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Central Sensitization in Chronic Whiplash Patients

2016年12月28日 更新者:University of Castilla-La Mancha

Central Sensitization in Chronic Whiplash Patients: Metabolite Concentrations in the Anterior Cingulate Cortex and Periacueductal Gray Matter

The purpose of this study is to determine whether the metabolite concentrations within the anterior cingulate cortex and periaqueductal gray matter predict the intensity and interference of neuropathic pain after the development of chronic whiplash syndrome.

研究概览

详细说明

Persistent chronic pain is a common symptom of whiplash leading to reduced quality of life. Little information is available regarding changes in brain processing areas and change in central sensitization to noxious input during the chronic phase of whiplash. Metabolite concentrations in the anterior cingulate cortex and periaqueductal gray matter may be predictors of neuropathic pain and these changes may explain the development of central sensitization in people with chronic whiplash.

Until now, there is not any study that show this approach.

研究类型

观察性的

注册 (预期的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients who have suffered whiplash syndrome. By one hand, patients with chronic pain (minimun 8 weeks) and 2 points or more of pain intensity. By the other hand, patiens without pain (2 points or less of pain intensity).

By last, subjects without whiplash syndrome.

描述

Inclusion Criteria:

  • Whiplash syndrome
  • Chronic pain
  • Age between 18 to 65 years
  • 4 months to 2 years after the whiplash syndrome

Exclusion Criteria:

  • Neurological disease
  • Claustrophobia

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:横截面

队列和干预

团体/队列
干预/治疗
Whiplash-Pain
Subjects with chronic whiplash syndrome and pain. The inclusion criteria for pain include the presence of daily pain during the previous 8 weeks. Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale. The minimum will be 2 points. Subjects will be recruited between the 4 months until 2 years after the whiplash.

Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration.

The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.

Questionnaires are important to assess the chronic pain and their impact in the quality of life. For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference. Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain. The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale. Also,we will assess the disability after whiplash using the Neck Disability Index.
Conditioned Pain Modulation over the tenar eminence. The test will be a heat tonic stimulus which evoke a 3-pain intensity. The conditioning stimulus will be a cold water immersion (12ºC)
Whiplash-no Pain
Subjects with chronic whiplash syndrome and pain. The inclusion criteria for pain include the ausence of daily pain during the previous 8 weeks. Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale. The maximun will be 2 points. Subjects will be recruited between the 4 months until 2 years after the whiplash.

Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration.

The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.

Questionnaires are important to assess the chronic pain and their impact in the quality of life. For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference. Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain. The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale. Also,we will assess the disability after whiplash using the Neck Disability Index.
Conditioned Pain Modulation over the tenar eminence. The test will be a heat tonic stimulus which evoke a 3-pain intensity. The conditioning stimulus will be a cold water immersion (12ºC)
Non-injured
Subjects without whiplash syndrome. The inclusion criteria are defined as a absence of previous or actual symptoms or signs of neck pain.

Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration.

The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.

Questionnaires are important to assess the chronic pain and their impact in the quality of life. For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference. Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain. The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale. Also,we will assess the disability after whiplash using the Neck Disability Index.
Conditioned Pain Modulation over the tenar eminence. The test will be a heat tonic stimulus which evoke a 3-pain intensity. The conditioning stimulus will be a cold water immersion (12ºC)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Metabolite concentrations
大体时间:Baseline at 0 min
The metabolite concentrations will be measured by magnetic resonance (spectroscopy)
Baseline at 0 min
Conditioned Pain Modulation
大体时间:Baseline at 0 min
Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)
Baseline at 0 min
Brief Pain Inventory
大体时间:Baseline at 0 min
Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
Baseline at 0 min
Neurophatic Pain Symptoms Inventory
大体时间:Baseline at 0 min
Neurophatic Pain Symptoms Inventory (NPSI), it is used to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
Baseline at 0 min
Pain Catastrophizing Helplessness Subscale
大体时间:Baseline at 0 min
Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score
Baseline at 0 min
Neck Disability Index
大体时间:Baseline at 0 min
Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome
Baseline at 0 min

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Diego Serrano-Muñoz, MsC、Hospital Nacional de Parapléjicos, Toledo

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2017年1月1日

初级完成 (预期的)

2017年3月1日

研究完成 (预期的)

2017年5月1日

研究注册日期

首次提交

2016年12月15日

首先提交符合 QC 标准的

2016年12月28日

首次发布 (估计)

2016年12月29日

研究记录更新

最后更新发布 (估计)

2016年12月29日

上次提交的符合 QC 标准的更新

2016年12月28日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • GFSM-HNP

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

To publish in impact journals

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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