RecruitingNot ApplicableNCT06365892

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

Sponsor

University of California, San Francisco

Enrollment

64 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Summary

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.

Eligibility

Min Age: 10 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an open-label placebo (a sugar pill that patients know is a placebo) can help reduce pain in children and teenagers undergoing surgery to correct scoliosis (curved spine). **You may be eligible if...** - Your child has been diagnosed with idiopathic (no known cause) spine deformity - Your child is between 10 and 18 years old - This is your child's first spine surgery - Both the child and guardian are able to provide consent and assent **You may NOT be eligible if...** - Your child has had prior spine surgery - Your child has a condition that prevents understanding the study requirements - Your child is not undergoing spinal fusion as part of their treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERopen-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.

OTHERTreatment 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).