Chronic PainNCT06225817
Placebo Impacts Sleep and Pain Modulation in Chronic Pain
A study of Chronic Pain and Headache, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Chronic Pain, Headache
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Baltimore School of Nursing
Baltimore, Maryland, 21201
Yang Wang, PhD, 410-706-7824, yang.wang@umaryland.edu
Rachel Massalee, MS, 4107065975, rmassalee@umaryland.edu
About this study
Official title: The Impact of Open-label Placebo on Sleep and Pain Modulation
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:
- 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)?
- 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?
- 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.
Read the detailed description
This is a longitudinal parallel randomized clinical trial with TMD participants randomly assigned to either 1) the open-label placebo (OLP) + expectations management group, 2) OLP only, and 3) the standard of care group. 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.
Phenotyping phase (2-day) The phenotyping phase includes an in-person visit and a 2-day at-home monitoring period. During the in-person visit, after signing the informed consent form with the trained staff, participants will complete a heat pain sensitivity test using a 30mmx30mm Advanced Thermal Stimulator (ATS) via the Medoc Pathway system (Medoc Advanced Medical Systems, Medoc Ltd., Israel). Painful and non-painful stimuli will be delivered to the ventral forearm of the non-dominant hand.
After the in-person visit, participants will enter a 2-day daily monitoring period, where their daily pain expectations, pain experience fluctuations, and sleep diaries will be assessed in real time and in their natural environment using the Ecological Momentary Assessment (EMA) method. Sleep profiles will be assessed using polysomnography to obtain natural sleep architectures, including the duration of different sleep stages, sleep efficiency, breathing, and body movement during sleep.
Free-choice OLP intervention Immediately following the phenotyping phase, participants will return to the laboratory before entering the 45-day intervention phase. Participants will be randomized to either 1. OLP+expectations management, 2. OLP alone, and 3. Standard of care groups. Participants in the two OLP groups will receive a bottle of 45 OLP pills. According to the free-choice paradigm, participants in the OLP group are allowed to choose whether to take the pills each day during the intervention. This paradigm maximizes participant benefit because it provides the option of "not" taking the placebo pills. Participants in the wait-list group will not receive OLP pills until the end of the 45-day monitoring period.
- Conditions
- Chronic Pain, Headache
- Being tested
- Open-label placebo pills
- Medical subject headings
- Chronic Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-label placebo pillsDietary supplement
Also called Zeebo pills
The placebo pills in this study are empty capsules without any ingredients inside. The capsules are made of microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Open-label placebo pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Daily over the 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start21 Apr 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225817
- Sponsor's protocol ID
- HP-00105618
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data including the daily monitoring of chronic pain and sleep quality will be shared after the publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Open-label Placebo on Sleep and Pain Modulation
- ClinicalTrials.gov ID
- NCT06225817
- Acronym / sponsor ID
- HP-00105618
- Conditions
- Chronic Pain, Headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- 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?
- 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.
Detailed description
This is a longitudinal parallel randomized clinical trial with TMD participants randomly assigned to either 1) the open-label placebo (OLP) + expectations management group, 2) OLP only, and 3) the standard of care group. 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.
Phenotyping phase (2-day) The phenotyping phase includes an in-person visit and a 2-day at-home monitoring period. During the in-person visit, after signing the informed consent form with the trained staff, participants will complete a heat pain sensitivity test using a 30mmx30mm Advanced Thermal Stimulator (ATS) via the Medoc Pathway system (Medoc Advanced Medical Systems, Medoc Ltd., Israel). Painful and non-painful stimuli will be delivered to the ventral forearm of the non-dominant hand.
After the in-person visit, participants will enter a 2-day daily monitoring period, where their daily pain expectations, pain experience fluctuations, and sleep diaries will be assessed in real time and in their natural environment using the Ecological Momentary Assessment (EMA) method. Sleep profiles will be assessed using polysomnography to obtain natural sleep architectures, including the duration of different sleep stages, sleep efficiency, breathing, and body movement during sleep.
Free-choice OLP intervention Immediately following the phenotyping phase, participants will return to the laboratory before entering the 45-day intervention phase. Participants will be randomized to either 1. OLP+expectations management, 2. OLP alone, and 3. Standard of care groups. Participants in the two OLP groups will receive a bottle of 45 OLP pills. According to the free-choice paradigm, participants in the OLP group are allowed to choose whether to take the pills each day during the intervention. This paradigm maximizes participant benefit because it provides the option of "not" taking the placebo pills. Participants in the wait-list group will not receive OLP pills until the end of the 45-day monitoring period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open label placebo only arm | Experimental | Dietary Supplement: Open-label placebo pillsParticipants 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. |
| 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 | Dietary Supplement: Open-label placebo pillsParticipants 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. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open-label placebo pillsAlso: Zeebo pillsThe placebo pills in this study are empty capsules without any ingredients inside. The capsules are made of microcrystalline cellulose. | Dietary supplement | Open label placebo + expectation management, Open label placebo only arm |
Primary outcome
Chronic pain intensity
Time frame: Daily over the 45 days
Chronic pain intensity will be measured using visual analog scale ranging from 0=no pain at all to 100=maximum tolerable pain
Sleep efficiency
Time frame: Daily over the 45 days
Sleep efficiency will be measured using actigraphy motion watch ranging from 0%=efficient at all to 100% maximum efficient sleep
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data including the daily monitoring of chronic pain and sleep quality will be shared after the publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Pain and Headache, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Wang, PhD (4107067824, yang.wang@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain intensity (time frame: Daily over the 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.