NCT06225817

Placebo Impacts Sleep and Pain Modulation in Chronic Pain

Recruiting now NA Last updated 4 June 2025

What this trial tests

NA trial testing Open-label placebo pills in Chronic Pain in 111 participants. Currently enrolling.

Timeline

21 April 2025

Primary endpoint
30 July 2026

30 July 2027

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	111
Start date	21 April 2025
Primary completion	30 July 2026
Estimated completion	30 July 2027
Sites	1 location across United States

Drugs / interventions tested

• Open-label placebo pills

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Headache — all drugs for Headache →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 88, any sex, with Chronic Pain or Headache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.