K23- Physical Self Regulation vs Placebo
RecruitingNot applicableNCT06357702
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain
- Conditions
- Interventions
- Behavioral: Physical Self Regulation Telehealth
- Behavioral: Psycho-education Telehealth
- Sponsor
- Ian Boggero, PhD
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Organization
- University of Kentucky
- Start date
- 2024-04-04
- Primary completion
- 2028-06-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06357702