Risultati per: Low Back Pain: raccomandazioni

Introduction
Wearable neuromuscular and biomechanical biofeedback technology has the potential to improve patient outcomes by facilitating exercise interventions. We will conduct a systematic review to examine whether the addition of wearable biofeedback to exercise interventions improves pain, disability and quality of life beyond exercise alone for adults with chronic non-specific spinal pain. Specific effects on clinical, physiological, psychological, exercise adherence and safety outcomes will also be examined.

Methods and analysis
A systematic search will be conducted from inception to February 2024. Full articles in the English language will be included. MEDLINE, PubMed, CINAHL, EMBASE, Web of Science, PsycINFO, AMED, SPORTDiscus, CENTRAL databases, clinical trial registries and ProQuest (PQDT) will be used to search for eligible studies. Grey literature and conference proceedings (2022–2024) will be searched for relevant reports. Randomised controlled trials using wearable neuromuscular or kinematic biofeedback devices as an adjunct to exercise interventions for the treatment of chronic spinal pain will be included in this systematic review. The comparators will be wearable biofeedback with exercise versus exercise alone, or wearable biofeedback with exercise versus placebo and exercise. Risk of bias will be assessed using Cochrane Back Review Group criteria and the quality of evidence using Grading of Recommendations Assessment, Development and Evaluation recommendations.

Ethics and dissemination
The systematic review will be based on published studies, and therefore, does not require ethical approval. The study results will be submitted for publication in an international, open-access, peer-reviewed journal and shared through conferences and public engagement.

PROSPERO registration number
CRD42023481393.

Introduction
Upper limb problems have a significant impact on the global population leading to pain and restricted joint mobility, ultimately impacting their quality of life. Traditional treatments, such as non-steroidal anti-inflammatory drugs and corticosteroids, often come with undesirable side effects, prompting patients to seek alternative therapies. In this trial, we hypothesise that soothing cream gel (SCG) will improve range of motion and chronic pain in the shoulder and elbow. The objective of this trial is to evaluate the efficacy of SCG in improving the range of motion and chronic pain in the shoulder and elbow.

Methods and analysis
A double-blinded, randomised, placebo-controlled trial is conducted to compare the effects of SCG and placebo gel. SCG contains Vitis vinifera essence, Melaleuca viridiflora essential oil, etc, and is manufactured according to Good Manufacturing Practice standards. The placebo gel will be processed with similar appearance, texture and scent but will lack active ingredients. 70 participants with upper limb problems will be recruited from four study sites, including clinical centres and a sport department at the Chinese University of Hong Kong (CUHK). Participants will be randomly assigned to either treatment group or placebo group for 2 weeks. Primary outcome will be the range of motion in the upper limb, assessed by a goniometer, to measure active flexion and abduction for the shoulder, and active flexion and extension for the elbow. The primary efficacy analyses will be based on the full analysis set following the intention-to-treat principle.

Ethics and dissemination
The trial has obtained approval from the joint CUHK–New Territories East Cluster (CRE-2023.142), and the patient enrolment commenced in July 2023. Written informed consent will be obtained from all participants prior to participation. Study results will be disseminated through publication in peer-reviewed journals and presentations at conference.

Trial registration number
NCT05799391.

Introduction
Pregnancies resulting from in vitro fertilisation are associated with an increased risk of developing hypertensive disorders of pregnancy, such as preeclampsia, when compared with naturally conceived pregnancies.

Objective
The efficacy of aspirin prophylaxis to reduce the incidence of preeclampsia is well established in naturally conceived pregnancies identified as high risk for developing preeclampsia. However, the efficacy of aspirin to reduce the rate of preeclampsia for all pregnancies resulting from in vitro fertilisation remains uncertain, although in vitro fertilisation conception is a well-known risk factor for preeclampsia. Therefore, the purpose of this scoping review is to provide a comprehensive overview of the current literature regarding the use of low-dose aspirin to prevent hypertensive disorders of pregnancy after in vitro fertilisation.

Inclusion criteria
This review will identify all peer-reviewed published articles including pregnant women who underwent embryo transfer after in vitro fertilisation and were prescribed low-dose aspirin to reduce the risk of hypertensive disorders of pregnancy.

