Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorUniversity of California, San Francisco

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 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • open-label placebo
  • Treatment as usual

Treatment groups

64 Participants
are divided into 2 treatment groups