Open-label placebo treatment in chronic low back pain: a randomized controlled trial.
Cláudia Carvalho, Joaquim Machado Caetano, Lidia Cunha...
https://pubmed.ncbi.nlm.nih.gov/27755279Actively Recruiting
Phase Not Applicable
Age: 10Years - 18Years
All Genders
ID06365892
Effectiveness of Conditioning and Open-label Placebo for Pain Management in Children Undergoing Surgery for Idiopathic Scoliosis
Led by University of California, San Francisco · Updated on 2026-03-13
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of adding an open-label placebo (COLP) to the usual postoperative treatment for adolescents aged 10 to 18 undergoing surgery for idiopathic scoliosis. This randomized controlled trial will involve 64 patients divided into two groups to compare opioid consumption and other clinical outcomes over 6 weeks following surgery. The study also examines associations between pain perception, anxiety, depression, and response to the treatments. Participants will be randomly assigned to either receive open-label placebo tablets along with standard treatment or standard treatment alone. The placebo is a 330mg tablet taken with each opioid dose and three additional times daily, starting the day after surgery. Standard treatment includes opioid analgesics (5mg Oxycodone tablets) and Tylenol, with specific restrictions on other medications. The trial will last 6 weeks with detailed monitoring. Throughout the study, clinical data will be collected at regular clinic visits, including patient surveys using PROMIS scales to assess mobility, anxiety, and depressive symptoms. Researchers will track opioid use, physical therapy independence, hospital stay length, return to school time, and side effects such as urinary retention, constipation, and oxygen needs. The total participation period covers from hospital admission to 6 weeks post-surgery, with close monitoring of recovery and medication use.
CONDITIONS
Brief Title
Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis
Who Can Participate
Age: 10Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic spine deformity
- Age greater than 10 years and less than 18 years
- Scheduled for primary spine surgery procedure
- Guardian provides signed informed consent
- Patient provides assent
- Undergoing fusion or fusionless instrumented spine surgery
You will not qualify if you...
- Non-idiopathic scoliosis such as neuromuscular or syndrome-related scoliosis
- Undergoing revision spine surgery
- Self-reported pregnancy or planned pregnancy within 2 months
- History of drug or alcohol abuse (excluding nicotine or caffeine) within 2 years
- Currently taking opioid medications
- Abnormal physical examination
- Inability to speak or read English
- Patient declines participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospital stay up to 6 weeks post-surgery
Participants undergo surgery for idiopathic scoliosis and begin immediate post-operative care including opioid and non-opioid pain management.
Daily hospital visits during stay
Treatment
Duration - 6 weeks post-operatively
Participants receive either open-label placebo tablets along with standardized opioid treatment or treatment as usual with opioid and non-opioid analgesics for pain management after surgery.
Weekly visits for up to 6 weeks
Follow-up
Duration - Up to 6 weeks post-operatively
Participants are monitored for recovery outcomes including mobility, anxiety, depression, opioid consumption, physical therapy independence, and return to school.
Weekly assessments for up to 6 weeks
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
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Research Team
M
Mohammad Diab, MD
T
Tripta Rughwani
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Kira S Furie, Kaitlyn James, Ted J Kaptchuk...
https://pubmed.ncbi.nlm.nih.gov/40536435