[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522572":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":65,"locations":74,"responsibleParty":136,"collaborators":138,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":149,"sex":155,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":38,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":77,"whyStopped":38,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Diakonhjemmet Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Intraarticular corticosteroid injection (IACS)","EXPERIMENTAL","A single ultrasound-guided intraarticular injection of 0.50 ml of 40 mg\u002Fml triamcinolone acetonide at baseline. A smaller dosage can be considered if there is increased resistance during injection. The same injection procedure will be repeated after 12 weeks if there is pain (NRS≥3) and inflammation (grey scale synovitis grade 1-3) present in the CMC-1 joint.",[13],"Drug: Injection of triamcinolone acetonide into the CMC-1 joint",{"label":15,"type":16,"description":17,"interventionNames":18},"Saline injection","PLACEBO_COMPARATOR","A single ultrasound-guided intraarticular injection of 0.50 ml of sodium chloride 9 mg\u002Fml at baseline. A smaller dosage can be considered if there is increased resistance during injection. The same injection procedure will be repeated after 12 weeks if there is pain (NRS≥3) and inflammation (grey scale synovitis grade 1-3) present in the CMC-1 joint.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Occupational Therapy intervention","Patient education, instructions about hand exercises and training in the Happy Hands app. Administration of day and night orthosis. The Happy Hands app involves a 12 week intervention.",[24],"Behavioral: Multimodal Occupational therapy for CMC-1 joint OA",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Injection of triamcinolone acetonide into the CMC-1 joint","intraarticular injection with triamcinolone acetonide",[9],[32],"Kenacort-T 40 mg\u002Fml",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"BEHAVIORAL","Multimodal Occupational therapy for CMC-1 joint OA","Patient education, instructions about hand exercises, orthosis and training",[21],null,{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Placebo","Intraarticular injection with saline",[15],[44],"Sodium chloride 9 mg\u002Fml",[46,49,53,56,59,62],{"name":47,"affiliation":5,"role":48},"Ida Kristin Haugen, MD, PhD","STUDY_DIRECTOR",{"name":50,"affiliation":51,"role":52},"Marte Ingeborg Sæther","Martina Hansens Hospital","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":55,"role":52},"Elisabet Esperø","Haugesund Rheumatism Hospital",{"name":57,"affiliation":58,"role":52},"Katrine Brække Norheim","Helse Stavanger HF",{"name":60,"affiliation":61,"role":52},"Mari Hoff","St. Olavs Hospital",{"name":63,"affiliation":64,"role":52},"Göran Karlsson","Nordland Hospital",[66,70],{"name":47,"role":67,"phone":68,"phoneExt":38,"email":69},"CONTACT","+4795859884","Ida.Haugen@diakonsyk.no",{"name":71,"role":67,"phone":72,"phoneExt":38,"email":73},"Marthe Gløersen, MD","+4748109310","Marthe.Gloersen@diakonsyk.no",[75,89,98,108,116,126],{"facility":76,"status":77,"city":78,"state":38,"zip":38,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Nordlands Hospital","RECRUITING","Bodø","Norway","NO",{"type":82,"coordinates":83},"Point",[84,85],14.37513,67.28267,{"lat":85,"lon":84},[88],{"name":63,"role":67,"phone":38,"phoneExt":38,"email":38},{"facility":55,"status":77,"city":90,"state":38,"zip":38,"country":79,"countryCode":80,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Haugesund",{"type":82,"coordinates":92},[93,94],5.268,59.41378,{"lat":94,"lon":93},[97],{"name":54,"role":67,"phone":38,"phoneExt":38,"email":38},{"facility":5,"status":77,"city":99,"state":38,"zip":38,"country":79,"countryCode":80,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Oslo",{"type":82,"coordinates":101},[102,103],10.74609,59.91273,{"lat":103,"lon":102},[106],{"name":107,"role":67,"phone":38,"phoneExt":38,"email":38},"Ida Kristin