Move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial.

BACKGROUND: The prevalence of chronic pain conditions is growing. Low back pain was the primary cause of disability worldwide out of 156 conditions assessed between 1990 and 2016, according to the Global Burden of Disease Study. Conventional medical approaches have failed to identify effective and long-lasting approaches for the management of chronic pain, and often fail to consider the multiple domains that influence overall health and can contribute to the pain experience. Leading international organizations that focus on pain research have stated the importance of considering these other domains within holistic and multidisciplinary frameworks for treating pain. While the research behind the theoretical link between these domains and chronic pain outcomes has expanded greatly over the last decade, there have been few practical and feasible methods to implement this type of care in normal clinical practice. METHODS: The purpose of this manuscript is to describe an implementation protocol that is being used to deliver a complex holistic health intervention at multiple sites within a large government health system, as part of a larger multisite trial for patients with chronic low back pain. The Move to Health program developed by the US Army Medical Command was tailored for specific application to patients with low back pain and begins by providing an empirical link between eight different health domains (that include physical, emotional, social, and psychological constructs) and chronic low back pain. Through a six-step process, a health coach leverages motivational interviewing and information from a personal health inventory to guide the patient through a series of conversations about behavioral lifestyle choices. The patient chooses which domains they want to prioritize, and the health coach helps implement the plan with the use of SMART (Specific, Measurable, Attainable, Realistic, Time-bound) goals and a series of resources for every domain, triaged from self-management to specialist referral. DISCUSSION: Complex interventions described in clinical trials are often challenging to implement because they lack sufficient details. Implementation protocols can improve the ability to properly deliver trial interventions into regular clinical practice with increased fidelity. TRIAL REGISTRATION: Implementation of this intervention protocol was developed for a clinical trial that was registered a priori (clinicaltrials.gov #NCT04172038).

Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes.

BACKGROUND: The NIH-DOD-VA Pain Management Collaboratory (PMC) supports 11 pragmatic clinical trials (PCTs) on nonpharmacological approaches to management of pain and co-occurring conditions in U.S. military and veteran health organizations. The Stakeholder Engagement Work Group is supported by a separately funded Coordinating Center and was formed with the goal of developing respectful and productive partnerships that will maximize the ability to generate trustworthy, internally valid findings directly relevant to veterans and military service members with pain, front-line primary care clinicians and health care teams, and health system leaders. The Stakeholder Engagement Work Group provides a forum to promote success of the PCTs in which principal investigators and/or their designees discuss various stakeholder engagement strategies, address challenges, and share experiences. Herein, we communicate features of meaningful stakeholder engagement in the design and implementation of pain management pragmatic trials, across the PMC. DESIGN: Our collective experiences suggest that an optimal stakeholder-engaged research project involves understanding the following: i) Who are research stakeholders in PMC trials? ii) How do investigators ensure that stakeholders represent the interests of a study's target treatment population, including individuals from underrepresented groups?, and iii) How can sustained stakeholder relationships help overcome implementation challenges over the course of a PCT? SUMMARY: Our experiences outline the role of stakeholders in pain research and may inform future pragmatic trial researchers regarding methods to engage stakeholders effectively.

A Sequential Multiple-Assignment Randomized Trial (SMART) for Stepped Care Management of Low Back Pain in the Military Health System: A Trial Protocol.

BACKGROUND: The Defense Health Agency has prioritized system-level pain management initiatives within the Military Health System (MHS), with low back pain as one of the key focus areas. A stepped care model focused on nonpharmacologic treatment to promote self-management is recommended. Implementation of stepped care is complicated by lack of information on the most effective nonpharmacologic strategies and how to sequence and tailor the various available options. The Sequential Multiple-Assignment Randomization Trial for Low Back Pain (SMART LBP) is a multisite pragmatic trial using a SMART design to assess the effectiveness of nonpharmacologic treatments for chronic low back pain. DESIGN: This SMART trial has two treatment phases. Participants from three military treatment facilities are randomized to 6 weeks of phase I treatment, receiving either physical therapy (PT) or Army Medicine's holistic Move2Health (M2H) program in a package specific to low back pain. Nonresponders to treatment in phase I are again randomized to phase II treatment of combined M2H + PT or mindfulness-based treatment using the Mindfulness-Oriented Recovery Enhancement (MORE) program. The primary outcome is the Patient-Reported Outcomes Measurement Information System pain interference computer-adapted test score. SUMMARY: This trial is part of an initiative funded by the National Institutes of Health, Veterans Affairs, and the Department of Defense to establish a national infrastructure for effective system-level management of chronic pain with a focus on nonpharmacologic treatments. The results of this study will provide important information on nonpharmacologic care for chronic LBP in the MHS embedded within a stepped care framework.

