Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378788
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-04
Brief Title:
Muscle Architecture and Muscle Strength in Fibromyalgia
Sponsor:
Bezmialem Vakif University
Organization:
Bezmialem Vakif University
Study Overview
Official Title:
Ultrasound-imaged Muscle Architecture and Muscle Strength in Fibromyalgia and its Correlation With Pain Disease Activity and Functionality
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 07-11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None