Periacetabular OsteotomyCOLP PAONCT07373210
Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy
A study testing Treatment as usual in people with Periacetabular Osteotomy and Opiates, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- Periacetabular Osteotomy, Opiates
- What is being tested?
- Treatment as usual
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Tripta Rughwani, 415-353-4701, tripta.rughwani@ucsf.edu
Mohammad Diab, MD
About this study
Official title: Conditioning, Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy (PAO)
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
- Being tested
- Open-Label Placebo, Treatment as usual
- Keywords
- periacetabular osteotomy, opiates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-Label PlaceboOther
One placebo tablet will be taken with each oral opioid dose, 5mg Oxycodone, 6 times per day, beginning on post-operative day 1.
Treatment as usualOther
Treatment As Usual (TAU) participants will receive their standard opioid dose, 5mg Oxycodone pill, 6 times a day beginning on post-operative day 1.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Admission to 6 weeks post-operatively.
Secondary outcomes (6)
Duration of time in days following surgery until patients establish independence with physical therapy
Participants will be treated by physical therapy services after surgery until their physical therapist determines that services are no longer needed.
Measured: Post-operative Day 1 to 6 weeks.
Length of hospital stay
Participants will be admitted to the hospital following surgery until cleared for discharge.
Measured: Admission to discharge, up to 6 weeks
Time to return to school or work
Participants will be asked to record date they have returned to school or work after surgery. The amount of time it takes to return, may determine if they are struggling with pain.
Measured: Discharge to first day of school or work, up to 6 weeks post-operatively
Urinary retention
Participants will be assessed in hospital to determine whether or not they experience urinary retention post surgery, a potential side effect of opioid consumption.
Measured: During hospitalization, until discharge, up to 6 weeks
Constipation & First Bowel Movement
Participants will record the first time they flatulate, the number of days until their first bowel movement after surgery to assess constipation, a potential side effect of opioid consumption.
Measured: Post-operatively to first flatus and bowel movement, up to 6 weeks
Number of postoperative clinical contacts in COLP compared to TAU
The number of interactions or communication between the participant and medical providers. This includes follow-up visits, phone calls, or messages.
Measured: Post-operatively to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startDec 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Periacetabular OsteotomyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Diab, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373210
- Sponsor's protocol ID
- 25-44743
- Acronym
- COLP PAO
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40536435Carvalho 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.
PubMed 27755279Blease 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.
PubMed 26840547von 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.
PubMed 33594150Kirchhof 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.
PubMed 29610294Ader 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.
PubMed 20028830Doering 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.
PubMed 22284159Sandler 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.
PubMed 20495473Nurko 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.
PubMed 35099543Flowers 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.
PubMed 33449503
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioning, Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy (PAO)
- ClinicalTrials.gov ID
- NCT07373210
- Acronym / sponsor ID
- COLP PAO / 25-44743
- Conditions
- Periacetabular Osteotomy, Opiates
- Keywords
- periacetabular osteotomy, opiates
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open-label Placebo (COLP) | Experimental | Other: Open-Label Placebo, Other: Treatment as usualOne placebo tablet will be taken with each oral opioid dose, 5mg Oxycodone, 6 times per day, beginning on post-operative day 1. |
| Treatment As Usual (TAU) | Experimental | Other: Treatment as usualTreatment As Usual (TAU) participants will receive their standard opioid dose, 5mg Oxycodone pill, 6 times a day beginning on post-operative day 1. |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open-Label PlaceboOne 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 (COLP) |
| Treatment as usualTreatment As Usual (TAU) participants will receive their standard opioid dose, 5mg Oxycodone pill, 6 times a day beginning on post-operative day 1. | Other | Open-label Placebo (COLP), Treatment As Usual (TAU) |
Primary outcome
Conditioning + Open-Label Placebo (COLP) results in significantly reduced opioid consumption compared with Treatment as Usual (TAU)
Time frame: Admission to 6 weeks post-operatively
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.
To determine if 6 weeks of COLP results in reduced pain perception compared with TAU.
Time frame: Admission to 6 weeks post-operatively.
Pain perception will be measured by surveys.
6 secondary outcomes
Duration of time in days following surgery until patients establish independence with physical therapy
Time frame: Post-operative Day 1 to 6 weeks.
Length of hospital stay
Time frame: Admission to discharge, up to 6 weeks
Time to return to school or work
Time frame: Discharge to first day of school or work, up to 6 weeks post-operatively
Urinary retention
Time frame: During hospitalization, until discharge, up to 6 weeks
Constipation & First Bowel Movement
Time frame: Post-operatively to first flatus and bowel movement, up to 6 weeks
Number of postoperative clinical contacts in COLP compared to TAU
Time frame: Post-operatively to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 40536435Furie 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.
- Background: PubMed 27755279Carvalho 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.
- Background: PubMed 26840547Blease 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.
- Background: PubMed 33594150von 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.
- Background: PubMed 29610294Kirchhof 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.
- Background: PubMed 20028830Ader 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.
- Background: PubMed 22284159Doering 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.
- Background: PubMed 20495473Sandler 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.
- Background: PubMed 35099543Nurko 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.
- Background: PubMed 33449503Flowers 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.
- Individual participant dataSharing planned: No
Related trials for Periacetabular Osteotomy
Recruiting
Clinical Trial of Concomitant Hip Arthroscopy During PAO
Hip Dysplasia
Recruiting
Exercise and Patient Education Compared With Usual Care in Patients With Hip Dysplasia
Hip Dysplasia
Enrolling by invitationObservational study
Evaluation of Return to Sports Activity After Periacetabular Osteotomy: An Observational Study
Hip Surgeries, Hip Developmental Dysplasia
Recruiting
Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology
Hip Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad Diab, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual in people with Periacetabular Osteotomy and Opiates, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tripta Rughwani (415-353-4701, tripta.rughwani@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioning + Open-Label Placebo (COLP) results in significantly reduced opioid consumption compared with Treatment as Usual (TAU) (time frame: Admission to 6 weeks post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07373210, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.