Physical and psychological predictors for persistent and recurrent non-specific neck pain: a protocol for a systematic review and meta-analysis

Introduction
Both physical adaptations (e.g., altered neck kinematics and muscle coordination) and psychological features are common in people presenting with neck pain (NP). Additionally, both physical and psychological features may be relevant for the development of persistent or recurrent NP. Although a number of original studies have reported this, currently there is no available systematic review reporting physical and psychological predictors for the recurrence of non-specific NP.

Methods and analysis
The report of this systematic review protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Studies will be searched from PubMed, MEDLINE, EMBASE, CINAHL Plus, PsycINFO and grey literature. Title, abstract and full-text screening, data extraction and risk of bias assessment will be conducted by two independent reviewers. Studies investigating the prediction of persistent or recurrent NP from physical or psychological predictors will be included. Physical predictors will be commonly reported objective measures including neck kinematics, measures of muscle activity and sensory function. Psychological predictors will include variables such as kinesiophobia, self-efficacy, pain coping strategies and quality of life. The main outcomes of interest are the Neck Disability Index, presence of pain recurrence, as well as pain intensity and frequency during a persistent or recurrent NP episode. Observational cohort studies will be included, and studies on both single-factor and multifactor predictions or associations will be investigated. Risk of bias will be assessed using the Quality in Prognosis Studies (QUIPS) tool. The certainty of evidence will be rated using Grading of Recommendations Assessment, Development and Evaluation (GRADE). A random-effect meta-analysis will be conducted if methodological and clinical homogeneity is deemed satisfactory.

Ethics and dissemination
Ethical approval will not be required for this review as there is no primary data collection involving humans. The findings will be published in peer-reviewed journals.

PROSPERO registration number
CRD42024596844.

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Febbraio 2025

A 58-Year-Old With Urticaria, Fever, and Joint Pain

A 58-year-old woman with no allergies or rheumatic disease had a 2-year history of spontaneous wheals that occurred daily, accompanied by pruritus, arthralgia, and intermittent fevers; the wheals resolved after several hours without residual hyperpigmentation or bruising. C-reactive protein level was elevated, and skin biopsy showed dermal neutrophilic infiltration. What is the diagnosis and what would you do next?

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Febbraio 2025

Using codesign workshops to develop a conceptual framework for a mobile health app targeting chronic low back pain self-management

Objectives
The aim of this study was to gather insights from a diverse group of stakeholders, identify existing challenges and explore associated solutions to develop a conceptual framework that assists in the development of a chronic low back pain (CLBP) self-management app.

Design
Codesign workshop methodology.

Setting
The study was conducted online, allowing for the participation of a diverse group of stakeholders.

Participants
Participants were recruited through social media platforms and professional networks, including individuals with LBP for at least 3 months, healthcare professionals experienced in CLBP management and app developers with a background in digital health applications.

Interventions
The study used codesign workshops focused on brainstorming, communication and reflection exercises designed to foster collaboration and gather insights from stakeholders.

Outcome measures
Identification of key challenges and potential solutions for mobile health (mHealth) apps targeting CLBP.

Results
Nine stakeholders identified four primary challenges in current back pain apps: belief and trust, motivation, safety and usability. The group also collaboratively developed and proposed practical solutions to these challenges.

Conclusions
This study illustrated the utility of the codesign workshop approach in generating critical insights for the development of a mHealth solution for CLBP. The insights gathered from these workshops can be used to inform future app development, potentially improving user engagement.

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Febbraio 2025

[Viewpoint] The Global Fund, Cervical Cancer, and HPV infections: what can low- and middle-income countries do to accelerate progress by 2030?

The footprint of cervical cancer mirrors the impact of global inequity and inequality on the right to health for girls and women. While today, cervical cancer is a relatively rare cause of death in Europe, North America, and Australia, almost 94% of deaths in 2022 occurred in low- and middle-income countries (LMICs). Governments adopted the WHO global strategy to eliminate cervical cancer. Still, the stark reality is that many countries may not reach the 90:70:90 targets by 2030 without political commitment and a sense of urgency.

