Clinical trial NCT03631251: Using Honest Placebos to Improve Pain Management in Hand Surgery Patients
Official title: Enhancing Analgesia With Non-Deceptive Placebos: A Proof-Of-Concept Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hand or Wrist Surgery
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
First posted: 2018-08-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Enrollment Percentage
timeFrame: Through study enrollment, 1 day
measure: Retention Rate
timeFrame: through study completion, approximately 2 months
measure: Placebo Intake
timeFrame: 7 days
measure: Placebo Analgesia
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: East Providence
country: United States
facility: University Orthopedics
state: Rhode Island
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
References: