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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia | Non-anemic FMS patients who were diagnosed based on 2011 FMS diagnostic criteria of the American Rheumatology College | ||
| Control | Non-anemic women without a FMS diagnosis |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This sectional study included 100 female patients older than 18 years of age who presented to Physical Treatment and Rehabilitation polyclinic in 2016-17 period.
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| Name | Affiliation | Role |
|---|---|---|
| sevil okan | Doctor | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fibromiyalgia | 100 Fibromyalgia Patient Group |
| FG001 | Control | 100 Control Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fibromiyalgia | 100 Fibromyalgia Patient Group |
| BG001 | Control | 100 Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 100 This index applied only Firomyalgia syndrome group | Posted | Mean | Standard Deviation | score on a questionnarie | 1 year |
|
no advers event 1 year
no advers event
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibromiyalgia | 100 Fibromyalgia Patient Group | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Sevil Okan | Tokat State Hospital | 5308211797 | doctorsevil@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2016 | Apr 4, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| 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 |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ferritin level | Median | Inter-Quartile Range | ng/ml |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Ferritin Level | Iron deficiency marker | 200 | Posted | Median | Inter-Quartile Range | ng/ml | 1 year |
|
|
|
| Secondary | 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. | 100 This questionnarie applied only Firomyalgia syndrome group | Posted | Mean | Standard Deviation | score on a questionnarie | 1 year |
|
|
|
| Secondary | 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. | 100 This questionnarie applied only Firomyalgia syndrome group | Posted | Mean | Standard Deviation | score on a questionnarie | 1 year |
|
|
|
| Secondary | 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 | 100 This inventory applied only Firomyalgia syndrome group | Posted | Mean | Standard Deviation | score on a questionnarie | 1 year |
|
|
|
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Control | 100 Control Group | 0 | 100 | 0 | 100 | 0 | 100 |
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| D009422 |
| Nervous System Diseases |