Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial.

BACKGROUND: We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). OBJECTIVE: This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. METHODS: E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. RESULTS: Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. CONCLUSIONS: Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25291.

Correction: Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial.

[This corrects the article DOI: 10.2196/37480.].

Impact of HIV-ART on the restoration of Th17 and Treg cells in blood and female genital mucosa.

The aim of this study was to evaluate the effectiveness of antiretroviral treatment (ART) on the proportion and functions of Th17 and Treg cells in peripheral blood and female genital tract (FGT) respectively. To this aim, samples from 41 HIV-neg, 33 HIV+ ART-naïve and 32 HIV+ ART+ subjects were obtained. In peripheral blood, altered Th17 and Th17/Treg proportions were normalized in HIV+ ART+, but certain abnormal Treg and activated T-cell proportions were still observed. In FGT, abnormal patterns of secretion for Th17-related cytokines were observed in cervical mononuclear cells (CMCs) from HIV+ women, even in those from HIV+ ART+, compared to the HIV-neg group. Moreover, these altered patterns of secretion were associated with diminished levels of CXCL5 and CXCL1 chemokines and with an immunoregulatory skew in the CCL17/CCL20 ratio in ectocervix samples of these women. Finally, ART did not restore proportions of Th17-precursor cells with gut-homing potential in PBMCs, and positive correlations between these cells and the levels of IL-17F and IL-21 production by CMCs may suggest that a better homing of these cells to the intestine could also imply a better restoration of these cells in the female genital tract. These results indicate that antiretroviral treatment did not restore Th17-related immune functions completely at the female mucosal level.

¿Es el fenotipo molecular determinante del ganglio centinela positivo? / Is the molecular phenotype determinant of the positive centinel gangly?

Introducción Durante años, la correlación directa entre el tamaño tumoral y el compromiso ganglionar fue uno de los parámetros de mayor importancia a la hora del diagnóstico del cáncer de mama. La biopsia del ganglio centinela permite estadificar la axila en pacientes con cáncer de mama y axila clínicamente negativa. Mediante este procedimiento, se evita la linfadenectomía axilar en una proporción de pacientes. Se han identificado variables independientes de compromiso ganglionar, como la edad de la paciente, el tamaño y grado tumoral, la invasión vasculolinfática, el alto índice de proliferación (Ki67), el estado de los receptores de estrógeno (re), de receptores de progesterona (rp) y de her2. Objetivo El objetivo de nuestro estudio fue estimar si existe relación entre el compromiso del ganglio centinela y el fenotipo molecular. Material y método Este es un estudio observacional, retrospectivo, transversal y analítico, en el cual se incluyeron 1.034 mujeres con diagnóstico de cáncer de mama en estadio temprano tratadas entre junio de 2008 y junio 2016 en la Sección de Mastología del Servicio de Ginecología del Hospital de Agudos Dr. Ignacio Pirovano y del consultorio de práctica privada. Los datos clínicos y anatomopatológicos fueron recabados de la base de datos de ambos centros ingresados en el Registro de Cáncer de Mama de la Sociedad Argentina de Mastología (rcm). Resultados El análisis multivariado demostró correlación estadísticamente significativa entre el compromiso del ganglio centinela y los fenotipos Luminal B (or 1,546; ic 95%, 1,065 - 2,244; p=0,022), her2 (or 2,23; ic 95%, 1,060 - 4,691; p=0,035) y Triple Negativo (or 0,247; ic 95%, 0,055 - 1,098; p=0,066) con respecto a los Luminales A en cáncer de mama estadio temprano. A mayor tamaño tumoral mayor compromiso del ganglio centinela: en tumores pT1b: or 3,154 (ic 95%, 1,231- 8,078; p= 0,017); en tumores pT1c: or 4,973 (ic 95%, 2,086 - 11,856; p<0,05) y en tumores pT2: or 6,180 (ic 95%, 2,458 - 15,536; p<0,05) con respecto al pT1a. No hubo diferencias significativas con respecto a la invasión linfovascular en nuestra población. Conclusiones En el análisis de nuestro estudio podemos concluir que existe relación estadísticamente significativa entre el fenotipo molecular (Luminales, her2) y el compromiso del ganglio centinela

Introduction The relation between tumor size and nodal involvement was one of the most important parameters. The sentinel node biopsy allows staging the axilla in patients with breast cancer and clinically negative axilla. It is possible to avoid the axillary dissection in a proportion of patients. It´s has been identified independent variables of nodal involvement as age, size and tumor grade, vascular and lymphatic invasion, high proliferation index (Ki67), status of estrogen receptors (er), progesterone receptors (pr) and her2. Objective The aim of our study was to estimate the correlation between the involvement of the sentinel node and the molecular phenotype. Materials and method This is an observational, retrospective, transversal and analytical study, in which 1,034 women presented diagnosis of early stage breast cancer between June 2008 and June 2016 in the Mastology Section of Hospital Dr. Ignacio Pirovano and private practice. Clinical and pathological data were collected from the database of both centers entered in the Register of Breast Cancer of the Society of Argentina Mastology (rcm). Results Multivariate analysis showed statistically significant correlation between the involvement of sentinel node and phenotypes Luminal B (or 1.546; ci 95%, 1.065 - 2.244; p=0.022), her2 (or 2.23; ci 95%. 1.060 - 4.691; p=0.035) and Triple Negative Breast Cancer (tnbc) (or 0.247; ci 95%, 0.055 - 1.098; p=0.066) in comparison with Luminal A phenotype in early stage breast cancer. Furthermore, if the tumor size is bigger the chance of the involvement of the sentinel node is greater. With tumors pT1b: or 3,154 (95% ci, 1.231- 8.078; p = 0.017); pT1c: or 4,973 (95% ci, 2.086 to 1.856; p <0.05) and pT2: or 6,180 (95% ci, 2.458 to 15.536; p <0.05) in comparison with pT1a. There were no significant differences regarding lymphovascular invasion in our population. Conclusions In the analysis of our study we can conclude that there is a statistically significant relationship between the molecular phenotype (Luminal, her2) and the involvement of the sentinel node