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NCT Number: NCT06948903

Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia

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?

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Key information

Conditions

Fibromyalgia Central Sensitisation Cognition Disorders Cognitive Dysfunction Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences University

Istanbul, Uskudar, 34100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Feyza Yücel, M.D.

CONTACT

[email protected]

(0216) 542 20 00 ext. +90

Sefa Kurt, M.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Central Sensitization Inventory

Diagnostic Test

The Central Sensitization Inventory is used by some researchers to investigate pain sensitivity through symptoms associated with central sensitization and related comorbidities. It can help determine the severity of central sensitization. The scale was developed to detect central sensitization in patients with chronic pain and consists of two sections: Section A and Section B. For scoring purposes, only Section A is used. A score of 40 or higher out of 100 is associated with an increased likelihood of central sensitization.

The Montreal Cognitive Assessment

Diagnostic Test

The Montreal Cognitive Assessment was initially developed as a test for mild cognitive impairment, but has also been determined to match qualities of the mini mental state examination 80. It assesses seven areas of cognition for a total possible score of 30 points. A score of 21 or less is indicative of cognitive impairment in Turkish population.

Cognitive Symptom Severity Scale-Extended

Diagnostic Test

The Cognitive Symptom Severity Scale extends the scale of the original cognitive symptom severity scale. Participants are asked to rate their cognitive symptoms related to concentration and memory on a single scale ranging from 1-5, rather than the original 1-3, where higher scores indicate greater severity.

Fibromyalgia Impact Questionnaire

Other

The Fibromyalgia Impact Questionnaire is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression. The maximum scale score is 100, with higher scores associated with increasing disability.

Numeric rating scale

Other

Numeric Rating Scale will be used to determine pain intensity during assessments. Participants will be asked to rate their pain intensity by selecting a value between 0 and 10. Higher scores are associated with increased pain severity.

Hospital Anxiety and Depression Scale

Other

This scale is used to assess anxiety and depression symptoms and consists of 14 items (7 items for anxiety, 7 items for depression). For each subscale, scores range from 0 to 21: • 0-7 points: No symptoms or very mild symptoms • 8-10 points: Moderate symptoms • 11 points or higher

Primary outcomes

  1. Central Sensitization Inventory

    Time frame: 6 months

    The Central Sensitization Inventory is used by some researchers to investigate pain sensitivity through symptoms associated with central sensitization and related comorbidities. It can help determine the severity of central sensitization. The scale was developed to detect central sensitization in patients with chronic pain and consists of two sections: Section A and Section B. For scoring purposes, only Section A is used. A score of 40 or higher out of 100 is associated with an increased likelihood of central sensitization.

  2. Montreal Cognitive Assessment

    Time frame: 6 months

    The Montreal Cognitive Assessment was initially developed as a test for mild cognitive impairment, but has also been determined to match qualities of the mini mental state examination 80. It assesses seven areas of cognition for a total possible score of 30 points. A score of 21 or less is indicative of cognitive impairment in Turkish population.

Secondary outcomes

  1. Cognitive Symptom Severity Scale-Extended

    Time frame: 6 months

    The Cognitive Symptom Severity Scale extends the scale of the original cognitive symptom severity scale. Participants are asked to rate their cognitive symptoms related to concentration and memory on a single scale ranging from 1-5, rather than the original 1-3, where higher scores indicate greater severity.

  2. Fibromyalgia Impact Questionnaire

    Time frame: 6 months

    This scale is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression. The maximum scale score is 100, with higher scores associated with increasing disability.

  3. Hospital Anxiety and Depression Scale

    Time frame: 6 months

    This scale is used to assess anxiety and depression symptoms and consists of 14 items (7 items for anxiety, 7 items for depression). For each subscale, scores range from 0 to 21: • 0-7 points: No symptoms or very mild symptoms • 8-10 points: Moderate symptoms • 11 points or higher

  4. Numeric rating scale

    Time frame: 6 months

    Numeric Rating Scale will be used to determine pain intensity during assessments. Participants will be asked to rate their pain intensity by selecting a value between 0 and 10. Higher scores are associated with increased pain severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Feyza Yücel, M.D.

CONTACT

[email protected]

(0216) 542 20 00 ext. +90

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Investigation of the Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Patients With Fibromyalgia

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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