Methods
We have devised a comprehensive search strategy to systematically identify pertinent studies published from January 2000 until May 2024, within the Medline (PubMed interface), Embase and Scopus databases. The search strategy is based on the keywords ‘aspirin,’ ‘pregnancy-induced hypertension,’ and (‘in vitro fertilization’ OR ‘oocyte donation’ OR ‘embryo transfer’ OR ‘donor conception’). Two reviewers will independently screen the titles, abstracts and full-text articles to select the relevant articles, using the Covidence software.

Ethics and dissemination
No patients are involved in this study. This study aims to be published in a peer-reviewed journal and could be presented at a conference.

Introduction
Non-ventilator-associated hospital-acquired pneumonia (nv-HAP) is the most common healthcare-associated infection (HCAI), is associated with high mortality and morbidity and places a major burden on healthcare systems. Diagnosis currently relies on chest x-rays to confirm pneumonia and sputum cultures to determine the microbiological cause. This approach leads to over-diagnosis of pneumonia, rarely identifies a causative pathogen and perpetuates unnecessary and imprecise antibiotic use. The HAP-FAST study aims to evaluate the feasibility of a randomised trial to evaluate the clinical impact of low-dose, non-contrast-enhanced thoracic CT scans and rapid molecular sputum analysis using the BIOFIRE® FILMARRAY® pneumonia plus panel (FAPP) for patients suspected with nv-HAP.

Methods and analysis
The HAP-FAST feasibility study consists of a pilot randomised trial, a qualitative study, a costing analysis and exploratory analyses of clinical samples to investigate the immune-pathophysiology of HAP. Participants are identified and recruited from four acute hospitals in the Northwest of the UK. Using a Research Without Prior Consent model, the pilot trial will recruit 220 adult participants, with or without mental capacity, and with suspected HAP. HAP-FAST is a non-blinded, sequential, multiple assignment, randomised trial with two possible stages of randomisation: first, chest x-ray (CXR) or CT; second, if treated as nv-HAP, FAPP or standard microbiological processing alone (no FAPP). Pathogen-specific antibiotic guidance will be provided for FAPP results. Randomisation uses a web-based platform and followed up for 90 days. The feasibility of a future trial will be determined by assessing trial processes, outcome measures and patient and staff experiences.

Ethics and dissemination
This study has undergone combined review by the UK NHS Research Ethics Committee and Health Research Authority. Results will be disseminated via peer-reviewed journals, via the funders’ website and through a range of media to engage the public.

Trial registration number
NCT05483309.

Objectives
Research indicates that people with lower socioeconomic status (SES) receive inferior healthcare and experience poorer health outcomes compared with those with higher SES, in part due to health professional (HP) bias. We conducted a scoping review of the impact of HP bias about SES on clinical decision-making and its effect on the care of adults with lower SES.

Design
JBI scoping review methods were used to perform a systematic comprehensive search for literature. The scoping review protocol has been published in BMJ Open.

Data sources
Medline, Embase, ASSIA, Scopus and CINAHL were searched, from the first available start date of the individual database to March 2023. Two independent reviewers filtered and screened papers.

Eligibility criteria
Studies of all designs were included in this review to provide a comprehensive map of the existing evidence of the impact of HP bias of SES on clinical decision-making and its effect on the care for people with lower SES.

Data extraction and synthesis
Data were gathered using an adapted JBI data extraction tool for systematic scoping reviews.

Results
Sixty-seven papers were included from 1975 to 2023. 35 (73%) of the included primary research studies reported an association between HP SES bias and decision-making. Thirteen (27%) of the included primary research studies did not find an association between HP SES bias and decision-making. Stereotyping and bias can adversely affect decision-making when the HP is fatigued or has a high cognitive load. There is evidence of intersectionality which can have a powerful cumulative effect on HP assessment and subsequent decision-making. HP implicit bias may be mitigated through the assertiveness of the patient with low SES.

Conclusion
HP decision-making is at times influenced by non-medical factors for people of low SES, and assumptions are made based on implicit bias and stereotyping, which compound or exacerbate health inequalities. Research that focuses on decision-making when the HP has a high cognitive load, would help the health community to better understand this potential influence.

