ANZCTR search results

This project aims to evaluate the effectiveness of home-based tDCS for CLBP, investigate potential neurophysiological and somatosensory mediators of treatment response, and assess implementation outcomes relevant to future clinical translation. Home-based tDCS could improve the accessibility and scalability of the intervention; however, its effectiveness, underlying mechanisms, and implementation potential have not been evaluated in people with CLBP. Evaluating implementation outcomes alongside clinical effectiveness may accelerate future translation and inform the design of larger effectiveness and implementation trials for rural and remote populations.

Anxiety disorders are highly prevalent and often go untreated in young Australians due to barriers such as extensive wait times, limited access to services and trained practitioners, financial constraints, and inconvenience. While cognitive behaviour therapy (CBT) is effective, many children do not receive this evidence-based treatment. One Session Treatment (OST) for childhood phobias which involves a single prolonged exposure session has been proven to be effective, cost-efficient and acceptable to families. Drawing on the success of OST and our pilot work, We propose a Two Session exposure Treatment (TST) for transdiagnostic child anxiety disorders. Through a rigorous non-inferiority randomised controlled trial, we aim to establish the clinical and cost effectiveness of Transdiagnostic TST for a broad range of child anxiety disorders in comparison to traditional CBT. This project seeks to make treatment more accessible, cost effective and acceptable for the many young Australians suffering from debilitating anxiety disorders, ultimately bridging the current treatment gap.

This project will be the first of its kind where an intervention for body image dissatisfaction (BID) will be co-designed for patients with inflammatory bowel disease (IBD). This project is a co-partnership between SALHN clinicians and researchers within the College of Education, Psychology and Social Work at Flinders University. Eligible participants will be randomised to either usual care or the intervention, and feedback will be collected regarding their experience of the intervention. We expect that participants who receive the intervention will show greater improvements in body image and wellbeing than participants receiving usual care.

Achilles tendinopathy can cause persistent pain and reduced ability to tolerate activities that load the tendon. This study will investigate whether ankle position changes the immediate response of the Achilles tendon and calf muscle to isometric loading in healthy adults and adults with mid-portion Achilles tendinopathy. Each participant will complete two laboratory sessions in a randomised order, with loading performed in either a neutral ankle position or 25° of plantarflexion. Ultrasound, force and muscle-activity measurements will be collected before, during and after loading to assess tendon stiffness, volume and deformation, as well as calf muscle structure. Pain, acceptability, fatigue and symptoms approximately 24 hours after testing will also be recorded to help inform future research on Achilles tendon loading and rehabilitation.

Actinic keratoses (AKs) and intraepidermal carcinomas (IECs) are common precursors to cutaneous squamous cell carcinoma (non-melanoma skin cancers). This study aims to assess the feasibility, acceptability, safety and preliminary clinical activity of two doses of 5-fluorouracil (5FU) and calcipotriol treatments. Who is it for? You may be eligible for this study if you are aged 18 to 85 years, you have been diagnosed with either actinic keratoses or intraepidermal carcinomas on your face and you are willing to attend multiple study appointments. Study details Participants who choose to enrol in this study will be asked to apply each of the two treatments to opposite sides of their face twice a day for up to 6 days. The specific treatment to be applied to each side of the face will be determined randomly, by chance (similar to flipping a coin). Before and after applying the treatments, participants will be asked to have clinical photos taken of their face and will be asked to complete a series of questionnaires for up to 2 years after the treatment period. It is hoped this research will determine that the combination of 5-fluorouracil (5FU) and calcipotriol treatments is safe and acceptable to people with actinic keratoses or intraepidermal carcinomas. If this study is successful, a larger trial enrolling more people with actinic keratoses or intraepidermal carcinomas may be undertaken to determine the most effective dose combination of these treatments.

People who take insulin for diabetes can have their glucose fall too low, and if this happens while they are driving it can affect concentration and reaction time. Most now wear a continuous glucose monitor that sends readings to their phone, and since 2023 Victorian road rules have allowed drivers to view a securely mounted display showing information about their own condition, but nobody has tested whether having that reading visible actually makes a difference on real roads. In this study, Victorian drivers with insulin-treated diabetes each take part for two months: for one month, chosen at random, they drive with their phone in a dashboard mount so their glucose is visible at a glance, and for the other they drive as they normally would without it. A small GPS logger in the car records when they were driving, so their glucose readings can be matched to the times they were actually behind the wheel and each person can be compared with themselves. We want to find out whether the visible reading keeps glucose in a safer range while driving, whether it reduces time spent low at the wheel, and what drivers themselves think of it, so that better advice can be given to drivers with diabetes and to those who set road safety policy.

Upper limb injuries, including broken bones and dislocations, often need to be physically realigned in the emergency department (ED). This is painful, so clinicians use various techniques to manage pain during the procedure. The most common approach is procedural sedation (PS), where participants receive medication through a drip that makes them sleepy or unconscious. While effective, this approach requires close monitoring, dedicated staff, and a recovery period before leaving the ED. It also carries risks such as breathing problems and low blood pressure. An emerging technique in ED is ultrasound-guided supraclavicular block (UGSCB), which involves using ultrasound to guide an injection of numbing medication near the nerves above the collar bone. This numbs the injured arm without the need for sedation, allowing the participant to remain awake. Our recent research showed that this technique was an effective form of regional pain relief for managing broken wrists. However, no study has compared it to PS, which anecdotally is often preferred by emergency physicians across Australia and New Zealand. This project is a clinical trial across four ED’s that will randomly assign participants to receive either UGSCB or PS. The main measure will be reported pain levels, with additional measures including participant satisfaction, safety, time spent in ED and painkiller use. We expect the nerve block will provide equally effective and safe pain relief while allowing participants to leave the ED sooner, which could help participants and their families and reduce pressure on busy emergency departments.

The VXM-301-001 study is a Phase I multi-centre clinical study to evaluate the safety and tolerability of VXM-301 typhoid conjugate vaccine delivered using HD-MAP, in healthy adults aged 18 to 45 years. The study design enables the evaluation of local reactogenicity and systemic toxicity events related to the in administration of TCV HD-MAPs in healthy adults at lower or equivalent doses than the standard adult IM dose. In addition, the VXM-301-001 study allows exploratory data collection on preliminary immunogenicity of TCV delivered using HD-MAP.

The aim of this project is to evaluate the effectiveness and implementation of CycLink across 4 regions in Victoria (Ballarat, Geelong, Inner South-East Metro Melbourne and Outer South-East Metro Melbourne). CycLink has been co-designed to link young people with disability and developmental differences to participation in cycling in their local communities. This project involves a hybrid effectiveness-implementation trial, including program and process evaluation of CycLink and an evaluation of the process of adapting the program to context (where CycLink is being delivered) through codesign. Our primary aim is to determine whether CycLink (goal setting, information + cycling program) is more effective for attainment of cycling participation goals than goal setting and information alone in young people aged 5-17 with disability and/or developmental differences.

Researchers are investigating how different types of dietary fats affect the way the body processes fats and a protein called amyloid-beta (Aß), which is linked to Alzheimer’s disease. The study will also look at whether these effects differ between people with different APOE genes, specifically APOE e3 and APOE e4. Participants will eat three different meals containing either saturated fat, unsaturated fat, or no added fat on separate days, with blood samples collected before and up to 8 hours after each meal. Based on previous research, the researchers expect that meals high in saturated fat may cause a greater increase in Aß in the blood compared with unsaturated fat. The study will help determine whether dietary fat and APOE type affect how Aß is produced, transported in the blood, and processed by the body after eating.