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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN15015327 |
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Date of registration:
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24/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Increased brain activation after painful stimulation of the forearm muscles in patients with fibromyalgia syndrome
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Scientific title:
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Increased cortical activation upon painful stimulation in fibromyalgia syndrome |
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Date of first enrolment:
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01/01/2007 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN15015327 |
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Study type:
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Observational |
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Study design:
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Non-interventional single-center study observational study. (Other)
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Nurcan
Üçeyler |
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Address:
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Department of Neurology
University of Würzburg
Josef-Schneider-Str. 11
97080
Würzburg
Germany |
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Telephone:
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+49 931 201 24617 |
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Email:
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ueceyler_n@ukw.de |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 years or over
2. Patients with:
2.1. Fibromyalgia syndrome
2.2. Unipolar major depression (MD) without pain
2.3.Healthy controls
Exclusion criteria: 1. Other possible differential diagnoses (e.g. rheumatoid arthritis; post-surgery pain)
2. Current or prior cerebral disease (e.g. stroke, cerebral hemorrhage, head trauma)
3. Any clinically relevant psychiatric disorder (examined by systematic psychiatric interview)
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibromyalgia
Musculoskeletal Diseases
Fibromyalgia
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Intervention(s)
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Twenty five patients with fibromyalgia syndrome, ten patients with unipolar major depression (MD) without pain, and thirty five healthy controls are recruited for the study. Patients undergo functional near-infrared spectroscopy (fNIRS) whilst being subjected to two stimulations:
1. Painful pressure stimulation at the dorsal forearm
2. Verbal fluency test (VFT) to asses cognitive function using memory recall
All patients underwent neurological examination and all subjects were investigated with questionnaires (pain, depression, FMS, empathy).
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Primary Outcome(s)
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Muscular pressure pain: fNIRS measurements were performed during the application of painful pressure on the muscle bulk of the finger extensors of the right side using a calibrated algesiometer. The stimulation conditions were as follows: pressure application for two seconds; pause for ten seconds between two stimuli; total of 40 stimuli, i.e. measurement at baseline and up to 8 minutes after first stimulation.
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Secondary Outcome(s)
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Verbal fluency test (VFT): The VFT paradigm consisted of three conditions. Subjects were asked to produce as many different nouns as possible a) starting with a certain letter (A, F, and S), or b) belonging to the same category (animals, fruits, and flowers) or c) to name the days of the week as a control condition. Each condition lasted for 30 sec followed by 30 sec rest. Subjects worked on nine blocks in total (3 x letters, 3 x categories, 3 x week days), i.e. measurement at baseline and up to 9 minutes after start.
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Source(s) of Monetary Support
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University of Würzburg (EFIC-Grünenthal Grant and intramural funds)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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