NCT06365892 · University of California, San Francisco
Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis
What this study is about
This study aims to investigate the effects of conditioning with where both patients and doctors know the treatment given placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomly assigned controlled, 6-week trial with 64 AIS patients randomly assigned to one of two treatment group$1: where both patients and doctors know the treatment given 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.
View original scientific 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.
Interventions
OTHER
open-label placebo
Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1.
OTHER
Treatment as usual
Each oral opioid dose is a 5mg Oxycodone tablet. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).
Primary outcome measures
The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery
Time frame: from admission to 6 weeks post-operatively
Oral morphine equivalents (OMEs) are values that represent the potency of an opioid dose relative to morphine. Using OMEs provides a standardized method for converting between various opiate medications. Each oral opioid dose is a 5mg Oxycodone tablet prescribed 6 times per day pro re nata. Participants will record the number of oral opioids taken each day for 6 weeks following surgery beginning on Post-op Day 1 (POD1). This data will be collected and converted into OMEs for comparison.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To be eligible for enrollment, patients must meet all of the following inclusion criteria:
- Diagnosis of idiopathic spine deformity.
- Age \>10 and \<18 years.
- Primary procedure.
- Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
- Patient provides assent.
- 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:
- Non-idiopathic scoliosis, such as neuromuscular or syndrome.
- Revision procedure.
- Self-reported pregnancy or planned pregnancy within the next two months.
- Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study
- Already taking opioids.
- Abnormal physical examination.
- Inability to speak or read English
- Patient declines participation.
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations