Association between sedentary behaviour and chronic pelvic pain in women: a protocol for systematic review and meta-analysis

Introduction
In light of the rising prevalence of sedentary behaviour worldwide, its impact on health has become a subject of growing interest. To clarify whether there is a significant correlation between sedentary behaviour and chronic pelvic pain in women and to explore its potential clinical implications, this study aims to provide a systematic review and meta-analysis of the association between the two. The findings of this study will inform the development of effective prevention and intervention strategies.

Methods and analysis
This study will conduct an exhaustive search across electronic databases, encompassing PubMed, Embase, Web of Science, the Cochrane Central Register of Controlled Trials and Scopus, for records published up until 26 June 2024. Two independent researchers will conduct the study selection, data extraction and assessment of bias risks, with any discrepancies resolved through the collaboration of a third reviewer. To accurately discern the underlying sources of heterogeneity, sensitivity, subgroup analyses and meta-regression will be conducted in parallel. Additionally, to ensure the rigour and integrity of our research, Begg’s and Egger’s tests will serve as the primary means of evaluating the potential for publication bias within the studies under consideration.

Ethics and dissemination
Ethical approval will not be required for this study, as it will use publicly accessible, non-identifiable data from the published literature. The research team will ensure data privacy and participant confidentiality through anonymised data processing and strict compliance with relevant regulations. The results of this study will be disseminated through publication in a peer-reviewed journal.

Prospero registration number
CRD42024562443.

Leggi
Maggio 2025

Clinical and cost-effectiveness of a personalised guided consultation versus usual physiotherapy care in people presenting with shoulder pain: a protocol for the PANDA-S cluster randomised controlled trial and process evaluation

Introduction
Musculoskeletal shoulder pain is a common reason for people to be treated in physiotherapy services, but diagnosis can be difficult and often does not guide treatment or predict outcome. People with shoulder pain cite a need for clear information, and timely, tailored consultations for their pain. This trial will evaluate the introduction of a personalised guided consultation to help physiotherapists manage care for individuals with shoulder pain.

Methods and analysis
This is a cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of introducing a personalised guided consultation compared with usual UK NHS physiotherapy care. Physiotherapy services (n=16) will be randomised in a 1:1 ratio to either intervention (physiotherapy training package and personalised guided consultation incorporating a new prognostic tool) or control (usual care); 832 participants (416 in each arm) identified from participating physiotherapy service waiting lists aged 18 years or over with shoulder pain will be enrolled. Follow-up will occur at 3 time points: 6 weeks, 6 months and 12 months. The primary outcome will be the Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes include global perceived change of the shoulder condition, sleep, work absence and the impact of shoulder pain on work performance, healthcare utilisation and health-related quality of life (using EuroQol 5 Dimension 5 Level (EQ-5D-5L)). A multimethod process evaluation will investigate views and experiences of participants and physiotherapists, assess uptake, facilitators and barriers to delivery, and changes in factors assumed to explain intervention outcomes. Primary analysis of effectiveness will be by intention-to-treat, and a health economic evaluation will assess cost-utility of introducing the personalised consultation.

Ethics and dissemination
The trial received ethics approval from the Yorkshire & The Humber (South Yorkshire) Research Ethics Committee (REC reference: 23/YH/0070). Findings will be shared through journal publications, media outlets and conference presentations. Supported by patient contributors and clinical advisors, we will communicate findings through a designated website, networks, newsletters, leaflets and in the participating physiotherapy services.

Trial registration number
ISRCTN45377604.

Leggi
Maggio 2025

Efficacy of acupuncture at pain-sensitive acupoints for diarrhoea-predominant irritable bowel syndrome (IBS-D): protocol of a multicentre, randomised, sham-controlled trial

Introduction
While recent research suggests that acupuncture may offer benefits to individuals with diarrhoea-predominant irritable bowel syndrome (IBS-D), high-quality studies are scarce in this area. We intend to investigate the efficacy and safety of individualised sensitised acupuncture in IBS-D.

Methods and analysis
The study is designed as a large-scale, multicentre, two-arm, randomised clinical trial involving 326 patients diagnosed with IBS-D. Participants will be randomly allocated into the acupuncture or the sham acupuncture group in a 1:1 ratio. Both groups will undergo 15 sessions over 6 weeks. The primary outcome is the effective response rate at week 6, with secondary outcomes including the effective response rate at alternative time points, percentage of patients with 3 or more effective response weeks throughout the treatment duration, IBS Symptom Severity Scale, IBS-Quality of Life, Patient Health Questionnaire-9, Adequate Relief of IBS Symptoms Scale, Extraintestinal Symptoms Scale and other symptoms.

Ethics and dissemination
The study protocol has been approved by the Medical Ethics Committee of Beijing University of Chinese Medicine (project number: 2023BZYLL0102) and the ethics committees of other participating institutions. Each participant will be required to provide written consent before enrolment. The study results will be submitted for publication in a peer-reviewed journal.

Trial registration number
ChiCTR2300078321.

Leggi
Maggio 2025

Comparative efficacy of non-pharmacological interventions on kinesiophobia in patients with chronic non-specific low back pain: a study protocol for a systematic review and network meta-analysis

Introduction
Kinesiophobia is a significant factor which influences the prognosis of patients with chronic non-specific low back pain (CNLBP). The restriction of functional training can severely impede functional recovery and contribute to negative emotional states (including anxiety and depression) and a heightened risk of insomnia while exacerbating the economic burden on patients. Although several randomised controlled trials have evaluated the effects of various non-pharmacological interventions on kinesiophobia in CNLBP, their relative efficacy and potential adverse effects remain ambiguous. This study will conduct a systematic review and network meta-analysis to identify which non-pharmacological intervention may represent the most effective treatment for kinesiophobia in patients with CNLBP.

Methods and analysis
Comprehensive searches will be conducted across English and Chinese databases (including The Cochrane Library, PubMed, Scopus, Springer, Embase, Wanfang Data, the Chongqing VIP Database and China National Knowledge Infrastructure) from the date of their inception to 20 November 2024. Only Chinese or English studies will be considered for analysis. The primary outcomes will include a significant reduction in secondary movement phobia associated with CNLBP, pain alleviation and enhancement of the functional status of the lumbar muscles. The Cochrane Bias Risk Assessment Tool will be used to conduct a bias risk assessment.
Pairwise meta-analysis will be performed by Review Manager V.5.3 software, Stata V.16.0 and Open BUGS V.3.2.3 software will be used to conduct a network meta-analysis. The Grading of Recommendations, Assessment, Development and Evaluation framework will be employed to assess the quality of evidence.

Ethics and dissemination
All of the data included in this study will be derived from the literature; therefore, ethical approval is not necessary. The findings will be disseminated via peer-reviewed journals and academic conferences.

PROSPERO registration number
CRD42024605343.

Leggi
Maggio 2025

Integrating Buprenorphine Into Chronic Pain Treatment—Putting the Choice in VOICE

More than 1 in 5 US adults live with chronic pain, defined as experiencing pain on most days or every day for at least 3 months. Chronic pain takes an immense toll on people’s lives, impacting work, relationships, mental health, and well-being. For those who experience chronic pain and their clinicians, it is evident that flexibility, persistence, and creativity are necessary to create a multimodal care plan that maximizes function and minimizes the interference of chronic pain with daily living. These care plans must be dynamic, as changing life circumstances, pain characteristics, and overall health constantly shift the risk-benefit calculus for various treatment modalities. As a clinician, having options to offer patients is key.

Leggi
Maggio 2025

Effect of osteopathic manipulation on pain, disability, range of motion and reposition sense in subjects with postural neck pain: a systematic review protocol

Introduction
Postural neck pain is a prevalent musculoskeletal condition associated with discomfort, disability and impaired quality of life. Osteopathic manipulation has emerged as a potential intervention for managing postural neck pain, but a comprehensive synthesis of the existing evidence is lacking. This systematic review protocol introduces the rationale and objective to evaluate the effectiveness of osteopathic manipulation in alleviating postural neck pain and improving associated outcomes, including pain intensity, disability, range of motion and reposition sense.

Methods
We outline a rigorous methodology for this systematic review. A comprehensive search strategy will be implemented across various databases to identify relevant studies. This systematic review will encompass randomised controlled trials through electronic and manual searches. Electronic searches will be carried out in databases such as PubMed, Medline, Scopus and Web of Science. The search will span articles published from 2004 to December 2024; predefined eligibility criteria involve participants without a history of postural neck pain within the past 6 months. Exposure includes participants diagnosed with postural neck pain, while the comparison group comprises participants without neck pain.

Analysis
Outcome measures focus on pain intensity, range of motion, disability and reposition sense. Two independent reviewers will conduct study selection, data extraction and risk of bias assessment. The primary outcomes encompassing pain intensity, disability, range of motion and reposition sense will be systematically analysed.

Ethics and dissemination
As no primary data will be collected, ethical approval is not required. The findings will be presented at relevant conferences and published in a peer-reviewed journal.

PROSPERO registration number
CRD42023471857.

Leggi
Aprile 2025

[Viewpoint] Developing IBD counsellors in low- and middle-income countries: bridging gaps in patient care

The global burden of inflammatory bowel disease (IBD) is progressively increasing, with a particularly sharp rise in newly industrialized and resource-limited settings. These regions face unique and pressing challenges in IBD care, including a shortage of trained specialists, delayed or missed diagnoses, financial and geographic barriers to access, and the persistent stigma surrounding the disease. Furthermore, cultural dynamics; especially the prominent role of family in healthcare decisions; profoundly influence patient engagement, treatment adherence, and overall outcomes.

Leggi
Aprile 2025

Expert Panel Advises Against Common Spine Treatments for Chronic Back Pain

Chronic back pain is the leading cause of disability worldwide, affecting 1 in 5 adults aged 20 to 59 years. But an analysis of randomized trials and observational studies led a panel of experts to strongly advise against the spine interventions commonly used for chronic axial and radicular back pain in a new clinical guideline. The panel found that the treatments offered little or no relief compared with placebos.

Leggi
Aprile 2025

Pooled prevalence and factors of low birth weight among newborns in the top 20 countries with the highest infant mortality: analysis of recent demographic and health surveys

Objective
This study aimed to assess the pooled prevalence and factors of low birth weight among newborns in the top 20 countries with the highest infant mortality rates.

Design
We conducted a community-based cross-sectional analysis using data from Demography and Health Surveys across these countries. The final analysis included a weighted sample of 82 430 live births. We employed binary logistic regression to identify predictors of low birth weight, allowing for the interpretation of results as probabilities. This approach enhances the understanding of event likelihood, which is particularly valuable for policymakers. Statistical significance was determined at a 95% CI with p values

Leggi
Aprile 2025

Parental involvement in infection prevention and control in low- and middle-income country neonatal units: a scoping review protocol

Introduction
Neonatal sepsis is a key contributor to neonatal mortality worldwide, and low- and middle-income countries (LMIC) are disproportionately affected. With antimicrobial resistance challenging effective treatment of neonatal sepsis, it is increasingly urgent to improve infection prevention and control (IPC) in LMIC neonatal units (NNU) and reduce transmission of infections. One pathway to improvement which merits further exploration is the collaboration with families to build an IPC intervention.
Families are constantly present on neonatal units, and much of the hands-on care for their newborns is given by them. For IPC to be effective, families must adhere to IPC standards within the NNU, but furthermore, any IPC intervention implemented must be feasible and acceptable for families as well as the hospital staff as this will increase uptake and effectiveness of the intervention. This scoping review aims to provide an overview of parental involvement in infection prevention and control in low- and middle-income setting neonatal units.

Methods and analysis
This protocol was developed in line with the Joanna Briggs Institute recommendations. Searches will be carried out on six databases (Medline, CINAHL, Global Health, EMBASE, Web of Science and Global Index Medicus), and reference searching will be carried out on included studies. The search will be carried out from 2000 to present (end date 28/02/2024), and included languages will be English, French, Spanish and Portuguese. Screening and data extraction will be performed independently by two reviewers, with a third reviewer to resolve conflicts. Results will be reported by narrative synthesis of each sub-question in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Ethics and dissemination
This study will be carried out using already published data exclusively and therefore does not require further ethical approval. Results will be disseminated through peer-reviewed publications and conference presentations and through engagement with peers and relevant stakeholders.

Trial registration number
Registered with Open Science Framework – https://osf.io/snc7a/?view_only=8ffc39d837594b4388c7394a838c3a9e

Leggi
Aprile 2025

Resilient, engaged and connected (REC) study: protocol for a type 2 cluster-randomised trial of the Chicago Parent Program in prekindergarten in low-income urban and rural communities

Background
Social, emotional and behavioural (SEB) problems are among the most common chronic disabilities affecting children growing up in poverty. They also have implications for children’s school success as they affect essential social-emotional learning skills such as the ability to comply with rules, regulate emotions and get along with others. These skills are first learnt before kindergarten, in the context of a supportive, responsive and consistent parenting relationship. To date, school-based interventions to improve young children’s SEB competence and learning have primarily targeted students and teachers. Yet, parents are central partners in promoting these skills. This study seeks to improve children’s SEB competence and kindergarten readiness by strengthening parenting skills and parent engagement in early childhood education during prekindergarten (PreK). This hybrid type 2 effectiveness-implementation trial will rigorously evaluate the effects of an evidence-based parenting programme, the Chicago Parent Program (CPP), in PreK on children’s SEB competence, kindergarten readiness, chronic school absenteeism and grade retention in urban and rural schools serving students from low-income families in Maryland.

Methods
Using a cluster randomised design (n=30 schools, 840 parents; >90% low-income), we will examine the effects of CPP offered universally to PreK parents on parenting skills and parent engagement in children’s education; children’s SEB competence and kindergarten readiness; and chronic absence and grade retention in kindergarten. Schools will be stratified by rural versus urban district, then randomised to CPP or usual practice conditions. Data will be analysed using mixed effects regression models. Using the reach, effectiveness-adoption, implementation, maintenance (RE-AIM) framework and a mixed methods approach, we will assess CPP reach, efficacy, acceptability, adoption, implementation, cost-effectiveness and sustainability when offered in different formats (virtual vs in-person CPP groups) and contexts (urban vs rural). Schools will participate for 2 years with experimental schools offering CPP twice, once in virtual group format and once in an in-person group format (format randomised and counterbalanced). Data will be collected using multiple informants (parents, teachers, district administrative data) and methods (quantitative and qualitative data). Knowledge gained will inform schools in under-resourced urban and rural communities on sustainable, cost-effective strategies for strengthening parent-school connections and improving young children’s SEB competence and academic success.

Ethics and dissemination
Ethics approval has been granted by Johns Hopkins University School of Medicine (protocol number 00428221) and the Baltimore City Public Schools (protocol number 2024-013). At the conclusion of the study, results will be summarised and shared with parents, teachers, school principals and district leaders for their perspectives on the outcomes. Final reports will be published in scientific journals and presented at professional meetings.

Trial registration number
NCT06197997.

