[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibromyalgia-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibromyalgia-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,42,73,100,130,156,183,223,246,271,295,322,346,387,421,440,465],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100645265","transcutaneous-vagus-nerve-stimulation-for-pain-and-autonomic-dysfunction-in-fibromyalgia-reset-fms-100645265",false,"NCT07682090","Transcutaneous Vagus Nerve Stimulation for Pain and Autonomic Dysfunction in Fibromyalgia (RESET-FMS)","RESET-FMS: A Randomized Sham-Controlled Trial of Transcutaneous Vagus Nerve Stimulation for Pain, Autonomic Dysfunction, and Fatigue in Patients With Fibromyalgia Syndrome","RESET-FMS","Inclusion Criteria:\n\n* Diagnosis of fibromyalgia syndrome according to the 2016 ACR\u002FEULAR classification criteria;\n* Stable pharmacological treatment for at least 1 month before enrollment;\n* Ability to understand and complete study procedures and questionnaires;\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of an active implantable medical device or any implanted metallic or electronic device near the ear or heart;\n* History of severe coronary artery disease or myocardial infarction;\n* Heart failure classified as New York Heart Association (NYHA) class II-IV;\n* Cardiac arrhythmias or severe bradycardia;\n* Carotid artery atherosclerosis;\n* Chronic kidney disease stage II or higher;\n* Concomitant immune-mediated rheumatic disease;\n* Pregnancy;\n* Active malignancy or previous malignancy not in remission;\n* Ongoing infection;\n* Changes in pharmacological treatment within 1 month before enrollment;\n* Concomitant central or peripheral nervous system disorders, except isolated small-fiber pathology on skin biopsy;\n* Cognitive impairment detected during neurological examination;\n* Severe psychiatric comorbidities requiring specific treatment;\n* Pain caused by other medical conditions that cannot be distinguished from fibromyalgia-related pain;\n* Current or previous alcohol or substance abuse;\n* Inadequate understanding of the Italian language.","FEMALE","18 Years","70 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by widespread pain, fatigue, sleep disturbances, cognitive symptoms, and autonomic dysfunction, significantly impairing quality of life. Increasing evidence suggests that, beyond central pain dysregulation, patients with FMS frequently exhibit autonomic nervous system dysfunction, characterized by sympathetic nervous system (SNS) hyperactivity at rest, with reduced SNS recruitment during orthostatic challenge. Moreover, approximately 50% of patients with FMS show reduced intraepidermal small fiber density on skin biopsy, a condition referred to as small fiber pathology (SFP), which has recently been suggested to contribute to autonomic dysfunction in these patients. Despite currently available pharmacological and non-pharmacological treatments, therapeutic efficacy remains limited, highlighting the need for novel mechanism-based interventions.\n\nTranscutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique that enhances parasympathetic activity through stimulation of the auricular branch of the vagus nerve. Preliminary studies suggest that tVNS may improve pain, autonomic symptoms, mood, and quality of life in patients with FMS, although available evidence is limited by small sample sizes and heterogeneous methodologies.\n\nThe RESET-FMS study is a randomized, sham-controlled, double-blind clinical trial designed to evaluate the efficacy of tVNS in patients with FMS. Participants will be randomized in a 1:1 ratio to receive either active tVNS or sham stimulation for four consecutive weeks. Stimulation will be administered daily for 30 minutes using the Nurosym™ device applied at the tragus of the external ear.\n\nThe primary objective is to assess the effect of active tVNS compared with sham stimulation on fibromyalgia severity, measured by the revised Fibromyalgia Impact Questionnaire (rFIQ) at the end of treatment (T4), adjusted for baseline values.\n\nExploratory objectives include:\n\n* evaluation of autonomic symptoms, fatigue, pain distribution, symptom severity, and sleep quality using validated clinical scales, including the Composite Autonomic Symptom Score (COMPASS-31), Fatigue Severity Scale (FSS), Widespread Pain Index (WPI), Symptom Severity Score (SSS), and Pittsburgh Sleep Quality Index (PSQI) at T4;\n* assessment of the persistence of treatment effects four weeks after treatment discontinuation (T8);\n* evaluation of treatment effects during intermediate assessments (T2);\n* evaluation of the effects of tVNS on non-invasive indices of autonomic nervous system function, including heart rate variability (HRV) and sudomotor function assessed by dynamic sweat test (DST);\n* analysis of serum biomarkers potentially associated with autonomic dysfunction, neuroinflammation, and cognitive symptoms, including neuropeptide Y (NPY), interleukin-6 (IL-6), and neurofilament light chain (NFL);\n* comparison of treatment response between patients with and without evidence of small-fiber pathology on skin biopsy;\n* identification of clinical and biological predictors of response to tVNS. The study is expected to provide clinically relevant evidence regarding the efficacy and safety of tVNS in FMS and to improve the understanding of the relationship between pain modulation, autonomic dysfunction, and peripheral nervous system involvement in this condition. The identification of predictors of treatment response may contribute to the development of more personalized therapeutic strategies for patients with FMS.",[28],"Fibromyalgia Syndrome","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-06-08",{"date":37,"type":22},"2027-09-30",{"name":39,"class":40},"University of Roma La Sapienza","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100644668","ai-and-computer-vision-assisted-telerehabilitation-in-fibromyalgia-the-fibroia-20-trial-100644668","NCT07674485","AI and Computer Vision-Assisted Telerehabilitation in Fibromyalgia: The FibroIA 2.0 Trial","Effectiveness of Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation, With and Without Resistance Training, on Disease Impact and Physical Function in People With Fibromyalgia: A Randomized Controlled Trial (FibroIA 2.0)","fibroIA 2","Inclusion Criteria:\n\n* Adults aged 18 years or older, of any sex\u002Fgender, with a documented medical diagnosis of fibromyalgia established in primary or secondary healthcare settings according to the American College of Rheumatology (ACR) criteria (Häuser \\& Fitzcharles, 2018).