Examining the Relationship Between Individual Patient Factors and Substantial Clinical Benefit From Telerehabilitation Among Patients With Chronic Low Back Pain.

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.

Significant Clinical Improvement Was Predicted in a Cohort of Patients With Low Back Pain Early in the Care Process.

OBJECTIVE: The purpose of this study was to determine the proportion of patients with low back pain who achieved clinical improvement in disability within 3 or 6 physical therapy visits, identify factors that predicted improvement, and predict the probability of improvement by the third and sixth visits. METHODS: This retrospective, observational study looked at patients (N = 6523) who completed a numeric pain scale and Modified Low Back Disability Questionnaire (MDQ) at every visit. Four prediction models were developed: 30% improvement by visit 3 and by visit 6 and 50% improvement by visit 3 and by visit 6. A logistic regression model was fit to predict patients' improvement in disability using the MDQ. Predictive models used age, disability scores, sex, symptom duration, and payer type as factors. Receiver operating characteristic curves and area under the curve were computed for the models. Nomograms illustrate the relative impacts of the predictor variables. RESULTS: Disability improved 30% in 42.7% of patients by visit 3 and 49% by visit 6. Disability improved 50% in 26% of patients by visit 3 and 32.9% by visit 6. First visit score (MDQ1) was strongest factor to predict 30% improvement by visit 3. The visit 3 score (MDQ3) was strongest factor to predict a 30% or 50% improvement by visit 6. The combination of MDQ1 and MDQ3 scores was strongest overall predictive factor for visit 6. The area under the curve values for models using only the MDQ1 and MDQ3 scores to predict 30% or 50% improvement by the sixth visit were 0.84 and 0.85, respectively, representing excellent overall diagnostic accuracy of the prediction models. CONCLUSION: Excellent discrimination to predict patients' significant clinical improvement by visit 6 using 2 outcome scores was demonstrated. Gathering outcomes routinely enhances assessment of prognosis and clinical decision making. IMPACT: Understanding prognosis of clinical improvement supports physical therapists' contribution to value-based care.

Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME).

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.

Treatment effect modifiers for individuals with acute low back pain: secondary analysis of the TARGET trial.

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.

Variation in Outcomes and Number of Visits Following Care Guideline Implementation: Part 2 of an Analysis of 12 355 Patients After Total Knee Arthroplasty.

OBJECTIVE: To describe the variation in outcomes and number of visits before and after implementing a care guideline for total knee arthroplasty (TKA) rehabilitation. DESIGN: Nonrandomized intervention study. METHODS: We compared 2558 patients with TKA who received care that was not standardized (non-care guideline [NCG] group) to 9797 patients with TKA who received care according to the care guideline (CG). We fit 2 Bayesian hierarchical linear regression models using the Knee Outcome Survey - Activities of Daily Living (KOS-ADL) change score and number of physical therapy (PT) visits as the response variables, controlling for relevant predictor variables. We also compared the ratio of the standard deviations of the KOS-ADL change scores and the number of PT visits within and between clinics. RESULTS: The overall estimated mean improvement in KOS-ADL change score was 23.0 points (95% confidence interval [CI]: 20.3, 25.7) in the NCG group and 28.7 points (95% CI: 27.5, 29.7) in the CG group; the mean difference was 5.6 (2.7-8.6). Mean KOS-ADL change scores were higher in the CG group than the NCG group in every clinic, although only 8 clinics improved significantly. The number of PT visits did not change meaningfully (NCG: mean, 10.7 [95% CI: 9.9, 11.5]; CG: mean, 10.5 [95% CI: 9.9, 10.9]). Variation in KOS-ADL change score decreased by 4% within clinics (CG-NCG ratio: 0.96 [95% CI: 0.93, 0.99]) and 63% between clinics (CG-NCG ratio: 0.37 [95% CI: 0.21, 0.62]). Variation in number of visits decreased by 7% within clinics (CG-NCG ratio: 0.93 [95% CI: 0.90, 0.96]) and 19% between clinics (CG-NCG ratio: 0.81 [95% CI: 0.39, 1.49]). CONCLUSION: Implementing a care guideline for TKA rehabilitation may improve outcomes and reduce unwarranted variation in practice within clinics and especially between clinics within a large health care system. J Orthop Sports Phys Ther 2023;53(3):151-158. Epub: 12 December 2022. doi:10.2519/jospt.2022.11370.

Improved Outcomes Following a Care Guideline Implementation: Part 1 of an Analysis of 12 355 Patients After Total Knee Arthroplasty.

OBJECTIVE: To describe the application and examine the influence of a continuous quality improvement intervention, which had a goal of standardizing care to reduce the proportion of patients who do not have a meaningful improvement in patient-reported outcomes following total knee arthroplasty (TKA). DESIGN: Continuous quality improvement. METHODS: A physical therapy (PT) care guideline was initiated in 2013 for patients following TKA. The Knee Outcome Survey - Activities of Daily Living (KOS-ADL) was measured at every visit, and scores were extracted from a clinical outcomes database to calculate the proportion of patients who did not achieve a minimal clinically important difference. Based on logistic regression analysis, we compared the proportion of patients who did not progress on the KOS-ADL in a non-care guideline group (2008-2012) to a care guideline (CG) group (2014-2019). RESULTS: This study included 12 355 patients (aged 18-92 years) following TKA incurring at least 3 PT visits from 2008 to 2019. The percentage of patients who did not progress in the non-care guideline group was 25.8% and in the care guideline group 14.3% (P<0.001). The relationship between care guideline adherence and lack of progression on the KOS-ADL was statistically significant, X2 (df = 1) = 148.7, P<.001. CONCLUSION: The percentage of patients who did not achieve meaningful progress on the KOS-ADL declined significantly in the 6 years after implementing a TKA care guideline without an increase in the number of clinical visits. The standardized care guideline was associated with meaningful improvements for patients following TKA when applied in conjunction with PT access to outcome data, feedback through audits, performance goals, and financial incentives. J Orthop Sports Phys Ther 2023;53(3):143-150. Epub: 12 December 2022. doi:10.2519/jospt.2022.11369.

Racial and Ethnic Disparities in the Incidence of High-Impact Chronic Pain Among Primary Care Patients with Acute Low Back Pain: A Cohort Study.

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.

Four Variables Were Sufficient for Low Back Pain: Determining Which Patient-Reported Tools Pain and Disability Improvements.

OBJECTIVE: To predict 30- and 180-day improvements in disability and pain for patients seeking physical therapy care for low back pain (LBP). DESIGN: Longitudinal cohort. METHODS: Baseline assessment was completed by 259 patients with chief complaint of LBP, and the assessment includes psychosocial measures (Keele STarT Back Screening [SBST] and the Optimal Screening for Prediction of Referral and Outcome Yellow Flag [OSPRO-YF] tools), the Optimal Screening for Prediction of Referral and Outcome Review of Symptoms (OSPRO-ROS) and the Review of Symptoms Plus (OSPRO-ROS+) tools, the Charlson Comorbidity Index (CCI), the Area Deprivation Index (ADI), and the National Institute of Health Chronic Pain Criteria (NIH-CP). Using the Modified Low Back Disability Questionnaire (MDQ) and the Numeric Pain Rating Scale (NPRS) as primary outcomes, statistical analysis determined multiple sets of predictor variables with similar model performance. RESULTS: The parsimonious "best model" for prediction of the 180-day MDQ change included 3 predictors (Admit MDQ, NIH-CP, and OSPRO ROS+) because it had the lowest penalized goodness-of-fit statistic (BIC = -35.21) and the highest explained variance (R2 = 0.295). The parsimonious "best model" for 180-day NPRS change included 2 variables (Admit NPRS and OSPRO-ROS+) with the lowest penalized goodness-of-fit statistic (BIC = -18.2) and the highest explained variance (R2 = 0.190). CONCLUSION: There were many model options with similar statistical performance when using established measures to predict MDQ and NPRS outcomes. A potential variable set for a standard predictive model that balances statistical performance with pragmatic considerations included the OSPRO-ROS+, OSPRO-YF, NIH-CP definition, and admit MDQ and NPRS scores. J Orthop Sports Phys Ther 2022;52(10):685-693. Epub: 12 August 2022. doi:10.2519/jospt.2022.11018.

Identifying Perceptions, Experiences, and Recommendations of Telehealth Physical Therapy for Patients With Chronic Low Back Pain: A Mixed Methods Survey.

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.

Outcomes of Telehealth Physical Therapy Provided Using Real-Time, Videoconferencing for Patients With Chronic Low Back Pain: A Longitudinal Observational Study.

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.

Perceptions of Telehealth Physical Therapy Among Patients with Chronic Low Back Pain.

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).

Bio-Fabrication of Human Amniotic Membrane Zinc Oxide Nanoparticles and the Wet/Dry HAM Dressing Membrane for Wound Healing.

The preparation of unique wet and dry wound dressing products derived from unprocessed human amniotic membrane (UP-HAM) is described. The UP-HAM was decellularized, and the constituent proteins were cross-linked and stabilized before being trimmed and packed in sterile Nucril-coated laminated aluminium foil pouches with isopropyl alcohol to manufacture processed wet human amniotic membrane (PW-HAM). The dry type of PD-HAM was prepared by decellularizing the membrane, UV irradiating it, lyophilizing/freeze-drying it, sterilizing it, and storing it at room temperature. The UP-HAM consists of a translucent yellowish mass of flexible membranes with an average thickness of 42 µm. PW-HAM wound dressings that had been processed, decellularized, and dehydrated had a thinner average thickness of 30 µm and lacked nuclear-cellular structures. Following successful decellularization, discrete bundle of fibrous components in the stromal spongy layers, microvilli and reticular ridges were still evident on the surface of the processed HAM, possibly representing the location of the cells that had been removed by the decellularization process. Both wet and dry HAM wound dressings are durable, portable, have a shelf life of 3-5 years, and are available all year. A slice of HAM dressing costs 1.0 US$/cm2. Automation and large-scale HAM membrane preparation, as well as storage and transportation of the dressings, can all help to establish advanced technologies, improve the efficiency of membrane production, and reduce costs. Successful treatment of wounds to the cornea of the eye was achieved with the application of the HAM wound dressings. The HAM protein analysis revealed 360 µg proteins per gram of tissue, divided into three main fractions with MWs of 100 kDa, 70 kDa, and 14 kDa, as well as seven minor proteins, with the 14 kDa protein displaying antibacterial properties against human pathogenic bacteria. A wide range of antibacterial activity was observed after treatment with 75 µg/ml zinc oxide nanoparticles derived from human amniotic membrane proteins (HAMP-ZnO NP), including dose-dependent biofilm inhibition and inhibition of Gram-positive (S. aureus, S. mutans, E. faecalis, and L. fusiformis) and Gram-negative bacteria (S. sonnei, P. aeruginosa, P. vulgaris, and C. freundii).

Predicting Clinical Improvement for Patients With Low Back Pain: Keeping It Simple for Patients Seeking Physical Therapy Care.

OBJECTIVE: This study sought to develop and validate an original prediction formula that estimated the probability of success for patients with low back pain (LBP) to achieve a minimal clinically important difference (MCID) on the Modified Low Back Disability Questionnaire (MDQ). METHODS: Patients were 10 to 90 years old in this retrospective cohort study. Data were extracted from Intermountain Healthcare's registry, Rehabilitation Outcomes Management System: 62,858 patients admitted to physical therapy from 2002 to 2013 formed the training dataset, and 15,128 patients admitted 2015 to 2016 formed the verification dataset. Predicted probability to achieve MCID was compared with the actual percentage who succeeded. Two models were developed: 6-point improvement and 30% improvement. MDQ assessed disability, and numeric pain score assessed pain intensity. Predictive models used restricted cubic splines on age, initial pain, and disability scores for non-linear effects. Sex, symptom duration, and payer type were included as indicator variables. Predicted chance of success was compared with the actual percentage of patients that succeeded. Relative change in R-squared was calculated to assess variable importance in predicting success. Odds ratios for duration of injury and payer were calculated. RESULTS: A positive trend was observed in both models between predicted and actual success achieved. Both "verification" models appear accurate and closely approximate the "training dataset." Baseline MDQ score was the most important factor to predict a 6-point improvement. Payer type and injury duration were important factors to predict 30% improvement. Best odds to achieve an MCID was having a workers compensation insurance payer and seeking care within 14 days. CONCLUSION: The 2 models demonstrated an accurate visualization of the chance of patients achieving significant improvement compared with the usual representation of the average rate of improvement for all patients. IMPACT: Enhancing physical therapists' understanding of the probability of a patient achieving significant clinical improvement can enhance decision-making processes and help physical therapists manage a patient's care more effectively.

The Relationship Between Neighborhood Deprivation and Perceived Changes for Pain-Related Experiences Among US Patients with Chronic Low Back Pain During the COVID-19 Pandemic.

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.

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

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.

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

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.

Physical Therapy Referral From Primary Care for Acute Back Pain With Sciatica : A Randomized Controlled Trial.

BACKGROUND: Few studies have examined primary care management for acute sciatica, including referral to physical therapy. OBJECTIVE: To evaluate whether early referral to physical therapy reduced disability more than usual care (UC) alone for patients with acute sciatica. DESIGN: Randomized controlled clinical trial. (ClinicalTrials.gov: NCT02391350). SETTING: 2 health care systems in Salt Lake City, Utah. PATIENTS: 220 adults aged 18 to 60 years with sciatica of less than 90 days' duration who were making an initial primary care consultation. INTERVENTION: All participants received imaging and medication at the discretion of the primary care provider before enrollment. A total of 110 participants randomly assigned to UC were provided 1 session of education, and 110 participants randomly assigned to early physical therapy (EPT) were provided 1 education session and then referred for 4 weeks of physical therapy, including exercise and manual therapy. MEASUREMENTS: The primary outcome was the Oswestry Disability Index (OSW) score after 6 months. Secondary outcomes were pain intensity, patient-reported treatment success, health care use, and missed workdays. RESULTS: Participants in the EPT group had greater improvement from baseline to 6 months for the primary outcome (relative difference, -5.4 points [95% CI, -9.4 to -1.3 points]; P = 0.009). The OSW and several secondary outcomes favored EPT after 4 weeks. After 1 year, between-group differences favored EPT for the OSW (relative difference, -4.8 points [CI, -8.9 to -0.7 points]) and back pain intensity (relative difference, -1.0 points [CI, -1.6 to -0.4 points]). The EPT group was more likely to self-report treatment success after 1 year (45.2%) than the UC group (27.6%) (relative risk, 1.6 [CI, 1.1 to 2.4]). There were no significant differences in health care use or missed workdays. LIMITATION: The patients and providers were unblinded, and specific physical therapy interventions responsible for effects could not be determined. CONCLUSION: Referral from primary care to physical therapy for recent-onset sciatica improved disability and other outcomes compared with UC. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain.

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).

Using the value-based care paradigm to compare physical therapy access to care models in cervical spine radiculopathy: a case report.

Background: The efficiency and effectiveness of multiple physical therapy care delivery models can be measured using the value-based care paradigm. Entering physical therapy through direct access can decrease health-care utilization and improve patient outcomes. Limited evidence exists which compares direct access physical therapy to referral using the value-based care paradigm specific to cervical spine radiculopathy. Case Description: The patient was a 39-year-old woman who presented to physical therapy through physician referral with the diagnoses of acute cervical radiculopathy. The patient was evaluated, provided guideline adherent treatment and discharged with a home exercise program. Sixteen months from being discharged, the same patient returned through direct access due to an acute onset of cervical spine symptoms and was evaluated and provided treatment that same morning. Outcomes: Direct access physical therapy saved the patient and third-party payer $434.30 and $3264.75 respectively. A 5×'s higher efficiency per visit and a 6.2×'s higher value in reducing disability was demonstrated when the patient accessed physical therapy directly. Physician referral and direct access entry pathways demonstrated neck disability index improvements of 6% and 16%, respectively. Discussion: This case report describes a clinical example of previous research that demonstrates improved cost efficiency, outcomes, and increased value with a patient who presented to physical therapy with cervical radiculopathy through two different access to care models. The results of this case demonstrate a clinical example of the use of the value-based care paradigm in comparing value and efficiency of two access to care models in a patient with cervical radiculopathy without other neurological deficits.

Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial).

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.