Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia

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?

Conditions

• Fibromyalgia
• Cognitive Dysfunction
• Central Sensitisation

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

The 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.

DIAGNOSTIC_TEST

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.

OTHER

Fibromyalgia Impact Questionnaire

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.

OTHER

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.

OTHER

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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

  lead OTHER

Principal Investigators

• Feyza Yücel · Saglik Bilimleri Universitesi

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-10

Primary Completion

2025-08-01

Completion

2025-10-01

Countries

• Turkey (Türkiye)

Study Locations