Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05177120
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2022-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Central Sensitization in Familial Mediterranean Fever (FMF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010505', 'term': 'Familial Mediterranean Fever'}], 'ancestors': [{'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020182', 'term': 'ametantrone'}, {'id': 'C018209', 'term': "4-amino-4'-hydroxylaminodiphenylsulfone"}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Sensitization Inventory (CSI)', 'timeFrame': '6 months', 'description': '25 somatic and psychosocial symptoms, which are frequently found in patients with central sensitization in part A, are questioned. In part B, the presence of diseases whose relationship with central sensitization is well defined is questioned in the patient without participating in scoring. Central sensitization is assumed in patients who score 40 or more over 100 points.'}], 'secondaryOutcomes': [{'measure': 'Short form-36 (SF-36)', 'timeFrame': '6 months', 'description': 'The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.The scale consists of 36 questions questioning 8 sub-parameters regarding the health status of the person.These parameters are physical function, pain, limitation due to physical and emotional problems, emotional well-being, social function, fatigue and general health perception. High scores are associated with improved quality of life.'}, {'measure': 'Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)', 'timeFrame': '6 months', 'description': 'FMF-QoL was developed to evaluate the quality of life in FMF patients. This scale consists of 20 questions in the form of a Likert scale and the total scoring is between 0-80. High scores indicate a decrease in quality of life.'}, {'measure': 'Health Assessment Questionnaire (HAQ)', 'timeFrame': '6 months', 'description': 'n the scale, difficulty in performing 20 specific tasks from 8 categories is questioned and the scoring is between 0-60. High scores are associated with increased disability.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '6 months', 'description': 'This scale consists of 14 questions in total, and anxiety symptoms are questioned in half of the questions and depression-related complaints in the other half. A subscore of 8 or higher for depression or anxiety is considered a clinical case.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '6 months', 'description': 'The questionnaire includes 21 questions covering 7 components that investigate the symptoms of sleep disturbances. Scores range from 0 to 21 and a score of \\>5 is considered as a sleep disorder.'}, {'measure': 'Fibromyalgia Rapid Screening Tool (FIRST).', 'timeFrame': '6 months', 'description': 'This scale consists of 6 questions investigating the most relevant clinical features of fibromyalgia. The questions are answered as yes/no and 5 or more out of 6 points in total are in favor of fibromyalgia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Familial Mediterranean Fever', 'Central Sensitization', 'Central Sensitization Inventory'], 'conditions': ['Familial Mediterranean Fever', 'Central Sensitisation']}, 'referencesModule': {'references': [{'pmid': '28437846', 'type': 'BACKGROUND', 'citation': 'Lee YC, Bingham CO 3rd, Edwards RR, Marder W, Phillips K, Bolster MB, Clauw DJ, Moreland LW, Lu B, Wohlfahrt A, Zhang Z, Neogi T. Association Between Pain Sensitization and Disease Activity in Patients With Rheumatoid Arthritis: A Cross-Sectional Study. Arthritis Care Res (Hoboken). 2018 Feb;70(2):197-204. doi: 10.1002/acr.23266.'}, {'pmid': '21951710', 'type': 'BACKGROUND', 'citation': 'Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.'}, {'pmid': '15789959', 'type': 'BACKGROUND', 'citation': 'Pinar R. Reliability and construct validity of the SF-36 in Turkish cancer patients. Qual Life Res. 2005 Feb;14(1):259-64. doi: 10.1007/s11136-004-2393-3.'}, {'pmid': '32475195', 'type': 'BACKGROUND', 'citation': 'Unal-Ulutatar C, Duruoz MT. Development and validation of a quality of life scale in Familial Mediterranean Fever (FMFQoL). Mod Rheumatol. 2021 May;31(3):710-717. doi: 10.1080/14397595.2020.1775946. Epub 2020 Jun 26.'}, {'pmid': '10088946', 'type': 'BACKGROUND', 'citation': 'Senerdem N, Gul A, Konice M, Aral O, Ocal L, Inanc M, Yuzbasioglu N. The use of two different Health Assessment Questionnaires in Turkish rheumatoid arthritis population and assessment of the associations with disability. Clin Rheumatol. 1999;18(1):33-7. doi: 10.1007/s100670050048.'}, {'pmid': '11832252', 'type': 'BACKGROUND', 'citation': 'Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.'}, {'pmid': '2748771', 'type': 'BACKGROUND', 'citation': 'Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.'}, {'pmid': '15643295', 'type': 'BACKGROUND', 'citation': 'Familial Mediterranean fever (FMF) in Turkey: results of a nationwide multicenter study. Medicine (Baltimore). 2005 Jan;84(1):1-11. doi: 10.1097/01.md.0000152370.84628.0c.'}, {'pmid': '9288758', 'type': 'BACKGROUND', 'citation': 'Ancient missense mutations in a new member of the RoRet gene family are likely to cause familial Mediterranean fever. The International FMF Consortium. Cell. 1997 Aug 22;90(4):797-807. doi: 10.1016/s0092-8674(00)80539-5.'