Risultati per: LBP (Low Back Pain): Cosa dicono le linee guida del mal di schiena

Introduction
Although evidence-based guidelines recommend non-pharmacologic treatments as first-line care for chronic low back pain (LBP), uptake has been limited, particularly in rural, low-income and ethnically diverse communities. The BeatPain study will evaluate the implementation and compare the effectiveness of two strategies to provide non-pharmacologic treatment for chronic LBP. The study will use telehealth to overcome access barriers for persons receiving care in federally qualified health centres (FQHCs) in the state of Utah.

Methods and analysis
BeatPain Utah is a pragmatic randomised clinical trial with a hybrid type I design investigating different strategies to provide non-pharmacologic care for adults with chronic LBP seen in Utah FQHCs. The intervention strategies include a brief pain consult (BPC) and telehealth physical therapy (PT) component provided using either an adaptive or sequenced delivery strategy across two 12-week treatment phases. Interventions are provided via telehealth by centrally located physical therapists. The sequenced delivery strategy provides the BPC, followed by telehealth PT in the first 12 weeks for all patients. The adaptive strategy uses a stepped care approach and provides the BPC in the first 12 weeks and telehealth PT to patients who are non-responders to the BPC component. We will recruit 500 English-speaking or Spanish-speaking participants who will be individually randomised with 1:1 allocation. The primary outcome is the Pain, Enjoyment and General Activity measure of pain impact with secondary outcomes including the additional pain assessment domains specified by the National Institutes (NIH) of Health Helping to End Addiction Long Initiative and implementation measures. Analyses of primary and secondary measures of effectiveness will be performed under longitudinal mixed effect models across assessments at baseline, and at 12, 26 and 52 weeks follow-ups.

Ethics and dissemination
Ethics approval for the study was obtained from the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with NIH data sharing policies.

Trial registration number
NCT04923334.

Introduction
Neuromuscular electrical stimulation (NMES) as an adjunctive strategy to increase isolated muscular strength or endurance has been widely investigated in patients with chronic kidney disease (CKD) undergoing haemodialysis (HD). However, the efficacy of combined low and high frequencies, to improve both muscular strength and endurance, is unknown. This trial aims to evaluate the efficacy of this combined NMES strategy in this population.

Methods and analysis
This is a randomised controlled trial with blinded assessments and analysis. A total of 56 patients with CKD undergoing HD will be recruited and randomised to an NMES protocol. The evaluations will be performed on three different days at baseline and after 24 sessions of follow-up. Assessments will include the background, insulin-like growth factor, lactate measurement, malnutrition and inflammation score evaluation, an electrical bioimpedance examination, global muscular evaluation by means of the Medical Research Council scale, handgrip strength evaluation, muscular isokinetic evaluation of lower limbs, 6 min step test performance and quality of life (QoL) questionnaire with emphasis on physical function. The patients will be allocated in one of the following four groups: 1) combined low and high frequencies; 2) low frequency; 3) high frequency; and 4) sham stimulation with minimal intensity to generate only sensory perception (with no visible contraction). In all groups, the intensity throughout the session will be the highest tolerated by patient (except for control group). The primary endpoint is the change of peripheral muscle function (muscular strength and endurance). The secondary endpoints will be the changes of body composition; muscle trophism; exercise tolerance; QoL; and nutritional, inflammatory, and metabolic markers. The findings of this study are expected to provide valuable knowledge on how to optimise the NMES intervention, with improvements in both muscle strength and endurance.

Ethics and dissemination
This protocol has been approved by the Ethics Committee on Research with Humans of Hospital Sírio-Libanês (approval no. 24337707). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.

Trial registration number
NCT03779126

Introduction
Chronic pain, defined as pain persisting longer than 3 months, is more than an unpleasant sensory experience. Persistent negative emotions and emotional comorbidities, such as depression and anxiety, plague people with chronic pain leading to worsening pain intensity and increasing disability. While cognitive–behavioural therapy (CBT) is the gold standard psychological treatment, recent evidence highlights that CBT lacks efficacy for the physical and emotional aspects of chronic pain. Increasingly, researchers are investigating emotion-centric psychological therapies. While treatment modalities vary, these interventions frequently target understanding emotions, and train individuals for an emotionally adaptive response. The aim of this systematic review and meta-analysis is to quantify the efficacy of emotion-centric interventions for the physical and emotional characteristics of chronic pain.

Methods/analysis
Electronic databases (EMBASE, PubMed, PsychINFO, Cochrane Central Register of Controlled Trials, CINAHL and Web of Science) will be systematically searched from inception to 28 April 2022 for randomised controlled trials. Studies that compare an emotion-centric intervention with another form of treatment or placebo/control for adults (≥18 years old) with chronic pain will be included. All treatment modes (eg, online or in-person), any duration and group-based or individual treatments will be included. Studies that do not investigate at least one emotion-centric treatment will be excluded. The primary outcome is pain intensity. Secondary outcomes include emotion dysregulation, depression, anxiety, affect, safety and intervention compliance. A quantitative synthesis using a random effects meta-analysis will be adopted. Risk of bias will be evaluated using Cochrane Risk of Bias V.2.0 with the certainty of evidence assessed according to Recommendation, Assessment, Development and Evaluation. Data permitting, subgroup analysis will be conducted for intervention type and pain condition.

