Reproducibility of Exercise Interventions in Randomized Controlled Trials for the Treatment of Rotator Cuff-Related Shoulder Pain: A Systematic Review.

OBJECTIVE: To determine the reproducibility of exercise therapy interventions in randomized controlled trials for rotator cuff-related shoulder pain (RCRSP). DATA SOURCES: Data sources included Medline, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, and SPORTDiscus from studies published from database inception to April 23, 2022. STUDY SELECTION: Randomized controlled trials studying the use of exercise therapy for RCRSP. DATA EXTRACTION: Two reviewers extracted exercise reporting details from all studies using the Template for Intervention Description and Replication (TIDieR) and the modified Consensus on Exercise Reporting Template (CERT). The same 2 reviewers assessed risk of bias of all studies using Cochrane Risk of Bias Tool version 2.0. DATA SYNTHESIS: For 104 studies meeting inclusion criteria, the average number of items reported on the TIDieR was 5.27 (SD 2.50, range 1-12 out of 12) and 5.09 (SD 4.01, range 0-16 out of 16) on the CERT. Improved reporting over time was seen on both the TIDieR and CERT dating back to 1993 and through April 23, 2022. When comparing groups of studies published before and after the TIDieR (2014) and CERT (2016) were established, a statistically significant increase in median scores was noted on the TIDieR (P=.02) but not the CERT (P=.31). Quality of exercise therapy reporting was highest in studies with "low risk" of bias, and lowest in studies with "high risk" of bias on the RoB-2. CONCLUSION: Overall exercise reporting in trials for RCRSP is incomplete despite the development of the TIDieR and CERT checklists. This has implications for translating evidence into practice.

Trials Investigating Exercise for Low Back Pain Lack Pragmatic Application: A Systematic Review.

OBJECTIVE: To systematically review the orientation of trials analyzing exercise for low back pain (LBP) on the efficacy-effectiveness spectrum. DATA SOURCES: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Ovid MEDLINE were searched for trials published between January 1, 2010, and August 13, 2022. STUDY SELECTION: Randomized controlled trials investigating exercise for adults with LBP. DATA EXTRACTION: Two reviewers independently used the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool to determine the efficacy-effectiveness orientation. The same 2 reviewers assessed the risk of bias for all studies using the Cochrane Collaboration risk of bias 2.0 tool. DATA SYNTHESIS: The search identified 2975 records. Full-text review was conducted on 674 studies, and 159 studies were included. The proportion of trials with a strong or rather strong efficacy orientation (RITES rating=1 or 2), balanced emphasis (RITES rating=3), or strong or rather strong effectiveness (RITES rating=4 or 5) orientation on the efficacy-effectiveness spectrum within each RITES domain were reported. A greater proportion of trials had an efficacy orientation when compared with effectiveness or a balanced emphasis within 4 domains: participant characteristics: efficacy 43.9%, 41.9% effectiveness, balanced 14.5%; trial setting: 69.0% efficacy, effectiveness 15.8% balanced 15.2%; flexibility of interventions: 74.2% efficacy, effectiveness 8.8%, balanced 17.0%; clinical relevance of experimental and comparison interventions: 50.3% efficacy, 33.3% effectiveness 33.3%, balanced 16.4%. A high risk of bias was found in 42.1% (n=67) of trials. CONCLUSION: Trials investigating the effect of exercise for LBP have a greater orientation toward efficacy across multiple trial design domains. Researchers should consider pragmatic designs in future trials to improve generalizability. Clinicians should consider the efficacy-effectiveness orientation when translating evidence into clinical practice.

Preoperative conservative treatment is insufficiently described in clinical trials of lumbar fusion: a scoping review.

PURPOSE: To identify how pre-surgical conservative care is characterized and reported in randomized controlled trials of adults undergoing elective lumbar fusion, including duration and type of treatment. METHODS: The study design is a scoping review. Data sources include PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Ovid Medline, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL). All randomized controlled trials published in English between January 1, 2005, and February 15, 2022, assessing lumbar fusion as the intervention were included in this review. RESULTS: Of 166 studies, 62.0% reported a failure in conservative care prior to lumbar fusion, but only 15.1% detailed the type of specific conservative care received. None of the trials provided sufficient details to understand the nature of the pre-surgical conservative treatment, such as frequency, recency/timing, or dosage of conservative interventions. CONCLUSION: Although roughly two-thirds of trials reported that patients failed conservative care prior to receiving a lumbar fusion, few studies named the conservative intervention provided and no studies provided any details regarding dosing or recency of care. This lack of information creates ambiguity in the surgical decision-making process, setting the assumption that all patients received adequate conservative care prior to surgery. Details about pre-surgical conservative care should be disclosed to allow for appropriate clinical application, decision-making, and interpretation of treatment effects.

Can a Psychologic Profile Predict Successful Return to Full Duty After a Musculoskeletal Injury?

BACKGROUND: Psychologic variables have been shown to have a strong relationship with recovery from injury and return to work or sports. The extent to which psychologic variables predict successful return to work in military settings is unknown. QUESTIONS/PURPOSES: In a population of active duty soldiers, (1) can a psychologic profile determine the risk of injury after return to full duty? (2) Do psychologic profiles differ between soldiers sustaining injuries in the spine (thoracic or lumbar) and those with injuries to the lower extremities? METHODS: Psychologic variables were assessed in soldiers returning to full, unrestricted duty after a recent musculoskeletal injury. Most of these were noncombat injuries from work-related physical activity. Between February 2016 and September 2017, 480 service members who were cleared to return to duty after musculoskeletal injuries (excluding those with high-velocity collisions, pregnancy, or amputation) were enrolled in a study that tracked subsequent injuries over the following year. Of those, we considered individuals with complete 12-month follow-up data as potentially eligible for analysis. Based on that, approximately 2% (8 of 480) were excluded because they did not complete baseline surveys, approximately 2% (11 of 480) were separated from the military during the follow-up period and had incomplete injury data, 1% (3 of 480) were excluded for not serving in the Army branch of the military, and approximately 2% (8 of 480) were excluded because they were not cleared to return to full duty. This resulted in 450 soldiers analyzed. Individuals were 86% (385 of 450) men; 74% (331 of 450) had lower extremity injuries and 26% (119 of 450) had spinal injuries, including soft tissue aches and pains (for example, strains and sprains), fractures, and disc herniations. Time-loss injury within 1 year was the primary outcome. While creating and validating a new prediction model using only psychological variables, 19 variables were assessed for nonlinearity, further factor selection was performed through elastic net, and models were internally validated through 2000 bootstrap iterations. Performance was deciphered through calibration, discrimination (area under the curve [AUC]), R 2 , and calibration in the large. Calibration assesses predicted versus actual risk by plotting the x and y intersection of these values; the more similar predicted risk values are to actual ones, the closer the slope of the line formed by the intersection points of all subjects is to equaling "1" (optimal calibration). Likewise, perfect discrimination (predicted injured versus actual injured) presents as an AUC of 1. Perfect calibration in the large would equal 0 because it represents the average predicted risk versus the actual outcome rate. Sensitivity analyses stratified groups by prior injury region (thoracic or lumbar spine and lower extremity) as well as the severity of injury by days of limited duty (moderate [7-27 days] and severe [28 + days]). RESULTS: A model comprising primarily psychologic variables including depression, anxiety, kinesiophobia, fear avoidance beliefs, and mood did not adequately determine the risk of subsequent injury. The derived logistic prediction model had 18 variables: R 2 = 0.03, calibration = 0.63 (95% confidence interval [CI] 0.30 to 0.97), AUC = 0.62 (95% CI 0.52 to 0.72), and calibration in the large = -0.17. Baseline psychologic profiles between body regions differed only for depression severity (mean difference 1 [95% CI 0 to 1]; p = 0.04), with greater mean scores for spine injuries than for lower extremity injuries. Performance was poor for those with prior spine injuries compared with those with lower extremity injuries (AUC 0.50 [95% CI 0.42 to 0.58] and 0.63 [95% CI 0.57 to 0.69], respectively) and moderate versus severe injury during the 1-year follow-up (AUC 0.61 [95% CI 0.51 to 0.71] versus 0.64 [95% CI 0.64 to 0.74], respectively). CONCLUSION: The psychologically based model poorly predicted subsequent injury. This study does not minimize the value of assessing the psychologic profiles of injured athletes, but rather suggests that models looking to identify injury risk should consider a multifactorial approach that also includes other nonpsychologic factors such as injury history. Future studies should refine the most important psychologic constructs that can add the most value and precision to multifactorial models aimed at identifying the risk of injury. LEVEL OF EVIDENCE: Level III, prognostic study.

