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

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

This study tests if giving teenagers open-label placebos along with regular pain treatment after scoliosis surgery can help them use less pain medication and recover faster.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 10 Years to 18 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06365892 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 10 to 18 diagnosed with idiopathic scoliosis who are undergoing their primary surgical procedure.

Not a fit: Patients with non-idiopathic scoliosis, those undergoing revision procedures, or individuals currently taking opioids may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced opioid consumption and improved recovery outcomes for adolescents undergoing scoliosis surgery.

How similar studies have performed: While the use of open-label placebos is a novel approach in this context, similar studies have shown promise in other areas of pain management.

Eligibility criteria

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 this trial is running

San Francisco, California

• 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

Conditions Adolescent Idiopathic Scoliosis; Conditioning with Open-Label Placebo