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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
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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 |
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Follistatin-Like Protein 1 (FSTL1) Levels
기간: Baseline (single study visit)
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Serum FSTL1 concentrations will be measured using ELISA and compared between women with fibromyalgia and healthy controls. |
Baseline (single study visit)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pressure Pain Threshold (PPT)
기간: Baseline (single study visit)
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Pressure pain thresholds will be measured using an algometer at the bilateral upper trapezius and tibialis anterior muscles. |
Baseline (single study visit)
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Handgrip Strength
기간: Baseline (single study visit)
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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)
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Fatigue Severity Scale (FSS) Score
기간: Baseline (single study visit)
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Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). Higher scores indicate greater fatigue severity. |
Baseline (single study visit)
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Revised Fibromyalgia Impact Questionnaire (FIQR) Score
기간: Baseline (single study visit)
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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)
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Pain Intensity Score
기간: Baseline (single study visit)
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Pain intensity will be assessed using a standardized 0-10 pain rating scale, with higher scores indicating greater pain intensity. |
Baseline (single study visit)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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