Placebo Impacts Sleep and Pain Modulation in Chronic Pain

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06225817
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain
  • Headache

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • Open-label placebo pills — DIETARY_SUPPLEMENT
    The placebo pills in this study are empty capsules without any ingredients inside. The capsules are made of microcrystalline cellulose.

Study Details

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 depression will be measured using PROMIS-anxiety, and PROMIS-depression scales respectively. Finally, sleep quality will be quantified using the objective measurement Motion Watch during the 45 days intervention and monitoring. In order to have a rigorous measurement of the baseline pain and sleep fluctuation, this study will include a 7-day phenotyping period before the starting of the 45-day intervention and monitoring. During the 7-day phenotyping period, participants will record their daily chronic pain and sleep quality using polysomnography.

Key Dates

Start date
Apr 21, 2025
Status verified
Jun 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2027

Study Design

Enrollment
111 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Open label placebo only arm
    Participants who are assigned to the OLP group will be given a bottle of OLP pills. They will be asked to take one pill per day for 45 days. They will be introduced to placebo effects and the therapeutic potential of using open-label placebo for chronic pain management and sleep improvement.
  • No Intervention: Wait-list arm
    Participants in the wait-list group will not receive OLP pills until the end of the 45-day monitoring period. Therefore, the 45 days without OLP will serve as an no intervention comparators relative to the OLP group.
  • Experimental: Open label placebo + expectation management
    Participants assigned to this arm will complete an 1 hour discussion about their expectations towards open-label placebo intervention. After that, they will continue with the 2-day run-in period and 45-day intervention. They will be asked to take 1 open-label placebo pill per day, for a total of 45 days.

Primary Outcome Measure

Chronic pain intensity [ Time Frame: Daily over the 45 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Baltimore School of NursingBaltimoreMaryland21201
Yang Wang, PhD
[email protected]
410-706-7824
Rachel Massalee, MS
[email protected]
4107065975
Yang Wang, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Maryland Baltimore School of Nursing· Baltimore, MD

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