Combined Treatments to Optimize Functional Recovery in Veterans with Chronic Low Back Pain

联合治疗可优化患有慢性腰痛的退伍军人的功能恢复

• 批准号: 10174853
• 负责人: Pradeep Suri
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2020-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10174853
• 关键词: Ablation; Accelerometer; Activities of Daily Living; Address; Affect; Area; Back; Back Pain; Behavior Therapy; Chronic low back pain; Clinic; Cognitive Therapy; Combined Modality Therapy; Conflict (Psychology); Distal; Dorsal; Education; Electrodes; Esthesia; Facet joint structure; Feedback; Financial compensation; Funding; Future; Goals; Grant; Hearing problem; Home environment; Individual; Intervention; Lesion; Local Anesthetics; Low Back Pain; Measures; Medial; Methodology; Methods; Nerve; Observational Study; Pain; Pain Clinics; Pain intensity; Pain management; Participant; Pathway interactions; Patient Selection; Patients; Persistent pain; Personal Computers; Personal Satisfaction; Physical therapy; Pilot Projects; Positioning Attribute; Procedures; Protocols documentation; Provider; Psychologist; Quality of life; Questionnaires; Radiofrequency Interstitial Ablation; Randomized Controlled Trials; Recommendation; Recovery of Function; Rehabilitation therapy; Reporting; Research; Secondary to; Severities; Spinal; Standardization; Structure; Tablet Computer; Tai Ji; Techniques; Technology; Telephone; Therapeutic; Therapeutic Intervention; Translations; Travel; United States; Veterans; Voice; Work; Yoga; active lifestyle; afferent nerve; base; behavior change; clinical care; comparative; cost; design; disability; experience; fitbit; follow-up; improved; inclusion criteria; innovation; minimally invasive; novel; opioid use; pain relief; primary outcome; programs; radio frequency; response; rural area; screening; secondary outcome; symposium; telehealth; therapy design; treatment arm; treatment effect; treatment optimization; trial design

Back pain is the #1 contributor to disability in the United States (US), and second only to hearing problems as a reason for new Veteran disability compensation. The societal burden of back pain is driven mainly by chronic low back pain (CLBP), defined as low back pain persisting for ≥3 months. Since most individual treatments for CLBP have only small effects on functional recovery, combining CLBP treatments has recently been recommended as a priority area for research. However, few prior studies of CLBP have been properly designed to evaluate the effects of treatment combinations. Large effects on functional recovery from CLBP may require combining interventions that each target different points on a theoretical pathway to functional recovery. Procedural treatments for CLBP aim primarily to address early stages in the pathway to functional recovery, such as problems with the lumbar spinal structures or low back pain itself. In contrast, behavioral interventions for CLBP generally have effects not only on pain itself, but also work by mitigating the degree to which the sensation of low back pain impacts function, well-being, and quality of life. These represent later stages in the pathway to functional recovery from CLBP. Combining procedural and behavioral treatments may have great potential for achieving large magnitude treatment effects for CLBP in Veterans. The proposed research uses an innovative application of the 2 x 2 factorial randomized controlled trial (RCT) design to examine the individual and combined effects of 1) lumbar medial branch nerve radiofrequency ablation (LRFA), a commonly used procedural intervention to target low back pain severity, and 2) a novel video telehealth tablet- and personal computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program (“AcTIVE-CBT”), a behavioral intervention designed primarily to target functional limitations both secondary to, and independent of, improvements in pain. The LRFA treatment to be used in the proposed study addresses the major patient selection, procedural/technical, methodologic and reporting limitations of prior studies. AcTIVE-CBT addresses problems with Veteran access and compliance associated with conventional cognitive behavioral therapy (CBT) delivered in clinic, and uses currently available activity tracking technology to better promote activity and behavior change as compared to conventional CBT. This pilot RCT involves 20 Veterans with CLBP who will be followed to evaluate functional recovery for up to 3 months. The primary outcome is participant-reported back-related functional limitations (mobility and ADLs) at 3 months, as measured by the validated Roland-Morris Disability Questionnaire. Secondary outcomes include activity tracker-assessed step counts, back pain intensity, reduction in opioid use, and quality of life. The study hypotheses are that 1) each individual treatment will result in improvements in back-related functional limitations and secondary outcomes compared to control, and 2) combined treatment will produce greater treatment effects than each of the individual treatments alone. Although both the LRFA and AcTIVE-CBT treatment arms are innovations on their own, the most unique aspect of the proposed study is the use of the factorial RCT design to examine whether `stacking' disparate CLBP treatments can result in greater treatment effects than that of each treatment alone. Although the proposed pilot study is unlikely to definitively address whether these treatments alone or in combination have significant effects on functional recovery, it will produce valid effect size estimates that will inform a future large-scale multicenter RCT (likely funded by a programmatic or cooperative grant mechanism) to determine the efficacy of LRFA, AcTIVE-CBT, or combined LRFA + AcTIVE-CBT, for Veterans with CLBP.

