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

NCT06365892 | Recruiting

• 1 other identifier: 22-36548
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Keywords

Conditioning with Open-Label Placebo (COLP)

Outcome Measures

Primary Outcomes (1)

• The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery

  Oral morphine equivalents (OMEs) are values that represent the potency of an opioid dose relative to morphine. Using OMEs provides a standardized method for converting between various opiate medications. Each oral opioid dose is a 5mg Oxycodone tablet prescribed 6 times per day pro re nata. Participants will record the number of oral opioids taken each day for 6 weeks following surgery beginning on Post-op Day 1 (POD1). This data will be collected and converted into OMEs for comparison.

  from admission to 6 weeks post-operatively

Secondary Outcomes (9)

• Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6.

  weekly from admission to 6 weeks post-operatively

• Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6.

  weekly from admission to 6 weeks post-operatively

• Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6.

  weekly from admission to 6 weeks post-operatively

• The duration of time in days following surgery until patients establish Independence with Physical Therapy

  from admission to final physical therapy assessment, up to 6 weeks

• The length of time in days following surgery until discharge from the hospital

  from admission to discharge, up to 6 weeks

Study Arms (2)

Open-label Placebo (COLP)

EXPERIMENTAL

Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Each oral opioid dose is a 5mg Oxycodone tablet. Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).

Other: open-label placebo; Other: Treatment as usual

Treatment As Usual (TAU)

EXPERIMENTAL

Treatment As Usual (TAU) subjects will receive equal access to opioid and non-opioid analgesics. The preferred oral opioid dose is a 5mg Oxycodone pill. Subjects will take a placebo with each oral opioid dose and additional three times per day beginning on POD 1.

Other: Treatment as usual

Interventions

open-label placebo OTHER

Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1.

Also known as: Inactive drug, Inactive medicine, Inactive substance, Sugar Pill Test Substance

Open-label Placebo (COLP)

Treatment as usual OTHER

Each oral opioid dose is a 5mg Oxycodone tablet. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).

Open-label Placebo (COLP); Treatment As Usual (TAU)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (10)

• Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016 Dec;157(12):2766-2772. doi: 10.1097/j.pain.0000000000000700.

  PMID: 27755279 BACKGROUND

• Blease C, Colloca L, Kaptchuk TJ. Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations. Bioethics. 2016 Jul;30(6):407-14. doi: 10.1111/bioe.12245. Epub 2016 Feb 3.

  PMID: 26840547 BACKGROUND

• von Wernsdorff M, Loef M, Tuschen-Caffier B, Schmidt S. Effects of open-label placebos in clinical trials: a systematic review and meta-analysis. Sci Rep. 2021 Feb 16;11(1):3855. doi: 10.1038/s41598-021-83148-6.

  PMID: 33594150 BACKGROUND

• Kirchhof J, Petrakova L, Brinkhoff A, Benson S, Schmidt J, Unteroberdorster M, Wilde B, Kaptchuk TJ, Witzke O, Schedlowski M. Learned immunosuppressive placebo responses in renal transplant patients. Proc Natl Acad Sci U S A. 2018 Apr 17;115(16):4223-4227. doi: 10.1073/pnas.1720548115. Epub 2018 Apr 2.

  PMID: 29610294 BACKGROUND

• Ader R, Mercurio MG, Walton J, James D, Davis M, Ojha V, Kimball AB, Fiorentino D. Conditioned pharmacotherapeutic effects: a preliminary study. Psychosom Med. 2010 Feb;72(2):192-7. doi: 10.1097/PSY.0b013e3181cbd38b. Epub 2009 Dec 22.

  PMID: 20028830 BACKGROUND

• Doering BK, Rief W. Utilizing placebo mechanisms for dose reduction in pharmacotherapy. Trends Pharmacol Sci. 2012 Mar;33(3):165-72. doi: 10.1016/j.tips.2011.12.001. Epub 2012 Jan 25.

  PMID: 22284159 BACKGROUND

• Sandler AD, Glesne CE, Bodfish JW. Conditioned placebo dose reduction: a new treatment in attention-deficit hyperactivity disorder? J Dev Behav Pediatr. 2010 Jun;31(5):369-75. doi: 10.1097/DBP.0b013e3181e121ed.

  PMID: 20495473 BACKGROUND

• Nurko S, Saps M, Kossowsky J, Zion SR, Di Lorenzo C, Vaz K, Hawthorne K, Wu R, Ciciora S, Rosen JM, Kaptchuk TJ, Kelley JM. Effect of Open-label Placebo on Children and Adolescents With Functional Abdominal Pain or Irritable Bowel Syndrome: A Randomized Clinical Trial. JAMA Pediatr. 2022 Apr 1;176(4):349-356. doi: 10.1001/jamapediatrics.2021.5750.

  PMID: 35099543 BACKGROUND

• Flowers KM, Patton ME, Hruschak VJ, Fields KG, Schwartz E, Zeballos J, Kang JD, Edwards RR, Kaptchuk TJ, Schreiber KL. Conditioned open-label placebo for opioid reduction after spine surgery: a randomized controlled trial. Pain. 2021 Jun 1;162(6):1828-1839. doi: 10.1097/j.pain.0000000000002185.

  PMID: 33449503 BACKGROUND

• Furie KS, James K, Kaptchuk TJ, Diab M. Effectiveness of conditioning + open-label placebo for post-operative pain management in adolescent idiopathic scoliosis. Pain Manag. 2025 Jul;15(7):363-371. doi: 10.1080/17581869.2025.2520148. Epub 2025 Jun 19.

  PMID: 40536435 DERIVED

Related Links

• Mohammad Diab, MD

MeSH Terms

Interventions

Sugars; Therapeutics

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Mohammad Diab, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Diab, MD

CONTACT

415-514-1519; mohammad.diab@ucsf.edu

Tripta Rughwani

CONTACT

tripta.rughwani@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of patients and providers will not be feasible due to the nature of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both arms - Open-label Placebo (COLP) and Treatment As Usual (TAU)

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)