Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-01-20 @ 6:36 AM
Study NCT ID:
NCT06948903
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C018209', 'term': "4-amino-4'-hydroxylaminodiphenylsulfone"}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Sensitization Inventory', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cognitive Symptom Severity Scale-Extended', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Fibromyalgia Impact Questionnaire', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Numeric rating scale', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Cognitive Dysfunction', 'Central Sensitisation'], 'conditions': ['Fibromyalgia', 'Cognitive Dysfunction', 'Central Sensitisation']}, 'referencesModule': {'references': [{'pmid': '26558538', 'type': 'RESULT', 'citation': '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': '29388512', 'type': 'RESULT', 'citation': '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': '26000686', 'type': 'RESULT', 'citation': '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': '23709236', 'type': 'RESULT', 'citation': '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': '33734966', 'type': 'RESULT', 'citation': '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': '35382371', 'type': 'RESULT', 'citation': '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': '15817019', 'type': 'RESULT', 'citation': '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': '24578463', 'type': 'RESULT', 'citation': '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': '11149662', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nDo 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?', 'detailedDescription': "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.\n\nFibromyalgia 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.\n\nA 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Fibromyalgia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria\n* Being between 18-65 years old\n* Being literate\n* Accepting to participate in the study\n\nExclusion Criteria:\n\n* Concomitant systemic inflammatory disease, central nervous system disease (cortical involvement), active infection and malignancy history\n* History of illness that may lead to cognitive impairment\n* Being \\<18 and \\>65 years old\n* Being illiterate\n* Not accepting to participate in the study'}, 'identificationModule': {'nctId': 'NCT06948903', 'briefTitle': 'Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'Investigation of the Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': '11111'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with fibromyalgia', 'interventionNames': ['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': [{'name': 'Central Sensitization Inventory', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Patients']}, {'name': 'The Montreal Cognitive Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Patients']}, {'name': 'Cognitive Symptom Severity Scale-Extended', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Patients']}, {'name': 'Fibromyalgia Impact Questionnaire', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Patients']}, {'name': 'Numeric rating scale', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Patients']}, {'name': 'Hospital Anxiety and Depression Scale', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34100', 'city': 'Istanbul', 'state': 'Uskudar', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Feyza Yücel, M.D.', 'role': 'CONTACT', 'email': 'dr.fny28@gmail.com', 'phone': '(0216) 542 20 00', 'phoneExt': '+90'}, {'name': 'Sefa Kurt, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Health Sciences University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Feyza Yücel, M.D.', 'role': 'CONTACT', 'email': 'dr.fny28@gmail.com', 'phone': '(0216) 542 20 00', 'phoneExt': '+90'}], 'overallOfficials': [{'name': 'Feyza Yücel', 'role': 'STUDY_CHAIR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing not planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}