K23- Physical Self Regulation vs Placebo

Recruiting now · Not applicable

Conditions studied: Temporomandibular Disorder

In brief

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.

Key facts

Study ID

NCT06357702

Run by

Ian Boggero, PhD

People needed

104

Starts

2024-04-04

Expected to finish

2028-08-31

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Kentucky — Lexington, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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