Muscle Architecture and Muscle Strength in Fibromyalgia

Recruiting

• Conditions: Fibromyalgia; Sarcopenia; Muscle Weakness

• 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.

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-19
• Study First Posted: 2024-04-22
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Meeting the 2016 ACR (American College of Rheumatology) diagnostic criteria.
• Diagnosed at least 1 year ago.

Exclusion Criteria

• 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

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.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey