Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-30 @ 6:50 AM
Study NCT ID:
NCT06365892
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2024-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Effectiveness of Conditioning + Open-label Placebo for the Management of Pain in Children Who Undergo Surgical Treatment of Idiopathic Scoliosis
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: