[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibromyalgia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibromyalgia":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,119,0,25,[9,41,71,93,116,153,183,203,235,256,278,296,316,334,354,379,407,430,453,473,493,513,533,553,578],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100610366","ultrasonic-neuromodulation-of-cingulate-cortex-for-fibromyalgia-100610366",false,"NCT07226648","Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia","Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia: A Blinded Randomized Sham-Controlled Trial","Inclusion Criteria:\n\n1. Willing and able to provide informed consent.\n2. Age ≥ 22 years.\n3. Meets 2016 American College of Rheumatology criteria for fibromyalgia:\n\n   1. Generalized pain, defined as pain in at least 4 of 5 regions, is present, AND\n   2. Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9, AND\n   3. Symptoms have been present at a similar level for at least 3 months, AND\n   4. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.\n4. Failure of at least two evidence-based medications or medications that are commonly used in clinical practice to treat fibromyalgia (e.g., pregabalin, duloxetine, milnacipran, sublingual cyclobenzaprine hydrochloride, tricyclics (e.g., amitriptyline, nortriptyline, desipramine),gabapentin, gabapentinoids, NSAIDS (including Cox-2 inhibitors), acetaminophen, SSRIs, SSNIs, muscle relaxants, non-sublingual forms of cyclobenzaprine hydrochloride, opioids, benzodiazepines), at least 1 of which is FDA-approved for the treatment of fibromyalgia (e.g., pregabalin, duloxetine, milnacipran, and sublingual cyclobenzaprine hydrochloride).\n5. Failure of one or more attempts at physical or Cognitive Behavioral Therapy (CBT) including:\n\n   1. Aerobic exercise like walking, cycling, and swimming,\n   2. Water therapy\u002Fhydrotherapy with warm water exercises,\n   3. Tai Chi involving slow, controlled movements,\n   4. Yoga,\n   5. Resistance training,\n   6. Bodyweight exercises,\n   7. Pilates,\n   8. Myofascial release therapy applying gentle pressure on trigger points,\n   9. Massage therapy,\n   10. Trigger point therapy targeting specific pain points,\n   11. Joint mobilization,\n   12. Postural retraining to correct body alignment,\n   13. Balance and coordination exercises,\n   14. Feldenkrais method for movement awareness,\n   15. Alexander technique to enhance posture and movement efficiency,\n   16. Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief,\n   17. Heat therapy using hot packs, infrared, or paraffin wax,\n   18. Cold therapy with ice packs or cryotherapy,\n   19. Ultrasound therapy for deep tissue relaxation,\n   20. Biofeedback to control muscle tension and pain response,\n   21. Gentle static stretching for prolonged duration,\n   22. Active dynamic stretching for full range of motion,\n   23. Proprioceptive Neuromuscular Facilitation (PNF) stretching,\n   24. Hydrotherapy pool exercises,\n   25. Ai Chi (water-based Tai Chi),\n   26. Underwater treadmill therapy, aa) Graded motor imagery (GMI), bb) Mirror therapy to retrain brain-body connections, cc) Mindfulness-based stress reduction (MBSR) combining meditation and movement, dd) Balance exercises to improve stability, ee)Gaze stabilization techniques for dizziness and disorientation, ff) CBT.\n6. Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Screening visit.\n7. Pain score of ≥ 4 on NRS-11 at Baseline visit averaged over 3 consecutive calendar days.\n8. Stated willingness and ability to comply with all study procedures.\n9. Has remained on the same psychiatric treatment regimen (e.g., medication, psychotherapy) for at least one (1) month prior to screening, and has stated willingness to remain on the same regimen for the duration of the study unless a change in treatment is recommended or agreed upon by the site investigator.\n10. For participants who could potentially become pregnant: negative urine pregnancy test at screening; agreement to either abstain from heterosexual intercourse or use an acceptable contraceptive method during study participation. Acceptable contraceptive methods include hormonal contraception, including oral contraceptive pills, tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), or long-acting reversible contraceptives (LARC).\n\nExclusion Criteria:\n\n1. Any previous diagnosis of bipolar disorder or schizophrenia-spectrum disorder during the participant's lifetime, according to Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5-TR) criteria.\n2. New or existing diagnosis of moderate or severe alcohol or other substance use disorder in the past 6 months, according to DSM-5-TR criteria.\n3. New or existing diagnosis of obsessive-compulsive disorder and\u002For posttraumatic stress disorder in the past 30 days, according to DSM-5-TR criteria, and which is unstable in the clinical judgment of the investigator.\n4. New or existing primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months, according to DSM-5-TR criteria.\n5. Clinically significant neurodevelopmental, neurocognitive, or personality disorder, according to DSM-5-TR criteria.\n6. Moderate-High Risk of Suicide, according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate Risk), or YES to Question 4, 5, or 6 (High Risk)), or in the clinical judgement of the site investigator.\n7. Lifetime history of a serious suicide attempt in the medical opinion of the site investigator.\n8. Changes in prescribed treatments for pain in the past 2 months that could confound study outcome assessments, in the opinion of the site investigator.\n9. Treatment with electroconvulsive therapy, transcranial magnetic stimulation, ketamine, or esketamine in the past 30 days.\n10. Currently diagnosed progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapid progressive arachnoiditis, brain or spinal cord tumor, or severe\u002Fcritical spinal stenosis (stenosis).\n11. Cancer-related pain.\n12. Diagnosis of malignancy other than basal cell carcinoma, or carcinoma in situ of the cervix within the past five years, to include life expectancy less than one year due to advanced malignancy.\n13. Autoimmune conditions that are known to cause pain.\n14. Inadequately managed general medical condition, in the opinion of the site investigator.\n15. Lifetime history of cerebral small vessel disease.\n16. Lifetime history of intracranial hemorrhage.\n17. Pregnant or breast feeding.\n18. MRI contraindication or electrically sensitive implants such as pacemakers, implanted cardioverter defibrillators, or neurostimulators. Routine dental hardware is not exclusionary.\n19. MRI intolerance.\n20. Previously enrolled in a DIADEM clinical trial. Note: a patient who screen fails is able to be rescreened at most one time.\n21. Has a history of a medical or psychiatric disorder, disease, condition, injury, symptoms, or circumstance that, in the opinion of the site investigator, may (1) reduce the participant's ability to fulfill the study requirements as per protocol; (2) adversely impact the integrity of the data or the validity of the study results; or (3) pose an increased risk to the participant during study participation.