Toward the Identification of Distinct Phenotypes: Research Protocol for the Low Back Pain Biological, Biomechanical, and Behavioral (LB3P) Cohort Study and the BACPAC Mechanistic Research Center at the University of Pittsburgh.

As a member of the Back Pain Consortium (BACPAC), the University of Pittsburgh Mechanistic Research Center's research goal is to phenotype chronic low back pain using biological, biomechanical, and behavioral domains using a prospective, observational cohort study. Data will be collected from 1,000 participants with chronic low back pain according to BACPAC-wide harmonized and study-specific protocols. Participation lasts 12 months with one required in person baseline visit, an optional second in person visit for advanced biomechanical assessment, and electronic follow ups at months 1, 2, 3, 4, 5, 6, 9, and 12 to assess low back pain status and response to prescribed treatments. Behavioral data analysis includes a battery of patient-reported outcomes, social determinants of health, quantitative sensory testing, and physical activity. Biological data analysis includes omics generated from blood, saliva, and spine tissue. Biomechanical data analysis includes a physical examination, lumbopelvic kinematics, and intervertebral kinematics. The statistical analysis includes traditional unsupervised machine learning approaches to categorize participants into groups and determine the variables that differentiate patients. Additional analysis includes the creation of a series of decision rules based on baseline measures and treatment pathways as inputs to predict clinical outcomes. The characteristics identified will contribute to future studies to assist clinicians in designing a personalized, optimal treatment approach for each patient.

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.

The Back Pain Consortium (BACPAC) Research Program Data Harmonization: Rationale for Data Elements and Standards.

OBJECTIVE: One aim of the Back Pain Consortium (BACPAC) Research Program is to develop an integrated model of chronic low back pain that is informed by combined data from translational research and clinical trials. We describe efforts to maximize data harmonization and accessibility to facilitate Consortium-wide analyses. METHODS: Consortium-wide working groups established harmonized data elements to be collected in all studies and developed standards for tabular and nontabular data (eg, imaging and omics). The BACPAC Data Portal was developed to facilitate research collaboration across the Consortium. RESULTS: Clinical experts developed the BACPAC Minimum Dataset with required domains and outcome measures to be collected by use of questionnaires across projects. Other nonrequired domain-specific measures are collected by multiple studies. To optimize cross-study analyses, a modified data standard was developed on the basis of the Clinical Data Interchange Standards Consortium Study Data Tabulation Model to harmonize data structures and facilitate integration of baseline characteristics, participant-reported outcomes, chronic low back pain treatments, clinical exam, functional performance, psychosocial characteristics, quantitative sensory testing, imaging, and biomechanical data. Standards to accommodate the unique features of chronic low back pain data were adopted. Research units submit standardized study data to the BACPAC Data Portal, developed as a secure cloud-based central data repository and computing infrastructure for researchers to access and conduct analyses on data collected by or acquired for BACPAC. CONCLUSIONS: BACPAC harmonization efforts and data standards serve as an innovative model for data integration that could be used as a framework for other consortia with multiple, decentralized research programs.

Effect of Short versus Long Duration Naps on Blood Pressure during Simulated Night Shift Work: A Randomized Crossover Trial.

OBJECTIVE: Blunting of the sleep-related dip in blood pressure (BP) has been linked to numerous cardiovascular outcomes including myocardial infarction. Blunting of BP dipping occurs during night shift work and previous research suggest that a 60-min or longer on-shift nap is needed to restore normal/healthy BP dipping. We sought to determine the effect of different durations of napping on BP during and following simulated night shifts. We hypothesized that the greatest benefit in terms of restoration of normal BP dipping during night shift work would be observed during a longer duration nap versus a shorter nap opportunity. METHODS: We used a randomized crossover laboratory-based study design. Participants consented to complete three separate 72-hr conditions that included a 12-hr simulated night shift. Nap conditions included a 30-min and 2-hr nap compared to a no-nap condition. Ambulatory BP monitoring was assessed hourly and every 10-30 mins during in-lab naps. Blunted BP dipping during in-lab naps was the primary outcome. Goal enrollment of 25 (35 with attrition) provided 80% power to detect a mean difference of 5 mmHg in BP between nap conditions. RESULTS: Of the 58 screened, 28 were consented, and 26 completed all three 72-hr conditions. More than half (53.6%) were female. Mean age was 24.4 years (SD7.2). Most (85.7%) were certified as emergency medical technicians or paramedics. The mean percentage dip in systolic BP (SBP) and diastolic BP (DBP) did not differ between the 30-min and 2-hr nap conditions (p > 0.05), yet a greater proportion of participants experienced a 10-20% dip in SBP or DBP during the 2-hr nap versus the 30-min nap (p < 0.05). For every additional minute of total sleep during the 30-min nap, the percentage of SBP dip improved by 0.60%, and the percentage of DBP dip improved by 0.68% (p < 0.05). These improvements approximate to a 6% per minute relative advancement toward normal/healthy BP dipping. CONCLUSIONS: Restoration of a normal/healthy dip in BP is achievable during short and long duration nap opportunities during simulated night shift work. Our findings support the hypothesis that BP dipping is more common during longer 2-hr versus shorter 30-min naps. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04469803. Registered on 9 July 2020.

Are Short Duration Naps Better than Long Duration Naps for Mitigating Sleep Inertia? Brief Report of a Randomized Crossover Trial of Simulated Night Shift Work.

OBJECTIVE: We sought to test the effects of different duration naps on post-nap cognitive performance during simulated night shifts. METHODS: We used a randomized laboratory-based crossover trial design with simulated 12-hr night shifts and each participant completing three conditions of 72 hrs each (Clinicaltrials.gov; registration # NCT04469803). The three conditions tested included no-nap, a 30-min nap opportunity, and a 2-hr nap opportunity. Naps occurred at 02:00 hrs. Cognitive performance was assessed with the Brief 3-min Psychomotor Vigilance Test (PVT-B). Four PVT-B measures include: reaction time (RT in milliseconds (ms)), lapses (RT > 355 ms), false starts (reactions before stimulus or RT <100 ms), and speed (1,000/RT). The PVT-B was performed at the start of the simulated night shift (19:00), end of shift (07:00), pre-nap (02:00), and at 0 mins, 10 mins, 20 mins, and 30 mins following the 30-min and 2-hr nap conditions. Simultaneously, participants reported subjective ratings of fatigue and other constructs. RESULTS: Twenty-eight (15 female), mostly certified emergency medical technicians or paramedics, consented to participate. For all three conditions, looking within condition, PVT-B lapse performance at the end of the 12-hr simulated night shift (at 07:00) was poorer compared to shift start (p < 0.05). Performance on PVT-B speed, RT, and false starts were poorer at shift end than shift start for the no-nap and 30-min nap conditions (p < 0.05), but not for the 2-hr nap condition (p > 0.05). Compared to pre-nap measures, performance on the PVT-B assessed at 0 mins post-nap showed significant performance declines for lapses and speed for both the 30-min and 2-hr nap conditions (p < 0.05), but not at 10, 20, or 30 mins post-nap. After waking from the 2-hr on-shift nap opportunity (at 0 mins), participants rated sleepiness, difficulty with concentration, and alertness poorer than pre-nap (p < 0.05). Participants in the 30-min nap condition rated alertness poorer immediately after the nap (at 0 mins) compared to pre-nap (p < 0.05). CONCLUSIONS: While sleep inertia was detectable immediately following short 30-min and long 2-hr nap opportunities during simulated night shift work, deficits in cognitive performance and subjective ratings quickly dissipated and were not detectable at 10-30 mins post-nap.

Individual participant data (IPD)-level meta-analysis of randomised controlled trials to estimate the vitamin D dietary requirements in dark-skinned individuals resident at high latitude.

CONTEXT AND PURPOSE: There is an urgent need to develop vitamin D dietary recommendations for dark-skinned populations resident at high latitude. Using data from randomised controlled trials (RCTs) with vitamin D3-supplements/fortified foods, we undertook an individual participant data-level meta-regression (IPD) analysis of the response of wintertime serum 25-hydroxyvitamin (25(OH)D) to total vitamin D intake among dark-skinned children and adults residing at ≥ 40° N and derived dietary requirement values for vitamin D. METHODS: IPD analysis using data from 677 dark-skinned participants (of Black or South Asian descent; ages 5-86 years) in 10 RCTs with vitamin D supplements/fortified foods identified via a systematic review and predefined eligibility criteria. Outcome measures were vitamin D intake estimates across a range of 25(OH)D thresholds. RESULTS: To maintain serum 25(OH)D concentrations ≥ 25 and 30 nmol/L in 97.5% of individuals, 23.9 and 27.3 µg/day of vitamin D, respectively, were required among South Asian and 24.1 and 33.2 µg/day, respectively, among Black participants. Overall, our age-stratified intake estimates did not exceed age-specific Tolerable Upper Intake Levels for vitamin D. The vitamin D intake required by dark-skinned individuals to maintain 97.5% of winter 25(OH)D concentrations ≥ 50 nmol/L was 66.8 µg/day. This intake predicted that the upper 2.5% of individuals could potentially achieve serum 25(OH)D concentrations ≥ 158 nmol/L, which has been linked to potential adverse effects in older adults in supplementation studies. CONCLUSIONS: Our IPD-derived vitamin D intakes required to maintain 97.5% of winter 25(OH)D concentrations ≥ 25, 30 and 50 nmol/L are substantially higher than the equivalent estimates for White individuals. These requirement estimates are also higher than those currently recommended internationally by several agencies, which are based predominantly on data from Whites and derived from standard meta-regression based on aggregate data. Much more work is needed in dark-skinned populations both in the dose-response relationship and risk characterisation for health outcomes. TRAIL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews (Registration Number: CRD42018097260).

Implementation of Coach McLungsSM into primary care using a cluster randomized stepped wedge trial design.

BACKGROUND: Asthma is a prevalent chronic disease that is difficult to manage and associated with marked disparities in outcomes. One promising approach to addressing disparities is shared decision making (SDM), a method by which the patient and provider cooperatively make a decision about asthma care. SDM is associated with improved outcomes for patients; however, time constraints and staff availability are noted implementation barriers. Use of health information technology (IT) solutions may facilitate the utilization of SDM. Coach McLungsSM is a collaborative web-based application that involves pediatric patients, their caregivers, and providers in a personalized experience while gathering patient-reported data. Background logic provides decision support so both audiences can develop a well-informed treatment plan together. The goal of this study is to evaluate the implementation of the Coach McLungsSM intervention into primary care. METHODS: Implementation will be evaluated using a stepped wedge randomized control study design at 21 pediatric and family medicine practices within a large, integrated, nonprofit healthcare system. We will measure changes in emergency department visits, hospitalizations, and oral steroid use, which serve as surrogate measures for patient-centered asthma outcomes. We will use a generalized linear mixed models with logit link to test the hypothesis for the reduction in exacerbation rates specifying the fixed effects of intervention and time and random effects for practice and practice*time. This design achieves 84% power to detect the hypothesized effect size difference of 10% in overall exacerbation between control (40%) and intervention (30%) periods (two-sided, p = 0.05). Implementation will be guided using the Expert Recommendations for Implementing Change (ERIC), a compilation of implementation strategies, and evaluated using the CFIR (Consolidated Framework for Implementation Research) and RE-AIM (Reach Effectiveness, Adoption, Implementation, Maintenance). DISCUSSION: We anticipate that a tailored implementation of Coach McLungsSM across diverse primary care practices will lead to a decrease in emergency department visits, hospitalizations, and oral steroid use for patients in the intervention group as compared to the control condition. TRIAL REGISTRATION: Clincaltrials.gov, NCT05059210. Registered 28 September 2021, https://www. CLINICALTRIALS: gov/ct2/show/NCT05059210.

Anatomic single vs. double-bundle ACL reconstruction: a randomized clinical trial-Part 1: clinical outcomes.

PURPOSE: Compare clinical outcomes of anatomic single-bundle (SB) to anatomic double-bundle (DB) anterior cruciate ligament reconstruction (ACLR). It was hypothesized that anatomic DB ACLR would result in better International Knee Documentation Committee Subjective Knee Form (IKDC-SKF) scores and reduced anterior and rotatory laxity compared to SB ACLR. METHODS: Active individuals between 14 and 50 years of age that presented within 12 months of injury were eligible to participate. Individuals with prior injury or surgery of either knee, greater than a grade 1 concomitant knee ligament injury, or ACL insertion sites less than 14 mm or greater than 18 mm were excluded. Subjects were randomized to undergo SB or DB ACLR with a 10 mm-wide quadriceps tendon autograft harvested with a patellar bone block and were followed for 24 months. The primary outcome measures included the IKDC-SKF and KT-1000 (side to side difference) and pivot shift tests. Other secondary outcomes included measures of sports activity and participation, range of motion (ROM) and re-injury. RESULTS: Enrollment in the study was suspended due to patellar fractures related to harvest of the patellar bone plug. At that time, 57 subjects had been randomized (29 DB) and two-year follow-up was attained from 51 (89.5%). At 24-month follow-up there were no between-group differences detected for the primary outcomes. Twenty-one (77.8%) DB's and 20 (83.3%) SB's reported returning to pre-injury sports 2 years after surgery (n.s) Three subjects (2 DB's, 5.3% of total) sustained a graft rupture and 5 individuals (4 SB's, 8.8% of total) had a subsequent meniscus injury. CONCLUSIONS: Due to the early termination of the study, there were no detectable differences in clinical outcome between anatomic SB and DB ACLR when performed with a quadriceps tendon autograft with a bone block in individuals with ACL insertion sites that range from 14 to 18 mm. LEVEL OF EVIDENCE: Level 2.

Resolving the Burden of Low Back Pain in Military Service Members and Veterans (RESOLVE): Protocol for a Multisite Pragmatic Clinical Trial.

BACKGROUND: Physical therapy (PT) is frequently used for the management of low back pain (LBP) within the US Departments of Defense (DOD) and Veterans Affairs (VA). However, variations in PT practice patterns and use of ineffective interventions lower the quality and increase the cost of care. Although adherence to the clinical practice guidelines (CPGs) can improve the outcomes and cost-effectiveness of LBP care, PT CPG adherence remains below 50%. The Resolving the Burden of Low Back Pain in Military Service Members and Veterans (RESOLVE) trial will evaluate the effectiveness of an active PT CPG implementation strategy using an education, audit, and feedback model for reducing pain, disability, medication use, and cost of LBP care within the DOD and VA health care systems. DESIGN: The RESOLVE trial will include 3,300 to 7,260 patients with LBP across three DOD and two VA medical facilities using a stepped-wedge study design. An education, audit, and feedback model will be used to encourage physical therapists to better adhere to the PT CPG recommendations. The Oswestry Disability Index and the Defense and Veterans Pain Rating Scale will be used as primary outcomes. Secondary outcomes will include the LBP-related medication use, medical resource utilization, and biopsychosocial predictors of outcomes. Statistical analyses will be based on the intention-to-treat principle and will use linear mixed models to compare treatment conditions and examine the interactions between treatment and subgrouping status (e.g., limb loss). SUMMARY: The RESOLVE trial will provide a pragmatic approach to evaluate whether better adherence to PT CPGs can reduce pain, disability, medication use, and LBP care cost within the DOD and VA health care systems.

Validity and Responsiveness of Floor Sitting-Rising Test in Post-Total Knee Arthroplasty: A Cohort Study.

OBJECTIVES: To assess the construct validity and responsiveness of the floor sitting-rising test (SRT) in individuals with total knee arthroplasty (TKA). DESIGN: Cohort study with 6-month follow-up. Secondary analysis using data from a randomized controlled trial. SETTING: An outpatient rehabilitation research center. PARTICIPANTS: Participants (N=240) enrolled in the parent study who had unilateral primary TKA. INTERVENTION: Participants in the parent study underwent 12 weeks of exercise programs. MAIN OUTCOME MEASURES: Validity analysis correlated baseline data of participants who completed the SRT and measures of knee motion, muscle strength, performance-based tests, and patient-reported outcomes of physical and psychosocial function. Responsiveness analysis used the 3- and 6-month follow-up data. Effect sizes were calculated using changes from baseline. Areas under the receiving operating characteristics curve were calculated using a global rating of change as the external anchor. RESULTS: Of the 240 participants (148 women; age, 70±7y), 180 (75%) were able to perform the SRT at baseline. Performers scored significantly better in all physical function tests (P<.0001) than nonperformers. SRT scores generally converged with measures of knee impairment and performance-based tests (associations ranged from small [r=0.15; P=.0516] to moderate [r=0.52; P<.0001]). SRT scores associated with self-efficacy for function (r=0.34; P<.0001) and fear of falls (r=-0.25; P=.001). At 3 (n=174) and 6 months (n=160), SRT effect sizes were 0.38 (95% confidence interval, 0.25-0.52) and 0.42 (95% confidence interval, 0.25-0.60), and areas under the curve were 0.59 (95% confidence interval, 0.49-0.69) and 0.62 (95% confidence interval, 0.52-0.73), respectively. CONCLUSIONS: The results add evidence to the validity of the SRT in patients after TKA. The strength of the associations suggests that the SRT measures a physical function construct not captured by the other tests. The magnitude of indices of responsiveness for the SRT were similar to other performance-based tests, indicating comparable responsiveness to more widespread tests of functional performance.

Six-Minute Walk Test as a Measure of Walking Capacity in Ambulatory Individuals With Amyotrophic Lateral Sclerosis.

OBJECTIVE: To determine the validity of the 6-minute walk test (6MWT) as an outcome measure to evaluate walking capacity in ambulatory patients with amyotrophic lateral sclerosis (ALS). DESIGN: Observational study. SETTING: Multidisciplinary ALS clinic at an academic medical center. PARTICIPANTS: Patients with ALS (N=186) who ambulate without (stage I) or with (stage II) an assistive device. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Walking distance obtained from the 6MWT. RESULTS: Participants performed the 6MWT, 25-foot walk test (25FWT), Timed Up and Go (TUG) test, lower extremity maximum voluntary isometric contraction (MVIC), ALS Functional Rating Scale-Revised (ALSFRS-R), and forced vital capacity (FVC). Walking capacity was reduced to 66% predicted of healthy subjects (75.2%±22% in stage I; 42.6%±22% in stage II). The 6MWT correlated with all other outcome measures in ambulatory patients with ALS (25FWT: r=-.74, P≤.0001; TUG test: r=-.80, P≤.0001; MVIC: r=.64, P≤.0001; percent predicted FVC: r=.25, P≤.0007; ALSFRS-R: r=.52, P≤.0001; ALSFRS-R gross motor subscore: r=.71, P≤.0001). When ambulatory patients with ALS were stratified by stage of ambulation, the 6MWT was associated with all other outcome measures in stage I (25FWT: r=-.56, P≤.0001; TUG test: r=-.66, P≤.0001; MVIC: r=.51, P≤.0001; percent predicted FVC: r=.40, P≤.02; ALSFRS-R: r=.52, P≤.0001; ALSFRS-R gross motor subscore: r=.61, P≤.0001). In stage II, the 6MWT correlated with the 25FWT (r=-.83, P≤.0001), TUG test (r=-.77, P≤.0001), MVIC (r=.47, P≤.0001), and ALSFRS gross motor subscore (r=.61, P≤.0001), but not with percent predicted FVC (r=.09, P≤.513) or ALSFRS-R (r=.21, P≤.141). CONCLUSIONS: The 6MWT is a valid measure of walking capacity of ambulatory patients with ALS that is associated with measures of lower extremity muscle strength and function in both stages of ambulation. The discordance between the 6MWT with the ALSFRS-R and percent predicted FVC in stage II ambulatory patients with ALS indicates that the 6MWT is an independent measure of ambulatory function in both stages of ambulation. The 6MWT may provide a quantitative, simple, and inexpensive outcome measure of walking capacity for early stage clinical trials in ambulatory patients with ALS.

The effect of a night shift nap on post-night shift performance, sleepiness, mood, and first recovery sleep: A randomized crossover trial.

OBJECTIVES: This study aimed to test the effect of a 30-minute nap versus a 2-hour nap opportunity taken during a simulated night shift on performance, fatigue, sleepiness, mood, and sleep at the end of shift and during post-night shift recovery. METHODS: We conducted a randomized crossover trial of three nap conditions (30-minute, 2-hour, and no-nap) during 12-hour simulated night shifts. We tested for differences in performance, fatigue, sleepiness, mood, and sleep during in-lab and at-home recovery. Performance was measured with the Brief Psychomotor Vigilance Test (PVT-B). Subjective ratings were assessed with single-item surveys. RESULTS: Twenty-eight individuals consented to participate [mean age 24.4 (standard deviation 7.2) years; 53.6% female; 85.7% Emergency Medical Services clinicians]. PVT-B false starts at the end of the 12-hour night shift (at 07:00 hours) and at the start of in-lab recovery (08:00 hours) were lower following the 2-hour nap versus other conditions (P<0.05). PVT-B response time at +0 minutes post-recovery nap was poorer compared to pre-recovery nap for the no-nap condition (P=0.003), yet not detected for other nap conditions (P>0.05). Sleepiness, fatigue, and some mood states were lower at most hourly assessments during the in-lab recovery period following the 2-hour nap condition compared to the other conditions. Sleep during recovery did not differ by duration of night shift nap. CONCLUSIONS: A 2-hour nap opportunity versus a 30-minute or no-nap opportunity is beneficial for performance, alertness, and mood post-night shift. No differences were detected in sleep during recovery.

The Influence of Active, Passive, and Manual Therapy Interventions on Escalation of Health Care Events After Physical Therapist Care in Veterans With Low Back Pain.

OBJECTIVE: The objective of this study was to examine the associations between active, passive, and manual therapy interventions with the escalation-of-care events following physical therapist care for veterans with low back pain (LBP). METHODS: A retrospective cohort study was conducted in 3618 veterans who received physical therapist care for LBP between January 1, 2015 and January 1, 2018. The VA Corporate Data Warehouse was utilized to identify LBP-related physical therapist visits and procedures, as well as opioid prescription and non-physical therapy clinic encounters. The association between physical therapist interventions with 1-year escalation-of-care events were assessed using adjusted odds ratios from logistic regression. RESULTS: Nearly all veterans (98%) received active interventions but only a minority (31%) received manual therapy. In the 1-year follow-up period, the odds of receiving an opioid prescription were 30% lower for those who received manual therapy in addition to active interventions, as compared with patients who received only active interventions. Moreover, the odds of receiving primary care, specialty care, and diagnostic testing were 30-130% higher for patients who received electrical stimulation or more than 1 passive intervention in addition to active treatments, as compared with patients who received only active interventions. CONCLUSION: The use of manual therapy along with active interventions was associated with reduced prescription of opioids, while utilization of specific passive interventions such as electrical stimulation or multiple modalities in conjunction with active interventions resulted in increased escalation-of-care events. IMPACT STATEMENT: The use of active interventions, which is supported by most Clinical Practice Guidelines (CPGs), was the cornerstone of physical therapist care for veterans with LBP. However, the use of CPG-recommended manual therapy interventions was low but associated with reduced opioid prescriptions. The use of 2 or more different passive interventions along with active interventions was common (34%) and associated with less-than-optimal escalation-of-care outcomes.

Hip-focused physical therapy versus spine-focused physical therapy for older adults with chronic low back pain at risk for mobility decline (MASH): a multicentre, single-masked, randomised controlled trial.

BACKGROUND: Previously, we identified a population of older adults with chronic low back pain, hip pain, and hip muscle weakness who had worse 12-month low back pain and functional outcomes than age-matched adults with only low back pain, indicating an increased risk for future mobility decline. We sought to determine whether tailored, hip-focused physical therapy reduced pain and functional limitations in this high-risk population compared with non-tailored, spine-focused physical therapy. METHODS: We did a multicentre, single-masked, randomised controlled trial at three research-based sites in the USA. We recruited older adults (aged 60-85 years) with hip pain and weakness who reported moderate low back pain intensity at least half the days in the last 6 months. Patients were randomly assigned to hip-focused physical therapy or spine-focused physical therapy using permuted blocks with random block size, stratified by site and sex (ie, male or female). The primary outcomes were self-reported disability using the Quebec Back Pain Disability Scale (QBPDS) and performance-based 10-Meter Walk Test (10MWT) at 8 weeks. All analyses were done in the intention-to-treat population. Adverse events were collected by study staff via a possible adverse event reporting form and then adjudicated by site investigators. This trial was registered with ClinicalTrials.gov, NCT04009837. FINDINGS: Between Nov 1, 2019, and April 30, 2022, 184 participants were randomly assigned to receive hip-focused (n=91) or spine-focused physical therapy (n=93) interventions. The mean age was 70·7 (SD 6·2) years. 121 (66%) of 184 participants were women, 63 (34%) were men, and 149 (81%) were White. At 8 weeks, the mean between-group difference on the QBPDS was 4·0 (95% CI 0·5 to 7·5), favouring hip-focused physical therapy. Both groups had similar, clinically meaningful gait speed improvements (10MWT) at 8 weeks (mean difference 0·004 m/s [95% CI -0·044 to 0·052]). No serious adverse events were related to study participation. INTERPRETATION: Tailored hip-focused physical therapy demonstrated greater improvements in low back pain-related disability at 8 weeks. However, both hip-focused physical therapy and spine-focused physical therapy produced clinically meaningful improvements in disability and function for this high-risk population at 6 months. These findings warrant further investigation before clinical implementation. FUNDING: US National Institute on Aging of the National Institutes of Health.

Referral to Community-Based Rehabilitation Following Acute Stroke: Findings From the COMPASS Pragmatic Trial.

BACKGROUND: Few studies on care transitions following acute stroke have evaluated whether referral to community-based rehabilitation occurred as part of discharge planning. Our objectives were to describe the extent to which patients discharged home were referred to community-based rehabilitation and identify the patient, hospital, and community-level predictors of referral. METHODS: We examined data from 40 North Carolina hospitals that participated in the COMPASS (Comprehensive Post-Acute Stroke Services) cluster-randomized trial. Participants included adults discharged home following stroke or transient ischemic attack (N=10 702). In this observational analysis, COMPASS data were supplemented with hospital-level and county-level data from various sources. The primary outcome was referral to community-based rehabilitation (physical, occupational, or speech therapy) at discharge. Predictor variables included patient (demographic, stroke-related, medical history), hospital (structure, process), and community (therapist supply) measures. We used generalized linear mixed models with a hospital random effect and hierarchical backward model selection procedures to identify predictors of therapy referral. RESULTS: Approximately, one-third (36%) of stroke survivors (mean age, 66.8 [SD, 14.0] years; 49% female, 72% White race) were referred to community-based rehabilitation. Rates of referral to physical, occupational, and speech therapists were 31%, 18%, and 10%, respectively. Referral rates by hospital ranged from 3% to 78% with a median of 35%. Patient-level predictors included higher stroke severity, presence of medical comorbidities, and older age. Female sex (odds ratio, 1.24 [95% CI, 1.12-1.38]), non-White race (2.20 [2.01-2.44]), and having Medicare insurance (1.12 [1.02-1.23]) were also predictors of referral. Referral was higher for patients living in counties with greater physical therapist supply. Much of the variation in referral across hospitals remained unexplained. CONCLUSIONS: One-third of stroke survivors were referred to community-based rehabilitation. Patient-level factors predominated as predictors. Variation across hospitals was notable and presents an opportunity for further evaluation and possible targets for improved poststroke rehabilitative care. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.

A Cluster Analysis of Initial Primary Care Orders for Patients with Acute Low Back Pain.

PURPOSE: Primary care physicians (PCPs) often face a complex intersection of patient expectations, evidence, and policy that influences their care recommendations for acute low back pain (aLBP). The purpose of this study was to elucidate patterns of PCP orders for patients with aLBP, identify the most common patterns, and describe patient clinical and demographic characteristics associated with patterns of aLBP care. METHODS: This prospective cohort study included 9574 aLBP patients presenting to 1 of 77 primary care practices in 4 geographic locations in the United States. We performed a cluster analysis of PCP orders extracted from electronic health records within the first 21 days of an initial visit for aLBP. RESULTS: 1401 (15%) patients did not receive a PCP order related to back pain within the first 21 days of their initial visit. These patients predominantly had aLBP without leg pain, less back-related disability, and were at low-risk for persistent disability. Of the remaining 8146 patients, we found 4 distinct order patterns: combined nonpharmacologic and first-line medication (44%); second-line medication (39%); imaging (10%); and specialty referral (7%). Among all patients, 29% received solely 1 order from their PCP. PCPs more often combined different guideline concordant and discordant orders. Patients with higher self-reported disability and psychological distress were more likely to receive guideline discordant care. CONCLUSION: Guideline discordant orders such as steroids and NSAIDS are often combined with guideline recommended orders such as physical therapy. Further defining patient, clinician, and health care setting characteristics associated with discordant care would inform targeted efforts for deimplementation initiatives.

Chronotropic Incompetence During Exercise Testing as a Marker of Autonomic Dysfunction in Individuals with Early Parkinson's Disease.

BACKGROUND: An attenuated heart rate response to exercise, termed chronotropic incompetence, has been reported in Parkinson's disease (PD). Chronotropic incompetence may be a marker of autonomic dysfunction and a cause of exercise intolerance in early stages of PD. OBJECTIVE: To investigate the relationship between chronotropic incompetence, orthostatic blood pressure change (supine - standing), and exercise performance (maximal oxygen consumption, VO2peak) in individuals with early PD within 5 years of diagnosis not on dopaminergic medications. METHODS: We performed secondary analyses of heart rate and blood pressure data from the Study in Parkinson's Disease of Exercise (SPARX). RESULTS: 128 individuals were enrolled into SPARX (63.7±9.3 years; 57.0% male, 0.4 years since diagnosis [median]). 103 individuals were not taking chronotropic medications, of which 90 had a normal maximal heart rate response to exercise testing (155.3±14.0 bpm; PDnon-chrono) and 13 showed evidence of chronotropic incompetence (121.3±11.3 bpm; PDchrono, p < 0.05). PDchrono had decreased VO2peak compared to PDnon-chrono (19.7±4.5 mL/kg/min and 24.3±5.8 mL/kg/min, respectively, p = 0.027). There was a positive correlation between peak heart rate during exercise and the change in systolic blood pressure from supine to standing (r = 0.365, p < 0.001). CONCLUSIONS: A subgroup of individuals with early PD not on dopaminergic medication had chronotropic incompetence and decreased VO2peak, which may be related to autonomic dysfunction. Evaluation of both heart rate responses to incremental exercise and orthostatic vital signs may serve as biomarkers of early autonomic impairment and guide treatment. Further studies should investigate whether cardiovascular autonomic dysfunction affects the ability to exercise and whether exercise training improves autonomic dysfunction.

Remote ischaemic conditioning combined with bimanual task training to enhance bimanual skill learning and corticospinal excitability in children with unilateral cerebral palsy: a study protocol of a single centre, phase II randomised controlled trial.

INTRODUCTION: Children with unilateral cerebral palsy (UCP) have difficulty in bimanual coordination that restricts the child's independence in daily activities. Although several efficacious interventions to improve bimanual coordination exist, these interventions often require higher training doses and have modest effect sizes. Thus, there is a critical need to find an effective priming agent that, when paired with task-specific training, will facilitate neurobiological processes to enhance the magnitude of training effects and subsequently improve functional capabilities of children with UCP. The aim of this study is to determine the effects of a novel priming agent, remote ischaemic conditioning (RIC), combined with bimanual training on bimanual skill learning and corticospinal excitability in children with UCP. METHODS AND ANALYSES: 46 children, aged 8-16 years, will be randomly assigned to receive RIC or sham conditioning combined with 5 days of bimanual skill (cup stacking) training (15 trials per session). RIC or sham conditioning will be performed with a standard conditioning protocol of five cycles of alternative inflation and deflation of a pressure cuff on the affected arm with the pressure of at least 20 mm Hg above systolic blood pressure for RIC and 25 mm Hg for sham conditioning. Primary outcomes will be movement time and corticospinal excitability measures determined with a single-pulse transcranial magnetic stimulation (TMS). Secondary outcomes include Assisting Hand Assessment, spatio-temporal kinematic variables and paired pulse TMS measures. All measures will be conducted before and immediately after the intervention. A mixed model analysis of variance will test the group×time interaction for all outcomes with group (RIC and sham) as between-subject and time (preintervention, postintervention) as within-subject factors. ETHICS AND DISSEMINATION: The study has been approved by the University Medical Centre Institutional Review Board (UMCIRB #21-001913). We will disseminate the study findings via peer-reviewed publications and presentations at professional conferences. TRIAL REGISTRATION NUMBER: NCT05777070.

Bimanual Movement Characteristics and Real-World Performance Following Hand-Arm Bimanual Intensive Therapy in Children with Unilateral Cerebral Palsy.

The purpose of this study was to quantify characteristics of bimanual movement intensity during 30 h of hand-arm bimanual intensive therapy (HABIT) and bimanual performance (activities and participation) in real-world settings using accelerometers in children with unilateral cerebral palsy (UCP). Twenty-five children with UCP participated in a 30 h HABIT program. Data were collected from bilateral wrist-worn accelerometers during 30 h of HABIT to quantify the movement intensity and three days pre- and post-HABIT to assess real-world performance gains. Movement intensity and performance gains were measured using six standard accelerometer-derived variables. Bimanual capacity (body function and activities) was assessed using standardized hand function tests. We found that accelerometer variables increased significantly during HABIT, indicating increased bimanual symmetry and intensity. Post-HABIT, children demonstrated significant improvements in all accelerometer metrics, reflecting real-world performance gains. Children also achieved significant and clinically relevant changes in hand capacity following HABIT. Therefore, our findings suggest that accelerometers can objectively quantify bimanual movement intensity during HABIT. Moreover, HABIT enhances hand function as well as activities and participation in real-world situations in children with UCP.