Physical Therapy Integrated with Mindfulness for Patients with Chronic Musculoskeletal Pain and Long-Term Opioid Treatment

物理治疗与正念相结合治疗慢性肌肉骨骼疼痛和长期阿片类药物治疗

• 批准号: 10576183
• 负责人: John Magel
• 金额: $ 53.42万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10576183
• 关键词: Address; American; Behavior; Caring; Cessation of life; Clinic; Clinical Trials; Cognitive Therapy; Competence; Conduct Clinical Trials; Degenerative polyarthritis; Diagnosis; Dose; Effectiveness; Evidence based treatment; Exercise; Feasibility Studies; Future; Goals; Health; Healthcare Systems; Individual; Intervention; Interview; Location; Manuals; Medication Management; Methods; Mindfulness Training; Musculoskeletal Pain; National Center for Complementary and Integrative Health; Opioid; Outcome; Outpatients; Overdose; Pain; Pain intensity; Pain management; Patient Simulation; Patients; Persons; Physical therapy; Play; Population; Practice Guidelines; Preparation; Prevalence; Psychological Techniques; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Rehabilitation therapy; Risk; Role; Site; Spine pain; Standardization; Structure; System; Testing; Therapeutic Intervention; Training; Training Programs; Treatment Protocols; addiction; arm; chronic musculoskeletal pain; chronic pain; chronic pain management; chronic pain patient; combat; design; disability; economic impact; evidence base; feasibility testing; feasibility trial; improved; innovation; mind/body; mindfulness; mindfulness intervention; multimodality; opioid epidemic; opioid misuse; opioid therapy; opioid use; physical therapist; pilot test; prescription opioid; psychologic; randomized, clinical trials; response; years lived with disability

PROJECT SUMMARY/ABSTRACT An estimated 20%–30% of persons with chronic musculoskeletal pain (CMP) use opioids for pain management. In recent years, the prevalence of long-term opioid treatment (LTOT) has increased in patients with musculoskeletal pain. Particularly concerning are the significant LTOT-related risks (e.g., opioid-related abuse, overdose, and death). Physical therapy (PT) is a common nonpharmacologic management strategy recommended for CMP. The majority of patients in outpatient PT clinics have musculoskeletal pain, and at least one in three use prescription opioids. Combining exercise-based interventions with mindfulness practices is effective for patients with CMP, and engaging in mindfulness practices leads to a reduction in opioid dose in patients with chronic pain and LTOT. However, the impact of physical therapist-led mindfulness-based interventions integrated with evidence-based PT (I-EPT) to manage patients with CMP and LTOT has not been elucidated. Our overall goal is to develop effective, scalable strategies to manage patients with CMP and LTOT in the PT setting. In response to the FOA PAR-21-241 for multisite feasibility clinical trials of mind and body interventions, this proposal focuses on evaluating the feasibility of conducting a fully-powered clinical trial that tests I-EPT. In preparation for a fully-powered trial, we propose a before and after multi-site feasibility clinical trial conducted in PT clinics located in an academic health care system in the Intermountain West and PT clinics that are part of a rehabilitation system in the Southeast. We will evaluate the feasibility of providing I- EPT to patients with CMP and LTOT by carrying 3 Specific Aims. Aim 1: Refine and manualize the I-EPT treatment protocol for patients with CMP and LTOT. Our approach will use semi-structured interviews of patients and physical therapists to refine I-EPT. Using the results of the semi-structured interviews, we will manualize the I-EPT treatment protocol. Aim 2: Evaluate different intensities of a physical therapist training programs for the refined I-EPT treatment protocol. Our approach will be to randomize physical therapists 2:1 to training and no training groups. The training group will include a high intensity training (HighIT) program and a low intensity training program (LowIT). Following the training programs, we will examine immediate post- training competency in providing I-EPT using a standardized patient simulation. Aim 3: Evaluate the feasibility of the I-EPT intervention across domains of the RE-AIM framework. Our approach will be to pilot test the refined I-EPT treatment protocol in patients managed by physical therapists randomized to training and no training arms. We will use mixed-methods to assess feasibility outcomes. The results of this feasibility study will inform the design and execution of our planned fully powered clinical trial and could lead to improved management of patients with CPM and LTOT.

项目总结/摘要 据估计，20%-30%的慢性肌肉骨骼疼痛（CMP）患者使用阿片类药物治疗疼痛 管理近年来，患者长期阿片类药物治疗（LTOT）的流行率有所增加， 肌肉骨骼疼痛特别值得关注的是与LTOT相关的重大风险（例如，阿片相关 滥用、过量和死亡）。物理治疗（PT）是一种常见的非药物管理策略 推荐CMP。PT门诊的大多数患者患有肌肉骨骼疼痛， 至少三分之一的人使用处方阿片类药物。将基于运动的干预与正念练习相结合 对CMP患者有效，参与正念练习可减少阿片类药物剂量， 慢性疼痛和LTOT患者。然而，物理治疗师主导的正念的影响 与循证PT（I-EPT）相结合的干预措施来管理CMP和LTOT患者， 阐明。我们的总体目标是制定有效的、可扩展的策略来管理CMP和LTOT患者 在PT设置中。为了响应FOA PAR-21-241关于精神和身体的多中心可行性临床试验 干预措施，这项建议的重点是评估进行充分的临床试验的可行性， 测试I-EPT。在准备一个充分的动力试验，我们提出了一个之前和之后的多地点可行性临床 在位于Intermountain West和PT的学术卫生保健系统的PT诊所进行的试验 这些诊所是东南部康复系统的一部分。我们将评估提供I-的可行性 EPT对CMP和LTOT患者进行3个特定目标。目标1：完善和手动化I-EPT CMP和LTOT患者的治疗方案。我们的方法将使用半结构化面试， 患者和物理治疗师来完善I-EPT。根据半结构化访谈的结果，我们将 手动化I-EPT治疗方案。目的2：评估物理治疗师培训的不同强度 改进的I-EPT治疗方案的程序。我们的方法是以2：1的比例随机分配物理治疗师， 培训和无培训组。训练组将包括高强度训练（HighIT）计划和 低强度训练计划（LowIT）。在培训计划之后，我们将立即检查- 使用标准化患者模拟提供I-EPT的培训能力。目标3：评估可行性 跨RE-AIM框架领域的I-EPT干预。我们的做法将是试点测试 在由物理治疗师管理的患者中进行的改良I-EPT治疗方案，随机接受培训， 训练武器。我们将使用混合方法来评估可行性结果。本可行性研究的结果 将告知我们计划的完全有效的临床试验的设计和执行，并可能导致改善 CPM和LTOT患者的管理。