K23- Physical Self Regulation vs Placebo

NCT ID: NCT06357702

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2028-08-31

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.

Detailed Description

Chronic masticatory muscle pain disorders (MMPD) consist of several conditions (e.g., myofascial pain, local myalgia) characterized by pain in the muscles of the temporomandibular area lasting longer than three months. MMPD affects 5-12% of adults, is the most common cause of chronic non-odontogenic facial pain, and the second most common musculoskeletal pain condition after chronic low back pain. MMPD is associated with pain-related interference with daily activities, diminished quality of life (QoL) and costs of > $4 billion/year in the US, representing a serious public health issue. Chronic MMPD is most effectively managed with multidisciplinary treatment. One brief psychological intervention that has been particularly promising for improving orofacial pain outcomes and QoL in MMPD is physical self-regulation (PSR). Relative to standard dental care (SDC) alone, those who received SDC+PSR experienced reduced pain intensity up to 6.5 months later (Cohen's D = 0.67). These data suggest that PSR may be a promising intervention for improving pain outcomes in MMPD. Despite the promise of PSR, one of its major shortcomings is that treatment utilization is low, with less than 50% of eligible patients beginning PSR when offered in person. Offering PSR via telehealth may be a solution. Telehealth interventions improve access to care and are preferred by patients over in-person interventions. Preliminary data of treatment utilization for PSR-TH are promising, with over 80% of eligible patients beginning the intervention when offered via telehealth. However, it is not known if PSR-TH is efficacious above and beyond nonspecific treatment effects (e.g., people having more contact with a therapist, people inadvertently modifying their behavior to please their therapist, natural regression to the mean of pain symptoms, etc.). The efficacy of PSR-TH to treat MMPD needs to be formally tested; however, additional data regarding feasibility and moderating/mediating factors of PSRTH are needed to support such a trial. First, PSR-TH and a control intervention need to be formally piloted in patients with MMPD to 1) determine how willing patients are to participate in research (i.e., recruitment), 2) determine the completion rates for both interventions (i.e., retention), 3) quantify how well interventionists are able to deliver the interventions in a standardized way (i.e., fidelity), and 4) establish patients' perceived acceptability, credibility, and burden of both interventions. Second, a body of work has examined biopsychosocial moderators and mediators of responses to psychological interventions (e.g., cognitive behavioral therapy, [CBT]) in MMPD, but never of PSR-TH specifically. Identifying relevant moderators and mediators in this project will allow for more thorough assessment of those specific relationships in a future Phase II trial, advancing understanding of how PSR-TH works, and for whom. To accomplish these aims, treatment-seeking patients with chronic MMPD will be randomly assigned to two 50-min telehealth sessions of PSR or a control intervention (N=52/group) and will provide biopsychosocial moderator, mediator, and outcome data at baseline, after each intervention sessions, two weeks following the intervention, and three months following the intervention. The 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). The 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical Self Regulation

2 experimental telehealth sessions approximately 2 weeks apart

Group Type: EXPERIMENTAL

Physical Self Regulation Telehealth

Intervention Type: 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.

Psycho-education

2 control telehealth sessions approximately 2 weeks apart

Group Type: ACTIVE_COMPARATOR

Psycho-education Telehealth

Intervention Type: 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

Interventions

Physical Self Regulation Telehealth

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.

Intervention Type: BEHAVIORAL

Psycho-education Telehealth

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

Intervention Type: BEHAVIORAL

Other Intervention Names

PSR-TH; Control

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Ian Boggero, PhD

OTHER

Sponsor Role: lead

Responsible Party

Ian Boggero, PhD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ian Boggero, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Courtney Brown

Role: CONTACT

cbrown@uky.edu

8593230246

Facility Contacts

Ian Boggero, Ph.D.

Role: primary

ian.boggero@uky.edu

8595623291

Other Identifiers

K23DE031807

Identifier Type: NIH

Identifier Source: secondary_id

View Link

81313

Identifier Type: -

Identifier Source: org_study_id