Evaluation of Chronotype and Central Sensitization in Patients With Fibromyalgia Syndrome

NCT06197087 | Unknown

• 1 other identifier: chronotypeandfibromyalgia2023
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study is to examine the chronotype preferences of patients with fibromyalgia syndrome and the relationship between central sensitization and chronotype, and to examine its relationship with pain intensity, disability and quality of life.

Conditions

Chronotype; Fibromyalgia Syndrome

Keywords

fibromyalgia syndrome; Chronotype; central sensitization; disability; quality of life

Outcome Measures

Primary Outcomes (3)

• Central Sensitization Inventory

  Central Sensitization Inventory (CSI) The CSI is a two-part questionnaire that contains a 25-item survey (Part A) that assesses the frequency of health-related symptoms associated with central sensitivity syndromes and a brief survey (Part B) asking if patients have been diagnosed with specific disorders (Neblett et al., 2013). For the purposes of this study, only responses from the 25-item survey were included. Participants are asked to rate each question on a 5-point scale with 0 meaning "never" and 4 meaning "always." A summed response is obtained with a total possible score of 100. Higher CSI scores represent greater self-reported symptomology. A cutoff score of 40 or greater has shown acceptable psychometrics for identifying patients with central sensitivity syndromes

  1 hour

• Morning and Evening Survey

  Sleep is one of the most commonly used tools to assess chronotype preferences. This screening questionnaire, consisting of 19 items, has a rating range between 16 and 86. Scoring results were classified as follows: evening types scoring between 16 and 41, morning types scoring between 59 and 86, and no types scoring between 42 and 58. The Turkish version has been shown to have good validity and reliability.

  1 hour

• Fibromyalgia Impact Survey

  It was developed by Burckhardt and his colleagues in 1991. It is the most commonly used scale to evaluate functional status in patients with FMS. It evaluates 10 different characteristics, including physical functioning, well-being, missed work days, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. The total score varies between 0 and 80. A high score indicates that the disease affects the person more. Cronbach's alpha coefficient for all items was 0.73.

  1 hour

Secondary Outcomes (5)

• VAS

  1 hour

• Pittsburg Sleep Quality Index (PSQI)

  1 hour

• Beck Depression Anxiety Scale

  1 hour

• Pain Catastrophizing Scale

  1 hour

• SF-12

  1 hour

Interventions

cross-sectional observational survey study OTHER

Patients' pain intensity (with VAS), quality of life (with SF-12), sleep quality (with Pittsburgh sleep quality scale), anxiety and depression symptoms (with Beck Depression Inventory), cognitive aspect of pain (with Pain Catastrophizing Scale), presence of central sensitization (with the central sensitization scale), functional status (with the Fibromyalgia impact questionnaire), and chronotype preferences will be evaluated with the Morningness and Eveningness Questionnaire.

Eligibility Criteria

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

Study Population

Female patients who applied to Yerköy State Hospital Physical Medicine and Rehabilitation Polyclinic and Afyonkarahisar Health Sciences University Faculty of Medicine Hospital Physical Medicine and Rehabilitation Polyclinic and were followed up with the diagnosis of FMS for at least 3 months will be included in the study.

You may qualify if:

• Being diagnosed according to ACR 2016 Fibromyalgia Syndrome Diagnostic criteria Continuing complaints for at least 3 months

You may not qualify if:

• Neurological and Inflammatory diseases Pregnancy Malignancy

Sponsors & Collaborators

• Oğuzhan Kandemir: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Andrade A, Vilarino GT, Sieczkowska SM, Coimbra DR, Bevilacqua GG, Steffens RAK. The relationship between sleep quality and fibromyalgia symptoms. J Health Psychol. 2020 Aug;25(9):1176-1186. doi: 10.1177/1359105317751615. Epub 2018 Jan 8.

  PMID: 29310453 BACKGROUND

• Boomershine CS. Fibromyalgia: the prototypical central sensitivity syndrome. Curr Rheumatol Rev. 2015;11(2):131-45. doi: 10.2174/1573397111666150619095007.

  PMID: 26088213 BACKGROUND

• Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choiniere M, Ko G, Moulin DE, Panopalis P, Proulx J, Shir Y; National Fibromyalgia Guideline Advisory Panel. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013 May-Jun;18(3):119-26. doi: 10.1155/2013/918216.

  PMID: 23748251 BACKGROUND

• Theadom A, Cropley M, Humphrey KL. Exploring the role of sleep and coping in quality of life in fibromyalgia. J Psychosom Res. 2007 Feb;62(2):145-51. doi: 10.1016/j.jpsychores.2006.09.013.

  PMID: 17270572 BACKGROUND

• Turkoglu G, Selvi Y. The relationship between chronotype, sleep disturbance, severity of fibromyalgia, and quality of life in patients with fibromyalgia. Chronobiol Int. 2020 Jan;37(1):68-81. doi: 10.1080/07420528.2019.1684314. Epub 2019 Nov 5.

  PMID: 31687843 BACKGROUND

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 BACKGROUND

• Czeisler CA, Gooley JJ. Sleep and circadian rhythms in humans. Cold Spring Harb Symp Quant Biol. 2007;72:579-97. doi: 10.1101/sqb.2007.72.064.

  PMID: 18419318 BACKGROUND

• Barclay NL, Rowe R, O'Leary R, Bream D, Gregory AM. Longitudinal Stability of Genetic and Environmental Influences on the Association between Diurnal Preference and Sleep Quality in Young Adult Twins and Siblings. J Biol Rhythms. 2016 Aug;31(4):375-86. doi: 10.1177/0748730416653533. Epub 2016 Jun 23.

  PMID: 27339174 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• sevda adar

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

• ümit dündar

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

oğuzhan kandemir

CONTACT

+905357400335; md.oguzhankandemir@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physical medicine and rehabilitation specialist doctor

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 9, 2024
• Study Start: December 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: December 15, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)