Evaluation of Chronotype and Central Sensitization in Patients With Fibromyalgia Syndrome
- Conditions
- Fibromyalgia SyndromeChronotype
- Registration Number
- NCT06197087
- Lead Sponsor
- Oğuzhan Kandemir
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 500
- Being diagnosed according to ACR 2016 Fibromyalgia Syndrome Diagnostic criteria Continuing complaints for at least 3 months
- Neurological and Inflammatory diseases Pregnancy Malignancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fibromyalgia Impact Survey 1 hour 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.
Central Sensitization Inventory 1 hour 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
Morning and Evening Survey 1 hour 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.
- Secondary Outcome Measures
Name Time Method Beck Depression Anxiety Scale 1 hour 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.
SF-12 1 hour 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.
VAS 1 hour 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.
Pittsburg Sleep Quality Index (PSQI) 1 hour 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".
Pain Catastrophizing Scale 1 hour 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.
Trial Locations
- Locations (1)
Afyonkarahisar Health Sciences University
🇹🇷Afyonkarahi̇sar, Turkey