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

Description

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.

Conditions

Adolescent Idiopathic Scoliosis (AIS)

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Study Overview

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Study Details

Study overview

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.

Effectiveness of Conditioning + Open-label Placebo for the Management of Pain in Children Who Undergo Surgical Treatment of Idiopathic Scoliosis

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

Condition
Adolescent Idiopathic Scoliosis (AIS)
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.

Ages Eligible for Study

10 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of California, San Francisco,

Mohammad Diab, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2026-01-01