Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (SUPPORT trial)

项目摘要 下背痛（LBP）疾病是全球最常见和致残的慢性疼痛疾病。近 1/3的LBP患者会出现背部相关性腿部疼痛（BRLP），这与更严重的疼痛有关， 生活质量差。慢性BRLP是复杂的，受到相互关联的生理，心理和社会因素的影响。 因素大多数病例没有得到最佳管理，表现为持续残疾和使用单模式 包括阿片类药物在内的治疗方法，科学支持有限，风险很大， 生物心理社会需求虽然指南提倡慢性LBP的几种补充方式， 关于BRLP治疗的高质量研究很少，特别是那些促进健康疼痛管理的研究 行为。物理治疗师（PT）和脊医（DC）是最常见的前线提供者， 保守的LBP治疗在美国，并且非常适合在支持患者自我护理方面发挥更大的作用 对于普遍的，负担沉重的，昂贵的BRLP条件。 这项研究的长期目标是将目前的BRLP范式从单峰模式转变为单峰模式， 从以行为为基础的护理，到个性化的、全人的、有针对性的行为方法。响应于电流 证据缺口，我们提出了一项试点研究（R34），以评估未来的II期多中心随机 临床试验（RCT）。根据我们之前和正在进行的LBP研究， 生物心理社会自我管理背部相关的腿部疼痛试验将评估的比较有效性 PT和DC提供的一种新的支持性生物心理社会自我管理（SBSM）干预， 医疗护理（MC）。R34试点研究的目标是： 目标1：进行规划阶段，以制定方案、培训人员并确保监管 批准。我们会特别强调为临时警务人员和区议会提供以能力为本的培训， SBSM干预措施侧重于提供全人护理，将心理社会和身体导向相结合 专门针对慢性BRLP的策略。 目的2：评估招募和入组的可行性（招募/入组率，参与者 关于参与的观点），提供实验性和比较性干预措施（可接受性和坚持性， 提供者忠诚度、参与者和提供者观点）和数据收集（随访率）。 这项研究涉及NCCIH的高度优先领域的综合身心方法， 慢性BRLP的症状管理，这是一种昂贵、致残和研究不足的疾病。试点研究将 为SUPPORT试验奠定必要的基础，这是第一个比较创新SBSM的RCT 对BRLP的医疗干预。在这样做的过程中，我们预计区议会和PT将发挥更大的作用 引导BRLP患者健康的疼痛自我管理行为，减少残疾，提高整体 健康和福祉。

PROJECT SUMMARY Low back pain (LBP) disorders are the most common and disabling chronic pain conditions worldwide. Nearly 1/3 of LBP patients develop back-related leg pain (BRLP), which is associated with greater pain severity and poorer quality of life. Chronic BRLP is complex, influenced by interrelated physical, psychological, and social factors. Most cases are not optimally managed, as demonstrated by persistent disability, and use of unimodal treatments, including opioids, which have limited scientific backing, are risky, and fail to meet patient biopsychosocial needs. While guidelines advocate several complementary modalities for chronic LBP, there is little high-quality research on treatments for BRLP, especially ones that promote healthy pain management behaviors. Physical therapists (PTs) and chiropractors (DCs) are the most common front-line providers of conservative LBP treatment in the US, and are well-suited to play a larger role in supporting patient self-care for the prevalent, burdensome, and costly BRLP conditions. The long-term objective of this research is to shift the current paradigm for BRLP away from unimodal, symptom-based care, to an individualized, whole person, behavioral targeted approach. In response to current evidence gaps, we propose a pilot study (R34) to assess the feasibility of a future phase II multi-site randomized clinical trial (RCT). Informed by our previous and ongoing LBP research, the Integrated SUPPORTed Biopsychosocial Self-Management for Back Related Leg Pain trial will assess the comparative effectiveness of a novel supported biopsychosocial self-management (SBSM) intervention delivered by PTs and DCs, versus Medical Care (MC). The R34 pilot study aims are: AIM 1: to conduct a Planning Phase to develop protocols, train personnel, and secure regulatory approvals. Special emphasis will be placed on providing competency-based training to PTs and DCs in the SBSM intervention focused on whole person care delivery, integrating psychosocial and physically oriented strategies specifically for chronic BRLP. AIM 2: To assess the feasibility of recruitment and enrollment (recruitment/enrollment rates, participant views on participation), delivering experimental and comparison interventions (acceptability and adherence, provider fidelity, participant and provider views), and data collection (follow-up rates). This research addresses NCCIH high priorities areas of integrated mind body approaches for symptom management of chronic BRLP, a costly, disabling, and understudied condition. The pilot study will establish the essential foundation for the SUPPORT trial, the first RCT comparing an innovative SBSM intervention to medical care for BRLP. In doing so, we anticipate DCs and PTs will play a more impactful role guiding BRLP patients’ healthy pain self-management behaviors, resulting in less disability and greater overall health and wellbeing.