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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Adolescent Idiopathic Scoliosis (AIS)

Treatments: Other: open-label placebo; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT06365892

22-36548

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Open-label Placebo (COLP)

Experimental group

Description:

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).

Treatment:

Other: Treatment as usual

Other: open-label placebo

Treatment As Usual (TAU)

Experimental group

Description:

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.

Treatment:

Other: Treatment as usual