Efficacy of a single low dose of esketamine for patients with irritable bowel syndrome: study protocol for a randomised controlled trial

Introduction
As a disorder of gut–brain interaction, irritable bowel syndrome (IBS) is a common reason for patient visits in primary and specialist care settings. IBS is associated with recurrent abdominal pain, altered bowel habit, resulting in alternating constipation and diarrhoea, bloating, without serious organic diseases. The bidirectional relationship between IBS and psychological factor is also complex. Studies have suggested that tricyclic antidepressants can effectively control the concomitant symptoms of IBS, especially some severe and refractory symptoms. At present, the conventional treatment of IBS remains somewhat unsatisfactory. Studies have shown that the antidepressant effects of esketamine are rapid and significant, whether a single low dose of esketamine is effective in IBS deserves further investigation. In this study, we hypothesise that a single low dose of esketamine will be effective for IBS.

Methods and analysis
This is a single-centre, randomised, double-blind, placebo-controlled trial. Patients with IBS are divided into three levels according to the severity of IBS: mild, moderate and severe. 92 patients in the esketamine group and 92 patients in the control group who are scheduled for colonoscopy will be prospectively recruited in each level. The primary outcome is the IBS Severity Scoring System at baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy. The secondary outcome includes IBS-Quality of Life, Bristol Stool Form scale, Hospital Anxiety and Depression Scale, Patient Health Questionnaire-12 Somatic Symptom Score and adverse events. The allocation sequence is assigned by a random number table using a block randomisation method by SPSS (Version 26, IBM Inc., USA) Statistics software. All enrolled patients, anaesthesiologist B and researchers responsible for follow-up and data collection and analysis are therefore fully blinded. All data will be performed using SPSS Statistics software, and a p value

Leggi
Giugno 2025

Vacation and back-to-school effect on influenza transmission among school-age children in Guangzhou, China: an ecological study from 2010 to 2023

Objective
To examine whether influenza transmission risk decreased during summer and winter vacations and increased after vacations and statutory holiday.

Design
An ecological study.

Setting
Guangzhou, Guangdong Province of China.

Participants
A total of 458 343 influenza cases in school-aged children were included, including 160 067 (35.05%) in kindergarten, 223 817 (48.83%) in primary school, 50 053 (10.92%) in middle school and 23 801 (5.19%) in high school.

Data and methods
Data on influenza cases were obtained from the Notifiable Infectious Disease Surveillance System operated by Guangzhou Centre for Disease Control and Prevention. Influenza incidence rate ratio (IRR) by negative binomial regression model was used to analyse the influenza risk of school-age children during/after vacation to before/during breaks.

Results
In all four groups, there was significantly lower incidence of influenza during winter and summer vacations compared with the 4 weeks preceding vacations. Compared with the 2 weeks preceding return, kindergarten students experienced the highest influenza risk in the third week after summer vacation (IRR=3.40, 95% CI 2.43to 4.79). Primary school students had the highest risk in the fourth week after winter vacation (IRR=9.59, 95% CI 6.71 to 13.87). Middle school students had the highest risk in the fourth week after summer (IRR=11.60, 95% CI 6.17 to 22.62). High school students also experienced the highest risk in the fourth week following summer (IRR=17.96, 95% CI 8.10 to 42.05). Despite the risk of influenza increasing after returning to school, it remained lower compared with before vacations and holidays.

Conclusions
Due to changes in contact patterns, influenza incidence was high towards the end of term, significantly decreased during vacations and started to rise on returning to school, peaking in the third or fourth week. These findings suggested using holiday periods strategically to promote influenza vaccination and implementing enhanced non-pharmaceutical interventions on students returning to school.

Leggi
Giugno 2025

Economic evaluation of a lifestyle intervention for individuals with overweight or obesity suffering from chronic low back pain (the BO2WL trial): a protocol for a health economic analysis

Introduction
Low back pain (LBP) is highly prevalent across the Western world, including Switzerland (CH) and Belgium (BE), with women experiencing higher disability rates than men. Chronic LBP (CLBP), persisting beyond 3 months, leads to diminished health-related quality of life and increased healthcare and societal costs. Evidence indicates a direct relationship between body mass index (BMI) and CLBP severity, with high BMI significantly driving LBP-related healthcare expenses. Current evidence supports combining pain neuroscience education (PNE) with cognition-targeted exercise therapy (CTET) to effectively manage CLBP.
An economic evaluation alongside a randomised controlled trial, entitled ‘Lifestyle Intervention in Overweight/Obese CLBP Patients: an International Multi-centre RCT’ (BO2WL), will be conducted in CH and BE. It aims to evaluate the addition of a lifestyle intervention to PNE and CTET compared with PNE and CTET alone for treating individuals with CLBP and overweight or obesity. This protocol outlines the details of the economic evaluation of this trial.

