The Relationship Between Diaphragm Muscle Thickness and Anxiety, Depression and Activities of Daily Living in Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pulmonary function test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with fibromyalgia according to the 2016 ACR (American College of Rheumatology) diagnostic criteria without any comorbidities (such as liver, kidney failure, DM, rheumatic disease)
- •Patients who underwent Pulmonary Function Test (PFT)
- •Patients without pulmonary disease
- •18 -50 years old women and men
排除标准
- •Congenital spinal, costal and diaphragmatic anomalies neuromuscular disease
- •Respiratory system diseases that affect lung functions
- •Patients who cannot cooperate with spirometry.
- •Having surgery to the chest wall or spine
- •Those with BMI > 25
- •Those with liver, kidney failure, DM, rheumatic disease, neurological disease
- •Individuals < 18 years and > 50 years old
结局指标
主要结局
Pulmonary function test
时间窗: 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.
Fibromyalgia diagnostic criteria-Symptom severity scale (SSS)
时间窗: Within 1 month of applying to the outpatient clinic
2. SSS score Fatigue Waking unrefreshed Cognitive symptoms For each of the three symptoms above, indicate the level of severity over the past week using the following scale: 0=no problem 1=slight or mild problems, generally mild or intermittent 2=moderate, considerable problems, often present and/or at a moderate level 3=severe: pervasive, continuous, life-disturbing problems The SSS score is the sum of the severity scores of the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms) (0∼9), plus the sum (0∼3) of the number of the following symptoms the patient has been bothered by that occurred during the previous 6 months: 1.Headaches (0∼1) 2. Pain or cramps in lower abdomen (0∼1) 3. Depression (0∼1). The final symptom severity score is between 0 and 12 The fibromyalgia severity scale is the sum of the WPI and SSS
Fibromyalgia study form
时间窗: 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.
Ultrasonographic Diaphragm Thickness Measurement
时间窗: 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.
Fibromyalgia diagnostic criteria-Widespread pain index (WPI)
时间窗: Within 1 month of applying to the outpatient clinic
Ascertainment 1. WPI: note the number of areas in which the patient has had pain over the past week. In how many areas has the patient had pain? Score will be between 0 and 19 (Region 1) (Left upper region); jaw, left shoulder girdle, left upper arm, left lower arm, (Region 2) (Right upper region); jaw, right shoulder girdle, right upper arm, right lower arm, (Region 3) (Left lower region); hip (buttock, trochanter), left upper leg, left lower leg, (Region 4) (Right lower region); hip (buttock, trochanter), right upper leg, right lower leg and (Region 5) (Axial region); neck, upper back, lower back, chest, abdomen
Fibromyalgia diagnostic criteria
时间窗: 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: 1. Widespread pain index (WPI) ≥7 and symptom severity scale (SSS) score ≥5, or WPI of 4∼6 and SSS score ≥9. 2. Generalized pain, defined as pain in at least four of five regions, must be present. Jaw, chest, and abdominal pain are excluded from the generalized pain definition. 3. Symptoms have been generally present for at least 3 months. 4. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.
次要结局
- Fibromyalgia Impact Questionnaire(Within 1 month of applying to the outpatient clinic)
- Beck Depression Inventory(Within 1 month of applying to the outpatient clinic)
- Beck Anxiety Inventory(Within 1 month of applying to the outpatient clinic)
- Short Form- 36 (SF-36)(Within 1 month of applying to the outpatient clinic)