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临床试验/NCT05161767
NCT05161767终止不适用

Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury

University Ghent1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
37
试验地点
1
主要终点
Blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state

研究概览

简要总结

Around half of the patients with neck pain after trauma (whiplash) will develop chronic pain. Understanding the transition from acute to chronic pain after whiplash is a priority since will help to identify those which patients are likely to fully recover and who do not. In the last years, there have been a call for an investigation of new biomarkers; particularly in brain structure and function. Alterations in the structure of the brain (gray matter, white matter and cortical thickness) as well as the brain function have been found in people with chronic WAD; which are also correlated with pain, disability and symptoms of central sensitization such as hyperalgesia. Previous research has found structural and functional brain differences between people who develop chronic low back pain compared to those who recovered; but research in this vein is still lacking in people with whiplash. Consequently, this study aims to examine the neural correlates of recovery following whiplash injury.

详细描述

This study aims to investigate whether or not there are differences in brain structure and function between people who recover after whiplash and those who do not. Thus, patients with acute neck pain after whiplash will be recruited. Also, a pain-free age- and sex-matched control group will be recruited for comparison.

A longitudinal prospective study will be conducted with two follow-up measurements (3 and 6 months). All measurements will take place at University Hospital of Ghent (UZ Gent), Ghent (Belgium). MRI measures will be taken at baseline (<4 weeks after the accident) and 6-months follow-up. The 3-months follow-up will only consist of the assessment of the online questionnaires; so, patients will not be required to come to UZ Gent.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Neck pain within 4 weeks after the trauma
  • Native Dutch speaker
  • Refraining from consuming caffeine, alcohol and nicotine in the hour before the MRI scans in both measurement times

排除标准

  • Neuropathic pain
  • Being pregnant
  • A history of a chronic pain syndrome
  • Chronic fatigue syndrome
  • Fibromyalgia
  • Cardiovascular disorders
  • Endocrinological disorders
  • Rheumatic disorders
  • Psychiatric disorders
  • History of neck surgery
  • Loss of consciousness during/after the whiplash trauma
  • MRI incompatible health condition (e.g., pacemaker, metal prosthetic devices)
  • Claustrophobia.
  • Healthy volunteers: (matched for age and gender). Additional exclusion criteria include for healthy volunteers
  • a history of a chronic pain syndrome
  • a pain condition in the last six months for which treatment was sought

结局指标

主要结局

Blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state

时间窗: Baseline and 6-months follow-up

Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.

Structural MRI measures (i.e., grey and white matter)

时间窗: Baseline and 6-months follow-up

Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.

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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