CADOR (Capsaicin in neuropathic-like pain in digital osteoarthritis) study protocol: a multicentre randomised parallel-group trial

Introduction
It is common for finger pain in hand osteoarthritis (HOA) to display a neuropathic component. Non-steroidal anti-inflammatory drugs (NSAIDs) and conventional analgesics are not very effective in relieving this neuropathic-like pain. Capsaicin, a compound extracted from chilli peppers, is approved for the management of localised neuropathic pain. However, the effectiveness of an 8% capsaicin transdermal patch has never been tested in HOA patients with neuropathic-like pain in a randomised setting. In this study, we aimed to compare the 60-day (D60) efficacy of a transdermal application of capsaicin 8% versus a control (very low-dose capsaicin at 0.04%) on hand pain in patients with painful digital osteoarthritis with a neuropathic-like pain component.

Methods and analysis
CADOR (CApsaicin in neuropathic-like pain in Digital Osteoarthritis: a Randomised trial) is a multicentre, randomised, controlled, double-blind, two parallel group, phase 3 clinical trial. Eligible patients have HOA according to the American College of Rheumatology criteria and at least Kellgren-Lawrence grade≥2, with neuropathic-like pain (‘Douleur neuropathique en 4 questions’ (DN4) score≥4/10 and pain intensity≥40/100 mm). At Day 0, 120 patients will be randomised (1:1) to receive a single 30 min topical application of either capsaicin 8% transdermal patch (experimental group) or capsaicin 0.04% transdermal patch (control group). The primary outcome is pain intensity in the fingers over the past 48 hours at Day 60, measured with a Visual Analogue Scale (VAS) ranging from 0 to 100 mm. Secondary outcomes are functional disability, quality of life, anxiety and depression, the patient’s global impression of improvement, use of analgesics and NSAIDs and the safety of capsaicin. At visit D60, patients who still have finger pain≥40/100 mm on the VAS will receive, if they wish a single 30 min topical application of capsaicin 8% transdermal patch (not blinded). The efficacy of two transdermal applications of capsaicin (either two applications of 8% patch in the experimental arm or one application of 0.04% and one application of 8% in the control arm) will be assessed on Day 120.

Ethics and dissemination
Ethics approval was obtained from the French Health Authorities (Comité de protection des Personnes SUD EST V and Agence Nationale de Sécurité du Médicament) on 23 May 2024 in accordance with European Regulation n°536/2014 of 16 April 2014 (ref: 2024-511159-16-00) before participant enrolment.

Trial registration number
ClinicalTrials.gov: NCT06444919.

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Marzo 2025

Perplexing case of abdominal pain with eosinophilia and fasciitis

Clinical presentation A 34-year-old man presented to our institution for review with recurrent abdominal pain, constipation, lethargy, fevers and episodic migratory soft tissue severe cellulitis of the limbs after minimal exercise. This was on a background of a diagnosis of eosinophilic enterocolitis at the age of 10 when due to recurrent abdominal pain, endoscopy was performed with biopsies showing eosinophilic infiltration of the oesophagus, stomach, duodenum and colon. This had been treated with steroids in the past with clinical response. A variety of disease-modifying antirheumatic drugs (DMARDs) failed to provide a steroid-sparing effect previously. Clinical history was otherwise significant for resolved childhood asthma and eczema. The patient underwent a gastroscopy and colonoscopy which demonstrated oesophageal (figure 1A), stomach, duodenal and terminal ileal eosinophilic infiltration, along with pancolitis on colonic biopsies. After initial endoscopic evaluation, the patient had a recurrence of abdominal pain and migratory right lower…

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Marzo 2025

Does interdisciplinary group care for the treatment of endometriosis improve pain interference: protocol for a pilot randomised controlled trial at an urban academic medical centre

Introduction
Endometriosis affects 10–15% of people assigned female at birth and can cause chronic pelvic pain and impair many domains of quality of life, such as fertility, mood and bladder, bowel and sexual function. Current treatments often fail, leading to recurrent pain and the need for reintervention. As endometriosis negatively affects many domains of life, a variety of non-pharmacological treatments modestly improve symptoms. To bundle these interventions into accessible packaging, our interdisciplinary team developed a novel endometriosis intervention titled ‘Peer-Empowered Endometriosis Pain Support (PEEPS)’, an 8-week integrative group care intervention. Here, we present the protocol for a pilot randomised controlled trial (RCT) to evaluate the effectiveness and implementation of PEEPS for people with endometriosis-associated pain refractory to surgical management. We hypothesise that patients who complete the PEEPS programme will show a greater decrease in pain interference in daily activities at intervention completion as compared with baseline than those in the education arm.

Methods and analysis
This is a hybrid type 1 effectiveness-implementation mixed-methods RCT in which 60 participants will be randomised using computer-generated random numbers stratified by group in the ratio 1:1 to PEEPS plus usual versus educational handout plus usual care. The primary outcome is change in pain interference from baseline to intervention completion. Secondary outcomes include change in pain interference from baseline to 6 months and 12 months postintervention, as well as change in other quality-of-life measures as measured by nine validated questionnaires from baseline to completion, 6 months and 12 months. Proctor et al’s Implementation Outcomes Framework will be used to evaluate acceptability, appropriateness and feasibility of PEEPS implementation, and the Consolidated Framework for Implementation Research will be used to guide the evaluation of barriers and facilitators of PEEPS at the patient and provider levels. Primary data analyses will follow the intention-to-treat principle. Descriptive statistics and two-sample t-tests for normally distributed values and Wilcoxon Rank-Sum test were performed for non-normally distributed values. Frequency analysis and Fisher’s exact or 2 tests will be used for categoric variables as appropriate. Longitudinal analysis of the primary and secondary outcomes will be conducted with a mixed-effects model to investigate the effect of PEEPS compared with education. Least square means (LSMs) and the corresponding 95% CIs at each timepoint, as well as LSM differences and 95% CIs between any post-baseline and baseline will be provided for the outcomes. ORs and 95% CIs will be calculated for categorical outcomes. Qualitative data will be collected in the form of open-ended feedback, focus groups with programme completers and semistructured interviews with participants who complete two or fewer sessions. The analysis will use an embedded design-experimental model in which quantitative and qualitative outcomes will occur concurrently with weight priority given to quantitative data.

Ethics and dissemination
This trial was approved by the Washington University in St. Louis Institutional Review Board (protocol 202402082) on 27 March 2024 and has low risk of harm to participants. All deidentified data from this project will be shared via Digital Commons@Becker. The findings of this study will be disseminated via scientific meetings and peer-reviewed journals. The results and conclusions will be summarised for patients and the public in common language using infographics to make the findings accessible. This pilot RCT will yield the effect size for PEEPS and generate implementation context and outcomes data to guide PEEPS application to real-world practice. If PEEPS proves to be effective, this study will inform adaptation and scaling to improve the lives of people with endometriosis through a non-hormonal, fertility-preserving approach.

Trial registration number
ClinicalTrials.gov; NCT06549985.

Leggi
Marzo 2025

The impact of blood flow restriction training combined with low-load resistance training on the risk of falls in patients with knee osteoarthritis in China: a single-centre, two-arm, single-blind, parallel randomised controlled trial protocol

Introduction
Patients with knee osteoarthritis are at a higher risk of falls compared to healthy individuals, thereby increasing the likelihood of accidental injury. Resistance training is an important strategy for managing knee osteoarthritis. Although some studies suggest that blood flow restriction training combined with low-load resistance training (LL-BFRT) is a beneficial treatment approach, its effect on fall risk and balance function in patients with knee osteoarthritis remains unclear. We aim to conduct a randomised controlled trial to assess the effectiveness of combined training in reducing fall risk and improving function in patients with knee osteoarthritis.

Methods and analysis
We will conduct a single-blind pilot randomised controlled trial involving patients with knee osteoarthritis. 98 patients will be randomly assigned to either the LL-BFRT group or the low-load resistance training (LL-RT) group, with a 1:1 allocation ratio. Both groups will undergo a 4-week intervention. Follow-up assessments will be conducted at baseline, 4 weeks, 16 weeks, 28 weeks and 52 weeks. The primary outcome will be the measurement of the fall risk stability index and overall stability index using the Biodex Balance System. Secondary outcomes include the Numerical Rating Scale, the Western Ontario and McMaster Universities Osteoarthritis Index, the 30 s Chair Stand Test, proprioception testing, the Timed Up and Go Test, the Short Form-36 scores, compliance and adverse events. Intention-to-treat principles will be applied in data analysis.

Ethics and dissemination
This study has been approved by the Ethics Review Committee of the First Hospital of Quanzhou Affiliated Fujian Medical University (2024-K161). The results of the study will be disseminated through peer-reviewed publications.

Trial registration number
ChiCTR2400087829.

Leggi
Marzo 2025

Prevalence of low back pain and its determinant factors among prehospital healthcare providers working in ambulance service centres in Addis Ababa, Ethiopia, 2024: a cross-sectional study design

Background
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Low back pain (LBP) is a discomfort in the spinal area around the 12th rib and the inferior gluteal folds with or without radiation to the lower extremities. It is a widespread public health problem throughout the world, especially a prominent problem for healthcare providers working in prehospital areas. Now, it is a major problem in low- and middle-income countries, but the magnitude and its determinant factors have not been researched in Ethiopia.

Objective
To assess the prevalence of LBP and associated factors among prehospital healthcare providers in selected ambulance service centres in Addis Ababa, Ethiopia, 2024.

Methods
A cross-sectional study was conducted from a total of 150 prehospital healthcare providers working in Addis Ababa, Ethiopia from 1 to 30 April 2024. A simple random sampling method was used to select the study participants. Data were collected using a standardised self-administered questionnaire by certified degree nursing professionals. The collected data were imported into EpiData V. 3.1 and exported to SPSS V. 25 for analysis. To determine whether there is a significant relationship between the dependent and independent variables, bivariable and multivariable logistic regression was carried out.

Result
The overall prevalence of LBP among prehospital healthcare providers was 80%. Working in a twisting position (AOR: 5.763 (95% CI 1.544 to 21.515)) and several call missions >6 times per week (AOR: 12.437 (95% CI 2.603 to 59.423)) were positive predictors, while using ergonomic manual guidelines (AOR: 0.159 (95% CI 0.032 to 0.787)) was a negative predictor of LBP.

Conclusion
There was a high prevalence of LBP among prehospital healthcare providers. Also, predictors of twisting position, using ergonomic manual guidelines and call missions per week were significantly associated with LBP. Healthcare facilities should be retrofitted with equipment enabling work based on the principles of back ergonomics.

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Marzo 2025

Reasons for emergency department use of low-acuity attender: results from the prospective, multicentre, cross-sectional EPICS-9/PiNo-Bund study

Background
The number of low-acuity emergency department (ED) visits varies across Europe and is often posited as a contributing factor to ED crowding. Many health policy-makers and health professionals assume that these cases are ‘avoidable’ ED visits or could be referred to other ambulatory healthcare providers.

Objectives
This study examines the care-seeking behaviour and the reasoning behind patients with low-acuity ED attendance according to emergency triage.

Design and setting
In a prospective multicentre cross-sectional survey, patients were invited to participate in an anonymised, paper-based survey in the waiting areas of nine EDs in Germany (2018–2020). The survey included questions on sociodemographic characteristics, reasons for using the ED, previous consultations in the outpatient healthcare system, self-rated urgency and knowledge of other emergency care structures. Due to the variance of missing values in the different responses, the valid percentages are shown.

Results
Of the 2752 survey respondents, 41.1% (n=1 120) indicated that ‘pain’ was the primary complaint for their ED attendance. Self-rated urgency was ‘less urgent’ for 58.7% (n=1552), ‘urgent’ for 41.3% (n=1093) and 57.7% reported the first episode of their symptoms (n=1505), with 30.8% (n=830) with symptom onset on the same day. The majority of patients completed the survey on weekdays (94.6%) between 08:00 and 18:00 (82.2%). 80.1% stated that they had a general practitioner (GP) (n=2103) and 55.8% contacted their GP before attending the ED (n=1403). In 77.8% of patients with GP contact, a visit to the ED was recommended by practice members or the GP (n=1068). The on-call service of the statutory health insurance physicians (SHIP) was contacted by 7.0% (n=172); in 64.6% of these cases (n=115), an ED visit was recommended. Of all patients without contact to the SHIP on-call service, 60.6% stated that they were not aware of these services (n=848).

Conclusions
Patients with low-acuity ED attendance stated acute onset and mainly new episodes of symptoms, with pain being the most common chief complaint. A high proportion reported having contacted their GP or SHIP on-call services (if known) but have been referred to the ED. As long as no fundamental changes are made to the provision of timely treatment options in the outpatient care sector, EDs may continue to be the foremost treatment option for these patients.

Leggi
Marzo 2025

Effect of motor control training and breathing exercises on pain, disability and core muscle activity in women with postpartum lumbopelvic pain: a study protocol for randomised controlled trial study

Introduction
Postpartum lumbopelvic pain (LPP) is a prevalent condition among women following childbirth. Due to the importance of respiratory muscles in lumbopelvic stability, and the changes they undergo during pregnancy, this study aims to assess the effects of motor control training and breathing exercises on pain, disability and core muscle activity in women suffering from LPP after childbirth.

Methods and analysis
52 women with postpartum LPP will participate in this two-parallel-armed, superiority randomised controlled trial, comprising 24 treatment sessions. The intervention group consists of motor control training and breathing exercises, and the control group includes motor control training. The diaphragm excursion, pelvic floor and abdominal muscle activity, pain and disability will be evaluated using ultrasound imaging, visual analogue scale and Oswestry Disability Index, before and after the intervention, respectively.

Ethics and dissemination
Ethical approval was obtained from the human research ethics committee of the Iran University of Medical Sciences (IR.IUMS.REC.1403.017). The study results will be submitted to a relevant journal and conferences.

Trial registration number
This clinical trial has been registered in the Iranian Registry of Clinical Trials on 21 May 2024 (registration number: IRCT20180916041051N2).

Leggi
Marzo 2025

Health literacy of primary caregivers of children with cerebral palsy in low- and middle-income countries: a systematic review

Objective
We aimed to synthesise existing literature on the health literacy of primary caregivers (PCGs) of children with cerebral palsy (CP) in low- and middle-income countries (LMICs).

Design
Systematic review informed by Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources
Ovid MEDLINE, Ovid EMBASE, CINAHL via EBSCO, Scopus and Web of Science were searched from inception to January 2024.

Eligibility criteria
Original studies including observational or experimental data, examining health literacy and/or health literacy proxies using Optimising Health Literacy and Access domains as indicators (eg, education, social support, self-efficacy, health attitudes, reading and writing skills) in primary caregivers of children with CP in LMICs.

Data extraction and synthesis
Data from included studies were systematically recorded using an Excel template, with information extracted independently by two reviewers. We used the Study Quality Assessment Tool developed by the National Health, Lung, and Blood Institute.

Results
The systematic review yielded 2734 articles, with 15 eligible for inclusion. None used health literacy (HL) measurement tools, and there was limited reporting on specific HL domains. Studies spanned 11 LMICs across 5 major regions. PCGs, predominantly mothers, exhibited varying levels of service awareness, service utilisation and social support. Literacy levels significantly impacted HL proficiency, exposing a notable research gap in LMICs.

Conclusions
This study presents the first comprehensive analysis of health literacy among PCGs of children with CP in LMICs. Findings reveal a striking absence of tailored health literacy literature, impacting current considerations of PCGs’ understanding and management of their child’s condition. Additionally, challenges in social support, healthcare navigation and low literacy levels further hinder effective caregiving in LMICs.

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Marzo 2025

Londons Ultra Low Emission Zone and active travel to school: a qualitative study exploring the experiences of children, families and teachers

Objective
Taking a qualitative approach, we aimed to understand how London’s Ultra Low Emission Zone (ULEZ) might work to change behaviour and improve health in the context of the school journey.

Design
Primary qualitative study embedded within an existing natural experimental study.

Setting
A population-level health intervention implemented across London.

Participants
Purposive sampling was used to recruit children (aged 10–11 years) from ethnically and socioeconomically diverse backgrounds within an existing cohort study, Children’s Health in London and Luton.

Methods
In-person and online interviews were conducted with 21 families and seven teachers from the children’s schools between November 2022 and March 2023. Verbatim transcripts were analysed drawing on Braun and Clarke’s reflexive thematic analysis and guided by realist evaluation principles to identify contexts, mechanisms and outcomes using NVivo.

Results
Common context, mechanism, outcome (CMO) configurations were identified reflecting congruent narratives across children, parents and teachers, for example, current active travellers (context) reported reductions in pollution (mechanism) leading to improvements in health, including alleviated symptoms of asthma (outcome). These CMOs were broadly captured by two themes: (i) how you travelled before the ULEZ matters: the impact of travel mode on experiences of the ULEZ and (ii) your context matters: the role of socioeconomic position in experiences of the ULEZ. Participants highlighted the potential for the ULEZ to positively impact their choice of travel mode to school, experiences of the journey and their health. However, the impact of the ULEZ differed inequitably by journey length, travel mode before implementation and access to reliable and affordable public transport.

Conclusions
The capacity for the ULEZ to both narrow and exacerbate inequities across different travel contexts suggests when developing such schemes, more emphasis needs to be placed on providing accessible and affordable alternatives to driving.

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Marzo 2025

Correction for 'Cost-utility analysis of MR imagingguided transurethral ultrasound ablation for the treatment of low- to intermediaterisk localised prostate cancer

Muhler P, AkuamoaBoateng D, Rosenbrock J, et al. Cost–utility analysis of MR imaging-guided transurethral ultrasound ablation for the treatment of low- to intermediate-risk localised prostate cancer. BMJ Open 2025;15:e088495. doi:10.1136/bmjopen-2024–0 88 495 This article has been corrected since it was published online. Page 1 ‘BACKGROUND […] Among all prostate cancer patients, those with low or favourable intermediate risk of prostate cancer who have a low risk of tumour & page 2 ‘[…] To evaluate the clinical and economic long-term consequences of applying MR-TULSA in low or favourable intermediate-risk prostate cancer in Germany’ We found inconsistencies in punctuation: Please correct them into ‘low- and favourable intermediate-risk (of) prostate cancer. Page 5: ‘Table 2 Cost calculation […] Salvage ADT withleuprorelinn for 2 years’ The typing mistake mentioned above, needs to be corrected in ‘with leuprorelin for 2 years’ Page 5: ‘Table 2 Cost calculation […] RARP, radical prostatectomy’ Please correct to ‘RARP, robot-assisted…

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Febbraio 2025