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?

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.

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?

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

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+