An observational study in Fibromyalgia, Cognitive Dysfunction and Central Sensitisation, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Observational
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?
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.
1,338 studies on the registry are indexed under Fibromyalgia; 268 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 270 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 104 studies on the registry; 28 are open to participants now.
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Patients with Fibromyalgia
Exclusion Criteria:
Patients with fibromyalgia
Diagnostic Test: Central Sensitization Inventory · Diagnostic Test: The Montreal Cognitive Assessment · Diagnostic Test: Cognitive Symptom Severity Scale-Extended · Other: Fibromyalgia Impact Questionnaire · Other: Numeric rating scale · Other: Hospital Anxiety and Depression Scale
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 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.
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.
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 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.
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
Central Sensitization Inventory
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.
Time frame: 6 months
Montreal Cognitive Assessment
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.
Time frame: 6 months
Cognitive Symptom Severity Scale-Extended
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.
Time frame: 6 months
Fibromyalgia Impact Questionnaire
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.
Time frame: 6 months
Hospital Anxiety and Depression Scale
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
Time frame: 6 months
Numeric rating scale
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.
Time frame: 6 months
Plan to share: No — Data sharing not planned
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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey