Optimizing Outcomes for Older Veterans with Chronic Low back Pain Syndrome: Aging Back Clinics

拟议的临床试验的目的是改善老年退伍军人（年龄65岁以上）的慢性低血糖护理。 背痛（CLBP，即，腰痛至少6个月，至少有一半的日子）。目前的CLBP护理是 由于过度专注于脊柱或一般规定而受到限制。以脊柱为重点的护理往往针对 腰椎的退行性疾病（例如，退行性椎间盘/小关节疾病，椎间盘膨出）， 在老年人中普遍存在，即使是那些没有疼痛的人。一般CLBP护理通常包括物理 治疗和口服止痛药，许多止痛药对老年人有潜在的严重副作用， 胃肠道出血和髋骨骨折以脊柱为中心的护理和一般护理往往导致次优的 改善疼痛和功能。通过之前的VA资金，我们已经奠定了必要的基础， 以患者为中心的方法来照顾老年退伍军人与CLBP，老化背部诊所（ABC），其中脊柱 是脆弱性的来源，但不是唯一的治疗目标。ABC将CLBP视为老年综合征， 也就是说，一个最终的共同途径，为表达多个贡献者，而不是一个疾病的脊柱。在我们 我们之前的工作有：1）与42名疼痛专家和初级保健提供者合作，使用修改后的德尔菲 方法开发12个循证，老年人量身定制的评估和治疗算法的重要 导致CLBP老年人疼痛和残疾的疾病，即，髋关节骨关节炎，纤维肌痛， 适应不良应对，下肢不等长，焦虑，抑郁，肌筋膜疼痛，失眠，骶髂关节 综合征，侧髋/大腿疼痛（例如，大转子疼痛综合征）、腰椎管狭窄症、痴呆症。 2)确立了这些贡献者在老年退伍军人中的平凡性质。3)验证了可行性， ABC护理对VA提供者和退伍军人的可接受性。4)使用迭代可用性测试来开发 交互式工具，收回你的背部，有效地筛选非肌肉骨骼条件（即， 适应不良的应对，抑郁，焦虑，失眠，纤维肌痛），并教育患者关于现实的 治疗期望和CLBP作为一种生物心理社会综合征，而不是脊柱疾病。的 拟进行一项随机对照临床试验，以检验ABC与氨氯地平相比的疗效 在乎330名65-89岁的退伍军人（来自VA匹兹堡医疗保健系统的3个站点各110名， 达拉斯弗吉尼亚州，亨特霍姆斯麦奎尔[里士满]弗吉尼亚州）与CLBP和没有红旗表明严重 基础疾病将随机分为ABC或UC，持续3个月，并在治疗后随访12个月。 随机化ABC将是由顾问组成的虚拟诊所（例如，老年医学，止痛药， 风湿病学）接受过与我们的算法一起工作的培训，这些算法将把患者推荐给其他提供者（例如，物理 治疗、行为健康、脊椎按摩疗法）。家庭护理将不会受到限制。基线措施 将在现场进行评估，包括：NIH研究工作组推荐的最小数据集 CLBP标准;奥斯韦斯特里残疾指数（ODI;主要结局）;认知功能（QMCI）; PROMIS-29 包括疼痛严重程度、疼痛相关活动干扰、身体功能、睡眠障碍、抑郁 症状，腿部症状; PROMIS-Global Health（GH）量表的生活质量，对阿片类药物的担忧 处方阿片类药物困难量表、步态速度、平衡信心和福尔斯疗效量表- 国际简表;以及前一个月的医疗保健使用情况-例如，止痛药，紧急情况 查房住院3、6、9和12个月结局（ODI、PROMIS 29和GH，平衡 置信度、医疗保健利用）将由对分组不知情的工作人员通过电话进行评估。 我们假设，随机分配到ABC护理的退伍军人在以下方面会有更大的改善： 疼痛相关性残疾（ODI）的发生率高于UC患者。拟议的临床试验不仅有可能改善 疼痛相关的残疾，但也降低发病率，提高生活质量和限制医疗保健的利用。

The purpose of the proposed clinical trial is to improve the care of older Veterans (age 65+) with chronic low back pain (CLBP, i.e., low back pain for at least 6 months on at least half the days). Current CLBP care is limited by being either overly spine-focused or generically prescribed. Spine-focused care often targets degenerative disease of the lumbar spine (e.g., degenerative disc/facet disease, disc bulge) that is nearly ubiquitous in older adults, even those who are pain-free. Generic CLBP care typically consists of physical therapy and oral analgesics, and many analgesics have potentially serious side effects in older adults such as gastrointestinal bleeding and hip fracture. Both spine-focused care and generic care often result in suboptimal improvement in pain and function. Through prior VA funding, we have laid the essential foundation for a patient-centered approach to care for older Veterans with CLBP, Aging Back Clinics (ABCs), in which the spine is a source of vulnerability but not the sole treatment target. ABCs approach CLBP as a geriatric syndrome, that is, a final common pathway for the expression of multiple contributors, not a disease of the spine. In our prior work we have: 1) Collaborated with 42 pain experts and primary care providers using a modified Delphi approach to develop 12 evidence-based, older adult-tailored evaluation and treatment algorithms for important conditions that contribute to pain and disability in older adults with CLBP, i.e., hip osteoarthritis, fibromyalgia, maladaptive coping, leg length discrepancy, anxiety, depression, myofascial pain, insomnia, sacroiliac joint syndrome, lateral hip/thigh pain (e.g., greater trochanteric pain syndrome), lumbar spinal stenosis, dementia. 