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 在他们的生活中的某个时候报告了一个重大的事件，23%的LBP患者报告了疼痛的高度。 残疾的强度。当LBP变成慢性时（cLBP），对社会造成的负担最大。 慢性疼痛管理不当会导致生产力的更大损失; 住院、手术和药物治疗;以及昂贵的患者自付费用。鉴于他们的高发病率 肌肉骨骼疾病，cLBP相关的残疾在我们国家的退伍军人群体中猖獗。的 cLBP和高药物使用的组合对退伍军人的工作效率和生活质量产生负面影响， 并产生长期残疾和阿片类药物成瘾的重大风险。可以说， 比退伍军人更重要的人群进行研究，以评估有效的非药物 治疗是安全的，缓解疼痛，具有成本效益，并包含恢复功能和质量的承诺， 生活一个这样的选择是脊椎护理。有几个关键因素支持需要深化对 退伍军人人群中的脊椎按摩护理：1）生物模型为可扩展性提供了强有力的支持; 2） 在系统评价中足够的证据强度已经获得了美国大学的推荐， 针对cLBP的脊柱推拿和/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名脊椎按摩医生纳入门诊 护理设置。这些进步在脊椎治疗护理整合发生，尽管大量的知识 差距，尤其是在国内。具体来说，研究检查脊椎按摩干预措施的交付， 在治疗持续时间或访视次数方面没有最佳“剂量”。因此 建议对18岁及以上诊断为cLBP的退伍军人进行研究是非常重要的。示范 项目研究人员将与美国国立卫生研究院-国防部-退伍军人事务部合作实验室密切合作，以完成以下项目 目标：1）计划和发展提供一个严格的，多站点， VA内的随机对照试验，涉及四类活动的15个里程碑; 2）评价 低剂量（1-5次就诊）的标准脊椎按摩治疗与高剂量（8- 10次就诊）的比较有效性。 12次访视）; 3）评估脊椎按摩疗法慢性疼痛的比较有效性 在目标1所述的初始治疗后，与常规护理相比，使用CCPM管理; 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 对非特异性治疗因素的看法，研究干预措施的有效性，以及不同 标准整脊治疗和CCPM剂量对3家VA机构的临床结局的影响， 方法、过程评价法。

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.