Physical Therapy versus Glucocorticoid Injection for Osteoarthritis of the Knee.

BACKGROUND: Both physical therapy and intraarticular injections of glucocorticoids have been shown to confer clinical benefit with respect to osteoarthritis of the knee. Whether the short-term and long-term effectiveness for relieving pain and improving physical function differ between these two therapies is uncertain. METHODS: We conducted a randomized trial to compare physical therapy with glucocorticoid injection in the primary care setting in the U.S. Military Health System. Patients with osteoarthritis in one or both knees were randomly assigned in a 1:1 ratio to receive a glucocorticoid injection or to undergo physical therapy. The primary outcome was the total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 1 year (scores range from 0 to 240, with higher scores indicating worse pain, function, and stiffness). The secondary outcomes were the time needed to complete the Alternate Step Test, the time needed to complete the Timed Up and Go test, and the score on the Global Rating of Change scale, all assessed at 1 year. RESULTS: We enrolled 156 patients with a mean age of 56 years; 78 patients were assigned to each group. Baseline characteristics, including severity of pain and level of disability, were similar in the two groups. The mean (±SD) baseline WOMAC scores were 108.8±47.1 in the glucocorticoid injection group and 107.1±42.4 in the physical therapy group. At 1 year, the mean scores were 55.8±53.8 and 37.0±30.7, respectively (mean between-group difference, 18.8 points; 95% confidence interval, 5.0 to 32.6), a finding favoring physical therapy. Changes in secondary outcomes were in the same direction as those of the primary outcome. One patient fainted while receiving a glucocorticoid injection. CONCLUSIONS: Patients with osteoarthritis of the knee who underwent physical therapy had less pain and functional disability at 1 year than patients who received an intraarticular glucocorticoid injection. (ClinicalTrials.gov number, NCT01427153.).

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.

BACKGROUND: Improving pain management for persons with chronic low back pain (LBP) undergoing surgery is an important consideration in improving patient-centered outcomes and reducing the risk of persistent opioid use after surgery. Nonpharmacological treatments, including physical therapy and mindfulness, are beneficial for nonsurgical 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 multisite randomized trial that compares an enriched pain management (EPM) pathway that integrates physical therapy and mindfulness vs usual-care pain management (UC) for persons undergoing surgery for LBP. DESIGN: Participants from military treatment facilities will be enrolled before surgery and individually randomized to the EPM or UC pain management pathways. Participants assigned to EPM will receive presurgical 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, which is focused on providing scientific solutions to the opioid crisis. The MIND-PT study will examine an innovative program combining nonpharmacological treatments designed to improve outcomes and reduce opioid overreliance in persons undergoing lumbar surgery.

The Back Pain Consortium (BACPAC) Research Program: Structure, Research Priorities, and Methods.

In 2019, the National Health Interview survey found that nearly 59% of adults reported pain some, most, or every day in the past 3 months, with 39% reporting back pain, making back pain the most prevalent source of pain, and a significant issue among adults. Often, identifying a direct, treatable cause for back pain is challenging, especially as it is often attributed to complex, multifaceted issues involving biological, psychological, and social components. Due to the difficulty in treating the true cause of chronic low back pain (cLBP), an over-reliance on opioid pain medications among cLBP patients has developed, which is associated with increased prevalence of opioid use disorder and increased risk of death. To combat the rise of opioid-related deaths, the National Institutes of Health (NIH) initiated the Helping to End Addiction Long-TermSM (HEAL) initiative, whose goal is to address the causes and treatment of opioid use disorder while also seeking to better understand, diagnose, and treat chronic pain. The NIH Back Pain Consortium (BACPAC) Research Program, a network of 14 funded entities, was launched as a part of the HEAL initiative to help address limitations surrounding the diagnosis and treatment of cLBP. This paper provides an overview of the BACPAC research program's goals and overall structure, and describes the harmonization efforts across the consortium, define its research agenda, and develop a collaborative project which utilizes the strengths of the network. The purpose of this paper is to serve as a blueprint for other consortia tasked with the advancement of pain related science.

Barriers and facilitators to implementation of musculoskeletal injury mitigation programmes for military service members around the world: a scoping review.

INTRODUCTION: Musculoskeletal injury (MSK-I) mitigation and prevention programmes (MSK-IMPPs) have been developed and implemented across militaries worldwide. Although programme efficacy is often reported, development and implementation details are often overlooked, limiting their scalability, sustainability and effectiveness. This scoping review aimed to identify the following in military populations: (1) barriers and facilitators to implementing and scaling MSK-IMPPs; (2) gaps in MSK-IMPP research and (3) future research priorities. METHODS: A scoping review assessed literature from inception to April 2022 that included studies on MSK-IMPP implementation and/or effectiveness in military populations. Barriers and facilitators to implementing these programmes were identified. RESULTS: From 132 articles, most were primary research studies (90; 68.2%); the remainder were review papers (42; 31.8%). Among primary studies, 3 (3.3%) investigated only women, 62 (69%) only men and 25 (27.8%) both. Barriers included limited resources, lack of stakeholder engagement, competing military priorities and equipment-related factors. Facilitators included strong stakeholder engagement, targeted programme design, involvement/proximity of MSK-I experts, providing MSK-I mitigation education, low burden on resources and emphasising end-user acceptability. Research gaps included variability in reported MSK-I outcomes and no consensus on relevant surveillance metrics and definitions. CONCLUSION: Despite a robust body of literature, there is a dearth of information about programme implementation; specifically, barriers or facilitators to success. Additionally, variability in outcomes and lack of consensus on MSK-I definitions may affect the development, implementation evaluation and comparison of MSK-IMPPs. There is a need for international consensus on definitions and optimal data reporting elements when conducting injury risk mitigation research in the military.

What is the incidence of subsequent adjacent joint injury after patellofemoral pain?

OBJECTIVE: To investigate the incidence of subsequent lumbar spine, hip, and ankle-foot injuries after a diagnosis of patellofemoral pain. DESIGN: Retrospective cohort study. SETTING: Military Health System. PARTICIPANTS: Individuals (n = 92,319) ages 17-60 diagnosed with patellofemoral pain between 2010-2011. INTERVENTIONS: Therapeutic exercise. MAIN OUTCOME MEASURES: Frequency of adjacent joint injuries in the 2-year period after initial patellofemoral pain injury, and hazard ratios (HR) with 95% confidence interval (CI) and Kaplan-Meier survival curves for risk of adjacent joint injury based on receiving therapeutic exercise for the initial injury. RESULTS: After initial patellofemoral pain diagnosis, 42,983 (46.6%) individuals sought care for an adjacent joint injury. Of these, 19,587 (21.2%) were subsequently diagnosed with a lumbar injury, 2837 (3.1%) a hip injury, and 10,166 (11.0%) an ankle-foot injury. One in five (19.5%; n = 17,966) received therapeutic exercise which reduced the risk of having a subsequent lumbar (HR = 0.78, 95% CI 0.76-0.81), hip (HR = 0.93, 95% CI 0.87-0.98) or ankle-foot (HR = 0.86, 95% CI 0.83-0.90) injury. CONCLUSION: The results suggest that a high number of individuals with patellofemoral pain will sustain an adjacent joint injury within 2 years although causal relationships cannot be determined. Receiving therapeutic exercise for the initial knee injury reduced the risk of sustaining an adjacent joint injury. This study helps provide normative data for subsequent injury rates in this population and guide development of future studies designed to understand causal factors.

TIDieR-telehealth: precision in reporting of telehealth interventions used in clinical trials - unique considerations for the Template for the Intervention Description and Replication (TIDieR) checklist.

BACKGROUND: Recent international health events have led to an increased proliferation of remotely delivered health interventions. Even with the pandemic seemingly coming under control, the experiences of the past year have fueled a growth in ideas and technology for increasing the scope of remote care delivery. Unfortunately, clinicians and health systems will have difficulty with the adoption and implementation of these interventions if ongoing and future clinical trials fail to report necessary details about execution, platforms, and infrastructure related to these interventions. The purpose was to develop guidance for reporting of telehealth interventions. METHODS: A working group from the US Pain Management Collaboratory developed guidance for complete reporting of telehealth interventions. The process went through 5-step process from conception to final checklist development with input for many stakeholders, to include all 11 primary investigators with trials in the Collaboratory. RESULTS: An extension focused on unique considerations relevant to telehealth interventions was developed for the Template for the Intervention Description and Replication (TIDieR) checklist. CONCLUSION: The Telehealth Intervention guideline encourages use of the Template for the Intervention Description and Replication (TIDieR) checklist as a valuable tool (TIDieR-Telehealth) to improve the quality of research through a reporting guide of relevant interventions that will help maximize reproducibility and implementation.

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).

Timing of physical therapy for individuals with patellofemoral pain and the influence on healthcare use, costs and recurrence rates: an observational study.

BACKGROUND: Early physical therapy has been shown to decrease downstream healthcare use, costs and recurrence rates in some musculoskeletal conditions, but it has not been investigated in individuals with patellofemoral pain. The purpose was to evaluate how the use and timing of physical therapy influenced downstream healthcare use, costs, and recurrence rates. METHODS: Seventy-four thousand four hundred eight individuals aged 18 to 50 diagnosed with patellofemoral pain between 2010 and 2011 in the Military Health System were categorized based on use and timing of physical therapy (first, early, or delayed). Healthcare use, costs, and recurrence rates were compared between the groups using descriptive statistics and a binary logit regression. RESULTS: The odds for receiving downstream healthcare use (i.e. imaging, prescription medications, and injections) were lowest in those who saw a physical therapist as the initial contact provider (physical therapy first), and highest in those who had delayed physical therapy (31-90 days after patellofemoral pain diagnosis). Knee-related costs for those receiving physical therapy were lowest in the physical therapy first group ($1,136, 95% CI $1,056, $1,217) and highest in the delayed physical therapy group ($2,283, 95% CI $2,192, $2,374). Recurrence rates were lowest in the physical therapy first group (AOR = 0.55, 95% CI 0.37, 0.79) and highest in the delayed physical therapy group (AOR = 1.78, 95% CI 1.36, 2.33). CONCLUSIONS: For individuals with patellofemoral pain using physical therapy, timing is likely to influence outcomes. Healthcare use and costs and the odds of having a recurrence of knee pain were lower for patients who had physical therapy first or early compared to having delayed physical therapy.

The influence of a MOBile-based video Instruction for Low back pain (MOBIL) on initial care decisions made by primary care providers: a randomized controlled trial.

BACKGROUND: Adherence to guidelines for back pain continues to be a challenge, prompting strategies focused on improving education around biopsychosocial frameworks. OBJECTIVE: Assess the influence of an interactive educational mobile app for patients on initial care decisions made for low back pain by the primary care provider. The secondary aim was to compare changes in self-reported pain and function between groups. METHODS: This was a randomized controlled trial involving patients consulting for an initial episode of low back pain. The intervention was a mobile video-based education session (Truth About Low Back Pain) compared to usual care. The app focused on addressing maladaptive beliefs typically associated with higher risk of receiving low-value care options. The primary outcome was initial medical utilization decisions made by primary care practitioners (x-rays, MRIs, opioid prescriptions, injections, procedures) and secondary outcomes included PROMIS pain interference and physical function subscales at 1 and 6 months, and total medical costs. RESULTS: Of 208 participants (71.2% male; mean age 35.4 years), rates of opioid prescriptions, advanced imaging, analgesic patches, spine injections, and physical therapy use were lower in the education group, but the differences were not significant. Total back-related medical costs for 1 year (mean diff = $132; P = 0.63) and none of the 6-month PROMIS subscales were significantly different between groups. Results were no different in opioid-naïve subjects. Instead, prior opioid use and high-risk of poor prognosis on the STarT Back Screening Tool predicted 1-year back pain-related costs and healthcare utilization, regardless of intervention. CONCLUSION: Factors that influence medical treatment decisions and guideline-concordant care are complex. This particular patient education approach directed at patients did not appear to influence healthcare decisions made by primary care providers. Future studies should focus on high-risk populations and/or the impact of including the medical provider as an active part of the educational process. TRIAL REGISTRATION: clinicaltrials.gov NCT02777983 .