\n22. Participants with braids, dreadlocks, or other hairstyles that prevent access to the side of the head and who are unwilling to temporarily adjust their hairstyle to allow such access.","ALL","22 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27],"Fibromyalgia","RECRUITING","2026-08-18",{"date":31,"type":32},"2026-08-20","ACTUAL",{"date":34,"type":32},"2025-12-11",{"date":36,"type":21},"2026-12",{"name":38,"class":39},"SPIRE Therapeutics Inc.","INDUSTRY",8,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100643267","empowered-relief-for-caregivers-100643267","NCT07636980","Empowered Relief for Caregivers","Empowered Relief for Caregivers (ER-CY): A Co-Designed Brief Intervention to Support Families of Youth With Chronic Pain","ER-CY","Inclusion Criteria:\n\n* Caregiver of a youth with a chronic pain diagnosis (\\>3 months in duration)\n* English speaking\n\nExclusion Criteria:\n\n* Significant psychosocial complexity based on clinical team assessment (e.g., severe depression\u002Fanxiety, unable to tolerate a group setting)","18 Years",{"count":51,"type":21},80,[24],"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.\n\nUp 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.",[55,56,27,57,58,59],"Chronic Pain","Musculoskeletal Pain","Neuropathic Pain","Complex Regional Pain Syndromes (CRPS)","Abdominal Pain (AP)","NOT_YET_RECRUITING","2026-08-17",{"date":31,"type":32},{"date":64,"type":21},"2026-10",{"date":66,"type":21},"2028-09",{"name":68,"class":69},"Stanford University","OTHER",1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":17,"minAge":49,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":70},"100460545","pain-processing-in-inflammatory-and-non-inflammatory-chronic-pain-syndromes-100460545","NCT05277025","Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes","Inclusion Criteria:\n\n* Ages 18-70\n* Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM\n* Fulfills the 2010 ACR-EULAR classification criteria for RA\n* Healthy volunteers: No significant pain\u002Ffatigue\u002Fdepression\u002Fanxiety.\n\nExclusion Criteria:\n\n* Diabetes\n* Cancer\n* Advanced liver, kidney or cardiovascular disease\n* Neuropathic pain",true,"70 Years",{"count":80,"type":21},150,"OBSERVATIONAL","Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that afflicts up to 4% of the general population. The evaluation of pain mechanisms in FM has shown predominant central abnormalities and therefore has been designated as nociplastic pain syndrome. Rheumatoid arthritis (RA) is characterized by polyarthritis and pain from inflamed tissues, consistent with nociceptive pain. FM and RA patients may utilize overlapping pain mechanisms resulting in nociceptive and nociplastic pain.",[27,84],"Rheumatoid Arthritis",{"date":86,"type":32},"2026-08-19",{"date":88,"type":32},"2022-03-22",{"date":90,"type":21},"2027-07-28",{"name":92,"class":69},"University of Florida",{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100652502","prevalence-of-fibromyalgia-in-patients-with-plaque-psoriasis-100652502","NCT07773766","Prevalence of Fibromyalgia in Patients With Plaque Psoriasis","Fibromyalgia in Patients With Plaque Psoriasis - Assiut University Hospital","Inclusion Criteria:\n\n* Adult patients (≥18 years) with clinically diagnosed plaque psoriasis.\n* Both males and females.\n* Willing to participate and provide written informed consent.\n* For controls: Apparently healthy age- and sex-matched volunteers.\n* For controls: No history of psoriasis, psoriatic arthritis, or other chronic inflammatory or rheumatic diseases.\n* For controls: Willing to participate and provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with psoriatic arthritis or other inflammatory arthritis.\n* Patients with other diagnosed rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis).\n* Patients with previously diagnosed major depressive disorder or generalized anxiety disorder.\n* Patients with uncontrolled diabetes mellitus, heart failure, renal failure, or thyroid disorders.\n* Current use of antidepressants, anticonvulsants, or benzodiazepines.\n* History of malignancy.\n* Pregnancy.",{"count":101,"type":21},110,"This observational study aims to determine how common fibromyalgia syndrome and central sensitization are in adults with plaque psoriasis compared to healthy individuals. Plaque psoriasis is a chronic inflammatory skin disease that can affect the entire body, which may increase the risk of developing chronic pain conditions. Fibromyalgia causes widespread musculoskeletal pain, fatigue, and sleep disturbances, while central sensitization involves the central nervous system becoming highly sensitive to pain.\n\nResearchers will evaluate 55 adult patients diagnosed with plaque psoriasis and 55 age- and sex-matched healthy volunteers at the Dermatology Outpatient Clinic at Assiut University Hospital. Participants will undergo a clinical examination to assess their psoriasis severity and will complete standardized questionnaires to evaluate pain intensity, fibromyalgia symptoms, central sensitization, and overall quality of life. The findings of this study may help doctors better understand these overlapping conditions to improve the early identification and management of pain in patients with psoriasis.",[104,27],"Plaque Psoriasis",[104,27,106,107,55],"Central Sensitization","Quality of Life","2026-08-14",{"date":86,"type":32},{"date":111,"type":21},"2026-09",{"date":113,"type":21},"2027-10",{"name":115,"class":69},"Assiut University",{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":70},"100623999","the-effect-of-fermented-grape-juice-consumption-on-fibromyalgia-patients-100623999","NCT07403929","The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients","Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients","Inclusion Criteria:\n\n* Female, 20-40 years\n* BMI 25.0-29.9 kg\u002Fm²\n* FM per 2016 ACR criteria; abdominal pain\u002Fcramp per SSS sub-item\n* MEDAS ≤5 at screening.\n* Willing to maintain habitual activity and comply with assigned intervention; able to provide informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C20 or \\>40\n* BMI ≤24.99 or ≥30.0 kg\u002Fm²\n* Professional athletes; night-shift workers\n* Food allergies; acute infection; antibiotic use within past month or during intervention.\n* Use (past 3 months) of dietary supplements; recent weight-loss or special diets (e.g., ketogenic).\n* Pregnancy\u002Flactation; menopause.\n* Major hepatic\u002Frenal\u002Fcardiac\u002Fimmune disease; chronic GI diseases; diabetes; CNS disorders; cancer; thyroid disease; severe pulmonary disease. Inflammatory arthritis\u002Fautoimmune disease impacting weight; medications including corticosteroids, estrogens, analgesics\u002Fanti-inflammatories, anti-diabetic or lipid-lowering drugs.\n* Severe psychiatric illness\u002Fsubstance use; heavy alcohol\u002Fsmoking.\n* High recent intake of grape juice\u002Fmolasses; excess tea\u002Fcoffee (≥7 cups\u002Fday).\n* Adherence \\\u003C80% to beverage or MNT during run-in\u002Fscreening.","FEMALE","20 Years","40 Years",{"count":127,"type":21},45,[24],"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.\n\nThe main questions are:\n\nDoes 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?