Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia

NCT06948903 | Recruiting

• 1 other identifier: 11111
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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?

Conditions

Fibromyalgia; Cognitive Dysfunction; Central Sensitisation

Keywords

Fibromyalgia; Cognitive Dysfunction; Central Sensitisation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (4)

• Cognitive Symptom Severity Scale-Extended

  6 months

• Fibromyalgia Impact Questionnaire

  6 months

• Hospital Anxiety and Depression Scale

  6 months

• Numeric rating scale

  6 months

Study Arms (1)

Patients

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

Interventions

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.

Patients

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.

Patients

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.

Patients

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.

Patients

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.

Patients

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

Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Fibromyalgia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Health Sciences University

Istanbul, Uskudar, 34100, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• Akinci A, Al Shaker M, Chang MH, Cheung CW, Danilov A, Jose Duenas H, Kim YC, Guillen R, Tassanawipas W, Treuer T, Wang Y. Predictive factors and clinical biomarkers for treatment in patients with chronic pain caused by osteoarthritis with a central sensitisation component. Int J Clin Pract. 2016 Jan;70(1):31-44. doi: 10.1111/ijcp.12749. Epub 2015 Nov 11.

  PMID: 26558538 RESULT

• Bell T, Trost Z, Buelow MT, Clay O, Younger J, Moore D, Crowe M. Meta-analysis of cognitive performance in fibromyalgia. J Clin Exp Neuropsychol. 2018 Sep;40(7):698-714. doi: 10.1080/13803395.2017.1422699. Epub 2018 Feb 1.

  PMID: 29388512 RESULT

• Coppieters I, Ickmans K, Cagnie B, Nijs J, De Pauw R, Noten S, Meeus M. Cognitive Performance Is Related to Central Sensitization and Health-related Quality of Life in Patients with Chronic Whiplash-Associated Disorders and Fibromyalgia. Pain Physician. 2015 May-Jun;18(3):E389-401.

  PMID: 26000686 RESULT

• Bertolucci PH, de Oliveira FF. Cognitive impairment in fibromyalgia. Curr Pain Headache Rep. 2013 Jul;17(7):344. doi: 10.1007/s11916-013-0344-9.

  PMID: 23709236 RESULT

• Elkana O, Yaalon C, Raev S, Sobol N, Ablin JN, Shorer R, Aloush V. A modified version of the 2016 ACR fibromyalgia criteria cognitive items results in stronger correlations between subjective and objective measures of cognitive impairment. Clin Exp Rheumatol. 2021 May-Jun;39 Suppl 130(3):66-71. doi: 10.55563/clinexprheumatol/403mpp. Epub 2021 Mar 16.

  PMID: 33734966 RESULT

• Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.

  PMID: 35382371 RESULT

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 RESULT

• Kaya Y, Aki OE, Can UA, Derle E, Kibaroglu S, Barak A. Validation of Montreal Cognitive Assessment and Discriminant Power of Montreal Cognitive Assessment Subtests in Patients With Mild Cognitive Impairment and Alzheimer Dementia in Turkish Population. J Geriatr Psychiatry Neurol. 2014 Jun;27(2):103-9. doi: 10.1177/0891988714522701. Epub 2014 Feb 26.

  PMID: 24578463 RESULT

• Sarmer S, Ergin S, Yavuzer G. The validity and reliability of the Turkish version of the Fibromyalgia Impact Questionnaire. Rheumatol Int. 2000 Dec;20(1):9-12. doi: 10.1007/s002960000077.

  PMID: 11149662 RESULT

MeSH Terms

Conditions

Fibromyalgia; Cognitive Dysfunction

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Feyza Yücel

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Central Study Contacts

Feyza Yücel, M.D.

CONTACT

(0216) 542 20 00; dr.fny28@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: January 10, 2023
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)