64 Participants Needed

Open-Label Placebo for Pain Management After Periacetabular Osteotomy

(COLP PAO Trial)

TR
Overseen ByTripta Rughwani
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a placebo (a pill with no active medication) might help manage pain after hip surgery for developmental dysplasia of the hip. Participants will be divided into two groups: one will receive a placebo pill alongside their regular pain medication, while the other will receive only the regular pain medication. The goal is to determine if adding a placebo can enhance pain management. Suitable candidates have no prior opioid use and are undergoing a specific hip surgery due to hip dysplasia. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative pain management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants will receive placebo pills alongside prescribed opioids, so you may continue with your prescribed pain medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that open-label placebos, where patients know they are taking a placebo, are generally safe. They have been used in pain management without causing major side effects. In this trial, participants take the placebo along with regular pain medicine after surgery. The placebo itself is safe, with no known serious side effects. Studies suggest that using a placebo can sometimes reduce the amount of real medicine needed, which could be beneficial. Overall, past research indicates that the treatment is well-tolerated and safe.12345

Why are researchers excited about this trial?

Researchers are excited about the use of an open-label placebo for pain management after periacetabular osteotomy because it offers a unique non-drug approach to pain relief. Unlike traditional treatments that rely solely on active medication like opioids, this method incorporates a placebo openly acknowledged to participants, potentially harnessing the power of suggestion and psychological factors to enhance pain relief. This could lead to reduced opioid consumption, lowering the risk of side effects and dependence, which are significant concerns with standard opioid therapy.

What evidence suggests that this open-label placebo is effective for pain management after periacetabular osteotomy?

Research has shown that even when people know they are taking a placebo—a pill with no active medicine—it can still help reduce pain. Studies have found that patients who took these placebos reported feeling less pain, despite knowing the pills were inactive. The power of belief and expectation likely explains this effect. In this trial, one group of participants will receive an open-label placebo alongside their regular pain treatment after periacetabular osteotomy (PAO). This approach might reduce the need for extra medication, such as opioids, potentially leading to less pain and a quicker recovery for patients.12346

Who Is on the Research Team?

MD

Mohammad Diab, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 13 to 40 who are undergoing their first PAO surgery for hip dysplasia, have never used opioids before, and can complete daily pain diaries and weekly questionnaires. It excludes those with a history of opioid or substance use, cognitive or physical impairments affecting consent or task completion, anyone having revision PAO or other major surgeries concurrently, and pregnant individuals.

Inclusion Criteria

I am having a PAO surgery for hip dysplasia.
I have not taken opioids before surgery.
I can complete daily and weekly study tasks.
See 1 more

Exclusion Criteria

History of opioid use, substance use disorders, or alcohol abuse
I can give consent and complete study tasks despite any impairments.
I am scheduled for or undergoing a major surgical procedure.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either COLP plus treatment as usual or treatment as usual alone, starting on post-operative day 1

6 weeks
Weekly follow-up via remote surveys and video visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Open-Label Placebo

Trial Overview

The study tests if an open-label placebo (COLP) given alongside usual postoperative care improves pain management compared to usual treatment alone in patients after PAO surgery. Participants will either receive placebo pills with prescribed opioids starting the day after surgery or just the standard treatment without placebos.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment As Usual (TAU)Experimental Treatment1 Intervention
Group II: Open-label Placebo (COLP)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

Open-label Placebo for Pain Management in Adolescents ...

In this randomized controlled trial, 64 participants undergoing PAO at UCSF will be enrolled and randomized to receive either COLP plus treatment as usual ...

Open-Label Placebo for Pain Management After ...

... Open-Label Placebo will have tolerable side effects & efficacy for patients with Opioid Addiction and Periacetabular Osteotomy. See if you qualify today!

Open-label Placebo for Pain Management in Adolescents ...

Clinical trial for Periacetabular Osteotomy | Opiates , Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing ...

Pain Management for Periacetabular Osteotomy: A Systematic ...

In summary, supplemental pain management strategies peri-operatively for PAO surgery can decrease pain, opioid use, and length of hospital stay, though there ...

a randomized double-blind placebo-controlled single ...

Key secondary outcomes included postoperative pain intensity, nausea and vomiting, antiemetic consumption and Timed Up and Go at 24 and 48 hours ...

Journal of ISAKOS | ISAKOS 2025 Congress Abstracts

Conference abstractOpen access. Mid-Term Return to Sport and Outcomes After Concomitant Periacetabular Osteotomy and Hip Arthroscopy. Article 100492: View PDF ...