Using Honest Placebos to Improve Pain Management in Hand Surgery Patients

Enhancing Analgesia With Non-Deceptive Placebos: A Proof-Of-Concept Pilot Study

America is in the midst of an opioid epidemic. One of the reasons opioid addiction and overdose deaths have recently increased is that doctors are frequently prescribing opioid medication as a treatment for pain. If it is possible to develop new ways of increasing the pain-relief patients experience from a set amount of opioids, then doctors might ultimately be able to prescribe fewer opioid medications, which could help curb the opioid crisis.

Although "placebos," a medication whose benefit derives solely from positive psychological factors rather than pharmacological factors, are often disparaged in medicine, research suggests that placebos can actually help reduce pain. In fact, there is reason to think that placebos are effective even when a patient knows they are taking a placebo.

The goal of the proposed study is to examine the feasibility of using an honest placebo to relieve pain for up to 20 real patients. People who are undergoing hand or wrist surgery or enrolled for upper extremity trauma in the Emergency Department and agree to participate will be asked to take placebo pills in addition to their standard course of opioid pills, given as part of standard care. Patients will also answer a few short questions over the phone once per day for seven days, and be invited to participate in an exit questionnaire at the end of the study. The investigators hypothesize that: 1) At least 50% of eligible participants will agree to enroll, 2) At least 80% of participants who are enrolled will be retained, and 3) Participants who are enrolled will take a placebo at least 50% of the time they also take an opioid pill

Study Overview

• Status: Completed
• Conditions: Hand or Wrist Surgery
• Intervention / Treatment: Drug: Open Placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • University Orthopedics
    • Providence, Rhode Island, United States, 02906
      • Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria, University Orthopedics & Department of Plastic & Reconstructive Surgery:

• 18 years or older
• English Speaking
• Have a working phone
• Scheduled for hand or wrist surgery
• Able to provide informed consent Inclusion Criteria, Miriam Hospital Emergency Department
• 18 years or older
• English Speaking
• Have a working phone
• Able to provide informed consent
• Present for upper extremity trauma
• Are expected to be prescribed opioids at discharge
• Are expected to be discharged from the Emergency Department

Exclusion Criteria, University Orthopedics & Department of Plastic & Reconstructive Surgery::

• Known history of Substance Use Disorder
• Chronic pain
• Chronic opioid use
• The prescribing physician deems opioid medication not appropriate as part of standard care for any reason Exclusion Criteria, Miriam Hospital Emergency Department
• Known history of Substance Use Disorder
• Chronic pain
• Chronic opioid use
• Unlikely to follow-up (discretion of investigator and treating provider)
• Likely to receive surgical repair of the indicated injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open Placebo; Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.	Drug: Open Placebo; Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Percentage	Percentage of Eligible Patients who Enroll	Through study enrollment, 1 day
Retention Rate	Percentage of Patients who are Retained at follow-up	through study completion, approximately 2 months
Placebo Intake	Number of Placebos Participants Take	7 days
Placebo Analgesia	Analgesia associated with placebo pills	7 days

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2018
• Primary Completion (ACTUAL): July 15, 2019
• Study Completion (ACTUAL): July 15, 2019

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (ACTUAL): August 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB00000556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No