Central Sensitization in Familial Mediterranean Fever (FMF)

NCT05177120 | Completed

• 1 other identifier: 06.12.2019.1053
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Familial Mediterranean Fever; Central Sensitisation

Keywords

Familial Mediterranean Fever; Central Sensitization; Central Sensitization Inventory

Outcome Measures

Primary Outcomes (1)

• Central Sensitization Inventory (CSI)

  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.

  6 months

Secondary Outcomes (6)

• Short form-36 (SF-36)

  6 months

• Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)

  6 months

• Health Assessment Questionnaire (HAQ)

  6 months

• Hospital Anxiety and Depression Scale (HADS)

  6 months

• Pittsburgh Sleep Quality Index (PSQI)

  6 months

Study Arms (1)

FMF patients

Patients with diagnosed FMF

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

Central Sensitization Inventory DIAGNOSTIC_TEST

Standardized questionnaire to determine the level of central sensitization

Also known as: CSI

FMF patients

Short form-36 OTHER

Standardized questionnaire to investigate the quality of life in patients

Also known as: SF-36

FMF patients

Pittsburgh Sleep Quality Index OTHER

Standardized questionnaire to investigate the sleep quality and disturbance

Also known as: PSQI

FMF patients

Health assessment questionnaire OTHER

Standardized questionnaire used to detect the presence of disability

Also known as: HAQ

FMF patients

Hospital anxiety and depression scale OTHER

Standardized questionnaire to investigate the depression and anxiety

Also known as: HADS

FMF patients

Fibromyalgia rapid screening tool DIAGNOSTIC_TEST

Standardized questionnaire to determine the presence of fibromyalgia

Also known as: FIRST

FMF patients

Familial Mediterranean Fever Quality of life scale OTHER

Standardized questionnaire to investigate the quality of life in Familial Mediterranean Fever patients

Also known as: FMFQoL

FMF patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with FMF

You may qualify if:

• Agree to participate in the study

You may not qualify if:

• Had another systemic inflammatory rheumatic diseases
• Using centrally acting pain medications (e.g., pregabalin, duloxetine, opioids) or glucocorticoids (\>10 mg prednisone or its equivalent)

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Feyza Nur Yücel

Sinop, 57200, Turkey (Türkiye)

Location

Related Publications (11)

• 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: 28437846 BACKGROUND

• 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: 21951710 BACKGROUND

• 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: 15789959 BACKGROUND

• 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: 32475195 BACKGROUND

• 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: 10088946 BACKGROUND

• 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: 11832252 BACKGROUND

• 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: 2748771 BACKGROUND

• 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: 15643295 BACKGROUND

• 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: 9288758 BACKGROUND

• 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: 19712899 BACKGROUND

• 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.

  PMID: 28587921 BACKGROUND

MeSH Terms

Conditions

Familial Mediterranean Fever

Interventions

ametantrone; 4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Canan Sanal- Toprak, Asst.Prof

  Marmara University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 4, 2022
• Study Start: June 1, 2021
• Primary Completion: April 10, 2022
• Study Completion: August 3, 2022
• Last Updated: November 10, 2022

Record last verified: 2021-12

Locations

TU (1)