Efficacy of conditioned autologous serum therapy (Orthokine®) on the dorsal root ganglion in patients with chronic radiculalgia: study protocol for a prospective randomized placebo-controlled double-blind clinical trial (RADISAC trial).

BACKGROUND: Pulsed radiofrequency (PRF) treatment on the dorsal root ganglion (DRG) has been proposed as a good option for the treatment of persistent radicular pain based on its effect of neuromodulation on neuropathic pain. Autologous conditioned serum (ACS) therapy is a conservative treatment based on the patient's own blood. The aim of this manuscript is to develop a study protocol using ACS on the DRG as a target for its molecular modulation. METHODS: We plan to conduct a randomized controlled study to compare the efficacy of PRF therapy plus ACS versus PRF therapy plus physiological saline 0.9% (PhS) on the DRG to reduce neuropathic pain in patients with persistent lower limb radiculalgia (LLR) and to contribute to the functional improvement and quality of life of these patients. Study participants will include patients who meet study the inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of treatment with PRF plus ACS (experimental group) or PRF plus PhS (placebo group). The study group will consist of 70 patients (35 per group) who have experienced radicular pain symptoms for ≥ 6 months' duration who have failed to respond to any therapy. Both groups will receive PRF on the DRG treatment before the injection of the sample (control or placebo). Patient assessments will occur at baseline, 1 month, 3 months, 6 months, and 12 months after therapy. The primary efficacy outcome measure is Numeric Pain Rating Scale (NPRS) responders from baseline to 12 months of follow-up using validated minimal important change (MIC) thresholds. A reduction of ≥ 2 points in NPRS is considered a clinically significant pain relief. The secondary efficacy outcome measure is the proportion of Oswestry Low Back Pain Disability Scale (ODS) responders from baseline to 12 months of follow-up in the experimental group (PRF plus ACS) versus the placebo group (PRF plus PhS). ODS responders are defined as those patients achieving the validated MIC of ≥ 10-point improvement in ODS from baseline to 12 months of follow-up as a clinically significant efficacy threshold. DISCUSSION: This prospective, double-blind, randomized placebo-controlled study will provide level I evidence of the safety and effectiveness of ACS on neuropathic symptoms in LLR patients. TRIAL REGISTRATION {2A}{2B}: EUDRACT number: 2021-005124-38. Validation date: 13 November 2021. Protocol version {3}: This manuscript presents the 2nd protocol version.

Independent and Joined Association between Socioeconomic Indicators and Pediatric Obesity in Spain: The PASOS Study.

Childhood obesity is a public health problem worldwide. An important determinant of child and adolescent obesity is socioeconomic status (SES). However, the magnitude of the impact of different SES indicators on pediatric obesity on the Spanish population scale is unclear. The aim of this study was to assess the association between three SES indicators and obesity in a nationwide, representative sample of Spanish children and adolescents. A total of 2791 boys and girls aged 8 to 16 years old were included. Their weight, height, and waist circumference were measured. SES was assessed using two parent/legal guardian self-reported indicators (educational level -University/non-University- and labor market status -Employed/Unemployed-). As a third SES indicator, the annual mean income per person was obtained from the census section where the participating schools were located (≥12.731€/<12.731€). The prevalence of obesity, severe obesity, and abdominal obesity was 11.5%, 1.4%, and 22.3%, respectively. Logistic regression models showed an inverse association of both education and labor market status with obesity, severe obesity, and abdominal obesity (all p < 0.001). Income was also inversely associated with obesity (p < 0.01) and abdominal obesity (p < 0.001). Finally, the highest composite SES category (University/Employed/≥12.731€ n = 517) showed a robust and inverse association with obesity (OR = 0.28; 95% CI: 0.16-0.48), severe obesity (OR = 0.20; 95% CI: 0.05-0.81), and abdominal obesity (OR = 0.36; 95% CI: 0.23-0.54) in comparison with the lowest composite SES category (Less than University/Unemployed/<12.731€; n = 164). No significant interaction between composite SES categories and age and gender was found. SES is strongly associated with pediatric obesity in Spain.

Clinical Impact of Electronic Monitoring Devices of Inhalers in Adults with Asthma or COPD: A Systematic Review and Meta-Analysis.

We conducted a systematic review and meta-analysis to gain insight into the characteristics and clinical impact of electronic monitoring devices of inhalers (EMDs) and their clinical interventions in adult patients with asthma or COPD. The search included PubMed, Web of Science, Cochrane, Scopus and Embase databases, as well as official EMDs websites. We found eight observational studies and ten clinical trials, assessing a wide range of clinical outcomes. Results from the meta-analysis on adherence to inhalers in a period over three months were favourable in the EMD group (fixed effects model: SMD: 0.36 [0.25-0.48]; random effects model SMD: 0.41 [0.22-0.60]). An exploratory meta-analysis found an improvement in ACT score (fixed effect model SMD: 0.25 [0.11-0.39]; random effects model: SMD: 0.47 [-0.14-1.08]). Other clinical outcomes showed mixed results in the descriptive analyses. The findings of this review highlight the benefits of EMDs in the optimization of adherence to inhaled therapy as well as the potential interest in other clinical outcomes.

The Impact of Pharmaceutical Care in Multidisciplinary Teams on Health Outcomes: Systematic Review and Meta-Analysis.

OBJECTIVES: Pharmacists' care has an essential role in multidisciplinary teams in charge of chronic patients. However, data available on the clinical outcomes of these activities appear inconclusive. This study aimed to systematically investigate the effect of multidisciplinary teams that include coordinated pharmaceutical care on clinical outcomes. DESIGN: Systematic review and meta-analysis. Relevant studies identified from MEDLINE, Cochrane, Web of Science, Scopus and CINAHL databases were analyzed. The search included randomized clinical trials published in 2000-2018. Included studies were all published studies in English that compared the effectiveness of multidisciplinary teams including pharmacist care to usual care. Meta-analysis was carried out using a random effects model, and subgroup analysis was conducted to determine the sources of heterogeneity. SETTING AND PARTICIPANTS: 29 studies involving 4186 adult patients were included. MEASURES: Follow-up time varied from 30 to 180 days. The most common primary endpoint was the frequency of hospitalizations or readmissions, followed by variation in clinical parameter variables related to quality of prescription, treatment adherence and costs. RESULTS: Twelve (41.3%) of the included studies scored low risk of bias according to the AMSTAR-2 scale, the remaining 17 (58.7%) being classified as intermediate risk. The intervention of a multidisciplinary team reduced the probability of readmission by 32% [odds ratio (OR) 0.74, 95% confidence interval (CI) 0.62-0.89]. Six of the 29 (20.7%) studies included met the inclusion criteria of the meta-analysis on quality-of-life outcomes. The intervention of the multidisciplinary team represented a significant increase in patients' quality of life (OR 0.58, 95% CI 0.47-0.69). Analysis of heterogeneity showed a significant difference between the studies. No evidence of publication bias was identified. CONCLUSIONS AND IMPLICATIONS: Multidisciplinary programs that include pharmaceutical care reduce the risk of visiting hospitals and improve patients' quality of life. This review supports the importance of the pharmacists as part of multidisciplinary teams.

Observational study with the objective of determining possible correlations between GRF and muscle activation at reception after a jump in an ACL injury

INTRODUCTION: The ACL injury is considered one of the most serious injuries and usually occurs in actions that include movements with changes of direction, jump and landing. It is a common injury between the young active population and the risk in women of suffering from non-contact injury is superior to that of men. Athletes who suffer from non-contact injuries of the ACL usually have common biomechanical profiles, with landings with large values in ground reaction force (GRF) and therefore, low cushioning on landing. OBJECTIVE: To determine possible correlations between GRF and muscular activation at lading after a jump. MATERIAL AND METHODS: The type of study carried out is an observational study in which, using surface electromyography (EMG), a force platform and an electrogoniometer, the aim is to assess muscle activation and its relationship with GRF (specifically the vertical component Fz). RESULTS: Correlations have been observed between the reaction force of the soil (Fz) in the moments where the reaction force of the soil is greater and the instant where the knee reaches maximum flexion after landing, with the activation of certain muscle groups and differences depending on the gender of the subject. DISCUSSION: The neuromuscular recruitment strategies in the phases of maximum GRF load and knee flexion are different depending on the sex of the individual, so it should be considered when scheduling prevention and recovery work. CONCLUSION: The evaluation of GRF and muscle activation patterns, allows to assess the dynamics of landing after a jump and to be able to detect different patterns according to sex, with the consequent importance that it can have in the injury mechanism