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Febbraio 2025

Impact of an acute 1-month cannabidiol treatment on pain and inflammation after a long bone fracture: a triple-blind randomised, placebo-controlled, clinical trial protocol

Introduction
Acute pain levels following orthopaedic injury (eg, fracture) are a predictor of the onset of chronic pain, which affects nearly 50% of fracture patients and impairs functional recovery. Among current pharmacological treatments for acute pain, non-steroidal anti-inflammatory drugs have been associated with delayed bone healing, while opioids inhibit effective bone remodelling, increase the risk of pseudarthrosis and carry a high risk of addiction. In light of this, the development of new pain treatments is essential. Cannabidiol (CBD), a non-addictive and non-psychotropic cannabis component stands out as a potential therapeutic agent, given its analgesic and anti-inflammatory properties as well as its potential benefits for bone healing. This randomised controlled trial aims to investigate the effect of acute CBD treatment, compared with placebo, on patients’ self-reported pain, inflammation and well-being following a fracture injury.

Methods and analysis
This is a triple-blind, randomised, placebo-controlled clinical trial. A total of 225 adults aged 18–70 years, who have suffered a long bone fracture and were treated at the Hôpital du Sacré-Coeur de Montréal, will be randomly assigned within 1 week to one of three treatment arms (25 mg or 50 mg of CBD or placebo) for 1 month. The primary outcome will be the difference in the pain score between groups at 1-month follow-up. Secondary outcomes will include measures of persistent pain, inflammation, opioid usage, quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function. Data will be collected at baseline, 1-month and 3-month follow-ups.

Ethics and dissemination
This study obtained a Health Canada licence for use of cannabis products. It has also been approved by Health Canada and the Research Ethics Board of the CIUSSS du Nord-de-l’Île-de-Montréal (Project ID 2025-2105). The findings will be published in a peer-reviewed journal and presented at local, national and international conferences. The trial’s results will be made publicly available on the ClinicalTrials.gov database.

Trial registration number
NCT06448923.

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Febbraio 2025

Effectiveness of pain neuroscience education, motivational interviewing and cognition targeted exercise therapy in patients with chronic neck pain: protocol for a multicentre randomised controlled trial (the COGMO-AP study)

Introduction
In primary care, the prevalence of neck pain has increased substantially. Evidence regarding treatment of chronic neck pain (CNP) is scarce, and its effectiveness is not entirely proven in different stages of chronicity, nor for different types of cervical disorders. The goal of this study is to evaluate the effectiveness of a complex intervention (COGMO intervention) compared with usual practice in primary care physiotherapy to improve neck pain intensity, severity and disability in patients with CNP.

Methods and analysis
Design: a pragmatic cluster-randomised clinical trial design with a 12-month follow-up. Setting: primary care. Participants: physiotherapists as randomisation unit, and patients as analysis unit. Inclusion criteria: individuals aged 18 to 65 years suffering from moderate to severe CNP. Sample size expected: 142 patients. Recruitment: patients referred from primary care physicians to physiotherapy. Intervention: pain neuroscience education (PNE), motivational interviewing (MI) and cognition targeted exercise therapy (CTE) compared with the standard treatment in primary care. Outcomes: the main variable is reduction in pain intensity; secondary variables include pain severity, conditioned pain modulation, temporal summation, neck disability, fear/avoidance behaviour, kinesiophobia, catastrophising, therapeutic alliance and quality of life. Sociodemographic information and adherence to the intervention will be recorded. Data collection: baseline, and follow-up at 3, 6 and 12 months. Analysis: it will follow intention-to-treat principles, and difference in percentage of subjects achieving success on the primary endpoint at 12 months. A model with multilevel analysis will be adjusted through logistic regression (being the dependent variable pain intensity, and the independent, the intervention).

Ethics and dissemination
Ethical approval has been awarded by the Regional Ethics Committee of Madrid (code: COGMO-AP) and the primary health care central commission of research (code: 20210011). The results of the study will be disseminated through international peer-reviewed journals, international conferences, press and social media.

Trial registration number
NCT05785455.

