Home › Temporomandibular Disorders › NCT06357702
K23- Physical Self Regulation vs Placebo
Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Physical Self Regulation Telehealth (behavioral)
- Psycho-education Telehealth (behavioral)
Sponsor: Ian Boggero, PhD · Participants: 104 · Started: Apr 4, 2024
Contact the study team
- Courtney Brown · Phone: 8593230246
Official record on ClinicalTrials.gov — NCT06357702
Locations in the U.S.
| Kentucky | University of Kentucky, Lexington |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.