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Tundra lists 36 Fibromyalgia (FM) clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07718984
Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC
Fibromyalgia (FM) pain and PTSD are highly prevalent and comorbid with associated increased risk of negative physical and mental health outcomes, including higher risk for opioid use and suicide. This project is designed to determine the effects of a 4 week trial of a device for pain management \[transauricular vagus nerve stimulation (taVNS)\] on pain interference and intensity \[Pain, Enjoyment, and Activity General Scale (PEG)\] and PTSD. The investigators will also examine how this impacts the Veterans by examining heart rate variability (HRV) as a stress response related biomarker. The investigators plan to randomize 180 Veterans (estimate up to 360 enrolled) with co-morbid FM and PTSD across pain integrated care and PTSD sites in this prospective study and compare: 1) active taVNS for pain + Prolonged Exposure in Primary Care (PE-PC) and 2) sham taVNS + PE-PC. Study includes 4 weeks of randomized treatment and 4 weeks of voluntary open label treatment. Veterans are assessed (self report \& interview measures, heart rate variability by wearable device) at Intake, Baseline/Post Run-In, Week 2, Week 4, Week 8 and 4 month follow-up. The investigators plan to retain data after the study for potential future use in research.
Gender: All
Ages: 18 Years - Any
Updated: 2026-07-22
1 state
NCT07583056
EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.
The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with fibromyalgia. As complementary goals, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment; and to describe the effectiveness of a high-dose home-based protocol applied to the motor cortex (M1) versus the dorsolateral prefrontal cortex (DLFPC) in patients with fibromyalgia.
Gender: All
Ages: 18 Years - Any
Updated: 2026-07-15
NCT07693998
Pain Neuroscience Education for Chronic Pain
Chronic pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, with a high prevalence in Spain (25.9%) and an average duration of 6.83 years, highlighting its significant health and social impact. Among its manifestations, chronic low back pain (CLBP) is the most common, affecting 58.1% of individuals with chronic pain, while fibromyalgia (FM) accounts for 10.4%. In both cases, a relevant proportion of patients do not present a clear organic cause, which complicates diagnosis and treatment and reflects the complexity of nonspecific chronic pain. CLBP is associated with a high functional and occupational impact, being one of the main causes of temporary disability. FM, on the other hand, is characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, and emotional symptoms, constituting a condition with systemic involvement. Both conditions can occur throughout the lifespan, with variations in prevalence depending on age, sex, social class, and the presence of comorbidities. Aging introduces relevant differences in pain experience and treatment response. At the physiological level, changes occur in the musculoskeletal system, such as the progressive loss of muscle mass (especially type II fibers) and decreased bone mineral density, which increases the risk of sarcopenia and frailty. In contrast, young adults show greater anabolic capacity, better hypertrophic response, and higher neuromuscular efficiency, favoring faster adaptations to exercise. These differences justify the need to consider age as a key factor in the therapeutic approach. In addition to structural changes, central sensitization plays a fundamental role in the chronification of pain. This process involves sustained hyperexcitability of the central nervous system, with a reduced pain threshold and altered inhibitory mechanisms, contributing to the persistence of pain even in the absence of significant tissue damage. Therapeutic exercise (TE) is one of the main non-pharmacological interventions for chronic pain and has demonstrated effectiveness in reducing pain and improving functionality. However, its long-term effects are limited, largely due to adherence issues related to pain, as well as psychological, social, and educational factors. Educational level influences both the understanding of the intervention and adherence, generally being higher in young adults, which may affect treatment outcomes. In this context, Pain Neuroscience Education (PNE) has emerged as a complementary strategy aimed at improving understanding of pain mechanisms and promoting adaptive behavioral changes. The combination of PNE and TE has shown positive effects in patients with CLBP and FM, especially in variables related to pain and psychosocial factors. However, there is a lack of evidence regarding the impact of this combination on objective functional parameters, such as spinal movement during functional activities. Therefore, it is necessary to investigate the effectiveness of the combined intervention of PNE and TE not only on pain but also on biomechanical variables such as range, velocity, and quality of movement, using precise measurement instruments.
Gender: All
Ages: 18 Years - Any
Updated: 2026-07-09
1 state
NCT07640607
Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia
Fibromyalgia is characterized by altered pain processing, including impaired descending pain inhibition and central sensitization. While both mechanisms have been independently associated with disease severity, their interrelationship remains unclear. This cross-sectional study aims to investigate whether central sensitization symptoms mediate the relationship between conditioned pain modulation and fibromyalgia impact.
Gender: FEMALE
Ages: 18 Years - 65 Years
Updated: 2026-07-07
NCT07674485
AI and Computer Vision-Assisted Telerehabilitation in Fibromyalgia: The FibroIA 2.0 Trial
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.
Gender: All
Ages: 18 Years - Any
Updated: 2026-07-01
NCT07661745
Interdisciplinary Program to Improve Quality of Life in People With Fibromyalgia
Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and psychological symptoms that significantly affect quality of life. This quasi-experimental study aims to evaluate the effectiveness of the FIBROCatCentral interdisciplinary program in improving health-related quality of life among adults with fibromyalgia receiving care in Primary Care centers in Central Catalonia, Spain. Participants in the intervention group will attend a structured multidisciplinary program consisting of 24 sessions delivered by healthcare professionals from different disciplines, including nursing, medicine, physiotherapy, nutrition, mental health, social work, and pharmacy. Outcomes will be assessed at baseline and at 3, 6, and 12 months. The primary outcome is health-related quality of life measured using the EuroQol-5D questionnaire. Secondary outcomes include fibromyalgia impact, depressive symptoms, treatment adherence, participant satisfaction, and changes in pharmacological treatment.
Gender: All
Ages: 18 Years - 85 Years
Updated: 2026-06-22
1 state
NCT07145788
The Effect of Physiotherapy Integrated With Yoga and Mindfulness on Individuals With Fibromyalgia
The current study investigates the effect of an integrative physiotherapy and mind-body program called PhYoMind intervention on disability and symptoms in individuals with fibromyalgia (FM). Participants will be randomized to either the PhYoMind intervention, which combines specific physiotherapy techniques with yoga and mindfulness, or to a home exercise control group. The intervention lasts 8 weeks, with supervised and home sessions. The primary outcome is disability, with secondary outcomes including measures of central and autonomic nervous system function, pain perception, stress, fatigue, and sleep quality. Adverse events and adherence of the intervention will be also assessed.
Gender: All
Ages: 18 Years - Any
Updated: 2026-06-10
1 state
NCT07443800
Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia
The overall objective of the research project presented here is to assess the prevalence of fibromyalgia in patients being treated for ADHD, the prevalence of ADHD in patients being treated for fibromyalgia, and the neurobiological correlates of ADHD-fibromyalgia comorbidity.
Gender: All
Ages: 18 Years - 100 Years
Updated: 2026-06-04
NCT07356206
Between Paws and Affections - Impact of Dog-Assisted Therapy in Fibromyalgia Patients
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).
Gender: All
Ages: 18 Years - Any
Updated: 2026-05-05
NCT07074275
Chronic Fibromyalgia Pain, Lifestyle Factors, and Inflammation
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
Gender: FEMALE
Ages: 18 Years - 65 Years
Updated: 2026-04-21
NCT07212829
The Added Value of Transcranial Direct Current Stimulation (tDCS) During Exercise for People With Chronic Widespread Pain
Many people with chronic widespread pain (CWP) feel more pain and fatigue after exercise. This makes it hard to stay active. Unfortunately, the investigators do not fully understand why this happens and how to prevent it. The primary goal of this study is to explore the underlying genetic and epigenetic mechanisms of BDNF gene in response to exercise, and investigate if transcranial direct current stimulation (tDCS) during exercise works to improve worsening symptoms response to exercise in people with CWP. The investigators designed a randomized crossover study and will enroll 60 patients with CWP and 60 healthy controls. Participants will undergo 2 interventions in random order: 1) exercise + active tDCS, and 2) exercise + sham tDCS. Participants will visit the hospital twice with at least one week in between the visits.
Gender: All
Ages: 18 Years - 70 Years
Updated: 2026-04-20
NCT07176078
Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome
Dietary modifications are often recommended as first-line treatment for irritable bowel syndrome, with the FODMAP diet being the most effective intervention to improve global gastrointestinal symptoms. Due to the heterogeneity of symptoms, patients often seek complementary or alternative therapies. This randomized clinical trial aims to determine whether osteopathic care provides additional improvement in gastrointestinal symptoms compared to sham osteopathic care, when both are combined with a flexible FODMAP diet. The trial will also assess the safety and tolerability of osteopathic care. The main questions it aims to answer are: Does osteopathic care reduce IBS symptom severity more than sham osteopathic care? Does osteopathic care improve pain, quality of life, anxiety, fatigue, work productivity, and gut microbiota compared to sham osteopathic care? Do participants adhere to the flexible FODMAP diet and osteopathic care, and are the effects of osteopathic care maintained at 3- and 6-months post-intervention? Can pretreatment factors, such as sociodemographic characteristics, IBS severity, predominant symptoms, psychological state, or gut microbiota composition, predict response to osteopathic care? What adverse effects occur with osteopathic care compared to sham care? Participants will: Visit the osteopathy clinic to receive four sessions of real or sham osteopathic care Complete online assessments before and after the intervention, and at 3- and 6-months post-intervention Provide stool samples before and after the four osteopathic or sham sessions Keep a three-day food diary and a ten-day stool diary before and after the intervention, and at 3- and 6-months post-intervention
Gender: All
Ages: 18 Years - Any
Updated: 2026-04-17
1 state
NCT07483216
Effects of a Isokinetic Exercise in Women With Fibromyalgia
Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional impairment, which significantly affects quality of life. Physical exercise is considered one of the most effective non-pharmacological interventions for the management of this condition; however, uncertainty remains regarding the most appropriate type, intensity, and frequency of exercise for different patient profiles. The aim of this study is to analyze the effects of a microdoses isokinetic exercise program on physical condition, perceived pain, inflammatory profile and quality of life in women diagnosed with fibromyalgia.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-04-16
1 state
NCT07517757
Dietary Strategies for the Treatment of Fibromyalgia in Overweight and Obese Patients
Spontaneous, non-sponsored, interventional, controlled, randomized, parallel-arm clinical study. Primary objective To assess the impact of specific dietary approaches (ketogenic diet, Mediterranean diet, or Mediterranean diet supplemented with GABA-producing probiotics, e.g., Bifidobacterium adolescentis PRL2019) on fibromyalgia (FM) severity-particularly pain, sleep quality, anxiety, and depression-using validated questionnaires in female patients with FM and overweight/class I obesity. Secondary objectives * Evaluate effects on anthropometric measures, metabolic profile, and body composition. * Assess changes in gut microbiota composition and metabolomic analysis. * Measure neurosteroids with positive allosteric activity on GABA-A or NMDA receptors in saliva and/or plasma. * Exploratory pilot sub-study to quantify brain GABA and glutamate levels through magnetic resonance spectroscopy (MRS) in a subset of patients. Methods Participants will be recruited from the Rheumatology Unit outpatient clinics of IRCCS Policlinico San Martino Hospital (Genoa). Eligible subjects will be adult women with FM and overweight/obesity, selected through protocol-defined criteria. Enrollment requires written informed consent. At enrollment (baseline), participants will complete validated questionnaires assessing FM severity (pain, sleep quality, depression, anxiety, bowel function). Data collection will include sociodemographic information, Mediterranean diet adherence through PREDIMED questionnaire, basal metabolic rate, medical and dietary history, smoking status, blood pressure, and recent laboratory results. Stool, blood, and saliva samples will be collected for routine tests, metabolomics, and ELISA-based measurement of neuroactive steroids like cortisol, progesterone, DHEA. Within 7 days T1, results will be reviewed and eligible participants randomized to one of three groups: hypocaloric ketogenic diet, Mediterranean diet, or Mediterranean diet plus probiotics. Individualized dietary plans will be provided with written and verbal instructions. Anthropometric measurements (weight, height, BMI, waist circumference, waist-hip ratio) and body composition via bioelectrical impedance analysis BIA will be recorded at T0, T4, T8, and T12, together with biological sample collection. Pilot MRS sub-study A subset of participants will undergo brain GABA and glutamate assessment through MRI spectroscopy performed on a 3T Siemens - Prisma magnet at the baseline, before dietary treatment and after 4 weeks. Results will be compared with spectra from control subjects screened through medical history to exclude relevant diseases.
Gender: FEMALE
Ages: 18 Years - 65 Years
Updated: 2026-04-08
1 state
NCT06880653
Dose Response of Exercise for Arthritis Management
The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.
Gender: All
Ages: 18 Years - Any
Updated: 2026-04-03
1 state
NCT07403929
The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients
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.
Gender: FEMALE
Ages: 20 Years - 40 Years
Updated: 2026-02-11
1 state
NCT07361328
Personalized Ultrasonic Brain Stimulation for Fibromyalgia
The primary purpose of this research is to evaluate a new kind of noninvasive brain stimulation intervention using the investigational ultrasound device, which might be useful for treating fibromyalgia. The device is for investigational use only and is not yet approved by the FDA for the intended use. * Participants will be asked to visit the study center 7 times for in-person assessment and treatment sessions. In addition, participants will be asked to complete an online assessment 7 times. During in-person or online visits: * Participants will undergo an MRI scan twice during the first and last in-person visit (1 hour each) The second MRI may be optional. * There will be 6 treatment sessions (45 minutes each) within a 2-week period * The online assessment occurs (15 minutes each) * two consecutive days before the first treatment session * 15 days after the first treatment session * 22 days after the first treatment session * 29 days after the first treatment session * 44 days after the first treatment session * 60 days after the first treatment session
Gender: All
Ages: 22 Years - 70 Years
Updated: 2026-01-23
1 state
NCT04806620
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.
Gender: All
Ages: 2 Years - Any
Updated: 2026-01-22
1 state
NCT07323199
Exercise and Neuromodulation in Fibromyalgia
Exercise is recommended for people with fibromyalgia because it can reduce symptoms and improve quality of life. Some studies show that high-intensity exercises like running or cycling (also called high-intensity interval training, or HIIT) may reduce symptoms more effectively than slower, traditional exercises. There are also new treatments, like non-invasive neuromodulation, which uses a gentle current to stimulate brain cells. This technique can help reduce pain in people with fibromyalgia. However, we don't yet know if combining HIIT and neuromodulation works better than exercise alone. We also want to find out if this combination helps improve other symptoms like fatigue and poor sleep. The goal of this study is to see how a combination of HIIT and neuromodulation affects pain, fatigue, sleep, and muscle strength in women with fibromyalgia. The investigators are asking two main questions: Does combining HIIT and neuromodulation reduce pain better than exercise alone? Does this combination improve how the brain controls pain, muscles, and other symptoms like fatigue and sleep problems? What Will the Study Involve? Three different exercise training programs will be compared: HIIT with neuromodulation (tDCS): The participant will do HIIT by cycling at a high intensity for 1 minute, then resting for 2 minutes. Then, this will be repeated 10 times. At the same time, the researchers will place two small, damp sponges on the head of the participant. These sponges connect to the tDCS device, which sends a gentle current to your brain. It might feel a tingling sensation at first, but it will fade away. HIIT with a "sham" (inactive) neuromodulation: This is similar to the first program, but the tDCS device will only be active for a few minutes at the beginning and end of the session. HIIT alone: This involves just the cycling exercise with no brain stimulation. Who Can Participate? The researchers are looking for women who: Are 18-65 years old and have been diagnosed with fibromyalgia Experience moderate to high levels of pain Have stable blood pressure (if they have hypertension) Are not regularly active (don't do more than 30 minutes of exercise at least 3 times per week) What Will the Study involve? The participant will: Attend 6 conditioning sessions (cycling) over two weeks to prepare their body. Complete 4 weeks of HIIT training, three times per week, at Universidad Andres Bello. Attend 3 assessment sessions in our lab: before the conditioning, before the training, and after the training. These will include: Non-invasive tests to measure your physical fitness, muscle strength, and pain sensitivity Brain and muscle connection tests. Questionnaires about your sleep, pain, fatigue, anxiety, depression, and exercise enjoyment What the participant will get? At the end of the study in addition to the training benefits, participants will receive a detailed report showing their body composition (muscle and fat levels) before and after the training.
