Isokinetic Knee Flexor and Extensor Strength, Torque, Ultrasonographic Muscle Thickness, Serum Vitamin D Levels, and Sleep Quality in Female Patients With Fibromyalgia Syndrome: A Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Isokinetic Muscle Strength Assessment
研究概览
简要总结
Fibromyalgia syndrome (FMS) is a chronic disease characterized by widespread body pain and tenderness in specific points, which may be accompanied by sleep disturbances, depression, fatigue, cognitive symptoms such as memory problems and attention deficit, and somatic symptoms such as irritable bowel syndrome and constipation. The prevalence of FMS has been found to be approximately 2%. It is more frequently diagnosed in women between the ages of thirty and fifty . It is more common in individuals with low socioeconomic status and education level. Its etiology is not fully known. Genetic and some environmental factors are thought to be influential. Central sensitization, autonomic nervous system dysfunction, immune system dysregulation, intestinal microbiota changes, hypothalamic-pituitary-adrenal (HPA) axis and endocrine system disorders are implicated in the pathogenesis (5; 6; 7; 8). FMS diagnostic criteria were first established in 1990 by the American College of Rheumatology (ACR).
According to these criteria, FMS is diagnosed based on the presence of widespread pain and tender points in the body.
In 2010, the ACR updated the diagnostic criteria by adding the Widespread Pain Index and Symptom Severity Scale. Currently, the 2016 ACR classification criteria are used in the diagnosis of FMS. These criteria consider the presence of pain for at least 3 months, the widespread pain index which assesses the presence of pain in 5 different areas of the body, and the symptom severity scale which assesses fatigue, waking up without rest, and cognitive symptoms. In these criteria, a diagnosis of fibromyalgia can be made independently of other diagnoses; the presence of fibromyalgia does not rule out the presence of other diseases.
The treatment approach for FMS is multidisciplinary. It is considered both non-pharmacological and pharmacological. Non-pharmacological treatment consists of patient education, lifestyle modification, cognitive behavioral therapy, and exercise. Pharmacological treatment includes tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and pregabalin. The aim of the study is to evaluate muscle strength, muscle power, muscle thickness, vitamin D levels, and sleep quality in individuals with and without fibromyalgia syndrome, and to identify possible risk factors.
详细描述
In individuals diagnosed with FMS, existing somatic and cognitive symptoms and chronic pain negatively affect the quality of life, sleep quality, work capacity, and productivity of patients. There are studies showing that patients have reduced muscle strength and power compared to the normal population. It is thought that accompanying vitamin D deficiency may deepen fibromyalgia symptoms. In light of this information, considering the importance of enabling individuals diagnosed with FMS in the community to continue to lead an active and pain-free life, the importance of clinical studies on this subject is increasing. The aim of our study is to evaluate muscle strength, muscle power, muscle thickness, vitamin D level, and sleep quality in individuals with and without fibromyalgia syndrome, to calculate possible risk factors, to determine the differences between the two groups, and to contribute to the literature with these data.Muscle tissue assessment is done by measuring functional and structural parameters.
Functionality is assessed by measuring muscle strength and muscle power. For structural measurement, muscle mass and muscle thickness should be considered. To draw a meaningful conclusion, all data must be evaluated together.Computed tomography (CT), magnetic resonance imaging (MRI), bioelectrical impedance analysis (BIA), dual energy X-ray absorptiometry (DEXA), ultrasonography (USG) and anthropometric measurements can be used to assess muscle mass and thickness .Although CT and MRI are gold standards, they are not used in clinical practice.
They are used in scientific research BIA provides information about body structure by taking advantage of the conductivity difference of tissues. It is affected by variables such as nutritional and hydration status, skin temperature, and physical condition. Therefore, it is difficult to establish standards for measurements.
DEXA calculates the difference between the absorption amounts of two different X-rays at low doses from tissues and provides information about body composition. It is frequently used, especially in the diagnosis and follow-up of osteoporosis. Compared to CT, it involves less radiation exposure and is less expensive.
USG is a radiation-free, low-cost, and easily applicable imaging method. Despite the disadvantage of being person-dependent, it is frequently preferred in musculoskeletal system assessment due to its easy accessibility and repeatability. Although there are different modes and frequencies, brightness (B)-mode USG at a frequency of 1-10 MHz is frequently used in tissue thickness measurement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient group:
- •female gender
- •18-55 years old
- •Clinical diagnosis of Fibromyaljia syndrome
- •Control group:
- •female gender
- •18-55 years old
- •absence of fibromyalgia syndrome diagnosis
排除标准
- •Rheumatological disease, crystal arthropathy, septic arthritis
- •Advanced osteoarthritis
- •History of major orthopedic surgery (total knee and hip replacement, etc.)
- •Neurological disease (Parkinson's disease, multiple sclerosis, cerebrovascular event, etc.)
- •Neuromuscular disease (Polyneuropathies, myasthenia gravis)
- •Active malignancy
- •Advanced organ failure/transplantation
研究组 & 干预措施
Fibromyalgia
Women aged 18-55 who have been diagnosed with fibromyalgia syndrome within the last 3 months according to the 2016 ACR Fibromyalgia Syndrome Diagnostic Criteria and the system has a 25 OH vitamin D measurement result.
Control
Healthy women aged 18-55 and the system has a 25 OH vitamin D measurement result.
结局指标
主要结局
Isokinetic Muscle Strength Assessment
时间窗: Baseline
An isokinetic computerized dynamometer system will be used to measure muscle strength in the dominant knee in both patient and control groups. Strenght (torque) will be measured and recorded in Newton-meters at a speed of 60 degrees per second for 5 repetitions.
Ultrasound Assessment of Muscle Thickness
时间窗: Baseline
For the ultrasonographic evaluation, a 5-12 MHz linear probe was used. Measurements were taken using standard USG gel. While participants lay supine with their knees fully extended, the distance between the anterior superior iliac spine (SIAS) and the superior aspect of the patella was measured and half of this measurement was marked. The thickness of the quadriceps femoris muscles (M. vastus intermedius and M. rectus femoris) was then measured by holding the USG probe axially without applying pressure.Measurements will be recorded in millimeters.
Isokinetic Muscle Power Assessment
时间窗: Baseline
An isokinetic computerized dynamometer system will be used to measure muscle power in the dominant knee in both patient and control groups. Power will be measured and recorded in Watts at 180 degrees/second for 15 repetitions.
次要结局
- Measuring Serum Vitamin D Levels(Baseline)
- Assessment of Sleep Quality(Baseline)
- Assessment of Fibromyalgia Syndrome Disease Severity(Baseline)
研究者
Basak Cigdem Karacay
Clinical Assoc. Professor
Kirsehir Ahi Evran Universitesi