Deniz Oke
Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)
NCT Number: NCT06396949
Fibromyalgia syndrome is characterized by chronic pain, fatigue, sleep problems and functional symptoms. Fatigue, anxiety and depression disorders, poor quality of life, sleep disorders, decreased concentration, and impaired cognitive functions are non-specific pain-related symptoms.
Various studies have reported decreased chest expansion, maximal ventilatory volume and maximal expiratory pressure in fibromyalgia patients with widespread body pain. Additionally, dyspnea is a symptom associated with respiratory muscle weakness and is associated with general fatigue. In these individuals, lower data are obtained in daily living activities and general health evaluation surveys. We did not find any study in the literature regarding the relationship between diaphragm thickness and fibromyalgia symptoms. In the light of these data, we aimed to evaluate the thickness of the diaphragm, one of the most important inspiratory muscles, in fibromyalgia patients.
Looking for future studies?
Notify Me18 year–50 year
All sexes
Observational
Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)
Demographic information of all individuals included in the study will be collected. Daily living activity will be evaluated with Short Form-36 (SF-36), Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Questionnaire (PSQI) and Beck Depression Inventory. In order to evaluate the respiratory function test in both the fibromyalgia and control groups, three consecutive measurements will be taken with a hand spirometer and the arithmetic average of these three measurements will be recorded. In fibromyalgia and control patients, diaphragm thickness was measured at 8-9 degrees on the right anterior axillary line with a 6-14 Mhz linear, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD., P.R. China) in the supine position. It will be measured at the end of inspiration and expiration from the intercostal space. Three measurements will be made and the arithmetic average will be evaluated.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fibromyalgia study form, consisting of clinical measurement, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36, who applied to the outpatient clinic with fibromyalgia will be filled in detail.
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders.
The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
Other names: Spirometry function test
Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (millimeter-mm), end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.
Time frame: Within 1 month of applying to the outpatient clinic
Fibromyalgia study form, consisting of clinical measurement (2016 ACR (American College of Rheumatology) fibromyalgia diagnostic criteria, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36), who applied to the outpatient clinic with fibromyalgia will be filled in detail.
Time frame: Within 1 month of applying to the outpatient clinic
The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
Time frame: Within 1 month of applying to the outpatient clinic
Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (millimeter-mm), end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) (percentage) will be evaluated three times and the arithmetic average of these three measurements will be taken.
Time frame: Within 1 month of applying to the outpatient clinic
2016 revised American College of Rheumatology fibromyalgia diagnostic criteria; A patient satisfies the modified 2016 fibromyalgia criteria if the following three conditions are met:
Time frame: Within 1 month of applying to the outpatient clinic
Ascertainment
Time frame: Within 1 month of applying to the outpatient clinic
Time frame: Within 1 month of applying to the outpatient clinic
The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. The FIQ is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
Time frame: Within 1 month of applying to the outpatient clinic
The BAI is a rating scale used to evaluate the severity of anxiety symptoms. The scale was developed by Aaron T Beck, MD.The BAI contains 21 self-report items. The items reflect symptoms of anxiety, including: numbness or tingling, feeling hot, wobbliness in legs, ability to relax, fear of the worst happening, dizziness or lightheadedness, pounding or racing heart, unsteadiness, feeling terrified, feeling nervous, feeling of choking, hands trembling, feeling shaky, fear of losing control, difficulty breathing, fear of dying, feeling scared, indigestion or abdominal discomfort, faintness, face flushing, and sweating. Each item allows the patient four choices from no symptom to severe symptom. For each item, the patient is asked to report how he or she has felt during the past week. The items are scored as 0, 1, 2, or 3. The score range is 0-63. A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe.
Time frame: Within 1 month of applying to the outpatient clinic
The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity
Time frame: Within 1 month of applying to the outpatient clinic
The SF-36 is a health status profile originally designed to measure health status of patients and outcomes of patients.The 36 questions on the SF-36 are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health. The categories of physical role and emotional role reflect performance at the activity and participation levels.To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Gaziosmanpasa Research and Education Hospital
Other Gov
The Relationship Between Diaphragm Muscle Thickness and Anxiety, Depression and Activities of Daily Living in Fibromyalgia Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04802577
Anxiety, Anxiety Disorders
Yıldırım, Bursa, Turkey (Türkiye)
View Trial DetailsNCT04476316
Anxiety, Anxiety Disorders
Barcelona, Spain
View Trial DetailsNCT02697435
Anxiety, Anxiety Disorders
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT01757301
Anxiety, Anxiety Disorders
Indianapolis, Indiana, United States
View Trial Details