Gender: FEMALE
Ages: 18 Years - 65 Years
Updated: 2026-01-07
1 state
NCT07203339
Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine: Non-inferiority Clinical Trial (FIBROSTIM)
Fibromyalgia is characterized by widespread pain, fatigue, non-restorative sleep, and psychocognitive alterations, compromising quality of life and leading to absenteeism and early retirement. Up to 70% of patients discontinue treatment with antidepressants and anticonvulsants due to adverse effects or low efficacy, and more than 30% resort to opioid use. Given the treatment challenges and the scarcity of safe alternatives, there is growing interest in interventions such as transcranial direct current stimulation (tDCS), which has shown efficacy in improving symptoms and functionality, with low cost and few side effects. In this context, we designed a randomized, double-blind, double-dummy clinical trial to compare the non-inferiority of 28 home-based anodal tDCS (2 mA) applied over the primary motor cortex (M1) versus duloxetine 60 mg. Both treatments will be combined with physical exercise and pain education. Outcomes will be assessed through multidimensional measures of pain, functionality, global impression of improvement, and the function of the descending pain inhibitory system. Secondary outcomes include quality of life, depressive symptoms, psychophysical pain measures, and treatment adherence. An additional analysis will compare the results of sham tDCS and duloxetine placebo within the non-inferiority model. Predictors of treatment response will also be explored, including symptom severity and oscillatory patterns of cortical electrical activity, rest-activity rhythm, and autonomic function assessed by R-R interval. Furthermore, serum levels of S100-B protein, brain-derived neurotrophic factor (BDNF), and genetic variants related to neuroplasticity in the BDNF Val66Met, Catechol-O-Methyltransferase (COMT) (rs4680) (G\>A), OPRM1, and PER2 genes will be analyzed. Inflammatory markers (TNF-α, IL-1, IL-2, IL-6, IL-10, C-reactive protein) and serum endorphins will also be assessed. A total of 610 women with fibromyalgia (aged 18 to 75 years) will be randomized into three groups (2:2:1): duloxetine + sham tDCS (n=244); active tDCS + placebo (n=244); and sham tDCS + placebo (n=122). Participants will be assessed during treatment and at 3, 6, and 12 months after completing the intervention protocol. An interim analysis will be conducted when \~50% of participants (n ≈ 305) complete the 3-month follow-up by an independent, blinded Data Monitoring Committee (DMC). (i) The trial may be stopped if the conditional probability of demonstrating non-inferiority is \<10%, based on frequentist or Bayesian methods. (i) The trial will be stopped if serious adverse events (SAEs) in the active tDCS group increase by ≥30% compared to duloxetine (p \< 0.01, adjusted). (ii) Early stopping for efficacy will be considered if active tDCS demonstrates clear non-inferiority or superiority over duloxetine on the primary outcome. Superiority requires: (iii) a clinically relevant difference exceeding the non-inferiority margin (≥10% pain reduction); (ii) statistical significance (p \< 0.005, O'Brien-Fleming adjusted); and (iii) a ≥2-point (20%) improvement on the BPI, confirmed in the ITT analysis. This study aims to generate evidence to support the decision-making process of the National Committee for Health Technology Incorporation (CONITEC) regarding the availability of tDCS in the Brazilian Unified Health System (SUS). In addition, identifying predictors of response to tDCS and duloxetine, through the integration of genetic, neurophysiological, inflammatory, and psychosocial markers using machine learning algorithms, will allow for identifying factors that can personalize fibromyalgia treatment. This approach enhances clinical efficacy, reduces costs associated with ineffective interventions, and supports more accurate therapeutic decisions, expanding access to safe, effective, and sustainable care within the public healthcare system
Gender: FEMALE
Ages: 18 Years - 75 Years
Updated: 2026-01-06
1 state
NCT07282392
Helping Lupus Patients Manage Fibromyalgia Symptoms Through Emotional Awareness and Expression Therapy (EAET)
