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临床试验/NL-OMON33998
NL-OMON33998
已完成
不适用

Functional brain imaging of the influence of interoceptive awareness and autonomic nervous system function in pain processing in fibromyalgia - Imaging of autonomic nervous system function in fibromyalgia

niversitair Medisch Centrum Utrecht0 个研究点目标入组 154 人待定

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
fibromyalgia
发起方
niversitair Medisch Centrum Utrecht
入组人数
154
状态
已完成
最后更新
去年

概览

简要总结

暂无简介。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
去年
研究类型
Observational invasive

研究者

发起方
niversitair Medisch Centrum Utrecht

入排标准

入选标准

  • Only female subjects will be recruited since most patients with fibromyalgia are female (\~85%). Fibromyalgia patients will have a diagnosis of primary fibromyalgia according to the American College of Rheumatology classification criteria. Control subjects will be healthy. Eligible participants will be: between 20\-50 years of age, in their pre\-menopausal state with a recurrent menstrual cycle, right\-handed, and speak Dutch fluently. Further, participants should adequately perceive stimuli as painful and non\-painful. This last criterion will be determined in the pre\-fMRI screening session and will serve as an inclusion criterion for the next visit. Healthy participants will be matched to fibromyalgia patients on age and educational level. All participants will sign informed consent.

排除标准

  • Exclusion criteria are: cognitive impairment as tested by the Mini\-Mental State Exam, if the painful stimulation fails to reach appropriate scores on a 0\-100 visual analog scale of pain intensity, if not able to undergo MRI scanning, for example due to metal parts in or on the body or claustrophobia, if pregnant, current use of sedative psychotropic medications, when there is any serious injury to the body regions to be tested, serious health problems other than fibromyalgia as assessed with a health questionnaire.

结局指标

主要结局

未指定

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