[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585472":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":36,"locations":47,"responsibleParty":64,"collaborators":66,"id":69,"slug":11,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":11,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"2 intra-articular injections of onabotulinumtoxinA","EXPERIMENTAL",null,[13],"Drug: OnabotulinumtoxinA",{"label":15,"type":10,"description":11,"interventionNames":16},"1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline",[13,17],"Drug: Normal saline (placebo)",{"label":19,"type":20,"description":11,"interventionNames":21},"2 intra-articular injections of normal saline","PLACEBO_COMPARATOR",[17],[23,28],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","OnabotulinumtoxinA","intra-articular injection",[15,9],{"type":24,"name":29,"description":26,"armGroupLabels":30,"otherNames":11},"Normal saline (placebo)",[15,19],[32],{"name":33,"affiliation":34,"role":35},"Christelle NGUYEN, MD,PhD","Organizational Affiliation: Université Paris Cité, Faculté de Santé | UFR de Médecine","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Christelle NGUYEN, MD, PhD","CONTACT","01 58 41 29 45","+33","christelle.nguyen2@aphp.fr",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Laetitia PEAUDECERF, PhD","01 58 41 12 13","laetitia.peaudecerf@aphp.fr",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis du Pr François Rannou, Hôpital Cochin","RECRUITING","Paris","Île-de-France Region","75014","France",{"type":56,"coordinates":57},"Point",[58,59],2.3488,48.85341,{"lat":59,"lon":58},[62],{"name":63,"role":39,"phone":40,"phoneExt":41,"email":42},"Christelle Nguyen, MD, PhD",{"type":65,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[67],{"name":68,"class":6},"URC-CIC Paris Descartes Necker Cochin","100585472",false,"NCT06902805","Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.","Medium-and Long-term Efficacy of Two Ultrasound-guided Intra-articular Injections of onabotulinumtoxinA (Botox®) Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis : a Randomized Double-blind Controlled Trial in Three-parallel Arms","RHIBOTII","Inclusion Criteria:\n\n* • Individuals aged at least 18 years;\n\n  * Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);\n  * Pain involving the base of the thumb;\n  * X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;\n  * 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.\n  * Patient able to give written informed consent prior to participation in the study\n  * Affiliation with a mode of social security (profit or being entitled).\n  * Negative pregnancy test in women of childbearing potential\n\nExclusion Criteria:\n\n* • Secondary osteoarthritis;\n\n  * History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;\n  * Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders;\n  * Contra-indication to onabotulinumtoxinA;\n  * Neurological disorders involving the hands other than carpal tunnel syndrome;\n  * Collagen disorders involving the hands;\n  * Osteoarthritis predominating at the scaphotrapezial joint on x-ray;\n  * Bilateral trapezometacarpial osteoarthritis without a predominant painful side;\n  * Hand or wrist trauma for up to 2 months;\n  * Intra-articular treatments for up to 2 months;\n  * Use of IM, IV or oral corticosteroids for up to 2 months.\n  * Protected adults (including individual under guardianship by court order)\n  * Pregnant women and lactation; lack of contraception for women of childbearing potential\n  * Patient participating in another investigational therapeutic study\n  * Patient unable to speak and read french","ALL","18 Years",{"count":79,"type":80},120,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE2","PHASE3","The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.",[87,88],"Base-of-thumb Osteoarthritis","Osteoarthritis",[90],"base-of-thumb osteoarthritis","2026-03-30",{"date":93,"type":94},"2026-04-03","ACTUAL",{"date":96,"type":94},"2025-12-03",{"date":98,"type":80},"2028-11",{"name":5,"class":6},1]