K23- Physical Self Regulation vs Placebo

NCT06357702 | Recruiting

• 2 other identifiers: 81313K23DE031807
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Temporomandibular Disorder

Keywords

myalgia; orofacial; telehealth

Outcome Measures

Primary Outcomes (10)

• Change in pain intensity

  Pain intensity will be measured with the Graded Chronic Pain Scale Pain Intensity Subscale. Participants rate their worst pain, least pain, average pain, in the last 24 hours and pain right now using an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater pain. Scores are averaged for the total pain intensity score.

  Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)

• Change in pain interference

  Pain interference will be measured with the The Graded Chronic Pain Scale Pain Interference Subscale. Participants rate how much the pain has interfered with 7 daily activities on an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater interference. Pain interference is scored as the mean of the 7 items.

  Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)

• Change in quality of life

  Quality of life will be measured with the Satisfaction with Life Scale. Likert scale with 7 items scores range from 7 to 35 with higher scores equating to better quality of life.

  Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)

• Recruitment rate

  Number of patients who are consented into the study per month

  Baseline (week 0)

• Retention rate

  Number of consented patients who also complete the three-month follow-up assessment

  Follow up Visit at Month 3 (week 15)

• Interventionist Fidelity Session 1

  Each intervention session will have a checklist of items that need to be covered by the interventionists. All study sessions will be audio-recorded. A subset of all audio recordings will be checked for interventionist fidelity, defined by the following percentage: Total items covered by interventionist/ Total possible items to be covered in that session

  Study Visit 1 (week 1)

• Interventionist Fidelity Session 2

  Each intervention session will have a checklist of items that need to be covered by the interventionists. All study sessions will be audio-recorded. A subset of all audio recordings will be checked for interventionist fidelity, defined by the following percentage: Total items covered by interventionist/ Total possible items to be covered in that session

  Study Visit 2 (week 3)

• Treatment Acceptability

  Treatment Acceptability and Adherence Scale. The scale will measure what participants overall evaluation of if treatment was fair, reasonable, and appropriate. 6 item Likert scale with scores on each item ranging from 1 to 9 with higher scores equating to greater acceptability. Acceptability is scored as the mean of the 6 items.

  Study Visits 1 and 2 (up to 2 weeks)

• Treatment Credibility

  Treatment Credibility/Expectancy Scale will measure how feasible is it the intervention will work and work for the participant. 6 item Likert scale with scores on each item ranging from 1 to 9 with higher scores equating to greater credibility. Acceptability is scored as the mean of the 6 items.

  Study Visits 1 and 2 (up to 2 weeks)

• Research Burden

  Research burden will be measured by administering 8 selected items from the Perceived Research Burden Assessment. Participants rate how burdensome the study was on an 8 item assessment on a 5 point Likert scale ranging from strongly disagree to strongly agree with higher scores equating to greater burden. Burden is scored as mean of the 8 items.

  Follow up Visit at Month 3 (week 15)

Secondary Outcomes (1)

• Treatment Satisfaction

  2-week follow-up (week 5)

Study Arms (2)

Physical Self Regulation

EXPERIMENTAL

2 experimental telehealth sessions approximately 2 weeks apart

Behavioral: Physical Self Regulation Telehealth

Psycho-education

ACTIVE COMPARATOR

2 control telehealth sessions approximately 2 weeks apart

Behavioral: Psycho-education Telehealth

Interventions

Physical Self Regulation Telehealth 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.

Also known as: PSR-TH

Physical Self Regulation

Psycho-education Telehealth 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

Also known as: Control

Psycho-education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Ian Boggero, PhD: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myalgia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Boggero, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Brown

CONTACT

8593230246; cbrown@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)