Open-Label Placebo for Adolescent Idiopathic Scoliosis

Overseen By Rhonda Bailey, MBA

Age: < 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of California, San Francisco

Must not be taking: Opioids

Disqualifiers: Non-idiopathic scoliosis, Pregnancy, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it does exclude those already taking opioids.

How does the open-label placebo treatment for adolescent idiopathic scoliosis differ from other treatments?

The open-label placebo treatment is unique because it involves giving patients a placebo (a treatment with no active ingredients) while being transparent about its nature, which can still lead to improvements due to the psychological effects of believing in the treatment. This approach differs from traditional treatments that typically involve active medical interventions. ^{1 2 3 4 5}

Research Team

Mohammad Diab, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adolescents with idiopathic scoliosis who are undergoing surgery. Participants must be willing to take an open-label placebo alongside their usual postoperative treatment and attend regular clinic visits where their medical data will be collected.

Inclusion Criteria

I am undergoing my first major medical procedure.

Patient provides assent

I am between 11 and 17 years old.

Exclusion Criteria

Already taking opioids

Inability to speak or read English

My doctor found something unusual in my last physical exam.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label placebo (COLP) or treatment as usual (TAU) for 6 weeks post-surgery

6 weeks

Weekly clinic visits for data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid consumption and mobility

6 weeks

Weekly assessments

Treatment Details

Interventions

• Open-label Placebo

Trial Overview The study is testing the effect of a known, inactive substance (open-label placebo) given openly in addition to the standard care after scoliosis surgery. It's designed to see if knowing they're taking a placebo still helps improve recovery outcomes.

Participant Groups

Group I: Treatment As Usual (TAU) Experimental Treatment 1 Intervention

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.

Group II: Open-label Placebo (COLP) Experimental Treatment 2 Interventions

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).

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

No long-term effects after a 3-week open-label placebo treatment for chronic low back pain: a 3-year follow-up of a randomized controlled trial. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Placebo Effect of Sham Spine Procedures in Chronic Low Back Pain: A Systematic Review. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Selecting an appropriate placebo for a trial of spinal manipulative therapy. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of placebo fidelity and trial design methodology in placebo-controlled surgical trials of musculoskeletal conditions: a systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

How orthopedic surgeons view open label placebo pills: Ethical and effective, but opposed to personal use. [2022]