Evaluation of Chronotype and Central Sensitization in Patients With Fibromyalgia Syndrome

Evaluation of Chronotype and Central Sensitization in Patients With Fibromyalgia Syndrome, Cross-sectional Study

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia Syndrome; Chronotype
• Intervention / Treatment: Other: cross-sectional observational survey study

Detailed Description

Fibromyalgia Syndrome (FMS); It is a syndrome characterized by chronic pain occurring in more than one part of the body and accompanied by fatigue, sleep disturbance, impairment in quality of life and daily functionality. Although FMS is seen in different age groups, it is most common in middle-aged women. FMS is classified as central sensitization syndrome, in which there is an abnormal response to painful stimuli and the processing of nociceptive stimuli in the central nervous system. In patients with FMS, pain may cause sleep disturbances such as non-restorative sleep or difficulty initiating or maintaining sleep. It is estimated that 65-99% of patients with FMS experience sleep disorders. Circadian rhythms reflect 24-hour physiological and behavioral cycles within each individual. Based on individual differences in the timing of these innate rhythms, individuals can be divided into 3 phenotypes (i.e., chronotypes): morning type (M-highest level of alertness in the morning), evening type (E most active in the evening), and intermediate type (I-neither M nor E). Chronotype is explained by both genetic and environmental factors and can be considered a fairly robust trait throughout adulthood. A study assessing 1548 people with FMS with an online survey including questions about sleep quality, well-being, pain, chronotype and FMS impact shows that late chronotypes are more affected by fibromyalgia. In another study conducted in 2019, patients with FMS were grouped according to chronotype preferences and showed that there was a strong relationship between FMS severity and poor quality of life in evening individuals.

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: oğuzhan kandemir; Phone Number: +905357400335; Email: md.oguzhankandemir@gmail.com

Study Locations

• Turkey
  • Afyonkarahi̇sar, Turkey, 03200
    • Recruiting
    • Afyonkarahisar Health Sciences University
    • Contact: oğuzhan kandemir; Phone Number: +905357400335; Email: md.oguzhankandemir@gmail.com
    • Contact: SEVDA ADAR; Phone Number: +905325940725; Email: drsevdaadar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Neurological and Inflammatory diseases Pregnancy Malignancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburg Sleep Quality Index (PSQI)	The first 18 questions answered by the participant are used in calculating the PSQI total score and component scores. The 18 questions answered by the participant included sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), sleep medication use (component 6), and It provides information about 7 components, including daytime sleep dysfunction (component 7). Each component is evaluated on a scale of 0-3 points. The sum of these 7 component scores gives the total PSQI score. The total PSQI score varies between 0-21. While the sleep quality of individuals with a total score of 5 or less is considered "good", the sleep quality of individuals with a score above 5 is considered "bad".	1 hour
Beck Depression Anxiety Scale	Beck Depression Inventory is a self-rating scale consisting of 21 items. Each item was given a score between 0 and 3, the highest score that could be obtained from the scale was 63 and the lowest score was 0. A high score from the scale indicates that the severity or level of depression is high.	1 hour
VAS	Visual Pain Scale (VAS), which is easy to understand, apply and interpret and provides valid and reliable data in a short time, is the most used method in clinics. Using a 100 mm visual linear scale, the patient is told that at point 0 there is no pain, and at point 100 it is the most severe pain ever felt in life, and the patient is asked to place a mark on the point corresponding to his pain.	1 hour
Pain Catastrophizing Scale	Sullivan et al. It is a 13-item self-report inventory using a 5-point Likert scale (0-4) developed by To measure the extent to which people catastrophize in response to pain. The original scale consists of three sub-factors called helplessness, magnification and rumination.	1 hour
SF-12	SF-12 is an easy-to-administer survey with proven reliability and validity, obtained by shortening and simplifying the SF-36. It is used to evaluate physical and mental health, the two main components of general health status. Consisting of twelve questions, SF-12 has mental and physical component scores. High scores indicate good health.	1 hour

Collaborators and Investigators

• Sponsor: Oğuzhan Kandemir
• Investigators: Principal Investigator: SEVDA ADAR, Afyonkarahisar Health Sciences University; Principal Investigator: ümit dündar, Afyonkarahisar Health Sciences University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; disability; central sensitization; fibromyalgia syndrome; Chronotype
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: chronotypeandfibromyalgia2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No