\n* Individuals able to understand and complete the self-report questionnaires used in the study.\n* Individuals with access to a compatible electronic device (smartphone, tablet, or computer) and an internet connection required for participation in the telerehabilitation intervention.\n* Individuals with basic digital literacy skills, defined as the ability to use electronic devices and interact with commonly used applications.\n* Individuals who provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Current participation in another structured therapeutic exercise program, whether supervised or unsupervised.\n* Moderate to severe functional dependence in activities of daily living, defined as a score \\\u003C60 on the Barthel Index.\n* Absolute contraindications to therapeutic exercise, including hypertensive crisis (≥170\u002F110 mmHg), dyspnea at rest, resting tachycardia, or severe glycemic abnormalities (blood glucose \\>250 mg\u002FdL or \\\u003C90 mg\u002FdL in individuals receiving insulin therapy).\n* Severe uncontrolled pain, defined as a score ≥8 on the Numeric Pain Rating Scale (NPRS) at rest.\n* Medical or neurological conditions that significantly limit the safe performance of physical exercise, as determined by clinical assessment.\n* Recent changes in fibromyalgia-specific pharmacological treatment within the previous 4 weeks, to ensure clinical stability throughout the intervention period.","ALL",{"count":52,"type":22},66,[25],"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.",[56,57,28],"Fibromyalgia","Fibromyalgia (FM)",[59,60,61,62],"fibromyalgia","exercise","telehealth","artificial intelligence","NOT_YET_RECRUITING","2026-06-28",{"date":66,"type":33},"2026-07-01",{"date":68,"type":22},"2027-01-04",{"date":70,"type":22},"2027-06-21",{"name":72,"class":40},"Instituto Neurociencia Del Dolor",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":41},"100642615","auricular-acupuncture-for-autonomic-balance-and-pain-in-fibromyalgia-100642615","NCT07641374","Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia","Impact of Semi-Permanent Auricular Acupuncture on Autonomic Balance and Pressure Pain Threshold in Patients With Fibromyalgia: A Longitudinal Study","Inclusion Criteria:\n\nConfirmed diagnosis of Fibromyalgia by a Rheumatologist according to the 2016 ACR (American College of Rheumatology) criteria.\n\n* Female sex.\n* Aged between 35 and 64 years.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Presence of cardiac rhythm disorders such as permanent Atrial Fibrillation.\n* Patients with Pacemakers.\n* Subjects affected by Chronic Obstructive Pulmonary Disease (COPD)\n* Patients taking continuous medications that can alter the autonomic response (e.g., beta-blockers, antiarrhythmics, inhaled beta2-agonists).\n* Subjects with specific contraindications to auricular acupuncture.","35 Years","64 Years",{"count":83,"type":22},30,[25],"This longitudinal study evaluates the effects of semi-permanent auricular acupuncture on the Autonomic Nervous System (ANS) activity and pressure pain threshold in adult female patients (aged 35-64) diagnosed with Fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria. The study aims to investigate how a 5-week treatment cycle influences cardiac autonomic regulation and pain sensitivity",[28],[88,89,90,56],"Ear acupuncture","Heart Rate Variability (HRV)","pressure pain threshold","2026-06-06",{"date":93,"type":33},"2026-06-11",{"date":95,"type":22},"2026-06-01",{"date":97,"type":22},"2026-08-31",{"name":99,"class":40},"Italian Association for the Research and the Scientific Update",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100633313","pain--reward-neuromodulation-of-cns-circuits-100633313","NCT07525063","Pain & Reward Neuromodulation of CNS Circuits","PRANCIR","Inclusions:\n\n1. Female and ages 18 +\n2. Ability to read\u002Funderstand English and give consent to participate\n3. Physician diagnosis \\& confirmation of primary fibromyalgia syndrome\n4. Verbal agreement to maintain dose of prescribed medication (if any) constant throughout the study, except exclusion medication and except if there is a medical emergency requiring changes in medication\n5. If enrolled in psychotherapy, verbal agreement to maintain (not change or stop) the psychotherapy during the study\n6. Absence of use of opioid medications (during the previous 90 days, and no greater than a 30-day period during lifetime)\n\nExclusions:\n\n1. limited ability to participate fully in behavioral tasks, longitudinal follow-up (e.g., plans to move out-of-state within 3 months)\n2. MRI contraindication (e.g., metal implants, claustrophobia, pregnant or planning to become pregnant)\n3. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head\u002Fneck injury, use of certain medications)\n4. male \\*\n\nTMS-Specific Exclusions:\n\n1\\. TMS contraindication (e.g., history of seizures, medications contraindicated for risks\u002Fefficacy of TMS procedures)\n\n1. current hypomania,\n2. meets diagnostic criteria for current psychotic disorder, or psychotic features,\n3. meets diagnostic criteria for Bipolar I disorder,\n4. meets diagnostic criteria for current alcohol or substance use disorder (moderate and high severity)\n5. current uncontrolled anorexia or other condition requiring hospitalization,\n6. current serious medical illness, including current severe migraine headaches,\n7. changed psychotropic medications in the prior 2 months, or plans to change medication during the study,\n8. history of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator),\n9. conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis,\n10. use of investigational drug or devices within 4 weeks of screening,\n11. cochlear implants,\n12. pregnancy\n\n    * Only females will be enrolled in this study because it focuses on patients who have fibromyalgia which is more prevalent (both diagnosed and self-reported) in females.\n\nDue to the contributions of hormones to the conditions under study in this project, female eligibility in this study will be defined as an individual who is female sex at birth and currently female sex",{"count":83,"type":22},[25],"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.",[28,56,111],"Chronic Pain and Fatigue",[56,113,114,115,116,117,118,119,120,28,121],"Transcranial Magnetic Stimulation","Neuromodulation","fatigue","cognitive issues","fibro fog","brain fog","trouble sleeping","AFSA","pain",{"date":123,"type":33},"2026-06-03",{"date":125,"type":22},"2026-07",{"date":127,"type":22},"2027-06",{"name":129,"class":40},"Duke University",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":41},"100635669","yishen-shujin-decoction-for-fibromyalgia-syndrome-100635669","NCT07555691","Yishen Shujin Decoction for Fibromyalgia Syndrome","A Randomized Controlled Clinical Trial and Mechanistic Investigation of Yishen Shujin Decoction for Fibromyalgia Syndrome","Inclusion Criteria:\n\n* Patients with primary fibromyalgia who met the FM classification criteria established by the American College of Rheumatology in 2016.\n* TCM syndromes of liver qi stagnation and yin blood insufficiency, or hepatic and renal yin deficiency.\n* aged 18 years old and above, 75 years old and below.\n* pain VAS score ≥ 4.\n* not taking the treatment of FM drugs or not using the treatment of FM program for more than 1 month.\n* Sign the informed consent.\n\nExclusion Criteria:\n\n* Patients with severe depression or anxiety ;\n* patients with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases and thrombotic diseases ;\n* Lactating or pregnant women ;\n* patients with allergy to therapeutic ingredients ;\n* patients with severe pain caused by other diseases ( such as diabetic pain or postherpetic neuralgia ) ;\n* patients who have recently participated in clinical trials of the same indications ；\n* Patients who are male, right-handed, or have contraindications for MRI will not undergo MRI scanning.\n\nContraindications include:\n\nHistory of neurological diseases: brain tumor, stroke, epilepsy, traumatic brain injury, multiple sclerosis, etc.\n\nIncompatible implants: cardiac pacemaker, defibrillator, certain types of aneurysm clips, cochlear implants, neurostimulators, etc.\n\nPresence of metallic foreign bodies in the body: dentures, intraorbital metallic fragments, shrapnel in certain body regions, etc.\n\nClaustrophobia.","75 Years",{"count":139,"type":22},100,[25],"This 24-week prospective study (12-week intervention + 12-week follow-up) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the therapeutic effects of YishenShujin Decoction, a clinically established herbal prescription, in patients with fibromyalgia (FM). The primary outcome is pain intensity measured by the Brief Pain Inventory (BPI). Secondary outcomes include improvements in the Fibromyalgia symptom scale(FS), revised Fibromyalgia Impact Questionnaire(FIQR), the Short Form-36 Health Status Questionnaire (SF-36), and FM-associated comorbidities. Safety profiles will be systematically monitored. In addition, brain structural and functional MRI will be used in this study to explore the underlying mechanisms.The findings aim to establish evidence for the formula's efficacy and provide insights into its role in FM management.",[28],[144,145,146],"MRI","RCT","Chinese medicine","2026-04-21",{"date":149,"type":33},"2026-04-29",{"date":151,"type":33},"2025-03-01",{"date":153,"type":22},"2027-10-31",{"name":155,"class":40},"Juan Jiao",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":163,"sex":50,"minAge":18,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100589704","craniovertebral-angle-and-fibromyalgia-severity-100589704","NCT06957873","Craniovertebral Angle and Fibromyalgia Severity","Evaluation of the Relationship Between Craniovertebral Angle and Fibromyalgia Symptom Severity","Inclusion Criteria:\n\n* Aged 18-55 years\n* Diagnosed with Fibromyalgia (FM) according to The American College of Rheumatology (ACR) 2010 Diagnostic Criteria for Fibromyalgia\n\nExclusion Criteria:\n\n* History of past or current pathology in the cervical spine, thoracic spine, or upper extremities\n* History of paraspinal or thoracic surgery involving the head, spine, or shoulders within the last six months\n* Structural spinal malformation\n* History of surgical or neurological disorders\n* Cervical trauma or pain treatment within the last 6 months\n* Temporomandibular surgery\n* Psychiatric disorders (e.g., dementia, amnesia, or delirium)\n* Systemic inflammatory rheumatic diseases",true,"55 Years",{"count":166,"type":22},134,"OBSERVATIONAL","Forward Head Posture Frequency in Fibromyalgia Patients Assessed by Craniovertebral Angle: Association with Symptom Severity. Forward head posture is more common in patients with fibromyalgia and is a factor that increases symptom severity.",[170,28],"Craniovertebral Angle",[28,172],"craniovertebral angle","2026-04-16",{"date":175,"type":33},"2026-04-17",{"date":177,"type":33},"2025-04-01",{"date":179,"type":22},"2026-08-01",{"name":181,"class":40},"Ankara Training and Research Hospital",3,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":196,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100631074","effects-of-2-aticyto-complex-and-d-ribose-on-pain-and-clinical-course-in-patients-with-fibromyalgia-100631074","NCT07495943","Effects of 2-Aticyto Complex and D-Ribose on Pain and Clinical Course in Patients With Fibromyalgia","Effects of 2-Aticyto Complex and D-Ribose on Pain, Symptoms, and Clinical Course in Patients With Fibromyalgia Syndrome","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Diagnosis of fibromyalgia syndrome according to the 2016 ACR criteria\n* Followed in a physical medicine and rehabilitation outpatient clinic for at least 1 year\n* Receiving pregabalin and\u002For duloxetine treatment for at least 3 months\n* Able to live independently in the community\n* Literate and able to record symptoms and responses\n* No cognitive dysfunction that would interfere with answering study questions\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Rheumatologic disease\n* Renal failure\n* Hepatic failure\n* Cardiovascular disease\n* Hypoglycemia or diabetes mellitus\n* Any neurologic disease (such as stroke, spinal cord injury, multiple sclerosis, or Parkinson's disease)\n* Known allergy or hypersensitivity to any active or excipient component of the study syrup\n* Use of any other dietary supplement or nutritional support product during the study period\n* Pregnancy or lactation\n* Active malignancy\n* Active infection\n* Severe psychiatric disease that may interfere with study participation or assessment\n* Refusal to participate or inability to provide informed consent","65 Years",{"count":192,"type":22},200,[25],"This multicenter, randomized, double-blind, placebo-controlled study will evaluate whether an oral supplement containing 2-Aticyto Complex and D-ribose (FibroThol), added to ongoing standard medical treatment, improves pain, symptoms, and clinical course in adults with fibromyalgia syndrome. Eligible participants are adults aged 18 to 65 years who have had fibromyalgia for at least 1 year and have been receiving pregabalin and\u002For duloxetine for at least 3 months. Participants will be randomly assigned to receive either FibroThol or placebo, administered as 15 mL three times daily for 4 weeks, while continuing their existing treatment. Follow-up assessments will be performed at baseline, week 2, and week 4 using patient-reported symptom and function measures. The study aims to determine whether this supportive supplement provides additional benefit compared with placebo in patients with persistent symptoms despite standard therapy.",[28,56],[56,28,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212],"2-Aticyto Complex","D-ribose","FibroThol","Dietary Supplement","Placebo-Controlled","Randomized","Double-Blind","Multicenter Study","Pregabalin","Duloxetine","Pain","Fatique","Sleep Quality","Depression","Anxiety","Quality of Life","2026-03-26",{"date":215,"type":33},"2026-04-01",{"date":217,"type":22},"2026-05-04",{"date":219,"type":22},"2027-05-04",{"name":221,"class":40},"Haydarpasa Numune Training and Research Hospital",5,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":137,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":41},"100508441","phase-2-metformin-for-fibromyalgia-symptoms-inform-trial-100508441","NCT05900466","Metformin for Fibromyalgia Symptoms (INFORM Trial)","Metformin as a Novel, Mechanistic Treatment of Fibromyalgia; a Proof of Concept RCT","Inclusion Criteria:\n\n* To be able to follow the protocol in English\n* Fibromyalgia Syndrome: Participant must meet the American College of Rheumatology 2016 revised classification criteria for Fibromyalgia\n* Ability to take oral medication and be willing to adhere to the metformin regimen (once daily)\n\nExclusion Criteria:\n\n* Co-occurring progressive disease (self-report, physician-diagnosed)\n* Diabetes\n* Pregnancy or planning to be pregnant in the next year (all premenopausal participants will be tested)\n* Having known cardiovascular, liver, kidney or pulmonary diseases (self-report, physician-diagnosed)\n* Having known serious psychopathology (Clinician diagnoses of psychosis, organic mental disorder, or dissociative disorder, self-reported active suicidal intent, self-reported history of inpatient admission to a psychiatric ward in the past year, evidence or self-report of self-injurious behaviors in the past year, reported current or recent history (2years) of non-IV substance abuse, any history of recreational IV drug use)\n* Having autoimmune disorder (e.g., rheumatoid arthritis) (self-report, physician-diagnosed)\n* Having neuropathic pain (self-report, physician-diagnosed)\n* Having pain associated with a terminal illness, acute pain, pain associated with specific organ damage (eg, stomach ulcer) (self-report, physician-diagnosed)\n* Concurrent use of weight controlling medications (eg, Xenical)\n* Requiring an interpreter to communicate\n* Abnormal levels of creatinine, vitamin B12, or hepatic function panel\n* eGFR of below 45mL\u002Fmin\u002F1.73m2",{"count":231,"type":22},72,[233],"PHASE2","The main purpose of the project is to evaluate the safety and efficacy of low dose metformin for improving symptoms associated with fibromyalgia syndrome (FMS) via modulating neuroinflammatory pathways. The investigators hypothesize that FMS patients in the low-dose metformin conditions will show