Predictive factors and clinical biomarkers for treatment in patients with chronic pain caused by osteoarthritis with a central sensitisation component.
A Akinci, M Al Shaker, M H Chang...
https://pubmed.ncbi.nlm.nih.gov/26558538Actively Recruiting
Age: 18Years - 65Years
All Genders
ID06948903
Investigation of the Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Patients With Fibromyalgia
Led by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Updated on 2025-09-12
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are examining the link between central sensitization symptoms and cognitive dysfunction in people with fibromyalgia, a condition marked by chronic widespread pain and impaired pain regulation. The study seeks to understand how these symptoms impact both objective and subjective cognitive complaints, and how cognitive issues relate to disease severity and other clinical factors. This observational study is conducted by Sultan Abdulhamid Han Training and Research Hospital in Istanbul, Turkey. Participants diagnosed with fibromyalgia will undergo assessments using tools such as the Central Sensitization Inventory and the Montreal Cognitive Assessment to evaluate pain sensitivity and cognitive function. Additional scales like the Cognitive Symptom Severity Scale-Extended, Fibromyalgia Impact Questionnaire, Hospital Anxiety and Depression Scale, and Numeric Rating Scale will also be used to assess symptoms of cognition, anxiety, depression, and pain severity. These tests occur over a 6-month period. During the study, participants will be evaluated at regular intervals to monitor changes in central sensitization and cognitive function. Researchers will collect data on cognitive symptoms, fibromyalgia impact, anxiety, depression, and pain intensity. The primary outcomes measured include scores on the Central Sensitization Inventory and the Montreal Cognitive Assessment after 6 months. This data will help clarify the relationship between central sensitization and cognitive dysfunction in fibromyalgia patients over the study period.
CONDITIONS
Brief Title
Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
- Between 18 and 65 years old
- Able to read and write
- Agree to participate in the study
You will not qualify if you...
- Having systemic inflammatory disease, central nervous system disease with cortical involvement, active infection, or history of cancer
- History of illness that may cause cognitive impairment
- Younger than 18 or older than 65 years
- Unable to read or write
- Decline to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 6 months
Participants undergo assessments including questionnaires and cognitive tests to evaluate central sensitization symptoms and cognitive function.
Periodic visits during the 6 months
Trial Site Locations
Total: 1 location
1
Health Sciences University
Istanbul, Uskudar, Turkey (Türkiye), 34100
Actively Recruiting
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Research Team
F
Feyza Yücel, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Meta-analysis of cognitive performance in fibromyalgia.
Tyler Bell, Zina Trost, Melissa T Buelow...
https://pubmed.ncbi.nlm.nih.gov/29388512Cognitive Performance Is Related to Central Sensitization and Health-related Quality of Life in Patients with Chronic Whiplash-Associated Disorders and Fibromyalgia.
Iris Coppieters, Kelly Ickmans, Barbara Cagnie...
https://pubmed.ncbi.nlm.nih.gov/26000686Cognitive impairment in fibromyalgia.
Paulo Henrique Ferreira Bertolucci, Fabricio Ferreira de Oliveira
https://pubmed.ncbi.nlm.nih.gov/23709236A modified version of the 2016 ACR fibromyalgia criteria cognitive items results in stronger correlations between subjective and objective measures of cognitive impairment.
Odelia Elkana, Chen Yaalon, Sheer Raev...
https://pubmed.ncbi.nlm.nih.gov/33734966Validity and reliability of the Turkish version of the central sensitization inventory.
Ela Düzce Keleş, Murat Birtane, Galip Ekuklu...
https://pubmed.ncbi.nlm.nih.gov/35382371The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment.
Ziad S Nasreddine, Natalie A Phillips, Valérie Bédirian...
https://pubmed.ncbi.nlm.nih.gov/15817019Validation of Montreal Cognitive Assessment and Discriminant Power of Montreal Cognitive Assessment Subtests in Patients With Mild Cognitive Impairment and Alzheimer Dementia in Turkish Population.
Yıldız Kaya, Ozlem Erden Aki, Ufuk Anik Can...
https://pubmed.ncbi.nlm.nih.gov/24578463The validity and reliability of the Turkish version of the Fibromyalgia Impact Questionnaire.
S Sarmer, S Ergin, G Yavuzer
https://pubmed.ncbi.nlm.nih.gov/11149662