Initial Evidence for a Brief Psychological Telehealth Intervention for Patients with Chronic Masticatory Muscle Pain

对慢性咀嚼肌疼痛患者进行简短心理远程医疗干预的初步证据

• 批准号: 10590375
• 负责人: Ian Andres Boggero
• 金额: $ 13.13万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10590375
• 关键词: Address; Adult; Affect; Age; Awareness; COVID-19 pandemic; Caring; Chronic; Chronic low back pain; Clinical; Clinical Research; Continuity of Patient Care; Data; Dental; Dental Care; Disease; Educational process of instructing; Eligibility Determination; Exercise; Fatigue; Female; Financial Hardship; Future; Goals; Habits; Individual; Informal Social Control; Intervention; Kentucky; Knowledge; Leadership; Literature; Loneliness; Manuals; Masticatory muscles; Mediating; Mediation; Mediator; Medical; Mental Health; Mentors; Muscle relaxation phase; Musculoskeletal Pain; Myalgia; Orofacial Pain; Outcome; Pain; Pain Disorder; Pain intensity; Pain interference; Pain management; Participant; Patients; Persistent pain; Persons; Phase; Population; Prognosis; Public Health; Publishing; Quality of life; Randomized; Readiness; Relaxation; Reporting; Research; Research Personnel; Self Efficacy; Social support; Standardization; Stress; Symptoms; Testing; Training; Universities; active control; anxiety symptoms; biopsychosocial; biopsychosocial factor; career; career development; chronic pain; chronic painful condition; collaborative environment; comorbidity; coping; cost; depressive symptoms; design; efficacy testing; efficacy trial; improved; intervention effect; multidisciplinary; pain catastrophizing; pain outcome; pain reduction; post intervention; psychologic; recruit; research and development; research study; retention rate; satisfaction; skills; sleep quality; social; telehealth; treatment effect

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.

慢性咀嚼肌肉疼痛障碍（MMPD）影响5-12％的人群，是第二个 慢性下腰痛后，最常见的肌肉骨骼疼痛状况，与 每年的管理费用超过40亿美元，这是一个严重的公共卫生问题。多学科护理 将牙齿护理与心理干预相结合似乎提供了最佳的预后。身体自我 调节（PSR）是一种简短的两项心理干预，已证明会导致长期 慢性MMPD患者仅比标准牙齿护理的疼痛强度降低。很遗憾， PSR的治疗利用率很低，当时提供了较低的人，其中符合条件的患者不到50％ 选择开始治疗。提供有关远程医疗（PSR-th）的PSR可能有助于解决此问题的问题 初步数据证明了PSR-TH的80％治疗利用。需要进行全面试验以测试 PSR-TH和1）确定PSR-Th效应是由于干预本身还是非特异性效果引起的 治疗效果和2）确定治疗效果的主持人和介体。但是，其他数据 需要在进行此类试验之前。该建议的目的是获取数据以支持未来 通过实现以下特定目标，全尺度II期有效性试验。首先，psr-th和一个对照 需要在MMPD患者中正式试用干预措施，以确定招募和保留率， 干预主义的保真度以及患者报告的干预措施的可接受性，可信度和负担（AIM 1）。 其次，我们需要确定PSR-Th的潜在主持人和调解人，以便我们可以专注于 在未来的试验中彻底评估这些特定变量（AIM 2）。寻求治疗的女性 慢性MMPD将随机分配给两个50分钟的PSR-th或一个对照 干预（n = 52/组），将提供生物心理社会主持人数据（第0周），治疗可行性数据 干预后（第3周），干预后两周（第5周），立即进行调解数据， 和结果数据（疼痛强度，疼痛干扰和生活质量）之后两个星期零三个月 干预措施（第5和15周）。我们假设PSR-TH和控制干预都将 证明可行性很强（即，每周至少招募1个参与者，> 75％保留率，> 95％ 干预主义的忠诚和充分的可接受性，信誉和负担）。我们还假设该具体 生物心理社会变量将适度与PSR相关的结果变化，并且与PSR相关的变化 在感知的控制疼痛，自我效能感，应对性，词典习惯和放松的控制中，将介导治疗 效果。除了支持PSR-TH的未来功效试验外，该项目还将利用我的 以前的培训，肯塔基大学的协作环境以及世界知名的专业知识 导师为我提供临床研究，评估主持人和介体疼痛的培训， 以及研究团队的领导，为我提供了成功的独立临床研究职业的技能。