Leggi
Febbraio 2025

Psychological stress-induced local immune response to food antigens increases pain signaling across the gut in mice

We recently showed that a bacterial infection can break oral tolerance to food and lead to IgE-dependent mast cell activation and food-induced abdominal pain, which could constitute an important pathogenic mechanism in post-infectious irritable bowel syndrome (IBS). Here, we investigated whether similar immune mechanisms in response to psychological stress lead to food-evoked pain signaling, and thus potentially explain the pathophysiology in a larger group of patients with IBS.

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Febbraio 2025

Cross-sectional evaluation of host biomarkers for guiding antibiotic use in bacterial and non-bacterial acute febrile illness in low- and middle-income tropical settings

Objectives
To evaluate the effectiveness of 18 different host biomarkers in differentiating bacterial from non-bacterial acute febrile illness (AFI) in resource-limited settings, specifically in Brazil, Malawi and Gabon.

Design
Multinational, cross-sectional study.

Setting
The study was carried out across multiple primary healthcare facilities, including urban and rural settings, with a total of three participating centres. Recruitment took place from October 2018 to July 2019 in Brazil, May to November 2019 in Gabon and April 2017 to April 2018 in Malawi.

Participants
A total of 1915 participants, including children and adults aged 21–65 years with a fever of≤7 days, were recruited through convenience sampling from outpatient clinics in Brazil, Gabon and Malawi. Individuals with signs of severe illness were excluded. Written consent was obtained from all participants or their guardians.

Intervention
This is not applicable as the study primarily focused on biomarker evaluation without specific therapeutic interventions.

Primary and secondary outcome measures
The primary outcome measure was the ability of each host biomarker to differentiate between bacterial and non-bacterial AFI, as evaluated by area under the receiver operating characteristic (AUROC) curves. Secondary outcomes included the performance of individual biomarkers across the different study sites and in a multivariable setting.

Results
A Kruskal-Wallis test, adjusted by Benjamini-Hochberg, was performed for each biomarker to identify covariates with a significant difference in the distribution of biomarker values. The analysis revealed that country of origin (Brazil, Gabon, Malawi), age, sex and malaria status significantly impacted biomarker distribution (p≤0.001). The most widely known biomarkers, such as white blood cell (WBC) count and C-reactive protein (CRP), demonstrated the best performance in distinguishing between bacterial and non-bacterial infections, with AUROCs reaching up to 0.83 (0.77–0.88) for WBC count and 0.71 (0.59–0.82) for CRP. However, none of the evaluated novel host biomarkers exhibited high performance (AUROC

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Febbraio 2025

How do hospitals that serve low socioeconomic status patients achieve low readmission rates? A qualitative study of safety-net hospitals

Background
Hospital readmissions are an important quality of care indicator and are tied to hospitals’ financial reimbursements. Safety-net hospitals, which serve a high proportion of patients of low socioeconomic status (SES), face unique challenges to reduce or maintain low readmission rates.

Objective
We sought to understand strategies high-performing safety-net hospitals used to achieve low 30-day risk-standardised readmission rates (RSRRs) using qualitative methodology.

Methods
Safety-net hospital status was defined by public ownership or a Medicaid population that is greater than 1 SD higher than the state proportion of Medicaid patients and the hospital payer source is composed of at least 15% Medicaid patients. Safety-net hospitals were selected based on their ranking among the lowest 20% of heart failure RSRRs, the best-performing quintile. We purposefully sampled hospitals to ensure variation in characteristics and conducted on-site interviews with key hospital staff. A multidisciplinary team analysed the data using thematic analysis.

Results
We performed site visits at 9 safety-net hospitals (RSRR range: 18.1%–21.6%) in 9 states and conducted in-depth interviews with 108 hospital staff. Several thematic attributes and organisational strategies were evident in high-performing safety-net hospitals: (1) strong hospital support for quality improvement at all levels; (2) tailoring resources to meet patient needs; (3) facilitating collaboration and communication among and between providers and patients; (4) creating strong relationships with postacute care facilities and communities and (5) proactive approach to healthcare policy changes and other external factors.

