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NCT06225817 · ClinicalTrials.gov registry record · NA
Placebo Impacts Sleep and Pain Modulation in Chronic Pain
A NA study of Chronic Pain and Headache, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- NA
- Development phase
- 111
- Enrollment target
- 1
- Study location
NCT06225817 is a NA study of Chronic Pain and Headache that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 111 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06225817, a NA study of Chronic Pain and Headache, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- NA
- Development phase
- 111 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this free-choice parallel design clinical trial is to examine the potential beneficial effects of using open-label placebo (OLP) in improving chronic pain related outcomes and sleep quality in people with temporomandibular disorders. This study will enroll a cohort of participants with temporomandibular disorders (TMD) which lasts for more than 3 months. The main questions it aims to answer are: 1. Will participants with TMD be more likely to take open-label placebo pills if they are introduced to the effects of placebo (e.g., going through an expectation management session)? 2. Will taking open-label placebo plus expectation management improve chronic pain related outcomes, such as chronic pain intensity, interference, levels of anxiety and depression, in the cohort of TMD? 3. Will open-label placebo plus expectation management improve sleep quality in participants suffering from TMD? To answer the above questions, participants with TMD will be randomly assigned to three groups: 1. Open-label placebo plus expectation management group, where participants will complete a 1-hour discussion session about their expectations toward open-lable placebo intervention, and then take 1 open-labe placebo pill per day for a total of 45 days. 2. Open-label placebo only group where participants will be asked to take open-label placebo pills, one pill per day, for a total of 45 days. 3. standard of care group where participants will maintain their usual care without introducing open-label placebo to them during the 45 days monitoring. Researchers will compare the chronic pain intensity, interference, mood, anxiety, and sleep quality between the open-label placebo group and the wait-list group. Daily chronic pain will be measured using visual analog scale (VAS) ranging from 0=no pain at all to 100=maximum tolerable pain. Chronic pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and pain behavior. Anxiety and dep
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Open-label placebo pills
Study Locations (1)
Maryland
- University of Maryland Baltimore School of Nursing - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2025-04-21 |
| Est. Completion | 2027-07-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06225817
The ClinicalTrials.gov registry entry for NCT06225817 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (86% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Pain appearing as the primary indexed condition, and to 1 intervention - of which Open-label placebo pills is the first listed.
NCT06225817 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06225817 about?
NCT06225817 is a clinical study titled "Placebo Impacts Sleep and Pain Modulation in Chronic Pain". The goal of this free-choice parallel design clinical trial is to examine the potential beneficial effects of using open-label placebo (OLP) in improving chronic pain related outcomes and sleep quality in people with temporomandibular disorders. This study will enroll a cohort of participants with t...
What is the current status of trial NCT06225817?
This trial is currently recruiting. It is a NA study. The enrollment target is 111 participants. The study started on 2025-04-21. Estimated completion is 2027-07-30.
What conditions does trial NCT06225817 study?
This clinical trial studies the following conditions: Chronic Pain, Headache.
What interventions are being tested in trial NCT06225817?
The interventions under investigation include: Open-label placebo pills (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06225817?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06225817 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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