The Effectiveness of a Mindfulness-Based Intervention Integrated with Physical Therapy (MIND-PT) for Post-Surgical Rehabilitation after Lumbar Surgery: A Protocol for a Randomized Controlled Trial as Part of the Back Pain Consortium (BACPAC) Research Program

Abstract

Abstract Background Improving pain management for persons with chronic low back pain (LBP) undergoing surgery is an important consideration to improve patient-centered outcomes and reduce the risk for persistent opioid use following surgery. Nonpharmacologic treatments, including physical therapy and mindfulness, are beneficial for non-surgical LBP through complementary biopsychosocial mechanisms; but their integration and application for persons undergoing surgery for LBP have not been examined. This study (MIND-PT) is a multi-site randomized trial that compares an enriched pain management (EPM) pathway integrating physical therapy and mindfulness to usual care pain management (UC) for persons undergoing surgery for LBP. Design Participants from military treatment facilities will be enrolled pre-surgery and individually randomized to the EPM or UC pain management pathway. Participants assigned to EPM will receive pre-surgical biopsychosocial education and mindfulness instruction. After surgery the EPM group will receive 10 sessions of physical therapy with integrated mindfulness techniques. Participants assigned to the UC group will receive usual pain management care after surgery. The primary outcome will be the pain impact assessed with the Pain, Enjoyment and General Activity (PEG) scale. Time to opioid discontinuation is the main secondary outcome. Summary This trial is part of the National Institutes of Health, Helping to End Addiction Long-term (HEAL) initiative focused on providing scientific solutions to the opioid crisis. The MIND-PT study will examine an innovative program combining nonpharmacologic treatments designed to improve outcomes and reduce opioid overreliance in persons undergoing lumbar surgery.