Evaluation of Myocardial Function by Global Longitudinal Strain (GLS) Measurement in 2D Echocardiography of Patients With Fibromyalgia
NCT07150455 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 118
Last updated 2026-03-25
Summary
Fibromyalgia (FM) is a chronic pain syndrome that affects multiple body systems and is often associated with fatigue, sleep disturbances, anxiety, and other comorbidities. Increasing evidence suggests that FM is also linked to cardiovascular dysfunction due to autonomic imbalance, sympathetic overactivity, and endothelial dysfunction. Patients with FM may therefore be at higher risk of developing subclinical ventricular dysfunction even before overt cardiovascular disease becomes apparent.
Traditional echocardiographic evaluation of left ventricular function is based on ejection fraction (LVEF). However, LVEF has important limitations. It may remain normal despite underlying myocardial impairment, is strongly influenced by loading conditions, and often fails to detect early myocardial dysfunction. Recent advances in echocardiography allow for the assessment of Global Longitudinal Strain (GLS), a sensitive and reproducible measure of myocardial deformation. GLS abnormalities can be detected earlier than changes in LVEF and are predictive of future declines in ejection fraction.
This study aims to evaluate myocardial function in fibromyalgia patients using GLS obtained by two-dimensional speckle-tracking echocardiography (2D-STE). By comparing FM patients with age- and sex-matched healthy controls, the study seeks to determine whether FM patients show a higher prevalence of subclinical ventricular dysfunction.
The study is designed as a prospective, observational, case-control study. A total of 118 participants will be enrolled: 59 patients diagnosed with fibromyalgia according to the 2010 American College of Rheumatology (ACR) criteria, and 59 control subjects without fibromyalgia. The control group will consist of volunteers presenting with mechanical low back pain but without systemic rheumatic disease.
All participants will undergo echocardiographic examination using a standardized protocol with Vivid E95 Dimension ultrasound equipment (GE Healthcare). Global Longitudinal Strain will be measured offline using EchoPAC software, and results will be analyzed according to recommendations of the American Society of Echocardiography. In addition, fibromyalgia patients will complete the Fibromyalgia Impact Questionnaire (FIQ) to evaluate disease severity, and results will be compared with echocardiographic findings.
Primary Outcome: Prevalence of subclinical left ventricular dysfunction, defined as impaired GLS, in fibromyalgia patients compared to controls.
Secondary Outcome: Correlation between GLS values and fibromyalgia disease severity scores.
This study is expected to provide new insights into the cardiovascular involvement of fibromyalgia. Detecting early myocardial impairment with GLS may help identify patients at risk of future cardiovascular complications and may support closer monitoring and preventive strategies in this population.
Conditions
- Fibromyalgia (FM)
- Subclinical Ventricular Dysfunction
- Myocardial Function
Interventions
- OTHER
-
Echocardiographic Assessment (2D Speckle Tracking)
All participants will undergo standardized 2D echocardiographic examination including Global Longitudinal Strain (GLS) measurement. No drug or device intervention is applied.
Sponsors & Collaborators
-
Ankara Training and Research Hospital
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2026-03-15
- Completion
- 2026-03-20
Countries
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Estrogen Receptor 1 Gene Polymorphism Frequency in Fibromyalgia Syndrome
NCT03786393 ·Status: COMPLETED
-
Frequency of Fibromyalgia Syndrome in Elderly Patients Aged 80 and Above and Its Relationship With Geriatric Parameters
NCT06969716 ·Status: COMPLETED
-
The Effect of Positive Psychotherapy Based Psychoeducation on Pain Perception With Fibromyalgia Syndrome
NCT06147882 ·Status: COMPLETED ·Phase: NA
-
Fibromyalgia Syndrome on Patients With Chronic Migraine
NCT05381012 ·Status: COMPLETED ·Phase: NA
-
Relationship Between Dysphonia And Anxiety In Fibromyalgia
NCT05410756 ·Status: COMPLETED
-
The Effect of Fibromyalgia Syndrome Accompanying Obstructive Sleep Apnea Syndrome on Clinical Findings
NCT05367167 ·Status: COMPLETED
-
Effects of the COVID-19 Pandemic on Fibromyalgia Patients
NCT04730934 ·Status: COMPLETED
-
Pain Severity in Fibromyalgia Syndrome
NCT05481086 ·Status: COMPLETED
-
Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia
NCT00302887 ·Status: COMPLETED
-
Pain Phenotypes in Patients With Fibromyalgia Syndrome
NCT05941780 ·Status: COMPLETED
-
Evaluation of the Sural Nerve With Ultrasonography and Electromyography in Patients With Fibromyalgia
NCT04985149 ·Status: UNKNOWN ·Phase: NA
-
Effect of Soundscapes on Emotional Distress in Fibromyalgia: a 4×4 Crossover Trial
NCT07231289 ·Status: COMPLETED ·Phase: NA
-
The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
NCT05835427 ·Status: COMPLETED ·Phase: NA
-
Fatigue Levels in Fibromyalgia Syndrome
NCT04827550 ·Status: COMPLETED
-
Association Between Autonomic Dysfunction and Choroidal Vascularity Index in Fibromyalgia
NCT07345546 ·Status: COMPLETED
-
Effectiveness of Neural Therapy in Patients With Fibromiyalgia
NCT04007172 ·Status: COMPLETED ·Phase: NA
-
The Effect of Perception of Improvement in Patients With Fibromyalgia
NCT06508385 ·Status: RECRUITING ·Phase: NA
-
Work-Related Fibromyalgia
NCT03535454 ·Status: COMPLETED
-
Treatment and Assessment of Fibromyalgia
NCT02760212 ·Status: COMPLETED ·Phase: NA
-
Artificial Intelligence, and E-Health Literacy in Fibromyalgia
NCT07020845 ·Status: COMPLETED
-
Kinesiophobia, Quality of Life, and Cognitive Functions in Fibromyalgia Syndrome
NCT04695288 ·Status: COMPLETED
-
A Study of the Effect of Rhythmic Sensory Stimulation on Fibromyalgia
NCT02493348 ·Status: COMPLETED ·Phase: NA
-
Relationship Between Central Sensitization Symptoms and Cognitive Dysfunction in Fibromyalgia
NCT06948903 ·Status: RECRUITING
-
Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
NCT03394898 ·Status: UNKNOWN
-
HRV Biofeedback in Fibromyalgia
NCT00222274 ·Status: COMPLETED ·Phase: NA