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临床试验/NCT07640607
NCT07640607尚未招募不适用

Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey0 个研究点目标入组 82 人开始时间: 2026年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
82

研究概览

简要总结

Fibromyalgia is characterized by altered pain processing, including impaired descending pain inhibition and central sensitization. While both mechanisms have been independently associated with disease severity, their interrelationship remains unclear. This cross-sectional study aims to investigate whether central sensitization symptoms mediate the relationship between conditioned pain modulation and fibromyalgia impact.

详细描述

Fibromyalgia is characterized by altered pain processing mechanisms, including impaired descending pain inhibition and central sensitization. Although both mechanisms have been independently associated with symptom severity and functional impairment, their interrelationship and relative contributions to disease impact are not fully understood.

This study aims to examine the associations between conditioned pain modulation, central sensitization symptoms, and fibromyalgia impact. In particular, the study evaluates whether central sensitization symptoms act as a mediator in the relationship between impaired pain modulation and clinical disease burden. Participants with fibromyalgia are assessed using standardized clinical and psychological measures, including the Fibromyalgia Impact Questionnaire, Central Sensitization Inventory, and Hospital Anxiety and Depression Scale. Quantitative sensory testing is performed to evaluate conditioned pain modulation, pressure pain threshold, and temporal summation.Statistical analyses are conducted to explore bivariate associations and to identify independent predictors of fibromyalgia impact. A mediation framework is applied to assess whether central sensitization symptoms explain the relationship between pain modulation and clinical outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Having received a diagnosis of fibromyalgia according to the 2016 ACR diagnostic criteria
  • Female patients aged 18-65
  • Being literate
  • Having signed the informed consent form upon agreeing to participate in the study

排除标准

  • Being under 18 or over 65 years of age
  • Having any condition that may lower the pain threshold or cause chronic pain (Rheumatoid Arthritis, Ankylosing Spondylitis, systemic inflammatory diseases, malignancies, etc.)
  • Any neurological condition (stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies…)
  • Peripheral artery disease
  • Severe cardiopulmonary insufficiency (stage 3-4)
  • Uncontrolled systemic diseases such as hypertension and diabetes
  • Presence of an active infection
  • Presence of cognitive impairment, hearing loss, or communication difficulties that would prevent understanding of questionnaires and protocols

研究组 & 干预措施

Patient

Women with Fibromyalgia

干预措施: Quantitative Sensory Tests(QST) protocol (Other)

Patient

Women with Fibromyalgia

干预措施: Clinical Scales (Other)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Feyza Nur Yucel

Associate Professor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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