Physical Therapy and Athletic Training, University of Utah, Salt Lake City, Utah, USA
Physical Therapy, University of Florida, Gainesville, Florida, USA.
BMJ Open. 2024 Jul 30;14(7):e082611. doi: 10.1136/bmjopen-2023-082611.
Many individuals receiving outpatient physical therapy have musculoskeletal pain and up to one-third use prescription opioids. The impact of physical therapist-led mindfulness-based interventions integrated with evidence-based physical therapy (I-EPT) to manage patients with chronic musculoskeletal pain and long-term opioid treatment has not been elucidated. This project evaluates the feasibility of conducting a cluster randomised trial to test the effectiveness of I-EPT.
Study 1 aim: Refine and manualise the I-EPT treatment protocol. Our approach will use semistructured interviews of patients and physical therapists to refine an I-EPT training manual. Study 2 aim: Evaluate different intensities of physical therapist training programmes for the refined I-EPT treatment protocol. Physical therapists will be randomised 1:1:1 to high-intensity training (HighIT), low-IT (LowIT) training and no training arms. Following training, competency in the provision of I-EPT (LowIT and HighIT groups) will be assessed using standardised patient simulations. Study 3 aim: Evaluate the feasibility of the I-EPT intervention across domains of the Reach, Effectiveness, Adoption, Implementation, Maintenance implementation framework. The refined I-EPT treatment protocol will be tested in two different health systems with 90 patients managed by the randomised physical therapists. The coprimary endpoints for study 3 are the proportions of the Pain, Enjoyment of Life and General Activity Scale and the Timeline Followback for opioid use/dose collected at 12 weeks.
Ethics approval for the study was obtained from the University of Utah, University of Florida and Florida State University Institutional Review Boards. Informed consent is required for participant enrolment in all phases of this project. On completion, study data will be made available in compliance with NIH data sharing policies.
NCT05875207.
许多接受门诊物理治疗的患者都有肌肉骨骼疼痛，多达三分之一的患者使用处方类阿片药物。目前，尚未阐明由物理治疗师主导的正念为基础的干预措施与循证物理治疗（I-EPT）相结合，对管理患有慢性肌肉骨骼疼痛和长期阿片类药物治疗的患者的影响。本项目评估了开展一项群组随机试验以测试 I-EPT 有效性的可行性。
研究 1 目的：完善并制定 I-EPT 治疗方案手册。我们的方法将使用患者和物理治疗师的半结构化访谈，对 I-EPT 培训手册进行完善。研究 2 目的：评估不同强度的物理治疗师培训方案对完善后的 I-EPT 治疗方案的效果。物理治疗师将随机分为高强度培训（HighIT）、低强度培训（LowIT）和无培训组。培训后，将使用标准化患者模拟评估提供 I-EPT 的能力（LowIT 和 HighIT 组）。研究 3 目的：评估 I-EPT 干预措施在 Reach、Effectiveness、Adoption、Implementation、Maintenance（RE-AIM）实施框架的各个领域的可行性。该完善后的 I-EPT 治疗方案将在两个不同的卫生系统中进行测试，由随机分配的物理治疗师管理 90 名患者。研究 3 的主要终点是 12 周时收集的疼痛、生活享受和一般活动量表和药物使用/剂量的时间线回溯的比例。
该研究已获得犹他大学、佛罗里达大学和佛罗里达州立大学机构审查委员会的伦理批准。本项目的所有阶段都需要参与者签署知情同意书。项目完成后，将按照 NIH 数据共享政策提供研究数据。
NCT05875207。
