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Showing 1-20 of 373 trials
NCT03325959
The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas. In the proposed study, the investigators intend to both repeat and expand our previous findings, treating FMS patients with HBOT while performing an extensive of evaluation both before and after treatment. In the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).
NCT07074275
The goal of this observational study is to understand how lifestyle factors (such as diet, physical activity, sleep, stress, smoking, and alcohol intake) predict changes in pain sensitivity and modulation in adults aged 18-65 with chronic fibromyalgia pain. The main questions it aims to answer are: What is the predictive relationship between lifestyle factors and pain sensitivity/modulation? What is the mediating role of inflammation in the relationship between lifestyle factors and pain? Researchers will explore how various lifestyle factors collectively and individually relate to pain responses and whether inflammatory markers (IL-6, TNF-α, IL-10) mediate these associations. Participants will: Wear a Fitbit for two weeks to measure physical activity and sleep Use the Nutritics app to log food intake Complete an online questionnaire on pain, sleep quality, stress, and quality of life Undergo pain sensitivity testing using a digital algometer and pressure cuff Have body weight, height, and BMI measured Provide a blood sample for analysis of inflammatory markers via ELISA
NCT04287283
In the investigator's institute there is ongoing treatment of different patients with cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo neuro-cognitive function computerized tests before and after treatment. The aim of this study was to retrospectively evaluate the cognitive changes before and after HBOT in different patients populations.
NCT04316702
The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas. In this study, the investigators intend to both repeat and expand the investigator's previous findings, treating FMS patients with history of emotional trauma with HBOT, while performing an extensive of evaluation both before and after treatment. In the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).
NCT04777500
In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.
NCT07226648
The goal of this clinical trial is to evaluate a new noninvasive brain stimulation intervention for fibromyalgia and to determine its effectiveness in reducing pain. Participants will receive four treatments over the course of one month and will complete surveys at multiple time points throughout the 16-week study.
NCT07358754
Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive symptoms. Central sensitization is considered a key mechanism in the pathophysiology of fibromyalgia; however, the underlying biological markers have not been fully clarified. Brain-derived neurotrophic factor (BDNF) and S100B protein have been suggested to play roles in neuroinflammation and central pain processing. This observational, cross-sectional study aims to evaluate serum S100B and BDNF levels in patients with fibromyalgia and to investigate their relationship with central sensitization and sleep quality. Serum biomarker levels and clinical assessment scales will be compared between patients with fibromyalgia and healthy controls.
NCT07528599
This study investigated the effects of a virtual reality-based motor imagery intervention integrated into a conventional exercise programme on pain outcomes (pain intensity, central sensitisation, pressure pain threshold, galvanic skin response, pain catastrophising), quality of life, sleep quality, fatigue, psychological outcomes (Hospital Anxiety and Depression Scale), imagery ability and patient satisfaction.
NCT06518278
BACKGROUND: Chronic pain continues for more than 12 weeks despite medication or treatment. Chronic pain is the main symptom of muscle and joint problems, rarely explained by damage to the muscle and joints alone. Activity in the central nervous system (CNS; nerves, spinal cord, and brain) pathways governs our ability to describe pain intensity and our emotional response to pain. Musculoskeletal conditions (e.g., inflammatory arthritis, osteoarthritis, low back pain, fibromyalgia) share altered CNS pathways, acknowledged by recent classifications of 'primary' and 'nociplastic' pain. Clinically useful tools to diagnose and measure activity and reveal abnormalities in these CNS pathways are needed to improve clinical decisions and accelerate new treatment development. Laboratory pain sensitivity testing and brain imaging confirm the CNS as a primary contributor to pain. These assessments are less acceptable or unfeasible for clinical practice. Simpler clinical pain sensitivity assessments are being developed. The investigators simple Central Aspects of Pain (CAP) questionnaire detects some people with pain sensitivity and knee, rheumatoid arthritis or low back pain. Combining the CAP questionnaire reflecting emotional processing and simpler pain sensitivity assessment, combining two different dimensions should be better than either approach alone. PURPOSE: To optimise diagnosis and measurement of CNS as the primary contribution to chronic musculoskeletal pain by using the CAP questionnaire and simpler pain sensitivity assessments to ensure timely, effective diagnosis and treatment. OBJECTIVES: 1. Assess the ease, ability and performance of the combined CAP questionnaire and simpler pain sensitivity assessments to identify CNS as the primary contributor to chronic pain across musculoskeletal conditions. 2\. Use the CAP questionnaire alone or with substitute measures of activity in CNS pathways, demographic, and clinical variables to indicate pain levels at six and twelve weeks. 3\. Understand the relationship between CAP and simpler pain sensitivity assessment with laboratory pain sensitivity assessments as a tool to inform the current CNS activity contributing to pain. 4\. Evaluate associations between the CAP questionnaire and simpler pain sensitivity assessments with patient outcomes.