greater improvement in FMS symptoms than those who are in the placebo group. Further, the investigators hypothesize that metformin will increase phosphorylated AMPK in peripheral immune cells of FMS patients and will decrease the transcription of mTORC1, NLRP3 inflammasome, and nociceptive cytokines interleukin 1beta and interleukin 18.",[28],[237],"FMS",{"date":239,"type":33},"2026-03-30",{"date":241,"type":33},"2023-04-01",{"date":243,"type":22},"2027-03-31",{"name":245,"class":40},"University of Utah",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":4},"100622255","validity-reliability-and-clinical-correlates-of-immersive-virtual-reality-adaptation-of-the-five-times-sit-to-stand-test-and-timed-up-and-go-tests-in-women-with-fibromyalgia-syndrome-100622255","NCT07381244","Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome","Inclusion Criteria:\n\n* • Having been diagnosed with FMS according to the American Rheumatology Association (ARB) 1990 classification criteria,\n\n  * Being female between the ages of 30-60\n  * Having the cognitive ability to understand the instructions\n  * Being a volunteer\n\nExclusion Criteria:\n\n* • Severe physical disability\n\n  * Rheumatological\u002Fneurological diseases\n  * Any musculoskeletal problem (fracture, deformity, sprain)\n  * Malignancy\n  * Severe cognitive impairment\n  * Pregnancy","30 Years","60 Years",{"count":255,"type":22},51,"Fibromyalgia syndrome (FMS) is a chronic rheumatic condition characterized by widespread pain, fatigue, and functional impairments that negatively affect physical activity levels, muscle strength, balance, and functional mobility. These impairments may lead to reduced functional capacity and increased sedentary behavior. Therefore, objective assessment of mobility, balance, and functional performance is essential in individuals with FMS.\n\nPerformance-based tests such as the Five Times Sit-to-Stand Test (5xSTS) and the Timed Up and Go (TUG) test are commonly used to evaluate lower extremity muscle function, balance, and functional mobility due to their simplicity, feasibility, and clinical relevance. Recently, virtual reality (VR)-based assessment methods have emerged as a standardized and objective approach for evaluating functional performance.\n\nThis study aims to investigate the feasibility and measurement properties of virtual reality-based adaptations of the 5xSTS and TUG tests in individuals with fibromyalgia syndrome using a head-mounted VR system. Findings from this study are expected to contribute to the clinical use of VR technology in mobility and balance assessment in individuals with FMS.",[28],[259,260,261],"Validity, reliability","fibromyalgia syndrome","virtual reality","2026-01-23",{"date":264,"type":33},"2026-02-02",{"date":266,"type":22},"2026-02-15",{"date":268,"type":22},"2026-07-30",{"name":270,"class":40},"Selcuk University",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":278,"enrollmentInfo":279,"targetDuration":280,"studyType":167,"phases":4,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":41},"100618142","fibromyalgia-disease-burden-in-mothers-of-children-with-attention-deficithyperactivity-disorder-100618142","NCT07327775","Fibromyalgia Disease Burden in Mothers of Children With Attention-Deficit\u002FHyperactivity Disorder","Is the Disease Burden of Fibromyalgia Syndrome Higher in Mothers of Children With Attention-Deficit\u002FHyperactivity Disorder? A Prospective Controlled Study","Inclusion Criteria:\n\nInclusion Criteria for Participants with Children Diagnosed with ADHD:\n\n* Being a female aged between 18 and 50 years\n* Having one or more children aged 6-17 years diagnosed with Attention Deficit\u002FHyperactivity Disorder (ADHD) according to DSM-5 diagnostic criteria\n* Having a diagnosis of Fibromyalgia Syndrome (FMS according to the 2016 American College of Rheumatology \\[ACR\\] criteria)\n* Being literate\n\nInclusion Criteria for Participants with Children Without Psychiatric Disorders:\n\n* Being a female aged between 18 and 50 years\n* Having one or more children aged 6-17 years without any psychiatric disorders\n* Having a diagnosis of Fibromyalgia Syndrome (FMS) according to the 2016 American College of Rheumatology (ACR) criteria\n* Being literate\n\nExclusion Criteria:\n\n* Receiving regular pharmacological treatment for Fibromyalgia Syndrome\n* Having an active psychiatric disorder or using psychiatric medication\n* Having a history of infectious disease, chronic inflammatory disease, or malignancy\n* Being pregnant or breastfeeding\n* Having a central or peripheral nervous system disorder (e.g., cerebrovascular disease, multiple sclerosis)\n* Being uncooperative during clinical evaluation\n* Having comorbid conditions that may affect quality of life, including congestive heart failure, chronic kidney disease, chronic liver disease, pulmonary disease, uncontrolled diabetes mellitus, or peripheral vascular disease\n* Having a diagnosis of hypothyroidism or hyperthyroidism\n* Having substance use disorder or alcohol use disorder","50 Years",{"count":139,"type":22},"1 Day","In this study, the investigators aimed to evaluate the impact of having a child diagnosed with Attention-Deficit\u002FHyperactivity Disorder (ADHD) on parental disease burden in mothers diagnosed with Fibromyalgia Syndrome (FMS).\n\nThe study will include 50 mothers with FMS who have a child diagnosed with ADHD and 50 mothers with FMS who have children without any psychiatric disorders.\n\nAmong mothers of children followed with a diagnosis of ADHD at the Child and Adolescent Psychiatry Outpatient Clinic of Edirne Sultan 1st Murat State Hospital, the presence of widespread body pain will be assessed. Mothers reporting widespread body pain will be referred to the Pain Management Outpatient Clinic of the same hospital for further evaluation for FMS. Mothers diagnosed with FMS will be included in the study group.