[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562476":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":72,"collaborators":31,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":31,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":31,"enrollmentInfo":82,"targetDuration":31,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":56,"whyStopped":31,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"WellSpan Health","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention A - Prednisone","ACTIVE_COMPARATOR","Subjects assigned to the Intervention A group will receive prednisone 50 mg once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.",[13],"Drug: Prednisone",{"label":15,"type":10,"description":16,"interventionNames":17},"Intervention B - Dexamethasone","Subjects assigned to the Intervention B group will receive a single dose of dexamethasone 10 mg, plus ibuprofen 600 mg every 8 hours for 5 days.",[18],"Drug: Dexamethasone",{"label":20,"type":21,"description":22,"interventionNames":23},"Control - Placebo","PLACEBO_COMPARATOR","Subjects assigned to the Control group will receive placebo once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.",[24],"Drug: Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Prednisone","Subjects assigned to the Intervention A group will receive oral prednisone 50 mg once a day for 5 days, plus standard ibuprofen 600 mg every 8 hours for 5 days.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Dexamethasone","Subjects assigned to the Intervention B group will receive a single oral dose of dexamethasone 10 mg, plus standard ibuprofen 600 mg every 8 hours for 5 days.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Placebo","Subjects assigned to the Control group will receive oral placebo once a day for 5 days, plus standard ibuprofen 600 mg every 8 hours.",[20],[41],{"name":42,"affiliation":5,"role":43},"Brent Becker, MD","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Kristen Oliff Oliff","CONTACT","717-812-5075","koliff@wellspan.org",{"name":42,"role":47,"phone":51,"phoneExt":31,"email":52},"717-851-4819","bbecker2@wellspan.org",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"WellSpan York Hospital","RECRUITING","York","Pennsylvania","17403","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-76.72774,39.9626,{"lat":66,"lon":65},[69,71],{"name":70,"role":47,"phone":48,"phoneExt":31,"email":49},"Kristen Oliff",{"name":42,"role":47,"phone":51,"phoneExt":31,"email":52},{"type":73,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100562476","phase-4-systemic-oral-glucocorticoids-for-the-treatment-of-acute-osteoarthritis-pain-in-the-emergency-department-100562476",false,"NCT06603662","Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department","Inclusion Criteria:\n\n* Age ≥18 years\n* Acute monoarticular arthritic joint pain affecting native knee, hip, or shoulder presumed to be related to osteoarthritis\n* Acute pain above baseline starting less than 72 hour prior to ED visit\n* Planned discharge from the ED\n* History of osteoarthritis of the affected joint based on radiography performed at index visit or prior available imaging\n\nExclusion Criteria:\n\n* Trauma to the affected joint within 30 days\n* Injection of affected joint within 60 days\n* Prior arthroplasty of the affected joint\n* History of coronary artery disease, severe gastrointestinal bleeding, gastric\u002Fpeptic ulcer disease, chronic kidney disease with GFR less than 30, or platelet disorders (including von Willebrand disease, hemophilia, severe thrombocytopenia with platelets less than 50 k\u002FmcL)\n* Joint pain suspected to be related to rheumatoid arthritis, gout, septic arthritis, or other non-osteoarthritis autoimmune\u002Finflammatory\u002Finfectious arthritis\n* Chronic\u002Fbaseline use of glucocorticoids (greater than 5 mg daily prednisone or equivalent within previous 7 days) or NSAIDs (daily use for more than 2 days prior to presentation)\n* Daily prescription opioid use or active opioid use disorder\n* Illicit drug use\n* Known allergy\u002Fintolerance to ibuprofen\u002FNSAIDs, prednisone, dexamethasone, or other medication precluding ability to participate in one or more study arms\n* Other contraindications to ibuprofen\u002FNSAIDs or glucocorticoids\n* Planned hospitalization from the ED\n* Pregnancy\n* Incarceration\n* Inability to provide informed consent\n* Other conditions that would preclude compliance with the study protocol and medication dosing","ALL","18 Years",{"count":83,"type":84},192,"ESTIMATED","INTERVENTIONAL",[87],"PHASE4","The purpose of this clinical trial is to compare the analgesic effects (relief of pain) of glucocorticoids (steroids) and pain medication versus pain medication alone in adult patients presenting to the emergency department with joint pain due to osteoarthritis. Steroids are drugs that can reduce inflammation and are used commonly for many different medical conditions.\n\nIn brief, the central aims of the study are to:\n\n1. Assess the efficacy of adding oral glucocorticoid medications to the standard pain medications used to treat the pain of osteoarthritis.\n2. Assess the safety and tolerability of oral glucocorticoid medication for the short-term treatment of osteoarthritis pain.\n\nWe hypothesize that: 1) The addition of glucocorticoids to standard pain medications will improve reported pain scores at 3 days following the initiation of treatment compared to standard pain medications alone and 2) The use of glucocorticoids will be well tolerated.\n\nParticipants in the study will be randomized (like flipping a coin) into one of three groups:\n\n1. Study Group 1 (Control) receiving placebo pills (no active ingredient) once a day for 5 days, plus ibuprofen (pain medication) for 5 days.\n2. Study Group 2 (Intervention A) who will receive prednisone (steroid) once a day for 5 days, plus ibuprofen (pain medication) for 5 days.\n3. Study Group 3 (Intervention B) who will receive one dose of dexamethasone (steroid) followed by placebo pills (no active ingredient) once a day for 4 days, plus ibuprofen (pain medication) for 5 days.\n\nIn all groups, acetaminophen (a different pain medication) can be taken as needed for pain that is not controlled with ibuprofen.\n\nParticipants will:\n\n* Receive follow up phone calls at 1, 3, 7 and 14 days.\n* Report pain scores related to joint pain.\n* Report the number of pills taken of the various medications used in the study.\n* Report any adverse events incurred during the follow up period.",[90,91,92,93],"Osteoarthritis","Osteoarthritis (OA) of the Knee","Osteoarthritis (OA) of the Shoulder","Osteoarthritis (OA) of the Hip",[95,96,97,98],"osteoarthritis","acute pain","glucocorticosteroids","emergency department","2025-03-26",{"date":101,"type":102},"2025-03-27","ACTUAL",{"date":104,"type":102},"2025-02-24",{"date":106,"type":84},"2027-12",{"name":5,"class":6},1]