Department of Physical Therapy & Athletic Training, The University of Utah, Salt Lake City, Utah, USA
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA.
BMJ Open. 2022 Nov 9;12(11):e067732. doi: 10.1136/bmjopen-2022-067732.
Although evidence-based guidelines recommend non-pharmacologic treatments as first-line care for chronic low back pain (LBP), uptake has been limited, particularly in rural, low-income and ethnically diverse communities. The BeatPain study will evaluate the implementation and compare the effectiveness of two strategies to provide non-pharmacologic treatment for chronic LBP. The study will use telehealth to overcome access barriers for persons receiving care in federally qualified health centres (FQHCs) in the state of Utah.
BeatPain Utah is a pragmatic randomised clinical trial with a hybrid type I design investigating different strategies to provide non-pharmacologic care for adults with chronic LBP seen in Utah FQHCs. The intervention strategies include a brief pain consult (BPC) and telehealth physical therapy (PT) component provided using either an adaptive or sequenced delivery strategy across two 12-week treatment phases. Interventions are provided via telehealth by centrally located physical therapists. The sequenced delivery strategy provides the BPC, followed by telehealth PT in the first 12 weeks for all patients. The adaptive strategy uses a stepped care approach and provides the BPC in the first 12 weeks and telehealth PT to patients who are non-responders to the BPC component. We will recruit 500 English-speaking or Spanish-speaking participants who will be individually randomised with 1:1 allocation. The primary outcome is the Pain, Enjoyment and General Activity measure of pain impact with secondary outcomes including the additional pain assessment domains specified by the National Institutes (NIH) of Health Helping to End Addiction Long Initiative and implementation measures. Analyses of primary and secondary measures of effectiveness will be performed under longitudinal mixed effect models across assessments at baseline, and at 12, 26 and 52 weeks follow-ups.
Ethics approval for the study was obtained from the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with NIH data sharing policies.
NCT04923334.
尽管循证指南推荐非药物治疗作为慢性下背痛（LBP）的一线治疗方法，但采用率一直有限，尤其是在农村、低收入和种族多样化的社区。BeatPain 研究将评估两种策略的实施情况，并比较其为慢性 LBP 患者提供非药物治疗的效果。该研究将利用远程医疗来克服犹他州联邦合格医疗中心（FQHC）接受治疗者的获取障碍。
BeatPain 犹他州是一项实用随机临床试验，采用混合 I 型设计，研究为犹他州 FQHC 就诊的慢性 LBP 成人提供非药物治疗的两种不同策略。干预策略包括简短疼痛咨询（BPC）和远程健康物理治疗（PT），在两个 12 周的治疗阶段，采用适应性或顺序交付策略提供。干预措施通过中央位置的物理治疗师通过远程医疗提供。顺序交付策略为所有患者在头 12 周内提供 BPC 和远程健康 PT。适应性策略采用阶梯式护理方法，为对 BPC 部分无反应的患者在头 12 周内提供 BPC 和远程健康 PT。我们将招募 500 名讲英语或西班牙语的参与者，他们将进行个体随机分组，1:1 分配。主要结局是疼痛、享受和一般活动测量疼痛影响，次要结局包括国家卫生研究院（NIH）规定的其他疼痛评估领域和实施措施。将根据基线、12 周、26 周和 52 周随访的评估，通过纵向混合效应模型分析主要和次要有效性测量结果。
该研究已获得犹他大学机构审查委员会的伦理批准。研究完成后，将按照 NIH 数据共享政策提供研究数据。
NCT04923334。
