Actively Recruiting

Phase Not Applicable
Age: 10Years - 18Years
All Genders
NCT06365892

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

Led by University of California, San Francisco · Updated on 2026-03-13

64

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 10Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of idiopathic spine deformity
  • Age greater than 10 and less than 18 years
  • Scheduled for primary spine surgery procedure
  • Guardian provides signed and dated informed consent
  • Patient provides assent to participate
  • Undergoing fusion or fusionless instrumented spine surgery
Not Eligible

You will not qualify if you...

  • Non-idiopathic scoliosis such as neuromuscular or syndrome-related scoliosis
  • Revision spine surgery procedure
  • Self-reported pregnancy or planned pregnancy within next two months
  • History of drug (excluding nicotine or caffeine) or alcohol abuse within 2 years
  • Currently taking opioid medications
  • Abnormal physical examination
  • Inability to speak or read English
  • Patient declines participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

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Research Team

M

Mohammad Diab, MD

CONTACT

T

Tripta Rughwani

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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