Temporomandibular Disorders (TMD)NCT07735520
Feasibility and Acceptability of OLP-EXP in Chronic Pain
A study testing OLP-EXP, OLP and EXP in people with Temporomandibular Disorders (TMD), run by University of Maryland, Baltimore.
Trial summary
The primary objective is to determine the feasibility of delivering OLP-EXP, EXP only, and OLP only over 6 weeks to adults with chronic TMD. The trial will be considered feasible for progression planning when the 6-week retention rate is at least 80% in each arm and average OLP pill adherence is at least 80% of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- OLP-EXP, OLP and EXP
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2027to 31 Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking (written and spoken)
- Age between 18 and 65 years
- Confirmed TMD for more than 3 months
- Grade II or above on the Graded Chronic Pain Scale
Who cannot join
- Personal (or family first degree) history of mania, schizophrenia, or other psychoses
- Severe psychiatric conditions require medication (e.g. schizophrenia, bipolar disorders, autism) or hospitalization within the last 3 years.
- Lifetime alcohol/drug dependence and alcohol/drug abuse in past one year
- Pregnancy/Breastfeeding
- Currently participating in another clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Feasibility and Acceptability of Expectation-optimized Open-label Placebo as an Adjuvant Treatment for Chronic Pain
The primary objective is to determine the feasibility of delivering OLP-EXP, EXP only, and OLP only over 6 weeks to adults with chronic TMD. The trial will be considered feasible for progression planning when the 6-week retention rate is at least 80% in each arm and average OLP pill adherence is at least 80% of prescribed days in each OLP arm.
Primary hypothesis: Each intervention arm will meet the prespecified 6-week retention benchmark, and each OLP arm will meet the prespecified pill-adherence benchmark.
Read more
The secondary objectives are:
- To evaluate acceptability of each intervention using the TFA measurement and semi-structured interviews.
- To assess the feasibility of collecting daily EMA, continuous actigraphy, weekly questionnaires, and 3-, 6-, and 12-month follow-up assessments.
- To identify intervention barriers, facilitators, perceived benefits, burden, ethical concerns, and recommendations for a future fully powered efficacy trial.
- To estimate variability, missingness, and measure reliability needed to select outcomes and design a future trial.
Read the detailed description
Pain lasting for more than 3 months becomes chronic, and is prevalent across the global population. Among chronic pain conditions, temporomandibular disorders (TMD), a common orofacial pain condition affecting 9 to 30% of the general population, have attracted the attention of clinical providers and researchers. The high incidence and disastrous consequences of TMD underscore the need for effective and safe treatments.
Clinical and mechanistic research has shown substantial placebo responses in pain trials, highlighting the great potential to harness placebo mechanisms in clinical care. For example, a meta-analysis estimated that placebo responses could account for up to 66% of observed improvement in migraine-related outcomes.8 In one efficacy and safety trial of an intravenously eptinezumab, as much as 74% of the apparent benefit was attributed to placebo responses.
In ethically translating placebo mechanisms, open-label placebo (OLP) offers an adjuvant to current pharmacological and psychological treatments for chronic pain. OLP refers to the transparent, honest administration of placebos. Studies have found that people can still experience improvements in symptoms even after receiving OLP.
Previous RCT has demonstrated efficacy of EXPECT in a pilot clinical trial showing a reduction in the length of hospital stay after cardiac surgery. Moreover, participants who received EXPECT showed greater improvements in disability, and reduced pro-inflammatory cytokine concentrations compared to those in the treatment as usual group.
The investigators aim to develop an expectation-optimized OLP intervention (OLP-EXP) that could potentially maximize OLP effects and yield larger improvement in managing chronic pain, and an EXP only intervention that delivers expectations induced analgesia without the negative connotations of "placebo".
The investigators hypothesize that the adapted OLP-EXP and EXP only will be feasible and well-accepted in chronic pain population.
