What this study is
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.
What's being tested
- Physical Self Regulation Telehealth
Intervention · BEHAVIORAL
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
Intervention · BEHAVIORAL
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
Study details
- Official title
- Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain
- Sponsor
- Ian Boggero, PhD
- Conditions
- Temporomandibular Disorder
- Enrolling
- 104 people
- Starts
- 2024-04-04
- Est. completion
- 2028-08-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Kentucky
Lexington, Kentucky, United States
- Ian Boggero, Ph.D. · Contact8595623291ian.boggero@uky.edu
Recruiting
Study team
Sponsor
Ian Boggero, PhD
Study ID 81313
Principal investigator
Ian Boggero, PhD
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.