Ultrasound imaging as a feedback tool in the rehabilitation of trunk muscle dysfunction for people with low back pain.

This commentary provides an overview of the current concepts and the emerging evidence related to rehabilitative ultrasound imaging (RUSI) for biofeedback purposes. Specifically, the role of RUSI to assess improvements in trunk muscle performance and motor learning will be discussed, highlighting the importance of retention and transfer testing to assess motor learning. The use of RUSI as an extrinsic (augmented) feedback tool and its ability to provide both knowledge of performance and knowledge of results information will be defined. An analysis of the limited available literature related to the role of RUSI as an augmented feedback tool to enhance motor skill acquisition related to the deep trunk muscles will be provided. Future research directions and priorities are recommended.

Rehabilitative ultrasound imaging of the abdominal muscles.

Rehabilitative ultrasound imaging (RUSI) of the abdominal muscles is increasingly being used in the management of conditions involving musculoskeletal dysfunctions associated with the abdominal muscles, including certain types of low back and pelvic pain. This commentary provides an overview of current concepts and evidence related to RUSI of the abdominal musculature, including issues addressing the potential role of ultrasound imaging in the assessment and training of these muscles. Both quantitative and qualitative aspects associated with clinical and research applications are considered, as are the possible limitations related to the interpretation of measurements made with RUSI. Research to date has utilized a range of methodological approaches, including different transducer placements and imaging techniques. The pros and cons of the various methods are discussed, and guidelines for future investigations are presented. Potential implications and opportunities for clinical use of RUSI to enhance evidence-based practice are outlined, as are suggestions for future research to further clarify the possible role of RUSI in the evaluation and treatment of abdominal muscular morphology and function.

Rehabilitative ultrasound imaging of pelvic floor muscle function.

This commentary provides an overview of the current concepts and evidence related to rehabilitative ultrasound imaging of pelvic floor (levator ani) function. As this is an emerging topic, the goal is to provide a basic understanding of ultrasound imaging applications related to levator ani function: the available quantitative and qualitative information, the limitations, as well as how ultrasound imaging can be incorporated as a form of biofeedback during rehabilitation. Furthermore, as the ability to compile and compare existing evidence depends on the degree of similarity in methodology by investigators, this commentary highlights points of consideration and provides guidelines, as well as an agenda, for future investigation.

The use of ultrasound imaging of the abdominal drawing-in maneuver in subjects with low back pain.

STUDY DESIGN: Randomized controlled trial among patients with low back pain (LBP). OBJECTIVES: (1) Determine the reliability of real-time ultrasound imaging for assessing activation of the lateral abdominal muscles; (2) characterize the extent to which the abdominal drawing-in maneuver (ADIM) results in preferential activation of the transverse abdominis (TrA); and (3) determine if ultrasound biofeedback improves short-term performance of the ADIM in patients with LBP. BACKGROUND: Ultrasound imaging is reportedly useful for measuring and training patients to preferentially activate the TrA muscle. However, research to support these claims is limited. METHODS AND MEASURES: Thirty patients with LBP referred for lumbar stabilization training were randomized to receive either traditional training (n = 15) or traditional training with biofeedback (n = 15). Ultrasound imaging was used to measure changes in thickness of the lateral abdominal muscles. Differences in preferential changes in muscle thickness of the TrA between groups and across time were assessed using analysis of variance. RESULTS: Intrarater reliability measuring lateral abdominal muscle thickness exceeded 0.93. On average, patients in both groups demonstrated a 2-fold increase in the thickness of the TrA during the ADIM. Performance of the ADIM did not differ between the groups. CONCLUSION: These data provide construct validity for the notion that the ADIM results in preferential activation of the TrA in patients with LBP. Although, the addition of biofeedback did not enhance the ability to perform the ADIM at a short-term follow-up, our data suggest a possible ceiling effect or an insufficient training stimulus. Further research is necessary to determine if there is a subgroup of patients with LBP who may benefit from biofeedback.