Fibromyalgia

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.

Fibromyalgia syndrome (FMS) is a chronic and heterogeneous disorder characterized primarily by widespread pain, accompanied by sleep disturbances, fatigue, depressive symptoms, and cognitive dysfunction. Although multiple therapeutic options are available, no curative treatment currently exists. Previous studies have demonstrated increased oxidative stress, dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and a predisposition to sarcopenia in patients with FMS. Ozone therapy has increasingly been used in chronic diseases due to its regulatory effects on oxidative stress. Although ozone is inherently an oxidative molecule, when administered at therapeutic doses it may induce antioxidant responses at the cellular level and exert anti-inflammatory effects by modulating inflammatory mediators. However, limited studies have evaluated the efficacy and underlying mechanisms of major ozone autohemotherapy (MOA) in FMS. This controlled, prospective, single-blind study aims to investigate the effects of major ozone autohemotherapy on clinical parameters of FMS, as well as its impact on HPA axis function and sarcopenia-related parameters. A total of 60 patients with FMS will be enrolled and randomized into two groups: (1) exercise therapy alone and (2) exercise therapy plus major ozone autohemotherapy. MOA will be administered twice weekly for a total of 10 sessions at a dose of 20-40 μg/mL. Participants will be evaluated at baseline, at week 6, and at 3 months. Outcome measures will include Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Fatigue Severity Scale (FSS), Pittsburgh Sleep Quality Index (PSQI), Short Form-12 (SF-12), and Hospital Anxiety and Depression Scale (HADS). Morning fasting serum cortisol levels will be measured to assess HPA axis function. Sarcopenia assessment will include handgrip strength measured by Jamar dynamometer, and ultrasonographic evaluation of muscle mass, muscle thickness, pennation angle, fascicle length, echogenicity, and cross-sectional area. Physical performance will be assessed using the Short Physical Performance Battery (SPPB). Unlike previous studies, this trial includes a 3-month follow-up evaluation after completion of ozone therapy to assess longer-term effects. By incorporating objective sarcopenia and endocrine assessments alongside validated clinical scales, the study aims to provide comprehensive evidence regarding the role of major ozone autohemotherapy in FMS management. This will be the first study to specifically evaluate the effects of major ozone autohemotherapy on sarcopenia parameters in patients with FMS.

Fibromyalgia (FM) is a primary chronic pain condition with an estimated prevalence of 3.3% in Chile. It is characterized by widespread musculoskeletal pain, fatigue, and impaired physical function. Although exercise therapy is considered the first-line intervention, barriers to access and poor adherence limit its effectiveness within the public healthcare system. This study evaluates the effectiveness of an Artificial Intelligence (AI)- and Computer Vision (CV)-assisted telerehabilitation platform called Rehbody. The aim is to determine whether real-time technology-driven feedback can overcome the limitations of traditional face-to-face rehabilitation models by improving disease impact and functional capacity in Chilean patients with fibromyalgia.

The Emotional Allodynia Questionnaire (AEQ) is an 11-item self-report instrument that measures disproportionate emotional reactivity to low-intensity interpersonal cues(perceived unresponsiveness, exclusion, loss of reciprocity), a pattern termed emotional allodynia. It was preliminarily validated in a single-center fibromyalgia sample. PEARL (validation phase) is a multicenter, prospective, observational psychometric validation study that (1) replicates the internal structure and convergent validity of the AEQ in an independent fibromyalgia sample, (2) tests its known-groups (discriminative) accuracy in separating fibromyalgia from non-fibromyalgia chronic pain of defined nociceptive or neuropathic origin, expressed as the area under the ROC curve (AUC), and (3) assesses test-retest reliability. There is no intervention.

Fibromyalgia is a debilitating chronic pain disorder. Based on prior research with MDMA, it can be hypothesized MDMA-assisted therapy in fibromyalgia patients may increase the range of positive emotions, interpersonal trust, and heighten the state of empathic rapport that can lead to an enhanced patient-clinician interaction and to initiate reattribution processes targeting dysfunctional thoughts towards pain. Therapeutic alliance, i.e. a positive patient-clinician relationship, is already acknowledged as an essential component for MDMA-assisted therapy. Despite its importance, the patient-clinician interaction and the neuroscience supporting patient/clinician therapeutic alliance has received almost no attention in MDMA research. The investigators will examine the potential therapeutic benefit of MDMA-assisted therapy for fibromyalgia. Additionally, this study will also target secondary objectives including the investigation of the clinical and physiological response (i.e. brain-to-brain concordance) supporting enhanced patient-clinician therapeutic alliance in fibromyalgia patients. The study includes two Experimental Sessions of therapy with MDMA combined with neuroimaging, along integrative therapy, baseline neuroimaging, and a 3 month follow up.

