Active clinical trials for "Fibromyalgia"

Background: Low-dose naltrexone (LDN) may be useful in managing the pathologies that alter inflammatory markers, such as Crohn's disease or fibromyalgia (FM). The anti-inflammatory effect of LDN should be produced through the inhibition of Toll-like receptor 4 activity expressed in the membrane of various immune system cells (e.g. microglia). Conversely, due to a rebound effect, LDN could exercise an analgesic effect that strengthens the endogenous inhibitory system. According to this hypothesis, the low-intensity and intermittent blocking of the opioid receptors generated by LDN should induce a compensatory mechanism that should facilitate an increase in the production of endogenous opioids and greater sensitivity of the system to their effects. To date, the effects of LDN in patients with FM have been evaluated through crossover studies that have yielded promising results. Given that the studies conducted up to now have had small sample sizes and crossover designs, and given that there are still no studies in which its potential cost-utility is assessed, studies with greater methodological rigor and larger samples are necessary to confirm the effectiveness of LDN in FM. Jointly evaluating the effectiveness and cost-utility, the changes in metabolites in certain areas of the brain, and systemic inflammatory markers potentially linked to the etiopathogenesis of FM, should allow us to gain a more detailed knowledge of the neurobiological mechanisms underlying the effectiveness of LDN in this population. Objectives: To evaluate the effectiveness and safety of LDN in patients with FM and analyse its cost-utility both from the government and the healthcare perspective at 1-year follow-up. Brain metabolites and systemic inflammatory biomarkers will be included to evaluate neurobiological mechanisms behind LDN therapeutic effects. Design: Randomized, Controlled Trial. Centre: Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat, Spain). Participants: 120 patients with FM will be randomly assigned to LDN (4.5mg/day) or placebo. Main outcome measure: Pain severity using Ecological Momentary Assessment. Secondary outcomes: functionality, affective symptoms, fibrofog, quality of life. Costs and QALYs will be also calculated. Biomarkers: 50% of the patients will be scanned at baseline and at week 12 for changes in brain metabolites related to neuroinflammation and central sensitization. Immune-inflammatory markers in serum will also be evaluated.

Fibromyalgia is a chronic condition with an unclear etiology. The syndrome includes symptoms such as chronic musculoskeletal pain, cognitive dysfunctions, fatigue, sleep disorders, and circadian rhythm disturbances. Fibromyalgia-related pain is associated with a substantial socioeconomic burden including greater health care costs and productivity loss from work. Light therapy can improve sleep quality and sleep architecture, advance sleep phases and reduce pain sensitivity and that the effect of light therapy on mood and cognitive function have been widely supported.This randomized controlled study aims to examine the effects of light therapy on sleep quality, depressive symptoms, psychomotor vigilance performance, and overall symptom severity in patients with fibromyalgia.

The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome. H0: Face-to-face and internet-based CFT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome. H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based CFT have no superiority over each other.

Relaxation techniques are a non-pharmacological therapy option applied to alleviate the symptoms of many different chronic diseases. It has been reported in the literature that PMR is effective on pain, fatigue and stress symptoms in fibromyalgia patients. No study has been found examining the effect of PMR on kinesiophobia and functional status in FM. This study was planned to examine the effect of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.

The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical [F-18]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer [F-18]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with [F-18]DPA-714-PET/MRI.

The hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Quantitative sensory testing is easier to perform and repeatable. Therefore, it will be used to evaluate the effects of Breathing Attention Training (BAT) on the hypersensitivity of FM participants. BAT is a form of mindfulness meditation shown to decrease FM symptoms and possibly pain sensitivity. We hypothesize that pain modulation of chronic pain patients is improved by BAT.

This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)] on pain control. Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the investigators designed a 2x2 factorial mechanistic trial [tDCS (active and sham) and aerobic exercise (AE) (active and control)] to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and compared to either intervention alone and to no intervention.

Drugs used for managing Fibromyalgia pain have not proven to be effective and pain continues to cost Canadians $60 billion a year without truly helping those who suffer. The study proposes to investigate the factors related to a person that can enhance or reduce the effectiveness of pain treatments in people suffering with Fibromyalgia pain. Treatment response to painkillers in a person may be related to their brain, social, and psychological makeup. The investigators aim to study these factors to identify and develop feasible and robust indicators based on a person's biological makeup (also called biomarkers). These biomarkers will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people. These measures will offer new opportunities for improving treatment such as by tailoring treatment to meet the specific needs of each patient based on his/her biological and psychological makeup. Towards the specific aim, data will first be collected in several experimental domains for studying treatment expectations (cognitive, psychosocial, brain-related). These 'experimental' data will be compared between Fibromyalgia (FM) and healthy participants to yield new understanding of the factors that govern treatment response. At the end of experimental data collection, the investigators will collect data in the 'clinical' domain. Hence, at the end of the experimental sessions, a subset of FM participants will receive a mock drug (placebo disguised as an approved pain treatment) and another subset will provide pain ratings only and hence serve as a waiting list control for the placebo trial. Data will be studied in steps to understand factors that mediate treatment outcomes and finally the investigators will use advanced computational tools used for big data analysis and aim to identify factors that can be used as biomarkers and precision medicine tools.

Background: Current pain management strategies for pediatric patients are not integrating the analgesic potential of movement-based therapies. To date, experiencing a painful stimulus has been known to disrupt motor activity in an attempt to minimize injury. However, physical activity, even when it increases ongoing pain initially, has been shown to significantly reduce pain symptoms eventually through neuromodulation. In both acute and chronic pain cohorts, exercise protocols and neuromodulation paradigms have produced exercise-related analgesia. Problem: It is not currently understood which brain regions are implicated in exercise-based analgesia and what brain regions moderate this response. Approach: The investigators intend to provide a physical activity intervention designed to promote exercise-induced analgesia. This intervention will be performed in a group of pediatric subjects with Chronic Widespread Pain Disorder. An exercise (n=10), no exercise (n=10) and healthy control (n=10) group will be recruited. Aims: This study has three aims: (1) To understand how thermal pain sensitivity, pain symptoms and motor performance are impacted in patients with chronic pain after an exercise-based intervention. (2) To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions of the brain. (3) To evaluate the network structure of the brain, with special emphasis on motor and pain regions, in youth with a pain disorder who have undergone an exercise-based intervention. Exercise-based therapy in pediatric subjects with a chronic pain condition is predicted to reduce pain symptom reporting through biasing activity in pain regions during motor performance. Significance: Findings from this investigation will address the clinical side of pain management strategies and provide potential therapeutic targets and feasibility data. The investigators anticipate that findings will show how pain and motor regions of the brain interact at the network level and if this interaction can be modulated through exercise. Findings will also evaluate the brain regions that mediate the analgesic properties of an exercise-based pain therapy and provide future therapeutic targets.

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest. The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest. Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.