In a placebo-controlled trial, topical diclofenac plus oral ibuprofen wasn’t better than ibuprofen alone.

Men with endogenous testosterone levels lower than 213 ng/dL tended to have a higher risk of dying from any cause, according to an analysis of data from 11 studies involving more than 24 100 participants. Although testosterone levels vary by age, the cut-off for low testosterone concentrations is less than 300 ng/dL, based on the American Urological Association’s definition. Very low concentrations of testosterone—less than 153 ng/dL—were also associated with higher chance of dying from cardiovascular disease specifically.

Introduction
Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery.

Methods and analyses
This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways.

Ethics and dissemination
This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH—Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals.

Trial registration number
Clinical Trials Platform (https://clinicaltrials.gov/) with the number NCT05816798.

Rationale
Acute hypoxaemic respiratory failure (AHRF) is associated with high mortality in sub-Saharan Africa. This is at least in part due to critical care-related resource constraints including limited access to invasive mechanical ventilation and/or highly skilled acute care workers. Continuous positive airway pressure (CPAP) and high-flow oxygen by nasal cannula (HFNC) may prove useful to reduce intubation, and therefore, improve survival outcomes among critically ill patients, particularly in resource-limited settings, but data in such settings are lacking. The aim of this study is to determine whether CPAP or HFNC as compared with standard oxygen therapy, could reduce mortality among adults presenting with AHRF in a resource-limited setting.

Methods
This is a prospective, multicentre, randomised, controlled, stepped wedge trial, in which patients presenting with AHRF in Uganda will be randomly assigned to standard oxygen therapy delivered through a face mask, HFNC oxygen or CPAP. The primary outcome is all-cause mortality at 28 days. Secondary outcomes include the number of patients with criteria for intubation at day 7, the number of patients intubated at day 28, ventilator-free days at day 28 and tolerance of each respiratory support.

Ethics and dissemination
The study has obtained ethical approval from the Research and Ethics Committee, School of Biomedical Sciences, College of Health Sciences, Makerere University as well as the Uganda National Council for Science and Technology. Patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT04693403.

Protocol version
8 September 2023; version 5.

Families must juggle many different expenses, including housing, utilities, food, transportation, medical care, and child care. When any of these expenses eat up too much of a family’s budget, there is a problem. This is particularly a problem for families with a low income because many expenses are not proportional to income.

In Reply In the response from Hogans to our study describing the effects of telehealth Mindfulness-Oriented Recovery Enhancement (MORE), they note that baseline Brief Pain Inventory (BPI) scores differed from the initial ecological momentary assessment (EMA) rating of pain and question whether this discrepancy relates to either a pain spike in the intervention group or excessive variance. It is unlikely that any potential increase in pain was due to MORE, given that MORE significantly reduced pain in our pilot study in the same population of patients with pain and opioid use disorder receiving methadone treatment, and MORE produced significant reductions in pain relative to active control conditions across 10 effect sizes from randomized clinical trials (RCTs) in a recent meta-analysis (standardized mean change = 0.60; 95% CI, −0.83 to −0.37; P 

To the Editor In their article describing the effects of telehealth mindfulness on opioid use reduction, Cooperman and colleagues include pain as a secondary outcome. Pain is assessed at baseline, 8 weeks, and 16 weeks using the Brief Pain Inventory (BPI), and twice daily throughout using Ecological Momentary Assessment (EMA). At baseline, BPI pain scores are 5.1 and 5.2 (intervention and comparison, respectively); initial EMA pain scores are 5.79 and 5.19, respectively. This potentially suggests either a pain spike in the intervention group or excessive variance. After treatment, EMA pain scores are 5.17 and 4.97 respectively; it appears that the treatment-induced pain decrease has brought treatment-group pain levels back to just above baseline. Interpretation is limited as final BPI values and EMA time course data are not provided. Although the provided protocol does not include specific timeline details, it is not uncommon for randomization to follow baseline testing; typically, this promotes baseline outcome similarity. If, as we postulate, randomization occurred after BPI baseline and before initial EMAs, then assignment to intervention, with frequent therapy and video-supervised drug testing, may have prompted elevated EMA pain scores. Perhaps treatment assignment had an impact, but clarifying data are not provided. A minor concern is that the study protocol proposed that BPI analysis would average all 4 elements at baseline, 8 weeks, and 16 weeks; instead, the article included just 1 BPI component and only at baseline. A second important concern: EMA pain score modeling uses a normal distribution term to represent intraindividual pain score variability. Normal distributions do not adequately capture variation in pain scores, especially those obtained outside controlled laboratory settings where pain score variation typically exceeds that of normal distributions. Increasingly, zero-inflated distributions are used to represent the intrinsic variability of pain scores. The authors use zero-inflated distributions to model substance use; inclusion of such to represent pain could be preferrable. No mention is made of any correction for multiple comparisons; this is a minor concern but potentially impactful. Finally, the authors indicate in the discussion that the decrease in treatment group EMA pain scores meets Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) criteria for significant change, but this is not correct. The referenced IMMPACT criteria specify that pain score changes of 15% to 20% are considered minimally significant. A change of 11%, which may actually represent a return to prerandomization baseline, and a secondary outcome at that, is not minimally significant.

Stroke, Ahead of Print. BACKGROUND:This study aimed to quantify the global stroke burden attributable to low physical activity and high body mass index in adults aged ≥55 years using data from the Global Burden of Disease 2019 study.METHODS:We extracted data on stroke mortality, disability-adjusted life years, and risk factor exposure from the Global Burden of Disease 2019 study for people aged ≥55 years. We calculated the population-attributable fraction and absolute number of stroke cases and disability-adjusted life years attributable to low physical activity and high body mass index by location, age group, sex, and year.RESULTS:Globally, body mass index and physical inactivity-attributable stroke burden have declined modestly since 1990, but with diverging escalatory regional trajectories. Population growth and aging drive this rising burden.CONCLUSIONS:Multidimensional, context-specific strategies focused on modifiable lifestyle risks are imperative to address the modest declines and escalatory regional trajectories in body mass index and physical inactivity-attributable stroke burden.

Objective
To explore if there are differences in the design and/or conduct of studies that have tested the STarTBack treatment approach for the management of low back pain (LBP), potentially explaining differences in study results.

Design
A literature review.

Data sources
MEDLINE, CINAHL and EMBASE were searched from inception to 26 July 2023.

Eligibility criteria
We included studies that included (1) participants with LBP and/or leg pain, (2) randomised controlled trials, controlled clinical trials and interrupted time series designs, (3) used the STarTBack Tool to stratify participants into subgroups and (4) studies provided matched treatments according to participants STarTBack score.

Data extraction and synthesis
Two review authors independently reviewed the search results and extracted data into the data extraction form. Due to the exploratory nature of this study, results are presented descriptively.

Results
11 studies conducted across 5 countries were included. There were substantial differences in the proportion of participants allocated to the different risk groups; low-risk group (range: 19%–58%), medium risk group (range: 31%–52%) and high-risk group (range: 6%–38%). There were large differences between studies in the implementation of the STarTBack approach. The original STarTBack trial (Hill et al, 2011) had a more explanatory design while in many subsequent studies, the design was more pragmatic/real world. Only the two original studies provided clear evidence that the implementation of the STarTBack tool led to a higher proportion of participants receiving matched treatment. In the other studies, there was no evidence of a difference, or it was unclear. In two studies, a researcher made the decision about which matched treatment participants received based on the STartTback Tool, while in nine studies, this was done by a clinician. Most studies recommended the same matched treatment for each risk group as per the original study except for a small number of studies. Only three studies reported whether the clinician delivering matched treatment followed the recommended treatment as per the tool. There was substantial variability in the training clinicians received.

Conclusions
Reporting of important study-level factors (eg, differences in study design, whether clinicians were trained and how the tool was used in each study) in how the STarTBack approach was implemented was unclear. There is some suggestion that key factors may include the individual who implemented the STarTBack tool, whether the recommendations of the tool were followed, the amount of training the clinician delivering the matched treatment received, and whether clinicians actually delivered the matched treatment.