[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibromyalgia-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibromyalgia-pain":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100530940","effects-of-tavns-on-fibromyalgia-pain-100530940",false,"NCT06193317","Effects of taVNS on Fibromyalgia Pain","Inclusion Criteria:\n\n1. Older than 18 years old.\n2. Diagnosis of FM pain according to the American College of Rheumatology (ACR) 2010 criteria (existing pain for more than six months with an average of at least 3 on a 0-10 VAS scale).\n3. must have the ability to feel sensation by Von-Frey fiber on the forearm.\n4. Able to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Subjects who have unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease) or who have functional deficits, as self-reported.\n2. history of substance abuse within the past six months as self-reported (if the subject reports a history of substance abuse, we will confirm using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria).\n3. Presence of implanted cranial electronic medical devices (e.g., cochlear implants).\n4. pregnancy (as the safety of taVNS in the pregnant population (and children) has not been assessed (though the risk is non-significant), we will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and every two weeks of stimulation).","ALL","18 Years",{"count":18,"type":19},152,"ESTIMATED","INTERVENTIONAL",[22],"NA","Transauricular vagus nerve stimulation (taVNS) is a newer delivery system, using a non-invasive stimulation device placed at the ear's concha. TaVNS is a portable, safe, and low-cost intervention, and according to some studies, taVNS may influence nociception and pain perception, which can lead to potential applications for various painful illnesses, including fibromyalgia (FM). This trial aims to investigate the clinical effects of taVNS on pain control in FM subjects.",[25],"Fibromyalgia, Pain","NOT_YET_RECRUITING","2025-09-15",{"date":29,"type":30},"2025-09-19","ACTUAL",{"date":32,"type":19},"2026-06-01",{"date":34,"type":19},"2029-05-01",{"name":36,"class":37},"Spaulding Rehabilitation Hospital","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":38},"100570048","using-a-multisite-tens-system-to-improve-fibromyalgia-related-symptoms-100570048","NCT06702176","\"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.","\"Using a Multisite TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Fibromyalgia-related Symptoms (EXOFIB 3)\"","EXOFIB3","Inclusion Criteria:\n\n* Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least three months\n* Patients should be French speakers, able to understand verbal instructions, and affiliated with the National Health insurance\n\nExclusion Criteria:\n\n* Patient included in another research protocol during the study period\n* Patient unable to undergo medical monitoring for the study purposes due to geographical or social reasons\n* Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and\u002For body mass index above 35 kg\u002Fm2)\n* Patient with somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain)\n* Any change in the pharmacological therapy in the last three months\n* Introduction of a medical device other than Exopulse Mollii suit during the study period\n* Patient under juridical protection (\" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice \")","75 Years",{"count":49,"type":19},40,[22],"Fibromyalgia is a debilitating pain condition that is characterized by the chronic occurrence of pain affecting the musculoskeletal system, a sensitivity to pressure stimuli, and a low threshold to noxious stimuli. The topography of pain is widespread, although it could be more pronounced in some bodily regions. Besides pain, patients suffer from a wide range of symptoms, including fatigue, anxiety and depression manifestations, and altered quality of life. Facing these debilitating symptoms, the available therapeutic strategies for treating pain and associated manifestations are usually faced with limited efficacy and numerous side effects. A previous pilot trial on fibromyalgia (EXOFIB-1 study) was conducted to evaluate the effects of Exopulse Mollii suit on fibromyalgia has showed beneficial and promising results. The intervention significantly alleviated pain, reduced fatigue, decreased physical and psychosocial impact of the disease, and improved the quality of life of patients with fibromyalgia. However, the observed effect sizes were small to medium. The investigators believe that a stimulation duration extended to six months would yield more positive outcomes and higher effect magnitude.",[25],[54],"Exopulse Mollii Suit, Fibromyalgia","RECRUITING","2024-11-20",{"date":58,"type":30},"2024-11-22",{"date":60,"type":30},"2024-03-01",{"date":62,"type":19},"2026-06-30",{"name":64,"class":37},"Institut De La Colonne Vertebrale Et Des Neurosciences","Fibromyalgia Pain"]