\n\nHow the groups are compared:\n\nResearchers will compare three groups for 8 weeks:\n\nDiet + 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)\n\nParticipants will:\n\nDrink 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\n\nWho can join:\n\nAdult women (20-40 years) with doctor-diagnosed fibromyalgia and BMI 25.0-29.9 kg\u002Fm² who meet the study's health and medication criteria.",[27,131,132],"Fibromyalgia (FM)","Fibromyalgia Syndrome, Primary",[134,135,136,137,138,139,140,141,142,143],"fibromyalgia","chronic pain","pain","inflammation","oxidative stress","sirtuin-1","SIRT1","gut microbiota","phytochemicals","nutrition","2026-07-30",{"date":146,"type":32},"2026-07-31",{"date":148,"type":32},"2026-03-15",{"date":150,"type":21},"2027-02-15",{"name":152,"class":69},"Hacettepe University",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":70},"100649866","prl2019-in-the-treatment-of-juvenile-fibromyalgia-100649866","NCT07738926","PRL2019 in the Treatment of Juvenile Fibromyalgia","A Prospective, Randomised, Controlled Crossover Study on the Effectiveness of Bifidobacterium Adolescentis PRL2019 in the Treatment of Juvenile Fibromyalgia","IGG-microbiota","Inclusion Criteria:\n\n* Patients aged between 9 and 25 years;\n* Written informed consent to participate in the study obtained prior to the start of the study from the patient or both parents\u002Flegal guardians of the patient if a minor, and the assent of the minor;\n* Diagnosis of JFS according to the 2010 American College of Rheumatology (ACR) criteria 15, with disease onset before 18 years of age;\n* Willingness to comply with follow-up visits and provide biological samples (blood and stool) according to the schedule defined in the protocol.\n\nExclusion Criteria:\n\n* any conditions that may affect the ability to complete informed consent;\n* denial of the informed consent;\n* presence of concomitant organic GI diseases, such as inflammatory bowel disease, celiac disease, eosinophilic or autoimmune gastroenteropathies, or history of major abdominal surgery;\n* acute infection at the time of recruitment;\n* antibiotic treatment within 3 months prior to recruitment;\n* use of any prebiotic, probiotic, or postbiotic in the previous 2 months before enrolment;\n* significant eating disorders, including diagnosed eating behaviour disorders.","9 Years","25 Years",{"count":164,"type":21},30,[24],"Juvenile Fibromyalgia Syndrome (JFS) is a chronic condition affecting children and adolescents, characterised by widespread musculoskeletal pain and a significant impact on daily life and quality of life. Gastrointestinal symptoms and changes in gut microbiota have been reported in patients with fibromyalgia, suggesting a possible role of the gut-immune system interaction in the disease.\n\nThis study aims to investigate whether Gabapral®, a food supplement containing the probiotic strain Bifidobacterium adolescentis PRL2019, may help reduce pain symptoms and improve clinical outcomes in paediatric patients with JFS.\n\nThe hypothesis of this study is that modulation of the gut microbiota with Gabapral® may contribute to improvement of symptoms related to Juvenile Fibromyalgia Syndrome.",[27,168],"Fibromyalgia Syndrome",[170,171,172,173,174],"Juvenile Fibromyalgia Syndrome","Probiotics","Gut microbiota","Microbiome modulation","Chronic musculoskeletal pain","2026-07-27",{"date":146,"type":32},{"date":178,"type":21},"2026-08-01",{"date":180,"type":21},"2026-09-30",{"name":182,"class":69},"Istituto Giannina Gaslini",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":199,"leadSponsor":201,"locationsCount":70},"100649460","mandala-coloring-for-pain-fatigue-and-sleep-in-patients-with-fibromyalgia-100649460","NCT07733739","Mandala Coloring for Pain, Fatigue, and Sleep in Patients With Fibromyalgia","The Effect of Mandala Coloring on Pain, Fatigue, and Sleep Quality in Patients With Fibromyalgia","Inclusion Criteria:\n\n* Aged 18 years or older\n* Diagnosed with fibromyalgia\n* Pain intensity score of 5 or higher on the Visual Analog Scale\n* Fatigue Severity Scale score of 4 or higher\n* Pittsburgh Sleep Quality Index global score of 5 or higher\n* Able to communicate and complete the study assessments\n* No physical limitation preventing mandala coloring\n* Willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Presence of a communication problem that prevents participation or completion of the assessments\n* Presence of a physical limitation that prevents mandala coloring\n* Refusal to participate or provide written informed consent",{"count":191,"type":21},60,[24],"Fibromyalgia is a chronic condition commonly associated with widespread pain, fatigue, and poor sleep quality. This randomized controlled study aims to determine whether mandala coloring, when added to routine treatment, improves pain, fatigue, and sleep quality in adults with fibromyalgia.\n\nA total of 60 eligible participants will be randomly assigned in a 1:1 ratio to either a mandala coloring group or a control group. Participants in the mandala coloring group will complete eight 60-minute coloring sessions over four weeks, with two sessions per week, while continuing their routine treatment. Participants in the control group will continue their routine treatment without taking part in a structured coloring activity.\n\nPain, fatigue, and sleep quality will be assessed at the beginning of the study and at the end of the fourth week. Changes in these outcomes will be compared between the two groups.",[27],"2026-07-24",{"date":197,"type":32},"2026-07-29",{"date":178,"type":21},{"date":200,"type":21},"2027-08-17",{"name":202,"class":69},"Artvin Coruh University",{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100623575","phase-3-fibromyalgia-response-with-esreboxetine-evaluated-using-a-randomized-withdrawal-research-design-100623575","NCT07398417","Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design","A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia","FORWARD","Inclusion Criteria:\n\n* Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.\n* Male or female, ≥18 years of age.\n* Provides written informed consent to participate in the study before conducting any study procedures.\n\nExclusion Criteria:\n\n* Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.",{"count":212,"type":21},620,[214],"PHASE3","The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.",[27],[27,106,218,219,220,221,222,223,224,225],"Allodynia","Hyperalgesia","Hypersensitivity to sensory stimuli","Inhibitor of the norepinephrine transporter (NET)","Esreboxetine","AXS-14","Axsome","Norepinephrine reuptake inhibitor","2026-07-23",{"date":195,"type":32},{"date":229,"type":32},"2026-01-14",{"date":231,"type":21},"2028-03",{"name":233,"class":39},"Axsome Therapeutics, Inc.",51,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":70},"100426473","development-of-a-therapeutic-endpoint-in-pediatric-rheumatologic-conditions-100426473","NCT04833465","Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions","Inclusion Criteria:\n\nIn order to be eligible for inclusion in the study, an individual must meet all of the following criteria:\n\n* Male or female ≥ 5 years of age at screening.