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临床试验/NCT02560675
NCT02560675已完成不适用

Why Does Acute Post Whiplash Injury Pain Transform Into Chronic Pain? Multi-modal Assessment of Risk Factors and Predictors of Pain Chronification

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 399 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
399
试验地点
1
主要终点
Chronic pain

研究概览

简要总结

Why does acute post whiplash injury pain transform into chronic pain? Multi-modal assessment of risk factors and predictors of pain chronification

详细描述

Background

The proposed study aims to explore why acute pain turns, in some patients, into chronic pain, and to develop tools for prediction of this transition. Based on the clinical and psychological assessment along with psychophysical and neurophysiological assessment of pain perception, with the analysis of connectivity between several brain centers relevant for pain processing, together with pain genetics, we expect to develop a tool, that will predict, for the individual patient with acute pain inflicted by a whiplash injury, what are the chances for him/her to go into chronic pain situation. Further, by knowing the dysfunctions of pain processing that a patient has, it will be possible to offer the treatment of highest chances to succeed.

Our specific aims are to evaluate, in the setup of acute whiplash injury, the risk of transition to chronic pain based on each of the following testing domains: (i) Psychophysical and neurophysiological data describing facilitatory and inhibitory modulation capacity of the patient. (ii) Psychological data describing patient's behavior such as catastrophizing, fear of pain, post-traumatic stress and depressed mood. (iii) Structural and functional neuro-imaging data describing brain anatomy and function, where we assess resting state MRI activity, grey matter properties using T1 weighted imaging, and white matter properties using diffusion tensor imaging. (iv) Genetic data describing the genetic epidemiology of every patient for the examination of genetic variants associated with transition to chronic pain, and (v) individual case data related to age, gender, education, socioeconomic parameters and personal medical history, as well as features of the specific injury. Overall, we aim to construct a composite scoring system, based on the most relevant of the above mentioned parameters, yielding the highest relative predictive value in identifying acute pain patients who have higher risk for chronification.

Subjects One hundred and twenty healthy subjects (range 20-79; 20 subjects per age decade, 10 M and 10 F) will participate in the first phase of the study aimed to collect normative data from healthy population.

Seven hundred and fifty acute whiplash-injury based mild traumatic brain injuries (TBI) will participate in this study.

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 70 Years(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

Chronic pain

时间窗: 12 months

acute post whiplash injury pain transform into chronic pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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