[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"base-of-thumb-osteoarthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:base-of-thumb-osteoarthritis":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27,28],"Base-of-thumb Osteoarthritis","Osteoarthritis",[30],"base-of-thumb osteoarthritis","RECRUITING","2026-03-30",{"date":34,"type":35},"2026-04-03","ACTUAL",{"date":37,"type":35},"2025-12-03",{"date":39,"type":20},"2028-11",{"name":41,"class":42},"Assistance Publique - Hôpitaux de Paris","OTHER",""]