\n\nThe comparison group will consist of mothers with FMS who have children without any psychiatric disorders. These participants will be selected from patients diagnosed with FMS who present to the Pain Management Outpatient Clinic of Edirne Sultan 1st Murat State Hospital.",[28,283,284],"Disease Burden","Attention-Deficit\u002FHyperactivity Disorder","2026-01-08",{"date":287,"type":33},"2026-01-12",{"date":289,"type":33},"2025-12-26",{"date":291,"type":22},"2026-04-30",{"name":293,"class":294},"Sultan 1. Murat State Hospital","OTHER_GOV",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":190,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":320,"locationsCount":321},"100567763","effectiveness-of-ai-guided-exercise-and-pain-neuroscience-education-for-fibromyalgia-fibroia-100567763","NCT06672419","Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA)","Effectiveness of Tele-Rehabilitation for Fibromyalgia Using AI-Guided Exercise and Computer Vision Combined With Pain Neuroscience Education (FIBRO IA): A Randomized Controlled Trial","FibroIA","Inclusion Criteria:\n\n* Clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016).\n* Age between 18 and 65 years.\n* Access to an internet-connected device (smartphone or computer).\n* Ability to participate in a tele-rehabilitation program.\n\nExclusion Criteria:\n\n* Participation in another clinical trial in the last 3 months.\n* Pregnancy or breastfeeding.\n* Uncontrolled severe medical conditions that could interfere with the intervention (e.g., cardiac or pulmonary diseases).\n* Physical or cognitive impairments that prevent following the exercise program.",{"count":304,"type":22},50,[25],"This randomized controlled trial will evaluate the effectiveness of a 12-week, home-based telerehabilitation program for adults with fibromyalgia (FM) combining AI-guided exercise with Pain Neuroscience Education (PNE). Fifty participants will be randomized (1:1) to the digital intervention or usual care. The primary outcome is change in pain intensity from baseline to post-intervention (week 13 ± 7 days), with secondary outcomes including physical function and health-related quality of life. Outcome assessors, the principal investigator, and the study statistician will be blinded to group allocation until database lock.",[56,28],[56,309,310,311,312,313],"Tele-rehabilitation","Artificial Intelligence","Computer Vision","Pain Neuroscience Education","Randomized Controlled Trial","2025-12-27",{"date":316,"type":33},"2026-01-02",{"date":318,"type":22},"2026-02-01",{"date":179,"type":22},{"name":72,"class":40},2,{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":190,"enrollmentInfo":329,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":331,"conditions":332,"keywords":335,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":41},"100581498","investigation-of-the-relationship-between-central-sensitization-and-balance-in-fibromyalgia-100581498","NCT06851091","Investigation of the Relationship Between Central Sensitization and Balance in Fibromyalgia","Investigation of the Relationship Between Central Sensitization Parameters and Balance Changes in Patients With Fibromyalgia","Inclusion Criteria:\n\n* Diagnosis of FMS according to the ACR 2016 diagnostic criteria\n* Being between the ages of 18 and 65\n* Being literate\n* Providing informed consent by signing the voluntary consent form\n\nExclusion Criteria:\n\n* Being under 18 years old or over 65 years old\n* Presence of vestibular disorders\n* Having undergone spinal and\u002For extremity surgery (such as for back\u002Fhip\u002Fknee\u002Ffoot) within the last 6 months\n* History of lower extremity amputation\n* Presence of spinal deformities\n* Peripheral arterial disease\n* Vitamin B12 deficiency\n* Any neurological disorder (e.g., stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies, etc.)\n* Severe cardiopulmonary insufficiency (stage 3-4)\n* Uncontrolled systemic diseases such as hypertension and diabetes\n* Presence of systemic inflammatory diseases, malignancies, or active infections\n* Pregnancy",{"count":330,"type":22},75,"The aim of the study is to investigate the relationship between central sensitization parameters and changes in static and dynamic balance in patients with fibromyalgia.\n\nThe main questions it aims to answer are:\n\n* Do central sensitization parameters differ in patients with fibromyalgia compared to healthy individuals?\n* How is balance performance in these individuals compared to healthy controls?\n* Do central sensitization parameters affect static and dynamic balance in patients with fibromyalgia?\n* Do central sensitization parameters lead to quantitative changes in balance in patients with fibromyalgia?",[28,333,334],"Central Sensitisation","Postural Balance",[56,333,336,334],"Balance Changes","2025-09-05",{"date":339,"type":33},"2025-09-12",{"date":341,"type":33},"2025-02-18",{"date":343,"type":22},"2025-12",{"name":345,"class":40},"Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":50,"minAge":354,"maxAge":18,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":366,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":321},"100587531","shiatsu-for-chronic-non-inflammatory-pain-in-children-and-adolescents-100587531","NCT06929598","Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents","The Efficacy of Adjunctive Shiatsu Therapy for Non-Inflammatory Chronic Pain in Pediatric Patients: A Single-Arm Prospective Trial","ShiQoL","Inclusion Criteria:\n\n* Children and adolescents aged 10-18 years\n* Diagnosed with non-inflammatory chronic pain syndromes\n* Actively followed by the Pediatric Rheumatology and\u002For