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

项目总结 下腰痛(LBP)疾病是全球最常见和最致残的慢性疼痛疾病。差一点 三分之一的LBP患者会出现背部相关性腿部疼痛(BRLP)，这种疼痛与更严重的疼痛和 生活质量更差。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 各种因素。大多数病例没有得到最佳的管理，如持续性残疾和单峰使用所证明的 治疗，包括阿片类药物，只有有限的科学支持，是有风险的，而且无法满足患者的要求 生物心理社会需求。虽然指南提倡几种治疗慢性LBP的补充方法，但有 很少有关于BRLP治疗的高质量研究，特别是那些促进健康疼痛管理的研究 行为。物理治疗师(PTS)和脊椎按摩师(DC)是最常见的前线提供者 在美国保守的LBP治疗，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、繁重和昂贵的BRLP疾病。 这项研究的长期目标是将当前的BRLP范式从单峰模式转变为 以症状为基础的护理，到个性化、全人、行为针对性的方法。为应对当前 证据差距，我们建议进行一项试验性研究(R34)，以评估未来第二阶段多点随机试验的可行性 临床试验(RCT)。根据我们之前和正在进行的LBP研究，集成支持 生物-心理-社会自我管理治疗背部相关性腿痛试验将评估 由PTS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，与 医疗(MC)。R34试点研究的目标是： 目标1：进行规划阶段，以制定协议、培训人员并确保监管 批准。该署会特别重视为警察和区议会提供以能力为本的培训。 SBSM干预侧重于提供全人护理，将心理社会和身体导向相结合 针对慢性BRLP的策略。 目标2：评估招募和招生的可行性(招生/招生比率、参与者 关于参与的观点)，提供实验和比较干预措施(可接受性和坚持性， 提供商保真度、参与者和提供商观点)和数据收集(随访率)。 这项研究解决了NCCIH的高度优先领域的综合心身方法 慢性BRLP的症状管理，这是一种代价高昂、致残和研究不足的疾病。这项初步研究将 为支持试验奠定必要的基础，这是第一个比较创新的SBSM的RCT BRLP患者的医疗干预。在这样做的过程中，我们预计区议会和临时立法会将发挥更大的作用。 引导BRLP患者健康的疼痛自我管理行为，导致残疾减少，总体上更大 健康和幸福。

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.