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Mirogabalin, a new highly selective α2δ ligand, has shown potential in animal models or preliminary clinical trials, but there is insufficient evidence for its application in FM. This study aims to explore the effectiveness and safety of pregabalin or mirogabalin in treating FM, with the aim of providing a better treatment option for FM patients.

This study aims to determine the feasibility of a shamanism intervention for patients with fibromyalgia, acquire efficacy data to determine if Shamanism reduces clinical pain and other common symptoms associated with fibromyalgia, and determine if the Shamanism intervention changes heart rate electrocardiogram (ECG), breathing rate, and brain wave electroencephalogram (EEG) outcomes in fibromyalgia patients and shamanic practitioners. The investigators hypothesize that 80% of individuals will complete at least 80% of study visits, clinical pain severity and/or interference will be significantly reduced following the Shamanic intervention, and lung, heart, and/or brain activity will be altered with the Shamanic intervention and also become more synchronized between Shamanic Practitioners (SPs) and patients during the course of treatment.

Chronic pain affects more than 20% of Canadians and is associated with significant impacts on physical function, mental health, and quality of life. Despite efforts to improve access to multidisciplinary pain care through centralized referral systems, many patients continue to experience prolonged wait times before receiving treatment. This study evaluates a self-guided digital psychological intervention designed to support chronic pain self-management during the waiting period for specialized pain care. The intervention was developed through a collaboration between the Transitional Pain Service and ManagingLife and aims to improve access to evidence-based psychological support, enhance self-management skills, and reduce pain-related distress among individuals living with chronic pain.

The aim of our study was to examine and compare the effects of different physiotherapy methods, namely connective tissue massage, transcutaneous auricular vagus nerve stimulation and both, on pain, health status, sleep quality, fatigue, psychosocial status, autonomic symptoms and quality of life in women with fibromyalgia.

This study aims to see whether acupuncture can help fibromyalgia patients by giving them acupuncture treatment and seeing whether acupuncture helps enhance the effects of an opioid.

Repetitive Transcranial Magnetic Stimulation (rTMS) of the motor cortex is a recognized analgesic technique for the treatment of fibromyalgia pain, which represents a largely unmet medical need. However, the effectiveness of motor cortex rTMS is inconsistent, being observed in only about 40% of patients and not always long-lasting. It has been previously shown that predictive factors for a lack of response to motor cortex rTMS include the presence of depressive symptoms, and that prefrontal cortex rTMS is not effective for pain, even though this treatment has proven efficacy in major depressive disorder. The hypothesis is that targeting both the motor and prefrontal cortices with rTMS will yield a particularly beneficial effect in fibromyalgia patients presenting with comorbid depressive symptoms. Given the absence of established biomarkers for predicting rTMS response, an additional aim will be to develop reliable indicators of rTMS efficacy, based on clinical phenotype and measurements of oscillatory patterns assessed by electroencephalogram (EEG) recordings.

Evaluate the effect of manual diaphragmatic release on exercise capacity, inspiratory muscles strength, symptoms severity, and health-related quality of life in women diagnosed with fibromyalgia.

Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the population. Current treatments are incompletely effective, often poorly tolerated, and costly: there remains an urgent need for novel, effective, and well-tolerated therapy. Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in this cohort. The VIPR trial will assess the efficacy of a single session of VCS - a safe \& cost-effective bedside technique using a plastic syringe and temperate water - relative to sham in treating pain \& improving quality of life using validated patient-reported outcomes.

The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are: * Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain? * What are predictors of recovery from chronic pain? * What brain systems are associated with the spread of pain? For this study participants will undergo: * Functional Magnetic Resonance Imaging (fMRI) * Quantitative Sensory Testing * Psychological Assessments

This study is testing a new program called Empowered Relief for Caregivers (ER-CY), designed to support caregivers of children and teens who live with chronic pain. ER-CY is a single two-hour class delivered online. It teaches skills for managing the stress of caring for a child in pain and for responding to a child's pain in helpful ways. Up to 80 caregivers of youth with chronic pain will take part in one ER-CY class and then complete surveys and a short interview over the following three months. The researchers want to learn two things: whether caregivers are willing and able to take part and find the program helpful and satisfying, and whether the program lowers caregiver distress and improves their child's day-to-day functioning. What is learned will help guide future programs and care for youth with chronic pain and their families.