在美国，背痛是导致残疾的第一大原因，仅次于听力问题 背痛的社会负担主要是由慢性病造成的。 腰痛（CLBP），定义为自大多数个体治疗以来腰痛持续≥3个月。 CLBP 对功能恢复的影响很小，最近已将 CLBP 联合治疗 推荐作为优先研究领域然而，之前对 CLBP 的研究很少得到适当的研究。 旨在评估治疗组合对 CLBP 功能恢复的影响。 可能需要结合干预措施，每种干预措施都针对功能性理论途径上的不同点 CLBP 的程序性治疗主要旨在解决功能途径的早期阶段。 康复，例如腰椎结构问题或腰痛本身，相反，行为。 CLBP 的干预措施通常不仅对疼痛本身有影响，而且还可以通过减轻疼痛程度来发挥作用。 腰痛的感觉会影响功能、幸福感和生活质量。 CLBP 功能恢复途径的各个阶段 可能具有在退伍军人中实现 CLBP 大规模治疗效果的巨大潜力。 拟议的研究采用了 2 x 2 析因随机对照试验 (RCT) 的创新应用 设计用于检查 1) 腰椎内侧支神经射频的个体和组合效应 消融 (LRFA)，一种针对腰痛严重程度的常用程序干预，以及 2) 一种新颖的方法 视频远程医疗 基于平板电脑和个人电脑 (PC) 的活动跟踪器-通知视频功能 认知行为治疗计划（“Active-CBT”）是一种行为干预，主要旨在 LRFA 治疗的目标是继发于且独立于疼痛改善的功能限制。 用于拟议研究的主要患者选择、程序/技术、方法 Active-CBT 解决了退伍军人访问和报告的局限性。 与临床上提供的传统认知行为疗法（CBT）相关的依从性，以及使用 与现有的活动跟踪技术相比，可以更好地促进活动和行为改变 该试点随机对照试验涉及 20 名患有 CLBP 的退伍军人，他们将接受跟踪评估功能 恢复期长达 3 个月，主要结果是参与者报告的背部相关功能限制。 3 个月时（活动能力和 ADL），通过经过验证的 Roland-Morris 残疾问卷进行测量。 次要结果包括活动追踪器评估的步数、背痛强度、阿片类药物使用的减少、 研究假设是：1）每种单独的治疗都会改善生活质量。 与对照相比，背部相关的功能限制和次要结果，以及 2) 联合治疗 尽管 LRFA 和 LRFA 均会产生比单独单独治疗更大的治疗效果。 和 Active-CBT 治疗臂本身就是创新，是拟议的最独特的方面 研究是使用析因随机对照试验设计来检验是否“叠加”不同的 CLBP 治疗 尽管拟议的试点可以产生比单独使用每种治疗更好的治疗效果。 研究不太可能明确说明这些治疗单独或联合治疗是否具有显着效果 对功能恢复的影响，它将产生有效的效应大小估计，这将为未来的大规模 多中心随机对照试验（可能由计划或合作资助机制资助）以确定疗效 LRFA、Active-CBT 或 LRFA + Active-CBT 组合，适用于患有 CLBP 的退伍军人。

项目成果

Combining Procedural and Behavioral Treatments for Chronic Low Back Pain: A Pilot Feasibility Randomized Controlled Trial.

结合程序和行为治疗慢性腰痛：试点可行性随机对照试验。

• 发表时间: 2023-06-05
• 作者: Tanus, Adrienne D;Nishio, Isuta;Williams, Rhonda;Friedly, Janna;Soares, Bosco;Anderson, Derek;Bambara, Jennifer;Dawson, Timothy;Hsu, Amy;Kim, Peggy Y;Krashin, Daniel;Piero, Larissa Del;Korpak, Anna;Timmons, Andrew;Suri, Pradeep
• 通讯作者: Suri, Pradeep