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Comparative Cognitive Effects of Choreographed Exercise and Multimodal Physical Therapy in Older Adults with Amnestic Mild Cognitive Impairment: Randomized Clinical Trial.

BACKGROUND: Recent research on mild cognitive impairment (MCI) has primarily focused on searching for measures to prevent or delay the progression of MCI to dementia. Physical exercise has shown to be effective in the prevention of age-related cognitive decline in elderly adults with MCI. However, the most effective type and dose of exercise for the improvement of cognition are yet to be determined. OBJECTIVE: To compare the cognitive effects of choreographed exercise (Choreography group) with a multimodal physical therapy program (Physical Therapy group) in elderly adults with amnestic MCI, a population with an increased risk of developing dementia. METHODS: We conducted a randomized clinical trial with two parallel groups under allocation concealment and assessor blinding. Participants were allocated into Choreography or Physical Therapy group and performed exercises twice per week in 60-minute sessions during 12 weeks. RESULTS: Thirty-six participants with amnestic MCI, ages 65 to 85, were assessed at baseline and after 12 weeks of intervention, by comprehensive validated neuropsychological and physical assessments. A Repeated measures General Lineal Model showed statistically significant differences in cognitive and physical outcomes. Both groups significantly improved in visual delayed recall. The Choreography group exhibited significantly more benefits on verbal recognition memory than the Physical Therapy group. CONCLUSION: Greater cognitive benefits were achieved in the choreographic intervention than in the multimodal physical therapy, mainly in those functions more related to the risk of conversion to dementia. Additional studies are needed to confirm whether the observed effects are related to delayed onset of Alzheimer's disease in elderly adults with amnestic MCI.

Signage Interventions for Stair Climbing at Work: More than 700,000 Reasons for Caution.

Increased stair climbing reduces cardiovascular disease risk. While signage interventions for workplace stair climbing offer a low-cost tool to improve population health, inconsistent effects of intervention occur. Pedestrian movement within the built environment has major effects on stair use, independent of any health initiative. This paper used pooled data from UK and Spanish workplaces to test the effects of signage interventions when pedestrian movement was controlled for in analyses. Automated counters measured stair and elevator usage at the ground floor throughout the working day. Signage interventions employed previously successful campaigns. In the UK, minute-by-minute stair/elevator choices measured effects of momentary pedestrian traffic at the choice-point (n = 426,605). In Spain, aggregated pedestrian traffic every 30 min measured effects for 'busyness' of the building (n = 293,300). Intervention effects on stair descent (3 of 4 analyses) were more frequent than effects on stair climbing, the behavior with proven health benefits (1 of 4 analyses). Any intervention effects were of small magnitude relative to the influence of pedestrian movement. Failure to control for pedestrian movement compromises any estimate for signage effectiveness. These pooled data provide limited evidence that signage interventions for stair climbing at work will enhance population health.

A case-control study of psychosocial factors and their relationship to impairment and functionality in multiple sclerosis.

The stress effect on multiple sclerosis remains unclear. Moderating psychosocial factors may be involved. This study compares some of them in people with multiple sclerosis and healthy controls, and their association with disease parameters. Coping style, social support, anxiety, alexithymia and early-life stress were measured, along with impairment and functionality. People with multiple sclerosis scored significantly higher on anxiety, alexithymia, and avoidance and instinctive coping but lower in social support. No differences were found in early-life stress. Impairment was related to avoidance, and functionality to avoidance and anxiety. Psychotherapeutic approaches focused on these psychosocial factors may improve functionality, impairment and quality of life in people with multiple sclerosis.

