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.

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.

Digital technology for delivering and monitoring exercise programs for people with cystic fibrosis.

BACKGROUND: Although exercise is recommended as part of the cystic fibrosis (CF) therapeutic routine, adherence to exercise is still limited. Digital health technologies can provide easy-to-access health information and may help improve healthcare and outcomes in individuals with long-term conditions. However, its effects for delivering and monitoring exercise programs in CF have not yet been synthesized. OBJECTIVES: To evaluate the benefits and harms of digital health technologies for delivering and monitoring exercise programs, increasing adherence to exercise regimens, and improving key clinical outcomes in people with CF. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 21 November 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) or quasi-RCTs of digital health technologies for delivering or monitoring exercise programs in CF. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. physical activity, 2. self-management behavior, and 3. pulmonary exacerbations. Our secondary outcomes were 4. usability of technologies, 5. quality of life, 6. lung function, 7. muscle strength, 8. exercise capacity, 9. physiologic parameters, and 10. ADVERSE EVENTS: We used GRADE to assess certainty of evidence. MAIN RESULTS: We identified four parallel RCTs (three single-center and one multicenter with 231 participants aged six years or older). The RCTs evaluated different modes of digital health technologies with distinct purposes, combined with diverse interventions. We identified important methodologic concerns in the RCTs, including insufficient information on the randomization process, blinding of outcome assessors, balance of non-protocol interventions across groups, and whether the analyses performed corrected for bias due to missing outcome data. Non-reporting of results may also be a concern, especially because some planned outcome results were reported incompletely. Furthermore, each trial had a small number of participants, resulting in imprecise effects. These limitations on the risk of bias, and on the precision of effect estimates resulted in overall low- to very low-certainty evidence. We undertook four comparisons and present the findings for our primary outcomes below. There is no information on the effectiveness of other modes of digital health technologies for monitoring physical activity or delivering exercise programs in people with CF, on adverse events related to the use of digital health technologies either for delivering or monitoring exercise programs in CF, and on their long-term effects (more than one year). Digital health technologies for monitoring physical activity Wearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone One trial (40 adults with CF) evaluated this outcome, but did not report data for any of our primary outcomes. Wearable fitness tracker plus text message for personalized feedback and goal setting compared to wearable fitness tracker alone The evidence is very uncertain about the effects of a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to wearable technology alone on physical activity measured by step count at six-month follow-up (mean difference [MD] 675.00 steps, 95% confidence interval [CI] -2406.37 to 3756.37; 1 trial, 32 participants). The same study measured pulmonary exacerbation rates and reported finding no difference between groups. Web-based application to record, monitor, and set goals on physical activity plus usual care compared to usual care alone Using a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference on time spent in moderate-to-vigorous physical activity measured via accelerometry compared to usual care alone at six-month follow-up (MD -4 minutes/day, 95% CI -37 to 29; 1 trial, 63 participants). Low certainty-evidence from the same trial suggests that the intervention may result in little to no difference on pulmonary exacerbations during 12 months of follow-up (median 1 respiratory hospitalization, interquartile range [IQR] 0 to 3) versus control (median 1 respiratory hospitalization, IQR 0 to 2; P = 0.6). Digital health technologies for delivering exercise programs Web-based versus face-to-face exercise delivery The evidence is very uncertain about the effects of web-based compared to face-to-face exercise delivery on adherence to physical activity as assessed by the number of participants who completed all exercise sessions after three months of intervention (risk ratio 0.92, 95% CI 0.69 to 1.23; 1 trial, 51 participants). AUTHORS' CONCLUSIONS: The evidence is very uncertain about the effects of an exercise program plus the use of a wearable fitness tracker integrated with a social media platform compared with exercise prescription alone and on the effects of receiving a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to a wearable fitness tracker alone. Low-certainty evidence suggests that using a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference in time spent in moderate-to-vigorous physical activity, total time spent in activity, pulmonary exacerbations, quality of life, lung function, and exercise capacity compared to usual care alone. Regarding the use of digital health technologies for delivering exercise programs in CF, the evidence is very uncertain about the effects of using a wearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone. Further high-quality RCTs, with blinded outcome assessors, reporting the effects of digital health technologies on clinically important outcome measures, such as physical activity participation and intensity, self-management behavior, and the occurrence of pulmonary exacerbations in the long term are needed. The results of six ongoing RCTs identified through our searches may help clarify the effects of different modes of digital health technologies for delivering and monitoring exercise programs in people with CF.

Day-One Pain Reductions After Hip and Knee Replacement When Buprenorphine-Clonidine-Dexamethasone Is Added to Bupivacaine Nerve/Plexus Blocks: A Randomized Clinical Trial.

OBJECTIVE: To compare pain outcome reports of patients undergoing hip or knee replacement who received single-injection nerve/plexus blocks with plain bupivacaine (BPV) with those of patients who received injections of buprenorphine-clonidine-dexamethasone (BCD) admixed with BPV. DESIGN: Prospective, parallel-arm, randomized, double-blind trial. SETTING: A single veterans' hospital. SUBJECTS: Ninety-eight veterans scheduled for total hip or knee replacement surgery with spinal as the primary anesthetic. METHODS: Participants were randomized to BPV-BCD or plain BPV groups. They underwent nerve/plexus blocks in the L2-L4 and L4-S3 distributions in advance of joint replacement surgery. The primary outcome was change in pain from baseline during the postoperative day, as assessed by the total pain score on the short-form McGill Pain Questionnaire-v2 (SF-MPQ-2). Secondary outcomes were pain during movement, pain interference, range of motion, mobility, and quality of recovery. RESULTS: On postoperative day one, the SF-MPQ-2 total score for the BPV-BCD group demonstrated greater pain reduction than that of the plain BPV group (mean difference 1.8 points, 95% confidence interval 0.6 to 3.0, P = 0.003). The BPV-BCD group also had larger reductions in pain during movement in the surgical joint and less pain interference, along with increased range of hip and knee flexion, compared with the plain BPV group. Outcomes of mobility and quality of recovery were not different between groups. CONCLUSIONS: Preoperative BPV-BCD blocks in the L2-L4 and L4-S3 nerve distributions for hip and knee replacements led to less pain on postoperative day one and increased knee and hip range of motion, compared with plain BPV blocks. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT02891798.

Extended Perineural Analgesia After Hip and Knee Replacement When Buprenorphine-Clonidine-Dexamethasone Is Added to Bupivacaine: Preliminary Report from a Randomized Clinical Trial.

OBJECTIVE: We tested the hypothesis that buprenorphine-clonidine-dexamethasone (BCD) extends perineural analgesia compared with plain bupivacaine (BPV) nerve blocks used for hip and knee replacement surgery. DESIGN: Prospective, parallel-arms, randomized, double-blind trial. SETTING: A single veterans' hospital. SUBJECTS: Seventy-eight veterans scheduled for total hip or knee replacement with plans for spinal as the primary anesthetic. METHODS: Participants underwent nerve/plexus blocks at L2-L4 and L4-S3 in advance of hip or knee joint replacement surgery. Patients were randomized to receive BPV-BCD or plain BPV in a 4:1 allocation ratio. Patients answered four block duration questions (listed below). Time differences between treatments were analyzed using the t test. RESULTS: Significant (P < 0.001) prolongation of the time parameters was reported by patients after the BPV-BCD blocks (N = 62) vs plain BPV (N = 16). The time until start of postoperative pain was 26 vs 11 hours (mean difference = 15 hours, 95% CI = 8 to 21). The time until no pain relief from the blocks was 32 vs 15 hours (mean difference = 17 hours, 95% CI = 10 to 24). The time until the numbness wore off was 37 vs 21 hours (mean difference = 16 hours, 95% CI = 8 to 23). The time until the worst postoperative pain was 39 vs 20 hours (mean difference = 19 hours, 95% CI = 11 to 27). CONCLUSIONS: BPV-BCD provided 26-39 hours of perineural analgesia in the L2-L4 and L4-S3 nerve distributions after hip/knee replacement surgery, compared with 11-21 hours for plain BPV.

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.

Associations between novel jump test measures, grip strength, and physical performance: the Osteoporotic Fractures in Men (MrOS) Study.

BACKGROUND/AIMS: Weight-bearing jump tests measure lower extremity muscle power, velocity, and force, and may be more strongly related to physical performance than grip strength. However, these relationships are not well described in older adults. METHODS: Participants were 1242 older men (mean age 84 ± 4 years) in the Osteoporotic Fractures in Men (MrOS) Study. Jump peak power (Watts/kg body weight), force (Newton/kg body weight) at peak power, and velocity (m/s) at peak power were measured by jump tests on a force plate. Grip strength (kg/kg body weight) was assessed by hand-held dynamometry. Physical performance included 400 m walk time (s), 6 m usual gait speed (m/s), and 5-repeated chair stands speed (#/s). RESULTS: In adjusted Pearson correlations, power/kg and velocity moderately correlated with all performance measures (range r = 0.41-0.51; all p < 0.001), while correlations for force/kg and grip strength/kg were weaker (range r = 0.20-0.33; all p < 0.001). Grip strength/kg moderately correlated with power/kg (r = 0.44; p < 0.001) but not velocity or force/kg. In adjusted linear regression with standardized ßs, 1 SD lower power/kg was associated with worse: 400 m walk time (ß = 0.47), gait speed (ß = 0.42), and chair stands speed (ß = 0.43) (all p < 0.05). Associations with velocity were similar (400 m walk time: ß = 0.42; gait speed: ß = 0.38; chair stands speed: ß = 0.37; all p < 0.05). Force/kg and grip strength/kg were more weakly associated with performance (range ß = 0.18-0.28; all p < 0.05). CONCLUSIONS/DISCUSSION: Jump power and velocity had stronger associations with physical performance than jump force or grip strength. This suggests lower extremity power and velocity may be more strongly related to physical performance than lower extremity force or upper extremity strength in older men.

A Portable System for Remote Rehabilitation Following a Total Knee Replacement: A Pilot Randomized Controlled Clinical Study.

Rehabilitation has been shown to improve functional outcomes following total knee replacement (TKR). However, its delivery and associated costs are highly variable. The authors have developed and previously validated the accuracy of a remote (wearable) rehabilitation monitoring platform (interACTION). The present study's objective was to assess the feasibility of utilizing interACTION for the remote management of rehabilitation after TKR and to determine a preliminary estimate of the effects of the interACTION system on the value of rehabilitation. Specifically, we tested post-operative outpatient rehabilitation supplemented with interACTION (n = 13) by comparing it to a standard post-operative outpatient rehabilitation program (n = 12) using a randomized design. Attrition rates were relatively low and not significantly different between groups, indicating that participants found both interventions acceptable. A small (not statistically significant) decrease in the number of physical therapy visits was observed in the interACTION Group, therefore no significant difference in total cost could be observed. All patients and physical therapists in the interACTION Group indicated that they would use the system again in the future. Therefore, the next steps are to address the concerns identified in this pilot study and to expand the platform to include behavioral change strategies prior to conducting a full-scale randomized controlled trial. Trial registration: ClinicalTrials.gov NCT02646761 "interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA" 6 January 2016.

Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial.

BACKGROUND: Primary care management decisions for patients with symptomatic lumbar spinal stenosis (LSS) are challenging, and nonsurgical guidance is limited by lack of evidence. OBJECTIVE: To compare surgical decompression with physical therapy (PT) for LSS and evaluate sex differences. DESIGN: Multisite randomized, controlled trial. (ClinicalTrials.gov: NCT00022776). SETTING: Neurologic and orthopedic surgery departments and PT clinics. PARTICIPANTS: Surgical candidates with LSS aged 50 years or older who consented to surgery. INTERVENTION: Surgical decompression or PT. MEASUREMENTS: Primary outcome was physical function score on the Short Form-36 Health Survey at 2 years assessed by masked testers. RESULTS: The study took place from November 2000 to September 2007. A total of 169 participants were randomly assigned and stratified by surgeon and sex (87 to surgery and 82 to PT), with 24-month follow-up completed by 74 and 73 participants in the surgery and PT groups, respectively. Mean improvement in physical function for the surgery and PT groups was 22.4 (95% CI, 16.9 to 27.9) and 19.2 (CI, 13.6 to 24.8), respectively. Intention-to-treat analyses revealed no difference between groups (24-month difference, 0.9 [CI, -7.9 to 9.6]). Sensitivity analyses using causal-effects methods to account for the high proportion of crossovers from PT to surgery (57%) showed no significant differences in physical function between groups. LIMITATION: Without a control group, it is not possible to judge success attributable to either intervention. CONCLUSION: Surgical decompression yielded similar effects to a PT regimen among patients with LSS who were surgical candidates. Patients and health care providers should engage in shared decision-making conversations that include full disclosure of evidence involving surgical and nonsurgical treatments for LSS. PRIMARY FUNDING SOURCE: National Institutes of Health and National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Validity of physical activity measures in individuals after total knee arthroplasty.

OBJECTIVE: To determine the concurrent criterion-related validity of 2 activity monitors in comparison with the criterion method of indirect calorimetry in older adults after total knee arthroplasty (TKA). DESIGN: Validation study. SETTING: Subjects completed 9 increasingly demanding daily activities in a research laboratory; each activity was performed for 7 minutes, for a total of 80 minutes, while the activity monitors and criterion method were used concurrently. PARTICIPANTS: Subjects (N=21, 67% women) had a mean age ± SD of 68±7 years and a body mass index of 29±4. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Energy expenditure (in kcal/min) measured by accelerometer-based and multisensor-based monitors and by a criterion method. Validity was assessed by the paired t test, intraclass correlation coefficient (ICC), and Bland-Altman plots comparing the measurements from the activity monitors with those of the criterion method. RESULTS: Measurements from the accelerometer-based monitor were significantly lower than those of the criterion method across all walking and nonwalking activities. The underestimations ranged from 40% to 100%. The accelerometer-based monitor demonstrated small to moderate agreement compared with the criterion method (ICCs from 0 to .38). Measurements from the multisensor-based monitor were significantly lower than those of the criterion method during several nonwalking activities; yet, the differences were minor (2%-19%). Measurements from the multisensor-based monitor during walking activities were not different compared with the criterion method. The multisensor-based monitor demonstrated moderate to excellent agreement with the criterion method (ICCs from .48 to .81). CONCLUSIONS: The multisensor-based monitor showed better criterion-related validity than the accelerometer-based monitor and should be considered as a tool to measure physical activity in individuals after TKA.

A randomized trial to compare exercise treatment methods for patients after total knee replacement: protocol paper.

BACKGROUND: Although the outcome of total knee replacement (TKR) is favorable, surgery alone fails to resolve the functional limitations and physical inactivity that existed prior to surgery. Exercise is likely the only intervention capable of improving these persistent limitations, but exercises have to be performed with intensity sufficient to promote significant changes, at levels that cannot be tolerated until later stages post TKR. The current evidence is limited regarding the effectiveness of exercise at a later stage post TKR. To that end, this study aims to compare the outcomes of physical function and physical activity between 3 treatment groups: clinic-based individual outpatient rehabilitative exercise during 12 weeks, community-based group exercise classes during 12 weeks, and usual medical care (wait-listed control group). The secondary aim is to identify baseline predictors of functional recovery for the exercise groups. METHODS/DESIGN: This protocol paper describes a comparative effectiveness study, designed as a 3-group single-blind randomized clinical trial. Two hundred and forty older adults who underwent TKR at least 2 months prior will be randomized into one of the three treatment approaches. Data will be collected at baseline, 3 months, and 6 months. The wait-listed control group will be randomized to one of the 2 exercise groups after 6 months of study participation, and will complete a 9-month follow-up. Primary outcome is physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index Physical Function Subscale (WOMAC-PF). Physical function is also measured by performance-based tests. Secondary outcomes include performance-based tests and physical activity assessed by a patient-reported survey and accelerometry-based physical activity monitors. Exploratory outcomes include adherence, co-interventions, attrition, and adverse events including number of falls. Linear mixed models will be fitted to compare the changes in outcome across groups. Logistic regression will identify patient characteristics that predict functional recovery in the exercise groups. Instrumental variable methods will be used to estimate the efficacy of the interventions in the presence of non-compliance. DISCUSSION: Results will inform recommendations on exercise programs to improve physical function and activity for patients at the later stage post TKR and help tailor interventions according with patients' characteristics. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02237911.

Validity of the Modified Defense and Veterans Pain Rating Scale Supplemented With Items Germane to Total Joint Replacement: Secondary Analysis From a Randomized Trial.

INTRODUCTION: Valid measures of pain are helpful to adjust treatment plans in real time after total joint replacement (TJR). We enhanced the existing Defense and Veterans Pain Rating Scale (DVPRS) with items related to pain at rest and movement, in specific reference to operative and nonoperative joints, creating the TJR-DVPRS. This manuscript is presented to validate the modified survey instrument. The aims of this psychometric study were to evaluate (1) the latent structure of the TJR-DVPRS, (2) the relationships among the pain dimensions represented on the TJR-DVPRS and the reference-standard Short-Form McGill Pain Questionnaire (version 2, SF-MPQ-2), and (3) the responsiveness of these two measures before and after TJR. MATERIALS AND METHODS: This report involves a secondary analysis of pain surveys from 135 veterans undergoing TJR at one center who participated in a randomized trial. The study was approved by the institutional review boards from participating institutions. The TJR-DVPRS and SF-MPQ-2 were completed preoperatively, during postoperative day 1, and 6 weeks post-surgery. Standard psychometric evaluations included correlations, principal component analysis, and internal consistency of survey items and subscales, using preoperative baseline data as a frame of reference. Responsiveness analysis included assessing both effect size and thresholds of clinically important change for survey subscales using data from all three time points. RESULTS: Two reliable subscales were identified for the TJR-DVPRS, one including items about pain intensity and interference related to the operative joint (Cronbach's α = .809) and the other including two pain items on the nonoperative joint. Combining the subscales indicated a two-factor solution: The first valid factor entailed the four subscales of the SF-MPQ-2 and the TJR-DVPRS operative joint subscales, indicating that these subscales validly represent the same pain dimension. The second valid factor entailed the TJR-DVPRS subscale addressing the nonoperative joint. Responsiveness analysis following accepted psychometric methods demonstrated significant decreases in pain from the preoperative period to 6 weeks postoperatively for all subscales. The TJR-DVPRS and SF-MPQ-2 subscales were similarly responsive, except for the SF-MPQ-2 neuropathic and TJR-DVPRS nonoperative joint subscales, which were minimally responsive during the preoperative to 6-week period. CONCLUSIONS: The TJR-DVPRS is valid for use among veterans undergoing TJR and poses significantly less respondent burden than does the SF-MPQ-2. The brevity and ease of use of the TJR-DVPRS make it a practical tool for use during surgical recovery to monitor pain intensity at rest and with movement in the operative joint, and to assess pain interference with activity, sleep, and mood. The TJR-DVPRS is at least as responsive as the SF-MPQ-2, but the SF-MPQ-2 neuropathic and TJR-DVPRS nonoperative joint subscales were minimally responsive. Limitations of this study include the small sample size, under-representation of women (which would be expected in the veteran population), and using only veterans. Future validations studies should include civilians and active military TJR patients.

Assessing Common Content and Responsiveness of the QoR-15 and the SF-8 in the Context of Recovery from Regional Anesthesia for Joint Replacement.

PURPOSE: There is no consensus regarding how best to measure postoperative quality of recovery after anesthesia/surgery (e.g., using 24-hour survey instruments) in veterans or active military. Our goals were to (1) describe health-related quality-of-life (HRQoL) and recovery across time in veterans, (2) examine the commonality between the quality of recovery (QoR-15) and short-form (SF) surveys (including the SF-8, 24-hour version), and (3) examine the responsiveness of these surveys. MATERIALS AND METHODS: This study was approved by the Institutional Review Boards from the University of Pittsburgh, the VA Pittsburgh, and the Human Research Protection Office of the Department of Defense. Secondary analyses of data were executed based on a randomized trial dataset of knee/hip arthroplasty patients, the study having recruited 135 total veterans. QoR-15 and HRQoL SF surveys were completed and self-reported before surgery (pre-op), on postoperative day 2 (PO-D2), and 6 weeks postoperatively. Descriptive statistics were used to examine scores across time. Common content was examined using Pearson's r. Responsiveness was examined using distribution-based methods. RESULTS: Average veteran age was 67 year, 89% were male, 88% white, and average body mass index was 33 kg∙m-2. QoR-15 scores declined from pre-op to PO-D2 but were higher than pre-op at 6 weeks. SF physical component summary (PCS) scores were low both pre-op and PO-D2, but were elevated over baseline at 6 weeks. SF mental component summary (MCS) scores declined from baseline to PO-D2 but were higher than pre-op at 6 weeks. Associations of the QoR-15 total score and PCS/MCS were medium/large and statistically significant at P ≤ .01. Both instruments were responsive to changes. CONCLUSION: QoR-15 and SF-8 have high content commonality and performed similarly in veterans across time. SF-8 has added benefits of (1) brevity, (2) assessment of physical and mental health components, and (3) being normed to the general population. The SF-8, if used without the QoR-15 in tandem in future study of anesthesia-related outcomes, would need to be supplemented by separate questions addressing postoperative nausea/vomiting (a frequent outcome after anesthesia that is relevant to same-day and next-day mobilization after elective joint replacement surgery).

Lower Leg Power and Grip Strength Are Associated With Increased Fall Injury Risk in Older Men: The Osteoporotic Fractures in Men Study.

BACKGROUND: Past research has not investigated both lower-extremity power and upper-extremity strength in the same fall injury study, particularly nonfracture fall injuries. METHODS: In the Osteoporotic Fractures in Men Study (baseline: N = 5 994; age 73.7 ± 5.9 years; 10.2% non-White), fall injuries (yes/no) were assessed prospectively with questionnaires approximately every 3 years over 9 years. Maximum leg power (Watts) from Nottingham single leg press and maximum grip strength (kg) from handheld dynamometry were assessed at baseline and standardized to kg body weight. Physical performance included gait speed (6-m usual; narrow walk) and chair stands speed. RESULTS: Of men with ≥1/4 follow-ups (N = 5 178; age 73.4 ± 5.7 years), 40.4% (N = 2 090) had ≥1 fall injury. In fully adjusted repeated-measures logistic regressions, lower power/kg and grip strength/kg had higher fall injury risk (trend across quartiles: both p < .0001), with lower quartiles at significantly increased risk versus highest Q4 except for grip strength Q3 versus Q4. Fall injury risk was 19% higher per 1 standard deviation (SD) lower power/kg (95% confidence interval [CI]: 1.12-1.26) and 16% higher per SD lower grip strength/kg (95% CI: 1.10-1.23). In models including both leg power/kg and grip strength/kg, odds ratios (ORs) were similar and independent of each other and physical performance (leg power/kg OR per SD = 1.13, 95% CI: 1.06-1.20; grip strength/kg OR per SD = 1.11, 95% CI: 1.05-1.17). CONCLUSIONS: Lower leg power/kg and grip strength/kg predicted future fall injury risk in older men independent of physical performance. Leg power potentially identifies fall injury risk better than grip strength at higher muscle function, though grip strength may be more suitable in clinical/practice settings.

Evaluation of Neck Disability Using Computed-Tomography in Head and Neck Cancer Survivors.

Objective: We have previously reported that 55% of head and neck cancer survivors have neck disability. However, it is unclear what factors contribute to their neck disability. Our study aim is to determine if survivors with neck disability have evidence of cervical spine degenerative disease assessed by computed tomography (CT). Materials/Methods: Cross-sectional analysis of patient-reported neck disability, prospectively collected on survivors of squamous cell carcinomas without recurrence or metastasis over one-year post-treatment. Neck disability and its impact on daily life was measured using the Neck Disability Index (NDI) and compared with cervical CT scans within 6 months. Scans were evaluated for degeneration of the disc and facet of the cervical vertebrae rated on a 5-point scale where 5 indicates more severe disease. Multivariable linear regression was used to analyze the association between NDI and radiographic findings. Results: 116 survivors of oropharyngeal carcinomas were identified, predominantly male (81.9%) with an average age of 62.8 ± 8.2 (range 43.8-81.4). Most survivors had advanced stage III-IVa cancer (94.0%) with treatment modalities including surgery (n=26, 52.0%), chemotherapy (n = 45, 90.0%), and radiation therapy (n = 49, 98.0%). Absence of neck disability was observed in 44.0% of survivors, 39.7% had mild disability, and 16.4% moderate disability. The time from treatment to clinic visit was an average of 3.1 ± 2.7 years (range 1.1-13.4). Multivariable analysis of NDI controlling for age, time since treatment, and treatment modality identified an inverse association between NDI and spinal degenerative disease examining cervical discs (-1.46 95% confidence interval (CI) [-2.86, -0.06], p = 0.041) and age (-0.24 95% CI[-0.40, -0.08], p = 0.004). Conclusions: Our study shows that neck impairment and pain in head and neck cancer survivors is not sufficiently explained by cervical degeneration related to age or trauma, supporting the theory that post-treatment neck disability occurs as a side effect of treatment. These results support the further assessment of structure and function of cervical musculature and degeneration following HNC treatment.

Differences between men and women in coupled subtalar and tibiofemoral joint kinematics during gait revealed through dynamic biplane radiography.

It has been suggested that subtalar and tibiofemoral kinematics are coupled, such that abnormal subtalar inversion during the impact and push-off portions of stance may affect tibial rotation, leading to abnormal compensatory knee motion. This study aimed to characterize tibiofemoral and subtalar coupled motion and to determine if sex-dependent differences exist in lower extremity coupled motion. Twenty young adults were imaged at 100 frames/s using dynamic biplane radiography while walking. Lower extremity CT scans were obtained and segmented into subject-specific 3D bone models. Digitally reconstructed radiographs generated from the models were matched to the biplane radiographs via a validated tracking process to obtain tibiofemoral and subtalar joint kinematics. Subtalar inversion/eversion was strongly associated with tibiofemoral internal/external rotation and tibiofemoral ab/adduction during impact and push-off (P < 0.001). Men reached neutral subtalar and tibiofemoral orientation at midstance, while women remained more inverted at the subtalar joint and more externally rotated at the tibiofemoral joint. The rate of tibiofemoral ab/adduction to subtalar eversion differed between sexes during push-off (P = 0.005). Women underwent subtalar inversion, as well as tibiofemoral internal rotation and adduction during push-off, while men underwent only subtalar inversion and tibiofemoral internal rotation, with effectively no tibiofemoral adduction. These results provide the first quantitative evidence characterizing subtalar and tibiofemoral coupled motion. Differences in coupled motion trajectories between men and women may be associated with the higher incidence of knee-related pathology in women. These novel findings may serve as a standard for comparison when evaluating patients with patellofemoral pain.

Preliminary feasibility and acute physiological effects of a single session of upper limb vibration training for persons with spinal cord injury.

CONTEXT: Strong upper limb musculature is essential for persons with spinal cord injury (SCI) to operate a manual wheelchair and live independently. Targeted upper limb vibration may be a viable exercise modality to build muscle efficiently while eliminating some of the barriers associated with exercise for persons with SCI. OBJECTIVE: The purpose of this study was to assess preliminary feasibility of completing a single exercise session of upper limb vibration and compare the acute physiological effects to a single session of standard dumbbell resistance exercise. METHODS: Individuals with SCI performed seven upper limb exercises (1) isometrically using a vibrating dumbbell at 30 Hz for 60 s (n = 22) and (2) using a standard isotonic resistance protocol (n = 15). RESULTS: Nineteen (86.4%) of 22 participants were able to perform all vibration exercises at 30 Hz but hold time success rates varied from 33% (side flies and front raises) to 95% (internal rotation). No significant differences were found between vibration exercise and standard resistance protocol for blood lactate, power output, and heart rate (P > 0.05). Perceptions of the training were positive, with most participants (>70%) expressing interest to train with vibration in the future. CONCLUSIONS: Vibration training was not feasible for all participants, suggesting an individualized approach to starting weight and progression may be necessary. Similar acute physiological changes were seen between vibration exercise and standard resistance protocol, suggesting they could have similar benefits. Additional research is needed to determine if vibration exercise is feasible and beneficial to incorporate into a long-term training program.

Exploring Race Differences in Satisfaction With Rehabilitation Following Total Knee Arthroplasty: A Qualitative Study.

BACKGROUND: The purpose of this qualitative focus group study was to explore race differences in the rehabilitation experience and satisfaction with rehabilitation following total knee arthroplasty (TKA). METHOD: We conducted a series of qualitative focus group discussions with groups of non-Hispanic White and non-Hispanic Black older adults who recently underwent TKA. We used grounded theory approach, which asks the researcher to develop theory from the data that are collected. Participants discussed barriers and facilitators to accessing rehabilitation after surgery, opinions regarding their physical therapists, the amount of postoperative physical therapy received, and overall satisfaction with the postoperative rehabilitation process. RESULTS: Thirty-six individuals participated in focus groups. Three major themes emerged: (i) Participants reported overall positive views of their post-TKA rehabilitation experience. They particularly enjoyed one-on-one care, the ability to participate in "prehabilitation," and often mentioned specific interventions they felt were most helpful in their recovery. (ii) Despite this, substantial barriers to accessing physical therapy exist. These include suboptimal pain management, copayments and other out-of-pocket costs, and transportation to visits. (iii) There were minor differences in the rehabilitation experiences between Black and White participants. Black participants reported longer paths toward surgery and occasional difficulty interacting with rehabilitation providers. CONCLUSIONS: Individuals undergoing TKA can largely expect positive rehabilitation experiences postoperatively. However, some barriers to postoperative physical therapy exist and may differ between Black and White patients. Physical therapists should increase their awareness of these barriers and work to minimize them whenever possible.