NCT06365892 Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis
| NCT ID | NCT06365892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Adolescent Idiopathic Scoliosis (AIS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2024-07-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Mohammad Diab, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06365892 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Adolescent Idiopathic Scoliosis (AIS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06365892 currently recruiting?
Yes, NCT06365892 is actively recruiting participants. Contact the research team at mohammad.diab@ucsf.edu for enrollment information.
Where is the NCT06365892 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06365892 clinical trial?
NCT06365892 is sponsored by University of California, San Francisco. The principal investigator is Mohammad Diab, MD at University of California, San Francisco. The trial plans to enroll 64 participants.