[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibromyalgia-fm-or-fibromyalgia-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibromyalgia-fm-or-fibromyalgia-syndrome":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100660018","multisite-transcutaneous-electrical-nerve-stimulation-in-fibromyalgia-a-randomized-double-blind-sham-controlled-crossover-trial-comparing-two-stimulation-modalities-100660018",false,"NCT07872631","Multisite Transcutaneous Electrical Nerve Stimulation in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities","Multisite Transcutaneous Electrical Nerve Stimulation (Exopulse Mollii Suit) in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities (FIBROPULSE)","FIBROPULSE","Inclusion Criteria:\n\n* Patients aged between 18 and 75 years,\n* Patients with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least one month\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* Inability to comply with study procedures or follow-up requirements for geographical, social, or organizational reasons;\n* Any contraindication to the use of the Exopulse Mollii Suit as specified in the device user manual;\n* Any significant neurological, psychiatric, cardiovascular, musculoskeletal, or other medical condition that, in the opinion of the investigator, could interfere with study participation, outcome assessment, or participant safety, with the exception of anxiety and depression commonly associated with fibromyalgia;\n* Modification of pharmacological treatment related to fibromyalgia or initiation\u002Fmodification of non-pharmacological therapies within the three months preceding inclusion;\n* Introduction of another therapeutic medical device during the study period;\n* Pregnant women;\n* Breastfeeding women;\n* Individuals subject to a legal protection measure (guardianship, curatorship, or judicial protection order).","ALL","18 Years","75 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"NA","Fibromyalgia is a chronic and multifactorial disorder characterized by widespread musculoskeletal pain, heightened pain sensitivity, fatigue, sleep disturbances, cognitive complaints, and affective symptoms such as anxiety and depression. Despite the availability of pharmacological and non-pharmacological interventions, symptom control often remains suboptimal, and currently available treatments may be associated with limited efficacy or poor tolerability. Consequently, there is a growing need for effective, safe, and personalized non-pharmacological therapeutic approaches.\n\nIn a previous randomized controlled trial (EXOFIB), we investigated the effects of the Exopulse Mollii Suit, a non-invasive neuromodulation device delivering multisite transcutaneous electrical nerve stimulation (TENS), in patients with fibromyalgia.\n\nUsing stimulation parameters consisting of a frequency of 20 Hz, a voltage of 20 V, and a pulse width of 55-85 µs, active stimulation was associated with clinically meaningful improvements in pain, fatigue, and quality of life compared with sham stimulation. These findings provided evidence supporting the therapeutic potential of the Exopulse Mollii Suit in the management of fibromyalgia-related symptoms.\n\nHowever, while EXOFIB established the efficacy of active stimulation relative to sham stimulation, it did not address whether alternative stimulation parameter configurations could yield superior clinical outcomes. To date, no randomized crossover study has directly compared different active stimulation settings of the Exopulse Mollii Suit in patients with fibromyalgia. Consequently, the optimal stimulation parameters for maximizing therapeutic benefit in this population remain unknown.\n\nThe present study has therefore been designed to compare the effects of three stimulation modalities delivered by the Exopulse Mollii Suit, including two active stimulation configurations and one sham stimulation condition. The primary objective is to evaluate and compare their effects on functional disability associated with fibromyalgia, assessed using the Fibromyalgia Impact Questionnaire (FIQ).\n\nThe inclusion of a sham condition allows assessment of non-specific effects while preserving participant blinding.\n\nThe stimulation conditions evaluated in this study are:\n\n* Condition A (active stimulation): frequency 20 Hz, voltage 20 V, pulse width 55-85 µs;\n* Condition B (active stimulation): frequency 20 Hz, voltage 20 V, pulse width 100-125 µs;\n* Condition C (sham stimulation): brief initial active stimulation followed by discontinuation of stimulation after one minute, while maintaining identical device settings, session duration, and study procedures in order to preserve participant blinding.\n\nBy identifying the most effective stimulation setting, this study aims to optimize the clinical use of the Exopulse Mollii Suit in fibromyalgia and to contribute to the development of more individualized neuromodulation strategies. Ultimately, the findings may improve symptom management, reduce functional disability, and enhance quality of life in patients living with fibromyalgia.",[28,29,30],"Fibromyalgia","Fibromyalgia (FM)","Fibromyalgia (FM) OR Fibromyalgia Syndrome",[32,33,34],"EXOPULSE Mollii Suit","TENS","Transcutaneous Electrical Nerve Stimulation","NOT_YET_RECRUITING","2026-10-08",{"date":38,"type":39},"2026-10-13","ACTUAL",{"date":41,"type":22},"2026-11-02",{"date":43,"type":22},"2027-10-31",{"name":45,"class":46},"Institut De La Colonne Vertebrale Et Des Neurosciences","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100656021","effects-of-reiki-therapy-in-women-with-fibromyalgia-a-randomized-controlled-trial-100656021","NCT07821034","Effects of Reiki Therapy in Women With Fibromyalgia","Effects of Reiki Therapy on Biopsychological Outcomes in Women With Fibromyalgia: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Female participants aged 18 years or older.\n* Medical diagnosis of fibromyalgia, confirmed according to the 2016 American College of Rheumatology (ACR) criteria using the Brazilian version of the Fibromyalgia Survey Questionnaire (FSQ-Brazil).\n\nExclusion Criteria:\n\n* Clinically unstable medical condition.\n* Presence of acute injuries.\n* Pregnancy.\n* Cognitive impairment or any other condition that prevents the participant from completing the study questionnaires.","FEMALE",{"count":56,"type":22},84,[25],"The goal of this randomized clinical trial is to evaluate the effects of a 4-week Reiki therapy program in women with fibromyalgia. The main questions it aims to answer are:\n\nDoes Reiki therapy lead to a greater change in pain intensity compared with a placebo intervention after 4 weeks of treatment?\n\nDoes Reiki therapy lead to a greater change in the impact of fibromyalgia compared with a placebo intervention after 4 weeks of treatment?\n\nResearchers will also evaluate whether Reiki therapy affects depressive symptoms, anxiety symptoms, sleep quality, and acute changes in pain intensity, heart rate, and respiratory rate.\n\nResearchers will compare participants receiving Reiki therapy with participants receiving a placebo intervention to determine whether changes in these outcomes differ between groups.\n\nParticipants will:\n\nbe randomly assigned to either the Reiki therapy group or the placebo group; receive one 30-minute intervention session per week for 4 weeks; complete assessments of pain intensity, fibromyalgia impact, depressive symptoms, anxiety symptoms, and sleep quality before and after the 4-week intervention period; have pain intensity, heart rate, and respiratory rate assessed immediately before and after each intervention session to evaluate acute responses.",[30],[28,61],"Reiki","RECRUITING","2026-09-15",{"date":65,"type":39},"2026-09-21",{"date":67,"type":39},"2025-09-18",{"date":69,"type":22},"2026-12-20",{"name":71,"class":46},"Federal University of the Valleys of Jequitinhonha and Mucuri",1]