About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- open-label placebo
- Treatment as usual