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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Placebo 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.
Each oral opioid dose is a 5mg Oxycodone tablet. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).
University of California, San Francisco
San Francisco, California, United States
RECRUITINGThe 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.
Time frame: from admission to 6 weeks post-operatively
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).
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: weekly from admission to 6 weeks post-operatively
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.
Time frame: from admission to final physical therapy assessment, up to 6 weeks
The length of time in days following surgery until discharge from the hospital
Participants will be admitted to the hospital following surgery until they are cleared for discharge from a medical standpoint. Length of stay = POD # that patient is discharged
Time frame: from admission to discharge, up to 6 weeks
The length of time in days following surgery until participant returns to school
Participants will record the date on which they return to school after surgery. The POD # on date of return to school = the length of time to return to school. The amount of time it takes to return to school can be used as a proxy for whether participants are struggling with their pain or not.
Time frame: from admission to date of return to school, up to 6 weeks post-operatively
Whether participants experience urinary retention following surgery.
Participants will be assessed in hospital to determine whether or not they experience urinary retention post-surgery, a potential side effect of opioid consumption. The urinary retention determination will be a yes/no answer.
Time frame: during hospitalization until discharge, up to 6 weeks
Whether participants experience constipation measured by the number of days between surgery and first bowel movement
Participants will record the number of days between surgery and first bowel movement to assess whether they experience constipation, a potential side effect of opioid consumption.
Time frame: 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.
Participants will be assessed in hospital for whether or not they have an oxygen requirement and the duration of requirement. The oxygen requirement will be a yes/no answer. If yes, the number of days that oxygen is required will be recorded for the duration.
Time frame: during hospitalization until discharge, up to 6 weeks
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