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Familial Mediterranean FeverFMFNCT05177120

Central Sensitization in Familial Mediterranean Fever (FMF)

An observational study of Familial Mediterranean Fever and Central Sensitisation, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Central Sensitization Inventory, Short form-36 and Pittsburgh Sleep Quality Index
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2021to 3 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with FMF

Who may be able to join

  • Agree to participate in the study

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Feyza Nur Yücel

    Sinop, 57200

Other trials in Turkey (Türkiye)

About this study

Official title: Central Sensitization in Familial Mediterranean Fever: A Cross-Sectional Observational Study

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.

Read the detailed description

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.

Being tested
Central Sensitization Inventory, Short form-36, Pittsburgh Sleep Quality Index, Health assessment questionnaire, Hospital anxiety and depression scale
Keywords
Familial Mediterranean Fever, Central Sensitization, Central Sensitization Inventory
Medical subject headings
Familial Mediterranean Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Central Sensitization InventoryDiagnostic test

    Also called CSI

    Standardized questionnaire to determine the level of central sensitization

  • Short form-36Other

    Also called SF-36

    Standardized questionnaire to investigate the quality of life in patients

  • Pittsburgh Sleep Quality IndexOther

    Also called PSQI

    Standardized questionnaire to investigate the sleep quality and disturbance

  • Health assessment questionnaireOther

    Also called HAQ

    Standardized questionnaire used to detect the presence of disability

  • Hospital anxiety and depression scaleOther

    Also called HADS

    Standardized questionnaire to investigate the depression and anxiety

  • Fibromyalgia rapid screening toolDiagnostic test

    Also called FIRST

    Standardized questionnaire to determine the presence of fibromyalgia

  • Familial Mediterranean Fever Quality of life scaleOther

    Also called FMFQoL

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

Study groups in NCT05177120
Study groupRoleWhat they receive
FMF patientsPatients with diagnosed FMF
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (6)

  1. Short form-36 (SF-36)

    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.

    Measured: 6 months

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

    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.

    Measured: 6 months

  3. Health Assessment Questionnaire (HAQ)

    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.

    Measured: 6 months

  4. Hospital Anxiety and Depression Scale (HADS)

    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.

    Measured: 6 months

  5. Pittsburgh Sleep Quality Index (PSQI)

    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.

    Measured: 6 months

  6. Fibromyalgia Rapid Screening Tool (FIRST).

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2022
  2. Study start1 Jun 2021
  3. Primary completion10 Apr 2022
  4. Study completion3 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05177120
Sponsor's protocol ID
06.12.2019.1053
Acronym
FMF
Status last verified
Dec 2021
First submitted
3 Jan 2022
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28437846

  • 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.

    PubMed 21951710

  • 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.

    PubMed 15789959

  • 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.

    PubMed 32475195

  • 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.

    PubMed 10088946

  • 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.

    PubMed 11832252

  • 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.

    PubMed 2748771

  • 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.

    PubMed 15643295

  • 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.

    PubMed 9288758

  • 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.

    PubMed 19712899

  • 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.

    PubMed 28587921

Questions about this trial

What is this clinical trial studying?

An observational study of Familial Mediterranean Fever and Central Sensitisation, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Sensitization Inventory (CSI) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05177120, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.

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