Ethics and dissemination
Ethical approval is not required for this systematic review. Results may inform an efficacy study examining a new emotion-centric intervention for chronic pain. Dissemination will be through peer-reviewed publications and in conference presentations.

PROSPERO registration number
CRD42021266815.

Objective
To support evidence informed decision-making, we systematically examine the effectiveness and cost-effectiveness of community engagement interventions on routine childhood immunisation outcomes in low-income and middle-income countries (LMICs) and identify contextual, design and implementation features associated with effectiveness.

Design
Mixed-methods systematic review and meta-analysis.

Data sources
21 databases of academic and grey literature and 12 additional websites were searched in May 2019 and May 2020.

Eligibility criteria for selecting studies
We included experimental and quasi-experimental impact evaluations of community engagement interventions considering outcomes related to routine child immunisation in LMICs. No language, publication type, or date restrictions were imposed.

Data extraction and synthesis
Two independent researchers extracted summary data from published reports and appraised quantitative risk of bias using adapted Cochrane tools. Random effects meta-analysis was used to examine effects on the primary outcome, full immunisation coverage.

Results
Our search identified over 43 000 studies and 61 were eligible for analysis. The average pooled effect of community engagement interventions on full immunisation coverage was standardised mean difference 0.14 (95% CI 0.06 to 0.23, I2=94.46). The most common source of risk to the quality of evidence (risk of bias) was outcome reporting bias: most studies used caregiver-reported measures of vaccinations received by a child in the absence or incompleteness of immunisation cards. Reasons consistently cited for intervention success include appropriate intervention design, including building in community engagement features; addressing common contextual barriers of immunisation and leveraging facilitators; and accounting for existing implementation constraints. The median intervention cost per treated child per vaccine dose (excluding the cost of vaccines) to increase absolute immunisation coverage by one percent was US$3.68.

Conclusion
Community engagement interventions are successful in improving outcomes related to routine child immunisation. The findings are robust to exclusion of studies assessed as high risk of bias.

Introduction
Persistent heel pain is a prevalent complaint affecting up to 10% of the population. Insoles adapted in flip-flop sandals are an alternative treatment for pain and function of individuals with persistent heel pain, showing improvement within 12 weeks of treatment. Most studies considered foot posture and biomechanics to prescribe insoles for persistent heel pain, but few verified the effects of a 12-week treatment on pain catastrophising. This study will investigate the effects of insoles adapted in flip-flop sandals on pain intensity, function, functional walking capacity and pain catastrophising of individuals with persistent heel pain.

Methods and analysis
This is a protocol for a sham-controlled randomised trial. Eighty individuals with persistent heel pain will be assessed and randomised into two intervention groups: insoles adapted in flip-flop sandals and flip-flop sandals with sham (ie, flat) insoles. Assessments will be conducted at baseline (T0), after 6 weeks (T6), 12 weeks postintervention (T12) and after a 4-week follow-up (T16). The primary outcome will be the pain intensity, and secondary outcomes will be foot function, functional walking capacity and pain catastrophising. Analysis of variance with mixed design (if normal distribution) or Friedman’s test (if not normal distribution) will verify intergroup and intragroup differences. Bonferroni post hoc tests will be performed in case of significant group or time interaction. Intent-to-treat analysis will be used, and a significance level of 5% and 95% CIs will be considered.

Ethics and dissemination
This study was approved by the research ethics committee of the Federal University of Rio Grande do Norte (registry no. 4,018,821). Results will be disseminated to individuals, submitted to a peer-reviewed journal and disclosed in scientific meetings.

Trial registration number
NCT04784598.

In Gut, Olesen et al present the first comprehensive multicentre cross-sectional study of pain in prospectively enrolled chronic pancreatitis (CP) patients.1 It is demonstrated that pain-related factors are often overlapping in these patients and have a cumulative detrimental effect on patient-reported outcomes. One might argue that the results of this study are lacking novelty, but there are several reasons why such studies are urgently warranted. Pain, may it be acute, recurring or chronic, is one of the cardinal symptoms of CP and impacts patients’ well-being significantly.2 Thus far, several efforts have been conducted to improve the treatment of painful CP, with variable outcome. At first it is interesting to note, that the methodology to quantify pain for most of the published efforts was not validated in CP patients before and as such results obtained in these studies might not truly reflect the patients’ situation.

Objective
Several factors have been suggested to mediate pain in patients with chronic pancreatitis. However, it is unknown whether these factors are overlapping and if they have cumulative effects on patient-reported outcomes (PROs).

Design
We performed a multicentre cross-sectional study of 201 prospectively enrolled subjects with definitive chronic pancreatitis. All subjects underwent evaluation for pancreatic duct obstruction, abnormalities in pain processing using quantitative sensory testing, and screening for psychological distress (anxiety, depression and pain catastrophising) based on validated questionnaires. Abnormality was defined by normal reference values. PROs included pain symptom severity (Brief Pain Inventory short form) and quality of life (EORTC-QLQ-C30 questionnaire). Associations between pain-related factors and PROs were investigated by linear trend analyses, multiple regression models and mediation analyses.

Results
Clinical evaluation suggestive of pancreatic duct obstruction was observed in 29%, abnormal pain processing in 23%, anxiety in 47%, depression in 39% and pain catastrophising in 28%; each of these factors was associated with severity of at least one PRO. Two or more factors were present in 51% of subjects. With an increasing number of factors, there was an increase in pain severity scores (p

Objective
This study aimed to identify the associated factors of low and medium household (HH) dietary diversity (DD) compared with high DD among marginalised households in rural Bangladesh.

Methods
Through the Suchana baseline survey, data on 5440 households from Sylhet and Moulvibazar districts of Bangladesh was collected between November 2016 and February 2017. Household DD was categorised as low, medium or high based on number of food groups consumed during the last 24 hours. Primary outcome measure was household DD; multinomial logistic regression was to determine independent correlations between outcome and independent variables.

Results
Of the households examined, 0.72%, 31.8% and 67.5% had low, medium and high DD, respectively. Around 99% and 97% of households consumed cereals and vegetables. Cereals, fruits and legumes accounted for 36%, 18% and 16% of total food expenditure; vegetables only represented 8% of total expenditure; 70% of total monthly expenditure was on food items. Compared with high DD, low DD was significantly associated with severe food insecurity, not receiving remittance, not being supported by social safety-net programs, household size of 6–10, household income and expenditure on food below-median. Severe food insecurity was the strongest predictor of low DD. Age, occupation and educational status of the household head, amount of land owned and presence of a homestead garden, fish production and domestic violence were not significantly associated with DD.

Conclusion
Our findings suggest that nine out of ten households were food insecure, and nearly two-thirds of households had high DD. Severe food insecurity was significantly associated with low DD. Expenditure on food items amounted to nearly two-thirds of total household expenditure. Diversification of income-generating activities would provide more sources of income to the households, allowing the households to spend more on non-cereal food items and increase the household dietary diversity.

New England Journal of Medicine, Ahead of Print.

Objectives
The aim of the study was to evaluate recovery of participation in post-COVID-19 patients during the first year after intensive care unit (ICU) discharge. The secondary aim was to identify the early determinants associated with recovery of participation.

Design
Prospective cohort study.

Setting
COVID-19 post-ICU inpatient rehabilitation in the Netherlands, during the first epidemic wave between April and July 2020, with 1-year follow-up.

Participants
COVID-19 ICU survivors ≥18 years of age needing inpatient rehabilitation.

Main outcome measures
Participation in society was assessed by the ‘Utrecht Scale for Evaluation of Rehabilitation-Participation’ (USER-P) restrictions scale. Secondary measures of body function impairments (muscle force, pulmonary function, fatigue (Multidimensional Fatigue Inventory), breathlessness (Medical Research Council (MRC) breathlessness scale), pain (Numerical Rating Scale)), activity limitations (6-minute walking test, Patient reported outcomes measurement information system (PROMIS) 8b), personal factors (coping (Utrecht Proactive Coping Scale), anxiety and depression (Hospital Anxiety and Depression Scale), post-traumatic stress (Global Psychotrauma Screen—Post Traumatic Stress Disorder), cognitive functioning (Checklist for Cognitive Consequences after an ICU-admission)) and social factors were used. Statistical analyses: linear mixed-effects model, with recovery of participation levels as dependent variable. Patient characteristics in domains of body function, activity limitations, personal and social factors were added as independent variables.

Results
This study included 67 COVID-19 ICU survivors (mean age 62 years, 78% male). Mean USER-P restrictions scores increased over time; mean participation levels increasing from 62.0, 76.5 to 86.1 at 1, 3 and 12 months, respectively. After 1 year, 50% had not fully resumed work and restrictions were reported in physical exercise (51%), household duties (46%) and leisure activities (29%). Self-reported complaints of breathlessness and fatigue, more perceived limitations in daily life, as well as personal factors (less proactive coping style and anxiety/depression complaints) were associated with delayed recovery of participation (all p value

Annals of Internal Medicine, Ahead of Print.

This randomized clinical trial compares the short-term efficacy of laparoscopic surgery vs open surgery for treatment of low rectal cancer.