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Clinical Trials/NCT06378788
NCT06378788
Recruiting
N/A

Ultrasound-imaged Muscle Architecture and Muscle Strength in Fibromyalgia and it's Correlation With Pain, Disease Activity, and Functionality

Bezmialem Vakif University1 site in 1 country30 target enrollmentFebruary 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Bezmialem Vakif University
Enrollment
30
Locations
1
Primary Endpoint
Quadriceps Femoris Vastus Lateralis Muscle Thickness
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quadriceps Femoris Vastus Lateralis Muscle Thickness

Time Frame: through study completion, an average of 16 weeks

Vastus lateralis ultrasonography will be performed to evaluate muscle thickness.

Quadriceps Femoris Vastus Medialis Muscle Thickness

Time Frame: through study completion, an average of 16 weeks

Vastus Medialis ultrasonography will be performed to evaluate muscle thickness.

Tibialis Anterior Muscle Thickness

Time Frame: through study completion, an average of 16 weeks

Tibialis Anterior ultrasonography will be performed to evaluate muscle thickness.

Quadriceps Femoris Vastus Medialis Fascicle Length

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: through study completion, an average of 16 weeks

Rectus Femoris ultrasonography will be performed to evaluate muscle thickness.

Quadriceps Femoris Rectus Femoris Fascicle Length

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: through study completion, an average of 16 weeks

Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate muscle thickness.

Ankle Muscle strength

Time Frame: 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.

Study Sites (1)

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