An observational study in Fibromyalgia Syndrome, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Not yet recruiting. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational
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.
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 279 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 225 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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 .
Exclusion Criteria:
Hematological, endocrine, inflammatory rheumatic, , renal, cardiovascular, gastrointestinal, or respiratory diseases.
Active infection, history of , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Serum Follistatin-Like Protein 1 (FSTL1) Levels
Serum FSTL1 concentrations will be measured using ELISA and compared between women with fibromyalgia and healthy controls.
Time frame: Baseline (single study visit)
Pressure Pain Threshold (PPT)
Pressure pain thresholds will be measured using an algometer at the bilateral upper trapezius and tibialis anterior muscles.
Time frame: Baseline (single study visit)
Handgrip Strength
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).
Time frame: Baseline (single study visit)
Fatigue Severity Scale (FSS) Score
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). Higher scores indicate greater fatigue severity.
Time frame: Baseline (single study visit)
Revised Fibromyalgia Impact Questionnaire (FIQR) Score
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.
Time frame: Baseline (single study visit)
Pain Intensity Score
Pain intensity will be assessed using a standardized 0-10 pain rating scale, with higher scores indicating greater pain intensity.
Time frame: Baseline (single study visit)
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Jan 2027, 2 months later.
Of 81 non-industry observational studies under Fibromyalgia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 109. This study's planned 2 months is below that.
Counting every sponsor, half of 88 studies reached it within 27 months; a quarter within 8 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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