Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
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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