Effectiveness of conditioning + open-label placebo for post-operative pain management in adolescent idiopathic scoliosis

The vast majority of placebos are administered with concealment or deception. Most clinicians and researchers believe that either deception or concealment is necessary to achieve a placebo response; however, recent studies with open-label placebo (OLP), conditioning, and conditioning + OLP (COLP) have shown that placebos can be effective even when patients know they are receiving a placebo. To date, no studies have examined COLP in a pediatric surgical population, which is vulnerable to developing opioid dependence. COLP may assist in lowering opioid doses administered and quicker tapering off opioids. This study investigates the effectiveness of COLP on postoperative treatment of patients ages 10 through 17 undergoing posterior fusion for adolescent idiopathic scoliosis (AIS). It is a randomized controlled trial of 64 AIS patients assigned to one of the two arms: COLP + treatment as usual (TAU) and TAU control. Randomization and baseline assessments occur at the preoperative visit. Opioid consumption is recorded weekly after hospitalization until the first in-person postoperative visit at 6 weeks. The primary outcome measure is postoperative opioid consumption, both amount and duration. Secondary outcomes include pain, functional ability, and mental health scores. A placebo is an inactive substance, such as a sugar pill. Historical use of placebos involves concealment in randomized controlled trials, such that patients do not know if they are receiving a placebo or an active medication. Recent research studies have shown that open-label placebos, meaning sugar pills that patients know are sugar pills, are able to help reduce pain and help relieve other uncomfortable symptoms. Other research has shown that pairing opioids with inert pills can cause inert pills to relieve pain. Our ongoing study pairs the effects of open-label placebos with conditioning. We hope to reduce overall opioid use. We are specifically looking at opioid use in the 6-week period after spinal surgery in patients aged 10 to 17 who are having surgery for a condition called adolescent idiopathic scoliosis. Scoliosis refers to an abnormal curvature of the spine, and idiopathic means that we are not sure of the exact cause of this curvature. If we find that placebos reduce opioid use, this research could help future children who undergo spine surgery and other painful surgeries take less opioids and have less pain. www.clinicaltrials.gov identifier is NCT06365892.