Feasibility and Acceptability of OLP-EXP in Chronic Pain (NCT07735520) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility and Acceptability of OLP-EXP in Chronic Pain
57 participantsStarted 2027-07-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.