Feasibility and Acceptability of OLP-EXP in Chronic Pain

NCT07735520 | Not Yet Recruiting DMC

• 1 other identifier: HP-00120206
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief 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 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:

1. 1.To evaluate acceptability of each intervention using the TFA measurement and semi-structured interviews.
2. 2.To assess the feasibility of collecting daily EMA, continuous actigraphy, weekly questionnaires, and 3-, 6-, and 12-month follow-up assessments.
3. 3.To identify intervention barriers, facilitators, perceived benefits, burden, ethical concerns, and recommendations for a future fully powered efficacy trial.
4. 4.To estimate variability, missingness, and measure reliability needed to select outcomes and design a future trial.

Conditions

Temporomandibular Disorders (TMD)

Keywords

expectations; chronic pain management; open-label placebo; psychological interventions

Outcome Measures

Primary Outcomes (3)

• Enrollment rate

  Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.

  At the enrollment

• Retention rate

  Retention rate: the proportion (%) of enrolled participants who finished the study

  End of week 6

• Daily survey completion rate

  Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.

  End of week 6

Study Arms (3)

OLP-EXP

EXPERIMENTAL

Expectation optimization addressing benefit, personal-control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters.

Other: OLP-EXP

EXP

EXPERIMENTAL

Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters.

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.

Dietary Supplement: OLP

Interventions

OLP-EXP OTHER

Expectation optimization addressing benefit, personal control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters.

Also known as: Zeebo pills, Expectations optimization intervention

OLP-EXP

OLP DIETARY_SUPPLEMENT

Open-label placebo pills. 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

OLP

EXP BEHAVIORAL

Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters.

Also known as: Expectations optimization intervention

EXP

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Yang Wang, PhD

CONTACT

410-706-7824; yang.wang@umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this open-label placebo trial, both the experimenters and participants will be aware of the arms assignment. The outcome assessor will be blinded about the group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07