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Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia

S

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status

Enrolling

Conditions

Fibromyalgia
Cognitive Dysfunction
Central Sensitisation

Treatments

Diagnostic Test: The Montreal Cognitive Assessment
Other: Numeric rating scale
Other: Fibromyalgia Impact Questionnaire
Other: Hospital Anxiety and Depression Scale
Diagnostic Test: Cognitive Symptom Severity Scale-Extended
Diagnostic Test: Central Sensitization Inventory

Study type

Observational

Funder types

Other

Identifiers

NCT06948903
11111 (Registry Identifier)

Details and patient eligibility

About

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?

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Patients
Description:
Patients with fibromyalgia
Treatment:
Diagnostic Test: Central Sensitization Inventory
Diagnostic Test: Cognitive Symptom Severity Scale-Extended
Other: Hospital Anxiety and Depression Scale
Other: Fibromyalgia Impact Questionnaire
Other: Numeric rating scale
Diagnostic Test: The Montreal Cognitive Assessment

Trial contacts and locations

1

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Central trial contact

Feyza Yücel, M.D.

Data sourced from clinicaltrials.gov

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