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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

Who can join

Ages 10 to 18 · All sexes

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.

About the study

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.

What is being tested

• open-label placebo (other)
• Treatment as usual (other)

Sponsor: University of California, San Francisco · Participants: 64 · Started: Jul 1, 2024

Contact the study team

• Mohammad Diab, MD · Phone: 415-514-1519

Official record on ClinicalTrials.gov — NCT06365892

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.