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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06197087
Enrollment
500
Registered
2024-01-09
Start date
2023-12-15
Completion date
2024-12-15
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronotype, Fibromyalgia Syndrome

Keywords

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

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.

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.

Interventions

OTHERcross-sectional observational survey study

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.

Sponsors

Oğuzhan Kandemir
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Central Sensitization Inventory1 hourCentral 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
Morning and Evening Survey1 hourSleep 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.
Fibromyalgia Impact Survey1 hourIt 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.

Secondary

MeasureTime frameDescription
Pain Catastrophizing Scale1 hourSullivan 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.
VAS1 hourVisual 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.
SF-121 hourSF-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.
Pittsburg Sleep Quality Index (PSQI)1 hourThe 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.
Beck Depression Anxiety Scale1 hourBeck 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.

Countries

Turkey (Türkiye)

Contacts

Primary Contactoğuzhan kandemir
md.oguzhankandemir@gmail.com+905357400335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026