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

"Conflicts of interest: Dr. Garland reports significant financial interest (remuneration and licensed intellectual property) from BehaVR, a non–publicly traded company that has licensed the investigator's intellectual property being used in the study."

"Funding This work is supported by grant number 3UH3AT009763-04S1 from the National Center for Complementary and Integrative Health at the National Institutes of Health (NIH). The study is part of the Helping to End Addiction Long-term (HEAL) initiative as part of a group of studies within the NIH Back Pain Consortium (BACPAC) program. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Conflicts of interest: Dr. Garland reports significant financial interest (remuneration and licensed intellectual property) from BehaVR, a non–publicly traded company that has licensed the investigator's intellectual property being used in the study."

"The MIND-PT study is a two-arm, parallel group, individual-randomized trial (). The trial is registered with clinicaltrials.gov (unique identifier NCT04770480). We will recruit persons scheduled for lumbar surgery in a participating facility. Individuals who provide consent will be randomized before surgery either to the EPM pathway that integrates PT and mindfulness or to usual-care pain management (UC). Presurgical and postsurgical care is based on the randomized group assignment with consideration of surgery type (fusion or nonfusion). The surgical procedure itself and perioperative care, including the use of prescription opioids, do not differ by treatment group and are based on the standard procedures at the participating facility and discretion of the surgeon. Assessments occur at enrollment (before surgery) and 2 and 26 weeks after surgery. Persons who do not undergo surgery for any reason will be removed from the study. Our hypotheses are that the EPM pathway will be superior to UC in the overall cohort for the primary outcome of pain impact. We further hypothesize that the EPM pathway will be superior to UC for the outcomes of pain impact and opioid discontinuation in predefined subgroups who could be at elevated risk of postsurgical long-term opioid use, indicating a need to explore treatment effect heterogeneity across different risk levels.  : Study registration: ClinicalTrials.gov ID NCT04770480."