Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Trea… (NCT06365892) | Clinical Trial Compass
RecruitingNot Applicable
Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis
United States64 participantsStarted 2024-07-01
Plain-language summary
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.
Who can participate
Age range10 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
✕
What they're measuring
1
The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery
Timeframe: from admission to 6 weeks post-operatively