Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome

Study Overview
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Brief Summary
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The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.

Detailed Description
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This sectional study included 100 patients with non-anemic FMS diagnosis and 100 patients with non anemic non FMS diagnosis whose ferritin levels were measured within the last four weeks. The participants were evaluated using Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Pittsburg Sleep Quality Index (PSQI) as well as with a questionnaire form about descriptive characteristics. Serum ferritin level of <30 ng/mL was considered iron deficiency.

Official Title
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Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome

Conditions
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Fibromyalgia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fibromyalgi syndrome patients ferritin levels were measured within the last four weeks Exclusion Criteria: parenteral or enteral iron usage in last four weeks hemoglobin level was less than 12 g/dl infection malignity active inflammatory arthritis serious skin variations serious peripheral vascular disease iron storing disorder pregnant or lactating patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fibromyalgia<br>Non-anemic FMS patients who were diagnosed based on 2011 FMS diagnostic criteria of the American Rheumatology College | |
| Control<br>Non-anemic women without a FMS diagnosis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pitsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes poor sleep from good sleep. minimum score 1 maximum score 9 ≥5 total points in PSQI mean poor sleep. <5 total points in PSQI mean good sleep. | 1 year | 
| Ferritin Level | Iron deficiency marker | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnarie Scores | Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality. mimimum score 0 maximum score 100 higher scores shows poor functionality. | 1 year | 
| Beck Depression Inventory | Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression). minimum 0 maximum 63 points higher scores mean worse outcome. | 1 year | 
| Beck Anxiety Inventory | Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety). minimum 0 maximum 63 points higher scores mean worse outcome | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia Syndrome, Ferritin, Sleep