Search Results for: Low Back Pain: raccomandazioni

Introduction
The current pharmacological management of type 2 diabetes mellitus (T2DM) faces challenges such as low rates of optimal glycaemic control, high incidences of adverse drug reactions and suboptimal treatment compliance. Pueraria lobata radix (PLR), a medicinal and edible herb, has shown hypoglycaemic effects in animal models. However, existing clinical studies have only assessed the hypoglycaemic effect of PLR-containing herb formulas or PLR extract preparations. The aim of this study is to investigate the efficacy and safety of using PLR solely as an adjuvant therapy for T2DM.

Methods and analysis
This study is a multicentre, randomised, double-blind, placebo-controlled trial. 200 patients with T2DM will be randomly allocated to either the PLR group or the placebo group for a consecutive 12-week intervention. Regular visits will be conducted at weeks 4, 8 and 12, following the initiation of the study to evaluate the efficacy and safety of PLR. The primary outcome is the change in haemoglobin A1c (HbA1c) from baseline at week 12. Secondary outcomes include changes in HbA1c from baseline at weeks 4 and 8; the HbA1c response rate (< 7%), changes in fasting blood glucose, 2-hour blood glucose, fasting C-peptide, body mass index, severity of diabetes symptoms, quality of life from baseline at weeks 4, 8 and 12; and changes in blood lipid indicators at week 12. Safety outcomes include the incidences of total adverse events (AEs), serious AEs and PLR-related AEs. Ethics and dissemination The protocol has been approved by the Ethics Committees of the First Affiliated Hospital of Nanchang University (approval number: IIT[2024]LLS No.303) and the Affiliated Hospital of Jiangxi University of Chinese Medicine (approval number: JZFYLL2024006200087). We will disseminate the study findings through publications in peer-reviewed journals and conference presentations. Trial registration number ClinicalTrials.gov NCT06494683.

Introduction
Sensorimotor training (SoMT) is a gradual balance training technique employed to treat various chronic musculoskeletal pain. Core strength training (CST) is one of the most commonly used interventions for managing low back pain (LBP). This randomied controlled trial protocol aims to determine whether the combination of SoMT and CST can significantly reduce LBP, and improve scoliosis-related outcomes and overall functional status in adult idiopathic scoliosis (AdIS) patients.

Methods and analysis
A total of 300 AdIS patients will be recruited from the outpatient clinic and randomly assigned to one of three groups: CST group, SoMT group or the combined therapy group, using stratified block randomization based on the severity of scoliosis curve. All groups will receive the intervention three times a week for 12 weeks. Sessions will be conducted in the hospital, and no home programme will be provided. Adherence and attendance will be monitored and recorded. The CST group will receive CST therapy, while the SoMT group will receive SoMT therapy, which consists of three progressive phases: static, dynamic and functional. Participants will progress to the next phase on achieving pelvic stability in the current phase. The combined therapy group will receive both CST and SoMT. Assessors and statisticians will remain blinded to participant allocation throughout the study. Assessments will be performed at baseline and at the endpoint, 12 weeks after the initiation of the intervention. The primary outcome will be the self-reported pain level, measured using the visual analogue scale. Secondary outcomes will include pain-related disability (by the Oswestry Disability Index and the Roland-Morris Disability Questionnaire), spinal morphology indicators (including Cobb angle, the angle of trunk rotation and the Sagittal Index), postural control ability (by the Tetrax IBSTM), proprioceptive sensitivity (by the repositioning error test) and health-related quality of life (by the 36-Item Short Form Health Survey). Statistical analysis will adhere to the intention-to-treat principle and will be complemented by per-protocol analysis. To compare the effects of SoMT versus CST and combined therapy versus SoMT on both primary and secondary outcomes, a linear mixed-effects model or generalised linear mixed model will be applied.

Ethics and dissemination
The current study received ethical approval from the Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2024-080-3). Written informed consent will be obtained from all participants. Any interim analysis and full results will be published in an international peer-reviewed journal.

Trial registration number
This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2400085370).

Objectives
To understand the current status of emotional intelligence, professional identity and humanistic care ability among standardised training nurses (STNs); to explore the mediating role of professional identity in the relationship between emotional intelligence and humanistic care ability; and to explore the potential mechanisms among these variables.

Design
A cross-sectional study.

Setting
A tertiary hospital in Chengdu, China.

Participants
A total of 134 STNs were recruited through convenience sampling.

Methods
Using convenience sampling, 134 STNs were recruited. Participants completed the Nurse Professional Identity Scale (5-point Likert), the Humanistic Care Ability Scale (7-point Likert) and the Emotional Intelligence Scale (7-point Likert) to assess their levels of professional identity, humanistic care ability and emotional intelligence. Structural equation modelling was used to test the mediation model.

Primary and secondary outcome measures
Participants completed the Nurses’ Professional Identity Rating Scale, the Caring Ability Inventory and the Emotional Intelligence Scale. Pearson correlation and mediation analyses were performed using the PROCESS macro for SPSS.

Results
STNs demonstrated low levels of humanistic care ability, moderate levels of professional identity and low levels of the ability to assess others’ emotions. Emotional intelligence had a significant positive direct effect (0.798) on humanistic care ability and professional identity partially mediated (0.109) this relationship.

Conclusion
Emotional intelligence directly enhances humanistic care ability, and professional identity plays a partial mediating role. Integrating emotional intelligence and professional identity training into standardised nurse education may strengthen humanistic care competencies. Targeted emotional intelligence training for STNs may enhance empathy and professional identity, thereby improving humanistic care ability and contributing to better doctor-patient relationships.

Introduction
Statins are among the most widely used drugs. While they are effective for primary and secondary prevention of cardiovascular (CV) disease in middle-aged subjects, their benefits for prevention in older adults (aged ≥70 years) without CV disease are uncertain, particularly for those with multimorbidity. Statin side effects and drug interactions are common in older patients and may negatively impact quality of life. To date, the only randomised controlled trial (RCT) investigating statin discontinuation in older adults has demonstrated no difference in survival but did note a small improvement in quality of life for those who discontinued statins. However, this trial exclusively enrolled patients with a life expectancy

Objective
To examine the feasibility, safety and perceived patient response of a combined repetitive transcranial magnetic stimulation (rTMS) and quadriceps strengthening exercise intervention for knee osteoarthritis.

Methods
A two-arm, participant-blinded, therapist-blinded and assessor-blinded, randomised controlled trial with additional follow-up of pain and function at 3 months. Participants were randomised to receive active rTMS+exercise (AR+EX) or sham rTMS+exercise (SR+EX) twice weekly for 6 weeks while completing home exercises twice a week. Primary outcomes included recruitment rate, treatment attendance, dropouts, willingness to undergo therapy (11-point Numeric Rating Scale, ‘not at all willing’=0 and ‘very willing’=10), success of participant, therapist and outcome assessor blinding, adverse events and Global Perceived Effect Scale. Secondary outcomes were pain, function and measures of physiological mechanisms.

Results
86 people were screened, 31 (36%) were randomised, 28 (90%) completed the treatments and 3 (10%) dropouts at 3-month follow-up. Both groups had high treatment attendance (98.4% and 100%). All participants scored at least 7 on the willingness to undergo therapy scale. Blinding was successful. No adverse events were reported. At the postintervention assessment, 80% in the AR+EX group and 75% in the SR+EX group reported an improvement on the Global Perceived Effect Scale. Both groups demonstrated within-group improvements in pain at the postintervention assessment but not at the 3-month follow-up. Function improved only in the AR+EX group at the postintervention assessment.

Conclusions
Combined rTMS and quadriceps strengthening exercise intervention for knee osteoarthritis is feasible, safe and well-received. A full-scale trial is justified to assess the clinical benefits of this novel treatment.

Trial registration number
ACTRN12621001712897.

Objectives
Tissue viability assessment is one of the main challenges in trauma surgery. Vitality assessment using indocyanine green fluorescence angiography (ICG-FA) may improve surgical decision-making. This systematic review gives an overview of current applications of ICG-FA in surgical treatment of traumatic injury and its effects on the incidence of postoperative complications and intraoperative decision-making.

Design
Systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources
PubMed, EMBASE and MEDLINE were searched through 18 December 2023.

Eligibility criteria for selecting studies
Primary research reports regarding indocyanine green (ICG)-fluorescence in patients with traumatic injury were included. Exclusion criteria were use of ICG for treatment of burn wounds, traumatic brain injury or reconstructive surgery, absence of an English or Dutch full-text and non-primary study design.

Data extraction and synthesis
Two independent reviewers performed the search and screening process according to standardised methods. Risk of bias was assessed using the Methodological Index for Non-Randomised Studies. Data were presented in text and overview tables.

Results
Thirteen studies were included, of which six were case series/reports including three or fewer patients. Within the other seven studies, 301 patients received ICG-guided surgery. ICG was used for perfusion assessment in all studies. Injury types consisted of traumatic extremity and abdominal injury. All studies reported beneficial effects such as necrosis detection, determination of resection/debridement margins and reduction of debridement procedures. ICG could improve intraoperative decision-making and significantly decrease postoperative complications. No included studies reported ICG-related complications or adverse events.

Conclusion
The available literature regarding the use of ICG-FA in trauma surgery is limited, and comparability is low. Still, the results are promising and show a large potential of ICG-FA for better and more efficient treatment of trauma patients. Further research with larger samples and comparable conditions is thus necessary and highly recommended.

Objectives
A consensus study to establish a Core Outcome Set for dysarthria after stroke identified four key outcome domains that should be measured in research and clinical practice: (1) intelligibility of speech, (2) ability to participate in conversations, (3) living well with dysarthria and (4) communication partners skills and knowledge (where relevant). This review aimed to systematically identify corresponding measurement instruments and to examine their clinical utility and psychometric properties.

Design
Systematic review conducted in alignment with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources
CINAHL, EMBASE, MEDLINE, PsycInfo and Cochrane Stroke Group Trials Register, CENTRAL, Linguistics and Language Behavioral Abstracts (LLBA). Major trials registers: WHO ICTRP, ISRCTN registry and ClinicalTrials.gov searched March 2024.

Eligibility criteria for selecting studies
We included trials that developed or used measurement instruments for poststroke dysarthria. We identified studies that could be included in an update of the Cochrane systematic review of interventions for non-progressive dysarthria to identify what measurement instruments were used in therapy trials for poststroke dysarthria.

Data extraction and synthesis
Records were screened independently by three authors. Psychometric data were extracted, by two authors, from included studies and methodological quality was evaluated using Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) and Core Outcome Measures in Effectiveness Trials (COMET) guidance. Assessment of clinical utility followed Outcome Measures in Rheumatology (OMERACT) guidance.

Results
Following screening, 19 publications reporting 12 measurement instruments were identified. According to COSMIN standards, all 19 publications were rated as having low, very low or unknown quality of evidence. Three measurement instruments were identified as having the most relevant clinical utility to the population, the highest quality of evidence and had the potential to measure some specific aspects from three of the four agreed domains, intelligibility, conversations and living well with dysarthria from the patient and clinician perspective. These were the Frenchay Dysarthria Assessment II, the Communication Outcomes After Stroke Scale and the Therapy Outcome Measures for Dysarthria.

Conclusions
This review provides a comprehensive overview and appraisal of dysarthria measurement instruments to align with a Core Outcome Set. We only included English language-based measurement instruments. Many dysarthria measurement instruments were developed for non-stroke populations, including progressive dysarthria, with limited psychometric data for stroke. Measurement instruments with uncertain quality of evidence can still be considered for inclusion with a Core Outcome Set and three have been suggested. There is a need for further psychometric testing of these and the development of new measurement instruments to cover all aspects of intelligibility, conversations, living well with dysarthria and communication partner skills.

PROSPERO registration number
CRD42022302998.

Introduction
Sarcopenia and frailty have been identified as negative predictors of health outcomes. Patients with stroke, traumatic brain injury (TBI), knee osteoarthritis (OA) and breast cancer commonly experience low physical activity levels in the chronic phase of recovery. This prospective study aims to explore the feasibility of multimodal screening and longitudinal tracking of various biomarkers from the acute to chronic phase of disease to determine the relationship with frailty outcomes.

Methods and analysis
A prospective longitudinal observational cohort study involving Asian populations is planned over 3 years. Enrolled participants with index conditions of acute stroke, TBI, knee OA and breast cancer will be recruited from rehabilitation hospitals and clinics and followed longitudinally. Reference thresholds from the Asian Working Group on Sarcopenia will be used. Variables include self-reported questionnaires, disease and comorbidity characteristics, anthropometric measurements, appetite questionnaires, muscle ultrasound (MUS), muscle/bone mass, blood biomarkers and markerless gait motion systems. In particular, physical performance (short physical performance battery and hand grip strength), sarcopenia (SARC-F questionnaire) and frailty assessment (FRAIL score, clinical frailty scale), four-region MUS, body composition analysis, dual X-ray absorptiometry, bone mineral densitometry, physical activity levels (International Physical Activity Questionnaire for the elderly [IPAQ-E], fitness trackers) and health-related quality of life assessment (EuroQoL-5D questionnaire five level [EQ5D-5L]) will be used. Blood biomarkers measuring metabolic health (eg, glycated haemoglobin, cholesterol, fasting glucose and 25-OH vitamin D) and inflammation (eg, Tumor Necrosis Factor-alpha [TNF-α] and Monocyte Chemoattractant Protein-1 [MCP-1]) will be measured at baseline. Data collection will take place at postrecruitment baseline (hospital admission), 1, 6 months, 12 months and 2 years postrecruitment (inpatient) and at postrecruitment baseline, 6 months, 12 months and 2 years postrecruitment (outpatient).

Ethics and dissemination
Ethical approval has been obtained from the National Healthcare Group Domain Specific Review Board (2023/00105). Findings will be disseminated through conference presentations and publication in scientific journals.

Trial registeration number
NCT06073106.

Introduction
Many women need to use medications during breastfeeding. Very few medications have been adequately monitored, tested and labelled with safety information for this use. Prednisolone is one of these drugs. We aim to conduct a multicentre low-intervention clinical trial to determine the concentration of prednisolone in plasma of breastfed infants of lactating women treated with prednisolone. In addition, we will measure the concentration in maternal plasma and breast milk and calculate the daily infant dose (DID) and relative infant dose (RID). Infant cortisol levels will be analysed as a measure of clinical effects in the infants.

Methods and analysis
The study will be conducted at departments of obstetrics and gynaecology and specialist maternity and paediatric outpatient clinics in Sweden. We aim to include 30 lactating women treated with prednisolone and their breastfed infants. Breast milk and blood will be collected merely to study the secretion of prednisolone into breast milk and transfer to the infant. Participants will be treated with prednisolone according to their physician’s prescription. Study visits take place when the infant is approximately 6–8 weeks old. Milk and blood sampling of the mother will be performed at 1 hour after drug intake, in conjunction with the infant being fed. Blood sampling of the infant will be performed 2 hours after the feed. Breast milk and plasma will be biobanked for future research. Recruitment was initiated in 2024 and is ongoing. Patient representatives from the Swedish Rheumatism Association were involved in the planning of the study, and the organisation is providing information about the study on their website.

Ethics and dissemination
The clinical trial was approved by the Swedish Medical Product Agency (Dnr. 5.1.1-2023-104170). The results will be published in peer-reviewed scientific journals and disseminated at scientific meetings and through patient organisations’ websites.

Trial registration number
The clinical trial protocol is available via the Clinical Trial Information System at the European Medicines Agency (No. 2023-508913-18-00). It is also registered and publicly accessible at the EU PAS Register (EUPAS 1000000059).

Introduction
Mental health is essential for well-being and critical to the quality of care delivered by healthcare professionals. Health workers face increased risks of mental health disorders due to long hours, high emotional and physical demands, and exposure to communicable diseases, which exacerbate stress and anxiety levels. Evidence from low-income countries, including Mozambique, is scarce, yet health professionals in these regions frequently deal with the dual burden of communicable diseases and resource constraints. This study addresses a critical evidence gap by focusing on the mental health of healthcare professionals in Mozambique who are frequently exposed to psychological stress while managing communicable diseases. It aims to assess the prevalence of stress, anxiety and depression among healthcare workers providing services related to communicable diseases in primary-level health units (PHUs) in Maputo City, Mozambique. The study also seeks to identify personal and professional factors associated with these mental health disorders.

Methods and analysis
This is an observational cross-sectional study targeting healthcare workers in PHUs who provide services related to communicable diseases in Maputo City. Using convenience sampling, 382 participants will be recruited, stratified by health unit type. This sample size was calculated manually using the formula by Wang and Ji (2020). Data will be collected through a questionnaire, including demographic and professional information and a validated tool (Depression, Anxiety and Stress Scale, DASS-21), using the Research Electronic Data Capture (REDCap) Software for secure data capture. Descriptive and inferential statistical analyses will be performed using IBM SPSS Statistics to estimate prevalence rates and explore associated factors.

Ethics and dissemination
The study was approved by the Interinstitutional Committee on Bioethics in Health of the Faculty of Medicine/Maputo Central Hospital (CIBS FM&HCM/117/2024). Written informed consent will be obtained, and participants experiencing significant discomfort will be referred for mental health support. Findings will be disseminated via academic theses, peer-reviewed publications, national conferences, and reports shared with the Ministry of Health to inform mental health interventions for healthcare workers.

Registration
This protocol is registered with the Interinstitutional Committee on Bioethics in Health of the Faculty of Medicine/Maputo Central Hospital (CIBS FM&HCM).

Objective
To determine wealth-based inequality and the dropout rate in the completion of the maternal continuum of care (CoC) in Ethiopia.

Setting
Ethiopian Demographic and Health Survey-2019.

Participants
Reproductive-age women (15–49 years) in Ethiopia.

Primary outcome
Completion of the maternal CoC services is the primary outcome. Maternal CoC is defined as a situation where women have at least four antenatal care (ANC) visits, deliver their babies at a health facility and receive at least one postnatal care service for both mother and newborn baby.

Methods
We analysed the 2019 Mini demographic and health survey data using STATA V.17. Multilevel logistic regression analysis was employed for the factors associated with the maternal CoC. The concentration index was used to measure equity.

Result
Overall, 24% (95% CI: 21.6 to 26.5) of women completed the maternal CoC. There was wealth-based inequality in the completion of maternal CoC in Ethiopia (concentration index: 0.25 (95% CI: 0.18 to 0.31, p≤0.001)), rural residents (concentration index: 0.15 (95% CI: 0.09 to 0.21, p≤0.001)) and urban residents (concentration index: 0.15 (95% CI: 0.05 to 0.26, p≤0.01)). Being an urban resident (adjusted OR (AOR)=1.59, 95% CI: 1.09 to 2.33), attaining secondary (AOR=1.67, 95% CI: 1.19 to 2.33) or higher education (AOR=1.93, 95% CI: 1.30 to 2.87) and early initiation of ANC (AOR=1.97, 95% CI: 1.61 to 2.41) were positively associated with the completion of maternal CoC. However, belonging to a pastoral region (Afar or Somali) (AOR=0.46, 95% CI: 0.28 to 0.77), belonging to the poorest (AOR=0.58, 95% CI: 0.37 to 0.92) or middle (AOR=0.62, 95% CI: 0.40 to 0.96) wealth quintile, not being informed about obstetric danger signs (AOR=0.54, 95% CI: 0.43 to 0.66) and blood pressure not being measured (AOR=0.53, 95% CI: 0.32 to 0.85) were negatively associated with maternal CoC.