\n* Documentation of a JIA, SLE or FM diagnosis as evidenced by history\n\nExclusion Criteria:\n\nAny individual who meets any of the following criteria will be excluded from participation in this study:\n\n• Documented history of eye disease precluding pupillometry","5 Years","21 Years",{"count":244,"type":21},90,"The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.",[247,248,27],"Juvenile Idiopathic Arthritis","Systemic Lupus Erythematosus",{"date":195,"type":32},{"date":251,"type":32},"2021-07-16",{"date":253,"type":21},"2028-12",{"name":255,"class":69},"Children's National Research Institute",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":78,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100513205","self-guided-acceptance-and-commitment-therapy-based-digital-smartphone-application-for-management-of-fibromyalgia-100513205","NCT05962437","Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia","Three-arm Randomized Controlled Trial Investigating the Effectiveness, Cost-utility, and Physiological Effects of the Spanish Version of STANZA®: A Self-guided Digital Acceptance and Commitment Therapy (ACT) for Fibromyalgia","SMART-FM-SP","Inclusion Criteria:\n\n* Fibromyalgia diagnosis according to the 2016 ACR criteria\n* Fibromyalgia Impact Questionnaire Revised (FIQR) total score within the range of 35-80 at baseline.\n* Willing to maintain their current pain treatment throughout the study.\n* Having a smartphone (iOS 12 or higher or Android OS 8 or higher).\n* Proficient understanding of Spanish.\n\nExclusion Criteria:\n\n* Presence of cognitive impairment according to clinical records.\n* Diagnosis of severe medical or mental disorders such as cancer, psychotic disorder, and drug abuse according to medical records.\n* Patients at risk of suicide.\n* Being pregnant or planning a pregnancy during the study period, or currently breastfeeding.\n* Participation in other clinical trials during the study or within the previous 12 months.\n* Unable to use a smartphone.\n\nExclusion criteria for biomarkers substudy (30-50 patients in each study arm):\n\n* Male sex\n* Comorbid rheumatologic disorders such as lupus or severe organ dysfunction.\n* History of fever (\\> 38ºC) or infection within the last 2 weeks.\n* Vaccination within the last 4 weeks.\n* Recent physical trauma\n* Needle phobia.\n* Consumption of more than 8 units of caffeine per day.\n* Smoking more than 5 cigarettes per day.\n* Current use of oral or topical corticosteroids.\n* Current use of anti-cytokine biologic medications.\n* Current use of oral contraceptives.",{"count":265,"type":21},360,[24],"Introduction: Fibromyalgia (FM) is a prevalent syndrome that lacks curative treatment, imposing high healthcare and societal costs. The SMART-FM-Spain study investigates the effectiveness, physiological effects, and cost-utility of a self-guided digital intervention (STANZA-Spain) based on Acceptance and Commitment Therapy (ACT) for patients with FM.\n\nMethodology: Six-month, 3-arm randomized controlled trial (RCT) A total of 360 adult individuals meeting the 2016 American College of Rheumatology (ACR) criteria for FM will be recruited at Vall d'Hebron University Hospital (Barcelona, Spain), The Rheumatology Service of the Parc Sanitari Sant Joan de Déu (Sant Boi, Spain), The San Juan de Dios Hospital of Palma (Palma de Mallorca, Spain) and The San Juan de Dios Hospital of Aljarafe (Sevilla, Spain). They will be randomly allocated to one of the three study arms: Treatment as usual (TAU) plus STANZA-Spain, TAU plus digital symptom tracking (FibroST), or TAU. Participants will be assessed at baseline, post-treatment, and 6 month-follow-up. The primary outcome will be functional impairment, as measured by the FIQR; secondary outcomes will include patient impression of change, depression-anxiety-stress, and pain catastrophizing, among others constructs relevant to FM. Effectiveness and cost-utility analysis from a societal perspective will be computed, whereas ACT-related constructs, such as psychological flexibility, will be assessed to identify processes of change that will be analyzed with path analyses. Immune-inflamatory biomarkers will be assessed at baseline and post-treatment in 30-40 participants of each study arm. Additionally, a qualitative substudy using focus group thematic analysis will be conducted to deepen the understanding of STANZA app user experiences.\n\nDiscussion: This study might represent a significant advancement in the management of FM in Spanish-speaking patients with FM, by examining the effectiveness, physiological effects, and cost-utility of a smartphone-based digital therapeutic with demonstrated empirical support in the United States of America.",[27],"2026-07-21",{"date":226,"type":32},{"date":272,"type":32},"2024-01-01",{"date":274,"type":21},"2027-03-31",{"name":276,"class":69},"Fundació Sant Joan de Déu",2,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":4},"100648472","effects-of-box-breathing-exercise-in-patients-with-fibromyalgia-100648472","NCT07722923","Effects of Box Breathing Exercise in Patients With Fibromyalgia","Effects of Box Breathing Exercise on Sleep Quality, Pain, Gastrointestinal Symptoms, and Comfort in Patients With Fibromyalgia","Inclusion Criteria:\n\n* Aged 18 years or older\n* Having a diagnosis of fibromyalgia\n* Having a Visual Analog Scale pain score of 5 or higher\n* Having a Pittsburgh Sleep Quality Index score of 5 or higher\n* Being able to communicate and complete the study assessments\n* Voluntarily agreeing to participate and providing informed consent\n\nExclusion Criteria:\n\n* Having a respiratory condition such as asthma or chronic obstructive pulmonary disease\n* Having a communication problem that prevents participation in the study procedures or completion of the assessment tools",{"count":191,"type":21},[24],"Fibromyalgia is a chronic condition that can cause widespread pain, sleep problems, fatigue, gastrointestinal symptoms, and reduced comfort. This study will evaluate whether box breathing exercise improves sleep quality, pain, gastrointestinal symptoms, and comfort in patients with fibromyalgia.\n\nA total of 60 participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will continue their routine treatment and perform box breathing exercises for 10 minutes twice daily for 30 days. Participants in the control group will continue their routine treatment without receiving the breathing exercise. Sleep quality, pain, gastrointestinal symptoms, and comfort will be assessed at the beginning and at the end of the 30-day study period",[27],"2026-07-20",{"date":226,"type":32},{"date":292,"type":21},"2026-09-15",{"date":294,"type":21},"2027-09-15",{"name":202,"class":69},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":77,"sex":17,"minAge":49,"maxAge":78,"enrollmentInfo":303,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":313,"leadSponsor":315,"locationsCount":4},"100638600","the-role-of-resilience-for-physical-functioning-of-patients-with-fibromyalgia-syndrome-using-the-6-min-walk-test-100638600","NCT07611539","The Role of Resilience for Physical Functioning of Patients With Fibromyalgia Syndrome Using the 6-Min Walk Test","6MWT","Inclusion Criteria:\n\n* Ages 18-70\n* Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM\n* Healthy volunteers: No significant pain\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Cancer\n* Uncontrolled coronary syndromes\n* Peripheral neuropathies\n* Unwillingness\u002Finability to discontinue