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NCT07150455
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.
NCT07013305
Fibromyalgia is a rheumatological disorder characterised by chronic widespread body pain, second most common after osteoarthritis. The overall prevalence is 2-8% and it is more common in women. Diffuse body pain, fatigue, sleep and cognitive dysfunction occur. The etiology of fibromyalgia is multifactorial and occurs due to central and peripheral pain mechanisms that occur with neuroendocrine imbalance due to psychological and physical stress in people with genetic predisposition. The diagnostic criteria for fibromyalgia were updated by the American College of Rheumatology in 2016 to include a widespread body pain scale and a symptom severity scale. Fibromyalgia treatment consists of drug (antidepressants and antiepileptics) and non-drug treatments. Pregabalin is also used in the treatment of epilepsy by blocking and modulating the α2 δ subunit of voltage-dependent calcium channels. There are studies showing that antiepileptics cause folate and vitamin B12 deficiency in epilepsy patients. In our study, we aimed to retrospectively investigate vitamin B12 and folic acid levels before and after treatment in patients with fibromyalgia using antiepileptics (anticonvulsants).
NCT07356206
The purpose of this study is to evaluate the effectiveness and medium-term maintenance of a structured dog-assisted therapy (DAT) protocol, "Entre Patas e Afetos" (Between Paws and Affections), in reducing pain, anxiety and depressive symptoms and in improving functional status and quality of life in Portuguese patients with fibromyalgia (FM) followed at ULS Alto Ave, with systematic outcome assessment in the immediate post intervention phase (T2), 6-month follow-up (T3) and 12-month follow-up (T4).
NCT06922747
The goal of this clinical trial is to learn if the combination of two interventions is more effective in treating fibromyalgia symptoms than one intervention alone. The participant group will be people with fibromyalgia in age group 18-65 years. The two interventions to be tested over sixteen weeks are: * weekly exercise sessions in groups * weekly consultations with a therapist The main question it aims to answer is: Is the combination of group exercising and somatic tracking work more efficient than physical activity alone in terms of managing fibromyalgia? Participants will wear Fitbit activity trackers, register pain intensity daily on a mobile app, and answer the Fibromyalgia Impact Questionnaire (FIQ). They will be divided into four groups: * one group receiving the exercise intervention * one group receiving the psychological intervention * one group receiving both intervention * one control group recieving general physical activity recommendations Before the sixteen weeks intervention period, there will be a baseline period of eight weeks. Durng the baseline period, participants will wear activity trackers and maintain their usual lifestyle. Researchers will compare the combination of the interventions against only one intervention and the control group.
NCT06658223
Fibromyalgia is considered a disease of unknown etiology, which It affects between 2 to 5% of the population in developed countries, mostly women, diagnosed mainly between 40 and 50 years of age, and whose main characteristic is generalized presence of musculoskeletal pain. Although the most described symptoms are multiple sensitive areas in trigger points, fatigue and cognitive dysfunction, this syndrome is associated commonly to anxiety disorders, depression and catastrophizing. In Chile, consultations specific cases of rheumatology due to Fibromyalgia reach 26.7%, with a similar reality in the commune of Concepción, as a result of which the need arises to implement a strategy different and innovative, in which an environment can be generated in which the user practices motor and cognitive strategies in different contexts, whether work or home, to through virtual reality, which has proven to be a promising tool in this group of the population, since by entering a controlled virtual environment, different techniques, taking them out of the conventional treatment box. In this way, it may include relaxation exercises, cognitive behavioral therapy, and physical activities adapted. This interaction may improve cognitive function, reduce anxiety symptoms, reduce painful perception associated with your health condition and improve your quality of life. Although there is knowledge and favorable experiences in its use, there is little information about the effects and the scope that it can have in patients with fibromyalgia. For this reason, it is proposed to carry out an investigation applying a Kinesiological treatment complemented with virtual reality. in patients with this disease. Therefore, the research question arises: What is the effectiveness of a kinesiological treatment, complemented with immersive virtual reality, on quality of life, cognitive and psychoemotional function in patients with fibromyalgia?