Behavioral intervention for chronic jaw pain via telehealth
Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain
This study is testing a new online program to help people with chronic jaw pain feel better by teaching them how to manage their pain and comparing it to a regular education program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06357702 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a brief behavioral intervention called Physical Self-Regulation (PSR) for patients suffering from chronic masticatory muscle pain. Participants will be randomly assigned to receive either the PSR intervention or a control psycho-education intervention, both delivered through telehealth. The study aims to assess the feasibility of these interventions, including recruitment rates and participant retention, while also exploring how various biopsychosocial factors may influence outcomes. Follow-up assessments will occur two weeks and three months after the interventions to evaluate their impact on pain and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with a diagnosis of chronic masticatory muscle pain who are seeking treatment.
Not a fit: Patients currently using certain medications for chronic pain or those with recent severe psychiatric symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve pain management and quality of life for patients with chronic jaw pain.
How similar studies have performed: Previous studies have shown promising results for similar telehealth interventions in managing chronic pain, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Ian Boggero, PhD — University of Kentucky
- Study coordinator: Courtney Brown
- Email: cbrown@uky.edu
- Phone: 8593230246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.