K23- Physical Self Regulation vs Placebo

Description

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.

Conditions

Temporomandibular Disorder

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Study Overview

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Study Details

Study overview

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.

Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain

K23- Physical Self Regulation vs Placebo

Condition
Temporomandibular Disorder
Intervention / Treatment

-

Contacts and Locations

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ian Boggero, PhD,

Ian Boggero, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

2028-08-31