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Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation

Por: Mitchell · N. · Vedhara · K. · Ayling · K. · Mitchell · A. · Sheehan · C. · Cullen · K. · Hart · R. · Okanlawon · A. A. · Arundel · C. · Bradbury · K. · Brewin · D. · Chalder · T. · Cullum · N. · Dayan · C. · Figueredo · G. · Fitzsimmons · D. · Hewitt · C. · Howard · G. · Lawton · J. · Metca
Introduction

Diabetic foot ulceration represents a prevalent, persistent and resource-intensive complication of diabetes. These ulcers are slow to heal, prone to recurrence and impose a substantial burden on both patients and healthcare providers. The reducing the impact of diabetic foot ulcers (REDUCE) intervention has been designed as a multifaceted approach targeting psychological and behavioural determinants linked to diabetic foot ulcer (DFU) outcomes. Following a successful pilot trial, the REDUCE trial has been designed as a pragmatic, multicentre randomised trial to compare the effectiveness and cost-effectiveness of the REDUCE intervention plus usual care versus usual care alone in reducing recurrence in people with healed DFUs. Additionally, there is an embedded process evaluation and two sub-studies which will be carried out alongside the main trial.

Methods and analysis

Adults over 18 years of age, with a recently healed DFU and two lower limbs, will be identified from around 30 specialist multidisciplinary diabetic foot clinics at participating National Health Service Trusts in the UK. Patients with active Charcot neuro-osteoarthropathy, active DFU or ulcers healed for more than 12 weeks will be excluded. We will aim to recruit 544 participants (1:1 randomisation). The primary outcome for this trial will be total ulcer-free days with limbs intact (ie, without amputation) between randomisation and the end of follow-up (18 months post-randomisation). Secondary outcomes include time to re-ulceration, total number of ulcers, amputation, quality of life (EQ-5D-5L), Patient Health Questionnaire-9, Nottingham Assessment of Functional Footcare, ICEpop capability measure for adults and resource use. As part of the process evaluation, up to 20 REDUCE intervention patient-participants will be interviewed, and the healthcare professionals delivering the intervention will also be interviewed. An assessment of intervention fidelity will also be carried out.

Ethics and dissemination

Ethics approval was granted by Wales 3 Research Ethics Committee (REC reference 22/WA/0053) on 16 March 2022. The findings will be presented at relevant conferences and disseminated via peer-reviewed research publications and to relevant stakeholders.

Trial registration number

ISRCTN15570706.

Seasonality of scabies and its association with climatic factors in Rohingya refugee camps, Coxs Bazar: a retrospective observational study, 2021-2023

Por: Halder · C. E. · Hasan · M. A. · Okello · J. C. · Khan · M. F. · Soma · E. R. · Poly · J. T. · Tassdik · H. · Hosen · M. S. · Prue · U. M. · Hannan · A.
Background

Scabies is a common skin condition and poses a substantial disease burden in resource-poor tropical settings. The Rohingya refugee camps in Cox’s Bazar, Bangladesh represent one of the world’s largest and most protracted humanitarian crises. Using 3 years of data from 2021 to 2023, this study analysed the seasonality of scabies and examined its association with climatic factors.

Methods

This is a retrospective observational study conducted in the Rohingya refugee camps and adjacent host communities in Ukhiya and Teknaf, Cox’s Bazar. All patients clinically diagnosed with scabies and who received treatment at 35 International Organization for Migration (IOM)-supported health facilities between 1 January 2021 and 31 December 2023 were included. Climate data, including daily mean, minimum and maximum temperature and total and maximum rainfall, were obtained from the Bangladesh Meteorological Department. Seasonal–Trend decomposition using LOESS (locally estimated scatterplot smoothing) (STL) was applied. Associations between climatic variables and the decomposed seasonal component of scabies cases and corresponding attack rate, as well as overall scabies case counts and overall attack rate, were assessed using Pearson’s correlation tests.