Can a workplace 'sit less, move more' programme help Spanish office employees achieve physical activity targets?

We evaluated the impact of a workplace 'sit less, move more' programme (Walk@WorkSpain, W@WS, 19-week) on self-reported activity-related energy expenditure (AREE) in Spanish office employees (n = 264; 42 ± 10 years; 171 female) randomly assigned to Intervention (IG; used W@WS; n = 129) or comparison groups (CGs; n = 135). A linear mixed model assessed changes in METs-min/wk of total, vigorous, moderate and light physical activity (IPAQ short form) between baseline and 2 months follow-up. Over the CG, IG significantly increased light intensity AREE (P = 0.027). W@WS secured sustained increases on AREE-but not on achieving PA recommendations-providing translational evidence that active living in office employees can be increased.

Impact of a workplace 'sit less, move more' program on efficiency-related outcomes of office employees.

BACKGROUND: Few studies have examined the impact of 'sit less, move more' interventions on workplace performance. This study assessed the short and mid-term impacts of and patterns of change within, a 19-week workplace web-based intervention (Walk@WorkSpain; W@WS; 2010-11) on employees´ presenteeism, mental well-being and lost work performance. METHODS: A site randomised control trial recruited employees at six Spanish university campuses (n = 264; 42 ± 10 years; 171 female), assigned by worksite and campus to an Intervention (IG; used W@WS; n = 129; 87 female) or an active Comparison group (A-CG; pedometer, paper diary and self-reported sitting time; n = 135; 84 female). A linear mixed model assessed changes between the baseline, ramping (8 weeks), maintenance (11 weeks) and follow-up (two months) phases for the IG versus A-CG on (i) % of lost work productivity (Work Limitations Questionnaire; WLQ); (ii) three scales for presenteeism (WLQ) assessing difficulty meeting scheduling demands (Time), performing cognitive and inter-personal tasks (Mental-Interpersonal) and decrements in meeting the quantity, quality and timeliness of completed work (Output); and (iii) mental well-being (Warwick-Edinburgh Mental Well-being Scale). T-tests assessed differences between groups for changes on the main outcomes. In the IG, a multivariate logistic regression model identified patterns of response according to baseline socio-demographic variables, physical activity and sitting time. RESULTS: There was a significant 2 (group) × 2 (program time points) interaction for the Time (F [3]=8.69, p = 0.005), Mental-Interpersonal (F [3]=10.01, p = 0.0185), Output scales for presenteeism (F [3]=8.56, p = 0.0357), and for % of lost work performance (F [3]=10.31, p = 0.0161). Presenteeism and lost performance rose significantly in both groups across all study time points; after baseline performance was consistently better in the IG than in the A-CG. Better performance was linked to employees being more active (Time, p = 0.041) and younger (Mental-interpersonal, p = 0.057; Output, p = 0.017). Higher total sitting time during nonworking days (Mental-interpersonal, p = 0.019) and lower sitting time during workdays (WLQ Index, p = 0.013) also improved performance. CONCLUSION: Versus an active comparison condition, a 'sit less, move more` workplace intervention effectively reduced an array of markers of lost workday productivity. TRIAL REGISTRATION: NCT02960750 ; Date of registration: 07/11/2016.

Patterns of impact resulting from a 'sit less, move more' web-based program in sedentary office employees.