Methods and analysis
The trial consists of a 14-week intervention followed by a 52-week post-intervention follow-up. Primary outcomes include direct and indirect costs, as well as quality-adjusted life years and pain intensity. Cost data will be converted into 2026 Belgium (BE) and 2026 Swiss Francs (CHF) for CH, with a discount rate of 3.5%. Incremental cost-utility and cost-effectiveness ratios will be calculated from a societal perspective for each country.

Ethics and dissemination
Ethics approval was obtained by the local ethics committees (Bern, CH: project ID 2022–02210; Brussels and Geel, BE: BUN 1432022000296). Results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal.

Trial registration number
NCT05811624.

Leggi
Giugno 2025

Uptake of the IMMPACT-recommended core outcome set in randomised controlled trials on chronic neck or shoulder pain: a cross-sectional study

Objective
To analyse the uptake rate of Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)-recommended core outcome set (COS) in randomised controlled trials (RCTs) on chronic neck or shoulder pain and its potential influencing factors.

Design
A cross-sectional study.

Setting
WHO International Clinical Trials Registry Platform, involving 15 registries.

Participants
RCT registrations on chronic neck or shoulder pain.

Primary outcome measures
The uptake rate of IMMPACT-recommended COS in RCTs focusing on chronic neck or shoulder pain.

Results
A total of 1057 RCT registrations were included between 2 February 2004 and 8 February 2023. The most used domains were pain (n=1003, 94.9%) and physical functioning (n=971, 91.9%), while the remaining four core domains and supplementary domains received less attention (

Leggi
Giugno 2025

Supplementary effects of low-frequency transcutaneous electrical nerve stimulation on individuals with obesity combined with metabolic syndromes: study protocol for a randomised controlled trial

Introduction
Obesity combined with metabolic syndrome is a major global public health problem. This trial aims to investigate the therapeutic effects of low-frequency transcutaneous electrical nerve stimulation (Lo-TENS) in individuals with obesity and coexisting metabolic syndrome. The study will also delve into the underlying mechanisms through which Lo-TENS may mitigate the symptoms of metabolic syndrome, providing insights into its potential as a novel treatment approach.

Methods and analysis
This randomised controlled trial will enrol 63 individuals with obesity and metabolic syndrome, and randomly assign them to one of the three groups: (1) peripheral stimulation group, (2) central stimulation group and (3) sham stimulation group. Each participant will receive a 30 min daily session of their assigned stimulation, conducted 5 days a week for a duration of 12 weeks. The primary outcomes of interest are body mass index and fasting blood glucose, with secondary outcomes encompassing blood pressure, triglyceride levels and various metabolic biomarkers. Comprehensive assessments will be performed at baseline, immediately post intervention, and followed by a 12-week follow-up evaluation to monitor long-term effects and sustainability of potential benefits.

Ethics and dissemination
The trial has been granted ethical approval by the ethics committee of the Second People’s Hospital of Kunming (approval number: 202305001). The study’s findings will be disseminated through peer-reviewed journal publications and international conference presentations.

Trial registration number
Chinese Clinical Trial Registry Platform: www.chictr.org.cn (No. ChiCTR2400089104).

Leggi
Giugno 2025

Assessing motor control and movement quality in patients with non-specific low back pain: a scoping review and development of an ICF-based conceptual framework

Objective
To describe frequently investigated and recommended movement tasks, the underlying motor control functions and the domains of movement quality that are assessed in patients with non-specific low back pain (LBP).

Design
A scoping review. Preferred Reporting for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and JBI methodology for scoping reviews were followed. A thematic approach was used in an iterative process to identify broader themes in the data synthesis.

Data sources
MEDLINE, CINAHL, EMBASE, Web of Science, Scopus, Cochrane Library, COSMIN database and DiTA were systematically searched as part of a three-step search strategy (last search: 22 April 2025).

Eligibility criteria for selecting studies
Various types of evidence (qualitative and quantitative, primary and secondary) exploring and discussing movement tasks for assessing lumbopelvic motor control and movement quality in adult patients with non-specific LBP were considered. Grey literature was excluded.

