Publications by authors named "Steven Z George"

276 Publications

Derivation of a Risk Assessment Tool for Prediction of Long-Term Pain Intensity Reduction After Physical Therapy.

J Pain Res 2021 28;14:1515-1524. Epub 2021 May 28.

Duke University, Department of Orthopaedic Surgery and Duke Clinical Research Institute, Durham, NC, 27701, USA.

Rationale: Risk assessment tools can improve clinical decision-making for individuals with musculoskeletal pain, but do not currently exist for predicting reduction of pain intensity as an outcome from physical therapy.

Aims And Objective: The objective of this study was to develop a tool that predicts failure to achieve a 50% pain intensity reduction by 1) determining the appropriate statistical model to inform the tool and 2) select the model that considers the tradeoff between clinical feasibility and statistical accuracy.

Methods: This was a retrospective, secondary data analysis of the Optimal Screening for Prediction of Referral and Outcome (OSPRO) cohort. Two hundred and seventy-nine individuals seeking physical therapy for neck, shoulder, back, or knee pain who completed 12-month follow-up were included. Two modeling approaches were taken: a longitudinal model included demographics, presence of previous episodes of pain, and regions of pain in addition to baseline and change in OSPRO Yellow Flag scores to 12 months; two comparison models included the same predictors but assessed only baseline and early change (4 weeks) scores. The primary outcome was failure to achieve a 50% reduction in pain intensity score at 12 months. We compared the area under the curve (AUC) to assess the performance of each candidate model and to determine which to inform the Personalized Pain Prediction (P3) risk assessment tool.

Results: The baseline only and early change models demonstrated lower accuracy (AUC=0.68 and 0.71, respectively) than the longitudinal model (0.79) but were within an acceptable predictive range. Therefore, both baseline and early change models were used to inform the P3 risk assessment tool.

Conclusion: The P3 tool provides physical therapists with a data-driven approach to identify patients who may be at risk for not achieving improvements in pain intensity following physical therapy.
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http://dx.doi.org/10.2147/JPR.S305973DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8169054PMC
May 2021

Author Response to Quintner and Cohen.

Phys Ther 2021 Jun 2. Epub 2021 Jun 2.

Laszlo Ormandy Distinguished Professor of Orthopaedic Surgery, Department of Orthopedic Surgery, Duke Clinical Research Institute, Duke University, Durham, North Carolina.

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http://dx.doi.org/10.1093/ptj/pzab137DOI Listing
June 2021

Prevalence and predictors of no-shows to physical therapy for musculoskeletal conditions.

PLoS One 2021 28;16(5):e0251336. Epub 2021 May 28.

Duke Clinical Research Institute, Duke University, Durham, NC, United Stated of America.

Objectives: Chronic pain affects 50 million Americans and is often treated with non-pharmacologic approaches like physical therapy. Developing a no-show prediction model for individuals seeking physical therapy care for musculoskeletal conditions has several benefits including enhancement of workforce efficiency without growing the existing provider pool, delivering guideline adherent care, and identifying those that may benefit from telehealth. The objective of this paper was to quantify the national prevalence of no-shows for patients seeking physical therapy care and to identify individual and organizational factors predicting whether a patient will be a no-show when seeking physical therapy care.

Design: Retrospective cohort study.

Setting: Commercial provider of physical therapy within the United States with 828 clinics across 26 states.

Participants: Adolescent and adult patients (age cutoffs: 14-117 years) seeking non-pharmacological treatment for musculoskeletal conditions from January 1, 2016, to December 31, 2017 (n = 542,685). Exclusion criteria were a primary complaint not considered an MSK condition or improbable values for height, weight, or body mass index values. The study included 444,995 individuals.

Primary And Secondary Outcome Measures: Prevalence of no-shows for musculoskeletal conditions and predictors of patient no-show.

Results: In our population, 73% missed at least 1 appointment for a given physical therapy care episode. Our model had moderate discrimination for no-shows (c-statistic:0.72, all appointments; 0.73, first 7 appointments) and was well calibrated, with predicted and observed no-shows in good agreement. Variables predicting higher no-show rates included insurance type; smoking-status; higher BMI; and more prior cancellations, time between visit and scheduling date, and between current and previous visit.

Conclusions: The high prevalence of no-shows when seeking care for musculoskeletal conditions from physical therapists highlights an inefficiency that, unaddressed, could limit delivery of guideline-adherent care that advocates for earlier use of non-pharmacological treatments for musculoskeletal conditions and result in missed opportunities for using telehealth to deliver physical therapy.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0251336PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162651PMC
May 2021

Static and Dynamic Pain Sensitivity in Adults With Persistent Low Back Pain: Comparison to Healthy Controls and Associations With Movement-evoked Pain Versus Traditional Clinical Pain Measures.

Clin J Pain 2021 Jul;37(7):494-503

Department of Orthopaedic Surgery.

Objectives: Despite its impact, individual factors associated with persistent low back pain (LBP) remain poorly understood. This study investigated static and dynamic pain sensitivity in adults with persistent LBP versus pain-free controls; and investigated associations between pain sensitivity and 3 clinical pain measures: recalled, resting, and movement-evoked pain (MEP).

Materials And Methods: A lifespan sample of 60 adults with persistent LBP and 30 age-matched/sex-matched controls completed 4 laboratory sessions. Static pain sensitivity (pressure pain threshold [PPT], heat pain threshold) and dynamic pain sensitivity (heat pain aftersensations [AS], temporal summation [TS] of second heat pain) were measured. Demographic and clinical factors collected were education, global cognition, and perceived health. Resting and recalled pain were measured via questionnaire, and MEP via the Back Performance Scale.

Results: LBP participants demonstrated lower PPT remotely (hand; F1,84=5.34, P=0.024) and locally (low back; F1,84=9.55, P=0.003) and also had higher AS (F1,84=6.01, P=0.016). Neither static nor dynamic pain sensitivity were associated with recalled pain (P>0.05). However, static pain sensitivity (local PPT) explained an additional 9% variance in resting pain, while dynamic pain sensitivity (AS, TS) explained an additional 10% to 12% variance in MEP.

Discussion: This study characterized pain sensitivity measures among individuals with persistent LBP and suggests static pain sensitivity plays a larger role in resting pain while dynamic pain sensitivity plays a larger role in MEP. Future studies will confirm these relationships and elucidate the extent to which changes in static or dynamic pain sensitivity predict or mediate clinical pain among adults with persistent LBP.
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http://dx.doi.org/10.1097/AJP.0000000000000945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8194013PMC
July 2021

Assessment of Common Comorbidity Phenotypes Among Older Adults With Knee Osteoarthritis to Inform Integrated Care Models.

Mayo Clin Proc Innov Qual Outcomes 2021 Apr 19;5(2):253-264. Epub 2021 Jan 19.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.

Objective: To establish the frequency of concordant, discordant, and clinically dominant comorbidities among Medicare beneficiaries with knee osteoarthritis (KOA) and to identify common concordant condition subgroups.

Participants And Methods: We used a 5% representative sample of Medicare claims data to identify beneficiaries who received a diagnosis of KOA between January 1, 2012, and September 30, 2015, and matched control group without an osteoarthritis (OA) diagnosis. Frequency of 34 comorbid conditions was categorized as concordant, discordant, or clinically dominant among those with KOA and a matched sample without OA. Comorbid condition phenotypes were characterized by concordant conditions and derived using latent class analysis among those with KOA.

Results: The study sample included 203,361 beneficiaries with KOA and 203,361 non-OA controls. The largest difference in frequency between the two cohorts was for co-occurring musculoskeletal conditions (23.7% absolute difference), chronic pain syndromes (6.5%), and rheumatic diseases (4.5%), all with a higher frequency among those with knee OA. Phenotypes were identified as low comorbidity (53% of cohort with classification), hypothyroid/osteoporosis (27%), vascular disease (10%), and high medical and psychological comorbidity (10%).

Conclusions: Approximately 47% of Medicare beneficiaries with KOA in this sample had a phenotype characterized by one or more concordant conditions, suggesting that existing clinical pathways that rely on single or dominant providers might be insufficient for a large proportion of older adults with KOA. These findings could guide development of integrated KOA-comorbidity care pathways that are responsive to emerging priorities for personalized, value-based health care.
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http://dx.doi.org/10.1016/j.mayocpiqo.2020.09.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8105527PMC
April 2021

Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

Pain Rep 2021 21;6(1):e895. Epub 2021 Jan 21.

Johnson and Johnson, Titusville, NJ, USA.

Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.
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http://dx.doi.org/10.1097/PR9.0000000000000895DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108588PMC
January 2021

Predictors of Lumbar Spine Degeneration and Low Back Pain in the Community: The Johnston County Osteoarthritis Project.

Arthritis Care Res (Hoboken) 2021 May 10. Epub 2021 May 10.

Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, USA.

Objective: To determine the incidence and worsening of lumbar spine structure and low back pain (LBP) and whether they are predicted by demographic characteristics or clinical characteristics or appendicular joint osteoarthritis (OA).

Methods: Paired baseline (2003-2004) and follow-up (2006-2010) lumbar spine radiographs from the Johnston County Osteoarthritis Project were graded for osteophytes (OST), disc space narrowing (DSN), spondylolisthesis, and presence of facet joint OA (FOA). Spine OA was defined as at least mild OST and mild DSN at the same level for any level of the lumbar spine. LBP, comorbidities, and back injury were self-reported. Weibull models were used to estimate hazard ratios and 95% confidence intervals (CI) of spine phenotypes accounting for potential predictors including demographics, clinical characteristics, comorbidities, obesity, and appendicular OA.

Results: Obesity was a consistent and strong predictor of incidence of DSN (HR=1.80, 95%CI 1.09-2.98), spine OA (HR=1.56, 95%CI 1.01-2.41), FOA (HR=4.99, 95%CI 1.46-17.10), spondylolisthesis (HR=1.87, 95%CI 1.02-3.43), and LBP (HR=1.75, 95%CI 1.19-2.56), and worsening of DSN (HR=1.51, 95%CI 1.09-2.09) and LBP (HR=1.51, 95%CI 1.12-2.06). Knee OA was a predictor of incident FOA (HR=4.18, 95%CI 1.44-12.2). Spine OA (HR=1.80, 95%CI 1.24-2.63) and OST (HR=1.85, 95%CI 1.02-3.36) were predictors of incidence of LBP. Hip OA (HR=1.39, 95%CI 1.04-1.85) and OST (HR=1.58, 95%CI 1.00-2.49) were predictors of LBP worsening.

Conclusion: Among the multiple predictors of spine phenotypes, obesity was a common predictor for both incidence and worsening of lumbar spine degeneration and LBP.
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http://dx.doi.org/10.1002/acr.24643DOI Listing
May 2021

Resilience and pain catastrophizing among patients with total knee arthroplasty: a cohort study to examine psychological constructs as predictors of post-operative outcomes.

Health Qual Life Outcomes 2021 May 1;19(1):136. Epub 2021 May 1.

Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC, USA.

Background: Patients' psychological health may influence recovery and functional outcomes after total knee arthroplasty (TKA). Pain catastrophizing, known to be associated with poor function following TKA, encompasses rumination, magnification, and helplessness that patients feel toward their pain. Resilience, however, is an individual's ability to adapt to adversity and may be an important psychological construct that supersedes the relationship between pain catastrophizing and recovery. In this study we sought to identify whether pre-operative resilience is predictive of 3-month postoperative outcomes after adjusting for pain catastrophizing and other covariates.

Methods: Patients undergoing TKA between January 2019 and November 2019 were included in this longitudinal cohort study. Demographics and questionnaires [Brief Resilience Scale (BRS), Pain Catastrophizing Scale (PCS), Knee injury and Osteoarthritis Outcome Score, Junior (KOOS, JR.) and Patient-Reported Outcomes Measurement Information System Physical and Mental Health (PROMIS PH and MH, respectively)] were collected preoperatively and 3 months postoperatively. Multivariable regression was used to test associations of preoperative BRS with postoperative outcomes, adjusting for PCS and other patient-level sociodemographic and clinical characteristics.

Results: The study cohort included 117 patients with a median age of 67.0 years (Q1-Q3: 59.0-72.0). Fifty-three percent of patients were women and 70.1% were white. Unadjusted analyses identified an association between resilience and post-operative outcomes and the relationship persisted for physical function after adjusting for PCS and other covariates; in multivariable linear regression analyses, higher baseline resilience was positively associated with better postoperative knee function (β = 0.24, p = 0.019) and better general physical health (β = 0.24, p = 0.013) but not general mental health (β = 0.04, p = 0.738).

Conclusions: Our prospective cohort study suggests that resilience predicts postoperative knee function and general physical health in patients undergoing TKA. Exploring interventions that address preoperative mental health and resilience more specifically may improve self-reported physical function outcomes of patients undergoing TKA.
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http://dx.doi.org/10.1186/s12955-021-01772-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088639PMC
May 2021

Predicting Recurrent Care Seeking of Physical Therapy for Musculoskeletal Pain Conditions.

