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

Interventional (clinical trial): Subject will be randomly assigned using permuted blocks (block size of 4). Before usage, random assignments will be created, stored in sealed envelopes, and numbered (1, 2, etc.). There will be stratified randomization: Later on, stratification will be incorporated into the analysis. 32 people will be in the group taking the placebo pills in addition to standardized treatment and 32 people will be in the group with standardized treatment alone.

Hypothesis: Open-label Placebo (COLP) \< treatment as usual (TAU) control. Secondary Aims Analysis Plan: There are three secondary aims in this study.

Aim 1. To determine whether 6 weeks of Open-label Placebo (COLP) results in significantly reduced opioid consumption compared to treatment as usual. To test this aim, the investigators will conduct a t-test comparing mean opioid use over the 6 weeks of follow up. In secondary analyses, the investigators will adjust for any baseline factors including gender, age, symptom severity or type of surgery that could be a confounding variable.

1a. To determine if 6 weeks of Open-label Placebo (COLP) results in reduced opioid consumption compared to treatment as usual. Hypothesis: Open-label Placebo (COLP) \< treatment as usual (TAU) control.

Secondary Aims Analysis Plan: There are three secondary aims in this study.

Secondary Aim 1: Determine if there are significant differences in time to independence with physical therapy, length of stay, time to return to school, urinary retention, constipation, oxygen requirement, and number of contacts with medical team in Open-label Placebo (COLP) compared to treatment as usual (TAU).

Secondary Aim 2: Determine if there is an association between preoperative pain catastrophization, kinesiophobia, positive/negative affect, anxiety, and/or depression and response to Open-label Placebo (COLP) and/or treatment as usual (TAU).

Secondary Aim 3: Determine if there is an association between postoperative PROMIS scores, anxiety, and/or depression in open-label placebo (COLP) compared to treatment as usual (TAU).

Primary Objectives The primary objectives of this study are to: (1) to determine whether 6 weeks of conditioning with open-label placebo (COLP) results in reduced opioid consumption (amount and duration) compared to treatment as usual (TAU) control and (2) to determine whether 6 weeks of Open-label Placebo (COLP) compared to treatment as usual (TAU) results in different clinical outcomes.

Secondary Objectives

* To determine whether open-label placebo (COLP) affects anxiety and/or depression. * To determine whether open-label placebo (COLP) affects length of stay, opioid side effects, time to independence with physical therapy, and/or number of contacts with medical team. * To determine if there is an association between pain catastrophizing, kinesiophobia, and clinical outcomes.

• 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. [Срок оценки: weekly from admission to 6 weeks post-operatively]
• 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. [Срок оценки: weekly from admission to 6 weeks post-operatively]
• 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. [Срок оценки: weekly from admission to 6 weeks post-operatively]
• The duration of time in days following surgery until patients establish Independence with Physical Therapy [Срок оценки: from admission to final physical therapy assessment, up to 6 weeks]
• The length of time in days following surgery until discharge from the hospital [Срок оценки: from admission to discharge, up to 6 weeks]
• The length of time in days following surgery until participant returns to school [Срок оценки: from admission to date of return to school, up to 6 weeks post-operatively]
• Whether participants experience urinary retention following surgery. [Срок оценки: during hospitalization until discharge, up to 6 weeks]
• Whether participants experience constipation measured by the number of days between surgery and first bowel movement [Срок оценки: from admission to date of first bowel movement, up to 6 weeks post-operatively]
• Whether participants experience an oxygen requirement and the duration of the requirement following surgery. [Срок оценки: during hospitalization until discharge, up to 6 weeks]