ANZCTR search results

It is difficult to manage patients with end-stage wrist osteoarthritis. Though fusion of the wrist is effective in reducing pain, there are significant losses in range of motion and potential complications relating to healing or hardware. For these reasons, a more conservative approach for management of chronic wrist pain may be preferable. Partial wrist denervation, instead, is a procedure which targets the small nerves in the wrist to manage chronic pain, whilst still preserving baseline range of motion. This has traditionally been performed surgically, which involves a small incision and resecting the relevant nerves. Patients receive an anaesthetic and parenteral sedation. Recently, a technique using ultrasound and heat ablation through the skin has instead been described. This avoids the risks of surgery and can be done on an outpatient basis without sedation. The limited data thus far show similar benefits to surgery, however it is still an emerging technique without a direct comparison to surgery. In this randomised control trial we look to compare two techniques of partial wrist denervation (surgery, radiofrequency ablation) for improvement of pain in end-stage wrist arthritis. Our hypothesis is that the intervention (radiofrequency ablation) is non inferior to the control (surgery). The primary outcome is to compare pain scores for the two groups using a visual analogue scale. The secondary outcomes include an assessment of function, motion, strength, satisfaction and return to work. We believe this study to have importance in guiding future management decisions for this complex clinical scenario. This study is therefore designed to compare the effectiveness of partial wrist denervation through surgery or through ultrasound ablation.

Objectives: 1 - To evaluate the effectiveness of a media-led intervention that includes evidence-based information on the management of low back pain (LBP), distributed and broadcasted at point-of-care in primary care settings (General Practice clinics), to change patient beliefs about LBP. Effectiveness will be measured in terms of patients’ beliefs and attitudes about LBP. 2 - To evaluate the delivery of care at a practice level to determine if the media-led intervention changes Medical Practitioner practice (i.e., prescriptions for opioid medication, referrals for medical imaging and Specialists). Target sample size: 30 GP practices 3780 participants Study Design: Stepped wedge cluster randomised clinical trial that will randomise 30 GP clinics into 5 clusters to receive the study information video intervention within their waiting rooms. The order by which each cluster receives the intervention will be randomised, and by the end of the study all 30 clinics will broadcast the media intervention. Patients attending GP clinics will be invited to participate in the study to capture their LBP beliefs at a single time-point either during the control period (no informative study video) or during the intervention period (during the delivery of the intervention video). GP key referral and prescriptions for LBP will be collected at 3 time points: pre, mid and post the delivery of the study intervention

This study is performing construct validation of a new virtual reality (VR) training software designed to teach regional anaesthesia needling skills.. Validation will compare novices versus experienced regional anaesthetists when they are using the software. Construct validity is determined if the software can discriminate between novice and experienced participants using generated performance scores; compare the quality of the virtual reality environment using validated questionnaires testing for the "realism" and "immersiveness" of the software; and compare cognitive task loads generated during use of the software against real-life medical procedural procedures.

Pelvic organ prolapse (POP) is a common gynaecological condition which has been observed in up to 50% of women above 50 and has an associated 20% risk of surgery during a woman’s lifetime. Despite impacting the lives of millions of women in our society, there are few options available for preventing or addressing this condition. Defined as the downward displacement of one or more pelvic organs into the vagina, POP can significantly impact the quality-of-life of women with the condition. It has a number of causes including injury from vaginal birth/pregnancy, and is exacerbated by ageing, obesity, genetics, constipation, chronic coughing, heavy lifting, and smoking. Severity is graded using the Pelvic Organ Prolapse Quantification (POP-Q) tool which classifies the degree of descent using the hymen as a reference point. Stages of descent vary from minor descent (Stage 1) to the complete external presentation of the organ (uterus, bladder, bowel) through the vagina (Stage 4). Symptoms include a heavy sensation or dragging feeling in the vagina, a lump in the vagina, a lump which bulges out and can be felt or seen when standing, painful intercourse or loss of sensation, difficulty emptying the bowel or bladder, recurring urinary tract infections, and faecal or urinary incontinence (UI). According to a report by the Australian Institute of Health and Welfare, UI alone accounts for >$200 million each year in healthcare expenditure in Australia, with drastically more women being affected than men for this condition. Current clinical protocols primarily have a passive management focus, which includes lifestyle changes or simple intravaginal pessaries, both of which require long-term (often until surgery or end-of-life) investment and adherence by patients; or a rehabilitation focus where pelvic floor muscle training attempts to strengthen the pelvic floor muscles. On the spectrum of invasive practices, 10-20% of women will undergo surgical intervention. However, surgery carries a number of risks, contraindications, and has the disadvantage that up to a third of women may have a recurrence. Additionally, vaginal mesh procedures introduced to reduce the risk of recurrence caused unacceptable adverse events and are no longer approved. Due to these limitations with current management protocols, there is a demand for novel non-surgical treatments which can improve or cure the condition. IVES could play a role in rehabilitating the pelvic floor muscles of women with POP. It does this by triggering neuromuscular contractions in the pelvic floor which may either increase muscle bulk or tone muscles to improve their ability to support the organs. With research suggesting that IVES may be effective at treating UI and at increasing pelvic floor muscle strength, it is possible that IVES may be an effective treatment for mild-to-moderate POP.

University students and young people are already a known high risk group for experiencing poor mental health and wellbeing. This at-risk group also demonstrates low uptake for early help seeking where the largest barrier often experienced by this group to seek help early is lack of awareness and understanding about the process and often associated bias or stigma. It is critically important to develop the resources and tools to support students in feeling like they understand mental health, can recognise early trends in mood and behaviours that might be early symptoms of poor mental health, and feel supported and empowered to reach out for help when they need it. The Monash THRIVE App is being developed to help students track their own feelings and set, and achieve, their own wellbeing goals through a tailor made resource that is private and secure on their own device. Through using the Monash THRIVE App students will learn more about mental health, and themselves and feel more supported to seek help early when they are struggling. This trial has been designed to measure both efficacy in terms of perceived willingness to seek help and overall wellbeing as well as the user feedback on the design, functionality, and usability of the Monash THRIVE App in a true co-design and co-development process with users. Note that no specific mental health condition or diagnosis is explored in this trial as all participants are pre-clinical. The core outcome of this trial is to explore improved wellbeing and App feedback amongst a healthy population of University students. It is hypothesised that through a 12-week period of using the THRIVE App to actively monitor emotions and engage in feedback from the app students will show an improvement in mental health awareness and psychological literacy outcomes, as well as a potential improvement in overall wellbeing and intention to seek help.

Frailty has been described as the ‘public health crisis for an ageing society’. As many as 24% of older Australians are frail, with heightened vulnerability and susceptibility to stressors, and growing economic and societal costs. The recent ABC TV show ‘Old People’s Home for Four Year Olds’ has shown on-screen benefits from a non-familial intergenerational practice – by bringing together community-dwelling older adults and pre-schoolers to reduce the older adults frailty. The shows popularity has lead communities around Australia to instigate similar intergenerational programs. However, our recent systematic review finds only small-scale, largely qualitative evidence for such intergenerational practice. Given the potential benefit at low interventional cost, we now urgently need to establish whether (and to what degree) intergenerational practice effectively reduces frailty in our aging population. To do this, the INTErGenerational Intervention to taRget fraIlTY (INTEGRITY) trial extends our pilot trials to rigorously test an intergenerational practice program using a cluster randomised, blinded endpoints clinical trial bringing older adults and preschool children together in 44 clusters. Frailty measures collected from clusters randomised to receive an intergenerational practice intervention or wait list control will be compared. Secondary outcomes include self-reported older adult health and quality of life, child language and empathy measures. We hypothesised that participating in a 20-week intergernerational program will prevent frailty, improve older adults' health and quality of life, and improve the children's developmental skills. The community-based INTEGRITY trial has been co-conceived and co-designed with a community and stakeholder team and will establish the first robust evidence for community based intergenerational practice. These results will help improve and inform both current and future practice programs. We will also use our learning from the trial to build an accessible online guide for communities wishing to run intergenerational activities.

