Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06357702

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (telehealth)

Outpatient Treatment

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

Follow-up

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

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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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