Results

A total of 323 106 new scabies cases were reported from IOM-supported health facilities between January 2021 and December 2023. Children aged under 5 years and 6–18 years accounted for the highest proportion of cases (32.08% and 38.95%, respectively). The average monthly number of scabies cases was highest in November (12 625) and lowest in May (5862). Case numbers increased from November to February (high season), with a peak between October and November, and declined between April and June (low season). An inverse relationship was observed between temperature and scabies incidence, with higher case numbers during cooler months and lower numbers during warmer months. Pearson’s correlation analysis demonstrated a strong and significant negative correlation between the seasonal components of both scabies cases and attack rate and temperature variables, including maximum (cases: r=–0.492, p=0.002; attack rate: r=–0.484, p=0.003), minimum (cases: r=–0.506, p=0.002; attack rate: r=–0.489, p=0.002) and mean temperature (cases: r=–0.525, p=0.001; attack rate: r=–0.511, p=0.001). No significant association was observed between the seasonal component of scabies cases or attack rate and humidity or rainfall.

Conclusion

This study identified a distinct seasonal pattern of scabies, with higher caseloads and attack rate during late autumn and winter (October to February) and lower caseloads and attack rate during summer months (April to June). Temperature showed a strong negative association with the seasonal component of scabies burden. These findings may inform the timing of public health strategies, including mass drug administration, intensified case management and social and behavioural change communication, in humanitarian settings.

Adding reciprocal inhibition to conventional physiotherapy for adhesive capsulitis of the shoulder in Bangladesh: a study protocol for a randomised controlled trial evaluating pain, function and range of motion

Por: Rahman · M. R. · Halder · P. · Hossain · M. E. · Ashfaquzzaman · M. · Mahmud · M. N. · Paul · R. C. · Sheikh · M. S. · Utshab · K. Z. · Hasan · M. M. · Hossain · M. M.
Introduction

Adhesive capsulitis (frozen shoulder) is a common condition characterised by pain, stiffness and reduced function. While conventional physiotherapy (typically comprising joint mobilisation, stretching, strengthening and electrotherapy) is widely used, there is limited evidence for the effectiveness of advanced neuromuscular techniques such as the reciprocal inhibition technique (RIT). This study aims to evaluate the impact of incorporating RIT into standard physiotherapy compared with standard physiotherapy alone in individuals with adhesive capsulitis.

Methods and analysis

This is a double-blind, randomised controlled trial. 30 adults aged 30–70 years with clinically confirmed adhesive capsulitis will be recruited from a tertiary rehabilitation centre in Dhaka, Bangladesh. Participants will be randomly allocated to receive either RIT combined with conventional physiotherapy or conventional physiotherapy alone, with both groups undergoing 12 treatment sessions over 4 weeks. The primary outcome is pain intensity at 4 weeks post-randomisation, measured by the Numeric Pain Rating Scale. Secondary outcomes include shoulder range of motion (abduction, internal and external rotation, assessed with a universal goniometer), functional ability (Shoulder Pain and Disability Index) and muscle strength (abduction, internal and external rotation, measured by hand-held dynamometry). Blinded assessors will conduct evaluations at baseline and after the intervention. Data will be analysed using intention-to-treat principles. Between-group comparisons will be made using linear mixed models with fixed effects for group, time and group-by-time interaction, and a random intercept for participants to account for repeated measurements. Within-group changes will be estimated from the models.

Ethics and dissemination

This trial has received ethical clearance from the Institutional Review Board of the Institute of Physiotherapy, Rehabilitation & Research (approval number BPA-IPRR/IRB/18/02/2025/32). Results will be disseminated through peer-reviewed publications and international conferences in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. By addressing a significant evidence gap, this study may establish RIT as an effective and affordable adjunct to standard physiotherapy for managing adhesive capsulitis.

Trial registration number

CTRI/2025/06/089288 [Registered on: 23/06/2025]

Feasibility of an adjunctive INtervention for Debilitating symptom complexes attributed to ticks (FIND): study protocol for a randomised, waitlist-controlled feasibility trial

Por: Kanaan · R. A. A. · Macdonell · R. · Long · M. · Richardson · R. J. · Rogers · C. · Mcmanus · M. · Braat · S. · Zaloumis · S. · Mihalopoulos · C. · Chatterton · M. L. · Gibney · K. B. · Oliver · G. · Wilson · S. J. · Chalder · T.
Background

Debilitating Symptom Complexes Attributed to Ticks (DSCATT) is a new term for an unexplained Australian syndrome—people who suffer from a chronic, multifaceted and debilitating illness, characteristically attributed to tick bites, but in a country without endemic Lyme disease. Despite the profound morbidity of DSCATT, no single causative agent has been identified and there are no recognised treatments for the illness at present. An increasing body of evidence shows psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life for other unexplained syndromes. Here we present a study protocol to assess the feasibility of an ACT-informed intervention for patients suffering from DSCATT, to be used adjunctively to their pre-existing healthcare. The study aims to assess the acceptability, practicality and demand for the treatment. Additionally, we will examine the effects of therapy on participants’ health and well-being, its safety, potential mediators of response to therapy and its preliminary cost-effectiveness.

Methods

We will assess the feasibility of a 32-week, randomised, waitlist-controlled, parallel convergent mixed-methods pilot trial for DSCATT. Participants will be randomised in a 1:1 ratio to receive either 16 sessions of ACT-informed therapy adjunctive to their pre-existing healthcare, delivered one-to-one with a trial therapist within a 20-week period or be assigned to the waitlist control group where they will continue their treatments as usual. We will collect quantitative and qualitative data to address study aims, with retention rate being the primary feasibility outcome.

Ethics and dissemination

The study has ethical approval from Austin Health Human Research Ethics Committee (HREC). The outcomes will be published in peer-reviewed journals. Data from participants who have given extended consent will be available for other HREC-approved studies.

Trial registration number

ACTRN12623000372684, prospectively registered 13 April 2023, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385579&isReview=true; the last participant is expected to complete in November 2026.

Exploring computer vision syndrome among primary school students in Dhaka, Bangladesh: a cross-sectional study

Por: Emon · H. H. · Pingky · J. S. · Halder · H. · Karmaker · S. · Rahman · M. · Shishir · F. M. · Tithi · T. R. · Akter · S. · Rahman · M. · Hossain · M. M.
Background

The use of different electronic devices is increasing among students due to rapid advancements in digital technology. The prevalence of computer vision syndrome (CVS) has increased among school children after the COVID-19 pandemic. Different symptoms of CVS, such as eye strain, headache, blurred vision and visual discomfort, have become major public health problems. This study aimed to assess the prevalence of CVS, identify its risk factors, evaluate parental awareness and examine the impact of COVID-19 on screen time among primary school children in Dhaka, Bangladesh.

Methods

Primary data were collected from the parents of 500 primary school students aged 5–14 years using a convenience sampling method through face-to-face interviews. A structured questionnaire was administered to collect demographic information, screen usage patterns, ambient conditions and details regarding the children’s academic performance. The Computer Vision Syndrome Questionnaire scale was used to assess the prevalence and severity of CVS. Various statistical analyses were performed, including 2 tests, Fisher’s exact tests and logistic regression, to identify significant predictors of CVS (p

Results

Findings revealed that 16.4% of children were affected by CVS, with key risk factors including age, school year, maternal education and daily screen time. Children with CVS commonly reported headaches and itchy eyes, which negatively impacted their academic performance. Surprisingly, 67.4% of parents were unaware of CVS, and the odds of developing CVS were 3.74 times higher among children using electronic devices for more than 4 hours daily.

Conclusions

The study explored the low prevalence of CVS among primary school students in Dhaka, Bangladesh. Several symptoms, like headaches and eye discomfort, were identified that impaired their academic performance. Additionally, many parents were largely unaware of CVS. Therefore, it is necessary to take proper strategies to be aware of the consequences and lessen the prevalence of CVS to save our future generation.

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