Using open-label placebos to manage pain after scoliosis surgery in adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of conditioning with open-label placebos on postoperative pain management for adolescents undergoing surgery for idiopathic scoliosis. A total of 64 participants aged 10 to 18 will be randomly assigned to receive either open-label placebos in addition to standard treatment or standard treatment alone. The study will assess opioid consumption and recovery metrics over a 6-week period, utilizing surveys and clinical data collection to evaluate outcomes. The trial aims to determine if the use of open-label placebos can reduce opioid use and improve recovery times compared to standard treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Mohammad Diab, MD — University of California, San Francisco
• Study coordinator: Mohammad Diab, MD
• Email: mohammad.diab@ucsf.edu
• Phone: 415-514-1519

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Understanding Proteins and Skepsis Progression in Adolescent Scoliosis

  Researchers will test blood protein markers to see if they can predict scoliosis progression in teens with AIS or neuromuscular scoliosis.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT07634627

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.