Leggi
Aprile 2025

Quantitative Ischemic Lesions of Portable Low–Field Strength MRI Using Deep Learning–Based Super-Resolution

Stroke, Ahead of Print. BACKGROUND:Deep learning–based synthetic super-resolution magnetic resonance imaging (SynthMRI) may improve the quantitative lesion performance of portable low–field strength magnetic resonance imaging (LF-MRI). The aim of this study is to evaluate whether SynthMRI improves the diagnostic performance of LF-MRI in assessing ischemic lesions.METHODS:We retrospectively included 178 stroke patients and 104 healthy controls with both LF-MRI and high–field strength magnetic resonance imaging (HF-MRI) examinations. Using HF-MRI as the ground truth, the deep learning–based super-resolution framework (SCUNet) was pretrained using large-scale open-source data sets to generate SynthMRI images from LF-MRI images. Participants were split into a training set (64.2%) to fine-tune the pretrained SCUNet, and a testing set (35.8%) to evaluate the performance of SynthMRI. Sensitivity and specificity of LF-MRI and SynthMRI were assessed. Agreement with HF-MRI for Alberta Stroke Program Early Computed Tomography Score in the anterior and posterior circulation (diffusion-weighted imaging–Alberta Stroke Program Early Computed Tomography Score and diffusion-weighted imaging–posterior circulation Alberta Stroke Program Early Computed Tomography Score) was evaluated using intraclass correlation coefficients (ICCs). Agreement with HF-MRI for lesion volume and mean apparent diffusion coefficient (ADC) within lesions was assessed using both ICCs and Pearson correlation coefficients.RESULTS:SynthMRI demonstrated significantly higher sensitivity and specificity than LF-MRI (89.0% [83.3%–94.6%] versus 77.1% [69.5%–84.7%];P0.35). Furthermore, for lesions during various poststroke phases, SynthMRI exhibited significantly higher agreement with HF-MRI than LF-MRI during the early hyperacute and subacute phases.CONCLUSIONS:SynthMRI demonstrates high agreement with HF-MRI in detecting and quantifying ischemic lesions and is better than LF-MRI, particularly for lesions during the early hyperacute and subacute phases.

Leggi
Aprile 2025

Pain management training for people with persistent pain and their informal carers (JOINT SUPPORT): multicentre randomised controlled feasibility trial with embedded qualitative study in English musculoskeletal services

Objectives
To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a pain management training intervention to support people with persistent musculoskeletal pain and their informal carers.

Design
Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.

Setting
National Health Service (NHS) providers in four English hospitals.

Participants
Adults receiving NHS care for persistent musculoskeletal pain and their informal carers.

Intervention
Control: usual NHS care. Experimental: usual NHS care plus a carer-patient pain management training intervention (JOINT SUPPORT), comprising five, 1-hour, group-based sessions for patients and carers, delivered by trained physiotherapists or occupational therapists. Content included understanding pain, pacing, graded activity, fear avoidance, goal-setting, understanding the benefits of physical activity and medication management. This was re-enforced with a workbook. After the group-based sessions, patients and carers were supported through three telephone sessions.

Randomisation
Central randomisation was computer-generated (2:1 Experimental:Control), stratified by hospital and patient-participant age (≤65 years). There was no blinding.

Main outcome measures
Data collected at baseline and 3 months post-randomisation included screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Interviews with 14 patient-carer participants and six health professionals who delivered the intervention.

Results
A total of 76 participants (38 patients; 38 carers) were enrolled. Sixty per cent (312/480) of patients screened were eligible with 12% consenting to be randomised (38/312). Fifty-four per cent (13/24) of the experimental group reached minimal compliance with the JOINT SUPPORT intervention. There was no evidence of treatment contamination. For patient-participant outcomes, within-group differences from baseline to 3 months favoured the control group when assessed by EQ-5D and Generalised Self-Efficacy total score, but favoured the intervention group when assessed by numerical rating scale pain, fatigue and Centre for Epidemiologic Studies Depression Scaletotal score. Qualitative data demonstrated the acceptability of the trial design and JOINT SUPPORT intervention with modifications to improve trial processes.

Conclusions
The JOINT SUPPORT intervention was acceptable to patient-carer dyads and health professionals. Modifications to trial design, particularly enhanced recruitment strategies, are required.

Trial registration number
ISRCTN78169443.

Data availability statement
The data that support the findings of this study are available from the corresponding author (TS) on reasonable request. This includes access to the full protocol, anonymised participant-level dataset and statistical code.

Leggi
Aprile 2025