Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy

NCT07373210 | Recruiting

• 1 other identifier: 25-44743
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized controlled trial, 64 participants undergoing PAO at UCSF will be enrolled and randomized to receive either COLP plus treatment as usual (TAU) or TAU alone. Patients in the COLP arm will receive placebo pills alongside prescribed opioids and at scheduled intervals, beginning on postoperative day one. Weekly follow-up will be conducted for six weeks postoperatively via remote surveys and video visits.

Conditions

Periacetabular Osteotomy; Opiates

Keywords

periacetabular osteotomy; opiates

Outcome Measures

Primary Outcomes (2)

• Conditioning + Open-Label Placebo (COLP) results in significantly reduced opioid consumption compared with Treatment as Usual (TAU)

  COLP participants will take one placebo pill with their standard post-operative medications. TAU participants will take standard post-operative medications. Opioid Daily Diary and surveys will compare the opioid amount.

  Admission to 6 weeks post-operatively

• To determine if 6 weeks of COLP results in reduced pain perception compared with TAU.

  Pain perception will be measured by surveys.

  Admission to 6 weeks post-operatively.

Secondary Outcomes (6)

• Duration of time in days following surgery until patients establish independence with physical therapy

  Post-operative Day 1 to 6 weeks.

• Length of hospital stay

  Admission to discharge, up to 6 weeks

• Time to return to school or work

  Discharge to first day of school or work, up to 6 weeks post-operatively

• Urinary retention

  During hospitalization, until discharge, up to 6 weeks

• Constipation & First Bowel Movement

  Post-operatively to first flatus and bowel movement, up to 6 weeks

Study Arms (2)

Open-label Placebo (COLP)

EXPERIMENTAL

One placebo tablet will be taken with each oral opioid dose, 5mg Oxycodone, 6 times per day, beginning on post-operative day 1.

Other: Open-Label Placebo; Other: Treatment as usual

Treatment As Usual (TAU)

EXPERIMENTAL

Treatment As Usual (TAU) participants will receive their standard opioid dose, 5mg Oxycodone pill, 6 times a day beginning on post-operative day 1.

Other: Treatment as usual

Interventions

Open-Label Placebo OTHER

One placebo tablet will be taken with each oral opioid dose, 5mg Oxycodone, 6 times per day, beginning on post-operative day 1.

Open-label Placebo (COLP)

Treatment as usual OTHER

Treatment As Usual (TAU) participants will receive their standard opioid dose, 5mg Oxycodone pill, 6 times a day beginning on post-operative day 1.

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

Eligibility Criteria

• Age: 13 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 13 to 40 years old, and
• Undergo primary Bernese Periacetabular osteotomy (PAO) for symptomatic developmental dysplasia of the hip (DDH), and
• Opioid-naïve prior to operation, and
• Capable of completing study procedures, including daily pain and medication diaries as well as weekly questionnaires.

You may not qualify if:

• Undergoing PAO revision or any concurrent major surgical procedure
• History of opioid use, substance use disorders, or alcohol abuse
• Those with cognitive or physical impairments that would interfere with providing their own consent and the completion of study-related tasks
• Pregnant individuals or those planning to become pregnant during the study period

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)

• 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 BACKGROUND

• 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

MeSH Terms

Interventions

Therapeutics

Study Officials

• Mohammad Diab, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tripta Rughwani

CONTACT

415-353-4701; tripta.rughwani@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 28, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)