Conclusion
We concluded that completion of the maternal CoC was low in Ethiopia. There was significant inequality in the completion of maternal CoC across wealth status, place of residence and educational status. Strategies and interventions that target the disadvantaged group of women are needed to improve the utilisation of maternal healthcare services. Tailored and multisectoral intervention considering women with poor or middle wealth, women in pastoralist regions and women with no information on obstetric danger signs improves the CoC practice in the country.

Introduction
Labour pain is an unavoidable feature of childbirth and is characterised by extreme intensity. Adequate pain management is thus essential not only from the aspect of physiological pain but also due to the adverse effects of pain on the psychological well-being of parturients. Many studies have shown the benefits of acupoint hot compress. However, to date, little is known about its use for alleviating labour pain. The purpose is to evaluate the effect of acupoint hot compress on relieving pain in primiparous women during the latent phase of the first stage of labour, as well as its effects on key maternal and neonatal outcomes.

Methods and analysis
This prospective, multicentre, randomised controlled trial will be conducted across 18 institutions in China from January 2024 to August 2025. A total of 1100 primiparous women aged 20–34 years, with singleton pregnancies at 37–41 weeks of gestation, will be enrolled and randomly allocated to two groups using a central stratified block randomisation method. The controls will be treated only with obstetrical care, while those in the intervention group will receive the same obstetrical care as the control group, with the addition of acupoint hot compress therapy at 42±2°C for 4 hours, starting 1 hour after the onset of regular uterine contractions during the latent phase of labour. The primary outcome will be the pain intensity measured at 1, 3 and 5 hours after the onset of regular uterine contractions using a Visual Analog Scale.

Ethics and dissemination
The study has been approved by the ethics committee of Women’s Hospital, School of Medicine, Zhejiang University (No. IRB-20230379-R). The results of the main trial will be submitted for publication in a peer-reviewed journal.

Trial registration number
This trial is registered at Chinese Clinical Trial Registry, ChiCTR2300079244.

Objectives
To update our previous systematic review to synthesise latest data on the prevalence of long-term pain in patients who underwent total hip replacement (THR) or total knee replacement (TKR). We aim to describe the prevalence estimates and trends in this review.

Design
Systematic review and meta-analysis.

Data sources
Update searches were conducted in MEDLINE and Embase databases from 1 January 2011 to 17 February 2024. Citation tracking was used to identify additional studies.

Eligibility criteria
We included prospective cohort studies reporting long-term pain after THR or TKR at 3, 6, 12 and 24 months postoperative.

Data extraction and synthesis
Two reviewers independently identified studies as eligible. One reviewer conducted data extraction, checked by a second reviewer. The risk of bias assessment was performed using Hoy’s checklist. Bayesian, random-effects meta-analysis was used to synthesise the results.

Results
For TKR, 68 studies with 89 time points, including 598 498 patients, were included. Multivariate meta-analysis showed a general decrease in pain proportions over time: 21.9% (95% CrI 15.6% to 29.4%) at 3 months, 14.1% (10.9% to 17.9%) at 6 months, 12.6% (9.9% to 15.9%) at 12 months and 14.6% (9.5% to 22.4%) at 24 months. Considerable heterogeneity, unrelated to examined moderators, was indicated by substantial prediction intervals in the univariate models. Substantial loss to follow-up and risk of bias led to low confidence in the results. For THR, only 11 studies were included, so it was not possible to describe the trend. Univariate meta-analysis estimated 13.8% (8.5% to 20.1%) and 13.7% (4.8% to 31.0%) of patients experiencing long-term pain 6 and 12 months after THR, respectively, though concerns in risk of bias results reduced confidence in these findings.

Conclusions
Our review suggests that approximately 22% of patients report pain 3 months post-TKR, with 12%–15% experiencing long-term pain up to 2 years. At least 14% report pain 6–12 months after THR. Given the prevalence of chronic postsurgical pain, implementing existing and developing new preventive and management strategies is crucial for optimal patient outcomes.

PROSPERO registration number
CRD42023475498.

Objectives
To examine how relationships between physicians, pharmacists and patients associate with generic drug (GE) utilisation in Japan’s healthcare system.