Pain Med 2021 Apr 27. Epub 2021 Apr 27.

Division of General Internal Medicine, Duke University, Durham, NC, (USA).

Objective: Musculoskeletal (MSK) pain conditions are a leading cause of pain and disability internationally and a common reason to seek health care. Accurate prediction of recurrence for health care seeking due to MSK conditions could allow for better tailoring of treatment. The aim of this project was to characterize patterns of recurrent physical therapy seeking for MSK pain conditions and to develop a preliminary prediction model to identify those at increased risk for recurrent care seeking.

Design: Retrospective cohort.

Setting: Ambulatory care.

Subjects: Patients (n = 578,461) seeking outpatient physical therapy (United States).

Methods: Potential predictor variables were extracted from the electronic medical record and patients were placed into three different recurrent care categories. Logistic regression models identified individual predictors of recurrent care seeking and Least Absolute Shrinkage and Selection Operator (LASSO) developed multivariate prediction models.

Results: Accuracy of models for different definitions of recurrent care ranged from 0.59 - 0.64 (c-statistic) and individual predictors were identified from multivariate models. Predictors of increased risk for recurrent care included: worker's compensation and Medicare insurance, comorbid arthritis, post-operative at time of first episode, age range from 44 -64 years, and reporting night sweats/night pain. Predictors of decreased risk for recurrent care included: lumbar pain, chronic injury, neck pain, pregnancy, age range from 25-44 years, and smoking.

Conclusion: This analysis identified a preliminary predictive model for recurrence of care seeking of physical therapy, but model accuracy needs to improve to better guide clinical decision making.
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http://dx.doi.org/10.1093/pm/pnab154DOI Listing
April 2021

Back and neck pain: in support of routine delivery of non-pharmacologic treatments as a way to improve individual and population health.

Transl Res 2021 Aug 24;234:129-140. Epub 2021 Apr 24.

Department of Orthopaedic Surgery and Duke Clinical Research Institute, Duke University, Durham, North Carolina.

Chronic back and neck pain are highly prevalent conditions that are among the largest drivers of physical disability and cost in the world. Recent clinical practice guidelines recommend use of non-pharmacologic treatments to decrease pain and improve physical function for individuals with back and neck pain. However, delivery of these treatments remains a challenge because common care delivery models for back and neck pain incentivize treatments that are not in the best interests of patients, the overall health system, or society. This narrative review focuses on the need to increase use of non-pharmacologic treatment as part of routine care for back and neck pain. First, we present the evidence base and summarize recommendations from clinical practice guidelines regarding non-pharmacologic treatments. Second, we characterize current use patterns for non-pharmacologic treatments and identify potential barriers to their delivery. Addressing these barriers will require coordinated efforts from multiple stakeholders to prioritize evidence-based non-pharmacologic treatment approaches over low value care for back and neck pain. These stakeholders include patients, health care providers, health care organizations, administrators, payers, policymakers and researchers.
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http://dx.doi.org/10.1016/j.trsl.2021.04.006DOI Listing
August 2021

Stratified care to prevent chronic low back pain in high-risk patients: The TARGET trial. A multi-site pragmatic cluster randomized trial.

EClinicalMedicine 2021 Apr 30;34:100795. Epub 2021 Mar 30.

Department of Family Medicine, Boston Medical Center, 1 Boston Medical Center Place, Dowling 5 South, Boston, MA 02118 USA.

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,  = 658) versus 51% of patients in the control arm (35 practices,  = 635; OR=0.83 95% CI 0.64, 1.09;  = 0.18). No differences in disability were detected (difference -2·1, 95% CI -4.9-0.6;  = 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.
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http://dx.doi.org/10.1016/j.eclinm.2021.100795DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8040279PMC
April 2021

Star-Shape Kinesio Taping Is Not Better Than a Minimal Intervention or Sham Kinesio Taping for Pain Intensity and Postural Control in Chronic Low Back Pain: A Randomized Controlled Trial.

Arch Phys Med Rehabil 2021 Apr 2. Epub 2021 Apr 2.

Graduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil; Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil. Electronic address:

Objective: This study investigated the effects of star-shape Kinesio taping (KT) compared with both sham KT and minimal intervention (MI) on pain intensity and postural control.

Design: Randomized controlled trial.

Setting: Outpatient physical therapy.

Participants: A total of 120 people with chronic low back pain (CLBP) aged 18-60 years (N=120).

Interventions: Star-shape KT, sham KT (no tension), and MI (educational booklet for self-management counseling).

Main Outcome Measures: The primary outcome measures were pain intensity and center of pressure (COP) mean sway speed, and disability score (Oswestry Disability Index) was a secondary outcome. The outcomes were obtained immediately after initial KT application, on the seventh day of intervention and at the 1-month follow-up. Linear mixed-model analyses using Bonferroni post hoc analyses were applied to investigate between-group differences. The model included treatment, time, and treatment×time interaction as fixed effects.

Results: Pain intensity was significantly lower for the star-shape KT group than for the MI group (mean difference [MD], -1.35; 95% confidence interval [CI], -2.63 to -0.07) immediately after the intervention and on the seventh day of intervention (MD, -1.32; 95% CI, -2.56 to -0.07). No difference in pain intensity between star-shape KT vs sham-KT groups was observed. In addition, no significant between-group differences were observed for the COP mean sway speed and disability score at any of the follow-up times.

Conclusions: Our results showed no meaningful effect of star-shape KT intervention on pain intensity and postural control in people with CLBP compared with MI or sham KT. The observed reduction of 1.3 units between star-shape KT and MI groups was statistically different, but it could not be considered clinically relevant. The results of this trial suggest that benefits from KT are more likely attributable to contextual factors rather than specific taping parameters.
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http://dx.doi.org/10.1016/j.apmr.2021.03.007DOI Listing
April 2021

The Impact of State Level Public Policy, Prescriber Education, and Patient Factors on Opioid Prescribing in Elective Orthopedic Surgery: Findings From a Tertiary, Academic Setting.

Mayo Clin Proc Innov Qual Outcomes 2021 Feb 6;5(1):23-34. Epub 2020 Nov 6.

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC.

Background: The United States is in the midst of an opioid misuse epidemic. There have been recent changes to North Carolina's public policy leading to institutional education attempting to reduce high-risk opioid prescribing. This study investigated whether state-level and institutional efforts were associated with provider-level changes in opioid prescriptions after common orthopedic surgeries.

