different phenotypes are also shown to have different responses to the different pain treatments. Such differences are usually attributed to the different mechanisms and fibers underlying the pathogenesis.

While patients show differences in QST results, evidence for the correlation between these variables and clinical symptoms of the patients are still scarce. Moreover, it is still yet to be known if these differences have a central origin as well as the peripheral mechanisms.

Functional Magnetic Resonance Imaging(fMRI) is a method to evaluate cerebral functions. It is mainly based on the blood flow changes that occur locally in regions that are in function[5]. As a result of the increased blood flow, the oxygen concentration also increases, creating a signal response called BOLD(Blood Oxygen Level Dependent) response. Since different types of pain are conducted through different fibers and pathways, it is also probable that they might show changes in cortical response as well.

In this study, the aim is to find whether QST results are correlated to clinical symptoms and pain properties of the patients, and these changes are related to the changes in the central nervous system

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with upper extremity neuropathic pain due to radiculopathy Duration of >1 month Unilateral extremity pain

排除标准

  • Severe cognitive impairment
  • Unstable systemic comorbidity
  • Presence of pacemaker or deep brain stimulation
  • Implants that aren't compatible with MRI
  • Claustrophobia
  • Complete or near complete loss of sensation
  • Brain injury or presence intracranial lesions

结局指标

主要结局

Functional MRI BOLD responses

时间窗: Baseline

In fMRI, patients will first be taking a resting state phase in case of activations. In the block design phase, they will be given tactile stimuli in affected extremity, and then healthy extremity in 3 blocks, followed by pauses in 10 second blocks.

次要结局

  • PainDETECT Questionnaire scores(Baseline)
  • QST(Quantitative Sensory Testing) parameters(Baseline)

研究者

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

Göksel Tanıgör M.D.

Researcher

Ege University

研究点 (1)

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