Fibromyalgia
Conditions
Keywords
Fibromyalgia Syndrome, Ferritin, Sleep
Brief summary
The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.
Detailed description
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.
Interventions
None listed
Sponsors
Tokat State Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pitsburgh Sleep Quality Index | 1 year | 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. |
| Ferritin Level | 1 year | Iron deficiency marker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Impact Questionnarie Scores | 1 year | 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. |
| Beck Depression Inventory | 1 year | 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. |
| Beck Anxiety Inventory | 1 year | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fibromiyalgia 100 Fibromyalgia Patient Group | 100 |
| Control 100 Control Group | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Fibromiyalgia | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 100 Participants | 200 Participants |
| ferritin level | 20.95 ng/ml | 34.91 ng/ml | 32.92 ng/ml |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Turkey | 100 Participants | 100 Participants | 200 Participants |
| Sex: Female, Male Female | 100 Participants | 100 Participants | 200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Ferritin Level
Iron deficiency marker
Time frame: 1 year
Population: 200
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fibromyalgia | Ferritin Level | 34.91 ng/ml |
| Fibromyalgia | Ferritin Level | 20.95 ng/ml |
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.
Time frame: 1 year
Population: 100 This index applied only Firomyalgia syndrome group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Pitsburgh Sleep Quality Index | 8.3 score on a questionnarie | Standard Deviation 3.77 |
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
Time frame: 1 year
Population: 100 This inventory applied only Firomyalgia syndrome group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Beck Anxiety Inventory | 22.58 score on a questionnarie | Standard Deviation 11.14 |
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.
Time frame: 1 year
Population: 100 This questionnarie applied only Firomyalgia syndrome group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Beck Depression Inventory | 15.73 score on a questionnarie | Standard Deviation 9.76 |
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.
Time frame: 1 year
Population: 100 This questionnarie applied only Firomyalgia syndrome group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Fibromyalgia Impact Questionnarie Scores | 61.69 score on a questionnarie | Standard Deviation 17.31 |