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Move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial
Journal of Translational Medicine ( IF 6.1 ) Pub Date : 2021-08-18 , DOI: 10.1186/s12967-021-03013-y
Daniel I Rhon 1, 2 , Julie M Fritz 3 , Tina A Greenlee 1 , Katie E Dry 1 , Rachel J Mayhew 1 , Mary C Laugesen 1 , Edita Dragusin 1 , Deydre S Teyhen 4
Affiliation  

The prevalence of chronic pain conditions is growing. Low back pain was the primary cause of disability worldwide out of 156 conditions assessed between 1990 and 2016, according to the Global Burden of Disease Study. Conventional medical approaches have failed to identify effective and long-lasting approaches for the management of chronic pain, and often fail to consider the multiple domains that influence overall health and can contribute to the pain experience. Leading international organizations that focus on pain research have stated the importance of considering these other domains within holistic and multidisciplinary frameworks for treating pain. While the research behind the theoretical link between these domains and chronic pain outcomes has expanded greatly over the last decade, there have been few practical and feasible methods to implement this type of care in normal clinical practice. The purpose of this manuscript is to describe an implementation protocol that is being used to deliver a complex holistic health intervention at multiple sites within a large government health system, as part of a larger multisite trial for patients with chronic low back pain. The Move to Health program developed by the US Army Medical Command was tailored for specific application to patients with low back pain and begins by providing an empirical link between eight different health domains (that include physical, emotional, social, and psychological constructs) and chronic low back pain. Through a six-step process, a health coach leverages motivational interviewing and information from a personal health inventory to guide the patient through a series of conversations about behavioral lifestyle choices. The patient chooses which domains they want to prioritize, and the health coach helps implement the plan with the use of SMART (Specific, Measurable, Attainable, Realistic, Time-bound) goals and a series of resources for every domain, triaged from self-management to specialist referral. Complex interventions described in clinical trials are often challenging to implement because they lack sufficient details. Implementation protocols can improve the ability to properly deliver trial interventions into regular clinical practice with increased fidelity. Implementation of this intervention protocol was developed for a clinical trial that was registered a priori (clinicaltrials.gov #NCT04172038).

中文翻译:


走向健康——治疗慢性腰痛的整体方法:为务实的临床试验制定的干预和实施方案



慢性疼痛的患病率正在增加。根据全球疾病负担研究,在 1990 年至 2016 年间评估的 156 种病症中,腰痛是全球残疾的主要原因。传统的医疗方法未能找到有效且持久的慢性疼痛管理方法,并且常常未能考虑影响整体健康并可能导致疼痛体验的多个领域。专注于疼痛研究的领先国际组织表示,在治疗疼痛的整体和多学科框架内考虑这些其他领域的重要性。虽然这些领域与慢性疼痛结果之间的理论联系背后的研究在过去十年中得到了极大的扩展,但在正常的临床实践中实施此类护理的实际可行的方法却很少。本手稿的目的是描述一种实施方案,该方案用于在大型政府卫生系统内的多个地点提供复杂的整体健康干预,作为针对慢性腰痛患者的更大规模多地点试验的一部分。美国陆军医疗司令部制定的“走向健康”计划专为腰痛患者量身定制,首先提供八个不同健康领域(包括身体、情感、社会和心理结构)与慢性疼痛之间的实证联系。腰背疼痛。通过六步流程,健康教练利用动机性访谈和个人健康清单中的信息来指导患者进行一系列有关行为生活方式选择的对话。 患者选择他们想要优先考虑的领域,健康教练使用 SMART(具体的、可测量的、可实现的、现实的、有时限的)目标和针对每个领域的一系列资源来帮助实施该计划,并根据自我分类进行分类。管理到专家转介。临床试验中描述的复杂干预措施往往难以实施,因为它们缺乏足够的细节。实施方案可以提高将试验干预措施正确地融入常规临床实践的能力,并提高保真度。该干预方案的实施是针对预先注册的临床试验制定的(clinicaltrials.gov #NCT04172038)。
更新日期:2021-08-19
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