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

优化患有慢性腰痛综合症的老年退伍军人的治疗结果：老龄化背部诊所

• 批准号: 10806928
• 负责人: DEBRA KAYE WEINER
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-10-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10806928
• 关键词: Address; Advisory Committees; Age; Aging; Algorithms; Analgesics; Anxiety; Arthritis; Back; Back Pain; Caring; Chronic low back pain; Clinic; Clinical Trials; Collaborations; Data Set; Degenerative Disorder; Delirium; Dementia; Disease; Elderly; Emergency department visit; Equilibrium; Evaluation; Evidence based treatment; Expert Opinion; Exposure to; Fibromyalgia; Foundations; Funding; Gait speed; Gastrointestinal Hemorrhage; Geriatrics; Guidelines; Health Personnel; Healthcare; Healthcare Systems; Heterogeneity; Hip Fractures; Hip Osteoarthritis; Hip region structure; Hospitalization; Individual; International; Lateral; Leg; Length; Life; Link; Low Back Pain; Masks; Measures; Medicine; Mental Depression; Modeling; Morbidity - disease rate; Myofascial Pain Syndromes; Nature; Obesity; Opioid; Oral; Outcome; Pain; Pain Free; Participant; Pathway interactions; Patient Care; Patient-Centered Care; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Physical Function; Physical therapy; Procedures; Protocols documentation; Provider; Publishing; Quality of life; Randomized; Randomized Controlled Clinical Trials; Recommendation; Research; Resources; Rheumatology; Sacroiliac joint structure; Severities; Site; Sleep disturbances; Sleeplessness; Source; Spinal Degenerative Disorder; Spinal Diseases; Spinal Injections; Spinal Stenosis; Spine surgery; Subgroup; Symptoms; Syndrome; Telephone; Testing; Thigh structure; Training; Treatment Efficacy; Treatment outcome; United States National Institutes of Health; Vertebral column; Veterans; Work; acceptability and feasibility; anxiety symptoms; behavioral health; biopsychosocial; chiropracty; cognitive function; comparative efficacy; coping; cost; depressive symptoms; design; disability; efficacy testing; evidence base; expectation; experience; falls; global health; health care service utilization; human old age (65+); improved; improved outcome; indexing; interactive tool; mild cognitive impairment; pain reduction; pain-related disability; patient oriented; prescription opioid; primary care provider; primary endpoint; primary outcome; randomized trial; recruit; rehabilitation research; research and development; secondary endpoint; secondary outcome; side effect; treatment as usual; usability; virtual

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.

拟议临床试验的目的是改善患有慢性低血压的老年退伍军人（65 岁以上）的护理 背痛（CLBP，即腰痛持续至少 6 个月，且至少有一半的天数）。 由于过度关注脊柱或以脊柱为重点的护理经常受到限制。 腰椎退行性疾病（例如退行性椎间盘/小关节疾病、椎间盘突出） 在老年人中普遍存在，即使是那些无痛的人，一般 CLBP 护理通常包括身体护理。 疗法和口服镇痛药，许多镇痛药对老年人有潜在的严重副作用，例如 胃肠道出血和髋部骨折。以脊柱为重点的护理和一般护理通常都会导致效果不佳。 通过之前的 VA 资助，我们为疼痛和功能的改善奠定了必要的基础。 以患者为中心的方法来护理患有 CLBP 的老年退伍军人，即老年背部诊所 (ABC)，其中脊柱 是脆弱性的根源，但不是 ABC 将 CLBP 作为老年综合征的唯一治疗目标， 也就是说，多种贡献者表达的最终共同途径，而不是我们的脊柱疾病。 我们之前的工作：1) 使用修改后的 Delphi 与 42 位疼痛专家和初级保健提供者合作 方法开发 12 种基于证据的、针对老年人的重要评估和治疗算法 导致 CLBP 老年人疼痛和残疾的病症，即髋骨关节炎、纤维肌痛、 适应不良、腿长差异、焦虑、抑郁、肌筋膜疼痛、失眠、骶髂关节 综合征、髋关节/大腿外侧疼痛（例如大转子疼痛综合征）、腰椎管狭窄、痴呆。 2) 确定了这些贡献者在老年退伍军人中的普遍性。 3) 验证了可行性和有效性。 VA 提供者和退伍军人对 ABC 护理的可接受性 4) 使用迭代可用性测试来开发 互动工具“收回你的背部”，可有效筛查非肌肉骨骼疾病（即， 适应不良的应对方式、抑郁、焦虑、失眠、纤维肌痛），并教育患者了解现实情况 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。 拟议的随机对照临床试验旨在测试 ABC 与常规药物相比的功效 护理。 330 名 65-89 岁的退伍军人（来自 3 个地点各 110 名 – VA 匹兹堡医疗系统， 弗吉尼亚州达拉斯市、弗吉尼亚州亨特·霍姆斯·麦奎尔 [里士满] VA）患有 CLBP，并且没有表明严重的危险信号 基础疾病将被随机分配到 ABC 或 UC 组，为期 3 个月，并在术后随访 12 个月 ABC 将是由顾问组成的虚拟诊所（例如老年病学、疼痛医学、 风湿病学）接受过使用我们的算法的培训，他们会将患者转介给其他提供者（例如，物理治疗师） 治疗、行为健康、脊椎按摩疗法），通常的护理将不受基线措施的限制。 将进行现场评估，包括： NIH 研究工作组推荐的最小数据集 CLBP 标准；Oswestry 残疾指数（ODI；主要结果）； 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-全球健康 (GH) 量表的生活质量、对阿片类药物的担忧 使用规定的阿片类药物困难量表、步态速度、平衡信心以及跌倒功效量表- 国际缩写；以及上个月的医疗保健使用情况 - 例如止痛药、紧急情况 3 个月、6 个月、9 个月和 12 个月的结果（ODI、PROMIS 29 和 GH，平衡） 信心、医疗保健利用率）将由不参与小组分配的工作人员通过电话进行评估。 我们发现，随机接受 ABC 护理的退伍军人将在以下方面经历显着更大的改善： 与 UC 相比，疼痛相关残疾 (ODI) 所提出的临床试验不仅有可能改善。 与疼痛相关的残疾，还可以降低发病率、提高生活质量并限制医疗保健的利用。