Conclusions
The provision of high-quality and equitable care in hospitals serving a high proportion of low-SES populations is influenced by several modifiable factors. These findings may serve to inform lower-performing safety-net hospitals on how to optimise patient care and improve readmission outcomes.

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Febbraio 2025

Protocol for a randomised phase 3 trial evaluating the role of Finasteride in Active Surveillance for men with low and intermediate-risk prostate cancer: the FINESSE Study

Background
Prostate cancer (PCa) is the most common male malignancy in the western world. Many men (40%) are diagnosed with localised low or intermediate-risk PCa, which is suitable for active surveillance (AS). AS affords careful monitoring to identify changes in otherwise non-life-threatening cancers. While AS reduces overtreatment (and quality of life impact), long-term compliance can be poor, with many men undergoing radical treatment after starting AS.

Methods and analysis
Finasteride in Active Surveillance for men with low and intermediate-risk prostate cancer (FINESSE) is a prospective, open-label, two-arm, phase 3 trial, in which men with low or intermediate PCa are randomised (1:1) to receive AS with or without finasteride (5 mg once a day for 2 years). Randomisation is stratified by age and PCa risk. AS includes regular prostate-specific antigen testing, MRI scans and the offer of repeat biopsy (at 3 years, or if imaging suggests progression). Additional MRI scans and/or biopsies will be performed for biochemical or clinical indications. We aim to recruit 550 men (aged 50 to 75 years) from up to eight sites. Active outpatient follow-up will be for 3–5 years (depending on date recruited), followed by passive registry-based follow-up for up to 10 years. Primary outcome is adherence to AS. Secondary outcomes include rates and type of disease progression, treatments received (for PCa and benign prostatic enlargement), overall and PCa-specific mortality, an understanding of patients/professionals views of this approach and health-related quality of life. An external panel of experts blinded to allocation will review all AS cessation and progression events. Trial pathologist’s and radiologist’s, blinded to allocation, will review representative cases. Analysis is Intention to Treat.

Ethics and dissemination
The study received Health Research Authority and South-Central Oxford Research Ethics Committee (14/12/2021: 21/SC/0349) and CTA/MHRA (29/12/2021: 21304/0274/001–0001) approvals. Results will be made available to providers and researchers via publicly accessible scientific journals.

Trial registration number
ISRCTN16867955

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Febbraio 2025

Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2): study protocol for a phase 2, prospective, multicentre, open-label, multiarm, biomarker-directed, signal-seeking, umbrella, clinical trial for recurrent IDH mutant, grade 2/3 glioma

Introduction
All grade 2/3 gliomas are incurable and at the time of inevitable relapse, patients have significant unmet needs with few effective treatments. This study aims to improve outcomes by molecular profiling of patients at relapse, then matching them with the best available drug based on their molecular profile, maximising the chances of patient benefit while simultaneously testing multiple novel drugs.

Methods and analysis
Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2) will be an international, phase 2, multicentre, open-label, biomarker-directed, umbrella clinical trial for recurrent isocitrate dehydrogenase mutant, histologically grade 2/3 gliomas. Investigational treatment will be assigned based on molecular profiling of contemporaneous tissue obtained at disease relapse using next-generation sequencing. LUMOS-2 will begin with three therapeutic treatment arms: paxalisib, cadonilimab and selinexor. Patient molecular profiles will be assessed by an expert, multidisciplinary Molecular Tumour Advisory Panel. Patients whose molecular profile is considered suitable for a targeted agent like paxalisib will be allocated to that arm, others will be randomised to the available arms of the trial. The primary endpoint is progression-free survival at 6 months. Secondary objectives include assessment of overall survival, response rate, safety and quality of life measures. Two additional therapeutic arms are currently in development.

Ethics and dissemination
Central ethics approval was obtained from the Sydney Local Health District Ethics Review Committee, Royal Prince Alfred Hospital Zone, Sydney, Australia (Approval: 2022/ETH02230). Other clinical sites will provide oversight through local governance processes, including obtaining informed consent from suitable participants. A report describing the results of the study will be submitted to international meetings and peer-reviewed journals.

Trial registration number
ACTRN12623000096651.

Leggi
Febbraio 2025