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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
|---|
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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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serum Follistatin-Like Protein 1 (FSTL1) Levels
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pressure Pain Threshold (PPT)
大体时间：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
大体时间：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
大体时间：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)
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Revised Fibromyalgia Impact Questionnaire (FIQR) Score
大体时间：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)
|
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Pain Intensity Score
大体时间：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)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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