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临床试验/NCT07358754
NCT07358754招募中不适用

The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor (BDNF) Levels and Central Sensitization and Sleep Quality in Patients With Fibromyalgia

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Association between serum S100B and serum BDNF

研究概览

简要总结

Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive symptoms. Central sensitization is considered a key mechanism in the pathophysiology of fibromyalgia; however, the underlying biological markers have not been fully clarified.

Brain-derived neurotrophic factor (BDNF) and S100B protein have been suggested to play roles in neuroinflammation and central pain processing. This observational, cross-sectional study aims to evaluate serum S100B and BDNF levels in patients with fibromyalgia and to investigate their relationship with central sensitization and sleep quality. Serum biomarker levels and clinical assessment scales will be compared between patients with fibromyalgia and healthy controls.

详细描述

Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive complaints. Central sensitization, defined as increased responsiveness of the central nervous system to sensory stimuli, is considered a core mechanism in the pathophysiology of fibromyalgia. However, the biological processes underlying central sensitization and associated clinical features such as sleep disturbances remain incompletely understood.

Brain-derived neurotrophic factor (BDNF) is a neurotrophin involved in synaptic plasticity, neuronal survival, and pain modulation, and has been suggested to be associated with central sensitization. S100B is a calcium-binding protein predominantly released by astrocytes and is considered a peripheral marker of neuroinflammation and glial activation. Alterations in serum levels of BDNF and S100B have been reported in chronic pain conditions, including fibromyalgia.

This observational, cross-sectional study aims to evaluate serum S100B and BDNF levels in patients diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria and to investigate their relationship with central sensitization and sleep quality. A healthy control group matched for age and sex will be included for comparative analysis.

All participants will undergo a single-time-point assessment, including collection of demographic and clinical data. Blood samples will be obtained to measure serum S100B and BDNF levels using standard laboratory methods. Central sensitization will be assessed using the Central Sensitization Inventory, while sleep quality will be evaluated using the Pittsburgh Sleep Quality Index. Additional clinical assessments will include the Fibromyalgia Impact Questionnaire, Beck Depression Inventory, and Beck Anxiety Inventory.

The study does not involve any therapeutic intervention or randomization. The findings are expected to contribute to a better understanding of the biological correlates of central sensitization and sleep disturbances in fibromyalgia.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female participants aged between 18 and 50 years
  • Diagnosis of fibromyalgia according to 2016 American College of Rheumatology (ACR) criteria
  • Symptoms present for at least 3 months
  • Ability to understand and complete study questionnaires
  • Provision of written informed consent
  • For healthy controls:
  • No diagnosis of fibromyalgia or chronic widespread pain
  • No known systemic disease

排除标准

  • 未提供

研究组 & 干预措施

Healthy Control Group

Age- and sex-matched healthy female volunteers without fibromyalgia or chronic widespread pain.

干预措施: No Intervention (Observational Study) (Other)

Fibromyalgia Group

Female patients aged 18-50 years diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria.

干预措施: No Intervention (Observational Study) (Other)

结局指标

主要结局

Association between serum S100B and serum BDNF

时间窗: Baseline

Serum S100B and serum BDNF concentrations will be measured from venous blood samples and the strength of association between the two biomarkers will be analyzed

次要结局

  • Correlation of serum S100B and BDNF with Central Sensitization Inventory (CSI)(Baseline)
  • Correlation of serum S100B and BDNF with Pittsburgh Sleep Quality Index (PSQI)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep Karakuzu Güngör

Physical Medicine and Rehabilitation Specialist

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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