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NCT06357702
K23- Physical Self Regulation vs Placebo
Conditions: Temporomandibular Disorder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 104
Sponsor: Ian Boggero, PhD
Location: University of Kentucky Lexington Kentucky
Summary
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.
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
Source: ClinicalTrials.gov (NCT06357702). StuddyBuddy aggregates publicly available trial information.