Placebo Impacts Sleep and Pain Modulation in Chronic Pain

NCT06225817 | Recruiting DMC

• 1 other identifier: HP-00105618
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.Will open-label placebo plus expectation management improve sleep quality in participants suffering from TMD?

Conditions

Chronic Pain; Headache

Outcome Measures

Primary Outcomes (2)

• Chronic pain intensity

  Chronic pain intensity will be measured using visual analog scale ranging from 0=no pain at all to 100=maximum tolerable pain

  Daily over the 45 days

• Sleep efficiency

  Sleep efficiency will be measured using actigraphy motion watch ranging from 0%=efficient at all to 100% maximum efficient sleep

  Daily over the 45 days

Study Arms (3)

Open label placebo only arm

EXPERIMENTAL

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.

Dietary Supplement: Open-label placebo pills

Wait-list arm

NO INTERVENTION

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.

Open label placebo + expectation management

EXPERIMENTAL

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.

Dietary Supplement: Open-label placebo pills

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.

Also known as: Zeebo pills

Open label placebo + expectation management; Open label placebo only arm

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ( 18-88 years old)
• English speaker (written and spoken)
• TMD for at least 3 months
• Grade Chronic Pain Scale (GCPS) ≥1
• Smartphone/text messaging capability

You may not qualify if:

• Present or past degenerative neuromuscular disease
• Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years
• Any personal (or family first degree) history of mania, schizophrenia, or other psychoses
• Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
• Lifetime alcohol/drug dependence or alcohol/drug abuse in past 3 months
• Pregnancy or breast feeding
• Impaired or uncorrected hearing

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Baltimore School of Nursing

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yang Wang, PhD

CONTACT

4107067824; yang.wang@umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: There is no masking in the study. Both the participants and the experimenter know that the participants will be taking open-label placebos.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a longitudinal parallel randomized clinical trial with chronic headache participants randomly assigned to either 1) OLP+Expectations management; 2) OLP alone; or 3) Standard of care. To examine how baseline chronic pain and sleep patterns could have impacted the effects of OLP, we will deep-phenotype participants based on their sleep profiles and fluctuations in their chronic pain characteristics via a 2-day phenotyping phase. Following the 2-day phenotyping phase, participants will enter a 45-day intervention phase. The nature of the participation will be voluntary. Namely, participants can withdraw during trial from the study without any consequences.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 26, 2024
• Study Start: April 21, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)