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Principal Investigator: Ian Andres Boggero
Organization: UNIVERSITY OF KENTUCKY
Fiscal Year: 2024
Award: $125,910
Funding agency: National Institute of Dental and Craniofacial Research
Chronic masticatory muscle pain disorders (MMPD) affect between 5-12% of the population, are the second
most common musculoskeletal pain conditions after chronic low back pain, and are associated with
management costs of over $4 billion per year, presenting a serious public health issue. Multidisciplinary care
combining dental care with psychological interventions appears to offer the best prognosis. Physical self-
regulation (PSR) is a brief, two-session psychological intervention that has been shown to lead to long-term
reductions in pain intensity over standard dental care alone in patients with chronic MMPD. Unfortunately,
treatment utilization for PSR is low when it is offered in-person, with fewer than 50% of eligible patients
choosing to begin treatment. Offering PSR over telehealth (PSR-TH) may help address this issue, with
preliminary data demonstrating >80% treatment utilization for PSR-TH. A full-scale trial is needed to test the
efficacy of PSR-TH and 1) determine if PSR-TH effects are due to the intervention itself or to nonspecific
treatment effects and 2) determine moderators and mediators of treatment effects. However, additional data
are needed before such a trial can be conducted. The goal of this proposal is to obtain data to support a future
full-scale Phase II efficacy trial by achieving the following specific aims. First, PSR-TH and a control
intervention need to be formally piloted in patients with MMPD to determine recruitment and retention rates,
interventionist fidelity, and patient-reported acceptability, credibility, and burden of the interventions (Aim 1).
Second, we need to identify potential moderators and mediators of PSR-TH so that we can focus on
thoroughly assessing those specific variables in the future trial (Aim 2). Treatment-seeking females with
chronic MMPD will be randomly assigned to two 50-min telehealth sessions of PSR-TH or a control
intervention (N=52/group) and will provide biopsychosocial moderator data (week 0), treatment feasibility data
immediately following the intervention (week 3), mediation data two weeks following the intervention (week 5),
and outcome data (pain intensity, pain interference, and quality of life) two weeks and three months following
the intervention (weeks 5 and 15). We 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). We also hypothesize that specific
biopsychosocial variables will moderate PSR-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. In addition to supporting a future efficacy trial of PSR-TH, the proposed project will leverage my
previous training, a collaborative environment at the University of Kentucky, and the expertise of world-renown
mentors to provide me training in clinical research, assessment of moderators and mediators in orofacial pain,
and leadership of research teams, giving me the skills for a successful independent clinical research career.
Terms: <21+ years old><Aching muscles><Address><Adult><Adult Human><Affect><Age><Awareness><Business-Friendly Atmosphere><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Caring><Chronic><Chronic low back pain><Clinical><Clinical Research><Clinical Study><Continuity of Care><Continuity of Patient Care><Continuum of Care><Data><Dental><Dental Care><Dental Procedure><Development and Research><Disease><Disorder><Educational process of instructing><Eligibility><Eligibility Determination><Emotional Depression><Exercise><Fatigue><Female><Financial Hardship><Future><Goals><Habits><Individual><Informal Social Control><Intervention><Intervention Strategies><Investigators><Kentucky><Knowledge><Lack of Energy><Leadership><Literature><Loneliness><Manuals><Masticatory muscles><Mediating><Mediation><Mediator><Medical><Mental Health><Mental Hygiene><Mentors><Muscle Relaxation><Muscle discomfort><Muscle pain><Muscle pain/fibrositis><Muscle relaxation phase><Muscle sorenesss><Musculoskeletal Pain><Myalgia><Myalgic><Myodynia><Myoneuralgia><Myosalgia><Negotiating><Negotiation><Orofacial Pain><Outcome><Pain><Pain Control><Pain Disorder><Pain Therapy><Pain intensity><Pain interference><Pain management><Painful><Participant><Patients><Persistent pain><Persons><Phase><Population><Preparedness><Prognosis><Protocol Screening><Psychological Health><Public Health><Publishing><QOL><Quality of life><R & D><R&D><Randomized><Readiness><Relaxation><Reporting><Research><Research Personnel><Researchers><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Self Efficacy><Self Regulation><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Social support><Standardization><Stress><Symptoms><Teaching><Testing><Training><Universities><active control><adulthood><ages><anxiety symptoms><anxious symptom><biopsychosocial><biopsychosocial factor><biopsychosocial variable><business-friendly environment><career><career development><chronic pain><chronic pain condition><chronic pain disorder><chronic painful condition><co-morbid><co-morbidity><collaborative atmosphere><collaborative environment><comorbidity><constant pain><coping><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><dental service><depression symptom><depressive><depressive symptoms><design><designing><efficacy testing><efficacy trial><female patients><financial adversity><financial burden><financial distress><financial insecurity><financial strain><financial stress><improved><interactive atmosphere><interactive environment><interdisciplinary atmosphere><interdisciplinary environment><intervention effect><interventional strategy><lasting pain><lonely><mastication muscle><multidisciplinary><on-going pain><ongoing pain><oral facial pain><pain catastrophizing><pain outcome><pain reduction><pain treatment><pain-related outcome><patients being female><patients being women><patients who are female><peer-group atmosphere><peer-group environment><post intervention><psychologic><psychological><quality of sleep><randomisation><randomization><randomly assigned><recruit><reduce pain><research and development><research study><retention rate><retention strategy><satisfaction><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><skills><sleep quality><social><social support network><telehealth><treatment effect><women patients>