Ultrasound-imaged Muscle Architecture and Muscle Strength in Fibromyalgia and it's Correlation With Pain, Disease Activity, and Functionality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quadriceps Femoris Vastus Lateralis Muscle Thickness
研究概览
简要总结
The goal of this observational study is to determine whether there is decrease in muscle mass and muscle strength in Fibromyalgia Syndrome (FMS) patients in comparison to controls. And to determine whether these parameters are correlated with clinical ones. Briefly the main questions investigators aims to answer are:
- Is there a significant difference in muscle morphology between FMS and controls?
- Is there a significant difference in muscle strength between FMS and controls?
- Is there a relationship between muscle thickness and pennation angle of the Quadriceps, gastrocnemius medialis, gastrocnemius lateralis and Tibialis anterior muscles and disease activity, pain and functionality?
- Is there a correlation between muscle strength in FMS and disease activity, pain and functionality?
详细描述
Fibromyalgia syndrome (FMS) was named by Smythe and Moldofsky when they defined tender points in 1970s. It is defined as chronic, generalized musculoskeletal pain accompanying with fatigue, sleep disturbance , cognitive and somatic disturbance. FMS has variable prevalence as %0,7-11 and usually affects middle aged women. It is second most common rheumatologic disease after osteoarthritis and thought to be the most common reason for musculoskeletal pain in middle aged women.
Recent studies have reported that both sarcopenia and decreased muscle strength occur in patients with chronic inflammatory diseases such as rheumatoid arthritis. There are concerns that sarcopenia may affect exercise tolerance, activities of daily living, and ultimately have a negative impact on cardiovascular fitness and physical and emotional well-being. On the other hand there is researches that support inflammation-driven pathways in the pathogenesis of fibromyalgia. Given the risk of pain related reduction in physical activity, patients are expected to have accelerated muscle wasting , decreased muscle strength and endurance and functionality.
However, there is no study that focused on muscle architecture and strength in FMS. This led us to design our study which will evaluate patients lower extremity muscles' thickness and pennation angles by ultrasound , most daily used muscles' strength by dynamometer, functionality by timed-up test and try to find whether there is a correlation between these parameters and patients' disease activity which will be determined with FMS specific scales.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meeting the 2016 ACR (American College of Rheumatology) diagnostic criteria.
- •Diagnosed at least 1 year ago.
排除标准
- •Patients diagnosed with other rheumatological diseases, muscle diseases, or neuropathies.
- •Patients with a history of trauma affecting muscle morphology.
- •Patients engaging in regular exercise (at least 3-4 times a week for a minimum of 40 minutes).
- •Patients with uncontrolled comorbid diseases
结局指标
主要结局
Quadriceps Femoris Vastus Lateralis Muscle Thickness
时间窗: through study completion, an average of 16 weeks
Vastus lateralis ultrasonography will be performed to evaluate muscle thickness.
Quadriceps Femoris Vastus Medialis Muscle Thickness
时间窗: through study completion, an average of 16 weeks
Vastus Medialis ultrasonography will be performed to evaluate muscle thickness.
Tibialis Anterior Muscle Thickness
时间窗: through study completion, an average of 16 weeks
Tibialis Anterior ultrasonography will be performed to evaluate muscle thickness.
Quadriceps Femoris Vastus Medialis Fascicle Length
时间窗: through study completion, an average of 16 weeks
Vastus Medialis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).
Gastrocnemius Muscle Vastus Lateralis Fascicle Length
时间窗: through study completion, an average of 16 weeks
Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).
Truncal Muscle strength
时间窗: through study completion, an average of 16 weeks
Isometric Truncal flexion (TF)and Isometric Truncal extension (TE) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Hip Muscle strength
时间窗: through study completion, an average of 16 weeks
Isometric Hip flexion (HF), Isometric Hip extension (HE), Isometric Hip abduction (HAB), Isometric Hip internal rotation (HIR) and Isometric Hip external rotation (HER), strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Tibialis Anterior Muscle Fascicle Length
时间窗: through study completion, an average of 16 weeks
Tibialis Anterior ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).
Cervical Muscle strength
时间窗: through study completion, an average of 16 weeks
Isometric Cervical Flexion (CF), Isometric Cervical Extension (CE) and Right and Left Isometric Cervical Lateral Flexion (CLF R/L) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Shoulder Muscle strength
时间窗: through study completion, an average of 16 weeks
Isometric Shoulder flexion (SF), Isometric Shoulder extension (SE), Isometric Shoulder abduction (SAB), Isometric Shoulder internal rotation (SIR) and Isometric Shoulder external rotation (SER) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Quadriceps Femoris Vastus Lateralis Fascicle Length
时间窗: through study completion, an average of 16 weeks
Vastus lateralis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).
Quadriceps Femoris Rectus Femoris Muscle Thickness
时间窗: through study completion, an average of 16 weeks
Rectus Femoris ultrasonography will be performed to evaluate muscle thickness.
Quadriceps Femoris Rectus Femoris Fascicle Length
时间窗: through study completion, an average of 16 weeks
Rectus Femoris ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).
Gastrocnemius Muscle Vastus Medialis Muscle Thickness
时间窗: through study completion, an average of 16 weeks
Gastrocnemius muscle vastus medialis ultrasonography will be performed to evaluate muscle thickness.
Gastrocnemius Muscle Vastus Medialis Fascicle Length
时间窗: through study completion, an average of 16 weeks
Gastrocnemius muscle vastus medialis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).
Knee Muscle strength
时间窗: through study completion, an average of 16 weeks
Isometric Knee extension (KE) and Isometric Knee Flexion (KF) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Timed Up & Go (TUG)
时间窗: through study completion, an average of 16 weeks
The patient sits in the chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the patient is seated and will be reported by seconds. This test aim to determine patients functional state and mobility .
Gastrocnemius Muscle Vastus Lateralis Muscle Thickness
时间窗: through study completion, an average of 16 weeks
Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate muscle thickness.
Ankle Muscle strength
时间窗: through study completion, an average of 16 weeks
Isometric Ankle Dorsiflexion (ADF) and Isometric Ankle Plantar flexion (APF) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
次要结局
未报告次要终点