Not yet recruitingNCT07927517ClinicalTrials.gov record

Serum FSTL1 Levels in Women With Fibromyalgia: A Case-Control Study

Fibromyalgia Syndrome

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Observational
Phase: Not applicable / not listed
Age range: 18 years - 50 years
Sex eligible: Female
Healthy volunteers: Accepted
Participants: 60 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Study population

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not reported
Masking: Not reported

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.

Prepare your questions