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STUDY DESIGN.: Prospective cohort study. OBJECTIVE.: To examine differences between preoperative and postoperative fear of movement and investigate the relationship between fear of movement and pain, disability and physical health after spinal surgery for degenerative conditions. SUMMARY OF BACKGROUND DATA.: Consistent evidence supports the relationship between fear of movement and higher levels of pain and disability in various chronic pain populations. Fear of movement among patients undergoing spinal surgery for chronic pain has received little attention in the literature. METHODS.: Participants were 141 patients treated with surgery for lumbar and cervical degenerative conditions. Assessments were conducted before surgery and 6 weeks and 3 months after hospitalization. Fear of movement was measured with the Tampa Scale for Kinesiophobia and outcomes were measured with the Brief Pain Inventory, Oswestry or Neck Disability Index, and 12-Item Short Form Health Survey (SF-12). RESULTS.: Follow-up rates were 91% and 87% for 6 weeks and 3 months, respectively. Fear of movement beliefs improved after surgery, but 49% of patients continued to have high fear of movement at 6-week follow-up and 39% at 3-month follow-up. Patients with higher levels of fear of movement had poorer postoperative outcomes. Multilevel linear regression analyses found that postoperative fear of movement was independently associated with postoperative pain intensity, pain interference, disability, and physical health (P < 0.001), after controlling for depression, age, sex, education, race, comorbidities, type and area of surgery, prior surgeries, and baseline outcome score. Preoperative fear of movement was not predictive of poorer surgical outcomes. CONCLUSION.: Results demonstrate that postoperative but not preoperative fear of movement beliefs explain unique and significant variance in postoperative pain, disability, and physical health. Clinicians interested in improving surgical outcomes should address postoperative fear of movement along with other traditional clinical and medical risk factors. Recommendations include postoperative screening for high fear of movement beliefs and incorporating cognitive-behavioral techniques into postoperative rehabilitation for at-risk surgical spine patients. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To describe the prevalence of perceived environmental barriers in a population of amputees; to compare and contrast those barriers reported by amputees with reported barriers of a sample of disabled and nondisabled persons; and to identify the correlates of barriers among amputees. DESIGN: Cross-sectional survey. SETTING: A community sample who were interviewed by telephone. PARTICIPANTS: A stratified sample by etiology of 914 community-dwelling persons with limb loss. INTERVENTION: Telephone interview. MAIN OUTCOME MEASURES: Frequency (never, less than monthly, monthly, weekly, daily) and magnitude (little problem, big problem) of perceived environmental barriers in 5 domains as measured by the Craig Hospital Inventory of Environmental Factors-Short Form (CHIEF-SF), characteristics of the amputation, prosthetic use, and sociodemographic characteristics of the amputee. RESULTS: The majority (87%) of persons surveyed reported barriers in 1 or more areas with 57% reporting barriers in 4 or more of the 5 domains (policies, physical/structural, work/school, attitudes/support, and services/assistance subscales). Mean frequency-magnitude scores were lower for amputees with cancer-related amputation across all subscales, while traumatic amputees reported the greatest perceived barriers, except in the area of services/assistance. Across all domains, poverty level and comorbidity were significant predictors of significant barriers (CHIEF-SF score >/=3; range, 0-8). When compared with a general population sample of disabled and nondisabled Americans, amputees were more likely to perceive barrier in all areas except work/school. CONCLUSIONS: Perceived environmental barriers among persons with limb loss are highly prevalent. Reduction of environmental barriers may lead to reduction of disability and improvement of overall quality of life for amputees. Copyright © 2006 by Elsevier Inc. [ABSTRACT FROM AUTHOR]

Objectives: (a) To trace the historical roots of denial of illness in order to understand how the construct of denial developed; (b) to review the literature based on proposed theses; and (c) to propose a taxonomy of the unawareness syndromes. Method: Review of the literature and theory and presentation of a new theoretical model. Results: Evidence from the literature demonstrated that (a) denial and anosognosia are two forms of unawareness syndromes; (b) denial is a multidimensional construct; (c) the use of denial can be both adaptive and maladaptive; and (d) denial interacts with time to have a differential impact on outcomes. Conclusion: A taxonomy is proposed that includes anosognosia (complete and partial) and denial of illness (complete and partial). [ABSTRACT FROM AUTHOR]

Individuals with chronic pain report disproportionally higher rates of trauma, yet it is unclear whether different types of trauma (eg, sexual, accidental trauma) are associated with worse pain outcomes. The present study sought to 1) identify subgroups of people with chronic pain based on trauma type, and 2) determine whether subgroups differ in terms of pain characteristics over a 2-year period. Individuals with chronic pain (N = 1,451) participated in an online study and completed self-report questionnaires at baseline, 3-, 12-, and 24-month follow-up. Trauma was assessed via the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Pain intensity and interference were measured via the Brief Pain Inventory, and pain distribution was evaluated using the Widespread Pain Index. Latent class analyses produced a 3-class solution consisting of individuals with high and diverse trauma (16.3%), high sexual trauma (18.4%), and low/accidental trauma (57.1%) with the rest of the sample endorsing no trauma history (8.2%). After controlling for key demographic variables and baseline outcome levels, individuals in the high- and diverse trauma group endorsed higher levels of pain severity and interference at the 3- and 12-month follow-ups compared with the group with no trauma (P < .01). Additionally, relative to the no trauma group, individuals in the high sexual trauma group reported higher levels of pain interference and more widespread pain at the 3-month follow-up (P < .05). The findings underscore the importance of screening for trauma and suggest that the type and variety of trauma experienced may be relevant to pain-related outcomes. PERSPECTIVE: This article highlights how an individual's unique trauma history may be related to their current pain experience. Knowledge of the type and frequency of past trauma may have relevant clinical implications for the treatment of chronic pain., (Copyright © 2024 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose/objective: Lack of patient participation and engagement remains a barrier to implementing effective online self-management and behavioral health interventions. Identifying patient characteristics associated with engagement rates may lead to interventions that improve engagement in traditional and online self-management programs. In this study, two online self-management and recovery programs were evaluated to identify factors that predict patient engagement., Research Method/design: Predictors were collected in a questionnaire at baseline before 435 participants started either of the two interventions. One or two online lessons were completed per week with seven or eight total lessons to complete in each program, and each lesson took about 20-30 min to finish. Full patient engagement was defined as completing all lessons and assessments in the program and partial engagement as attempting at least one lesson or assessment., Results: Predictors of full patient engagement were self-rated confidence in completing the program or being over 60 years of age. Predictors of at least partial patient engagement were experienced ordering online or being over 50 years of age., Conclusions/implications: Identifying profiles of individuals who predict poor engagement may improve implementation and the health outcomes of intervention programs. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Objective: The coronavirus disease-2019 pandemic has facilitated the emergence of telerehabilitation, but it is unclear which patients are most likely to respond to physical therapy provided this way. The purpose of this study was to examine the relationship between individual patient factors and substantial clinical benefit from telerehabilitation among a cohort of patients with chronic low back pain (LBP)., Methods: This is a secondary analysis of data collected during a prospective longitudinal cohort study. Patients with chronic LBP (N = 98) were provided with a standardized physical therapy protocol adapted for telerehabilitation. We examined the relationship between patient factors and substantial clinical benefit with telerehabilitation, defined as a ≥50% improvement in disability at 10 weeks, measured using the Oswestry Disability Index., Results: Sixteen (16.3%) patients reported a substantial clinical benefit from telerehabilitation. Patients reporting substantial clinical benefit from telerehabilitation had lower initial pain intensity, lower psychosocial risk per the STarT Back Screening Tool, higher levels of pain self-efficacy, and reported higher therapeutic alliance with their physical therapist compared to other patients., Conclusion: Patients with lower psychosocial risk and higher pain-self efficacy experienced substantial clinical benefit from telerehabilitation for chronic LBP more often than other patients in our cohort. Therapeutic alliance was higher among patients who experienced a substantial clinical benefit compared to those who did not., Impact: This study indicates that psychosocial factors play an important role in the outcomes of patients receiving telerehabilitation for chronic LBP. Baseline psychosocial screening may serve as a method for identifying patients likely to benefit from this approach., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Abstract: Musculoskeletal injury is a leading cause of pain and disability worldwide; 35% to 75% of people experience persistent pain for months and years after injury. Psychological treatments can reduce pain, functional impairment, and psychological distress but are not widely used after injury. This systematic review and meta-analysis (PROSPERO ID: CRD42021236807) aimed to synthesize the literature testing psychological treatments for pain after musculoskeletal injury. We searched EMBASE, MEDLINE, PubMed, PsycINFO, and CENTRAL from inception to May 2022. We extracted participant, treatment, and injury characteristics and primary (eg, pain intensity, functional impairment, depression, anxiety, and PTSD symptoms) and secondary (treatment feasibility and acceptability) outcomes. Twenty-four randomized controlled trials (N = 1966) were included. Immediately posttreatment, people who received psychological treatments (versus any control) reported lower pain intensity (standardized mean differences [SMD] = -0.25, 95% confidence interval [-0.49, -0.02]), functional impairment (SMD = -0.32 [-0.55, -0.09]), and symptoms of depression (SMD = -0.46 [-0.64, -0.29]), anxiety (SMD = -0.34 [-0.65, -0.04]), and PTSD (SMD = -0.43 [-0.70, -0.15]); at 6-month follow-up, only depression symptoms were significantly lower. Included trials varied widely in treatment and injury characteristics. The certainty of evidence was low or very low for most effects and heterogeneity moderate to substantial. Most studies had risk of bias domains judged to be high or unclear. Owing to very low certainty of results, we are unsure whether psychological therapies reduce pain and functional impairment after musculoskeletal injury; they may result in improved depression immediately posttreatment and at follow-up. More research is needed to identify treatments that result in enduring effects., (Copyright © 2023 International Association for the Study of Pain.)

Background: Little evidence is available to guide physical therapy (PT) following lower extremity fracture repair distal to the hip. As such, variability has been reported in the way PT is utilized post-operatively. Examination of current practice by orthopedic surgeons (OS) and physical therapists is needed to inform clinical practice guidelines in this area., Objective: To describe current PT referral practices among OS, identify patient and clinical factors that affect PT referral, and examine differences between OS and physical therapists with regard to visit frequency, duration, and use of specific PT interventions., Methods: Provider surveys., Results: Surveys were completed by 100 OS and 347 physical therapists. Over half (54%) of OS reported referring "most patients" to PT and identified joint stiffness and strength limitations as top reasons for PT referral. Over 80% of OS and physical therapists indicated that joint stiffness, strength limitations, and patients' functional goals affected their recommendations for PT visit frequency. More physical therapists than OS reported that pain severity (55% vs 25%, p < .001), maladaptive pain behaviors (64% vs. 33%, p < .001), and patient self-efficacy (70% vs. 49%, p = .003) affected their visit frequency recommendations. While OS recommended more frequent PT for patients with peri-articular fractures, fracture type had minimal impact on the visit frequencies recommended by physical therapists., Conclusion: OS and physical therapists consider similar physical impairments when determining the need for PT and visit frequencies, however, physical therapists consider pain and psychosocial factors more often, with OS focusing more on injury type.

Studies have identified insomnia as having significant influence on chronic pain. A rising body of research has also underscored the association between eveningness and chronic pain. However, co-assessment of insomnia and eveningness in the context of chronic pain adjustment has been limited. The present study sought to investigate the effects of insomnia and eveningness on pain severity, pain interference, and emotional distress (ie, depressive and anxiety symptoms) over nearly 2 years among adults with chronic pain in the U.S. Adults with chronic pain (N = 884) were surveyed 3 times via Amazon's MTurk online crowdsourcing platform: baseline, 9-month follow-up, and 21-month follow-up. Path analysis was conducted to examine the effects of baseline insomnia severity (Insomnia Severity Index) and eveningness (Morningness and Eveningness Questionnaire), as well as their moderating effects on outcomes. Controlling for select sociodemographic variables and baseline outcome levels, greater insomnia severity at baseline was associated with worsening of all of the pain-related outcomes at 9-month follow-up, and pain interreference and emotional distress at 21-month follow-up. We did not find evidence that evening types are at a higher risk of experiencing worsening pain-related outcomes over time compared to morning and intermediate types. There were also no significant insomnia severity and eveningness moderation effects on any outcome. Our findings suggest that insomnia is a more robust predictor of changes in pain-related outcomes as compared to eveningness. Treatment of insomnia can be important in chronic pain management. Future studies should evaluate the role of circadian misalignment on pain using more accurate biobehavioral makers. PERSPECTIVE: This study examined the effects of insomnia and eveningness on pain and emotional distress in a large sample of individuals with chronic pain. Insomnia severity is a stronger predictor of changes in pain and emotional distress than eveningness, highlighting insomnia as an important clinical target for chronic pain management., (Copyright © 2023 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: Disparities exist in health care access, diagnosis, and treatment of chronic pain in Latino populations and other minority populations. Cognitive behavioral-based physical therapy (CBPT) interventions have been shown to be effective in predominantly non-Hispanic white populations with chronic spine pain. However, there is a need for culturally adapted CBPT interventions that focus on the conservative management of chronic spine pain. The primary purpose of the study described in this protocol is to test the efficacy of an adapted cognitive behavioral-based hybrid telerehabilitation intervention for Latino patients with chronic spine pain., Methods: A single-blind, 2-arm parallel group, superiority randomized clinical trial is planned to compare an adapted CBPT intervention to Usual Care physical therapy. Goal Oriented Activity for Latinos with chronic Spine pain (GOALS/Metas) is an 8-week hybrid telerehabilitation intervention that integrates guideline-based physical therapy and pain management interventions using cognitive behavioral approaches and has been adapted for Latino patients with chronic spine pain. Usual Care physical therapy will be administered based on institutional standards at the referring health center. Outcome measures will be evaluated preintervention and at 1-week, 3-months, and 6-months postintervention. The primary outcome is pain-related disability 1-week postintervention using the Brief Pain Inventory Pain Interference subscale. Secondary outcome measures include behavioral measures of functional activity, social participation, physical activity, and sleep. Determinants of treatment effect, including pain-related psychological measures, posture and movement, self-efficacy, treatment expectancy, and therapeutic alliance, will be included in the secondary moderation and mediation analyses., Impact: This clinical trial will provide information on the extent to which an adapted CBPT hybrid telerehabilitation intervention is effective in reducing pain-related disability for Latino patients with chronic spine pain. This information will be useful for clinicians to integrate in their practice, given the growing population of Latino patients who experience disparities in health care management of chronic pain., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Study Design: Qualitative interview study., Objective: The aim was to develop a conceptual model for Spine Surgery Recovery in order to better understand why patients undergo lumbar spine surgery and what factors influence patient satisfaction., Summary of Background Data: Quantitative studies have assessed patients' expectations for lumbar spine surgery outcomes, with greater expectation fulfillment leading to higher satisfaction. However, there is limited literature using qualitative methods to understand the patient perspective from the decision to undergo lumbar spine surgery through long-term recovery., Materials and Methods: Semistructured phone interviews were conducted with 20 participants (nine females, mean age ±SD=61.2±11.1 yr) and three focus groups with 12 participants (nine females, mean age ±SD=62.0±10.9 yr). Sessions were audio recorded and transcribed. Two independent researchers coded the transcripts using a hierarchical coding system. Major themes were identified and a conceptual model was developed., Results: A total of 1355 coded quotes were analyzed. The decision to have lumbar spine surgery was influenced by chronic pain impact on daily function, pain coping, and patient expectations. Results demonstrated that fulfilled expectations and setting realistic expectations are key factors for patient satisfaction after surgery, while less known constructs of accepting limitations, adjusting expectations, and optimism were found by many patients to be essential for a successful recovery. Emotional factors of fear, anxiety, and depression were important aspects of presurgical and postsurgical experiences., Conclusion: Our Spine Surgery Recovery conceptual model provides guidance for future research and clinical practice to optimize treatment and improve overall patient satisfaction. Recommendations based on this model include the assessment of patient expectations and mental well-being throughout postoperative recovery as well as preoperatively to help set realistic expectations and improve satisfaction. Educational, acceptance-based or positive psychological interventions may be potentially beneficial for addressing key factors identified in this model., Competing Interests: J.S.P. receives consulting fees from 3 Spine and Steamboat Orthopaedic Spine Institute. K.R.A. receives consulting fees from NeuroSpinal Innovation Inc. and financial support as a deputy editor for Spine. The remaining authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: We assessed whether race or ethnicity was associated with the incidence of high-impact chronic low back pain (cLBP) among adults consulting a primary care provider for acute low back pain (aLBP)., Methods: In this secondary analysis of a prospective cohort study, patients with aLBP were identified through screening at seventy-seven primary care practices from four geographic regions. Incidence of high-impact cLBP was defined as the subset of patients with cLBP and at least moderate disability on Oswestry Disability Index [ODI >30]) at 6 months. General linear mixed models provided adjusted estimates of association between race/ethnicity and high-impact cLBP., Results: We identified 9,088 patients with aLBP (81.3% White; 14.3% Black; 4.4% Hispanic). Black/Hispanic patients compared to White patients, were younger and more likely to be female, obese, have Medicaid insurance, worse disability on ODI, and were at higher risk of persistent disability on STarT Back Tool (all P < .0001). At 6 months, more Black and Hispanic patients reported high-impact cLBP (30% and 25%, respectively) compared to White patients (15%, P < .0001, n = 5,035). After adjusting for measured differences in socioeconomic and back-related risk factors, compared to White patients, the increased odds of high-impact cLBP remained statistically significant for Black but not Hispanic patients (adjusted odds ration [aOR] = 1.40, 95% confidence interval [CI]: 1.05-1.87 and aOR = 1.25, 95%CI: 0.83-1.90, respectively)., Conclusions: We observed an increased incidence of high-impact cLBP among Black and Hispanic patients compared to White patients. This disparity was partly explained by racial/ethnic differences in socioeconomic and back-related risk factors. Interventions that target these factors to reduce pain-related disparities should be evaluated., Clinicaltrials.gov Identifier: NCT02647658., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Difficulties with pain-specific emotion regulation (ER; eg, pain catastrophizing, pain acceptance) are associated with poor pain outcomes. Less is known about how general ER relates to pain outcomes, or the extent to which pain-specific and general ER interact. In a sample (N = 1,453) of adults with chronic pain, the current study used latent profile analysis to identify subgroups of people with distinct pain-specific and general ER profiles, and determined how subgroup membership at baseline related to pain severity, pain interference, depression and anxiety symptoms at 12-month follow-up. Four groups were identified: 1) general ER difficulties only (29.6%); 2) pain-specific and general ER difficulties (26.3%); 3) skillful pain-specific and general ER (24.6%); 4) pain-specific ER difficulties only (19.4%). Controlling for auto-correlation and demographic covariates, those with pain-specific and general ER difficulties had the worst outcomes in all domains. Membership to other groups did not differentiate between pain severity or interference outcomes; those skillful in pain-specific and general ER had the lowest depression and anxiety symptoms at 12 months. General ER difficulties are common among adults with chronic pain and raise relative risk when paired with pain-specific ER difficulties. Findings offer potential directions for individualizing pain psychology treatment. PERSPECTIVE: This article shows that people with chronic pain have different sets of strengths and difficulties when it comes to regulating emotions related and/or unrelated to the experience of pain itself. Understanding an individual's unique constellation of emotion regulation skills and difficulties might help personalize the psychological treatment of pain., (Copyright © 2022 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Background: The OPTIMIZE trial is a multi-site, comparative effectiveness research (CER) study that uses a Sequential Multiple Assessment Randomized Trial (SMART) designed to examine the effectiveness of complex health interventions (cognitive behavioral therapy, physical therapy, and mindfulness) for adults with chronic low back pain. Modifications are anticipated when implementing complex interventions in CER. Disruptions due to COVID have created unanticipated challenges also requiring modifications. Recent methodologic standards for CER studies emphasize that fully characterizing modifications made is necessary to interpret and implement trial results. The purpose of this paper is to outline the modifications made to the OPTIMIZE trial using the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) to characterize modifications to the OPTIMIZE trial in response to the COVID pandemic and other challenges encountered., Methods: The FRAME outlines a strategy to identify and report modifications to evidence-based interventions or implementation strategies, whether planned or unplanned. We use the FRAME to characterize the process used to modify the aspects of the OPTIMIZE trial. Modifications were made to improve lower-than-anticipated rates of treatment initiation and COVID-related restrictions. Contextual modifications were made to permit telehealth delivery of treatments originally designed for in-person delivery. Training modifications were made with study personnel to provide more detailed information to potential participants, use motivational interviewing communication techniques to clarify potential participants' motivation and possible barriers to initiating treatment, and provide greater assistance with scheduling of assigned treatments., Results: Modifications were developed with input from the trial's patient and stakeholder advisory panels. The goals of the modifications were to improve trial feasibility without compromising the interventions' core functions. Modifications were approved by the study funder and the trial steering committee., Conclusions: Full and transparent reporting of modifications to clinical trials, whether planned or unplanned, is critical for interpreting the trial's eventual results and considering future implementation efforts., Trial Registration: ClinicalTrials.gov NCT03859713. Registered on March 1, 2019., (© 2023. The Author(s).)

Abstract: Functional recovery and the response to rehabilitation interventions after stroke are highly variable. Understanding this variability will promote precision rehabilitation for stroke, allowing us to deliver targeted interventions to the right person at the right time. Capitalizing on large, heterogeneous data sets, such as those generated through clinical care and housed within the electronic health record, can lead to understanding of poststroke variability. However, accessing data from the electronic health record can be challenging because of data quality, privacy concerns, and the resources required for data extraction. Therefore, creating infrastructure that overcomes these challenges and contributes to a learning health system is needed to achieve precision rehabilitation after stroke. We describe the creation of a Precision Rehabilitation Data Repository that facilitates access to systematically collected data from the electronic health record as part of a learning health system to drive precision rehabilitation. Specifically, we describe the process of (1) standardizing the documentation of functional assessments, (2) obtaining regulatory approval, (3) defining the patient cohort, and (4) extracting data for the Precision Rehabilitation Data Repository. The development of similar infrastructures at other institutions can help generate large, heterogeneous data sets to drive poststroke care toward precision rehabilitation, thereby maximizing poststroke function within an efficient healthcare system., Competing Interests: Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Abstract: Treatment effect modifiers identify patient characteristics associated with treatment responses. The purpose of this secondary analysis was to identify potential treatment effect modifiers for disability from the TARGET trial that compared usual care (control) with usual care + psychologically informed physical therapy (PIPT). The sample consisted of a STarT Back tool identified high-risk patients with acute low back pain that completed Oswestry Disability Index (ODI) data at index visit and 6 months later (n = 1250). Candidate treatment effect modifiers were identified a priori and informed by the literature. Linear mixed models tested for treatment effect modification through tests of statistical interaction. All statistical interactions ( P ≤ 0.20) were stratified by modifier to inspect for specific effects ( P ≤ 0.05). Smoking was identified as a potential effect modifier (treatment * smoking interaction, P = 0.08). In participants who were smokers, the effect of PIPT was (ODI = 5.5; 95% CI: 0.6-10.4; P = 0.03) compared with usual care. In participants who were nonsmokers, the effect of PIPT was (ODI = 1.5; 95% CI: -1.4 to 4.4; P = 0.31) compared with usual care. Pain medication was also identified as a potential effect modifier (treatment × pain medication interaction, P = 0.10). In participants prescribed ≥3 pain medications, the effect of PIPT was (ODI = 7.1; 95% CI: -0.1 to 14.2; P = 0.05) compared with usual care. The PIPT effect for participants prescribed no pain medication was (ODI = 3.5; 95% CI: -0.4 to 7.4; P = 0.08) and for participants prescribed 1 to 2 pain medications was (ODI = 0.6; 95% CI: -2.5 to 3.7; P = 0.70) when compared with usual care. These findings may be used for generating hypotheses and planning future clinical trials investigating the effectiveness of tailored application of PIPT., (Copyright © 2022 International Association for the Study of Pain.)

Objective: To describe concerns, advantages, and disadvantages encountered in an evidence-based physical therapy (PT) program for persons with chronic low back pain (CLBP) delivered by telehealth., Design: Mixed methods survey and semistructured interview of persons with CLBP., Setting: Prospective observational cohort study of persons with CLBP from 3 health care systems receiving 8 sessions of evidence-based telehealth PT., Participants: Participants were selected after completing week 10 (from baseline) assessment from an ongoing cohort study. We enrolled 31 of 126 participants (mean age, 42.4 years; 71.0% female) from the cohort study (N=31)., Interventions: Participants had completed 8 sessions of evidence-based telehealth PT and participated in semistructured interviews., Main Outcome Measures: Baseline and week 10 and 26 assessments assessed psychosocial risk (StarTBack Screening Tool), working alliance (Working Alliance Inventory-Short Form), pain (Oswestry Disability Index), and health-related quality of life (Patient-Reported Outcomes Measurement Information System-29 profile, version 2). Semistructured interviews were conducted by telephone and consisted of open-ended questions assessing perception, satisfaction, and likelihood of recommending telehealth PT. Participants identified advantages and disadvantages to telehealth PT. Interviews were recorded, transcribed, and coded using an iterative qualitative process. Statistical comparisons by experience were made using analysis of variance (continuous) and Fisher exact test (categorical)., Results: Compared with the negative experience group (n=5), participants in positive (n=16) and neutral (n=10) experience groups endorsed higher bond working alliance with their therapist. Participants with a positive experience were more likely to view telehealth PT as cost-saving (n=10, 62.5%) compared with those with a neutral (n=1, 10.0%) or negative (n=1, 20.0%) experience and less likely to view telehealth PT as lower quality (n=0, 0.0%; n=1, 10.0%; n=2, 40.0%, respectively). Prior to starting telehealth, based on semistructured interviews, 18 participants (58.1%) had concerns and these persisted after starting in half of this group. Concerns regarded telehealth being different from or inferior to in-person PT, lack of physical correction, and worries of not using technology appropriately. Convenience, time savings, and personalization were seen as advantages. Difficulty making a personal connection with the therapist, lack of physical correction, and problems with technology were seen as disadvantages. Many participants endorsed a hybrid approach that included in-person and telehealth PT. Providing necessary equipment and technology assistance was seen as ways to improve telehealth PT experience., Conclusions: Telehealth is an acceptable modality to deliver PT for patients with CLBP with most having a positive experience and reporting advantages. Improvements could include offering a hybrid approach (in-person and telehealth combined) and providing necessary equipment and technical support. More research is needed to optimize the most effective strategies for providing telehealth PT for patients with CLBP., (Copyright © 2022 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To describe the feasibility of an evidence-based physical therapy (PT) program for persons with chronic low back pain (LBP) originally designed for in-person delivery, adapted for telehealth using videoconferencing., Design: Prospective, longitudinal cohort., Setting: Three health care systems in the United States., Participants: Adults, aged 18-64 years (N=126), with chronic LBP recruited from August through December 2020., Intervention: Up to 8 weekly sessions of telehealth PT., Main Outcome Measures: Follow-up assessments were 10 and 26 weeks after baseline. Participant outcomes collected were the Oswestry Disability Index, Patient-Reported Outcomes Measurement Information System-29 health domains, and pain self-efficacy. Implementation outcomes included acceptability, adoption, feasibility, and fidelity assessed using participant surveys and compliance with session attendance., Results: We enrolled 126 participants (mean age, 51.5 years; 62.7% female). Baseline perceptions about telehealth were generally positive. Eighty-eight participants (69.8%) initiated telehealth PT, with a median of 5 sessions attended. Participants in telehealth PT were generally satisfied (76.3%), although only 39.5% perceived the quality equal to in-person PT. Telehealth PT participants reported significant improvement in LBP-related disability, pain intensity, pain interference, physical function, and sleep disturbance at 10- and 26-week follow-ups., Conclusions: The findings generally support the feasibility of telehealth PT using videoconferencing. Implementation and participant outcomes were similar to in-person PT as delivered in the participating health care systems. We identified barriers that may detract from the patient experience and likelihood of benefitting from telehealth PT. More research is needed to optimize and evaluate the most effective strategies for providing telehealth PT for patients with chronic LBP., (Copyright © 2022 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to examine the association between goal attainment and patient-reported outcomes in patients who engaged in a 6-session, telephone-based, cognitive-behavioral-based physical therapy (CBPT) intervention after spine surgery., Methods: In this secondary analysis of a randomized trial, data from 112 participants (mean age = 63.3 [SD = 11.2] years; 57 [51%] women) who attended at least 2 CBPT sessions (median = 6 [range = 2-6]) were examined. At each session, participants set weekly goals and used goal attainment scaling (GAS) to report goal attainment from the previous session. The number and type of goals and percentage of goals met were tracked. An individual GAS t score was computed across sessions. Participants were categorized based on goals met as expected (GAS t score ≥ 50) or goals not met as expected (GAS t score < 50). Six- and 12-month outcomes included disability (Oswestry Disability Index), physical and mental health (12-Item Short-Form Health Survey), physical function (Patient-Reported Outcomes Measurement Information System), pain interference (Patient-Reported Outcomes Measurement Information System), and back and leg pain intensity (numeric rating scale). Outcome differences over time between groups were examined with mixed-effects regression., Results: Participants set a median of 3 goals (range = 1-6) at each session. The most common goal categories were recreational/physical activity (36%), adopting a CBPT strategy (28%), exercising (11%), and performing activities of daily living (11%). Forty-eight participants (43%) met their goals as expected. Participants who met their goals as expected had greater physical function improvement at 6 months (estimate = 3.7; 95% CI = 1.0 to 6.5) and 12 months (estimate = 2.8; 95% CI = 0.04 to 5.6). No other outcome differences were noted., Conclusions: Goal attainment within a CBPT program was associated with 6- and 12-month improvements in postoperative physical functioning., Impact: This study highlights goal attainment as an important rehabilitation component related to physical function recovery after spine surgery., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Orthopedic surgeons are sometimes hesitant to assess and address psychosocial factors. Surgeon-specific modifiable factors may contribute to surgeon attitudes and beliefs regarding the mental and social aspects of illness. A better understanding of these factors could help inform interventions to support surgeons and improve patient outcomes. We aimed to investigate whether orthopedic surgeons' self-reported compassion, perceived stress, and experiential avoidance are independently associated with various surgeon attitudes and beliefs regarding psychosocial aspects of health., Methods: This is a cross-sectional study of 165 members of the Science of Variation Group (SOVG). Surgeons completed measures of compassion, stress, experiential avoidance, and demographics. They answered questions addressing attitudes and beliefs regarding psychosocial aspects of care, which were condensed to the following 6 dimensions through factor analysis: (1) confidence, (2) perceived resource availability, (3) blame towards patients, (4) fear of offending patients, (5) professional role resistance, and (6) fear of negative patient reactions. We performed 6 multivariable hierarchical regression analyses to determine whether self-reported compassion, perceived stress, and experiential avoidance were associated with aspects of surgeons' attitudes and beliefs regarding psychosocial care., Results: After accounting for the influence of relevant covariates, experiential avoidance explained 2.9-6.6% of the variance ( P-values .002 to .031) in all aspects of surgeon attitudes and beliefs regarding psychosocial care, except for perceived resource availability. Perceived stress and compassion toward others were not associated with any outcome variable., Conclusion: Targeting orthopedic surgeons' tendency to avoid discomfort (i.e., experiential avoidance) via supportive/educational programs may decrease barriers and increase their abilities to address psychosocial factors, resulting in improved patient outcomes.

Recent studies suggest that the COVID-19 pandemic can serve as a unique psychosocial stressor that can negatively impact individuals with chronic pain. Using a large online sample in the U.S., the present study sought to investigate the impact of the pandemic on the trajectories of pain severity and interference, emotional distress (ie, anxiety and depressive symptoms), and opioid misuse behaviors across one year. Potential moderating effects of socio-demographic factors and individual differences in pain catastrophizing, pain acceptance, and sleep disturbance on outcome trajectories were also examined. Adults with chronic pain were surveyed three times across 1 year (April/May 2020 [N = 1,453]; June/July 2020 [N = 878], and May 2021 [N = 813]) via Amazon's Mechanical Turk online crowdsourcing platform. Mixed-effects growth models revealed that pain severity and interference, emotional distress, and opioid misuse behaviors did not significantly deteriorate across one year during the pandemic. None of the socio-demographic factors, pain catastrophizing, or sleep disturbance moderated outcome trajectories. However, individuals with higher pain acceptance reported greater improvement in pain severity (P< .008, 95% CI: -.0002, -.00004) and depressive symptoms (P< .001, 95% CI: -.001, -.0004) over time. Our findings suggest that the negative impact of the pandemic on pain, emotional distress, and opioid misuse behaviors is quite small overall. The outcome trajectories were also stable across different socio-demographic factors, as well as individual differences in pain catastrophizing and sleep disturbance. Nevertheless, interventions that target improvement of pain acceptance may help individuals with chronic pain be resilient during the pandemic. PERSPECTIVE: Individuals with chronic pain overall did not experience significant exacerbation of pain, emotional distress, and opioid misuse across one year during the COVID-19 pandemic. Individuals with higher pain acceptance showed greater improvement in pain severity and depressive symptoms over time during the pandemic., (Copyright © 2022 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Competing Interests: The authors declare no conflicts of interest.

The Clinical Practice Guideline for Evaluation of Psychosocial Factors Influencing Recovery from Adult Orthopaedic Trauma is based on a systematic review of current scientific and clinical research. The purpose of this clinical practice guideline is to improve outcomes after adult orthopaedic trauma by evaluating, and addressing, the psychosocial factors that affect recovery. This guideline contains one recommendation to address eight psychosocial factors after military and civilian adult orthopaedic trauma that may influence clinical, functional, and quality of life recovery. Furthermore, it addresses additional factors that may be associated with greater biopsychosocial symptom intensity, limitations, and/or diminished health-related quality of life. However, this guideline did not evaluate effective treatment strategies for the treatment or prevention of psychosocial factors. This guideline cannot be fully extrapolated to the treatment of children or adolescents. In addition, the work group highlighted the need for additional research because studies of general traumatic injuries do not always generalize to specific orthopaedic populations., (Copyright © 2021 by the American Academy of Orthopaedic Surgeons.)

