Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Poor sleep is common among adults with chronic low back pain (cLBP), but the influence of cLBP treatments, such as yoga and physical therapy (PT), on sleep quality is under studied. OBJECTIVE: Evaluate the effectiveness of yoga and PT for improving sleep quality in adults with cLBP. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Academic safety-net hospital and 7 affiliated community health centers. PARTICIPANTS: A total of 320 adults with cLBP. INTERVENTION: Twelve weekly yoga classes, 1-on-1 PT sessions, or an educational book. MAIN MEASURES: Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) global score (0-21) at baseline, 12 weeks, and 52 weeks. Additionally, we also evaluated how the proportion of participants who achieved a clinically meaningful improvement in sleep quality (> 3-point reduction in PSQI) at 12 weeks varied by changes in pain and physical function at 6 weeks. KEY RESULTS: Among participants (mean age = 46.0, 64% female, 82% non-white), nearly all (92%) reported poor sleep quality (PSQI > 5) at baseline. At 12 weeks, modest improvements in sleep quality were observed among the yoga (PSQI mean difference [MD] = - 1.19, 95% confidence interval [CI] - 1.82, - 0.55) and PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) groups. Participants who reported a ≥ 30% improvement in pain or physical function at 6 weeks, compared with those who improved < 10%, were more likely to be a sleep quality responder at 12 weeks (odds ratio [OR] = 3.51, 95% CI 1.73, 7.11 and OR = 2.16, 95% CI 1.18, 3.95, respectively). Results were similar at 52 weeks. CONCLUSION: In a sample of adults with cLBP, virtually all with poor sleep quality prior to intervention, modest but statistically significant improvements in sleep quality were observed with both yoga and PT. Irrespective of treatment, clinically important sleep improvements at the end of the intervention were associated with mid-intervention pain and physical function improvements. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01343927.

Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial.

BACKGROUND: Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain. OBJECTIVE: To determine whether yoga is noninferior to PT for cLBP. DESIGN: 12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927). SETTING: Academic safety-net hospital and 7 affiliated community health centers. PARTICIPANTS: 320 predominantly low-income, racially diverse adults with nonspecific cLBP. INTERVENTION: Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice. MEASUREMENTS: Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life. RESULTS: One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups. LIMITATIONS: Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up. CONCLUSION: A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain. PRIMARY FUNDING SOURCE: National Center for Complementary and Integrative Health of the National Institutes of Health.

Comparison between admission natriuretic peptides, NGAL and sST2 testing for the prediction of worsening renal function in patients with acutely decompensated heart failure.

BACKGROUND: In order to predict the occurrence of worsening renal function (WRF) and of WRF plus in-hospital death, 101 emergency department (ED) patients with acute decompensated heart failure (ADHF) were evaluated with testing for amino-terminal pro-B-type natriuretic peptide (NT-proBNP), BNP, sST2, and neutrophil gelatinase associated lipocalin (NGAL). METHODS: In a prospective international study, biomarkers were collected at the time of admission; the occurrence of subsequent in hospital WRF was evaluated. RESULTS: In total 26% of patients developed WRF. Compared to patients without WRF, those with WRF had a longer in-hospital length of stay (LOS) (mean LOS 13.1±13.4 days vs. 4.8±3.7 days, p<0.001) and higher in-hospital mortality [6/26 (23%) vs. 2/75 (2.6%), p<0.001]. Among the biomarkers assessed, baseline NT-proBNP (4846 vs. 3024 pg/mL; p=0.04), BNP (609 vs. 435 pg/mL; p=0.05) and NGAL (234 vs. 174 pg/mL; p=0.05) were each higher in those who developed WRF. In logistic regression, the combination of elevated natriuretic peptide and NGAL were additively predictive for WRF (ORNT-proBNP+NGAL=2.79; ORBNP+NGAL=3.11; both p<0.04). Rates of WRF were considerably higher in patients with elevation of both classes of biomarker. Comparable results were observed in a separate cohort of 162 patients with ADHF from a different center. CONCLUSIONS: In ED patients with ADHF, the combination of NT-proBNP or BNP plus NGAL at presentation may be useful to predict impending WRF (Clinicaltrials.gov NCT#0150153).

Reference interval evaluation of high-sensitivity troponin T and N-terminal B-type natriuretic peptide in Vietnam and the US: The North South East West Trial.

BACKGROUND: Reference intervals of high-sensitivity troponin T (hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) have been determined from Western populations. No data are available regarding expected values in Asian populations. METHODS: A total of 1157 age- and sex-matched healthy individuals (mean age, 41.2 years; 48.0% male) were prospectively enrolled from the US (n = 565) and Vietnam (n = 592). Blood samples were analyzed for hs-cTnT and NT-proBNP. Median values were determined for each country and compared in unadjusted analyses and in analyses adjusted for age, sex, body mass index, study site, race, and vital signs. RESULTS: Median hs-cTnT concentrations were slightly higher for individuals from the US than for those from Vietnam, but both were below the limit of detection (3.7 vs 3.0 ng/L, respectively; P = 0.03). More US participants had an hs-cTnT concentration above the limit of detection (57.2% vs 47.3%; P = 0.001), but the 99th percentile concentration was slightly higher for Asians (US 15.1 vs Vietnam 19.0 ng/L). Concentrations for >98% of both populations were below the standard hs-cTnT 99th percentile of 14.0 ng/L (P = 0.54). Median NT-proBNP concentrations were slightly higher for US participants compared with Vietnamese participants (28 vs 16 ng/L, respectively; P < 0.001). Following adjustment, differences in concentrations of NT-proBNP between healthy US and Vietnamese populations remained significant, whereas for hs-cTnT the differences were no longer significant. Inclusion of hs-cTnT values down to the limit of blank did not change the result. CONCLUSIONS: The differences in hs-cTnT and NT-proBNP between healthy individuals from the US and Vietnam are small. Previously derived reference intervals for both analytes may be applied in Asian populations.

Earliest phases of chondrogenesis are dependent upon angiogenesis during ectopic bone formation in mice.

Endochondral ossification is the process where cartilage forms prior to ossification and in which new bone forms during both fracture healing and ectopic bone formation. Transitioning to ossification is a highly coordinated process between hypertrophic chondrocytes, vascular endothelial cells, osteoblasts and osteoclasts. A critical biological process that is central to the interactions of these various cell types is angiogenesis. Although it is well established that angiogenesis is crucial for fracture repair, less is known pertaining to the role of angiogenesis in ectopic bone formation. Furthermore, fracture repair models are complicated by extensive trauma, subsequent inflammatory responses and concurrent repair processes in multiple tissues. In order to more definitively characterize the relationship between angiogenesis and postnatal endochondral ossification, a model of ectopic bone formation was used. Human demineralized bone matrix (DBM) was implanted in immune-deficient mice (rag null (B6.129S7-Rag1tm1/MOM/J)) to induce ectopic bone. Inhibition of angiogenesis with either a small molecule (TNP-470) or a targeted biological (Vascular Endothelial Growth Factor Receptor type 2 [VEGFR2] blocking antibody) prevented ectopic bone formation by 83% and 77%, respectively. Most striking was that the progression of chondrogenesis was halted during very early phases of chondrocyte differentiation between condensation and prehypertrophy (TNP-470) or the proliferative phase (VEGFR2 blockade) prior to hypertrophy, while osteoclast recruitment and resorption were almost completely inhibited. Our results demonstrate angiogenesis plays a developmental role in endochondral bone formation at a much earlier phase of chondrogenesis than suggested by prior findings.

Evidence of uncoupling between renal dysfunction and injury in cardiorenal syndrome: insights from the BIONICS study.

OBJECTIVE: The objective of the study was to assess urinary biomarkers of renal injury for their individual or collective ability to predict Worsening renal function (WRF) in patients with acutely decompensated heart failure (ADHF). METHODS: In a prospective, blinded international study, 87 emergency department (ED) patients with ADHF were evaluated with biomarkers of cardiac stretch (B type natriuretic peptide [BNP] and its amino terminal equivalent [NT-proBNP], ST2), biomarkers of renal function (creatinine, estimated glomerular filtration rate [eGFR]) and biomarkers of renal injury (plasma neutrophil gelatinase associated lipocalin [pNGAL], urine kidney injury molecule-1 [KIM-1], urine N-acetyl-beta-D-glucosaminidase [NAG], urine Cystatin C, urine fibrinogen). The primary endpoint was WRF. RESULTS: 26% developed WRF; baseline characteristics of subjects who developed WRF were generally comparable to those who did not. Biomarkers of renal function and urine biomarkers of renal injury were not correlated, while urine biomarkers of renal injury correlated between each other. Biomarker concentrations were similar between patients with and without WRF except for baseline BNP. Although plasma NGAL was associated with the combined endpoint, none of the biomarker showed predictive accuracy for WRF. CONCLUSIONS: In ED patients with ADHF, urine biomarkers of renal injury did not predict WRF. Our data suggest that a weak association exists between renal dysfunction and renal injury in this setting (Clinicaltrials.gov NCT#0150153).