This is a single-site, three-arm, parallel-group, randomized pilot/feasibility clinical trial. Fifty-seven adults with chronic TMD will be randomized 1:1:1 to OLP-EXP, EXP only, or OLP only. All participants will continue treatment as usual. The intervention period is 6 weeks, followed by remote assessments at 3, 6, and 12 months.
The intervention arms are:
- OLP-EXP: Expectation optimization addressing benefit, personal-control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters.
- EXP only: Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters.
- OLP only: Standard transparent OLP rationale and daily OLP pills for 6 weeks, with neutral matched study contacts that do not deliver expectation-optimization content.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- OLP-EXP, OLP, EXP
- Keywords
- expectations, chronic pain management, open-label placebo, psychological interventions
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLP-EXPOther
Also called Zeebo pills, Expectations optimization intervention
Expectation optimization addressing benefit, personal control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters.
OLPDietary supplement
Also called Zeebo pills
Open-label placebo pills. The placebo pills in this study are empty capsules without any ingredients inside. The capsules are made of microcrystalline cellulose.
EXPBehavioural
Also called Expectations optimization intervention
Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters.
| Study group | Role | What they receive |
|---|---|---|
| OLP-EXP | Experimental | Expectation optimization addressing benefit, personal-control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters. Receives: Other: OLP-EXP |
| EXP | Experimental | Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters. Receives: Behavioral: EXP |
| OLP | Active comparator | Standard transparent OLP rationale and daily OLP pills for 6 weeks, with neutral matched study contacts that do not deliver expectation-optimization content. Receives: Dietary Supplement: OLP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
Measured: At the enrollment
Retention rate
Retention rate: the proportion (%) of enrolled participants who finished the study
Measured: End of week 6
Daily survey completion rate
Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
Measured: End of week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a longitudinal pilot randomized clinical trial with chronic TMD pain participants randomly assigned to either 1\) OLP-EXP, 2) OLP alone; or 3) EXP alone groups. The EXP intervention and OLP rational instructions will be launched at in-person Visit 1. Following Visit 1, 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
- 57 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
- NCT07735520
- Sponsor's protocol ID
- HP-00120206
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Acceptability of Expectation-optimized Open-label Placebo as an Adjuvant Treatment for Chronic Pain
- ClinicalTrials.gov ID
- NCT07735520
- Acronym / sponsor ID
- HP-00120206
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- expectations, chronic pain management, open-label placebo, psychological interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jul 2026 (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 primary objective is to determine the feasibility of delivering OLP-EXP, EXP only, and OLP only over 6 weeks to adults with chronic TMD. The trial will be considered feasible for progression planning when the 6-week retention rate is at least 80% in each arm and average OLP pill adherence is at least 80% of prescribed days in each OLP arm.
Primary hypothesis: Each intervention arm will meet the prespecified 6-week retention benchmark, and each OLP arm will meet the prespecified pill-adherence benchmark.
The secondary objectives are:
- To evaluate acceptability of each intervention using the TFA measurement and semi-structured interviews.
- To assess the feasibility of collecting daily EMA, continuous actigraphy, weekly questionnaires, and 3-, 6-, and 12-month follow-up assessments.
- To identify intervention barriers, facilitators, perceived benefits, burden, ethical concerns, and recommendations for a future fully powered efficacy trial.
- To estimate variability, missingness, and measure reliability needed to select outcomes and design a future trial.
Detailed description
Pain lasting for more than 3 months becomes chronic, and is prevalent across the global population. Among chronic pain conditions, temporomandibular disorders (TMD), a common orofacial pain condition affecting 9 to 30% of the general population, have attracted the attention of clinical providers and researchers. The high incidence and disastrous consequences of TMD underscore the need for effective and safe treatments.
Clinical and mechanistic research has shown substantial placebo responses in pain trials, highlighting the great potential to harness placebo mechanisms in clinical care. For example, a meta-analysis estimated that placebo responses could account for up to 66% of observed improvement in migraine-related outcomes.8 In one efficacy and safety trial of an intravenously eptinezumab, as much as 74% of the apparent benefit was attributed to placebo responses.
