[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100585472","phase-2-efficacy-of-two-ultrasound-guided-intra-articular-injections-of-botox-combined-with-custom-made-rigid-splinting-in-painful-base-of-thumb-osteoarthritis-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":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29],"Base-of-thumb Osteoarthritis","Osteoarthritis",[31],"base-of-thumb osteoarthritis","RECRUITING","2026-03-30",{"date":35,"type":36},"2026-04-03","ACTUAL",{"date":38,"type":36},"2025-12-03",{"date":40,"type":21},"2028-11",{"name":42,"class":43},"Assistance Publique - Hôpitaux de Paris","OTHER"]