Chiropractic Care for Veterans: A Pragmatic Randomized Trial Addressing Dose Effects for cLBP

摘要 据估计，美国成年人中腰痛(LBP)的患病率为20%，其中50%-80%的人 报告在他们生命中的某个时间点发生了重大事件，23%的LBP患者报告了高位疼痛 身体残废时的紧张程度。当腰痛变得慢性(慢性腰痛)时，会给社会带来最大的负担。 慢性疼痛管理不善会导致更大的生产力损失；增加用于 住院、手术和药物；以及昂贵的自付病人费用。考虑到他们的高比率 肌肉骨骼疾病，cLBP相关的残疾在我国的退伍军人中非常猖獗。这个 CLBP和大量药物使用的结合对退伍军人的工作效率和生活质量产生了负面影响， 并产生长期残疾和阿片成瘾的巨大风险。可以说，没有更多的 比退伍军人更重要的人群进行研究以评估有效的非药理学 安全、缓解疼痛、经济高效的治疗，并包含恢复功能和质量的承诺 生活。其中一个选择就是脊椎疗法。几个关键因素支持有必要深化对 退伍军人群体中的脊椎疗法护理：1)生物模型为似是而非提供强有力的支持；2) 在系统评估中的足够证据已经获得了美国大学 针对cLBP的脊柱手法和/或脊椎按摩护理的医生，以及3)自2004年开始， 退伍军人健康管理局(VA)已成功地将115名脊椎按摩医生整合到门诊 护理设置。尽管有大量的知识，脊椎治疗一体化方面的这些进展还是发生了 差距，特别是退伍军人事务部内部。具体地说，审查脊椎按摩干预措施交付情况的研究已经 变数很大，而且在治疗持续时间或就诊次数方面没有最佳的“剂量”。因此， 建议对18岁及以上的退伍军人进行诊断为慢性下腰痛的研究具有重要意义。游行示威 项目调查人员将与NIH-DOD-VA合作实验室密切合作，以完成以下项目 目标：1)规划和开发所需的务实研究基础设施，以提供严谨、多站点、 退伍军人事务部内的随机对照试验，涉及四类活动中的15个里程碑；2)评估 低剂量(1-5次)标准脊椎护理与高剂量(8-5次)的疗效比较 12次访问)患有慢性下腰痛的退伍军人；3)评估脊椎按摩慢性疼痛的比较疗效 管理(CCPM)与常规护理的比较，遵循目标1中描述的初始治疗；4)评估 与常规护理相比，CCPM对卫生服务结果的影响；5)评估患者和临床医生 对非特定治疗因素的认知、研究干预的有效性以及变化的影响 标准脊椎疗法和CCPM的剂量对3个退伍军人医院的临床结果的影响 方法、过程评价方法。

ABSTRACT The prevalence of low back pain (LBP) among U.S. adults is estimated at 20%, with 50-80% of people reporting a significant episode at some point in their life, and 23% of LBP patients reporting pain of high intensity with disability. The greatest burden placed on society occurs when LBP becomes chronic (cLBP). Inadequately managed chronic pain results in greater loss of productivity; increased expenditures for hospitalization, surgery and medications; and costly out-of-pocket patient expenses. Given their high rates of musculoskeletal disease, cLBP-related disability is rampant within our nation's Veteran population. The combination of cLBP and high medication use negatively impacts Veterans' work productivity and quality of life, and generates substantial risk for long-term disability and opioid addiction. There is arguably no more important population than Veterans for performing research to evaluate effective non-pharmacological treatments that are safe, pain relieving, cost-effective, and contain promise to restore function and quality of life. One such option is chiropractic care. Several key factors support the need to deepen the study of chiropractic care within the Veteran population: 1) biological models offer strong support for plausibility; 2) sufficient strength of evidence in systematic reviews has garnered a recommendation by American College of Physicians for spinal manipulation and/or chiropractic care targeting cLBP, and 3) since beginning in 2004, the Veterans Health Administration (VA) has successfully integrated 115 doctors of chiropractic into ambulatory care settings. These advances in chiropractic care integration have occurred despite substantial knowledge gaps, particularly within VA. Specifically, studies examining the delivery of chiropractic interventions have been highly variable and there is no optimal “dosing” in terms of treatment duration or number of visits. Thus, the proposed study of Veterans age 18 and older with a diagnosis of cLBP is highly significant. Demonstration project investigators will work closely with the NIH-DOD-VA Collaboratory to accomplish the following project Aims: 1) Plan and develop the pragmatic research infrastructure needed to deliver a rigorous, multi-site, randomized controlled trial within the VA addressing 15 milestones in four categories of activities; 2) Evaluate the comparative effectiveness of a low dose (1-5 visits) of standard chiropractic care against a higher dose (8- 12 visits) in Veterans with cLBP; 3) Evaluate the comparative effectiveness of chiropractic chronic pain management (CCPM) compared to usual care, following the initial treatment described in Aim 1; 4) Evaluate the impact of CCPM on health services outcomes, compared to usual care; 5) Evaluate patient and clinician perceptions of non-specific treatment factors, effectiveness of study interventions, and impact of the varying doses of standard chiropractic care and the CCPM on clinical outcomes across 3 VA facilities using a mixed method, process evaluation approach.