[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494657":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":41,"locations":46,"responsibleParty":69,"collaborators":27,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":27,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":27,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":49,"whyStopped":27,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Montefiore Medical Center","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Ibuprofen + dexamethasone + educational intervention","EXPERIMENTAL","Ibuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.",[13,14,15],"Drug: Ibuprofen 400 mg","Drug: Dexamethasone Oral","Behavioral: Educational Intervention",{"label":17,"type":18,"description":19,"interventionNames":20},"Ibuprofen + placebo + educational intervention","PLACEBO_COMPARATOR","Ibuprofen 400 mg PO every 8 hours as needed for 7 days + placebo PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.",[13,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Ibuprofen 400 mg","Ibuprofen 400 mg PO every 8 hours as needed for 7 days",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Dexamethasone Oral","Dexamethasone 16 mg PO during ED visit and next day",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"BEHAVIORAL","Educational Intervention","Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information",[9,17],[38],{"name":39,"affiliation":5,"role":40},"Eddie Irizarry, MD","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":27,"email":45},"CONTACT","718-920-6626","eddiriza@montefiore.org",[47,61],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":27},"Albert Einstein College of Medicine\u002FMontefiore Medical Center - Weiler ED","RECRUITING","The Bronx","New York","10461","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-73.86641,40.84985,{"lat":59,"lon":58},{"facility":62,"status":49,"city":50,"state":51,"zip":63,"country":53,"countryCode":54,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"Montefiore Medical Center - Moses ED","10467",{"type":56,"coordinates":65},[58,59],{"lat":59,"lon":58},[68],{"name":39,"role":43,"phone":27,"phoneExt":27,"email":27},{"type":70,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100494657","phase-4-ibuprofen-with-or-without-dexamethasone-for-acute-radicular-low-back-pain-100494657",false,"NCT05721027","Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.","Inclusion Criteria:\n\n* Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. Some patients may not have prominent LBP but a radicular symptom--we will include these patients as well.\n* Patient is to be discharged home.\n* Age 18-70 Enrollment will be limited to adults \\\u003C70 years because of the increased risk of adverse medication effects in older adults.\n* Pain duration \\\u003C2 week\n* Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more frequent back pain\u002Fsciatica are at increased risk of poor pain and functional outcomes.10\n* Non-traumatic cause of pain: no substantial and direct trauma to the back within the previous month\n* Functionally impairing radicular LBP: A baseline score of \\> 5 on the Roland-Morris Disability Questionnaire\n\nExclusion Criteria:\n\n* Not available for follow-up\n* Pregnant\n* Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis\n* Allergic to or intolerant of investigational medications\n* Chronic steroid use\n* Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR \\\u003C60ml\u002Fmin) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)",true,"ALL","18 Years","70 Years",{"count":82,"type":83},132,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.",[89,90,91],"Radiculopathy, Lumbosacral Region","Back Pain With Radiation","Low Back Pain",[93,94,95,96,97],"ibuprofen","dexamethasone","radiculopathy","low back pain","back pain with radiation","2026-04-07",{"date":100,"type":101},"2026-04-13","ACTUAL",{"date":103,"type":101},"2023-07-05",{"date":105,"type":83},"2027-10",{"name":5,"class":6},2]