Summary: Physical and psychological impairment resulting from traumatic injuries is often significant and affects employment and functional independence. Extremity trauma has been shown to negatively affect long-term self-reported physical function, the ability to work, and participation in recreational activities and contributes to increased rates of anxiety and/or depression. High pain levels early in the recovery process and psychosocial factors play a prominent role in recovery after traumatic lower extremity injury. Cognitive-behavioral therapy pain programs have been shown to mitigate these effects. However, patient access issues related to financial and transportation constraints and the competing demands of treatment focused on the physical sequelae of traumatic injury limit patient participation in this treatment modality. This article describes a telephone-delivered cognitive-behavioral-based physical therapy (CBPT-Trauma) program and design of a multicenter trial to determine its effectiveness after lower extremity trauma. Three hundred twenty-five patients from 7 Level 1 trauma centers were randomized to CBPT-Trauma or an education program after hospital discharge. The primary hypothesis is that compared with patients who receive an education program, patients who receive the CBPT-Trauma program will have improved physical function, pain, and physical and mental health at 12 months after hospital discharge., Competing Interests: The authors have declared no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Disruptions caused by the COVID-19 pandemic could disproportionately affect the health of vulnerable populations, including patients experiencing persistent health conditions (i.e., chronic pain), along with populations living within deprived, lower socioeconomic areas. The current cross-sectional study characterized relationships between neighborhood deprivation and perceived changes in pain-related experiences during the COVID-19 pandemic (early-September to mid-October 2020) for adult patients (N = 97) with nonspecific chronic low back pain., Methods: We collected self-report perceived experiences from participants enrolled in an ongoing pragmatic randomized trial across medical centers within the Salt Lake City, Utah and Baltimore, Maryland metropolitans. The Area Deprivation Index (composite of 17 US Census deprivation metrics) reflected neighborhood deprivation based on participants' zip codes., Results: Although those living in the neighborhoods with greater deprivation endorsed significantly poorer physical (pain severity, pain interference, physical functioning), mental (depression, anxiety), and social health during the pandemic, there were no significant differences for perceived changes in pain-related experiences (pain severity, pain interference, sleep quality) between levels of neighborhood deprivation since the onset of the pandemic. However, those in neighborhoods with greater deprivation endorsed disproportionately worse perceived changes in pain coping, social support, and mood since the pandemic., Conclusions: The current findings offer evidence that changes in pain coping during the pandemic may be disproportionately worse for those living in deprived areas. Considering poorer pain coping may contribute to long-term consequences, the current findings suggest the need for further attention and intervention to reduce the negative effect of the pandemic for such vulnerable populations., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Coronavirus disease 2019 prompted the rapid adoption of telehealth to provide physical therapy. Patients' perceptions about telehealth physical therapy are mostly unknown. This study describes perceptions of telehealth physical therapy among patients with chronic low back pain (LBP). Methods: This study surveyed participants in an ongoing multisite clinical trial of nonpharmacological LBP treatments. Participants were asked about their willingness to use telehealth for physical therapy and with other providers and completed the PROMIS-29. Results: Surveys were received from 102 participants (mean age = 48.5 [standard deviation; SD = 11.6]). Thirty-six (35.3%) expressed willingness to receive telehealth physical therapy, 22 were neutral (21.6%), and 44 were unwilling (43.1%). The percentage expressing willingness for telehealth physical therapy was lower than it was for family medicine ( p  < 0.001) or mental health ( p  < 0.001). Older ( p  = 0.049) and Black participants ( p  = 0.01) more likely expressed willingness to use telehealth for physical therapy. Conclusion: Education and familiarity may help patients view telehealth physical therapy more favorably. Clinical Trial Registration (clinicaltrials.gov NCT03859713)., Competing Interests: No competing financial interests exist., (© Julie M. Fritz et al., 2021; Published by Mary Ann Liebert, Inc.)

Background: The purpose of this study was to investigate the longitudinal postoperative relationship between physical activity, psychosocial factors, and physical function in patients undergoing lumbar spine surgery., Methods: We enrolled 248 participants undergoing surgery for a degenerative lumbar spine condition. Physical activity was measured using a triaxial accelerometer (Actigraph GT3X) at 6-weeks (6wk), 6-months (6M), 12-months (12M) and 24-months (24M) following spine surgery. Physical function (computerized adaptive test domain version of Patient-Reported Outcomes Measurement Information System) and psychosocial factors (pain self-efficacy, depression and fear of movement) were assessed at preoperative visit and 6wk, 6M, 12M and 24M after surgery. Structural equation modeling (SEM) techniques were utilized to analyze data, and results are represented as standardized regression weights (SRW). Overall SRW were computed across five imputed datasets to account for missing data. The mediation effect of each psychosocial factor on the effect of physical activity on physical function were computed [(SRW for effect of activity on psychosocial factor X SRW for effect of psychosocial factor on function) ÷ SRW for effect of activity on function]. Each SEM model was tested for model fit by assessing established fit indexes., Results: The overall effect of steps per day on physical function (SRW ranged from 0.08 to 0.19, p<0.05) was stronger compared to the overall effect of physical function on steps per day (SRW ranged from non-existent to 0.14, p<0.01 to 0.3). The effect of steps per day on physical function and function on steps per day remained consistent after accounting for psychosocial factors in each of the mediation models. Depression and fear of movement at 6M mediated 3.4% and 5.4% of the effect of steps per day at 6wk on physical function at 12M, respectively. Pain self-efficacy was not a statistically significant mediator., Conclusions: The findings of this study suggest that the relationship between physical activity and physical function is stronger than the relationship of function to activity. However, future research is needed to examine whether promoting physical activity during the early postoperative period may result in improvement of long-term physical function. Since depression and fear of movement had a very small mediating effect, additional work is needed to investigate other potential mediating factors such as pain catastrophizing, resilience and exercise self-efficacy., (© 2021. The Author(s).)

Objective: To investigate whether early postoperative walking is associated with "best outcome" and no opioid use at 1 year after lumbar spine surgery and establish a threshold for steps/day to inform clinical practice., Design: Secondary analysis from randomized controlled trial., Setting: Two academic medical centers in the United States., Participants: We enrolled 248 participants undergoing surgery for a degenerative lumbar spine condition (N=248). A total of 212 participants (mean age, 62.8±11.4y, 53.3% female) had valid walking data at baseline., Interventions: Not applicable., Main Outcome Measures: Disability (Oswestry Disability Index), back and leg pain (Brief Pain Inventory), and opioid use (yes vs no) were assessed at baseline and 1 year after surgery. "Best outcome" was defined as Oswestry Disability Index ≤20, back pain ≤2, and leg pain ≤2. Steps/day (walking) was assessed with an accelerometer worn for at least 3 days and 10 h/d at 6 weeks after spine surgery, which was considered as study baseline. Separate multivariable logistic regression analyses were conducted to determine the association between steps/day at 6 weeks and "best outcome" and no opioid use at 1-year. Receiver operating characteristic curves identified a steps/day threshold for achieving outcomes., Results: Each additional 1000 steps/d at 6 weeks after spine surgery was associated with 41% higher odds of achieving "best outcome" (95% confidence interval [CI], 1.15-1.74) and 38% higher odds of no opioid use (95% CI, 1.09-1.76) at 1 year. Walking ≥3500 steps/d was associated with 3.75 times the odds (95% CI, 1.56-9.02) of achieving "best outcome" and 2.37 times the odds (95% CI, 1.07-5.24) of not using opioids., Conclusions: Walking early after surgery may optimize patient-reported outcomes after lumbar spine surgery. A 3500 steps/d threshold may serve as an initial recommendation during early postoperative counseling., (Copyright © 2021 The American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To investigate the feasibility and effectiveness of an online motivational interviewing training program for rehabilitation professionals., Design: Pre-post design with two groups., Setting: Private rehabilitation hospital and an academic medical center., Subjects: Group 1 included 19 motivational interviewing-experienced rehabilitation professionals. Group 2 included 25 motivational interviewing-naïve rehabilitation professionals., Interventions: Group 1 was exposed to an online motivational training program and Group 2 was exposed to an online motivational training program and a live booster session., Main Measures: Motivational interviewing communication skills were measured with an adapted Helpful Responses Questionnaire. Knowledge and attitudes were measured with an adapted Motivational Interviewing Knowledge and Attitudes Test. Confidence, importance, and feasibility for implementing motivational interviewing were measured using the Motivational Interviewing Rulers., Results: Group 1 showed improvement in communication skills (2.6/5-3.3/5; P  < 0.05) and confidence (6.0/01-7.4/10; P  < 0.01) after online training. Improvements seen in skills and confidence were maintained at three months. Group 2 showed improvement in skills (2.1/5-3.3/5; P  < 0.001), knowledge (7.7/10-8.5/10; P  < 0.01), confidence (6.4/10-7.5/10; P  < 0.01), and importance (8.3/10-8.9/10; P  < 0.05) after online training. At three-months post-booster, improvements in communication skills and knowledge were maintained., Conclusions: Online training can be a cost and time effective approach to improve rehabilitation professionals' skills in motivational interviewing. Follow-up training activities are needed to maintain the level of knowledge and skill improvement.

Objective: To (1) evaluate the effects of a group-based self-management treatment intervention (VETPALS) on physical and psychosocial functioning (primary outcomes) and quality of life (secondary outcome) in individuals with amputation and (2) examine the feasibility and acceptability of the intervention in a large national health care system., Design: Randomized controlled trial with masked outcome assessment., Setting: Five Veterans Affairs medical centers geographically dispersed across the United States., Participants: 147 individuals with amputation during the past 2 years due to chronic limb threatening ischemia (N=147)., Interventions: Participants were randomized into VETPALS (N =71) or education control (N=76). VETPALS consisted of a 4-hour workshop and 4 additional 2-hour sessions addressing self-management skills, health and activity, managing emotions, communication and social support, and maintaining goals and gains. Education control consisted of the provision of amputation-related educational materials and provider follow-up if requested., Main Outcome Measures: Primary outcomes were physical functioning (Short Musculoskeletal Functional Assessment) and psychosocial functioning (Patient Health Questionnaire-9). Secondary outcomes were quality of life (global) and quality of life (satisfaction with health) from the World Health Organization Quality of Life Scale (brief). Assessment was conducted at baseline, 6 weeks (treatment completion), and 6 months (follow-up)., Results: Participants randomized to VETPALS reported significantly improved psychosocial functioning and quality of life (satisfaction with health) relative to controls at 6 months (B=1.84; 95% confidence interval, 0.37,3.31 and B=-0.61; 95% confidence interval, -1.11,-0.12, respectively). There were no differences in physical functioning over time between VETPALS and education control at either time point. Follow-up multiple imputation sensitivity analyses produced an identical pattern of results. Among VETPALS participants, treatment initiation was low (56%), but treatment retention (93% attended 4 of 5 classes) and overall satisfaction (100% reported very helpful or better and would recommend to a friend) were high., Conclusions: Group-based self-management improves psychosocial functioning for individuals with amputation due to chronic limb threatening ischemia. In-person participation is challenging for this population, but individuals who successfully initiate treatment typically persist and are highly satisfied., (Published by Elsevier Inc.)

Background: Many patients with acute low back pain (LBP) first seek care from primary care physicians. Evidence is lacking for interventions to prevent transition to chronic LBP in this setting. We aimed to test if implementation of a risk-stratified approach to care would result in lower rates of chronic LBP and improved self-reported disability., Methods: We conducted a pragmatic, cluster randomized trial using 77 primary care clinics in four health care systems across the United States. Practices were randomly assigned to a stratified approach to care (intervention) or usual care (control). Using the STarTBack screening tool, adults with acute LBP were screened low, medium, and high-risk. Patients screened as high-risk were eligible. The intervention included electronic best practice alerts triggering referrals for psychologically informed physical therapy (PIPT). PIPT education was targeted to community clinics geographically close to intervention primary care clinics. Primary outcomes were transition to chronic LBP and self-reported disability at six months. Trial Registry: ClinicalTrials.gov NCT02647658., Findings: Between May 2016 and June 2018, 1207 patients from 38 intervention and 1093 from 37 control practices were followed. In the intervention arm, around 50% of patients were referred for physical therapy (36% for PIPT) compared to 30% in the control. At 6 months, 47% of patients reported transition to chronic LBP in the intervention arm (38 practices, n  = 658) versus 51% of patients in the control arm (35 practices, n  = 635; OR=0.83 95% CI 0.64, 1.09; p  = 0.18). No differences in disability were detected (difference -2·1, 95% CI -4.9-0.6; p  = 0.12). Opioids and imaging were prescribed in 22%-25% and 23%-26% of initial visits, for intervention and control, respectively. Twelve-month LBP utilization was similar in the two groups., Interpretation: There were no differences detected in transition to chronic LBP among patients presenting with acute LBP using a stratified approach to care. Opioid and imaging prescribing rates were non-concordant with clinical guidelines., Funding: Patient-Centered Outcomes Research Institute (PCORI) contract # PCS-1402-10867., Competing Interests: Dr. Delitto reports grants from PCORI, grants from NIH, grants from DOD, outside the submitted work; Dr. Patterson reports grants from Patient Centered Outcomes Research Institute, during the conduct of the study; Dr. Stevans reports grants from PCORI, during the conduct of the study; Dr. Khoja reports grants from PCORI, during the conduct of the study; Dr. Freel has nothing to disclose; Dr. Schneider reports grants from Patient Centered Outcomes Research Institute, during the conduct of the study; Dr. Greco reports grants from Patient-Centered Outcomes Research Institute, during the conduct of the study; Dr. Sowa reports grants from PCORI, during the conduct of the study; grants from NIH, USAMRMC, VA, The Pittsburgh Foundation, outside the submitted work; Dr. Brennan reports other institutional support from Patient Centered Outcomes Research Institute (PCORI), during the conduct of the study; other institutional support from Patient Centered Outcomes Research Institute (PCORI), outside the submitted work; Stephen J. Hunter has nothing to disclose; Dr. Minick has nothing to disclose; Dr. Wasan has nothing to disclose; Dr. Wegener reports grants from PCORI, during the conduct of the study; Ms. Ephraim has nothing to disclose; Dr. Freburger reports other from American Physical Therapy Association, outside the submitted work; Dr. Beneciuk reports grants from Patient-Centered Outcomes Research Institute, during the conduct of the study; Dr. George reports personal fees from Rehab Essentials, Inc, personal fees from Med Risk, LLC, grants from NIH, other from Duke University, all outside the submitted work; Dr. Saper has nothing to disclose., (© 2021 The Authors.)

Introduction: Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients., Methods and Analysis: PREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections., Ethics and Dissemination: The PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients., Trial Registration Number: NCT02984384., Competing Interests: Competing interests: CDM has received grant funding as PI from Merck and receives consulting income from AstraZeneca, Bayer Pharmaceuticals, Janssen/J&J, Merck and Pfizer. ERH is/was the primary investigator of contracts from The Patient-Centred Outcomes Research Institute (PCORI) entitled 'Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centred Care via Health Information Technology' (CE-12-11-4489) and 'Preventing Venous Thromboembolism (VTE): Engaging Patients to Reduce Preventable Harm from Missed/Refused Doses of VTE Prophylaxis' (DI-1603-34596); is the primary investigator of a grant from the Agency for Healthcare Research and Quality (AHRQ) (1R01HS024547) entitled 'Individualised Performance Feedback on Venous Thromboembolism Prevention Practice,' and is a co-investigator on a grant from the NIH/NHLBI (R21HL129028) entitled 'Analysis of the Impact of Missed Doses of Venous Thromboembolism Prophylaxis'; receives research grant support from the DOD/Army Medical Research Acquisition Activity and has received grant support from the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF); receives book royalties from Lippincott, Williams, Wilkins; and is a paid consultant to Vizient for their HIIN Venous Thromboembolism (VTE) Prevention Action Network., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The number of people surviving critical illness is rising rapidly around the globe. Survivorship comes at a cost, with approximately half of patients with acute respiratory failure (ARF) experiencing clinically significant symptoms of anxiety, and 32-40% of survivors having substantial anxiety symptoms in the months or years after hospitalization., Methods: This feasibility study reports on 11 consecutive ARF patients receiving up to six sessions of a psychological intervention for self-management of anxiety., Results: All 11 patients accepted and received the psychological intervention. Four patients did not fully complete all 6 sessions due to death ( n = 1, 2 sessions completed), and early hospital discharge ( n = 3, patients completed 2, 3 and 5 sessions). The median (IQR) score (range: 0-100; minimal clinically important difference: 13) for the Visual Analog Scale-Anxiety (VAS-A) pre-intervention was 70 (57, 75) points. During the intervention, all 11 patients had a decrease in VAS-A, with a median (IQR) decrease of 44 (19, 48) points., Conclusions: This self-management intervention appears acceptable and feasible to implement among ARF patients during and after an ICU stay.

Importance: Acute low back pain (LBP) is highly prevalent, with a presumed favorable prognosis; however, once chronic, LBP becomes a disabling and expensive condition. Acute to chronic LBP transition rates vary widely owing to absence of standardized operational definitions, and it is unknown whether a standardized prognostic tool (ie, Subgroups for Targeted Treatment Back tool [SBT]) can estimate this transition or whether early non-guideline concordant treatment is associated with the transition to chronic LBP., Objective: To assess the associations between the transition from acute to chronic LBP with SBT risk strata; demographic, clinical, and practice characteristics; and guideline nonconcordant processes of care., Design, Setting, and Participants: This inception cohort study was conducted alongside a multisite, pragmatic cluster randomized trial. Adult patients with acute LBP stratified by SBT risk were enrolled in 77 primary care practices in 4 regions across the United States between May 2016 and June 2018 and followed up for 6 months, with final follow-up completed by March 2019. Data analysis was conducted from January to March 2020., Exposures: SBT risk strata and early LBP guideline nonconcordant processes of care (eg, receipt of opioids, imaging, and subspecialty referral)., Main Outcomes and Measures: Transition from acute to chronic LBP at 6 months using the National Institutes of Health Task Force on Research Standards consensus definition of chronic LBP. Patient demographic characteristics, clinical factors, and LBP process of care were obtained via electronic medical records., Results: Overall, 5233 patients with acute LBP (3029 [58%] women; 4353 [83%] White individuals; mean [SD] age 50.6 [16.9] years; 1788 [34%] low risk; 2152 [41%] medium risk; and 1293 [25%] high risk) were included. Overall transition rate to chronic LBP at six months was 32% (1666 patients). In a multivariable model, SBT risk stratum was positively associated with transition to chronic LBP (eg, high-risk vs low-risk groups: adjusted odds ratio [aOR], 2.45; 95% CI, 2.00-2.98; P < .001). Patient and clinical characteristics associated with transition to chronic LBP included obesity (aOR, 1.52; 95% CI, 1.28-1.80; P < .001); smoking (aOR, 1.56; 95% CI, 1.29-1.89; P < .001); severe and very severe baseline disability (aOR, 1.82; 95% CI, 1.48-2.24; P < .001 and aOR, 2.08; 95% CI, 1.60-2.68; P < .001, respectively) and diagnosed depression/anxiety (aOR, 1.66; 95% CI, 1.28-2.15; P < .001). After controlling for all other variables, patients exposed to 1, 2, or 3 nonconcordant processes of care within the first 21 days were 1.39 (95% CI, 1.21-2.32), 1.88 (95% CI, 1.53-2.32), and 2.16 (95% CI, 1.10-4.25) times more likely to develop chronic LBP compared with those with no exposure (P < .001)., Conclusions and Relevance: In this cohort study, the transition rate to chronic LBP was substantial and increased correspondingly with SBT stratum and early exposure to guideline nonconcordant care.

Background Context: Positive psychosocial factors early after surgery, such as resilience and self-efficacy, may be important characteristics for informing individualized postoperative care., Purpose: To examine the association of early postoperative resilience and self-efficacy on 12-month physical function, pain interference, social participation, disability, pain intensity, and physical activity after lumbar spine surgery., Study Design/setting: Pooled secondary analysis of prospectively collected trial data from two academic medical centers., Patient Sample: Two hundred and forty-eight patients who underwent laminectomy with or without fusion for a degenerative lumbar condition., Outcome Measures: Physical function, pain inference, and social participation (ability to participate in social roles and activities) were measured using the Patient Reported Outcomes Measurement Information System. The Oswestry Disability Index, Numeric Rating Scale, and accelerometer activity counts were used to measure disability, pain intensity, and physical activity, respectively., Methods: Participants completed validated outcome questionnaires at 6 weeks (baseline) and 12 months after surgery. Baseline positive psychosocial factors included resilience (Brief Resilience Scale) and self-efficacy (Pain Self-Efficacy Questionnaire). Multivariable linear regression analyses were used to assess the associations between early postoperative psychosocial factors and 12-month outcomes adjusting for age, sex, study site, randomized group, fusion status, fear of movement (Tampa Scale for Kinesiophobia), and outcome score at baseline. This study was funded by Patient-Centered Outcomes Research Institute and Foundation for Physical Therapy Research. There are no conflicts of interest., Results: Resilience at 6 weeks after surgery was associated with 12-month physical function (unstandardized beta=1.85 [95% confidence interval [CI]: 0.29; 3.40]), pain interference (unstandardized beta=-1.80 [95% CI: -3.48; -0.12]), social participation (unstandardized beta=2.69 [95% CI: 0.97; 4.41]), and disability (unstandardized beta=-3.03 [95% CI: -6.04; -0.02]). Self-efficacy was associated with 12-month disability (unstandardized beta=-0.21 [95% CI: -0.37; -0.04]., Conclusions: Postoperative resilience and pain self-efficacy were associated with improved 12-month patient-reported outcomes after spine surgery. Future work should consider how early postoperative screening for positive psychosocial characteristics can enhance risk stratification and targeted rehabilitation management in patients undergoing spine surgery., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Study Design: Secondary analysis of randomized controlled trial data., Objective: The aim of this study was to examine whether preoperative physical performance is an independent predictor of patient-reported disability and pain at 12 months after lumbar spine surgery., Summary of Background Data: Patient-reported outcome measures (PROMs) are commonly used to assess clinical improvement after lumbar spine surgery. However, there is evidence in the orthopedic literature to suggest that PROMs should be supplemented with physical performance tests to accurately evaluate long-term outcomes., Methods: A total of 248 patients undergoing surgery for degenerative lumbar spine conditions were recruited from two institutions. Physical performance tests (5-Chair Stand and Timed Up and Go) and PROMs of disability (Oswestry Disability Index: ODI) and back and leg pain (Brief Pain Inventory) were assessed preoperatively and at 12 months after surgery., Results: Physical performance tests and PROMs significantly improved over 12 months following lumbar spine surgery (P < 0.01). Weak correlations were found between physical performance tests and disability and pain (ρ = 0.15 to 0.32, P < 0.05). Multivariable regression analyses controlling for age, education, preoperative outcome score, fusion, previous spine surgery, depressive symptoms, and randomization group found that preoperative 5-Chair Stand test was significantly associated with disability and back pain at 12-month follow-up. Each additional 10 seconds needed to complete the 5-Chair Stand test were associated with six-point increase in ODI (P = 0.047) and one-point increase in back pain (P = 0.028) scores. The physical performance tests identified an additional 14% to 19% of patients as achieving clinical improvement that were not captured by disability or pain questionnaires., Conclusion: Results indicate that physical performance tests may provide distinct information in both predicting and assessing clinical outcomes in patients undergoing lumbar spine surgery. Our findings suggest that the 5-Chair Stand test may be a useful test to include within a comprehensive risk assessment before surgery and as an outcome measure at long-term follow-up., Level of Evidence: 3.

Background: The purpose of this prospective case series study was to compare changes in early postoperative physical activity and physical function between 6 weeks and 3 and 6 months after lumbar spine surgery., Methods: Fifty-three patients (mean [95% confidence interval; CI] age = 59.2 [56.2, 62.3] years, 64% female) who underwent spine surgery for a degenerative lumbar condition were assessed at 6 weeks and 3- and 6-months after surgery. The outcomes were objectively-measured physical activity (accelerometry) and patient-reported and objective physical function. Physical activity was assessed using mean steps/day and time spent in moderate to vigorous physical activity (MVPA) over a week. Physical function measures included Oswestry Disability Index (ODI), 12-item Short Form Health Survey (SF-12), Timed Up and Go (TUG), and 10-Meter Walk (10 MW). We compared changes over time in physical activity and function using generalized estimating equations with robust estimator and first-order autoregressive covariance structure. Proportion of patients who engaged in meaningful physical activity (e.g., walked at least 4400 and 6000 steps/day or engaged in at least 150 min/week in MVPA) and achieved clinically meaningful changes in physical function were compared at 3 and 6 months., Results: After surgery, 72% of patients initiated physical therapy (mean [95%CI] sessions =8.5 [6.6, 10.4]) between 6 weeks and 3 months. Compared to 6 weeks post-surgery, no change in steps/day or time in MVPA/week was observed at 3 or 6 months. From 21 to 23% and 9 to 11% of participants walked at least 4400 and 6000 steps/day at 3 and 6 months, respectively, while none of the participants spent at least 150 min/week in MVPA at these same time points. Significant improvements were observed on ODI, SF-12, TUG and 10 MW (p <  0.05), with over 43 to 68% and 62 to 87% achieving clinically meaningful improvements on these measures at 3 and 6 months, respectively., Conclusion: Limited improvement was observed in objectively-measured physical activity from 6 weeks to 6 months after spine surgery, despite moderate to large function gains. Early postoperative physical therapy interventions targeting physical activity may be needed.

Objective: Changing Behavior through Physical Therapy (CBPT), a cognitive-behavioral-based program, has been shown to improve outcomes after lumbar spine surgery in patients with a high psychosocial risk profile; however, little is known about potential mechanisms associated with CBPT treatment effects. The purpose of this study was to explore potential mediators underlying CBPT efficacy after spine surgery., Methods: In this secondary analysis, 86 participants were enrolled in a randomized trial comparing a postoperative CBPT (n = 43) and education program (n = 43). Participants completed validated questionnaires at 6 weeks (baseline) and 3 and 6 months following surgery for back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (12-Item Short-Form Health Survey), fear of movement (Tampa Scale for Kinesiophobia), pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Parallel multiple mediation analyses using Statistical Package for the Social Sciences (SPSS) were conducted to examine whether 3- and 6-month changes in fear of movement, pain catastrophizing, and pain self-efficacy mediate treatment outcome effects at 6 months., Results: Six-month changes, but not 3-month changes, in fear of movement and pain self-efficacy mediated postoperative outcomes at 6 months. Specifically, changes in fear of movement mediated the effects of CBPT treatment on disability (indirect effect = -2.0 [95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5 [95% CI = 1.2 to 6.1])., Conclusions: This study advances evidence on potential mechanisms underlying cognitive-behavioral strategies. Future work with larger samples is needed to establish whether these factors are a definitive causal mechanism., Impact: Fear of movement and pain self-efficacy may be important mechanisms to consider when developing and testing psychologically informed physical therapy programs., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Psychologically informed physical therapy (PIPT) blends psychological strategies within a physical therapist's treatment approach for the prevention and management of chronic musculoskeletal pain. Several randomized trials have been conducted examining the efficacy of PIPT compared to standard physical therapy on important patient-reported outcomes of disability, physical function, and pain. In this review, we examine recent trials published since 2012 to describe current PIPT methods, discuss implications from findings, and offer future directions. Twenty-two studies, representing 18 trials, were identified. The studied PIPT interventions included (1) graded activity or graded exposure (n = 6), (2) cognitive-behavioral-based physical therapy (n = 9), (3) acceptance and commitment-based physical therapy (n = 1), and (4) internet-based psychological programs with physical therapy (n = 2). Consistent with prior reviews, graded activity is not superior to other forms of physical activity or exercise. In a few recent studies, cognitive-behavioral-based physical therapy had short-term efficacy when compared to a program of standardized exercise. There is a need to further examine approaches integrating alternative strategies including acceptance-based therapies (ie, acceptance and commitment therapy or mindfulness) or internet-based cognitive-behavioral programs within physical therapy. Although PIPT remains a promising care model, more convincing evidence is needed to support widespread adoption, especially in light of training demands and implementation challenges., Competing Interests: The authors have no conflicts of interest to declare. During manuscript development, R.A. Coronado was supported by a Vanderbilt Faculty Research Scholars Award.Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.)

Chronic pain is a common and costly condition, and some people with chronic pain engage in problematic opioid use. There is a critical need to identify factors underlying this co-occurrence, so that treatment can be targeted to improve outcomes. We propose that difficulty with emotion regulation (ER) is a transdiagnostic factor that underlies the co-occurrence of chronic pain and problematic opioid use (CP-POU). In this narrative review, we draw from prominent models of ER to summarize the literature characterizing ER in chronic pain and CP-POU. We conclude that chronic pain is associated with various ER difficulties, including emotion identification and the up- and down-regulation of both positive and negative emotion. Little research has examined ER specifically in CP-POU; however, initial evidence suggests CP-POU is characterized by difficulties with ER that are similar to those found in chronic pain more generally. There is great potential to expand the treatment of ER to improve pain-related outcomes in chronic pain and CP-POU. More research is needed, however, to elucidate ER in CP-POU and to determine which types of ER strategies are optimal for different clinical presentations and categories of problematic opioid use. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Background: Low back pain is a prevalent condition that causes a substantial health burden. Despite intensive and expensive clinical efforts, its prevalence is growing. Nonpharmacologic treatments are effective at improving pain-related outcomes; however, treatment effect sizes are often modest. Physical therapy (PT) and cognitive behavioral therapy (CBT) have the most consistent evidence of effectiveness. Growing evidence also supports mindfulness-based approaches. Discussions with providers and patients highlight the importance of discussing and trying options to find the treatment that works for them and determining what to do when initial treatment is not successful. Herein, we present the protocol for a study that will evaluate evidence-based, protocol-driven treatments using PT, CBT, or mindfulness to examine comparative effectiveness and optimal sequencing for patients with chronic low back pain., Methods: The Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE) Study will be a multisite, comparative effectiveness trial using a sequential multiple assessment randomized trial design enrolling 945 individuals with chronic low back pain. The co-primary outcomes will be disability (measured using the Oswestry Disability Index) and pain intensity (measured using the Numerical Pain Rating Scale). After baseline assessment, participants will be randomly assigned to PT or CBT. At week 10, participants who have not experienced at least 50% improvement in disability will be randomized to cross-over phase-1 treatments (e.g., PT to CBT) or to Mindfulness-Oriented Recovery Enhancement (MORE). Treatment will consist of 8 weekly sessions. Long-term outcome assessments will be performed at weeks 26 and 52., Discussion: Results of this study may inform referring providers and patients about the most effective nonoperative treatment and/or sequence of nonoperative treatments to treat chronic low back pain., Trial Registration: This study was prospectively registered on March 1, 2019, with Clinicaltrials.gov under the registration number NCT03859713 (https://clinicaltrials.gov/ct2/show/NCT03859713).

Rehabilitation psychology is based on foundational principles that can guide us toward health equity among disabled and nondisabled communities. We summarize the literature on disparities in the disability community and underscore the urgency to address underlying inequities to eliminate disparities. We include examples of population-level interventions that promote equity in the disability community. We conclude with a call for a broader mission for rehabilitation psychologists based on the field's foundational principles, and outline emerging opportunities to widen our impact and advance equity. Our foundational principles, built on systems theory, call on rehabilitation psychologist to work at macrosystemic levels. As rehabilitation psychologists, we need to widen our focus from the micro (individual) to the macro (population) level. We need to bring the respect, dignity, and collaborative spirit that inspire our work with individuals to the broader community by advocating for structures and policies that promote equity for disabled persons. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Objectives: To describe feasibility, adherence, acceptability, and outcomes of a cognitive-behavioral-based physical therapy (CBPT-ACLR) intervention for improving postoperative recovery after anterior cruciate ligament reconstruction (ACLR)., Design: Pilot study., Setting: Academic medical center., Participants: Eight patients (mean age [SD] = 20.1 [2.6] years, 6 females) participated in a 7-session telephone-based CBPT-ACLR intervention beginning preoperatively and lasting 8 weeks after surgery., Main Outcome Measures: At 6 months, patients completed Knee Injury and Osteoarthritis Outcome Score (KOOS) sports/recreation and quality of life (QOL) subscales, International Knee Documentation Committee (IKDC), Tampa Scale of Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), and Knee Self-Efficacy Scale (K-SES), return to sport (Subjective Patient Outcome for Return to Sports), and satisfaction. Minimal clinically important difference (MCID) was used for meaningful change., Results: Seven (88%) patients completed all sessions. Seven (88%) patients exceeded MCID on the TSK, 6 (75%) on the PCS, 5 (63%) on the KOOS sports/recreation subscale, 4 (50%) on the IKDC, and 3 (38%) on the KOOS QOL subscale. Three (38%) patients returned to their same sport at the same level of effort and performance. All patients were satisfied with their recovery., Conclusions: A CBPT-ACLR program is feasible and acceptable for addressing psychological risk factors after ACLR., Competing Interests: Declaration of competing interest None declared., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Purpose/objective: Intensive care unit (ICU) survivors frequently experience long-lasting mental health, cognitive, and physiologic challenges. Psychologists have a role in providing interventions to reduce patient distress during critical illness and improve outcomes. There is limited data regarding psychology consultations in the ICU. This brief report characterizes psychology consultations in a medical intensive care unit (MICU) in an academic medical center., Method: Psychology consultations were prospectively tracked, with patient-related data retrospectively collected and analyzed., Results: A total of 79 consecutive psychology consultations occurred at mean of 8 ± 6 days after MICU admission. Reasons for consultation were patient emotional distress (56%), rehabilitation therapy engagement (24%), family engagement (13%), cognitive disturbance (4%), and pain (4%). Patient characteristics were: mean age 56 ± 15 years, 54% women, 53% White, and 34% with psychiatric comorbidity at MICU admission. Patients referred for consultation had a longer MICU length of stay than the total MICU population (12 ± 9 days vs. 4 ± 6 days, p < .01). For consultations for emotional distress compared with limited rehabilitation therapy engagement, patient demographic characteristics were similar, with the exception of women (vs. men) being more commonly consulted for emotional distress (64 vs. 26%, p = .01)., Conclusions: Patients with a longer MICU stay more commonly had a rehabilitation psychology consultation request, typically to provide support for emotional distress or engagement in rehabilitation therapy. Future research should evaluate the effectiveness of psychology interventions in the ICU. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Background: Low back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP., Methods and Study Design: The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently., Discussion: The TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT., Trial Registration: ClinicalTrials.govNCT02647658 Registered Jan. 6, 2016., (Copyright © 2019. Published by Elsevier Inc.)