Results
In total, 354 articles from 34 countries were included. Among them, 224 were primary research studies in laboratory settings, 68 studies in clinical settings, 7 meta-analyses, 13 systematic reviews and 42 articles classified as ‘other sources’. Overall, 20 movement task clusters were identified, with ‘hip movements in various positions’ and ‘forward bending’ being the two most common. A conceptual framework was constructed, consisting of five International Classification of Functioning, Disability and Health-based broad motor control functions and 10 movement quality domains, namely flexibility, stability, accuracy, symmetry, speed, smoothness, adaptability, variability, efficiency and coordination.

Conclusion
The provided conceptual framework for motor control functions and movement quality domains can serve as a structural foundation for future research on the content validity of assessment approaches in the context of LBP.

Leggi
Giugno 2025

Behavioural activation for low mood and anxiety in male frontline NHS workers (BALM): a pre-post intervention study

Objectives
To evaluate the impact and acceptability of a tailored, gender-responsive behavioural activation (BA) intervention for improving depression and anxiety in male National Health Service (NHS) frontline workers.

Design
Pre-post intervention study.

Setting
Three NHS organisations in the North of England.

Participants
45 men aged ≥18 years working in a frontline NHS role scoring in the subclinical range (5–14) on the Patient Health Questionnaire-9 (PHQ-9) (depression) and/or the Generalised Anxiety Disorder-7 (GAD-7) (anxiety) at baseline.

Interventions
A tailored BA treatment programme consisting of up to eight telephone support sessions over a period of 4–6 weeks, accompanied by a BA self-help manual.

Main outcome measures
Self-reported symptom severity of depression, assessed by PHQ-9, and anxiety, assessed by GAD-7, at baseline and 4 and 6 months. Acceptability from the perspectives of male study participants and coaches who delivered the intervention was assessed in a nested qualitative study using the theoretical framework of acceptability (TFA).

Results
PHQ-9 and GAD-7 scores decreased from baseline to 4 months on both the PHQ-9 and GAD-7. While scores increased from 4 months to 6 months, the 6-month scores remained below those of the baseline scores. Acceptability of the intervention was high across all constructs of the TFA. The practical and action-oriented strategies of the intervention, and the confidential, flexible, convenient mode of delivery, worked to support men’s engagement with the intervention.

Conclusions
Delivery of a tailored, gender-responsive BA intervention was appealing to, and beneficial for, men working in frontline NHS roles with less severe depression and anxiety. The BALM intervention offers promise as a tailored workplace mental health programme that is aligned with men’s needs and preferences and can help overcome a reticence to engage with mental health support in NHS staff and beyond.

Trial registration number
ISRCTN48636092.

Leggi
Giugno 2025

Comparison of percutaneous neuromodulation and therapeutic exercise in patients with chronic non-specific neck pain: a study protocol for a randomised controlled trial

Introduction
Neck pain is highly prevalent worldwide with no reliable or approved therapies. Recently, percutaneous neuromodulation (PNM) has gained popularity as an alternative to conventional treatments for managing musculoskeletal disorders.

Objective
This study aims to assess the comparative effectiveness of PNM compared with therapeutic exercise in the management of patients with chronic non-specific neck pain (CNNP).

Methods and analysis
In this randomised, controlled, single-blind study, 100 patients with CNNP will be allocated in a 1:1 ratio into two study groups: treatment with PNM and treatment with therapeutic exercise (specific neck exercises). A total of 18 structured exercise sessions will be administered three times per week for 6 weeks. Disability, pain intensity, fear of movement, quality of life, quality of sleep, catastrophising, cervical range of motion and pressure pain threshold will be recorded at 6 weeks (immediately post-treatment) and 8 weeks after initiation (or the end of treatment).

Ethics and dissemination
Ethical approval was obtained from the provincial research ethics committee of Almeria (AP-0429-2023 C4-F2) in June 2024. The results of the study, including feasibility outcomes, will be published in peer-reviewed journals and presented at academic, clinical and healthcare conferences.

Trial registration number
ClinicalTrials.gov: NCT06695949.

Leggi
Giugno 2025

Low-dose versus high-dose intravenous nitroglycerin in the treatment of sympathetic crashing acute pulmonary oedema: a systematic review and meta-analysis focusing on efficacy, safety and outcomes

Objectives
Sympathetic crashing acute pulmonary oedema (SCAPE) is a menacing medical emergency and a severe form of acute heart failure that requires urgent intervention. Nitroglycerin (NTG) is commonly used in SCAPE management, but the optimal dosing remains uncertain. This meta-analysis compared the efficacy and safety of high-dose vs low-dose NTG in SCAPE patients, assessing mechanical ventilation need, symptom resolution, hospital stay and major adverse cardiovascular events (MACE).