Pediatric Pain Clinics at Tel Aviv Sourasky Medical Center (at least twice a year)\n* Informed consent signed by at least one legal guardian (or both guardians in cases of separated parents)\n* If participant is 16 years or older, they must also sign the informed consent\n\nExclusion Criteria:\n\n* Informed consent cannot be obtained from the participant or their legal guardians\n* Legal guardians unable to provide informed consent\n* Patients with severe conditions (e.g., bone metastasis)\n* Patients unable to participate in Shiatsu therapy sessions\n* Participation in Shiatsu therapy within 6 months prior to study enrollment\n* Participant or legal guardian refuses participation","10 Years",{"count":356,"type":22},40,[25],"The goal of this clinical trial is to learn if adding Shiatsu therapy to standard treatment can improve quality of life in children and adolescents with chronic pain that is not caused by inflammation. The main question it aims to answer is: Does Shiatsu therapy help improve the quality of life in children with long-lasting pain?\n\nAll participants will continue their regular treatment and will also:\n\n* Receive a 30-minute Shiatsu session once a week for six weeks\n* Complete questionnaires about their quality of life and family impact before, during, and after the treatment period\n\nThe study includes about 40 participants between the ages of 10 and 18, who are already being followed at the pediatric pain and rheumatology clinics at Tel Aviv Sourasky Medical Center.",[360,361,362,363,364,56,28,365],"Chronic Pain","Chronic Pain Syndrome","Chronic Pain and Comorbid Emotional Problems","Chronic Pain, Psychogenic","Chronic Pain, Widespread","Functional Pain",[367,368,369,370,212,371,372,373,374,375,376,365,377],"Shiatsu","Complementary and Integrative Medicine","Pediatric Chronic Pain","Non-inflammatory Pain","PedsQL","Adolescent Pain","Manual Therapy","Mind-Body Therapy","Pediatric Rheumatology","Integrative Medicine","Pain Management","2025-08-27",{"date":380,"type":33},"2025-09-04",{"date":382,"type":33},"2025-05-01",{"date":384,"type":22},"2027-04-30",{"name":386,"class":40},"Tel Aviv University",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":190,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":41},"100587004","fibromyalgia-somatic-tracking-and-exercise-program-study-100587004","NCT06922747","FIBROmyalgia: Somatic Tracking and Exercise Program Study","FIBROSTEPS Protocol: A 2×2 Factorial Randomized Controlled Trial Evaluating Group Exercise and Somatic Tracking in Fibromyalgia","FIBROSTEPS","Inclusion Criteria:\n\n* Diagnosed with fibromyalgia according to the criteria specified in Wolfe et al (2016)\n* Able to perform light physical activity\n* Able to provide written informed consent\n* Owning a smartphone\n* Able to be followed for 24 weeks\n\nExclusion Criteria:\n\n* Pregnant\n* Severe co-morbid psychiatric or neurological disorders\n* Current participation in another clinical trial\n* Recent surgery or other physical constraints preventing exercise",{"count":192,"type":22},[25],"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:\n\n* weekly exercise sessions in groups\n* weekly consultations with a therapist\n\nThe 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?\n\nParticipants 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:\n\n* one group receiving the exercise intervention\n* one group receiving the psychological intervention\n* one group receiving both intervention\n* one control group recieving general physical activity recommendations\n\nBefore 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.\n\nResearchers will compare the combination of the interventions against only one intervention and the control group.",[57,56,28],[400,401,402,403,404,405,406,407,59,121,408,409,410,411],"fibromyalgia impact questionnaire","randomized controlled trial","clinical trial","factorial design","2*2 factorial design","physical activity","somatic tracking","activity","effect study","musculoskeletal pain","rheumatic diseases","musculoskeletal diseases","2025-05-07",{"date":414,"type":33},"2025-05-13",{"date":416,"type":22},"2027-01",{"date":418,"type":22},"2028-01",{"name":420,"class":40},"University of Tromso",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":163,"sex":50,"minAge":18,"maxAge":190,"enrollmentInfo":428,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":438,"locationsCount":41},"100568262","arm-exercise-capacity-muscle-strength-and-activities-of-daily-living-in-patients-with-fibromyalgia-syndrome-100568262","NCT06678932","Arm Exercise Capacity, Muscle Strength and Activities of Daily Living in Patients with Fibromyalgia Syndrome","Comparison of Arm Exercise Capacity, Muscle Strength and Daily Living Activities of Patients with Fibromyalgia Syndrome and Healthy Controls","Inclusion Criteria-fibromyalgia syndrome:\n\n* Being diagnosed with fibromyalgia syndrome\n* Being aged 18-65\n* Stable use of medication for at least 3 months or longer\n* Volunteering to participate in the study\n\nExclusion Criteria-fibromyalgia syndrome:\n\n* Having comorbidities that may affect physical functions\n* Failure to cooperate with tests to be performed\n* Presence of exercise test contraindication\n\nInclusion Criteria-healthy control:\n\n* Being aged 18-65\n* Volunteering to participate in the study\n\nExclusion Criteria-healthy control:\n\n* Having a chronic or systemic disease\n* Failure to cooperate with tests to be performed",{"count":429,"type":22},36,"The aim of this study is to compare the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals.",[28],"2024-11-06",{"date":434,"type":33},"2024-11-07",{"date":436,"type":22},"2024-11",{"date":343,"type":22},{"name":439,"class":40},"Kirsehir Ahi Evran Universitesi",{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":50,"minAge":252,"maxAge":19,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":452,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":4},"100563439","tdcs-and-tele-rehabilitation-exercise-in-fibromyalgia-100563439","NCT06616181","TDCS and Tele-rehabilitation Exercise in Fibromyalgia","Effects of Anodal TDCS Applied Over M1 and DLPFC Combined with a Telerehabilitation Exercise Program in Patients with Fibromyalgia: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 30 and 70 years.