NCT07454395
Individuals with ME/CFS experience profound exercise intolerance and post-exertional malaise. This remote (app-based) pilot study explores whether light, fully self-paced, swimming may be a tolerable form of movement for people with ME/CFS and related conditions, due to the distinct physiological effects of water immersion. The horizontal posture and hydrostatic pressure of water supports venous return and reduces orthostatic stress, while cool water exposure may influence autonomic and inflammatory responses. We are recruiting adults with mild-to-moderate ME/CFS and related conditions for this study examining short-term symptom and autonomic responses to gentle swimming. Participants will choose their own intensity and duration and may stop at any time. A light cycling session is available as an optional comparator for those who feel comfortable doing so. \[Note: this is not an exercise training or rehabilitation study, and participation is only intended for individuals who can tolerate some gentle activity and can be in public spaces without triggering post-exertional malaise. You should be comfortable with swimming, but flotation or other assistive devices are welcome\]
NCT06923800
Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness. Central sensitization plays a key role, making the nervous system more responsive to pain. Though muscles are mainly affected, joint pain, stiffness, and reduced mobility are also common. Chronic pain and poor posture can worsen musculoskeletal health. FM is not mainly inflammatory, but pain and stress may affect bone health. Sleep disorders, like non-restorative sleep and apnea, are frequent and worsen fatigue. Neurotransmitter imbalances (e.g., serotonin, dopamine) affect pain and muscle function. The American College of Rheumatology defines FM by widespread bilateral pain lasting at least three months. FM mainly affects women, with a prevalence of 0.2-6.6%, often starting between the ages of 30 and 35. Besides physical symptoms, many patients suffer from anxiety, depression, and mood disorders, affecting their quality of life. Gastrointestinal issues, especially irritable bowel syndrome (IBS), are also frequent in FM patients. Both conditions share mechanisms such as pain hypersensitivity, altered autonomic regulation, gut-brain axis disruption, and immune dysfunction. Low-grade inflammation and intestinal permeability may contribute to chronic symptoms. FM treatment includes anticonvulsants, antidepressants, and painkillers. IBS is managed with diet changes and medications like antispasmodics. Due to limited drug effectiveness, multidisciplinary approaches are gaining attention. Physical exercise is a proven non-drug strategy that improves pain, fatigue, and mental health in FM and IBS. Still, adherence is low due to fear of pain, fatigue, and low motivation. Exercise, especially aerobic activity, benefits IBS patients by improving gut symptoms and reducing inflammation. It may also strengthen the gut barrier in both conditions. While optimal programs need more study, exercise is a promising therapy. Major health bodies recommend aerobic, resistance, and flexibility training for FM and aerobic exercise for IBS.
NCT05057676
The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple sclerosis (MS), clinically isolated syndrome (CIS), fibromyalgia, post acute sequela of covid, and cancer in remission with persisting fatigue.
NCT04606095
This project is being conducted to evaluate the impact of explosive synchronization (ES) and its treatment with non-invasive brain stimulation in fibromyalgia (FM). The study design has three components, however, only 2 aims are enrolling participants. The first part (Aim1) is a cross sectional assessment of brain network explosive synchronization activity, connectivity, and response to pain in healthy controls and age and sex-matched fibromyalgia patients; the third part (Aim 3) is a longitudinal assessment of fibromyalgia patients undergoing one week of sham followed by high-definition transcranial direct current stimulation (HD-tDCS) of the motor cortex (M1) or one week of ES HD-tDCS of a brain region identified from computer modelling (Aim 2).
NCT07424534
The primary goal of this research project is to develop different prediction models in fibromyalgia disease through the application of machine learning techniques and to assess the explainability of the results. As specific objective the research project intends to evaluate the influence of psychosocial variables, fatigue, and sleep quality on the prediction of disease severity in patients with fibromyalgia using an artificial intelligence-based model.
NCT07326163
This study was designed to evaluate the effect of topically applied peppermint oil (Mentha × piperita) on chronic pain and functional capacity experienced by fibromyalgia patients, as well as its cost-effectiveness.
NCT05901259
The objective is to explore the potential short and long-term impact of the EXOPULSE Mollii Suit and EXOPULSE Suit on subjects with CP, MS, stroke, fibromyalgia or other neurologic disorders which may cause such types of symptoms, and to identify high responders among the sub-categories of the diagnoses. The primary endpoint will be improvements in the Berg/Pediatric Balance Scale (BBS/PBS) as a measurement of balance and risk of falls.
NCT03759522
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.
NCT05956067
Participants with chronic pain conditions including chronic low back pain and fibromyalgia may benefit from light stimuli presented to the retina to reduce chronic pain severity and pain sensitivity. Participants will be recruited into this study and will be presented with one of three uniform light stimuli via a wide-field ganzfeld in three conditions to determine the retinal mechanisms that reduce pain. This work will lead to a greater understanding of retinal mechanisms that contribute to pain and will assist the design of future studies to harness the potential of light based pain therapies.
NCT07403929
The goal of this clinical trial is to learn if a traditional grape-based fermented drink called hardaliye helps treat fibromyalgia in adult women. We will also learn whether adding hardaliye to a personalized nutrition plan works better than using either one alone. The main questions are: Does diet + hardaliye improve antioxidant status and lower oxidative stress more than diet only or hardaliye only? Does diet + hardaliye lower inflammation (TNF-α, IL-6, hs-CRP) and raise SIRT1 levels? Do these changes relate to less pain and better symptoms (fibromyalgia impact, gut symptoms, sleep, mood)? Are there benefits for weight, waist size, blood pressure, and blood lipids? How the groups are compared: Researchers will compare three groups for 8 weeks: Diet + Hardaliye (personalized medical nutrition plan + one 200 mL bottle of hardaliye daily) Diet only (personalized medical nutrition plan) Hardaliye only (usual diet + one 200 mL bottle of hardaliye daily) Participants will: Drink one 200 mL bottle of hardaliye each day if assigned to Diet + Hardaliye or Hardaliye only Follow a personalized nutrition plan if assigned to Diet + Hardaliye or Diet only Visit the clinic at the start and end of the study, with brief check-ins around weeks 2, 4, and 6 Give blood samples before and after the 8-week period Complete short questionnaires on pain, fibromyalgia impact, gut symptoms, sleep, and mood Keep simple logs of daily drink intake and diet plan adherence, and report any side effects Who can join: Adult women (20-40 years) with doctor-diagnosed fibromyalgia and BMI 25.0-29.9 kg/m² who meet the study's health and medication criteria.
NCT07398417
The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.