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RecruitingNot ApplicableNCT06365892

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

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

Sponsor

University of California, San Francisco

Enrollment

64 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Adolescent Idiopathic Scoliosis (AIS)

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

Min Age: 10 YearsMax Age: 18 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria8

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

Interventions

OTHERopen-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.

OTHERTreatment 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).

Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT06365892