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临床试验/NCT01506817
NCT01506817Unknown不适用

Dynamic Contrast Enhanced MRI of the Hands in Patients With Fibromyalgia. A Pilot Study

Frederiksberg University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Imaging patterns obtained at DCE-MRI using the software program DYNAMIKA (www.imageanalysis.org.uk) of the dominant hand as evaluated by a specialist in radiology will be the primary outcome of the study.

研究概览

简要总结

The primary objective of the current pilot study is to analyze MRI contrast-enhancement patterns in the hands of patients with fibromyalgia as compared to the findings in healthy controls. Further, to compare enhancement patterns obtained in fibromyalgia patients with those described in inflammatory joint disorders, i.e. rheumatoid arthritis and psoriatic arthritis.

Hypothesis:

Dynamic contrast-enhanced MRI (DCE-MRI) of the hands in patients with fibromyalgia reveals pathological imaging patterns indicative of diffuse non-arthrogenic inflammation of e.g. superficial soft tissues and /or muscle with patterns distinct from those of inflammatory joint disorders e.g. rheumatoid arthritis and psoriatic arthritis.

详细描述

Systematic, diagnostic studies applying DCE-MRI have never been performed in patients with fibromyalgia. However, characteristic contrast-enhancement patterns different from those seen in patients with rheumatoid arthritis and psoriatic arthritis have been observed in a small sample of fibromyalgia patients referred for DCE-MRI of the hands for differential diagnostic purposes at department of radiology, Frederiksberg Hospital. In these patients enhancement parameters indicative of vasodilatation and diffuse hyperperfusion involving subcutaneous tissues and muscles of the hands and fingers were found, whereas no synovial inflammation in joints or tendons could be demonstrated in the majority of these patients. Whether these observations are part of a "normal" physiological perfusion in healthy individual or a potential novel marker of disease activity remains to be studied.

If a pathological imaging pattern indicative of superficial soft tissue or muscle inflammation/hyper perfusion can be demonstrated it will have far-reaching implications for future research related to this patient population. Not only may this line of research contribute to a better neurobiological understanding of fibromyalgia and the neurobiological link between inflammation and pain modulation, but also to the development of more objective examination methods, which will make diagnosing more reliable and less subjective. Further, a better understanding of the neurobiology and phenomenological manifestations of fibromyalgia may have critical treatment implications

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age above 18
  • Fibromyalgia according to the 1990-ACR research criteria
  • Pain in the hands as a prominent clinical feature

排除标准

  • Other know medical condition capable of causing patients symptoms (e.g. uncontrolled inflammatory/autoimmune disorder, uncontrolled endocrine disorder, malignancy)
  • Renal impairment
  • Contraindications for MRI

结局指标

主要结局

Imaging patterns obtained at DCE-MRI using the software program DYNAMIKA (www.imageanalysis.org.uk) of the dominant hand as evaluated by a specialist in radiology will be the primary outcome of the study.

时间窗: at baseline

The hand and wrist will be examined in a 3T Siemens Verio® MR scanner with the patients and normal controls supine and the hand along the side of the body (3T Verio) using a semiflex 15 channel body coil.

次要结局

未报告次要终点

研究者

发起方
Frederiksberg University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Henning Bliddal

Professor, MD, DMSci

Frederiksberg University Hospital

研究点 (1)

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