Serum FSTL1 Levels in Women With Fibromyalgia: A Case-Control Study (FMS-FSTL1)
Evaluation of the Relationship Between Serum Follistatin-Like Protein 1 (FSTL1) Levels and Clinical and Functional Parameters in Fibromyalgia Syndrome
This observational, cross-sectional case-control study aims to evaluate serum Follistatin-Like Protein 1 (FSTL1) levels in women with fibromyalgia syndrome (FMS) and healthy controls. A total of 60 women aged 18-50 years will be included, comprising 30 patients with FMS and 30 healthy controls.
Serum FSTL1 levels will be compared between the groups. Associations between FSTL1 levels and pain sensitivity, handgrip strength, fatigue, pain severity, and functional status will also be investigated.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This single-center, observational, cross-sectional case-control study will investigate serum Follistatin-Like Protein 1 (FSTL1) levels and their associations with clinical and functional parameters in women with fibromyalgia syndrome (FMS).
The study will include 60 women aged 18-50 years: 30 patients diagnosed with FMS according to the 2016 ACR criteria and 30 healthy controls.
Serum FSTL1 levels will be measured and compared between groups. Clinical assessments will include pressure pain thresholds, handgrip strength, fatigue severity, pain intensity, and functional status.
The relationships between serum FSTL1 levels and clinical parameters will be analyzed. All assessments will be performed during a single study visit, without any therapeutic intervention.
Studietype
Registrering (Antatt)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
The study population will consist of 60 women aged 18-50 years, including 30 patients diagnosed with fibromyalgia syndrome according to the 2016 ACR criteria and 30 healthy controls without fibromyalgia or chronic widespread pain. Participants will be recruited from Kanuni Sultan Suleyman Training and Research Hospital and healthy volunteers from the hospital staff and community.
Beskrivelse
Inclusion Criteria:Women aged 18-50 years.
Patients diagnosed with fibromyalgia syndrome according to the 2016 ACR criteria.
Healthy controls without fibromyalgia or chronic widespread pain.
Ability to complete clinical and functional assessments.
Provision of written informed consent.
Exclusion Criteria:
Hematological, endocrine, inflammatory rheumatic, autoimmune, renal, cardiovascular, gastrointestinal, or respiratory diseases.
Active infection, history of malignancy, or vitamin D deficiency.
Surgery or major trauma within the previous year.
Pharmacological or non-pharmacological treatment for fibromyalgia within the previous 3 months.
Current smoking.
Pregnancy or breastfeeding.
Neurological or musculoskeletal conditions affecting handgrip strength or pressure pain threshold measurements.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Fibromyalgia Group
Thirty women aged 18-50 years diagnosed with fibromyalgia syndrome according to the 2016 ACR criteria. Serum FSTL1 levels and clinical and functional parameters will be evaluated. Kopyala |
|
Healthy Control Group
Thirty healthy women aged 18-50 years without fibromyalgia syndrome or chronic widespread pain. Serum FSTL1 levels and clinical and functional parameters will be evaluated. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum Follistatin-Like Protein 1 (FSTL1) Levels
Tidsramme: Baseline (single study visit)
|
Serum FSTL1 concentrations will be measured using ELISA and compared between women with fibromyalgia and healthy controls. |
Baseline (single study visit)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pressure Pain Threshold (PPT)
Tidsramme: Baseline (single study visit)
|
Pressure pain thresholds will be measured using an algometer at the bilateral upper trapezius and tibialis anterior muscles. |
Baseline (single study visit)
|
|
Handgrip Strength
Tidsramme: Baseline (single study visit)
|
Handgrip strength will be measured bilaterally using a hand dynamometer. Three measurements will be performed for each hand, and strength will be recorded in kilograms (kg). |
Baseline (single study visit)
|
|
Fatigue Severity Scale (FSS) Score
Tidsramme: Baseline (single study visit)
|
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). Higher scores indicate greater fatigue severity. |
Baseline (single study visit)
|
|
Revised Fibromyalgia Impact Questionnaire (FIQR) Score
Tidsramme: Baseline (single study visit)
|
The impact of fibromyalgia on symptoms and daily functioning will be assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR). Total scores range from 0 to 100, with higher scores indicating greater disease impact. |
Baseline (single study visit)
|
|
Pain Intensity Score
Tidsramme: Baseline (single study visit)
|
Pain intensity will be assessed using a standardized 0-10 pain rating scale, with higher scores indicating greater pain intensity. |
Baseline (single study visit)
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FMS-FSTL1-2026-001
Legemiddel- og utstyrsinformasjon, studiedokumenter
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