RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-01
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06365892

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.

Ages Eligible for Study:10 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Non-idiopathic scoliosis, such as neuromuscular or syndrome.
  2. 2. Revision procedure.
  3. 3. Self-reported pregnancy or planned pregnancy within the next two months.
  4. 4. Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study
  5. 5. Already taking opioids.
  6. 6. Abnormal physical examination.
  7. 7. Inability to speak or read English
  8. 8. Patient declines participation.

Contacts and Locations

Study Contact

Mohammad Diab, MD
CONTACT
415-514-1519
mohammad.diab@ucsf.edu
Rhonda Bailey, MBA
CONTACT
317-507-4718
Rhonda.Bailey@ucsf.edu

Principal Investigator

Mohammad Diab, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Mohammad Diab, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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 Registration Dates

Study Start Date2024-07-01
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • Conditioning with Open-Label Placebo (COLP)

Additional Relevant MeSH Terms

  • Adolescent Idiopathic Scoliosis (AIS)