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

April 9, 2024 updated by: University of California, San Francisco

Effectiveness of Conditioning + Open-label Placebo for the Management of Pain in Children Who Undergo Surgical Treatment of Idiopathic Scoliosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

To be eligible for enrollment, patients must meet all of the following inclusion criteria:

  1. Diagnosis of idiopathic spine deformity.
  2. Age >10 and <18 years.
  3. Primary procedure.
  4. Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
  5. Patient provides assent.
  6. Fusion and fusionless instrumented spine surgery.

Exclusion Criteria:

If any of the following exclusion criteria are met, the patient is not eligible for the study:

  1. Non-idiopathic scoliosis, such as neuromuscular or syndrome.
  2. Revision procedure.
  3. Self-reported pregnancy or planned pregnancy within the next two months.
  4. Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study
  5. Already taking opioids.
  6. Abnormal physical examination.
  7. Inability to speak or read English
  8. Patient declines participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label Placebo (COLP)
Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Each oral opioid dose is a 5mg Oxycodone tablet. Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).
Drug: open-label placebo
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.
Other Names:
  • Inactive drug, Inactive medicine, Inactive substance, Sugar Pill Test Substance
Other: Treatment as usual
Each oral opioid dose is a 5mg Oxycodone tablet. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).
Experimental: Treatment As Usual (TAU)
Treatment As Usual (TAU) subjects will receive equal access to opioid and non-opioid analgesics. The preferred oral opioid dose is a 5mg Oxycodone pill. Subjects will take a placebo with each oral opioid dose and additional three times per day beginning on POD 1.
Other: Treatment as usual
Each oral opioid dose is a 5mg Oxycodone tablet. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery
Time Frame: from admission to 6 weeks post-operatively
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.
from admission to 6 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: weekly from admission to 6 weeks post-operatively
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 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.
Time Frame: weekly from admission to 6 weeks post-operatively
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 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.
Time Frame: weekly from admission to 6 weeks post-operatively

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).
weekly from admission to 6 weeks post-operatively
The duration of time in days following surgery until patients establish Independence with Physical Therapy
Time Frame: from admission to final physical therapy assessment, up to 6 weeks
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.
from admission to final physical therapy assessment, up to 6 weeks
The length of time in days following surgery until discharge from the hospital
Time Frame: from admission to discharge, up to 6 weeks

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
from admission to discharge, up to 6 weeks
The length of time in days following surgery until participant returns to school
Time Frame: from admission to date of return to school, up to 6 weeks post-operatively
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.
from admission to date of return to school, up to 6 weeks post-operatively
Whether participants experience urinary retention following surgery.
Time Frame: during hospitalization until discharge, up to 6 weeks
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.
during hospitalization until discharge, up to 6 weeks
Whether participants experience constipation measured by the number of days between surgery and first bowel movement
Time Frame: from admission to date of first bowel movement, up to 6 weeks post-operatively
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.
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.
Time Frame: during hospitalization until discharge, up to 6 weeks
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.
during hospitalization until discharge, up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Mohammad Diab, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-36548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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