analgesics, hypnotics, anxiolytics, or stimulants",{"count":304,"type":21},100,"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.",[27,307,308],"Physical Function","Six-minute Walk Test","2026-07-02",{"date":311,"type":32},"2026-07-06",{"date":144,"type":21},{"date":314,"type":21},"2031-04-30",{"name":92,"class":69},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":77,"sex":17,"minAge":49,"maxAge":78,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":70},"100498686","effects-of-breathing-and-attention-training-bat-on-pain-modulation-100498686","NCT05773482","Effects of Breathing and Attention Training (BAT) on Pain Modulation","Effects of Breathing and Attention Training (BAT) on Pain Modulation in Healthy Individuals and Patients With Chronic Musculoskeletal Pain","Inclusion Criteria:\n\n* Individuals diagnosed with fibromyalgia will have pain of duration \\> 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR)\n* Healthy, pain-free age matched controls without chronic pain\n\nExclusion Criteria:\n\n* Personal or family history of photosensitive epilepsy\n* Prior history of cancer or diabetes\n* Patients must be willing to discontinue their analgesics, hypnotics, anxiolytics, or anti-depressants during the study period for at least 5 half-lives.",{"count":324,"type":21},40,[24],"The hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Quantitative sensory testing is easier to perform and repeatable. Therefore, it will be used to evaluate the effects of Breathing Attention Training (BAT) on the hypersensitivity of FM participants. BAT is a form of mindfulness meditation shown to decrease FM symptoms and possibly pain sensitivity. We hypothesize that pain modulation of chronic pain patients is improved by BAT.",[27],{"date":311,"type":32},{"date":330,"type":32},"2023-04-03",{"date":332,"type":21},"2028-03-09",{"name":92,"class":69},{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":70},"100645400","impact-of-major-ozone-autohemotherapy-on-sarcopenia-parameters-in-fibromyalgia-100645400","NCT07680621","Impact of Major Ozone Autohemotherapy on Sarcopenia Parameters in Fibromyalgia","Effects of Major Ozone Autohemotherapy on Sarcopenia Parameters and Clinical Features in Fibromyalgia","Inclusion Criteria:\n\n* Female patients aged 18-65 years\n* Diagnosis of fibromyalgia syndrome according to the 2016 ACR criteria:\n* Symptoms present at a similar level for at least 3 months\n* Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Scale (SSS) ≥ 5\n* WPI 4-6 and SSS ≥ 9\n* Not currently receiving medical treatment for fibromyalgia (except NSAIDs)\n\nExclusion Criteria:\n\n* Current or previous pharmacological treatment specifically for fibromyalgia\n* Pregnancy or breastfeeding\n* History of active or previous malignancy\n* History of systemic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, dermatomyositis, familial Mediterranean fever)\n* Endocrine disorders (e.g., hypothyroidism, Cushing's syndrome, adrenal insufficiency)\n* Anemia\n* Chronic renal failure\n* Chronic liver failure\n* Chronic obstructive pulmonary disease (COPD)\n* Known severe cardiovascular disease\n* Body mass index (BMI) \\> 30 kg\u002Fm²\n* Glucose-6-phosphate dehydrogenase (G6PD) deficiency","65 Years",{"count":191,"type":21},[24],"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.\n\nOzone 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.\n\nThis 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\u002FmL.\n\nParticipants 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).\n\nUnlike 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.",[27],"2026-07-01",{"date":309,"type":32},{"date":349,"type":21},"2026-08",{"date":351,"type":21},"2027-03",{"name":353,"class":69},"Sakarya University",{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"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.",{"count":363,"type":21},66,[24],"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.",[27,131,168],[134,368,369,370],"exercise","telehealth","artificial intelligence","2026-06-28",{"date":346,"type":32},{"date":374,"type":21},"2027-01-04",{"date":376,"type":21},"2027-06-21",{"name":378,"class":69},"Instituto Neurociencia Del Dolor",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":406},"100645231","emotional-allodynia-questionnaire-aeq-in-fibromyalgia-pearl-100645231","NCT07677631","Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)","Pain, Emotional Allodynia, and Relational Load (PEARL): A Multicenter Validation Study of the Emotional Allodynia Questionnaire in Fibromyalgia","PEARL","CASES (fibromyalgia)\n\nInclusion Criteria:\n\n* Age 18 years or older\n* Clinical diagnosis of fibromyalgia confirmed according to the 2016 revision of the ACR criteria\n* Chronic non-cancer pain for at least 3 months\n* Ability to understand and independently complete self-report questionnaires in Italian\n* Willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Active oncological disease or cancer-related pain\n* Any current or past psychiatric diagnosis except Major Depressive Disorder and Panic Disorder (assessed by clinical history)\n* Severe cognitive impairment precluding questionnaire completion\n* Inability to understand or complete questionnaires in Italian\n\nCONTROLS (non-fibromyalgia chronic pain)\n\nInclusion Criteria:\n\n* Age 18 years or older\n* Chronic non-cancer pain for at least 3 months with a defined nociceptive or neuropathic generator (e.g., radiologically or surgically documented degenerative, structural, or post-surgical musculoskeletal pain, or neuropathic pain with an identifiable neurological lesion or disease)\n* Not meeting the 2016 ACR criteria for fibromyalgia\n* Ability to understand and independently complete self-report questionnaires in Italian\n* Willingness to provide written informed consent\n\nExclusion Criteria (parallel to cases):\n\n* Diagnosis of fibromyalgia or another recognized nociplastic primary pain condition (e.g., primary chronic widespread pain)\n* Active oncological disease or cancer-related pain\n* Any current or past psychiatric diagnosis except Major Depressive Disorder and Panic Disorder\n* Severe cognitive impairment precluding questionnaire completion\n* Inability to understand or complete questionnaires in Italian\n\nNote: ongoing pharmacological treatment for pain or mental health is not an exclusion criterion in either group; Major Depressive Disorder and Panic Disorder are recorded at baseline and used in covariate-adjusted and stratified analyses.",{"count":388,"type":21},423,"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.",[27,55,391],"Nociplastic Pain",[393,27,394,395,396,397],"Emotional Allodynia Questionnaire","Nociplastic pain","Psychometric validation","Central sensitization","Emotion regulation","2026-06-24",{"date":346,"type":32},{"date":401,"type":32},"2025-09-10",{"date":403,"type":21},"2027-08",{"name":405,"class":69},"University of Bari",5,{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":242,"maxAge":341,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":427,"leadSponsor":428,"locationsCount":70},"100521227","early-phase-1-mdma-assisted-therapy-for-fibromyalgia-100521227","NCT06066853","MDMA-assisted Therapy for Fibromyalgia","Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA-assisted Therapy for Fibromyalgia","Inclusion Criteria:\n\n* Are at least 21 years to 65 years of age inclusive, at the time of signing the informed consent.