The goal of this clinical trial is to learn if a psychotherapy intervention works to relieve widespread pain in patients with lupus. The main questions it aims to answer are: Is the psychotherapy treatment safe for lupus patients? Are lupus patients able to complete the treatment? Can the treatment help improve chronic pain and other symptoms in lupus patients? Researchers will compare the treatment to a control (participants who will continue their medical treatment but will not receive psychotherapy for the time frame of the treatment) to see if the psychotherapy treatment works to relieve widespread pain and other lupus-related symptoms. Participants will: Fill out questionnaires before and after the treatment. Participate in 8 weekly treatment sessions, 2 hours per session, delivered via Zoom from their own home. Keep a list of medications and monitor any changes in their medication regimen.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2025-12-29
1 state
NCT07293767
Silymarin vs Hesperidin/Diosmin in Fibromyalgia
Fibromyalgia is a chronic disease, characterized by chronic widespread pain, physical exhaustion, sleep problems, and unexplained pain in both joints and muscles. Fibromyalgia's causes still unknown, but there are various risk factors that can cause fibromyalgia such as genetic causes, physical shock, and infections. Fibromyalgia typically presents in young or middle aged females, it occurs in females more than males, and it is characterized with widespread pain throughout the whole body in both sides such as arms, shoulders, head, and abdominal areas. The etiology of fibromyalgia still unclear, but there are several factors such as alterations in the sleep pattern, changes in the neuroendocrine transmitters such as cortisol, growth hormones and serotonin, dysfunction of central and autonomic nervous systems, psychiatric aspects and external stressors . The pain seems to result from neurochemical imbalances in the central nervous system that lead to a "central amplification" of pain perception characterized by allodynia (a heightened sensitivity to stimuli that are not normally painful) and hyperalgesia (an increased response to painful stimuli). this interventional study aims to study effect of silymarin and hesperidin/diosmin combination on fibromyalgia patients and compare their effect with control patients on the following 1. Management of pain. 2. Inflammatory biomarkers. 3. Quality of life.
Gender: All
Ages: 18 Years - 60 Years
Updated: 2025-12-19
NCT07260864
Investigating the Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Brain in People With Fibromyalgia
The first goal of this study is to see how brain activity changes in people with fibromyalgia after they get a treatment called rTMS (repetitive transcranial magnetic stimulation). Researchers are looking at how the parts of the brain that control movement (called motor cortices) respond to this treatment. The second goal is to find out if the changes in brain activity are different between the right and left sides of the brain, depending on which side gets the treatment.
Gender: FEMALE
Ages: 18 Years - 65 Years
Updated: 2025-12-03
1 state
NCT06813352
Analysis of Facial Expressions for Pain Recognition in Fibromyalgia: Using Artificial Intelligence and Biomarkers
Fibromyalgia (FM) is a chronic musculoskeletal pain syndrome with characteristics of generalized body pain, low pain threshold, tenderness and stiffness in muscles, tendons and joints. The assessment of pain in this condition is a challenge due to its subjective nature. A promising approach to assessing pain intensity is facial expression analysis, which can serve as an objective indicator. In addition, research seeks to identify molecular molecular markers to quantify pain. However, the lack of a standardized system has made it difficult to identify reliable markers. In summary, the search for objective methods of assessing pain in fibromyalgia is essential in order to develop more effective more effective treatments. Facial expression analysis and the investigation of molecular markers are promising ways of quantifying pain intensity more accurately and intensity of pain more accurately and reliably in fibromyalgia.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2025-11-19
1 state