Actively Recruiting
Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain
Led by Ian Boggero, PhD · Updated on 2025-04-22
104
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
Ian Boggero, PhD
Lead Sponsor
N
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a brief behavioral telehealth intervention called Physical Self-Regulation (PSR-TH) for adults with chronic masticatory muscle pain disorders (MMPD), conditions causing pain in jaw muscles lasting more than three months. This study aims to assess the feasibility of PSR-TH compared to a control psycho-education intervention, examining how well patients respond and identifying factors that influence treatment effects. Chronic MMPD affects 5-12% of adults and significantly impacts daily life and quality of life, making effective treatments important. Participants will be randomly assigned to receive either two 50-minute telehealth sessions of PSR-TH, which include self-monitoring exercises and diaphragmatic breathing practice, or two 50-minute telehealth psycho-education sessions covering nerve function, anatomy, posture, stress, and sleep hygiene. Sessions are scheduled about two weeks apart. Both groups will receive similar attention and follow-up measures to evaluate treatment effects and acceptability. During the study, participants will provide data on pain intensity, pain interference, quality of life, and treatment satisfaction at baseline, after each session, two weeks post-intervention, and at three months. Researchers will monitor recruitment, retention, intervention delivery quality, acceptability, credibility, and burden. The total study duration includes these assessments and follow-ups to understand how PSR-TH works and whom it may help best.
CONDITIONS
Brief Title
K23- Physical Self Regulation vs Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a primary or secondary diagnosis of chronic masticatory muscle pain
- Provide signed and dated electronic informed consent form
- Willing to comply with all study procedures
- Male or female aged 18 years or older
- Able to speak and write in English
- Seeking treatment at UKOPC
- Have access to telehealth visits through internet and a device with audio/visual capabilities
You will not qualify if you...
- Currently using anticonvulsant, steroid, antispasmodic, or opioid medication for chronic pain two or more days per week
- Have current or recent (within last 3 months) psychotic, suicidal, homicidal, or manic symptoms without psychiatric stability for 6 months under medical care
- On medication for diabetes or seizures without medical clearance
- History of seizures within the last 12 months
- Pain lasting less than 3 months
- Pregnant or planning to become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (telehealth)
Duration - Approximately 4 weeks
Participants receive two telehealth sessions approximately 2 weeks apart, either physical self-regulation or psycho-education interventions.
2 telehealth sessions spaced about 2 weeks apart
Duration - Up to 3 months after treatment
Participants provide outcome data and assessments two weeks after the last session and again at three months post intervention.
1 follow-up visit at 2 weeks post intervention and 1 follow-up visit at 3 months post intervention
Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
Research Team
C
Courtney Brown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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