Design
Observational study using longitudinal medical claims from April 2015 to March 2021.

Setting
Pharmacies across Japan serving beneficiaries of the National Health Insurance Association.

Participants
69 395 pharmacies, resulting in 322 097 pharmacy-year observations.

Main outcome measures
Quantity share of GEs dispensed by pharmacies.

Results
Higher hospital prescription concentration was consistently associated with increased GE usage (1.1–2.3 percentage points higher for moderate to very high concentrations compared with low). The relationship between patient prescription concentration and GE usage varied, showing a positive association (0.3–0.6 percentage points higher) overall, but negative in settings with low hospital concentration. Smaller pharmacies exhibited a stronger positive association between hospital concentration and GE usage, while larger pharmacies and those in less urbanised areas showed a stronger positive association between patient concentration and GE usage.

Conclusions
This study reveals that pharmacy-stakeholder relationships significantly influence GE utilisation in Japan’s healthcare system. Our findings demonstrate that hospital-pharmacy relationships consistently drive generic usage, while patient-pharmacy relationships show contextual effectiveness. By measuring these relationships through concentration rates, we provide evidence that stakeholder interactions may affect medication dispensing decisions. These findings suggest that policies promoting GEs may benefit from considering the specific characteristics of pharmacies and their existing relationships with hospitals and patients. These insights can inform more effective policy design for GE promotion across different healthcare contexts.

Introduction
Recessive dystrophic epidermolysis bullosa (RDEB) is a severe genetic mucocutaneous fragility disorder characterised by chronic blistering, slow wound healing and increased risk of squamous cell carcinoma. Current management options are very limited.

Methods
This is a randomised (1:1), placebo-controlled, double-blinded crossover (A/B) trial with an internal phase I dose de-escalation (4+5 design) in the first 3 months and a 12-month continued treatment follow-on open-label study if 3-month outcome data from the crossover trial indicate safe and beneficial effects. RDEB is a rare condition, so we expect to recruit a maximum of 36 participants based on feasibility and not formal power considerations. Participants aged >6 months and

Introduction
Injury to triangular fibrocartilage complex (TFCC) is a common cause of ulnar-sided wrist pain, of which peripheral TFCC tears are amenable to repair. The surgical approaches to treat TFCC tears are well-established, with arthroscopic or arthroscopic-assisted repair as the preferred method. However, the postoperative rehabilitation protocols significantly vary across different studies, ranging from 2 to 9 weeks, often without sufficient justification.

Methods and analysis
This research is designed to conduct a randomised controlled trial at a single centre with double-blinding to compare the clinical and functional results of two immobilisation protocols of 3 weeks and 6 weeks, following arthroscopic repair of peripheral TFCC tears (ie, Palmar 1B, 1C and 1D) in adults, considering the phase of ligament healing. The hypothesis that there will be no significant difference in outcomes between the two groups is considered. Adults aged 18–60 years of both genders who present with ulnar-sided wrist pain and satisfy the inclusion criteria are included in the study. Following the arthroscopic TFCC repair using the Polydioxanone Suture (PDS) inside-out suture technique, the patients will be immobilised in an above-elbow cast according to their assigned immobilisation groups, which will be determined by a computer-generated 1:1 block randomisation. In this study, each group will have at least 16 participants. The primary outcomes will be evaluated by the weight-bearing press test and the ballottement test. Secondary outcomes, including the Visual Analogue Scale (VAS) score, grip strength, pinch strength, foveal sign, Modified Mayo Wrist Score (MMWS), patient-rated wrist/hand evaluation (PRWHE) score and the range of movements in the wrist and forearm, will be assessed and compared across the groups at each point of assessment, with the results subsequently reported in a detailed manner. The study will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Ethics and dissemination
The Ethics Committee of Kasturba Medical College, Manipal, approved the trial (approval No. IEC1 – 386). The data from this trial will be presented at academic conferences and published in peer-reviewed international journals.

Trial registration number
This trial has been registered at the Clinical Trial Registry of India (registration number: CTRI/2023/03/050692).