fibromyalgia
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes are brain activation patterns and the relationship between physiological measures, pain and interoceptive awareness. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are physiological data measures during brain imaging and verbal pain scores upon painful stimulation. These outcomes will be correlated to brain imaging patterns. Other outcomes are the physiological data assessments obtained at the screening session, detailed QST pain testing, physical fitness assessments, and questionnaire scores. | — |
Countries
Netherlands
Outcome results
None listed