Design
Systematic review and meta-analysis conducted per Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, registered in Prospective Register of Systematic Reviews (CRD42024527486).

Data sources
A comprehensive search in PubMed, Europe PMC and ScienceDirect up to November 2024. Reference lists of included studies were also reviewed.

Eligibility criteria
Randomised controlled trials (RCTs) and observational studies comparing high-dose NTG (≥100 mcg/min) with low-dose NTG (

Leggi
Giugno 2025

ARBOR-Telehealth study: an examination of telerehabilitation to improve function and reduce opioid use in persons with chronic low back pain in rural communities – protocol of a pragmatic, individually randomised group treatment trial

Introduction
Chronic low back pain (LBP) imposes significant burden on patients, healthcare systems and society. Physical therapy is a cost-effective method for improving pain and disability; however, only a small number of patients (7–13%) with LBP ever receive physical therapy services. Patients report obstacles to accessing physical therapy, such as transportation, provider availability and missed work. Access is especially limited in rural communities, where approximately 40% fewer physical therapists are available per capita than in metropolitan regions. This lack of access likely contributes to the greater rates of LBP-related disability and opioid consumption in rural communities. Innovative methods for improving access to physical therapy for patients with chronic LBP are urgently needed; these can help address differences in health outcomes and mitigate opioid dependence for patients with chronic LBP living in rural communities. Telerehabilitation increases access to physical therapy, which can potentially improve health outcomes for these patients.

Methods and analysis
This prospective, individually randomised group treatment trial will involve primary care clinics serving rural communities on Maryland’s Eastern Shore. We will enroll 434 individuals with chronic LBP. Eligible patients will be randomised to either standardised education for back pain delivered via website or to a risk-informed telerehabilitation. Standardised education will be delivered via a study website containing information consistent with materials provided by primary care providers. Risk-informed telerehabilitation will be delivered by trained physical therapists using a web-based, video-enabled telehealth platform. The primary outcome is LBP-related disability. Secondary outcomes are opioid use, pain intensity, health-related quality of life and LBP-related healthcare use assessed using standard patient-reported outcome measures, participant self-report and medical chart abstraction. Implementation outcomes are acceptability, adoption, feasibility and fidelity of our treatment approach guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and assessed using surveys, semi-structured interviews and key performance metrics.

Ethics and dissemination
Ethics approval was obtained from the Johns Hopkins Medicine Institutional Review Boards (IRB), which serves as the single IRB for this trial. Upon completion, study data will be shared in compliance with National Institutes of Health guidelines.

Trial registration number
NCT06471920.

Leggi
Giugno 2025

Development of a Physical Activity Maintenance intervention for people with PERsistent musculoskeletal pain (PAMPER): a mixed-methods study protocol

Introduction
Persistent musculoskeletal pain is a leading cause of disability and need for rehabilitation globally. Many people with the condition attend pain management programmes (PMPs) for rehabilitation and support with self-management. Physical activity (PA) is an essential self-management strategy facilitated on PMPs as it benefits symptoms, general health and well-being. PA needs to be maintained in the long term to continue to be beneficial. However, while many patients increase their PA during or immediately after a PMP, they commonly find it difficult to maintain it in the long term. This study aims to address this problem by developing an intervention to support PA maintenance after a PMP.

Methods and analysis
This mixed-methods study will be guided by the Medical Research Council guidelines for developing complex interventions and the Behaviour Change Wheel intervention development framework. Participants will be recruited from multiple UK National Health Service PMPs. Participants will include patients with persistent musculoskeletal pain who have completed PMPs, their PA partners (people who support them with PA) and healthcare professionals who facilitate PA on PMPs. The study will be conducted in three phases. In phase 1, qualitative interviews will explore the experiences, barriers and facilitators of PA maintenance after a PMP and potential characteristics for a PA maintenance intervention from patient, PA partner and healthcare professional perspectives. Phase 2 will consist of a prospective longitudinal pilot study to identify factors associated with PA maintenance after a PMP. Phase 3 will involve developing a logic model and co-designing the intervention with patient, PA partner and healthcare professional stakeholder groups.

Ethics and dissemination
The project received research ethics committee (REC) and Health Research Authority approval on 4 June 2024 (REC: North West—Liverpool Central, REC reference: 24/NW/0174, IRAS Project ID: 340674). Findings will be disseminated by peer-reviewed publications, conference presentations, social media and lay summaries for patients and the public.

Leggi
Giugno 2025