Hand or Wrist SurgeryEarly Phase 1NCT03631251
Using Honest Placebos to Improve Pain Management in Hand Surgery Patients
A Early Phase 1 study of Hand or Wrist Surgery, run by Brown University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand or Wrist Surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2018to 15 Jul 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Orthopedics
East Providence, Rhode Island, 02915
Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: 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
- Conditions
- Hand or Wrist Surgery
- Being tested
- Open Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open PlaceboDrug
Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.
| Study group | Role | What they receive |
|---|---|---|
| Open Placebo | Experimental | Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care. Receives: Drug: Open Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Percentage
Percentage of Eligible Patients who Enroll
Measured: Through study enrollment, 1 day
Retention Rate
Percentage of Patients who are Retained at follow-up
Measured: through study completion, approximately 2 months
Placebo Intake
Number of Placebos Participants Take
Measured: 7 days
Placebo Analgesia
Analgesia associated with placebo pills
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start17 Aug 2018
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand or Wrist SurgeryStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital
- Responsible party
- Principal investigator, Michael Bernstein, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631251
- Sponsor's protocol ID
- IRB00000556
- Status last verified
- Jul 2020
- First submitted
- 26 Jul 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Analgesia With Non-Deceptive Placebos: A Proof-Of-Concept Pilot Study
- ClinicalTrials.gov ID
- NCT03631251
- Acronym / sponsor ID
- IRB00000556
- Conditions
- Hand or Wrist Surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 15 Aug 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Placebo | Experimental | Drug: Open PlaceboOpen placebo in addition to the standard course of opioids. Opioids are given consistent with standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 PlaceboOpen placebo in addition to the standard course of opioids. Opioids are given consistent with standard care. | Drug | Open Placebo |
Primary outcome
Enrollment Percentage
Time frame: Through study enrollment, 1 day
Percentage of Eligible Patients who Enroll
Retention Rate
Time frame: through study completion, approximately 2 months
Percentage of Patients who are Retained at follow-up
Placebo Intake
Time frame: 7 days
Number of Placebos Participants Take
Placebo Analgesia
Time frame: 7 days
Analgesia associated with placebo pills
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Hand or Wrist Surgery, run by Brown University at 2 sites 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?
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: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Percentage (time frame: Through study enrollment, 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2020.