In ethically translating placebo mechanisms, open-label placebo (OLP) offers an adjuvant to current pharmacological and psychological treatments for chronic pain. OLP refers to the transparent, honest administration of placebos. Studies have found that people can still experience improvements in symptoms even after receiving OLP.
Previous RCT has demonstrated efficacy of EXPECT in a pilot clinical trial showing a reduction in the length of hospital stay after cardiac surgery. Moreover, participants who received EXPECT showed greater improvements in disability, and reduced pro-inflammatory cytokine concentrations compared to those in the treatment as usual group.
The investigators aim to develop an expectation-optimized OLP intervention (OLP-EXP) that could potentially maximize OLP effects and yield larger improvement in managing chronic pain, and an EXP only intervention that delivers expectations induced analgesia without the negative connotations of "placebo".
The investigators hypothesize that the adapted OLP-EXP and EXP only will be feasible and well-accepted in chronic pain population.
This is a single-site, three-arm, parallel-group, randomized pilot/feasibility clinical trial. Fifty-seven adults with chronic TMD will be randomized 1:1:1 to OLP-EXP, EXP only, or OLP only. All participants will continue treatment as usual. The intervention period is 6 weeks, followed by remote assessments at 3, 6, and 12 months.
The intervention arms are:
- OLP-EXP: Expectation optimization addressing benefit, personal-control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters.
- EXP only: Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters.
- OLP only: Standard transparent OLP rationale and daily OLP pills for 6 weeks, with neutral matched study contacts that do not deliver expectation-optimization content.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a longitudinal pilot randomized clinical trial with chronic TMD pain participants randomly assigned to either 1) OLP-EXP, 2) OLP alone; or 3) EXP alone groups. The EXP intervention and OLP rational instructions will be launched at in-person Visit 1. Following Visit 1, 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 |
|---|---|---|
| OLP-EXP | Experimental | Other: OLP-EXPExpectation optimization addressing benefit, personal-control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters. |
| EXP | Experimental | Behavioral: EXPExpectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters. |
| OLP | Active comparator | Dietary Supplement: OLPStandard transparent OLP rationale and daily OLP pills for 6 weeks, with neutral matched study contacts that do not deliver expectation-optimization content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking (written and spoken)
- Age between 18 and 65 years
- Confirmed TMD for more than 3 months
- Grade II or above on the Graded Chronic Pain Scale
Key exclusion criteria (5 listed)
- Personal (or family first degree) history of mania, schizophrenia, or other psychoses
- Severe psychiatric conditions require medication (e.g. schizophrenia, bipolar disorders, autism) or hospitalization within the last 3 years.
- Lifetime alcohol/drug dependence and alcohol/drug abuse in past one year
- Pregnancy/Breastfeeding
- Currently participating in another clinical trial
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 |
|---|---|---|
| OLP-EXPAlso: Zeebo pills, Expectations optimization interventionExpectation optimization addressing benefit, personal control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters. | Other | OLP-EXP |
| OLPAlso: Zeebo pillsOpen-label placebo pills. The placebo pills in this study are empty capsules without any ingredients inside. The capsules are made of microcrystalline cellulose. | Dietary supplement | OLP |
| EXPAlso: Expectations optimization interventionExpectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters. | Behavioural | EXP |
Primary outcome
Enrollment rate
Time frame: At the enrollment
Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
Retention rate
Time frame: End of week 6
Retention rate: the proportion (%) of enrolled participants who finished the study
Daily survey completion rate
Time frame: End of week 6
Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
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 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing OLP-EXP, OLP and EXP in people with Temporomandibular Disorders (TMD), run by University of Maryland, Baltimore.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (410-706-7824, yang.wang@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: At the enrollment). The study lists 3 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 25 Aug 2026.