}, {'pmid': '19712899', 'type': 'BACKGROUND', 'citation': 'Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 Sep;10(9):895-926. doi: 10.1016/j.jpain.2009.06.012.'}, {'pmid': '28587921', 'type': 'BACKGROUND', 'citation': 'Silva RL, Lopes AH, Guimaraes RM, Cunha TM. CXCL1/CXCR2 signaling in pathological pain: Role in peripheral and central sensitization. Neurobiol Dis. 2017 Sep;105:109-116. doi: 10.1016/j.nbd.2017.06.001. Epub 2017 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'Familial Mediterranean Fever (FMF) is an autosomal recessive inherited disease with a course of autoinflammation, which is characterized by the episodes of fever and serositis. Central sensitization (CS) is defined as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with many rheumatological diseases has been demonstrated in several studies. However, there are no data on the frequency of CS in FMF patients.', 'detailedDescription': 'Familial Mediterranean fever (FMF) is a self-limiting autoinflammatory disease with well-defined genetic and clinical features. Recurrent episodes of fever and serositis accompanied by increased acute phase reactants and good response to colchicine are the core components of the disease. The frequency of this disease, which is common in Eastern Mediterranean countries, is variable according to regions, but it is reported as 1/1000. In the pathogenesis of the disease, the mutation of the MEFV (Mediterranean Fever) gene, which is located on the 16th chromosome and encodes the pyrin protein, is known as the basic mechanism.In rheumatic diseases, inflammatory mediators cause CS by first creating changes in the regulation of pain in peripheral neurons and then in spinal and supraspinal pathways. Stimulation of peripheral nerves by mediators released during inflammation results in neurogenic inflammation, which is among the peripheral sensitization (PS) mechanisms. PS is defined as the increased sensitivity of nociceptive neurons to normal or below-threshold stimuli and constitutes the first step in the development of CS.Similar to other autoimmune diseases, it is possible that the neuroinflammatory process triggers peripheral and central sensitization mechanisms in FMF patients and affects pain pathways.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with FMF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Agree to participate in the study\n\nExclusion Criteria:\n\n* Had another systemic inflammatory rheumatic diseases\n* Using centrally acting pain medications (e.g., pregabalin, duloxetine, opioids) or glucocorticoids (\\>10 mg prednisone or its equivalent)'}, 'identificationModule': {'nctId': 'NCT05177120', 'acronym': 'FMF', 'briefTitle': 'Central Sensitization in Familial Mediterranean Fever (FMF)', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Central Sensitization in Familial Mediterranean Fever: A Cross-Sectional Observational Study', 'orgStudyIdInfo': {'id': '06.12.2019.1053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FMF patients', 'description': 'Patients with diagnosed FMF', 'interventionNames': ['Diagnostic Test: Central Sensitization Inventory', 'Other: Short form-36', 'Other: Pittsburgh Sleep Quality Index', 'Other: Health assessment questionnaire', 'Other: Hospital anxiety and depression scale', 'Diagnostic Test: Fibromyalgia rapid screening tool', 'Other: Familial Mediterranean Fever Quality of life scale']}], 'interventions': [{'name': 'Central Sensitization Inventory', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CSI'], 'description': 'Standardized questionnaire to determine the level of central sensitization', 'armGroupLabels': ['FMF patients']}, {'name': 'Short form-36', 'type': 'OTHER', 'otherNames': ['SF-36'], 'description': 'Standardized questionnaire to investigate the quality of life in patients', 'armGroupLabels': ['FMF patients']}, {'name': 'Pittsburgh Sleep Quality Index', 'type': 'OTHER', 'otherNames': ['PSQI'], 'description': 'Standardized questionnaire to investigate the sleep quality and disturbance', 'armGroupLabels': ['FMF patients']}, {'name': 'Health assessment questionnaire', 'type': 'OTHER', 'otherNames': ['HAQ'], 'description': 'Standardized questionnaire used to detect the presence of disability', 'armGroupLabels': ['FMF patients']}, {'name': 'Hospital anxiety and depression scale', 'type': 'OTHER', 'otherNames': ['HADS'], 'description': 'Standardized questionnaire to investigate the depression and anxiety', 'armGroupLabels': ['FMF patients']}, {'name': 'Fibromyalgia rapid screening tool', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['FIRST'], 'description': 'Standardized questionnaire to determine the presence of fibromyalgia', 'armGroupLabels': ['FMF patients']}, {'name': 'Familial Mediterranean Fever Quality of life scale', 'type': 'OTHER', 'otherNames': ['FMFQoL'], 'description': 'Standardized questionnaire to investigate the quality of life in Familial Mediterranean Fever patients', 'armGroupLabels': ['FMF patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57200', 'city': 'Sinop', 'country': 'Turkey (Türkiye)', 'facility': 'Feyza Nur Yücel', 'geoPoint': {'lat': 42.02683, 'lon': 35.16253}}], 'overallOfficials': [{'name': 'Canan Sanal- Toprak, Asst.Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Marmara University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}