\n* Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year.\n* Typical fibromyalgia pain intensity of 4\u002F10 or greater.\n* Fluent in speaking and reading English.\n* Able to swallow pills.\n* Agree to have some study visits audiovisually recorded, including Experimental Sessions\u002F neuroimaging sessions.\n* Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.\n* Able to identify appropriate support person(s) to stay with the participant on the evenings of the Experimental Sessions\n* Have a body weight of at least 45 kilograms (kg). Participants with a body weight of 45 to 48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg\u002Fm2\n* Participants assigned female sex at birth must not be pregnant or become pregnant throughout participation in the study\n* Capable of giving signed informed consent\n* Are on stable doses of allowable medication for 30 days prior to entering the study and agree not to change medications or dosages during the trial, except for medications falling under the tapering scheduling\n\nExclusion Criteria:\n\n* Presence of any medical or psychiatric illness that is judged to interfere with the study (ex. Fibromyalgia, PTSD, bipolar, schizophrenia) determined by a self-report measure.\n* Presence of any contraindications to fMRI scanning or EEG scanning. (ex. Cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy).\n* Unwillingness to receive brief experimental pain\n* Lower extremity pain or vascular issues that may interfere with the study procedures\n* Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n* Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, heart failure, severe coronary artery disease, or aneurysm.\n* Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic.\n* Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n* Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n* Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.\n* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n* Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment, including Electroconvulsive Therapy (ECT), and ketamine-assisted therapy.\n* Have a current moderate or severe alcohol or cannabis use disorder within the 12 months prior to enrollment.\n* Have an active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.\n* Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion.\n* Unable or unwilling to safely taper-off prohibited psychiatric and non-psychiatric medication with exceptions determined by study staff or require use of prohibited medications during experimental sessions.\n* Require use of concomitant medications that could prolong the QT interval during Experimental Sessions.\n* Have used Ecstasy (unregulated material represented as containing MDMA) more than 10 times within the last 10 years, or at least once within 6 months of the first Experimental Session.\n* Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.\n* Have current Personality and\u002For Psychotic Disorders.\n* Have a current eating disorder with compensatory behaviors.\n* Have current major depressive disorder with psychotic features.\n* Have a history of, or a current primary psychotic disorder, bipolar affective disorder type 1.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the sponsor-investigator or study clinician, contraindicates participation in the study.\n* Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of fibromyalgia or any psychiatric disorders.\n* Lack social support or lack a stable living situation.\n* Previous participation in a MAPS-sponsored MDMA clinical trial.\n* Employees (and their immediate family members) of MAPS, MAPS Public Benefit Corporation, or MAPS Europe B.V; or individuals in a personal relationship with the site investigator.\n* Presence of any medical or psychiatric illness that is judged to interfere with trial\n* Presence of any contraindications to fMRI scanning or EEG scanning (ex. Cardiac pacemaker, metal implants, fear of closed spaces)\n* Lower extremity pain or vascular issues that may interfere with study procedures\n* Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia\n* Have any severe anxiety disorders or significant anxiety symptoms interfering with fMRI scanning (e.g. panic)\n* Is a current patient of the matched dyad clinician enrolled in the study\n* Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.\n* Have any current problem which, in the opinion of the sponsor-investigator or study clinician, might interfere with study participation or prevent satisfactory completion of study protocol.",{"count":415,"type":21},20,[417],"EARLY_PHASE1","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\u002Fclinician 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.",[27],[421,27,422,423],"N-Methyl-3,4-methylenedioxyamphetamine","MDMA","Pain",{"date":425,"type":32},"2026-06-29",{"date":346,"type":21},{"date":36,"type":21},{"name":429,"class":69},"Spaulding Rehabilitation Hospital",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":22,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":70},"100605079","the-efficacy-and-safety-of-pregabalin-and-mirogabalin-in-patients-with-fibromyalgia-100605079","NCT07157852","The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia","Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Mirogabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study","Inclusion Criteria:\n\n* Newly diagnosed with FM according to the 2016 Revisions to the 2010\u002F2011 FM diagnostic criteria;\\[1\\]\n* Aged over 18 years old;\n* Suffering from moderate to severe FM, refractory to non-pharmacological interventions and without prior exposure to recommend pharmacological treatments for FM;\n* Baseline numeric rating scale (NRS) score of 4 or higher;\n* Aspartate aminotransferase and alanine aminotransferase levels below twice the upper limit of normal range;\n* Estimated glomerular filtration rate (eGFR) of at least 30 mL\u002Fmin\u002F1.73 m²;\n* Willingness to provide informed consent and adequate cognitive and language capabilities to meet all study requirements;\n\nExclusion Criteria:\n\n* Previous allergic reactions to pregabalin, mirogabalin, or any of their excipients;\n* Prior diagnosis of epilepsy or depression requiring antidepressant therapy;\n* Women who are pregnant or breastfeeding;\n* Has severe systemic illnesses, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or significant cardiac impairment;\n* Suffering from acute or chronic pain disorders other than FM.",{"count":438,"type":21},674,[24],"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.",[27,442,443,423],"Pregabalin","Mirogabalin","2026-06-23",{"date":446,"type":32},"2026-06-25",{"date":448,"type":32},"2025-09-05",{"date":450,"type":21},"2027-08-31",{"name":452,"class":69},"Beijing Tiantan Hospital",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":123,"minAge":49,"maxAge":459,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":464,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":70},"100560600","the-effects-of-core-shamanism-in-fibromyalgia-100560600","NCT06579261","The Effects of Core Shamanism in Fibromyalgia","Inclusion Criteria for Fibromyalgia participants:\n\n* Female\n* Over 18 and under 75 years of age.\n* Fibromyalgia patients and satisfies the 2016 Fibromyalgia Diagnostic Criteria for the classification of FM.\n* Mean recalled pain over the last seven days (7-day recall) greater than or equal to 4 on a 10 cm Visual Analog Scale (VAS) for pain; 7-day recall.\n* Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.\n* Able to travel to the study site to receive shamanic treatments up to twice weekly.\n* Understanding and willing to complete all study procedures.\n* Capable of giving written informed consent.\n* Proficient ability to speak, read, and write in english.\n\nExclusion Criteria:\n\n* Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain.\n* History of head injury with substantial loss of consciousness\n* Peripheral neuropathy of known cause that interferes with activities of daily living.\n* Routine daily use of opioid analgesics, marijuana, or history of substance abuse.\n* Stimulant medications, such as those used to treat Attention Deficit Disorder (ADD)\u002FAttention-deficit\u002Fhyperactivity disorder (ADHD). (e.g., amphetamine\u002F dextroamphetamine \\[Adderall®\\], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.\n* Concurrent participation in other therapeutic trials.\n* Use of as needed (PRN) over the counter (OTC) pain medications (Nonsteroidal anti-inflammatory drugs (NSAIDs), etc.) on day of electroencephalogram (EEG) testing.\n* Use of PRN opioid analgesics 48 hours prior to electroencephalogram (EEG) testing.\n* Pregnant or nursing. A pregnancy test will be given prior to electroencephalogram (EEG) sessions.\n* Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).\n* Contraindications to EEG methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material.\n* Any impairment, activity or situation that is in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.\n* Sufficient knowledge of Shamanism techniques that may bias participant outcomes.\n* Presence of factors that may preclude the safe use of the Shamanism intervention.\n* History vascular surgery in lower limbs or current lower limb vascular dysfunction.\n* Presence of uncontrolled cardiovascular disease.\n* Subjects with Worker's Compensation, Workman's Compensation, civil litigation or disability claims pertinent to the subject's fibromyalgia; current involvement in out-of-court settlements for claims pertinent to the subject's fibromyalgia; or currently receiving monetary compensation as a result of any of the above.\n* Inability or unwillingness of an individual to give written informed consent.","75 Years",{"count":7,"type":21},[24],"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.\n\nThe investigators hypothesize that 80% of individuals will complete at least 80% of study visits, clinical pain severity and\u002For interference will be significantly reduced following the Shamanic intervention, and lung, heart, and\u002For 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.",[27],[465],"fibromyalgia chronic pain","2026-06-18",{"date":444,"type":32},{"date":469,"type":32},"2024-08-01",{"date":36,"type":21},{"name":472,"class":69},"University of California, Irvine",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":22,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":491,"locationsCount":70},"100641869","advancing-online-psychology-tools-for-chronic-pain-100641869","NCT07659873","Advancing Online Psychology Tools for Chronic Pain","Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP): Feasibility of a Scalable Digital Psychology Intervention and AI-Powered Support for Patients on the Waitlist for Pain Services","ADOPT-CP","Inclusion Criteria:\n\n1. Must be deemed to have capacity to provide informed consent;\n2. Must sign and date the informed consent form;\n3. Must state willingness to comply with all study procedures;\n4. Must be at least 18 years of age;\n5. Must be referred to TAPMI;\n6. Must have either fibromyalgia or chronic pelvic pain\n7. Must be on the waitlist at TAPMI;\n8. Must have access to a device that can connect to the Internet with access to email.\n\nExclusion Criteria:\n\n1. Currently engaged in psychotherapy or engaged in psychotherapy within the last month at the time of enrolment;\n2. Unable to read, understand, or communicate in English sufficiently to provide informed consent and complete the study procedures and questionnaires;\n3. Has active serious mental illness or psychiatric instability that, in the opinion of the research team, may impair the ability to safely participate in the study or to provide informed consent (e.g., active psychosis, active mania);\n4. Has a visual, auditory, or other functional impairment that would prevent independent access to and use of the digital intervention and study procedures on an internet-enabled device.",{"count":191,"type":21},[24],"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.\n\nThis 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.",[27,485],"Chronic Pelvic Pain Syndrome","2026-06-15",{"date":488,"type":32},"2026-06-22",{"date":64,"type":21},{"date":231,"type":21},{"name":492,"class":69},"Women's College Hospital",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":123,"minAge":49,"maxAge":341,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":70},"100625670","physiotherapy-methods-for-fibromyalgia-100625670","NCT07425652","Physiotherapy Methods for Fibromyalgia","Comparison of the Effects of Different Physiotherapy Methods in Women With Fibromyalgia","Inclusion Criteria:\n\n* Having been diagnosed with fibromyalgia\n* Being female between the ages of 18-65\n* Volunteering to participate in the study\n\nExclusion Criteria:\n\n* Diagnosed neurological and infectious diseases\n* Uncontrolled endocrine and\u002For autoimmune diseases\n* Serious psychiatric disorders (bipolar disorder, schizophrenia, psychosis, etc.)\n* Pregnancy or breastfeeding\n* Malignancy\n* History of known arrhythmia or any implanted electronic device\n* Presence of sensory loss\n* Acute inflammation, open wounds, erythema in massage areas\n* History of any surgery within the last 6 months\n* Having received physical therapy for FM within the last 6 months and\u002For being included in a new treatment program during the study period",{"count":363,"type":21},[24],"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.",[27],"2026-06-13",{"date":506,"type":32},"2026-06-16",{"date":508,"type":32},"2026-03-01",{"date":510,"type":21},"2028-01",{"name":512,"class":69},"Ankara Yildirim Beyazıt University",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":519,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":524,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":70},"100559974","analgesic-response-to-opioids-in-patients-with-fibromyalgia-after-conventional-acupuncture-versus-sham-acupuncture-100559974","NCT06571110","Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture","Inclusion Criteria:\n\n* Are 18 - 80 years old\n* have been diagnosed with Fibromyalgia for more than 6 months\n* Are already using chronic, continuous opioid therapy, including but not limited to the use of Hydrocodone (Norco), Oxycodone (Percocet), morphine, methadone or Tylenol #3 daily\n* Have moderate to excruciating pain at baseline, determined by a 5 or greater score on the Visual