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New treatment option for Adolescent Idiopathic Scoliosis (AIS)
Official title Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis
ClinicalTrials.gov ID: NCT06365892
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 18
You may be able to join if
- To be eligible for enrollment, patients must meet all of the following
- Diagnosis of idiopathic spine deformity.
- Age \>10 and \<18 years.
- Primary procedure.
- Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
You likely can't join if
- If any of the following exclusion criteria are met, the patient is not eligible for the study:
- Non-idiopathic scoliosis, such as neuromuscular or syndrome.
- Revision procedure.
- Self-reported pregnancy or planned pregnancy within the next two months.
- Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study
- Already taking opioids.
See the full eligibility criteria
- To be eligible for enrollment, patients must meet all of the following
- Diagnosis of idiopathic spine deformity.
- Age \>10 and \<18 years.
- Primary procedure.
- Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
- Patient provides assent.
- Fusion and fusionless instrumented spine surgery.
- If any of the following exclusion criteria are met, the patient is not eligible for the study:
- Non-idiopathic scoliosis, such as neuromuscular or syndrome.
- Revision procedure.
- Self-reported pregnancy or planned pregnancy within the next two months.
- Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study
- Already taking opioids.
- Abnormal physical examination.
- Inability to speak or read English
- Patient declines participation.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.