Clinical trial NCT06948903: Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia.
Official title: Investigation of the Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Patients With Fibromyalgia.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Cognitive Dysfunction
Central Sensitisation
Keywords: Fibromyalgia
Cognitive Dysfunction
Central Sensitisation
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Fibromyalgia

Brief summary: The aim of the study is to investigate the relationship between central sensitization parameters and cognitive dysfunction in patients with fibromyalgia.The main questions it aims to answer are:

Do central sensitization symptoms affect cognitive dysfunction in patients with fibromyalgia? To what extent do central sensitization symptoms affect objective and subjective cognitive complaints in fibromyalgia patients? How do cognitive complaints relate to other clinical parameters, including disease severity, in these patients?

Detailed description: Central sensitization is defined as an increase in pain sensitivity with amplification of neuron-derived signals in the central nervous system. Fibromyalgia is a disease characterized by chronic widespread pain, and although its etiology and pathophysiology are still not fully known, it is considered a major member of the group of diseases known as central sensitivity syndromes, which progress with impaired pain regulation.

Fibromyalgia negatively affects the patient's functionality in various ways. One of these is cognitive dysfunction, and previous studies have shown that fibromyalgia patients experience significant deterioration in all parameters related to cognitive function compared to healthy controls. Central sensitization has been shown to be associated with comorbidities such as depression, anxiety, sleep disorders and fatigue in many disease groups, including fibromyalgia, and data on its effect on cognitive dysfunction are limited.

A study found that impaired conditioned pain modulation, one of the methods used in the evaluation of central sensitization in fibromyalgia patients, was associated with cognitive dysfunction.In addition, cognitive impairment in these patients is associated with a decrease in the quality of life of the patients and is suggested to be one of the important clinical findings of the disease. Considering all these data, it seems likely that central sensitization negatively affects cognitive function in fibromyalgia, and this study aimed to examine in detail the relationship between central sensitization and cognitive dysfunction in fibromyalgia patients.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
* Being between 18-65 years old
* Being literate
* Accepting to participate in the study

Exclusion Criteria:

* Concomitant systemic inflammatory disease, central nervous system disease (cortical involvement), active infection and malignancy history
* History of illness that may lead to cognitive impairment
* Being \<18 and \>65 years old
* Being illiterate
* Not accepting to participate in the study

Primary outcomes:
measure: Central Sensitization Inventory
timeFrame: 6 months
measure: Montreal Cognitive Assessment
timeFrame: 6 months
Secondary outcomes:
measure: Cognitive Symptom Severity Scale-Extended
timeFrame: 6 months
measure: Fibromyalgia Impact Questionnaire
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 6 months
measure: Numeric rating scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Health Sciences University
state: Uskudar
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Feyza Yücel
role: STUDY_CHAIR
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