[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544208":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":61,"collaborators":30,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":30,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-label Placebo (COLP)","EXPERIMENTAL","Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Each oral opioid dose is a 5mg Oxycodone tablet. Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).",[13,14],"Other: open-label placebo","Other: Treatment as usual",{"label":16,"type":10,"description":17,"interventionNames":18},"Treatment As Usual (TAU)","Treatment As Usual (TAU) subjects will receive equal access to opioid and non-opioid analgesics. The preferred oral opioid dose is a 5mg Oxycodone pill. Subjects will take a placebo with each oral opioid dose and additional three times per day beginning on POD 1.",[14],[20,26],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"open-label placebo","Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1.",[9],[25],"Inactive drug, Inactive medicine, Inactive substance, Sugar Pill Test Substance",{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Treatment as usual","Each oral opioid dose is a 5mg Oxycodone tablet. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).",[9,16],null,[32],{"name":33,"affiliation":5,"role":34},"Mohammad Diab, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":30,"email":39},"CONTACT","415-514-1519","mohammad.diab@ucsf.edu",{"name":41,"role":37,"phone":30,"phoneExt":30,"email":42},"Tripta Rughwani","tripta.rughwani@ucsf.edu",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","San Francisco","California","94158","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-122.41942,37.77493,{"lat":55,"lon":54},[58,60],{"name":33,"role":37,"phone":38,"phoneExt":30,"email":59},"Mohammad.Diab@ucsf.edu",{"name":33,"role":34,"phone":30,"phoneExt":30,"email":30},{"type":62,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100544208","open-label-placebo-colp-for-pain-in-adolescent-idiopathic-scoliosis-ais-surgerysurgical-treatment-of-idiopathic-scoliosis-100544208",false,"NCT06365892","Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis","Effectiveness of Conditioning + Open-label Placebo for the Management of Pain in Children Who Undergo Surgical Treatment of Idiopathic Scoliosis","Inclusion Criteria:\n\nTo be eligible for enrollment, patients must meet all of the following inclusion criteria:\n\n1. Diagnosis of idiopathic spine deformity.\n2. Age \\>10 and \\\u003C18 years.\n3. Primary procedure.\n4. Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.\n5. Patient provides assent.\n6. Fusion and fusionless instrumented spine surgery.\n\nExclusion Criteria:\n\nIf any of the following exclusion criteria are met, the patient is not eligible for the study:\n\n1. Non-idiopathic scoliosis, such as neuromuscular or syndrome.\n2. Revision procedure.\n3. Self-reported pregnancy or planned pregnancy within the next two months.\n4. Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study\n5. Already taking opioids.\n6. Abnormal physical examination.\n7. Inability to speak or read English\n8. Patient declines participation.","ALL","10 Years","18 Years",{"count":74,"type":75},64,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU \u002F TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years.",[81],"Adolescent Idiopathic Scoliosis (AIS)",[83],"Conditioning with Open-Label Placebo (COLP)","2026-03-10",{"date":86,"type":87},"2026-03-13","ACTUAL",{"date":89,"type":87},"2024-07-01",{"date":91,"type":75},"2026-12",{"name":5,"class":6},1]