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.

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.

Utility of catastrophizing, body symptom diagram score and history of opioid use to predict future health care utilization after a primary care visit for musculoskeletal pain.

BACKGROUND: Self-report information about pain and pain beliefs are often collected during initial consultation for musculoskeletal pain. These data may provide utility beyond the initial encounter, helping provide further insight into prognosis and long-term interactions of the patient with the health system. OBJECTIVE: The aim of this study was to determine if pain catastrophizing and pain-related body symptoms can predict future health care utilization. METHODS: This was a longitudinal cohort study. Baseline data were collected after receiving initial care for a musculoskeletal disorder in a multidisciplinary clinic within a large military hospital. Subjects completed the Pain Catastrophizing Scale, a region-specific disability measure, numeric pain rating scale and a body symptom diagram. Health care utilization data for 1 year prior and after the visit were extracted from the Military Health System Data Repository. Multivariable regression models appropriate for skewed and count data were developed to predict (i) musculoskeletal-specific medical visits, (ii) 12-month opioid use, (iii) musculoskeletal-specific medical costs and (iv) total medical costs. We investigated whether a pain catastrophizing × body symptom diagram interaction improved prediction, and developed separate models for opioid-naïve individuals and those with a history of opioid use in an exploratory analysis. RESULTS: Pain catastrophizing but not body symptom diagram was a significant predictor of musculoskeletal visits, musculoskeletal costs and total medical costs. Exploratory analyses suggest these relationships are most robust for patients with a history of opioid use. CONCLUSIONS: Pain catastrophizing can identify risk of high health care utilization and costs, even after controlling for common clinical variables. Addressing pain catastrophizing in the primary care setting may help to mitigate future health care utilization and costs, while improving clinical outcomes. These results provide direction for future validation studies in larger and more traditional primary care settings.

Are Exercise and Physical Therapy Common Forms of Conservative Management in the Year Before Lumbar Spine Surgery?

OBJECTIVE: To quantify and compare utilization of opioids, exercise therapy, and physical therapy in the year before spine surgery. DESIGN: A retrospective cohort of surgical and claims data. SETTING: Beneficiaries of the Military Health System seen at Brooke Army Medical Center PARTICIPANTS: Patients (N=411) undergoing surgery between January 1, 2014, and December 31, 2015, identified retrospectively through the Surgical Scheduling System (S3) based on procedure type (fusion, laminectomy, arthroplasty, vertebroplasty, and diskectomy). INTERVENTIONS: Elective lumbar spine surgery. MAIN OUTCOME MEASURES: Health care utilization variables present during the full 12 months before surgery, which included physical therapy services and visits for exercise therapy or manual therapy procedures and opioid prescriptions. RESULTS: The mean age of participants was 44.8±11.7 years and 32.4% were female. In the year before surgery, 143 (34.8%) patients had a physical therapy plan of care, 140 (34.1%) had at least 1 visit that included exercise therapy, and only 60 (14.6%) had a minimum of 6 exercise therapy visits. However, 347 (84.4%) patients received at least 1 opioid prescription fill (mean of 6.1 unique fills). CONCLUSIONS: Before elective lumbar spine surgery, opioid prescriptions were common but physical therapy services and exercise therapy utilization occurred infrequently.

