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SMART Embedded Intervention for Military Postsurgical Engagement Readiness (SEMPER)

Principal Investigator (PI) / Project Lead:

GARLAND, ERIC

Funding Organization:

Department of Defense (DoD), US Army Medical Research Acquisition Activity (USAMRAA)

RFP / FOA Number:

PR203509

Award Number:

W81XWH-21-1-0328

Funding Period:

5/15/2021 – 5/14/2025

Total Funding:

$4,996,715

Project Status:

In progress; Recruiting

 

Public Abstract:

Optimal musculoskeletal health is essential for active-duty Service Members, who are required to maintain physical fitness to meet intense occupational demands. Knee osteoarthritis (OA) is one of the most common chronic overuse musculoskeletal disorders afflicting U.S. military Service Members, and is among the primary conditions leading to medical separation from active-duty service. Given the magnitude and growth in knee OA prevalence, total knee arthroplasty (TKA) surgeries have surged to historic highs in recent years. Today, TKA is one of the most common inpatient surgeries performed in the U.S., but surgical outcomes can be highly variable and suboptimal. Even after a technically sound TKA, up to 25% of patients are dissatisfied with their surgical outcome, and many patients continue to experience prolonged pain and opioid use after surgery. In fact, TKA increases an opioid-naïve patient’s risk of developing chronic opioid use five-fold, and chronic opioid use leads to medical separation and undermines mission readiness across the Military Health System (MHS). Clearly, novel non-opioid pain management strategies are needed in the MHS.

 

New scientific findings indicate that prolonged pain disrupts functioning in brain regions responsible for self-control, undermining patients’ ability to engage in effective self-management (i.e., self-regulation) of pain, and resulting in avoidance of physical activity, disengagement from physical therapy, and functional impairment. In the absence of effective self-regulation, patients become increasingly dependent on opioids for pain relief. However, chronic opioid use causes changes in stress and reward circuitry in the brain, increasing reactivity to distress and pain and driving opioid dose escalation as a means of preserving a dwindling sense of well-being. Thus, patients become caught in a vicious cycle where the perceived solution (i.e., opioid use) to their problem (i.e., postoperative pain and distress) only magnifies the problem. Interventions are urgently needed to prevent TKA patients’ downward spiral into chronic pain, opioid dependence, and impaired musculoskeletal health. Unfortunately, standard of care during TKA does not address these factors, and current interventions often treat pain, addictive behaviors, and distress in isolation. To fill this gap, this research proposal aims to conduct a pragmatic trial of a novel, adaptive therapeutic approach that integrates brief and intensive mindfulness-based interventions (MBIs) into surgical care pathways within the MHS.

 

MBIs are mental training programs designed to strengthen present-moment attention, awareness, and self-control. Prior research has demonstrated that MBIs increase cognitive performance, stress resilience, and mental health in active-duty Service Members, and our study team has shown that both brief and intensive MBIs can reduce pain and opioid use in civilians. However, we have yet to test whether TKA outcomes can be improved by providing a brief, single-session MBI preoperatively to accelerate postoperative recovery, and providing a more intensive, 8-week week MBI, Mindfulness-Oriented Recovery Enhancement (MORE) to treat chronic pain and opioid use in those patients in need of greater intervention.

 

This research project will help active-duty and retired Service Members with OA undergoing TKA, and will also inform the treatment of Veterans and civilians with similar issues. Should our adaptive mindfulness-based strategy prove to be effective in this trial, within 2 years following completion of the project it could be easily transported into military installations across the U.S. and around the world as part of the MHS Stepped Care Model of Pain Management.

 

A secondary objective of the proposed project is to utilize wearable biometric technology to understand how mindfulness works to create therapeutic change. To accomplish this objective, a wearable device will evaluate Service Members’ ability to use mindfulness to self-regulate their heart-rate variability (HRV) as an indicator of control over their parasympathetic nervous system. Because the parasympathetic nervous system is involved in self-control over the urge to use substances (like opioids) and calming the “fight or flight response” to reduce stress and pain, mindfulness should produce clinical benefits by changing HRV. If so, inexpensive wearable technology could be used to objectively monitor and quantify Service Members’ progress in learning mindfulness as a therapeutic technique from preoperative prevention to postoperative recovery.

 

The final objective of this project is to understand for whom MBIs work best, to help ensure that more efficient healthcare resource allocation to the MHS beneficiaries who need it most. The proposed project will enable healthcare providers to more effectively deliver low-cost treatment to improve musculoskeletal health and prevent chronic opioid use, thereby averting costly inpatient stays, medical separation from active-duty military service, and social, legal, and occupational problems among Service Members. Ultimately, the proposed research could significantly enhance the psychological and physical health of military personnel by addressing the need for new integrative treatment options with findings from the leading edge of science.

 

Outcomes:

Project currently in progress.

  


For more information, contact utahpainstudy@utah.edu

 

Updated as of July 30, 2021

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Last Updated: 9/3/21