Clinical trial NCT01506817: Dynamic Contrast Enhanced (DCE)-MRI in Fibromyalgia
Official title: Dynamic Contrast Enhanced MRI of the Hands in Patients With Fibromyalgia. A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Keywords: fibromyalgia
DCE-MRI
neurogenic inflammation
contrast-enhancement patterns
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
Collaborators: name: Oak Foundation
First posted: 2012-01-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with fibromyalgia recruited from Department of Rheumatology, Frederiksberg Hospital. Inclusion in the study will be based on clinical assessment by a specialist in rheumatology and member of the research team. Patients fulfilling the 1990-ACR criteria for fibromyalgia and with pain in the hands as a prominent clinical feature will be referred for DCE-MRI as part of the diagnostic workup.

Healthy controls will be recruited by advertisement at www.forsøgsperson.dk or in the daily press and included in the project based on written, informed consent.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute, Frederiksberg University Hospital
Study officials:
affiliation: The Parker Institute and Department of Radiology, Frederiksberg Hospital Denmark
name: Mikael Boesen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Parker Institute, Frederiksberg Hospital Denmark
name: Henning Bliddal, Professor, DMSci
role: STUDY_DIRECTOR
affiliation: The Parker Institute and Department of Rheumatology, Frederiksberg Hospital Denmark
name: Kirstine Amris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kennedy Institute of Rheumatology, University of Oxford, England
name: Peter Taylor, Professor, MA, PhD
role: PRINCIPAL_INVESTIGATOR
References: