[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660018":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":49,"studyPopulation":49,"armGroups":61,"interventions":77,"overallOfficials":49,"centralContacts":83,"locations":49,"responsibleParty":89,"collaborators":49,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":49,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":116,"whyStopped":49,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":49},{"fullName":5,"class":6},"Institut De La Colonne Vertebrale Et Des Neurosciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in functional disability as assessed using the Fibromyalgia Impact Questionnaire scores","The primary endpoint is the change in functional disability assessed using the Fibromyalgia Impact Questionnaire across the three stimulation conditions (Condition A, Condition B and sham stimulation). The scores ranges from a minimal score of 0 to a maximal score of 100, with higher scores reflecting a greater impact of fibromyalgia.","before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)",[14,17,20,23,26,29,32,35,38,42,45],{"measure":15,"description":16,"timeFrame":12},"Change from baseline in pain intensity as assessed using the Visual Analogue Scale for pain","Visual Analogue scale of Pain consists of rating the symptom on a 10 cm horizontal line going from 0 meaning \"no pain\" to 10 meaning \"worst pain imaginable\". It has good psychometric properties for assessing pain and has a high sensibility and sensitivity and a good discriminative power in patients with fibromyalgia.",{"measure":18,"description":19,"timeFrame":12},"Change from baseline in pain severity and pain interference, assessed using the Brief Pain Inventory","The validated French version of the Brief Pain Inventory will be used to assess pain severity (4 items) and pain interference (7 items) (Cronbach's alpha ranging from 0.86 to 0.90). Brief Pain Inventory items are rated on a 10-point scale running from 0 (no pain\u002Fdoes not interfere) to 10 (pain as bad as you can\u002Finterferes completely).",{"measure":21,"description":22,"timeFrame":12},"Change from baseline in pain catastrophizing, assessed using the Pain Catastrophizing Scale","The Pain Catastrophizing Scale will also be employed, it is a valid and reliable scale that includes 13 items assessing the presence and severity of feelings or thoughts that emerge when experiencing pain. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time). The total score ranges from a minimum of 0 to a maximum of 52 with a higher score reflecting worse condition. It is possible to calculate a total and three subscale scores (i.e., helplessness, magnification, and rumination) . The total PCS has good psychometric properties: internal consistency (Cronbach's alpha =0.91) and test-retest reliability (r=0.85 at two weeks and r=0.77 at six weeks).",{"measure":24,"description":25,"timeFrame":12},"Change from baseline in fatigue as assessed using the Visual Analogue Scale for fatigue","The visual Analogue Scale for fatigue consists of rating the symptom on a 10 cm horizontal line going from a minimum of 0 reflecting \"no fatigue\" to a maximum of 10 reflecting the \"worst fatigue imaginable\". It has good psychometric properties for assessing fatigue and has a high sensibility and sensitivity and a good discriminative power",{"measure":27,"description":28,"timeFrame":12},"Change from baseline in anxiety and depression symptoms, assessed using the Hospital Anxiety and Depression Scale","The Hospital Anxiety and Depression Scale is a 14-item generic scale with good psychometric properties. It consists of seven items assessing anxiety and seven others assessing depression. Scores can range from 0 to 21 on each subscale, with higher scores indicating worse symptomatology.",{"measure":30,"description":31,"timeFrame":12},"Change from baseline in global sleep quality, assessed using the Pittsburgh Sleep Quality Index","The Pittsburgh Sleep Quality Index is a self-rated questionnaire that evaluates sleep quality. Its 19 questions aim to assess the sleep pattern during the previous month. Scores can range from a minimum of 0 (better sleep quality) to a maximum of 21 (worse sleep quality). This scale has good psychometric properties and its utility in clinical practice and research activities has been proven.",{"measure":33,"description":34,"timeFrame":12},"Change from baseline in subjective sleep experience, assessed using the Leeds Sleep Evaluation Questionnaire","The Leeds Sleep Evaluation Questionnaire consists of 10 items that evaluate four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness. Items