\n* Medical diagnosis of fibromyalgia.Compliance with the latest diagnostic criteria from the American College of Rheumatology.\n* Stable medication for at least 12 weeks prior to the start of the study.\n* Ability to use communication technologies, such as smartphones and computers.\n* Capacity to participate in an aerobic exercise program.\n* Access to the internet.\n* Proficiency in oral and written Spanish.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe psychiatric disorders.\n* Uncontrolled cardiovascular, respiratory, metabolic, neurological, rheumatic, or hepatic diseases.\n* Concurrent chronic inflammatory or autoimmune disease.\n* Contraindications to physical activity.\n* Metal implants in the head.\n* History of cancer, brain tumor, epileptic episodes, stroke, severe head trauma, or brain surgery.\n* Pregnancy or lactation.\n* Use of carbamazepine in the past 6 months.\n* Changes in medication during the study.\n* Participation in other non-pharmacological conservative therapies (e.g., hydrotherapy, electrotherapy, manual therapy, exercise, dry needling) during the study.",{"count":448,"type":22},45,[25],"This randomized controlled trial aims to analyze the effects of anodal tDCS applied over the primary motor cortex and dorsolateral prefrontal cortex combined with a tele-rehabilitation exercise program in patients with fibromyalgia. The study will compare these effects with each other and with placebo tDCS on the following variables: pain intensity, pain mechanosensitivity, quality of life, fatigue, anxiety, depression, sleep quality, pain catastrophizing, functional capacity, isometric strength, and exercise adherence.\n\nSecondary objectives include:\n\n* Describing the sociodemographic, clinical, and functional characteristics of fibromyalgia patients.\n* Comparing exercise intensity levels between patients receiving tDCS on M1, DLPFC, and placebo stimulation.\n* Reporting any adverse effects of the intervention. Adult participants with fibromyalgia will be randomized into three groups: a) anodal tDCS over M1 + telerehabilitation, b) anodal tDCS over DLPFC + telerehabilitation, and c) sham-tDCS + telerehabilitation. The intervention will last for 12 weeks. The telerehabilitation exercise program will include an aerobic phase and a resistance phase, with four intensity levels regulated based on the Borg Rating of Perceived Exertion (0-10). The program will be conducted remotely through phone contact, with materials and videos provided to guide exercise execution. tDCS will be applied once per week for 20 minutes at 2 mA, either over M1 or DLPFC.\n\nThe dependent variables-pain intensity, fibromyalgia impact, fatigue, anxiety and depression levels, pain catastrophizing, sleep quality, functional capacity, and isometric muscle strength-will be collected in the week prior to the intervention, the week following the intervention, and 12 weeks after its completion. Additionally, pain intensity, fibromyalgia impact, fatigue severity, anxiety and depression levels, pain catastrophizing, and sleep quality will be evaluated during the 6th week of the intervention.\n\nExercise intensity, exercise adherence, and any adverse effects related to the intervention will be recorded weekly.",[28],[453,60,454,455,59],"tDCS","telerehabilitation","home-based exercise","2024-09-24",{"date":458,"type":33},"2024-09-27",{"date":460,"type":22},"2024-12-01",{"date":462,"type":22},"2026-12-01",{"name":464,"class":40},"University of Valladolid",{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":50,"minAge":471,"maxAge":80,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":476,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":41},"100557567","effect-of-neuromodulation-on-pain-biomarkers-and-functional-outcome-in-patients-with-fibromyalgia-syndrome-100557567","NCT06539793","Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome","Inclusion Criteria:\n\n1. Patients fibromyalgia from both genders.\n2. The duration of fibromyalgia is more than 6 month (all patients with history of cervical or lumbar pain) and following diagnosis of FM using the 2016 revised FM criteria, on the basis of the ACR-2010 criteria.\n3. Their ages will be ranged from 25-35 years old.\n4. They will be medically stable and have sufficient cognitive abilities that enable them to understand and follow instruction according to Montreal Cognitive Assessment (MoCA) \\>26.\n\nExclusion Criteria:\n\n1. Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease\n2. Pacemaker\n3. Spinal fusion-cervical or lumbar\n4. Metal implants in the spine\n5. Pregnancy\n6. Epilepsy\n7. Severe psychiatric disorder or alcohol and drug abuse.\n8. Unstable medical condition which could compromise the participant's welfare or confound the study results.\n9. Uncontrolled blood pressure or diabetes\n10. Visual or auditory problems.\n11. Active inflammatory conditions","25 Years",{"count":356,"type":22},[25],"Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years.",[28],[56,477,478,479,480],"NEUROMODULATION","Centralization","PAIN BIOMARKERS","FUNCTIONAL OUTCOME","2024-08-05",{"date":483,"type":33},"2024-08-06",{"date":485,"type":22},"2024-09-01",{"date":487,"type":22},"2025-07-03",{"name":489,"class":40},"Ahmed Alshimy"]