This randomized controlled trial aims to investigate the effect of foot reflexology on pain and sleep disorders in Egyptian female patients with fibromyalgia. Sixty female participants aged 18 to 65 years diagnosed with fibromyalgia will be randomly assigned into two equal groups. The control group will receive conventional physical therapy, including aerobic exercise, resistance training, and transcutaneous electrical nerve stimulation (TENS), while the experimental group will receive the same treatment in addition to foot reflexology. Interventions will be delivered twice weekly for six weeks. Pain, sleep quality, psychological distress, and functional activity will be evaluated at baseline and after treatment using validated Arabic assessment tools and pressure pain threshold measurements. The study aims to determine whether reflexology provides additional benefits when combined with conventional physical therapy in women with fibromyalgia.

This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.

This pilot feasibility study aims to evaluate transcranial magnetic stimulation (TMS) targeting the prefrontal cortex in patients with fibromyalgia syndrome (FMS). The study will assess preliminary efficacy and mechanisms of central nervous system changes using neuroimaging, behavioral tasks, sensory testing, and neuroimmune markers. Participants will undergo MRI scans, multi-day TMS sessions, and complete questionnaires. The goal is to generate pilot data for future trials on neuromodulation for chronic pain.

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.

This study, in a quasi-experimental matched two-group pre-post design, investigates the effect of serial water-filtered whole-body hyperthermia on circadian core body temperature, the somatosensory system (nociception) and the movement evoked pain in healthy and patients with chronic primary pain (e.g., fibromyalgia). The intervention lasts 3 weeks with two treatment sessions per week.

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.

Fibromyalgia (FM) is a prevalent chronic pain disorder, characterized by widespread musculoskeletal pain and fatigue that is associated with significant functional limitations. Its mechanisms are only partially understood. The investigators hypothesize that physical functioning (as measured by the 6-Min Walk Test) of FM patients and healthy controls is negatively influenced by resilience and pain sensitivity. The investigators will perform a case control study to test our hypothesis within and between groups.

PENFS (percutaneous electrical nerve field stimulation) is an FDA-cleared acupuncture-like therapy applied to the external ear targeting several cranial nerve branches including the auricular branch of the vagus nerve to improve pain, physical function, and reduce symptoms of opioid withdrawal. PENFS has been previously shown to provide improvements in fibromyalgia, a difficult to treat chronic pain syndrome, which correlate with changes observed using a special kind of MRI called resting state functional connectivity MRI (rs-fcMRI) that evaluates brain activity at rest. The goals of this study are to rigorously test the initial promising results of PENFS in a much larger group of Veterans suffering from fibromyalgia and to identify potential mechanisms of PENFS effects. Further developing non-pharmacologic therapies for pain can help to improve quality of life and function for those suffering from fibromyalgia and decrease reliance on opioids and other drugs that have numerous side effects for individuals suffering from chronic pain.

The purpose of the study is to discover at least two distinct Musculoskeletal pain subtypes. These types are caused by different brain-and-immune system signals that affect how the body feels pain, and they are also shaped by a person's biology, psychology, and social environment. Aim 1. We want to sort adolescents and young adults with long lasting muscle and bone pain into two different groups. To do this, we will look at participants' childhood medical histories, past treatments, when their pain started, the sex they were assigned at birth, what their pain feels like now, tests of how their body senses pain, and immune system markers found in their blood. We think we will find at least two different types of chronic pain groups, plus one group of patients who had a higher risk for pain (because of a rheumatic disease or past surgery) but never developed long term pain. Aim 2. We want to find out if certain patterns of inflammation in the body change how nerve cells react to pain. Aim 3: We want to understand how different biological, psychological, and social factors are connected to the chronic pain groups we identified. We think we will find certain mental, behavioral, and social risks-as well as protective factors-that help explain why some people develop long-lasting pain and others do not. We expect these factors to play different roles in each pain group, including the group that does not develop chronic pain.

Fibromyalgia is a complex widespread pain disorder. OBJECTIVES To evaluate the effectiveness of oral magnesium supplementation in reducing symptom severity among fibromyalgia patients who have not responded to standard treatment, using validated scoring systems such as the Fibromyalgia Impact Questionnaire Revised (FIQR).