HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain
NCT ID: NCT06931158
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
340 participants
INTERVENTIONAL
2025-03-01
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Open-label placebo pill for 21 days at 2 per day
Standard Rationale
Scientific rationale about the placebo effect
OLP + Mindfulness Rationale
Participants in this group will receive an open-label placebo along with information with mindfulness information.
Open-label Placebo
Open-label placebo pill for 21 days at 2 per day
Mindfulness
Mindfulness based rationale
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
Open-label placebo pill for 21 days at 2 per day
Control Rationale
Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups
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.
Control Rationale
Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups
Interventions
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Open-label Placebo
Open-label placebo pill for 21 days at 2 per day
Standard Rationale
Scientific rationale about the placebo effect
Mindfulness
Mindfulness based rationale
Control Rationale
Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Over 89 years of age
* Suspect an allergy to any placebo ingredient
* Currently receiving worker's compensation.
18 Years
89 Years
ALL
No
Sponsors
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Rhode Island Hospital
OTHER
Responsible Party
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Michael Bernstein
Assistant Professor
Locations
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Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RIH-2053624-7
Identifier Type: -
Identifier Source: org_study_id
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