Analogue Scale (VAS)\n\nExclusion Criteria:\n\n* Are younger than 18 or older than 80 years old\n* Have been diagnosed with a Substance Use Disorder (SUD)\n* Pregnant\n* Have an active litigation or worker's compensation case\n* Have an active mental health diagnosis, such as bipolar disorder, psychosis, or suicidal ideation\n* Are prescribed and actively using low dose Naltrexone . Have tried acupuncture in the last 6 months","80 Years",{"count":127,"type":21},[24],"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.",[27],[525],"Acupunture","2026-06-11",{"date":486,"type":32},{"date":529,"type":32},"2025-03-15",{"date":531,"type":21},"2027-12-01",{"name":472,"class":69},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":123,"minAge":49,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":4},"100643176","manual-diaphragmatic-release-on-exercise-capacity-and-quality-of-life-in-women-with-fibromyalgia-100643176","NCT07641166","Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia","Effect of Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Confirmed clinical diagnosis of fibromyalgia fulfilling the American College of Rheumatology diagnostic criteria.\n* Sedentary or low physical activity status (not participating in structured exercise programs within the past 3 months).\n\nExclusion Criteria:\n\n* Severe psychiatric comorbidities (e.g., major depressive disorder with active suicidal ideation) or cognitive impairments.\n* Presence of comorbid rheumatologic or autoimmune conditions that overlap with muscle\u002Fjoint symptoms (e.g., severe rheumatoid arthritis, systemic lupus erythematosus).\n* Primary chronic respiratory\u002Fchest diseases (e.g., severe COPD or active asthma).\n* Cardiovascular disorders or uncontrolled hypertension.\n* Pregnancy.","55 Years",{"count":191,"type":21},[24],"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.",[27],"2026-06-08",{"date":526,"type":32},{"date":548,"type":21},"2026-06-17",{"date":550,"type":21},"2026-11-08",{"name":552,"class":69},"Middle East University",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":519,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":567,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":574,"leadSponsor":576,"locationsCount":70},"100642658","analgesic-efficacy-of-multisite-rtms-in-fibromyalgia-patients-100642658","NCT07642882","Analgesic Efficacy of Multisite rTMS in Fibromyalgia Patients","Analgesic Efficacy of Multisite rTMS in Depressed and Nondepressed Patients With Fibromyalgia and Prediction of the Response: a Double-Blind Randomized Sham-Controlled Study.","MultiStimFM","Inclusion Criteria:\n\n* Chronic pain lasting at least 6 months, with or without associated depressive symptoms;\n* Fibromyalgia (2016 revised ACR criteria and a FIRST questionnaire score of at least 5 out of 6);\n* Average pain intensity ≥ 4\u002F10 on a 0-10 numeric rating scale;\n* Pain present daily or almost daily (≥ 4 days per week);\n* Patients aged over 18 and under 80 years;\n* Patients who have provided written informed consent;\n* Patients whose analgesic treatment has been stable for at least 1 month prior to inclusion and will not need to be modified during the study;\n* Patients who can be followed for the duration of the study (10 weeks);\n* Patients covered by a health insurance plan or otherwise eligible.\n\nExclusion Criteria:\n\n* Ongoing litigation;\n* Contraindication to rTMS:\n* Implanted electronic devices and\u002For conductive objects near the coil: Patients with an active implanted device that is activated or controlled by physiological signals (e.g., pacemakers, implantable cardiac defibrillators \\[ICD\\], vagus nerve stimulators \\[VNS\\], wearable cardioverter defibrillators \\[WCD\\], ocular implants, deep brain stimulation systems, drug infusion pumps or ports, intracardiac leads), even if the device has been removed.\n* Non-removable metallic objects near the coil:\\*\\* Patients with a conductive, ferromagnetic, or magnetically sensitive metal implant in the head or within 30 cm of the coil (e.g., cochlear implants, implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents, or bullet fragments);\n* Current abuse of drugs or psychoactive substances, including alcohol (according to DSM-5 criteria);\n* Pregnancy or breastfeeding;\n* Epilepsy or a history of epilepsy;\n* Unstable or progressive medical conditions (e.g., cancer);\n* Psychosis according to DSM-5 criteria;\n* Presence of another pain condition more severe than the one qualifying for inclusion;\n* Failure to correctly complete pain self-assessment diaries between inclusion and randomization (fewer than 4 pain scores recorded over 7 days);\n* Inability to understand the informed consent form, or subjects under legal guardianship or curatorship;\n* Participation in another research protocol within 30 days prior to inclusion.",{"count":562,"type":21},36,[24],"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.\n\nThe 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.\n\nGiven 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.",[27,566,55],"Depression - Major Depressive Disorder",[27,55,568,569,570,571],"rTMS","Depression","Neuromodulation","EEG",{"date":526,"type":32},{"date":111,"type":21},{"date":575,"type":21},"2028-11",{"name":577,"class":69},"Hospital Ambroise Paré Paris",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":70},"100625495","vestibular-innovation-in-pain-2-100625495","NCT07423377","Vestibular Innovation in Pain 2","Vestibular Innovation in Pain: A Randomized Controlled Trial","VIPR","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Age equal to or \\>18 years old\n* Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure.\n* Owns or has access to a smart phone or computer to complete outcome measures\n* Fluency in English\n* Diagnosis of Fibromyalgia (FM)\n\n  * Diagnosis by American College of Rheumatology 2016 questionnaire\n  * Pain score 4\u002F10 or more and less than 10\u002F10 on the numeric rating scale at the time of inclusion.\n\nExclusion Criteria:\n\n* History of tympanic membrane injury, rupture, or surgery a. Including tympanostomy, or \"ear tubes,\" and\u002For cochlear implant.\n* Right ear infection within the last 3 months, or current right ear pain.\n* Current pregnancy\n* Bipolar Disorder\n* History of seizures (including non-epileptiform seizures)\n* History of syncope within the last 3 months. a. Not including presyncope or in setting of known medical illness (i.e., heatstroke)\n* Inability to lay supine for 15 minutes\n* Receiving disability benefits for fibromyalgia or involved in litigation related to fibromyalgia.\n* Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study.\n* History of or current Meniere's Disease\n* History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last 3 months\n* History of hospitalization for severe hypertension\n* History of vestibular schwannoma or meningioma resection.\n* Patients taking opioid therapy (not including tramadol).",{"count":587,"type":21},56,[24],"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.",[27,391],[136,592],"quality of life","2026-06-05",{"date":545,"type":32},{"date":596,"type":32},"2026-03-19",{"date":598,"type":21},"2027-07-31",{"name":600,"class":69},"Icahn School of Medicine at Mount Sinai"]