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

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of using open-label placebos alongside standard treatment for adolescents undergoing surgery for idiopathic scoliosis, a condition that causes an abnormal curvature of the spine. In this study, 64 participants aged 10 to 18 years will be randomly assigned to receive either the open-label placebo treatment plus usual care or just the usual care alone. The goal is to see if the placebo can help improve pain management after surgery.

To be eligible for this trial, participants must be diagnosed with idiopathic scoliosis, be between the ages of 10 and 18, and have their first surgery for this condition. They will need to have consent from a parent or guardian to participate, and they must agree to be part of the study themselves. Throughout the six-week trial, patients will attend regular clinic visits where the research team will collect information about their recovery and complete surveys to assess their pain and overall well-being. This study aims to gather valuable data that could improve how pain is managed for young patients after scoliosis surgery.

Gender

ALL

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.