HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain (HOPE)
Optimizing Open Placebos for Chronic Pain Patients
The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other.
This study will include patients with chronic low back pain. The main question it aims to answer is:
How do rationales influence the effects of open-label placebos?
Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Rhode Island Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria are:
- chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over)
- at least 18 years old
- English speaking
- have a smartphone or computer with video access
- the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate)
Exclusion Criteria
- Have chronic pain because of a cancer diagnosis
- Over 89 years of age
- Suspect an allergy to any placebo ingredient
- Currently receiving worker's compensation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OLP + Standard Rationale
Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies.
|
Open-label placebo pill for 21 days at 2 per day
Other Names:
Scientific rationale about the placebo effect
|
|
Experimental: OLP + Mindfulness Rationale
Participants in this group will receive an open-label placebo along with information with mindfulness information.
|
Open-label placebo pill for 21 days at 2 per day
Other Names:
Mindfulness based rationale
|
|
Placebo Comparator: OLP + Control Rationale
Participants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.
|
Open-label placebo pill for 21 days at 2 per day
Other Names:
Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups
|
|
Sham Comparator: No Treatment + Control Rationale
Participants in this group will receive no treatment.
They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.
|
Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: across 42 days
|
Single-item assessing current pain level from 0 (min value) to 10 (max value).
Higher scores indicate more pain intensity
|
across 42 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prescription Medication use (including opioids)
Time Frame: across 42 days
|
across 42 days
|
|
|
Pain interference
Time Frame: across 42 days
|
Pain Interference subscale from Brief Pain Inventory Pain interference is measured for general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life on a 0-10 NRS with 0 = "does not interfere" and 10 = "completely interferes" Higher scores indicated greater pain intensity or greater interference with function.
|
across 42 days
|
|
Pain catastrophizing
Time Frame: across 42 days
|
Single item assessing how much the patient catastrophizes about their pain from 0 (minimum) to 10 (maximum). Higher scores indicate more catastrophizing. 13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time Higher score indicates higher level of catastrophizing Item scores are summed into a total score (PCS-T) and three subscale scores:
|
across 42 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Placebo use
Time Frame: across 21 days
|
across 21 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIH-2053624-7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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