University of California, San Francisco
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 / 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.
Interventional (clinical trial): Subject will be randomly assigned using permuted blocks (block size of 4). Before usage, random assignments will be created, stored in sealed envelopes, and numbered (1, 2, etc.). There will be stratified randomization: Later on, stratification will be incorporated into the analysis. 32 people will be in the group taking the placebo pills in addition to standardized treatment and 32 people will be in the group with standardized treatment alone. Hypothesis: Open-label Placebo (COLP) \< treatment as usual (TAU) control. Secondary Aims Analysis Plan: There are th…
Inclusion Criteria: To be eligible for enrollment, patients must meet all of the following inclusion criteria: 1. Diagnosis of idiopathic spine deformity. 2. Age \>10 and \<18 years. 3. Primary procedure. 4. Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments. 5. Patient provides assent. 6. Fusion and fusionless instrumented spine surgery. Exclusion Criteria: If any of the following exclusion criteria are met, the patient is not eligible for the study: 1. Non-idiopathic scoliosis, such as neur…
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.
Each oral opioid dose is a 5mg Oxycodone tablet. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).
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