K23- Physical Self Regulation vs Placebo

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIan Boggero, PhD

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Physical Self Regulation Telehealth
  • Psycho-education Telehealth

Treatment groups

104 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ian Boggero, PhD

Lead sponsor

University of Kentucky

Sponsor institution

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator