Muscle Architecture and Muscle Strength in Fibromyalgia
- Conditions
- FibromyalgiaSarcopeniaMuscle Weakness
- Interventions
- Other: Demographic information formDiagnostic Test: widespread pain index (WPI)Diagnostic Test: symptom severity scale (SSS)Other: Sarcopenia assessed by measuring isometric strengths of different parts of the bodyDiagnostic Test: Fibromyalgia Impact Questionnaire (FIQ)Diagnostic Test: Tender Point examinationOther: Muscle Architecture visualized with ultrasoundOther: Timed Up & Go (TUG)
- Registration Number
- NCT06378788
- Lead Sponsor
- Bezmialem Vakif University
- 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?
- 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 %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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- Meeting the 2016 ACR (American College of Rheumatology) diagnostic criteria.
- Diagnosed at least 1 year ago.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fibromyalgia Fibromyalgia Impact Questionnaire (FIQ) Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia Fibromyalgia Muscle Architecture visualized with ultrasound Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia Fibromyalgia Demographic information form Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia Fibromyalgia symptom severity scale (SSS) Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia Fibromyalgia Tender Point examination Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia Control Sarcopenia assessed by measuring isometric strengths of different parts of the body healthy participants Fibromyalgia widespread pain index (WPI) Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia Control Muscle Architecture visualized with ultrasound healthy participants Control Demographic information form healthy participants Fibromyalgia Sarcopenia assessed by measuring isometric strengths of different parts of the body Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia Fibromyalgia Timed Up & Go (TUG) Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia
- Primary Outcome Measures
Name Time Method Quadriceps Femoris Vastus Lateralis Muscle Thickness through study completion, an average of 16 weeks Vastus lateralis ultrasonography will be performed to evaluate muscle thickness.
Quadriceps Femoris Vastus Medialis Muscle Thickness through study completion, an average of 16 weeks Vastus Medialis ultrasonography will be performed to evaluate muscle thickness.
Tibialis Anterior Muscle Thickness through study completion, an average of 16 weeks Tibialis Anterior ultrasonography will be performed to evaluate muscle thickness.
Quadriceps Femoris Vastus Medialis Fascicle Length 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 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 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 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 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 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 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 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 through study completion, an average of 16 weeks Rectus Femoris ultrasonography will be performed to evaluate muscle thickness.
Quadriceps Femoris Rectus Femoris Fascicle Length 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 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 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 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) 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 through study completion, an average of 16 weeks Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate muscle thickness.
Ankle Muscle strength 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bezmialem Vakif University
🇹🇷Istanbul, Fatih, Turkey