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.

慢性咀嚼肌疼痛障碍（MMPD）影响5-12%的人口，是第二大 最常见的肌肉骨骼疼痛条件后，慢性腰痛，并与 每年的管理费用超过40亿美元，构成严重的公共卫生问题。多学科护理 将牙科护理与心理干预相结合似乎提供了最佳的预后。身体自我- PSR是一种简短的两次心理干预，已被证明可以导致长期的 在慢性MMPD患者中，与单独的标准牙科护理相比，疼痛强度降低。不幸的是， 当亲自提供PSR治疗时，PSR的治疗利用率较低，符合条件的患者不到50% 选择开始治疗。提供远程医疗PSR（PSR-TH）可能有助于解决这一问题， 初步数据表明PSR-TH的处理利用率>80%。需要进行全面的试验来测试 PSR-TH的疗效和1）确定PSR-TH效应是由于干预本身还是由于非特异性 治疗效果和2）确定治疗效果的调节剂和介质。然而，额外的数据 在进行这样的审判之前，必须有这样的证据。该提案的目标是获得数据，以支持未来的 全面II期疗效试验，实现以下具体目标。首先，PSR-TH和控制 干预需要在MMPD患者中正式试点，以确定招募和保留率， 干预者的忠诚度，以及患者报告的可接受性，可信度和干预负担（目标1）。 其次，我们需要确定PSR-TH的潜在调节者和中介者，以便我们能够专注于 在未来的试验中彻底评估这些特定变量（目标2）。寻求治疗的女性， 慢性MMPD将被随机分配到两个50分钟的PSR-TH或对照远程医疗会话 干预（N=52/组），并将提供生物心理社会调节数据（第0周）、治疗可行性数据 干预后立即（第3周），干预后两周（第5周）的调解数据， 以及两周和三个月后的结果数据（疼痛强度、疼痛干扰和生活质量） 干预（第5和15周）。我们假设PSR-TH和对照干预都将 证明了强可行性（即，每周至少招募1名参与者，保留率>75%，>95% 干预主义的忠诚，以及足够的可接受性，可信度和负担）。我们还假设， 生物心理社会变量将调节PSR相关的结局变化，并且PSR-TH相关的变化 在疼痛控制感知中，自我效能、应对、功能异常习惯和放松将介导治疗 方面的影响.除了支持PSR-TH的未来疗效试验外，拟议项目将利用我的 以前的培训，在肯塔基州大学的协作环境，以及世界知名的专业知识， 导师为我提供临床研究培训，评估口腔面部疼痛的调节剂和介导剂， 和研究团队的领导，给了我一个成功的独立的临床研究生涯的技能。