Health TrialsbyHealthPanel

Feasibility and Acceptability of OLP-EXP in Chronic Pain

ConditionTemporomandibular Disorders (TMD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • OLP-EXP

    Other intervention

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

  • 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.

  • EXP

    Behavioral

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

Treatment groups

57 Participants
are divided into 3 treatment groups
Group A: OLP-EXPExperimental treatment 1 intervention
Group B: EXPExperimental treatment 1 intervention
Group C: OLPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Enrollment rate

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

Time frame
At the enrollment
2

Retention rate

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

Time frame
End of week 6
3

Daily survey completion rate

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

Time frame
End of week 6

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: