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

项目总结

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.