[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611591":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":52,"locations":58,"responsibleParty":77,"collaborators":31,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":31,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":31,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":61,"whyStopped":31,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland","NETWORK",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"1. Physical Training Group","EXPERIMENTAL","Participants receive a structured physical training program using the Zebris diagnostic treadmill and Alfa balance platform, combined with conventional physiotherapy. Sessions are conducted 5 times per week for 3 weeks and include aerobic, balance, and coordination exercises tailored individually to each patient.",[13],"Other: Physical Training Program",{"label":15,"type":10,"description":16,"interventionNames":17},"2. Neuromodulation Group","Participants undergo non-invasive transcutaneous neuromodulation (NESA X-Signal) combined with conventional physiotherapy. Sessions last 30 minutes and are performed 5 times per week for 3 weeks.",[18],"Device: NESA X-Signal",{"label":20,"type":21,"description":22,"interventionNames":23},"3. Control Group","ACTIVE_COMPARATOR","Participants receive conventional physiotherapy only, including general exercise therapy, manual therapy, laser therapy, and relaxation sessions, consistent with standard clinical care for fibromyalgia patients.",[24],"Other: Conventional Physiotherapy",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"OTHER","Physical Training Program","Structured physical training using Zebris diagnostic treadmill and Alfa balance platform, performed under physiotherapist supervision. Sessions are held 5 times per week for 3 weeks and include aerobic, balance, and coordination exercises tailored to individual patient needs.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DEVICE","NESA X-Signal","Non-invasive transcutaneous neuromodulation using the NESA X-Signal device. The device delivers microcurrent stimulation through gloves and socks electrodes (25 total) to modulate autonomic nervous system activity and reduce pain. Sessions last 30 minutes, performed 3 times per week for 6 weeks.",[15],{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Conventional Physiotherapy","Standard physiotherapy program consisting of general exercise therapy, relaxation and breathing training, manual therapy, and light physical modalities (e.g., laser, heat therapy). No neuromodulation or device-based interventions are applied.",[20],[42,46,49],{"name":43,"affiliation":44,"role":45},"Beata Tarnacka, Professor, MD, PhD","Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR), Warsaw, Poland","STUDY_DIRECTOR",{"name":47,"affiliation":44,"role":48},"Justyna Frasuńska, MD, PhD","STUDY_CHAIR",{"name":50,"affiliation":44,"role":51},"Filip Królikowski, MSc, Physiotherapist","PRINCIPAL_INVESTIGATOR",[53],{"name":50,"role":54,"phone":55,"phoneExt":56,"email":57},"CONTACT","226709161","+48","Filip.krolikowski@spartanska.pl",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Rehabilitation Clinic, National Institute of Geriatrics, Rheumatology and Rehabilitation (NIGRiR)","RECRUITING","Warsaw","Masovian Voivodeship","02-637","Poland","PL",{"type":68,"coordinates":69},"Point",[70,71],21.01178,52.22977,{"lat":71,"lon":70},[74],{"name":75,"role":54,"phone":76,"phoneExt":56,"email":57},"Filip Królikowski, MSc","22 670 91 61",{"type":78,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100611591","effect-of-physical-exercise-and-neuromodulation-on-pain-sleep-and-fatigue-in-patients-with-fibromyalgia-100611591",false,"NCT07242573","Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia","Evaluation of the Effect of Individualized Physical Training and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 20 and 80 years\n* Confirmed diagnosis of fibromyalgia\n* Presence of chronic fatigue symptoms\n* Stable health condition\n* Presence of sleep disturbances\n* Ability to provide written informed consent and cooperate during the study\n\nExclusion Criteria:\n\n* Lack of informed consent or cooperation\n* Refusal to undergo procedures beyond standard NFZ physiotherapy\n* Cancer\n* Neurological disorders (e.g., neuralgia, multiple sclerosis, diabetic polyneuropathy, stroke)\n* Diagnosed dementia or cognitive impairment\n* Implanted electronic devices (e.g., pacemaker)\n* Internal bleeding or acute febrile illness\n* Acute thrombophlebitis\n* Hysteria or electric phobia\n* Neurotic addiction to stimulation\n* Infectious skin diseases (e.g., mycosis, purulent dermatitis)\n* Inability to communicate in Polish sufficiently to complete questionnaires or follow instructions","ALL","20 Years","80 Years",{"count":90,"type":91},75,"ESTIMATED","INTERVENTIONAL",[94],"NA","Fibromyalgia (FMS) is a chronic, multifactorial syndrome characterized by widespread pain, fatigue, and cognitive disturbances. This interventional study evaluates the impact of structured physical training using diagnostic-training devices (Zebris treadmill and Alfa balance platform) and transcutaneous neuromodulation (NESA X-Signal) on pain, sleep quality, and overall health status in patients with fibromyalgia and chronic fatigue symptom.\n\nParticipants are allocated into three groups:\n\n1. Physical training + conventional physiotherapy,\n2. Transcutaneous neuromodulation + conventional physiotherapy,\n3. Control (conventional physiotherapy only). The results will support the development of evidence-based rehabilitation protocols for fibromyalgia patients.",[97,98],"Fibromyalgia","Chronic Fatigue Syndrome (CFS)",[97,100,101,102,103,34,104,105,106,107,108],"Rehabilitation","Sleep Quality","Pain Management","Exercise Therapy","Transcutaneous Electrical Stimulation","Neuromodulation","Physiotherapy","Physical Training","Chronic Fatigue Syndrome","2026-02-20",{"date":111,"type":112},"2026-02-24","ACTUAL",{"date":114,"type":112},"2025-11-01",{"date":116,"type":91},"2027-12-15",{"name":5,"class":6},1]