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Ultrasound-imaged Muscle Architecture and Muscle Strength in Fibromyalgia and it's Correlation With Pain, Disease Activity, and Functionality
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?
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.
Age
18 - 65 years
Sex
FEMALE
Healthy Volunteers
No
Bezmialem Vakif University
Istanbul, Fatih, Turkey (Türkiye)
Start Date
February 1, 2024
Primary Completion Date
April 30, 2024
Completion Date
June 30, 2024
Last Updated
April 25, 2024
30
ESTIMATED participants
Demographic information form
OTHER
widespread pain index (WPI)
DIAGNOSTIC_TEST
symptom severity scale (SSS)
DIAGNOSTIC_TEST
Fibromyalgia Impact Questionnaire (FIQ)
DIAGNOSTIC_TEST
Tender Point examination
DIAGNOSTIC_TEST
Muscle Architecture visualized with ultrasound
OTHER
Sarcopenia assessed by measuring isometric strengths of different parts of the body
OTHER
Timed Up & Go (TUG)
OTHER
Lead Sponsor
Bezmialem Vakif University
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06950125