Patients And Methods: Six-week post-operative opioid prescribing in patients 18 years or older undergoing high-volume elective surgeries were reviewed retrospectively. Three patient cohorts from equivalent calendar year periods were included in this analysis; preceding policy implementation (January 1, 2017, to March 31, 2017), immediately after policy implementation (January 1, 2018, to March 31, 2018), and 1 year after policy implementation (January 1, 2019, to March 31, 2019). Multivariable models were constructed to evaluate the effects of public policy and institutional education on postoperative opioid prescribing.

Results: The mean (standard deviation) amount of oxycodone 5-mg equivalents prescribed at discharge decreased from 75.6 (53.2) in 2017 to 55.7 (36.2) in 2018 and then 45.6 (32.6) in 2019 ( < .05). Similarly, 6-week postoperative cumulative oxycodone 5-mg equivalents prescribed also significantly decreased from 123.3 (145.8) in 2017 to 84.1 (90.3) in 2018 and to 80.2 (150.1) in 2019. Other outcomes including prescription duration and rates of outlier prescribing showed similar trends.

Conclusion: In a North Carolina tertiary academic hospital, opioid prescribing decreased after public policy implementation and an institutional response of education for prescribers within a national context of changing practices in opioid prescribing. State-level public policy and prescriber education could be important avenues for decreasing postoperative opioid prescription in orthopedic settings.
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http://dx.doi.org/10.1016/j.mayocpiqo.2020.08.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7930871PMC
February 2021

Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care.

JAMA Netw Open 2021 02 1;4(2):e2037371. Epub 2021 Feb 1.

Department of Family Medicine, Boston Medical Center, Boston, Massachusetts.

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.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.37371DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887659PMC
February 2021

Physical therapy and opioid use for musculoskeletal pain management: competitors or companions?

Pain Rep 2020 Sep-Oct;5(5):e827. Epub 2020 Sep 24.

Department of Orthopaedic Surgery, Duke Clinical Research Institute Duke University, Durham, NC, United States.

Musculoskeletal (MSK) pain conditions are highly prevalent and a leading cause of disability globally. When people with MSK pain seek health care, they often receive treatment not aligned with best practices, including initial management options such as opioids. In recent practice guidelines, nonpharmacological treatments have been emphasized for initial pain management, and physical therapists are providers who routinely deliver nonpharmacological treatments. The purpose of this review is to describe the current and future state for how physical therapy may be used to increase exposure to nonpharmacological treatments for MSK pain conditions. For the current state, we review existing observational evidence investigating early exposure to physical therapy and its influence on subsequent opioid use. For the future state, we propose clinical research questions that could define the role of physical therapy on interdisciplinary teams working towards improving effectiveness of nonpharmacological treatments through more rigorous study designs. These clinical questions are intended to guide health services research and clinical trials when building an evidence base of nonpharmacological care options for MSK pain conditions.
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http://dx.doi.org/10.1097/PR9.0000000000000827DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7808685PMC
September 2020

A New Definition of Pain: Update and Implications for Physical Therapist Practice and Rehabilitation Science.

Phys Ther 2021 Apr;101(4)

Department of Orthopedic Surgery, Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.

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http://dx.doi.org/10.1093/ptj/pzab019DOI Listing
April 2021

Sensory and Psychological Factors Predict Exercise-Induced Shoulder Injury Responses in a High-Risk Phenotype Cohort.

J Pain 2021 Jun 2;22(6):669-679. Epub 2021 Jan 2.

Department of Orthopaedic Surgery and Duke Clinical Research Institute, Duke University, Durham, North Carolina. Electronic address:

Our prior studies identified a high-risk phenotype (ie, high pain sensitivity variant of the catechol-O-methyltransferase gene (Single Nucleotide Polymorphism [SNP] rs6269) and pain catastrophizing scores) for shoulder pain. The current study identified sensory and psychological predictors of heightened pain responses following exercise-induced shoulder injury. Healthy participants (N = 131) with the SNP rs6269 catechol-O-methyltransferase gene and Pain Catastrophizing Scale scores ≥5 underwent baseline sensory and psychological testing followed by an established shoulder fatigue protocol, to induce muscle injury. Movement-evoked pain, pain intensity, disability, and strength were assessed 24 hours postinjury. Demographic, sensory, and psychological variables were included as predictors in full and parsimonious models for each outcome. The highest variance explained was for the shoulder disability outcome (full model R = .20, parsimonious R = .13). In parsimonious models, the individual predictors identified were: 1) 1st pulse heat pain sensitivity for isometric shoulder movement-evoked pain and pain intensity; 2) pressure pain threshold for shoulder disability; 3) fear of pain for active shoulder movement-evoked pain and shoulder disability; and 4) depressive symptoms for shoulder strength. Findings indicate specific pain sensitivity and psychological measures may have additional prognostic value for self-reported disability within a high-risk phenotype. These findings should be tested in a clinical cohort for validation. PERSPECTIVE: The current study extends previous work by providing insight regarding how poor shoulder outcomes may develop within a high-risk phenotype. Specifically, 1st pulse heat pain sensitivity and pressure pain threshold were sensory measures, and fear of pain and depressive symptoms were psychological measures, that improved prediction of different shoulder outcomes.
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http://dx.doi.org/10.1016/j.jpain.2020.12.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197727PMC
June 2021

Determination of Pain Phenotypes in Knee Osteoarthritis Using Latent Profile Analysis.

Pain Med 2021 03;22(3):653-662

Physical Therapy Program, Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, Colorado, USA.

Objective: To identify clinical phenotypes of knee osteoarthritis (OA) using measures from the following domains: 1) multimorbidity; 2) psychological distress; 3) pain sensitivity; and 4) knee impairment or pathology.

Design: Data were collected from 152 people with knee OA and from 31 pain-free individuals. In participants with knee OA, latent profile analysis (LPA) was applied to the following measures: normalized knee extensor strength, Functional Comorbidity Index (FCI), Pain Catastrophizing Scale (PCS), and local (knee) pressure pain threshold. Comparisons were performed between empirically derived phenotypes from the LPA and healthy older adults on these measures. Comparisons were also made between pheonotypes on pain intensity, functional measures, use of health care, and history of knee injury.

Results: LPA resulted in a four-group solution. Compared with all other groups, group 1 (9% of the study population) had higher FCI scores. Group 2 (63%) had elevated pain sensitivity and quadriceps weakness relative to group 4 and healthy older adults. Group 3 (11%) had higher PCS scores than all other groups. Group 4 (17%) had greater leg strength, except relative to healthy older adults, and reduced pain sensitivity relative to all groups. Groups 1 and 3 demonstrated higher pain and worse function than other groups, and group 4 had higher rates of knee injury.

Conclusion: Four phenotypes of knee OA were identified using psychological factors, comorbidity status, pain sensitivity, and leg strength. Follow-up analyses supported the replicability of this phenotype structure, but future research is needed to determine its usefulness in knee OA care.
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http://dx.doi.org/10.1093/pm/pnaa398DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7971470PMC
March 2021

FEAR-AVOIDANCE AND SELF-EFFICACY PSYCHOSOCIAL FACTORS ARE ALTERED AFTER PARTIAL MENISCECTOMY AND ASSOCIATED WITH REHABILITATION OUTCOMES.

Int J Sports Phys Ther 2020 Aug;15(4):557-570

TRIA Orthopaedic Center, Bloomington, MN, USA.

Background: Little research has examined how psychosocial factors change over time and influence rehabilitation outcomes following meniscectomy. This information can inform the need to assess and address psychosocial factors in meniscectomy rehabilitation.

Hypothesis/purpose: The purpose of this study was to examine changes in fear-avoidance and self-efficacy psychosocial factors from pre-surgery to one year after meniscectomy and their associations with rehabilitation outcomes. The hypothesis was that psychosocial factors would improve following meniscectomy, and less improvement in psychosocial factors would be associated with less improvement in rehabilitation outcomes.

Study Design: Prospective cohort.

Methods: Twenty-five patients with partial meniscectomy participated. Testing time points were pre-surgery, after post-surgical rehabilitation, and one-year post-surgery. Fear avoidance (pain catastrophizing and kinesiophobia) and self-efficacy (knee-related activity) psychosocial factors were assessed with the Pain Catastrophizing Scale (PCS), the Tampa Scale for Kinesiophobia (TSK-11), and Knee Activity Self-efficacy (KASE) questionnaires; respectively. Rehabilitation outcomes were quadriceps strength, evaluated with isokinetic testing at 60 °/sec; knee pain, measured with the Numeric Pain Rating Scale (NPRS); and self-reported knee function, measured with the International Knee Documentation Committee Subjective Knee Form (IKDC-SKF).

Results: PCS scores improved from pre-surgery to after post-surgical rehabilitation, while TSK-11 and KASE scores improved from pre-surgery to after post-surgical rehabilitation and from after post-surgical rehabilitation to 1-year post-surgery. Pre-surgery PCS and KASE scores were associated with 1-year post-surgery NPRS score (r = 0.50) and quadriceps peak torque (r = 0.48), respectively. From pre-surgery to 1-year post-surgery, change in TSK-11 score was associated with change in NPRS score (r = 0.65), and change in KASE score was associated with change in IKDC-SKF score (r = 0.44). From pre-surgery to after post-surgical rehabilitation, changes in TSK-11 and KASE scores were associated with changes in NPRS (TSK-11, r = 0.47; KASE, r = -0.50) and IKDC-SKF scores (TSK-11, r = -0.39; KASE, r = 0.71). From after post-surgical rehabilitation to 1-year post-surgery, changes in KASE score was associated with changes in IKDC-SKF score (r = 0.59).

Conclusions: Assessment of pain catastrophizing and knee activity self-efficacy pre-surgery might help to identify patients at risk for sustained knee pain and quadriceps muscle weakness. Decreasing kinesiophobia and increasing knee activity self-efficacy were associated with improved knee pain and function.

Level Of Evidence: 2b.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735696PMC
August 2020

Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial.

Pain Med 2020 12;21(Suppl 2):S62-S72

Durham Center of Innovation to Accelerate Discovery and Practice, Durham VA Health Care System, Geriatric Research, Education and Clinical Center at Durham VAHCS Health Services Research & Development, Durham, North Carolina.

Background: Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown.

Design: The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures.

Summary: AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.
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http://dx.doi.org/10.1093/pm/pnaa348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734660PMC
December 2020

Strategy for addressing research-site overlap in pragmatic clinical trials: lessons learned from the NIH-DOD-VA Pain Management Collaboratory (PMC).

Trials 2020 Dec 11;21(1):1021. Epub 2020 Dec 11.

The Pain Management Collaboratory Coordinating Center, Yale University, New Haven, CT, USA.

Background: The Pain Management Collaboratory (PMC) is a multi-site network of pragmatic clinical trials (PCTs) focused on nonpharmacological approaches to pain management, conducted in health care systems of the US Department of Defense (DoD) and Department of Veterans Affairs (VA) and co-funded by the National Institutes of Health (NIH). Concerns about potential research-site overlap prompted the PMC investigator community to consider strategies to avert this problem that could negatively affect recruitment and contaminate interventions and thus pose a threat to trial integrity.

Methods: We developed a two-step strategy to identify and remediate research-site overlap by obtaining detailed recruitment plans across all PMC PCTs that addressed eligibility criteria, recruitment methods, trial settings, and timeframes. The first, information-gathering phase consisted of a 2-month period for data collection from PIs, stakeholders, and ClinicalTrials.gov . The second, remediation phase consisted of a series of moderated conference calls over a 1-month time period to develop plans to address overlap. Remediation efforts focused on exclusion criteria and recruitment strategies, and they involved collaboration with sponsors and stakeholder groups such as the Military Treatment Facility Engagement Committee (MTFEC). The MTFEC is comprised of collaborating DoD and university-affiliated PIs, clinicians, and educators devoted to facilitating successful pragmatic trials in DoD settings.

Results: Of 61 recruitment sites for the 11 PMC PCTs, 17 (28%) overlapped. Four PCTs had five overlapping Military Treatment Facilities (MTFs), and eight PCTs had 12 overlapping VA Medical Centers (VAMCs). We developed three general strategies to avoid research-site overlap: (i) modify exclusion criteria, (ii) coordinate recruitment efforts, and/or (iii) replace or avoid any overlapping sites. Potential overlap from competing studies outside of the PMC was apparent at 26 sites, but we were not able to confirm them as true conflicts.

Conclusion: Proactive strategies can be used to resolve the issue of overlapping research sites in the PMC. These strategies, combined with open and impartial mediation approaches that include researchers, sponsors, and stakeholders, provide lessons learned from this large and complex pragmatic research effort.
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http://dx.doi.org/10.1186/s13063-020-04941-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7731473PMC
December 2020

Empirically derived back pain subgroups differentiated walking performance, pain, and disability.

Pain 2021 06;162(6):1806-1815

Department of Orthopaedic Surgery, Duke Clinical Research Institute, Duke University, Durham, NC, United States.

Abstract: Low back pain (LBP) is a leading cause of disability. However, the processes contributing to disability are not well understood. Therefore, this study (1) empirically derived LBP subgroups and (2) validated these subgroups using walking performance, pain, and disability measures. Seventy adults with LBP underwent testing for a priori determined sensory (temporal summation; conditioned pain modulation), psychological (positive affect/coping; negative coping), and motor (trunk extensor muscle activation during forward bending and walking) measures. A hierarchical cluster analysis determined subgroups that were then validated using walking (walking speed; Timed Up and Go [TUG]; TUG-Cognitive [TUG-Cog]; obstacle negotiation) and clinical (Brief Pain Inventory; Oswestry Disability Index; low back pressure pain threshold) measures. Two subgroups were derived: (1) a "Maladaptive" subgroup (n = 21) characterized by low positive affect/coping, high negative coping, low pain modulation, and atypical trunk extensor activation and (2) an "Adaptive" subgroup (n = 49) characterized by high positive affect/coping, low negative coping, high pain modulation, and typical trunk extensor activation. There were subgroup differences on 7 of 12 validation measures. The Maladaptive subgroup had reduced walking performance (slower self-selected walking speed, TUG completion, and obstacle approach and crossing speed) and worse clinical presentation (higher pain intensity, pain interference, and disability) (moderate to large effect sizes; P's < 0.05). Findings support the construct validity of this multidimensional subgrouping approach. Longitudinal studies are needed to determine whether the Maladaptive subgroup is predictive of poor outcomes, such as pain chronicity or persistent disability.
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http://dx.doi.org/10.1097/j.pain.0000000000002167DOI Listing
June 2021

Reporting and utilization of Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures in orthopedic research and practice: a systematic review.

J Orthop Surg Res 2020 Nov 23;15(1):553. Epub 2020 Nov 23.

Duke Clinical Research Institute, Duke University, Durham, NC, USA.

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) is a dynamic system of psychometrically sound patient-reported outcome (PRO) measures. There has been a recent increase in the use of PROMIS measures, yet little has been written about the reporting of these measures in the field of orthopedics. The purpose of this study was to conduct a systematic review to determine the uptake of PROMIS measures across orthopedics and to identify the type of PROMIS measures and domains that are most commonly used in orthopedic research and practice.

Methods: We searched PubMed, Embase, and Scopus using keywords and database-specific subject headings to capture orthopedic studies reporting PROMIS measures through November 2018. Our inclusion criteria were use of PROMIS measures as an outcome or used to describe a population of patients in an orthopedic setting in patients ≥ 18 years of age. We excluded non-quantitative studies, reviews, and case reports.

Results: Our final search yielded 88 studies published from 2013 through 2018, with 57% (50 studies) published in 2018 alone. By body region, 28% (25 studies) reported PROMIS measures in the upper extremity (shoulder, elbow, hand), 36% (32 studies) reported PROMIS measures in the lower extremity (hip, knee, ankle, foot), 19% (17 studies) reported PROMIS measures in the spine, 10% (9 studies) reported PROMIS measures in trauma patients, and 6% (5 studies) reported PROMIS measures in general orthopedic patients. The majority of studies reported between one and three PROMIS domains (82%, 73 studies). The PROMIS Computerized Adaptive Test (CAT) approach was most commonly used (81%, 72 studies). The most frequently reported PROMIS domains were physical function (81%, 71 studies) and pain interference (61%, 54 studies).

Conclusion: Our review found an increase in the reporting of PROMIS measures over the recent years. Utilization of PROMIS measures in orthopedic populations is clinically appropriate and can facilitate communication of outcomes across different provider types and with reduced respondent burden.

Registration: The protocol for this systematic review was designed in accordance with the PRISMA guidelines and is registered with the PROSPERO database (CRD42018088260).
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http://dx.doi.org/10.1186/s13018-020-02068-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7684926PMC
November 2020

Introduction of a psychologically informed educational intervention for pre-licensure physical therapists in a classroom setting.

BMC Med Educ 2020 Oct 23;20(1):382. Epub 2020 Oct 23.

Department of Orthopaedic Surgery and Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27001, USA.

Background: There is an increasing need for physical therapists to address psychosocial aspects of musculoskeletal pain. Psychologically informed practice is one way to deliver this type of care through the integration of biopsychosocial interventions into patient management. An important component of psychologically informed practice is patient centered communication. However, there is little research on how to effectively implement patient centered communication into pre-licensure training for physical therapists.

Methods: Thirty Doctor of Physical Therapy (DPT) students took part in an educational intervention that consisted of one 4-h didactic teaching session and three 1-h experiential learning sessions. Prior to the first session, students performed an examination of a standardized patient with chronic low back pain and were assessed on psychologically informed physical therapy (PIPT) adherent behaviors via a rating scale. Students also completed the Pain Attitudes and Beliefs Scale (PABS-PT). After the last experiential session, students evaluated another standardized patient and were reassessed on PIPT adherent behaviors. Students retook the PABS-PT and qualitative data was also collected.

Results: After the educational intervention, students had positive changes in their pain attitudes and belief scores indicating a stronger orientation toward a psychosocial approach to patient care (p < 0.05). Additionally, after the intervention, students showed improvements in their adherence to using PIPT behaviors in their simulated patient interactions (p < 0.05). Qualitatively, students reported a high acceptability of the educational intervention with common themes indicating improved confidence with treating and communicating with complex patients.

Conclusion: Students had attitudes and beliefs shift towards a more psychosocial orientation and demonstrated improved PIPT behaviors in simulated patient interactions after a brief educational intervention. Future research should investigate best practices for implementation of psychologically informed physical therapy for licensed clinicians.
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http://dx.doi.org/10.1186/s12909-020-02272-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7583179PMC
October 2020

What General and Pain-associated Psychological Distress Phenotypes Exist Among Patients with Hip and Knee Osteoarthritis?

Clin Orthop Relat Res 2020 Dec;478(12):2768-2783

T. A. Lentz, S. Z. George, R. C. Mather, Duke Clinical Research Institute at Duke University, Durham NC, USA.

Background: Psychological distress can negatively influence disability, quality of life, and treatment outcomes for individuals with hip and knee osteoarthritis (OA). Clinical practice guidelines recommend a comprehensive disease management approach to OA that includes the identification, evaluation, and management of psychological distress. However, uncertainty around the best psychological screening and assessment methods, a poor understanding of the heterogeneity of psychological distress in those with OA, and lack of guidance on how to scale treatment have limited the growth of OA care models that effectively address individual psychological needs.

Questions/purposes: (1) Across which general and pain-related psychological distress constructs do individuals seeking conservative care for hip or knee OA report higher scores than the general population of individuals seeking conservative care for musculoskeletal pain conditions? (2) What common psychological phenotypes exist among nonsurgical care-seeking individuals with hip or knee OA?

Methods: The sample included participants from the Duke Joint Health Program (n = 1239), a comprehensive hip and knee OA care program, and the Optimal Screening for Prediction of Referral and Outcome (OSPRO) cohort studies (n = 871) comprising individuals seeking conservative care for knee, shoulder, low back, or neck pain. At the initial evaluation, patients completed the OSPRO Yellow Flag (OSPRO-YF) Assessment Tool, which assesses 11 general and pain-related psychological distress constructs (depression, anxiety, fear of movement, self-efficacy for managing one's own pain). We used OSPRO-YF scores to compare levels of psychological distress between the cohorts. Cohen's d effect sizes were calculated to determine the magnitude of differences between the groups, with d = 0.20, d = 0.50, and d = 0.80 indicating small, medium, and large effect sizes, respectively. We used a latent class analysis to derive psychological distress phenotypes in people with OA based on the 11 OSPRO-YF psychological distress indicators. Psychological distress phenotypes are characterized by specific mood, belief, and behavioral factors that differentiate subgroups within a population. Phenotyping can help providers develop scalable treatment pathways that are better tailored to the common needs of patients.

Results: Patients with OA demonstrated higher levels of general and pain-related psychological distress across all psychological constructs except for trait anxiety (that is, anxiety level as a personal characteristic rather than as a response to a stressful situation, like surgery) with small-to-moderate effect sizes. Characteristics with the largest effect sizes in the OA and overall OSPRO cohort were (Cohen's d) general anxiety (-0.66, lower in the OA cohort), pain catastrophizing (the tendency to ruminate over, maginfiy, or feel helpless about a pain experience, 0.47), kinesiophobia (pain-related fear of movement, 0.46), pain self-efficacy (confidence in one's own ability to manage his or her pain, -0.46, lower in the OA cohort), and self-efficacy for rehabilitation (confidence in one's own ability to perform their rehabilitation treatments, -0.44, lower in the OA cohort). The latent class analysis yielded four phenotypes (% sample): high distress (52%, 647 of 1239), low distress (26%, 322 of 1239), low self-efficacy and acceptance (low confidence in managing and willingness to accept pain) (15%, 186 of 1239), and negative pain coping (exhibiting poor pain coping skills) (7%, 84 of 1239). The classification error rate was near zero (2%), and the median of posterior probabilities used to assign subgroup membership was 0.99 (interquartile range 0.98 to 1.00), both indicating excellent model performance. The high-distress group had the lowest mean age (61 ± 11 years) and highest levels of pain intensity (6 ± 2) and disability (HOOS JR: 50 ± 15; KOOS JR: 47 ± 15), whereas the low-distress group had the highest mean age (63 ± 10 years) and lowest levels of pain (4 ± 2) and disability (HOOS JR: 63 ± 15; KOOS JR: 60 ± 12). However, none of these differences met or exceeded anchor-based minimal clinically important difference thresholds.

Conclusions: General and pain-related psychological distress are common among individuals seeking comprehensive care for hip or knee OA. Predominant existing OA care models that focus on biomedical interventions, such as corticosteroid injection or joint replacement that are designed to directly address underlying joint pathology and inflammation, may be inadequate to fully meet the care-related needs of many patients with OA due to their underlying psychological distress. We believe this because biomedical interventions do not often address psychological characteristics, which are known to influence OA-related pain and disability independent of joint pathology. Healthcare providers can develop new comprehensive hip and knee OA treatment pathways tailored to these phenotypes where services such as pain coping skills training, relaxation training, and psychological therapies are delivered to patients who exhibit phenotypes characterized by high distress or negative pain coping. Future studies should evaluate whether tailoring treatment to specific psychological phenotypes yields better clinical outcomes than nontailored treatments, or treatments that have a more biomedical focus.

Level Of Evidence: Level III, diagnostic study.
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http://dx.doi.org/10.1097/CORR.0000000000001520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899410PMC
December 2020

The association between the supply of select nonpharmacologic providers for pain and use of nonpharmacologic pain management services and initial opioid prescribing patterns for Medicare beneficiaries with persistent musculoskeletal pain.

Health Serv Res 2021 Apr 1;56(2):275-288. Epub 2020 Oct 1.

Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Oakland, California, USA.

Objective: To test the relationship between the supply of select nonpharmacologic providers (physical therapy (PT) and mental health (MH)) and use of nonpharmacologic services among older adults with a persistent musculoskeletal pain (MSP) episode.

Data Sources/study Setting: Claims data from a 5 percent random sample of Medicare beneficiaries enrolled fee-for-service (2007-2014) and the Area Health Resource File (AHRF).

Study Design: This retrospective study used generalized estimating equations to estimate the association between the county nonpharmacologic provider supply and individual service use with opioid prescriptions filled during Phase 1 (first three months of an episode) and Phase 2 (three months following Phase 1).

Data Collection/extraction Methods: We identified beneficiaries (>65 years) with ≥2 MSP diagnoses ≥90 days apart and no opioid prescription six months before the first pain diagnosis (N = 69 456). Beneficiaries' county characteristics were assigned using the AHRF.

Principal Findings: About 13.9 percent of beneficiaries used PT, 1.8 percent used MH services, and 10.7 percent had an opioid prescription during the first three months of a persistent MSP episode. An additional MH provider/10 000 people/county [aOR: 0.97, 95% CI: 0.96-0.98] and PT/10 000 people/county [aOR: 0.98, 95% CI: 0.97-1.00] was associated with lower odds of filling an opioid prescription in Phase 1. An additional MH provider/10 000 people/county [aOR: 0.97, 95% CI: 0.96-0.98] and PT use in Phase 1 [aOR: 0.62, 95% CI: 0.58-0.67] were associated with lower odds of filling an opioid prescription in Phase 2. The associations between the supply of providers and nonpharmacologic service use in Phase 1 and Phase 1 opioid prescriptions significantly differed by metropolitan and rural counties (P-value: .019).

Conclusions: Limited access to nonpharmacologic services is associated with opioid prescriptions at the onset of a persistent MSP episode. Initiating PT at the onset of an episode may reduce future opioid use. Strategies for engaging beneficiaries in nonpharmacologic services should be tailored for metropolitan and rural counties.
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http://dx.doi.org/10.1111/1475-6773.13561DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7969208PMC
April 2021

Adding Physical Impairment to Risk Stratification Improved Outcome Prediction in Low Back Pain.

Phys Ther 2021 01;101(1)

Department of Orthopaedic Surgery and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.

Objective: Identifying subgroups of low back pain (LBP) has the potential to improve prediction of clinical outcomes. Risk stratification is one such strategy that identifies similar characteristics indicative of a common clinical outcome trajectory. The purpose of this study was to determine if an empirically derived subgrouping approach based on physical impairment measures improves information provided from the STarT Back Tool (SBT).

Methods: At baseline in this secondary analysis of a cohort study, patients (N = 144) receiving physical therapy for LBP completed the SBT and tests (active lumbar flexion, extension, lateral bending, and passive straight-leg raise) from a validated physical impairment index. Clinical outcomes were assessed at 4 weeks and included the Numerical Pain Rating Scale and Oswestry Disability Index. Exploratory hierarchical agglomerative cluster analysis identified empirically derived subgroups based on physical impairment measures. Independent samples t testing and chi-square analysis were used to assess baseline subgroup differences in demographic and clinical measures. Spearman rho correlation coefficient was used to assess baseline SBT risk and impairment subgroup relationships, and a 3-way mixed-model ANOVA was used to assessed SBT risk and impairment subgroup relationships with clinical outcomes at 4 weeks.

Results: Two physical impairment-based subgroups emerged from cluster analysis: (1) low-risk impairment (n = 119, 81.5%), characterized by greater lumbar mobility; and (2) high-risk impairment (n = 25, 17.1%), characterized by less lumbar mobility. A weak, positive relationship was observed between baseline SBT risk and impairment subgroups (rs = .170). An impairment-by-SBT risk-by-time interaction effect was observed for Oswestry Disability Index scores but not for Numerical Pain Rating Scale scores at 4 weeks.

Conclusions: Physical impairment subgroups were not redundant with SBT risk categories and could improve prediction of 4-week LBP disability outcomes. Physical impairment subgroups did not improve the prediction of 4-week pain intensity scores.

Impact: Subgroups based on physical impairment and psychosocial risk could lead to better prediction of LBP disability outcomes and eventually allow for treatment options tailored to physical and psychosocial risk.
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http://dx.doi.org/10.1093/ptj/pzaa179DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8179624PMC
January 2021

Transforming low back pain care delivery in the United States.

Pain 2020 12;161(12):2667-2673

Department of Physical Therapy and Athletic Training, College of Health, University of Utah, Salt Lake City, UT, United States.

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http://dx.doi.org/10.1097/j.pain.0000000000001989DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7669560PMC
December 2020

Plasma Concentrations of Select Inflammatory Cytokines Predicts Pain Intensity 48 Hours Post-Shoulder Muscle Injury.

Clin J Pain 2020 10;36(10):775-781

Department of Orthopaedic Surgery and Duke Clinical Research Institute, Duke University, Durham, NC.

Objectives: The relationship between elevated inflammatory cytokine levels and peak pain intensity following acute musculoskeletal injury has not been fully elucidated in high risk subgroups. Identifying the role that these cytokines have on pain responses may help with developing tailored therapeutic approaches.

Methods: Data were collected from 54 participants who were vulnerable to a robust pain response and delayed recovery following musculoskeletal injury. Participants completed baseline active and resting pain measurements and a blood draw before an exercised induced shoulder muscle injury. Participants returned at 24 and 48 hours postinjury for follow-up pain measurements and blood draws. Blood plasma was analyzed for interleukin (IL)-1β, IL-6, IL-8, IL-10, and tumor necrosis factor α. Pearson bivariate correlations were performed between cytokines and pain measurements to identify candidate variables for stepwise multiple linear regression predicting pain intensity reports.

Results: Pearson bivariate correlation identified 13/45 correlations between inflammatory cytokines and resting pain intensity and 9/45 between inflammatory cytokines and active pain (P<0.05, r≥0.3 or r≤-0.3). This led to 5 stepwise multiple linear regression models, of which 4 met the statistical criterion (P<0.0167); including IL-10 baseline plasma concentrations predicting active pain (r=0.19) and resting pain (r=0.15) intensity 48 hours postinjury. IL-6 and IL-10 plasma concentrations at 48 hours were respectively associated with active and resting pain at 48 hours.

Discussion: These findings suggest that elevated concentrations of inflammatory cytokines, specifically IL-10 (at baseline and 48 h) and IL-6 (at 48 h), may play a role in heightened pain responses following exercise-induced muscle injury.
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http://dx.doi.org/10.1097/AJP.0000000000000861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7484373PMC
October 2020

Longitudinal Monitoring of Pain Associated Distress With the Optimal Screening for Prediction of Referral and Outcome Yellow Flag Tool: Predicting Reduction in Pain Intensity and Disability.

Arch Phys Med Rehabil 2020 10 26;101(10):1763-1770. Epub 2020 Jun 26.

Duke Clinical Research Institute, Duke University, Durham, North Carolina; Department of Orthopaedic Surgery, Duke University, Durham, North Carolina.

Objective: To investigate the Optimal Screening for Prediction of Referral and Outcome Yellow Flag (OSPRO-YF) tool for longitudinal monitoring of pain associated distress with the goal of improving prediction of 50% reduction in pain intensity and disability outcomes.

Design: Cohort study with 12-month follow-up after initial care episode.

Setting: Ambulatory care, participants seeking care from outpatient physical therapy clinics.

Participants: Participants (N=440) were seeking care for primary complaint of neck, low back, knee, or shoulder pain. This secondary analysis included 440 subjects (62.5% female; mean age, 45.1±17y) at baseline with n=279 (63.4%) providing follow-up data at 12 months.

Interventions: Not applicable.

Main Outcome Measures: A 50% reduction (baseline to 12-mo follow-up) in pain intensity and self-reported disability.

Results: Trends for prediction accuracy were similar for all versions of the OSPRO-YF. For predicting 50% reduction in pain intensity, model fit met the statistical criterion for improvement (P<.05) with each additional time point added from baseline. Model discrimination improved statistically when the 6-month to 12-month change was added to the model (area under the curve=0.849, P=.003). For predicting 50% reduction in disability, there was no evidence of improvement in model fit or discrimination from baseline with the addition of 4-week, 6-month, or 12-month changes (P>.05).

Conclusions: These results suggested that longitudinal monitoring improved prediction accuracy for reduction in pain intensity but not for disability reduction. Differences in OSPRO-YF item sets (10 vs 17 items) or scoring methods (simple summary score vs yellow flag count) did not affect predictive accuracy for pain intensity, providing flexibility for implementing this tool in practice settings.
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http://dx.doi.org/10.1016/j.apmr.2020.05.025DOI Listing
October 2020