This pilot study aims to demonstrate the effects of using coconut oil compared to standard therapy (sorbelene cream) for the treatment of burns scars. Burn injuries in children are common and result in painful wounds with a varying capacity to heal. Time to healing is key in driving long-term scar outcomes. Deeper wounds will be treated surgically with a combination of traditional skin grafts and cell-based therapies. Standard of care (SOC) is to commence skin moisturizing the newly sealed wounds with massage of topical ointments to prevent surface drying and secondary disruption of the surface and associated infections, which usually occur between 7 to 14 days post operation. Coconut oil is rich in fatty acids, which have natural activity against common skin microbes and inflammation. Coconut oil for skin care has been shown to improve skin condition. Laboratory studies have shown that Monolaurin (the primary fatty acid in coconut oil), at the concentrations present in the coconut oil used for skin care, has substantial antimicrobial activity. In this pilot randomised controlled trial we aim to assess the healing properties of virgin coconut oil in the treatment of burns injuries. We will randomise 100 paediatric burns patients to either receive coconut oil or standard care (sorbelene cream) for burns care. In the intervention group coconut oil will be applied twice per day to surgically managed burn wound sites, skin graft donor sites and conservatively managed burn wound sites for a period of 12 weeks. In the control group, patients will receive routine care (sorbelene cream) forburn wound sites, skin graft donor sites and conservatively managed burn wound sites for the same time period. This study will provide valuable pilot data for the potential role of coconut oil in children with burns, which will be used to design future large multi-centre studies and potentially change the standard of care.

ExTRA will develop and pilot an 8-week self-directed web-based exercise intervention to reduce anxiety. Participants will undertake the program independently and receive strategies/prompts/encouragement/reminders to their email/smart phone tailored to activity level measured by a device, and rating scale responses – this process will be pre-determined so that it can become an automated or semi-automated process in future research. It will aim to be cost-effective and scalable to increase access. Feasibility and acceptability will be investigated with 20-30 participants. It will target mid-life onwards to maximise impact given the higher risk of chronic disease in this age group. The findings will provide crucial data for larger effectiveness and implementation trials.

Implantation of an intraocular lens (IOL) is a standard method of visual rehabilitation in pseudophakic eyes following cataract removal. Although modern IOLs can offer high quality vision at a selected distance, correction over a continuous range of viewing distance is challenging. Plethora of IOL designs, such as accommodating, multifocal and extended depth-of-focus (EDoF) IOLs, have been introduced in attempts to address the issue. To date, commercially available IOL designs are limited in their ability to provide clear vision over a range of focal distances without causing undesirable disturbances in vision– Some fail to offer adequate near vision and others have inherent design-related visual disturbances and dysphotopsia. RayOne EMV IOL is a non-diffractive Extended Depth of Field (EDoF) presbyopia correcting IOL using a non difractive technique based on enhancing and utilising the normal positive spherical aberration of the human optical system. The IOL is specifically designed to avoid the photopic symptoms associated with the diffractive and split refractive designs currently available. This study aims to investigate visual outcome and patient satisfaction after implantation of RayOne EMV EDoF IOL employing a monovision (-0.75 to -1.0D) strategy and compare the results from those using a standard RayOne aspheric IOL with the same Monovision approach. This will be a single centre randomised clinical trial. A total of 110 subjects with bilateral senile cataract will be recruited and randomised equally into two treatment arms. Four to six weeks and 12 to 16 weeks post-operative monocular and binocular visual acuities at distance, intermediate and near will be investigated as the primary outcome variables and compared between the two groups. Other outcome variables will include stereoacuity, contrast sensitivity, patient satisfaction and spectacle independence.

This pilot feasibility randomised controlled trial will recruit 24 people with knee osteoarthritis. Consenting participants will be randomised to either a self-directed exercise-therapy (n=16) or supervised exercise-therapy (n=8). Both groups will receive a digitally support patient education through the ‘My Knee’ tool kit. The primary aim of this study is to determine the feasibility of conducting a fully powered randomised controlled trial to compare self-directed to supervised exercise-therapy for people with knee osteoarthritis. Secondary aims include: • To compare outcomes between groups, 12 weeks following treatment commencement, related to average pain, physical function, joint- and health-quality of life, exercise and physical activity participation, self-efficacy with exercise and osteoarthritis management, outcome expectations for exercise, people’s beliefs about management treatment, determinants of exercise behaviour, global rating of change and treatment satisfaction; • To explore barriers and enablers to intervention effectiveness, potential intervention and study design improvements, and other factors that might influence the participant’s adherence.