This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, \>75% retention, \>95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects.
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:
* Have a primary or secondary chronic masticatory muscle pain diagnosis
* Provide signed and dated electronic informed consent form
* Willing to comply with all study procedures
* Male or female, aged 18 or over
* Be able to speak and write in English
* Be seeking treatment at UKOPC
* Have the ability to perform telehealth visits (i.e., internet access, phone, tablet, computer or other device with audio/visual capabilities)
Exclusion Criteria:
* Currently using anticonvulsant, steroid, antispasmodic, or opioid medication for chronic pain 2 days a week or more often
* Have current or recent (within the last 3 months) psychotic, suicidal, homicidal, or manic symptoms. Participants with a history of such symptoms must demonstrate psychiatric stability for at least 6 months and be under the care of a medical or mental health professional for symptom management prior to being eligible for the study (must have written note from physician authorizing them to participate)
* Patients who are currently on medication for diabetes or seizures (i.e., epilepsy) must have written clearance from their medical providers prior to participating in the study
* History of seizures within the last 12 months
* Pain duration less than 3 months
* Pregnant or planning to become pregnant
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.
1This trial is testing a physical self-regulation approach against a placebo for temporomandibular disorder — can you help me understand what 'physical self-regulation' actually involves as a treatment, and how it compares to what I'm already doing to manage my jaw pain?
2Since this study is listed as Phase NA and appears to be focused on feasibility measures like recruitment rates, retention, and research burden alongside pain outcomes, does that mean it's still in early stages of figuring out whether this approach is worth a larger trial, and what does that mean for how much is already known about its safety and effectiveness?
3The trial is measuring both pain intensity and pain interference with daily life — given how my TMD currently affects my day-to-day functioning, do you think I'm a realistic candidate worth discussing with the research team, or would a more established standard treatment make more sense for me right now?
4The study also measures treatment acceptability and credibility, which suggests patients' experiences with the intervention matter a lot — can you tell me what the time commitment looks like for the sessions, and whether the demands of participating would be realistic given my current schedule and health situation?
5Since this is a placebo-controlled trial, there's a chance I could be assigned to the placebo group rather than the active treatment — how would that affect my care during the study, and would I still have access to my usual TMD treatments if my symptoms got worse?
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.
What they're measuring
1
Change in pain intensity
Timeframe: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
2
Change in pain interference
Timeframe: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)
3
Change in quality of life
Timeframe: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)