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Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis

RecruitingNAAges 10 Years - 18 YearsAllUniversity of California, San Francisco
NCT06365892 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 neuromuscular or syndrome. 2. Revision procedure. 3. Self-reported pregnancy or planned pregnancy within the next two months. 4. Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study 5. Already taking opioids. 6. Abnormal physical examination. 7. Inability to speak or read English 8. Patient declines participation.
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What it tests

  • open-label placebo
  • Treatment as usual
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Where

1 site
University of California, San Francisco
San Francisco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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