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.
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.
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
Parallel
open-label placebo
Other interventionPlacebo 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.
Treatment as usual
Other interventionEach oral opioid dose is a 5mg Oxycodone tablet. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).
The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery
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.
Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6.
the PROMIS Pediatric Mobility SF 7a is a validated, self-reported instrument that consists of 7 items rating mobility on average over the past 7 days from 4 (With no trouble) to 0 (not able to do). Weekly level of mobility = mobility score reported at each week Change = (Week 6 Score - Baseline Score).
Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6.
the PROMIS Anxiety SF 8a is a validated, self-reported instrument that consists of 8 items rating anxiety on average over the past 7 days from 1 (never) to 5 (almost always). Weekly level of anxiety = anxiety score reported at each week Change = (Week 6 Score - Baseline Score).
Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6.
the PROMIS Depressive Symptoms SF 8a is a validated, self-reported instrument that consists of 8 items rating depressive symptoms on average over the past 7 days from 1 (never) to 5 (almost always). Weekly level of depressive symptoms = depressive symptoms score reported at each week Change = (Week 6 Score - Baseline Score).
The duration of time in days following surgery until patients establish Independence with Physical Therapy
Participants will be treated by physical therapy services after surgery until their physical therapist determines that they no longer require physical therapy services. Duration of time to independence with physical therapy is equal to the POD # where physical therapist determines formal PT is no longer required.
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