Open-label Placebo for Adolescent Idiopathic Scoliosis Surgery
Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis
Recruiting
N/A
Interventional Study
Adolescent Idiopathic Scoliosis (AIS)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 10 – 18
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 64 (estimated)
- Sponsor
- University of California, San Francisco · Other
Who this trial is looking for
This trial is looking for patients aged 10 to 18 undergoing surgery for idiopathic scoliosis. Participants will complete surveys and have their medical data collected over 6 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with idiopathic scoliosis.
- I am between 10 and 18 years old.
- I will have my first surgery for scoliosis.
- I have a parent or guardian who can sign consent.
- I agree to participate in the study.
- I will have either fusion or fusionless spine surgery.
You may not be able to join if
- I have a type of scoliosis that is not idiopathic.
- I have had a revision surgery for my scoliosis.
- I am pregnant or planning to become pregnant soon.
- I have abused drugs or alcohol in the last 2 years.
- I am already taking opioids.
- I had an abnormal physical exam recently.
- I cannot speak or read English.
- I do not want to participate in the study.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About 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 medi…
Trial Locations
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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…
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