Recruiting

K23- Physical Self Regulation

Sponsor:

Ian Boggero, PhD

Code:

NCT06357702

Conditions

Temporomandibular Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical Self Regulation Telehealth

Psycho-education Telehealth

Study Details

Brief 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.

Conditions

Temporomandibular Disorder

Study ID

NCT06357702

Start date

Apr 4, 2024

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Physical Self Regulation

2 experimental telehealth sessions approximately 2 weeks apart

active comparator: Psycho-education

2 control telehealth sessions approximately 2 weeks apart

Interventions

Physical Self Regulation Telehealth

2 sessions of an intervention delivered via telehealth. Session 1 includes awareness and strategies for monitoring habits and 4 exercises to practice 5 times per day. Session 2 will be 2 weeks later and is a review of session 1 and an introduction to diaphragmatic breathing. Breathing is practiced for 15 minutes twice per day.

Psycho-education Telehealth

2 sessions of an intervention delivered via telehealth. Session 1 includes discussing trigeminal nerve function, jaw and muscle anatomy, posture, pain referral patterns, and stress biology. Participants rate pain and jaw fatigue 5 times per day. Session 2 will be 2 weeks later and consists of checking on the homework and information from session 1,followed by a discussion of autonomic nervous system activity, and a discussion of sleep quality and sleep hygiene. Participants will be instructed to rate their stress levels, pain, and mood several times per day, similar to the times when participants in the PSR-TH condition would be practicing diaphragmatic breathing

Primary outcome measure

  • Change in pain intensity [ Time Frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15) ]
  • Change in pain interference [ Time Frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15) ]
  • Change in quality of life [ Time Frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15) ]
  • Recruitment rate [ Time Frame: Baseline (week 0) ]
  • Retention rate [ Time Frame: Follow up Visit at Month 3 (week 15) ]
  • Interventionist Fidelity Session 1 [ Time Frame: Study Visit 1 (week 1) ]
  • Interventionist Fidelity Session 2 [ Time Frame: Study Visit 2 (week 3) ]
  • Treatment Acceptability [ Time Frame: Study Visits 1 and 2 (up to 2 weeks) ]
  • Treatment Credibility [ Time Frame: Study Visits 1 and 2 (up to 2 weeks) ]
  • Research Burden [ Time Frame: Follow up Visit at Month 3 (week 15) ]

Central Contacts and Locations

Central contacts

Courtney Brown

8593230246cbrown@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Ian Boggero, Ph.D.

8595623291ian.boggero@uky.edu

More Information

Sponsor

Ian Boggero, PhD

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • myalgia
  • orofacial
  • telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ian Boggero, PhD on 2026-06-17.