are rated on a 100 mm scale with a minimal score of 0 mm (represents the worst outcome) and a maximal score of 100 mm (represents the best outcome). It is an easy to implement questionnaire that has been widely used to evaluate the subjective aspect of sleep. It has been employed in a huge amount of psychological and psychopharmacological studies.",{"measure":36,"description":37,"timeFrame":12},"Change from baseline in health-related quality of life, assessed using the Short Form-36 Health Survey","The Short Form-36 Health Survey is a generic survey that contains 36 items that assess the quality of life and yield eight dimensions: physical functioning, physical role, emotional role, bodily pain, general health, vitality, social functioning, and mental health. The score of each dimension ranges from 0 to 100, with higher scales implying better health status. The French version has excellent convergent and discriminant validity (100% and 97.9%, respectively) and good to excellent internal consistency (Cronbach's alpha: 0.76-0.92)",{"measure":39,"description":40,"timeFrame":41},"Overall clinical improvement assessed using the Clinical Global Impression","The Clinical Global Impression is a 7-point measure ranging from \"very much improved\" to \"very much worse\" since the initiation of the treatment period","After the first intervention (week 5), after the second intervention (week 11), after the third intervention (week 17)",{"measure":43,"description":44,"timeFrame":41},"Maintenance of blinding, assessed using the blinding questionnaire","Participants will complete a blinding questionnaire designed to assess the effectiveness of participant blinding and their perception of the stimulation condition received",{"measure":46,"description":47,"timeFrame":48},"Difference in daily pain reporting using a Visual Analogue Scale of pain among the three stimulation conditions","Daily pain evolution, assessed using a daily pain diary based on the VAS pain throughout the study period. Visual Analogue scale of Pain consists of rating the symptom on a 10 cm horizontal line going from 0 meaning \"no pain\" to 10 meaning \"worst pain imaginable\".","Pain will be daily recorded between the first visit (week 1) and the last visit of the protocol (week 17)",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":55,"maskingDescription":49,"whoMasked":56},"QUADRUPLE",[57,58,59,60],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[62,68,72],{"label":63,"type":64,"description":65,"interventionNames":66},"Condition A (active stimulation):","EXPERIMENTAL","stimulation parameters: frequency 20 Hz, voltage 20 V, pulse width 55-85 µs",[67],"Device: EXOPULSE Mollii Suit",{"label":69,"type":64,"description":70,"interventionNames":71},"Condition B (active stimulation)","stimulation parameters frequency 20 Hz, voltage 20 V, pulse width 100-125 µs",[67],{"label":73,"type":74,"description":75,"interventionNames":76},"Condition C (sham stimulation)","SHAM_COMPARATOR","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.",[67],[78],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":49},"DEVICE","EXOPULSE Mollii Suit","The Exopulse Mollii Suit is a CE-marked neuromodulation device with a favorable safety profile, good tolerability, and ease of use. Developed by Exoneural Network AB, the device consists of a full-body garment incorporating 58 electrodes capable of delivering transcutaneous electrical stimulation to 40 muscle groups using low-frequency (20 Hz), low-intensity electrical currents (current intensity: 2 mA; pulse width: 25-170 µs).\n\nThe stimulation is not intended to induce muscle contraction but rather to modulate pain processing through activation of large-diameter afferent fibers, thereby reducing nociceptive transmission in accordance with the gate control theory of pain. The device is intended for pain reduction and is used as a daily, non-pharmacological neuromodulation intervention.",[63,69,73],[84],{"name":85,"role":86,"phone":87,"phoneExt":49,"email":88},"Samar Ayache, MD, PhD, HDR","CONTACT","0149814662","samarayache@gmail.com",{"type":90,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","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":103,"type":104},24,"ESTIMATED","INTERVENTIONAL",[107],"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.",[110,111,112],"Fibromyalgia","Fibromyalgia (FM)","Fibromyalgia (FM) OR Fibromyalgia Syndrome",[80,114,115],"TENS","Transcutaneous Electrical Nerve Stimulation","NOT_YET_RECRUITING","2026-10-08",{"date":119,"type":120},"2026-10-13","ACTUAL",{"date":122,"type":104},"2026-11-02",{"date":124,"type":104},"2027-10-31",{"name":5,"class":6}]