[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567763":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":82,"collaborators":84,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":25,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":114,"whyStopped":25,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Instituto Neurociencia Del Dolor","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Guided Tele-rehabilitation","EXPERIMENTAL","Participants in this arm will receive a 12-week tele-rehabilitation program guided by artificial intelligence (AI) and computer vision technology. The program consists of three personalized exercise sessions per week, delivered remotely and adapted in real time to participants' capabilities and progress. In addition, participants will attend weekly educational sessions focused on pain neuroscience to improve their understanding of chronic pain mechanisms and enhance self-management strategies.\n\nThe intervention is delivered through a visually identical digital platform used by all participants. Supervising physiotherapists monitor progress and provide standardized support but remain blinded to treatment allocation, as only the intervention group receives the active content (AI-guided exercise and PNE).",[13],"Other: AI-Guided Exercise and Pain Neuroscience Education",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care for Fibromyalgia","ACTIVE_COMPARATOR","Participants in this arm will receive standard care for fibromyalgia, which typically includes pharmacological management such as pain relievers (e.g., paracetamol, tramadol), antidepressants (e.g., amitriptyline, duloxetine), and anticonvulsants (e.g., pregabalin, gabapentin). They will also be provided with general recommendations on physical activity and disease self-management, in line with current clinical guidelines. In addition, participants will use the same digital platform with a visually identical interface, receiving standard, non-specific educational materials and general activity guidance (without AI-guided exercise feedback or pain neuroscience education modules)",[19],"Other: Usual Care for Fibromyalgia",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"AI-Guided Exercise and Pain Neuroscience Education","This intervention consists of a 12-week tele-rehabilitation program using AI and computer vision technology to guide personalized exercise sessions (three per week). Exercises are adjusted in real time by the AI system, and participants also attend weekly sessions of pain neuroscience education to develop improved pain management strategies. The program is delivered remotely via a digital platform that is visually identical for all participants. Supervising physiotherapists oversee progress and provide standardized support but remain blinded to group allocation.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standard care includes pharmacological management (pain relievers, antidepressants, anticonvulsants) and general recommendations on physical activity and disease management.\n\nDrug: Pain Relievers - e.g., paracetamol, tramadol\n\nDrug: Antidepressants - e.g., amitriptyline, duloxetine\n\nDrug: Anticonvulsants - e.g., pregabalin, gabapentin\n\nOther: General Physical Activity and Disease Education - recommendations consistent with current clinical guidelines",[15],[30],{"name":31,"affiliation":32,"role":33},"Marco Morales-Osorio, PhD","Universidad San Sebastian","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Marco A Morales-Osorio, PhD","CONTACT","+56932367359","marco.morales@uss.cl",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":25},"Romualdo Ordoñez-Vega, MsC",[43,68],{"facility":44,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Universidad San Sebastián","Concepción","Biobio","4030000","Chile","CL",{"type":51,"coordinates":52},"Point",[53,54],-73.04977,-36.82699,{"lat":54,"lon":53},[57,60,64,67],{"name":31,"role":37,"phone":58,"phoneExt":25,"email":59},"+57932367359","cec@uss.cl",{"name":61,"role":37,"phone":62,"phoneExt":25,"email":63},"Romualdo Ordoñez, Msc","+56 9 8225 6426","kine.ordonez@gmail.com",{"name":65,"role":66,"phone":25,"phoneExt":25,"email":25},"Tatiana Ordoñe-Mora, PhD","SUB_INVESTIGATOR",{"name":31,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":69,"status":25,"city":70,"state":25,"zip":25,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Universidad Santiago de Cali","Cali","Colombia","CO",{"type":51,"coordinates":74},[75,76],-76.5199,3.43054,{"lat":76,"lon":75},[79],{"name":80,"role":37,"phone":25,"phoneExt":25,"email":81},"Leidy Tatiana Ordoñez-Mora, PhD","leidy.ordonez01@usc.edu.co",{"type":83,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[85,86],{"name":44,"class":6},{"name":69,"class":6},"100567763","effectiveness-of-ai-guided-exercise-and-pain-neuroscience-education-for-fibromyalgia-fibroia-100567763",false,"NCT06672419","Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA)","Effectiveness of Tele-Rehabilitation for Fibromyalgia Using AI-Guided Exercise and Computer Vision Combined With Pain Neuroscience Education (FIBRO IA): A Randomized Controlled Trial","FibroIA","Inclusion Criteria:\n\n* Clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016).\n* Age between 18 and 65 years.\n* Access to an internet-connected device (smartphone or computer).\n* Ability to participate in a tele-rehabilitation program.\n\nExclusion Criteria:\n\n* Participation in another clinical trial in the last 3 months.\n* Pregnancy or breastfeeding.\n* Uncontrolled severe medical conditions that could interfere with the intervention (e.g., cardiac or pulmonary diseases).\n* Physical or cognitive impairments that prevent following the exercise program.","ALL","18 Years","65 Years",{"count":99,"type":100},50,"ESTIMATED","INTERVENTIONAL",[103],"NA","This randomized controlled trial will evaluate the effectiveness of a 12-week, home-based telerehabilitation program for adults with fibromyalgia (FM) combining AI-guided exercise with Pain Neuroscience Education (PNE). Fifty participants will be randomized (1:1) to the digital intervention or usual care. The primary outcome is change in pain intensity from baseline to post-intervention (week 13 ± 7 days), with secondary outcomes including physical function and health-related quality of life. Outcome assessors, the principal investigator, and the study statistician will be blinded to group allocation until database lock.",[106,107],"Fibromyalgia","Fibromyalgia Syndrome",[106,109,110,111,112,113],"Tele-rehabilitation","Artificial Intelligence","Computer Vision","Pain Neuroscience Education","Randomized Controlled Trial","NOT_YET_RECRUITING","2025-12-27",{"date":117,"type":118},"2026-01-02","ACTUAL",{"date":120,"type":100},"2026-02-01",{"date":122,"type":100},"2026-08-01",{"name":5,"class":6},2]