Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-09
Brief Title:
Open-label Placebo COLP for Pain in Adolescent Idiopathic Scoliosis AIS SurgerySurgical Treatment of Idiopathic Scoliosis
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 childs 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 positivenegative affect anxiety andor depression and response to Open-label Placebo COLP andor treatment as usual TAU
Secondary Aim 3 Determine if there is an association between postoperative PROMIS scores anxiety andor 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 andor depression
To determine whether open-label placebo COLP affects length of stay opioid side effects time to independence with physical therapy andor 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 positivenegative affect anxiety andor depression and response to Open-label Placebo COLP andor treatment as usual TAU
Secondary Aim 3 Determine if there is an association between postoperative PROMIS scores anxiety andor 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 andor depression
To determine whether open-label placebo COLP affects length of stay opioid side effects time to independence with physical therapy andor 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:
None
Is a FDA Regulated Drug?:
True
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?:
None