PURPOSE: Encouraging office workers to 'sit less and move more' encompasses two public health priorities. However, there is little evidence on the effectiveness of workplace interventions for reducing sitting, even less about the longer term effects of such interventions and still less on dual-focused interventions. This study assessed the short and mid-term impacts of a workplace web-based intervention (Walk@WorkSpain, W@WS; 2010-11) on self-reported sitting time, step counts and physical risk factors (waist circumference, BMI, blood pressure) for chronic disease. METHODS: Employees at six Spanish university campuses (n=264; 42±10 years; 171 female) were randomly assigned by worksite and campus to an Intervention (used W@WS; n=129; 87 female) or a Comparison group (maintained normal behavior; n=135; 84 female). This phased, 19-week program aimed to decrease occupational sitting time through increased incidental movement and short walks. A linear mixed model assessed changes in outcome measures between the baseline, ramping (8 weeks), maintenance (11 weeks) and follow-up (two months) phases for Intervention versus Comparison groups. RESULTS: A significant 2 (group) × 2 (program phases) interaction was found for self-reported occupational sitting (F[3]=7.97, p=0.046), daily step counts (F[3]=15.68, p=0.0013) and waist circumference (F[3]=11.67, p=0.0086). The Intervention group decreased minutes of daily occupational sitting while also increasing step counts from baseline (446±126; 8,862±2,475) through ramping (+425±120; 9,345±2,435), maintenance (+422±123; 9,638±3,131) and follow-up (+414±129; 9,786±3,205). In the Comparison group, compared to baseline (404±106), sitting time remained unchanged through ramping and maintenance, but decreased at follow-up (-388±120), while step counts diminished across all phases. The Intervention group significantly reduced waist circumference by 2.1cms from baseline to follow-up while the Comparison group reduced waist circumference by 1.3cms over the same period. CONCLUSIONS: W@WS is a feasible and effective evidence-based intervention that can be successfully deployed with sedentary employees to elicit sustained changes on "sitting less and moving more".

Stress and multiple sclerosis: A systematic review considering potential moderating and mediating factors and methods of assessing stress.

Research about the effects of stress on multiple sclerosis has yielded contradictory results. This study aims to systematically review the evidence focusing on two possible causes: the role of stress assessment and potential moderating and mediating factors. The Web of Knowledge (MEDLINE and Web of Science), Scopus, and PsycINFO databases were searched for relevant articles published from 1900 through December 2014 using the terms "stress*" AND "multiple sclerosis." Twenty-three articles were included. Studies focused on the effect of stress on multiple sclerosis onset (n = 9) were mostly retrospective, and semi-structured interviews and scales yielded the most consistent associations. Studies focused on multiple sclerosis progression (n = 14) were mostly prospective, and self-reported diaries yielded the most consistent results. The most important modifying factors were stressor duration, severity, and frequency; cardiovascular reactivity and heart rate; and social support and escitalopram intake. Future studies should consider the use of prospective design with self-reported evaluations and the study of moderators and mediators related to amount of stress and autonomic nervous system reactivity to determine the effects of stress on multiple sclerosis.

"Cooking and Active Leisure" TAS Program, Spain: a Program Impact Pathways (PIP) analysis.

BACKGROUND: The "Cooking and Active Leisure" Tu y Alícia por la Salud (CAL-TAS) Program is a school-based pilot that addresses healthy lifestyle needs of Spanish secondary school students with initiatives that research has proven to improve dietary and physical activity behaviors. OBJECTIVE: The objectives were to perform a Program Impact Pathways (PIP) analysis to describe key activities and processes of the CAL-TAS Program, identify Critical Quality Control Points (CCPs), and identify a suite of common indicators of healthy lifestyles to be applied across participant schools. METHODS: The CAL-TAS Program designers and implementation team developed this PIP analysis through an iterative process and presented the results for feedback at the seven-country Healthy Lifestyles Program Evaluation Workshop held in Granada, Spain, 13-14 September 2013, under the auspices of the Mondelez International Foundation. RESULTS: The team identified three PIP CCPs: teachers' motivation and training, changes in students' knowledge of healthy lifestyles, and changes in students' healthy lifestyle behavior. The selected indicators of the program's impact on healthy lifestyles are adequacy of food intake, level of knowledge of healthy lifestyles gained, and adequacy of physical activity level according to World Health Organization recommendations. A clear definition of impact indicators, as well as collection of accurate data on healthy lifestyle behaviors and knowledge, is essential to understanding the effectiveness of this program before it can be scaled up. CONCLUSIONS: CAL-TAS is an effective secondary school-based program encouraging healthy lifestyles. The PIP analysis was instrumental in identifying CCPs to sustain and improve the quality of the program. The team hopes to sustain and improve the program through these program evaluation recommendations.