Open-Label Placebo for Adolescent Idiopathic Scoliosis

Overseen By Tripta Rughwani

Age: < 65

Sex: Any

Trial Phase: Academic

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)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how open-label placebos (a placebo given with the patient's knowledge) may enhance recovery from surgery for idiopathic scoliosis, a spine condition. Participants will receive either their usual pain treatment plus a placebo or just the usual treatment. The goal is to determine if knowing about taking a placebo can still aid in pain management after surgery. The trial seeks young patients who have undergone primary spine surgery for idiopathic scoliosis and are not currently taking opioids. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve post-surgery pain management.

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.

What prior data suggests that this open-label placebo is safe for adolescent idiopathic scoliosis patients?

Research has shown that open-label placebos have been tested for safety and effectiveness in various treatments. In this trial, patients will take a placebo (a pill with no active medicine) alongside their regular pain medication after surgery for scoliosis (a curve in the spine).

Placebos are generally well-tolerated in medical settings. Since placebo pills lack active ingredients, they are unlikely to cause side effects. Simply put, taking a placebo is usually safe because it doesn't contain any potentially harmful medicine.

Previous studies have found that patients often did not report side effects when taking placebos. This is because placebos are designed to be safe and inactive. Participants in this trial can expect a similar level of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for adolescent idiopathic scoliosis focus on physical interventions like bracing or surgery. But the open-label placebo approach offers a novel angle by leveraging the power of expectation and belief in pain management. This trial is exploring how placebo pills, openly given alongside standard pain medications like Oxycodone, might help reduce pain perception without additional active ingredients. Researchers are excited because this method could minimize reliance on higher doses of opioids, potentially reducing side effects and addiction risks.

What evidence suggests that this trial's treatments could be effective for adolescent idiopathic scoliosis?

Research shows that even when people know they are taking a placebo (a pill with no active medicine), it can still help with pain relief. Studies have found that if patients learn to associate taking a placebo with feeling less pain, their bodies can actually start to feel less pain. In this trial, one group of teenagers with idiopathic scoliosis will receive an open-label placebo alongside their regular pain treatments to help manage pain after surgery. The idea is that the brain can cause real changes in the body, even when patients know they're taking a placebo. Early results suggest this approach can enhance the effectiveness of regular pain treatments without needing more medication. ^{1 2 3 4 6}

Who Is on the Research Team?

Mohammad Diab, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40536435/

Effectiveness of conditioning + open-label placebo for post- ... This study investigates the effectiveness of COLP on postoperative treatment of patients ages 10 through 17 undergoing posterior fusion for adolescent ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06365892

Study Details | NCT06365892 | Open-label Placebo (COLP ... This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06365892

Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis ... This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12218585/

Effectiveness of conditioning + open-label placebo for post- ... This study investigates the effectiveness of COLP on postoperative treatment of patients ages 10 through 17 undergoing posterior fusion for adolescent ...

5. trials.arthritis.org trials.arthritis.org/trials/NCT06365892

Open-label Placebo (COLP) for Pain in Adolescent Idiopathic ... 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 ...

6. withpower.com withpower.com/trial/phase-2-and-3-scoliosis-4-2024-57edd

Open-Label Placebo for Adolescent Idiopathic Scoliosis This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for ...