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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: f
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⁃ To be eligible for enrollment, patients must meet all of the following inclusion criteria:

• Diagnosis of idiopathic spine deformity.

• Age \>10 and \<18 years.

• Primary procedure.

• Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.

• Patient provides assent.

• Fusion and fusionless instrumented spine surgery.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Mohammad Diab, MD
mohammad.diab@ucsf.edu
415-514-1519
Backup
Tripta Rughwani
tripta.rughwani@ucsf.edu
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 64
Treatments
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).
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov