Risultati per: Low Back Pain: raccomandazioni

Introduction
Chronic post-thoracotomy pain (CPTP) is a persistent and disabling condition affecting a significant proportion of patients after thoracotomy and posing a challenge for clinicians, despite advances in surgical and pain management strategies. Esketamine, the S-enantiomer of ketamine, has emerged as a promising therapeutic agent for various pain conditions, with evidence for its effectiveness in alleviating acute and chronic pain. This systematic review and meta-analysis will be conducted to assess the efficacy of esketamine in treating CPTP, and evaluate its effectiveness in reducing pain intensity, improving functional outcomes, and reducing opioid consumption, as well as its adverse effects.

Methods and analysis
Computer-based literature retrieval in the PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang database and China Science and Technology Journal Database (VIP) for randomised controlled trials will be conducted from database inception to April 2024, with no restrictions on the language of publication. Eligible trials will be those focused on esketamine use to prevent and treat CPTP in adult patients; trial groups will have received esketamine and control groups will have been treated with placebo, standard treatment or other non-esketamine medications. Primary outcome measures can include the incidence of CPTP at 3 months, 6 months or 12 months postoperatively. Secondary outcome measures will encompass Visual Analogue Scale and Numerical Rating Scale Scores for rest and movement at different postoperative timepoints, the total number and effective number of patient-controlled analgesia button presses, total consumption of sufentanil, rate of rescue analgesia, and the occurrence of postoperative adverse reactions. Two researchers will independently screen the literature, evaluate its quality and extract the data. Meta-analysis will be performed on literature meeting the quality criteria using Review Manager V.5.3 software.

Ethics and dissemination
This review does not require ethical approval. On completion, the results of the review will be submitted to a peer-reviewed journal for publication and/or presented at an academic conference.

Trial registration number
PROSPERO, CRD42024526945.

Introduction
Sciatica is a debilitating condition that often becomes chronic, and for which there are few effective treatment options. Treatments such as the anti-depressant duloxetine have shown promise, but the evidence is inconclusive. We are describing a high quality, definitive trial to investigate the efficacy, safety and cost-effectiveness of duloxetine in chronic sciatica.

Methods and analysis
The duloxetine for chronic sciatica (DREAM) trial is a randomised, superiority, parallel-group, placebo-controlled, triple-blinded (participant, clinician, assessor) trial with an adaptive group sequential design investigating the efficacy and safety of duloxetine in participants with chronic sciatica of at least 3 months duration. Participants will be randomised at a 1:1 ratio to duloxetine or placebo. 332 participants will be recruited on presentation to general practices, specialist clinics and hospital emergency departments or from hospital in-patient wards and from the community. In the active treatment group, participants will receive duloxetine 60 mg per day for 12 weeks, including 1 week of titration at 30 mg/day. The treatment phase will be followed by a 2-week tapering phase where they will receive duloxetine 30 mg/day. Participants will be followed-up for 1 year, with outcomes being measured 4, 8, 12, 16, 26, and 52 weeks post-randomisation. The primary outcome is leg pain intensity at 12 weeks post-randomisation. Secondary outcomes include back pain intensity, disability, time to recovery, quality of life, depressive and anxiety symptoms, and sleep disturbance. Adverse events will be recorded, and a cost-effectiveness analysis will be conducted.

Ethics and dissemination
Ethical approval has been granted by the University of Sydney Human Research Ethics Committee. Trial results will be disseminated by publications, conference presentations and via the media.

Trial registration number
ACTRN12624000919516.

Introduction
Fear of recurrence is a transdiagnostic problem experienced by people with psychosis, which is associated with anxiety, depression and risk of future relapse events. Despite this, there is a lack of available psychological interventions for fear of recurrence, and psychological therapies for schizophrenia are often poorly implemented in general. However, low-intensity psychological therapy is available for people who experience fear of recurrence in the context of cancer, which means there is an opportunity to learn what has worked in a well-implemented psychological therapy to see if any learning can be adapted for schizophrenia care. This article describes the design, methods and expected data collection of development, acceptability, feasibility, and preliminary outcome signals for a coproduced low-intensity psychological intervention targeting fear of relapse in people with schizophrenia (INDIGO), which aims to develop an acceptable psychological intervention for fear of recurrence.

Methods and analysis
INDIGO will use a mixed-methods approach to co-design and deliver a model and treatment pathway for a psychological intervention for people diagnosed with schizophrenia who experience fear of recurrence. The study will consist of four stages. First, in-depth interviews with mental health staff and people diagnosed with schizophrenia (with a further social network mapping task for patient participants only) to develop the intervention. Second, in-depth interviews with people who have accessed the Glasgow Fear of Recurrence service and oncology staff will be conducted to inform further development of the intervention. Third, co-design workshops will be held with people diagnosed with schizophrenia and mental health staff to co-design intervention content and the treatment pathway. Finally, people diagnosed with schizophrenia will be presented with an intervention prototype and invited to complete ‘think-aloud’ interviews to gather further feedback so adaptations can be implemented.

Ethics and dissemination
The INDIGO study received ethical approval from East Midlands—Nottingham 2 Research Ethics Committee (24/EM/0124). The study received independent peer review prior to funding. This co-design study is expected to lead to a future feasibility study and, if indicated, a randomised controlled trial.

Introduction
Healthcare practices providing minimal or no benefit to recipients have been estimated to represent 20% of healthcare costs. However, defining, measuring and monitoring low-value care (LVC) and its downstream consequences remain a major challenge. The purpose of the National Data Stream (LUCID NDS) is to identify and monitor LVC in medical inpatients using routinely collected hospital data.

Methods and analysis
This protocol describes a multistep approach to the identification and surveillance of LVC: (1) creating an NDS based on Findable, Accessible, Interoperable, Reusable (FAIR) principles using routinely collected hospital data from medical inpatients who signed a general consent for data reuse from 2014 onwards; (2) selecting recommendations applicable to medical inpatients using data from LUCID NDS to develop a comprehensive and robust set of LVC indicators; (3) establishing expert consensus on the most relevant and actionable recommendations to prevent LVC; (4) applying the Strength of Recommendation Taxonomy methodology to assess the level of evidence of recommendations; (5) involving patients and the public at various stages of LUCID NDS; and (6) designing monitoring rules within the LUCID NDS and validating quality measures.

Ethics and dissemination
The ethics committees of all five participating university hospitals (Basel, Bern, Geneva, Lausanne and Zurich) approved LUCID NDS as a national registry on quality of care. We will disseminate our findings in peer-reviewed journals, at professional conferences, and through short reports sent to participating entities and stakeholders; moreover, lay summaries are provided for patients and the broader public on our webpage (www.LUCID-nds.ch).

Objective
To assess the diagnostic accuracy of postnatal foot length (FL) measurements as a proxy to identify low birth weight (LBW) for frontline healthcare workers in rural Sindh Province, Pakistan.

Design
A community-based cross-sectional study.

Setting
This study was conducted in the catchment area of Global Network’s Maternal and Newborn Health Registry, Thatta, Sindh Province, Pakistan, from January to June 2023.

Participants
Singleton live births irrespective of gestational age at birth.

Reference standard
Birth weight was measured using calibrated digital weighing scales in grams based on the average of three readings with minimal clothing.

Index test
FL was measured within 48 hours of birth using a rigid transparent plastic ruler in centimetres based on the average of three measurements.

Primary outcome
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), receiver operating characteristics curve and area under the curve with 95% CI were calculated. Euclidean distance was used to identify the cutoff of FL to identify LBW. A simple linear equation was created to predict the birth weight.

Results
Out of 336 analysed newborns, 179 (53.3%) were male and 157 (46.7%) were female. The median birth weight was 2801 g (IQR: 2465–3057), of whom 88 (26.2%) were LBW. The median foot length was 7.9 cm (IQR: 7.6–8.1). For identifying LBW, the foot length cutoff was ≤7.6 cm with 90.3% sensitivity, 81.8% specificity, 63.8% PPV and 96.0% NPV. A FL of 7.6 cm predicted birth weight of 2459.4 g.

Conclusion
Postnatal FL cutoff of ≤7.6 cm has adequate predictive value served as a simple, low-cost and reliable method to identify LBW for frontline healthcare providers in the rural settings of Thatta without calibrated weighing scales to triage LBW newborns in need of higher-level care.

Trial registration number
NCT05515211.

Introduction
People with cystic fibrosis (PwCF) are at high risk for developing cystic fibrosis (CF)-related diabetes (CFRD), which worsens morbidity and mortality. Although the pathological events leading to the development of CFRD are complex and not completely understood, dietary factors may play a role. For example, habitual intake of dietary added sugar (i.e., sugar not naturally occurring in foods) has been shown to be increased in PwCF and this excess intake of added sugar could increase the risk of CFRD.

Methods and analysis/design
The goal of this ongoing double-blind, randomised, parallel-group clinical trial is to recruit approximately 60 clinically stable adults with CF to determine if a low-added sugar intervention improves beta-cell responsiveness and insulin sensitivity (Aim 1), reduces visceral adipose tissue (VAT) and other ectopic fat deposition (Aim 2) and improves plasma redox status (Aim 3) over 8 weeks compared with a typical CF diet. All foods will be provided. Participant selection criteria include confirmed CF diagnosis without CFRD, ≥18 years of age, and baseline estimated daily total added sugar intake >16 tsp. Eligible participants will be randomised to one of two arms: a low-added sugar diet (

Objectives
This study aimed to identify a preference-based health-related quality of life (HRQOL) measure that best reflects disease-specific features in patients with neck pain by comparing the characteristics of the instruments.

Design
Pooled data from three multicentre randomised controlled clinical trials (RCTs) on neck pain were included for analysis in this study.

Setting
All three RCTs were conducted between 2017 and 2020 in Korea, and patients were recruited from four hospitals and one university teaching hospital.

Participants
In total, 313 patients with neck pain were included in the three RCTs.

Primary and secondary outcome measures
A correlation analysis was conducted using Spearman’s correlation coefficients between preference-based HRQOL scores (EuroQol-5 Dimension 5 Levels (EQ-5D-5L) and Short-Form 6-Dimension version 1 (SF-6Dv1)) and the disease-specific measures for pain and function (Numerical Rating Scale (NRS), Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Northwick Park Questionnaire).

Results
Spearman’s correlation analyses (p value 5), EQ-5D-5L appeared to better capture functional and pain aspects. Despite these differences, both instruments consistently reflected treatment-related improvements in pain and function. Distribution analysis further indicated that EQ-5D-5L and SF-6Dv1 were not fully interchangeable due to variations in domain-level scoring patterns and ceiling effects observed in EQ-5D-5L.

Conclusions
EQ-5D-5L showed stronger negative correlations with both pain and functional outcomes compared with SF-6Dv1, suggesting that it may better capture the functional aspects of chronic neck pain, particularly in moderate-to-severe conditions. However, the ceiling effect observed in EQ-5D-5L warrants caution when interpreting results in patients with mild neck pain. These findings provide practical guidance for selecting preference-based HRQOL measures in economic evaluations of musculoskeletal conditions, supporting more informed healthcare decision-making.

Trial registration number
NCT03294785, Post-results; NCT03558178, Results; NCT04035018, Post-results.

Introduction
Pain is reported as one of the most troubling symptoms for people with Parkinson’s (PwP); however, the literature exploring their lived experience of pain and how to manage it is limited. Pain affects PwP at all stages of their condition and can fluctuate and change over time. Therefore, it is pertinent to speak to PwP to understand their experiences of pain to inform the development of tailored behavioural interventions to manage pain. How pain interacts with other Parkinson’s symptoms lacks consensus. Gaining a better understanding of this from the perspective of PwP is important to inform interventions. Exploring the behavioural determinants, including the barriers and enablers to pain management from the perspective of PwP, the role of healthcare professionals and impact of other symptoms alongside pain will inform the development of a fit for purpose, pain management toolkit for PwP.

Methods and analysis
A longitudinal qualitative study using semi structured interviews at two time points within an 18-month period will be conducted. PwP living with pain will be purposefully sampled from four NHS sites in the North of England. Data will be thematically analysed with reference to the Theoretical Domains Framework.

Ethics and dissemination
A favourable ethical opinion has been granted by the National Health Service East Midlands-Derby Research Ethics Committee (22/EM/0176) and the NHS Health Research Authority (IRAS ID 316403). Findings will be disseminated via scientific conferences, academic journals, lay summaries and public engagement events.

Introduction
Chronic pain is one of the most common and serious symptoms of cancer. Despite the limitations of dose titration using only one type of opioid, the effects of opioid combinations are poorly understood.

Methods and analysis
This study will be conducted in accordance with the Cochrane Handbook of Systematic Reviews of Interventions 6.3. We will search the Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science databases from their inception to June 2023. This review will consider all clinical trials involving patients aged ≥18 years who received opioids for chronic cancer pain. Two reviewers will independently screen and select relevant studies. The intervention will be a combination of opioids, including both strong and weak, to control cancer pain. The comparator will be set as a single opioid, with or without a placebo. For randomised controlled trials, version 2 of the Cochrane tool will be used to assess the risk of bias. For non-randomised studies, the risk of bias will be assessed using a tool for assessing the Risk of Bias In Non-randomised Studies of Interventions (ROBINS-I). The primary outcome will be pain response; if a quantitative synthesis is not appropriate, a synthesis without a meta-analysis will be undertaken. The quality of evidence for each primary outcome will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation guidelines.

Ethics and dissemination
Ethical approval was not required for this systematic review and meta-analysis. The findings will be disseminated through peer-reviewed (open-access) journal publications and conference presentations. Given the widespread use of opioid-based cancer pain management in clinical practice, this study is expected to generate significant interest among physicians, many of whom are likely to review and consider the findings in the context of their clinical decision-making.

PROSPERO registration number
PROSPERO CRD42023427299.

Objectives
Chronic pain treatment engagement is dominated by pharmaceutical methods, while previous research has assessed barriers to uptake of non-pharmaceutical treatments, there has not been research one step earlier in the treatment development pipeline; assessing barriers to take part in research that develops non-pharmaceutical chronic pain treatment methods.

Design
A two-phase approach was used to assess barriers and facilitators to research participation for people living with chronic pain. Online focus groups were run in phase 1, generating qualitative data, while phase 2 used the themes identified within phase 1 to assess agreement and disagreement.

Setting
Participants consisted of people with chronic pain across the UK.

Participants
36 participants with chronic pain conditions (defined as any pain lasting or recurring for more than 3 months) were recruited for phase 1. Seven participants could not attend their focus group or a subsequent session, leaving a final sample size of 29 participants (83% female, 17% male; age=20–78 years, M=44.3 years). Phase 2 consisted of 103 participants (89% female, 10% male, 1% prefer not to say; age=20–80 years, M=46.6 years).

Results
Phase 1 identified the largest barrier to be ‘distrust’, relating to a distrust of medical and research professionals, distrust of confidentiality assurances and distrust that the research would have an impact. The greatest facilitator identified was ‘improved accessibility’, which related to the accessibility of the research environment, the type of research being conducted and accessible advertisement of the research within trusted settings. Phase 2 found around 80% agreement with all facilitator themes and a mix of opinions regarding barrier themes, highlighting the individuality of barriers experienced when living with chronic pain.

Conclusions
Addressing the barriers and implementing the facilitators identified here ensures that patient participants are comfortable and safe within research environments. Furthermore, this project provides recommendations for researchers to follow to help increase patient engagement in research studies.

Introduction
Scaling up evidence-based practices (EBPs) in family planning (FP), as recommended by the WHO, has increasingly been accepted by global health actors as core to their mission, goals and activities. National policies, strategies, guidance, training materials, political commitment and donor support exist in many countries to adopt and scale up a range of EBPs, including postpregnancy FP, task sharing for FP and the promotion of social and behaviour change (SBC) for FP. While there has been some success in implementing these practices, coverage remains inadequate in many countries. To gain a better understanding of the factors that may be hindering the sustained scale-up of these interventions, WHO has developed an assessment protocol to systematically identify the health systems’ ‘bottlenecks’ to implementation and to then identify solutions and develop strategies to address them.

Methods and analysis
A mixed method approach that includes document review, secondary data analysis (from surveys, service delivery data and case studies) and key informant interviews with policymakers, programme managers, health providers and community groups will be used to identify bottlenecks. This will be followed by a workshop to prioritise bottlenecks and characterise their root causes. Finally, solutions for the root causes of prioritised bottlenecks will be proposed. The protocol is structured in a modular format, with separate modules on postpregnancy FP, task sharing and SBC. Assessment themes and questions are informed by a wide body of literature on the three programmatic components, as well as studies on health policy implementation and scale-up.

Ethics and dissemination
The protocol was exempt from ethical review by the WHO ethics committee. The findings of the bottleneck analysis will be presented at local, national and international conferences and disseminated through peer-reviewed publications and webinars.

Objectives
This study aimed to identify distinct trajectories of long-term sickness absence (LTSA, >10 consecutive working days) among young and early midlife Finnish employees who experienced pain at baseline. It also aimed to determine the pain characteristics and occupational and lifestyle factors associated with these LTSA patterns.

Design
Longitudinal occupational cohort study with register linkage.

Setting
The largest municipal employer in Finland.

Participants
The study population comprised 19–39-year-old Finnish municipal employees (n=1685) who reported pain in 2017.

Outcome measures
Prospective register data on all-cause LTSA through March 2020 were obtained from the Social Insurance Institution of Finland. Group-based trajectory modelling was used to identify distinct all-cause LTSA trajectories. Multinomial logistic regression was used to examine associations of pain characteristics and work- and lifestyle-related factors with trajectory group membership.

Results
Three distinct LTSA-trajectory groups were identified: no LTSA (74%), decreasing (18%) and increasing (8%). The decreasing trajectory group had a higher prevalence of chronic or multisite pain, smoking (average marginal effects (AME) 6% points, 95% CI 2 to 11), obesity (AME 8% points, 95% CI 2 to 13), manual or routine non-manual occupation (AME 9% points, 95% CI 4 to 13) and high physical workload, after adjusting for age and gender. No predictor was identified for the increasing trajectory.

Conclusion
A majority of young and early midlife employees with pain had no LTSA during follow-up; however, chronic and multisite pain, smoking, overweight or obesity, lower occupational class and higher physical workload were associated with the decreasing LTSA trajectory. Interventions at workplaces and in occupational healthcare to prevent LTSA should aim at supporting employees who work with pain and have these risk factors.

Introduction
People experiencing low back pain (LBP) could potentially benefit from multimedia educational resources that integrate self-management strategies and improve awareness of the benefits of staying active and about medications that offer limited benefits, such as paracetamol. Primary care waiting rooms are potential spaces for presenting health promotion resources to improve health literacy through the dissemination of easily accessible health information. This feasibility study aims to explore the feasibility of conducting a large-scale trial to investigate the benefits of multimedia educational resources delivered at outpatient physiotherapy waiting rooms of public hospitals to support patients to participate in physical activity and reduce paracetamol intake for LBP.

Methods and analysis
A hybrid type III feasibility study will be conducted at a public hospital in Sydney, Australia, from March to September 2024. The multimedia strategy development (pre-implementation) involves collaborative planning among healthcare professionals, policymakers and community stakeholders in physiotherapy practice. Phase II (implementation) will evaluate the acceptability and implementation processes of delivering the multimedia educational resources in the physiotherapy waiting room following the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework. Findings from the quantitative data will be reported descriptively, and categorical data by counts and percentages. Qualitative (open-ended questions) will be integrated with the feasibility trial outcomes to inform the design of a full-scale randomised controlled trial.

Ethics and dissemination
This study has ethical approval from the Sydney Local Health District Human Research Ethics Committee (2023/ETH02683). The findings will be disseminated via peer-reviewed publications, articles in relevant newsletters and presentations at national and international conferences. Social media platforms including X will also be used to generate awareness.

Introduction
Ischaemic heart disease is the single most common cause of death worldwide. Traditionally, distinguishing patients with cardiac ischaemia from patients with less alarming disease, in prehospital triage of chest pain, is challenging for both general practitioners and ambulance paramedics. Less than 20% of patients with chest pain, transferred to the emergency department (ED), have an acute coronary syndrome (ACS) and the transportation and analysis at the ED of non-ACS patients result in substantial healthcare costs and a great patient burden. Advanced risk stratification, with the help of cardiac troponin measurements, seems crucial to improve prehospital diagnostic accuracy.

Methods and analysis
The URGENT 2.0 trial is a randomised controlled trial in which the primary objective is to reduce the referral of non-cardiac chest pain (NCCP) patients, using a modified HEART score including a high-sensitivity capillary point-of-care high-sensitivity cardiac troponin I measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) regular care (control group) or (2) modified HEART score analysis (intervention group) and non-referral in case of a low modified HEART score (0–3). In total, 852 patients will be included. Follow-up will be performed at 30 days, 6 months and 12 months. Both referral rates of NCCP patients and the occurrence of major adverse cardiac events are defined as primary outcome measures.

Ethics and dissemination
The medical ethics committee Zuyderland-Zuyd Hogeschool (Netherlands) has approved this trial (reference numbers NL71820.096.19 and METCZ20190139). Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses.

Trial registration
ClinicalTrials.gov, NCT04904107.

Objective
Evidence suggests interventions targeting low-acuity attendances have been hampered by insufficient characterisation of potential target groups. This study aimed to estimate the frequency of low-acuity emergency department (ED) attendances and to provide an overview of their demographic, diagnosis and consultation patterns.

Design
Observational analyses of routine healthcare data.

Setting
German EDs.

Participants
Adult patients with statutory health insurance who visited the ED of 16 participating hospitals in 2016.

Main outcome measures
Frequency, demographics, diagnoses and consultation patterns of low-acuity and high-acuity attendees.

Main results
Of the 454 747 ED visits, 370 756 visits (50.1% female) were included for analysis. Four participating hospitals had to be excluded due to the lack of data that were necessary for the stepwise approach to define low and high acuity. We identified 101 337 visits as low acuity (27.3%) and 256 876 as high acuity (69.3%), whereas 12 543 (3.4%) could not be classified. The proportion of attendees classified as low acuity decreased with age (highest at 40.6% in the age group

Introduction
Health education, weight control and exercise therapy are recognised treatment options for the non-surgical management of knee osteoarthritis (KOA); however, the pain and muscle fatigue associated with exercise make it difficult for patients to initially adhere. Traditional Chinese medicine (TCM) massage is an important complementary and alternative therapy that can effectively address these deficiencies. According to TCM theory and preliminary clinical practice, loosening of the muscles while pointing to acupoints can promote the recovery of KOA. Therefore, we hypothesised that exercise therapy in conjunction with TCM massage may lead to more satisfactory results in terms of pain management, active functional muscle activation patterns and proprioception in patients with KOA.

Methods and analysis
A parallel, single-centre, randomised controlled trial involving 106 patients will be conducted at Shuguang Hospital, Shanghai University of Traditional Chinese Medicine. Eligible patients with KOA who agree to participate will be randomised via a 1:1 randomisation system into the experimental group (receiving TCM massage and exercise treatment) and the control group (receiving exercise treatment). The primary endpoint is the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain from baseline to 24 weeks. Secondary outcomes include knee function (measured using the WOMAC stiffness and WOMAC functional subscale questionnaire and the timed ‘Up and Go’ test), muscle activation states (evaluated with electromyography techniques), knee proprioception and treatment satisfaction, adherence, safety evaluation and other relevant factors. Outcome assessors and data analysts will be blinded to the allocations, and the participants will not disclose their specific allocations. Outcome analyses will be conducted on both intention-to-treat and per-protocol populations. A preliminary analysis will test whether TCM massage, in addition to exercise, has statistically better outcomes.

Ethics and dissemination
The study protocol has received approval from the Ethics Committee of Shuguang Hospital, Shanghai University of Traditional Chinese Medicine (2023-1357-124-01).
All study participants will be required to give written informed consent. The findings of the study will be submitted to a peer-reviewed journal for publication and presented at scientific conferences. Additionally, the participants will receive copies of the results.

Trial registration number
ChiCTR2300077308.