Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06357702

K23- Physical Self Regulation vs Placebo

Led by Ian Boggero, PhD · Updated on 2025-04-22

104

Participants Needed

1

Research Sites

230 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

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.

CONDITIONS

Official 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 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)
Not Eligible

You will not qualify if you...

  • 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 have a physician's written authorization to participate
  • Patients on medication for diabetes or seizures must have written clearance from their medical providers
  • History of seizures within the last 12 months
  • Pain duration less than 3 months
  • Pregnant or planning to become pregnant

AI-Screening

AI-Powered Screening

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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

CONTACT

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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