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

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia

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.

• Study Type: Observational
• Enrollment (Actual): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tokat State Hospital
• Investigators: Principal Investigator: sevil okan, Doctor

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: January 26, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Fibromyalgia Syndrome, Ferritin, Sleep
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 123456 (UMMashhad)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No