Haugen",{"facility":51,"status":109,"city":110,"state":38,"zip":38,"country":79,"countryCode":80,"cosmosGeoPoint":111,"geoPoint":115,"contacts":38},"ACTIVE_NOT_RECRUITING","Sandvika",{"type":82,"coordinates":112},[113,114],13.59125,64.46377,{"lat":114,"lon":113},{"facility":117,"status":77,"city":118,"state":38,"zip":38,"country":79,"countryCode":80,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Stavanger University Hospital","Stavanger",{"type":82,"coordinates":120},[121,122],5.73332,58.97005,{"lat":122,"lon":121},[125],{"name":57,"role":67,"phone":38,"phoneExt":38,"email":38},{"facility":127,"status":77,"city":128,"state":38,"zip":38,"country":79,"countryCode":80,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"St Olavs Hospital","Trondheim",{"type":82,"coordinates":130},[131,132],10.39506,63.43049,{"lat":132,"lon":131},[135],{"name":60,"role":67,"phone":38,"phoneExt":38,"email":38},{"type":52,"investigatorFullName":107,"investigatorTitle":137,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Rheumatologist, senior researcher",[139,141,143,144,145],{"name":140,"class":6},"Vestre Viken Hospital Trust",{"name":58,"class":142},"OTHER_GOV",{"name":55,"class":6},{"name":61,"class":6},{"name":146,"class":6},"Nordlandssykehuset HF","100522572","phase-4-intraarticular-steroids-saline-and-occupational-therapy-in-people-with-cmc1-osteoarthritis-100522572",false,"NCT06084364","Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis","Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial.","PICASSO","Inclusion Criteria:\n\n\\- Adult (40-85 years of age) men and women\n\nIn target CMC-1 joint:\n\n* OA confirmed by radiographs or ultrasound examination, and\n* Inflammation by ultrasound (grey scale synovitis grade 1-3), and\n* Pain of at least 3 on a 0-10 Numeric Rating Scale (NRS) at rest or during activities at both pre-screening and screening.\n* Patient is assessed as eligible for the proposed use of Kenacort-T\n\nExclusion Criteria:\n\n* Use of thumb orthosis on most of the days or structured hand exercises in the last 12 weeks\n* Intraarticular injections in the target CMC-1 joint in the last 12 weeks\n* More than 3 previous IACS in the target CMC-1 joint\n* Use of oral, intramuscular or intravenous steroids in the last 12 weeks\n* Previous surgery of the target CMC-1 joint\n* Planned hand surgery in the coming 24 weeks\n* Do not want to quit using oral or topical NSAIDs on the hands (such as ibuprofen, diclofenac, etoricoxib, naproxen) in the next 12 weeks\n* Systemic inflammatory joint diseases (such as rheumatoid arthritis (RA), psoriatic arthritis or gout) or other conditions that can better explain the hand pain (such as thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, hand injury in previous six months, or palmar tenosynovitis\u002Ftrigger finger)\n* Diagnosis of fibromyalgia\n* Diagnosis of psoriasis\n* Infection, skin disease or wounds at joint injection site\n* Serious comorbidities, cognitive dysfunction, substance\u002Falcohol abuse or any other medical condition that makes adherence to the study protocol difficult\n* Severe or uncontrolled infections\n* Known hypersensitivity to Triamcinolone acetonide (Kenacort) or any of the excipients (sodium carboxymethylcellulose, sodium chloride, polysorbate, benzyl alcohol, sodium hydroxide or hydrochloric acid)\n* Included in another clinical study\n* Use of digitalis glycosides\n* Patients vaccinated or immunized with live virus vaccines in the last 2 weeks\n* Not being able to talk or understand Norwegian\n* Known pregnancy or planned pregnancy in the next 6 months\n* Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures","ALL","40 Years","85 Years",{"count":159,"type":160},354,"ESTIMATED","INTERVENTIONAL",[163],"PHASE4","A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis",[166],"Osteoarthritis Thumb",[168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184],"thumb","pain","inflammation","steroids","RCT","Occupational Therapy","Carpometacarpal-1","HappyHands","CMC-1","Picasso","intraarticular corticosteroid injections","IACS injections","thumb base pain","triamcinolone acetonide","Kenacort-T","osteoarthritis","OA","2026-02-06",{"date":187,"type":188},"2026-02-10","ACTUAL",{"date":190,"type":188},"2023-11-03",{"date":192,"type":160},"2028-10",{"name":5,"class":6},6]