2) Established the commonplace nature of these contributors in older Veterans. 3) Verified the feasibility and acceptability of ABC care to VA providers and Veterans. 4) Used iterative usability testing to develop an interactive tool, Take Back Your Back, that efficiently screens for non-musculoskeletal conditions (i.e., maladaptive coping, depression, anxiety, insomnia, fibromyalgia), and educates patients about realistic treatment expectations and CLBP as a biopsychosocial syndrome rather than a disease of the spine. The proposed randomized controlled clinical trial is designed to test the efficacy of ABCs as compared with Usual Care. Three hundred thirty Veterans age 65-89 (110 from each of 3 sites – VA Pittsburgh Healthcare System, Dallas VA, Hunter Holmes McGuire [Richmond] VA) with CLBP and no red flags indicative of serious underlying illness will be randomized to ABCs or UC for 3 months and followed for 12 months after randomization. The ABCs will be virtual clinics staffed by consultants (e.g., geriatrics, pain medicine, rheumatology) trained in working with our algorithms who will refer patients to other providers (e.g., physical therapy, Behavioral Health, chiropractic) as needed. Usual care will not be constrained. Baseline measures will be assessed on site and include: the Minimal Data Set recommended by the NIH Task Force on research standards for CLBP; Oswestry Disability Index (ODI; main outcome); cognitive function (QMCI); PROMIS-29 that includes pain severity, pain-related activity interference, physical function, sleep disturbance, depressive symptoms, leg symptoms; quality of life with the PROMIS-Global Health (GH) scale, concerns about opioids with the Prescribed Opioids Difficulties Scale, gait speed, balance confidence with the Falls Efficacy Scale- International short form; and healthcare utilization over the prior month – e.g., pain medications, emergency room visits, hospitalizations. Three, 6-, 9-, and 12-months outcomes (ODI, PROMIS 29 and GH, balance confidence, healthcare utilization) will be assessed over the telephone by staff masked to group assignment. We hypothesize that Veterans randomized to ABC care will experience significantly greater improvement in pain-related disability (ODI) than those in UC. The proposed clinical trial has the potential not only to improve pain-related disability, but also to reduce morbidity, increase quality of life and limit healthcare utilization.