The Influence of a Guideline-Concordant Stepped Care Approach on Downstream Health Care Utilization in Patients with Spine and Shoulder Pain.

BACKGROUND: Stepped care approaches are emphasized in guidelines for musculoskeletal pain, recommending less invasive or risky evidence-based intervention, such as manual therapy (MT), before more aggressive interventions such as opioid prescriptions. The order and timing of care can alter recovery trajectories. OBJECTIVE: To compare one-year downstream health care utilization in patients with spine or shoulder disorders who received only MT vs MT and opioids. The secondary aim was to compare differences based on order and timing of opioids and MT. DESIGN: Retrospective observational cohort. METHODS: Patients with an initial consultation for a spine or shoulder disorder who received at least one visit for MT were included. Person-level data from the Military Health System Management and Reporting Tool (M2) database were aggregated by a senior health care analyst at Madigan Army Medical Center. Groups were created based on the order and timing of interventions provided. Outcomes included health care utilization (medical costs and visits) over the year following initial consultation. Control measures included metabolic, mental health, chronic pain, sleep, and substance abuse comorbidities, as well as prior opioid prescriptions. Generalized linear models with gamma log links were run due to the heavily skewed nature of cost data. RESULTS: From 1,876 unique patients with spine or shoulder disorders receiving MT, 1,162 (61.9%) also received prescription opioids. Mean one-year costs in the MT-only group ($5,410, 95% confidence interval [CI] = $5,109 to $5,730) were significantly lower than in the MT+opioid group ($10,498, 95% CI = $10,043 to $10,973). When patients had both treatments, mean one-year costs in the MT-first ($10,782, 95% CI = $10,050 to $11,567) were significantly lower (P = 0.030) than opioid-first ($11,938, 95% CI = $11,272 to $12,643), and MT-first had a significantly lower mean days' supply of opioids (34.2 vs 70.9, P < 0.001) and mean number of unique opioid prescriptions (3.1 vs 6.5, P < 0.001). CONCLUSIONS: MT alone resulted in lower downstream costs than with opioid prescriptions. Both the order of treatment (MT before opioid prescriptions) and the timing of treatment (MT < 30 days) resulted in a significant reduction of resources (costs, visits, and opioid utilization) in the year after initial consultation. Clinicians should consider the implications of first-choice decisions and the timing of care for treatment choices utilized for patients with spine and shoulder disorders.

Which patients do not seek additional medical care after a self-management class for low back pain? An observational cohort.

OBJECTIVES: (1) To identify baseline variables associated with patients that sought no additional care during the 12 months following a single self-management education session for low back pain (LBP), and (2) in those who sought care, to determine whether the same variables were associated with low versus high downstream LBP-related healthcare utilization. DESIGN: An observational cohort. SETTING: Single large military hospital. PARTICIPANTS: A total of 733 patients with LBP. INTERVENTION: Single self-management education session. MAIN OUTCOMES: Eleven variables were explored in two distinct logistic regression models: (1) no additional care versus additional care, and (2) low versus high number of additional visits in the additional care group. RESULTS: In the first model, not being on active duty service (odds ratio (OR) = 1.98, 95% confidence interval (CI) = 1.37-2.86), low baseline disability (OR = 1.02, 95% CI = 1.00-1.04), low baseline fear-avoidance related to work (OR = 1.02, 95% CI = 1.00-1.03), and, in the last year, no opioid prescriptions (OR = 1.44, 95% CI = 1.00-2.07), physical therapy (OR = 1.63, 95% CI = 1.00-2.65), or sleep disorder diagnosis (OR = 1.62, 95% CI = 1.05-2.51) significantly increased the odds that patients would not seek any additional care. In the second model, not being on active duty service (OR = 2.18, 95% CI = 1.38-3.46), low baseline disability (OR = 1.04, 95% CI = 1.02-1.06), and no opioid prescriptions in the prior year (OR = 2.19, 95% CI = 1.42-3.37) increased the odds that patients would have less visits (⩽2 visits). CONCLUSION: Our study found several variables that helped determine whether patients would seek little or no additional care during the 12 months following a self-management education class for LBP.