ANZCTR search results

Shoulder pain affects up to one in four people at any time(1) and is a common reason for people to visit a health professional.(2) Rotator cuff-related shoulder pain is the most common cause of shoulder pain (~85%)(3) and is an umbrella diagnosis that captures pathology related to the rotator cuff (e.g. tendinopathy, tear, tendinitis, calcific tendinitis) or subacromial bursa (e.g. bursitis). Advice and education are recommended in clinical practice guidelines for most musculoskeletal conditions. For low back pain, 86% of guidelines recommend advice to maintain normal activities, 72% recommend reassurance on the favourable prognosis of low back pain, and 92% recommend against bed rest.(5) For neck pain, 73% of guidelines recommend advice to stay active and to avoid rest for greater than three days.(6) Yet for rotator cuff-related shoulder pain, only one guideline recommends advice to resume usual activities and providing information about the benefits and harms of treatment options.(7) This is likely due to a paucity of trials evaluating advice/education as an intervention. The primary aim of this study is to investigate the comparative effectiveness of three forms of advice on reassurance in people with rotator cuff-related shoulder pain. We also aim to: - Investigate the effectiveness of three forms of advice on intentions to stay active, see a health professional, see a specialist, and request imaging - Investigate the credibility and relevance of three forms of advice - Explore people’s feelings and perceived treatment needs evoked by three forms of advice. We hypothesise best-practice advice plus pain science education will be more reassuring than best practice advice alone and structure focused advice, and have a more beneficial effect on the other secondary outcomes. REFERENCES 1. Luime JJ, et al. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. 2. Rekola KE, et al. Use of primary health services in sparsely populated country districts by patients with musculoskeletal symptoms: consultations with a physician. J Epidemiol Community Health. 1993;47(2):153-7. 3. Ostor AJ, et al. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatol. 2005;44(6):800-5. 4. Whittle S, Buchbinder R. In the clinic. Rotator cuff disease. Ann Intern Med. 2015;162(1):Itc1-15. 5. Oliveira CB, et al. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018;27(11):2791-803. 6. Parikh P, et al. Comparison of CPG’s for the diagnosis, prognosis and management of non-specific neck pain: a systematic review. BMC Musculoskelet Dis. 2019;20(1):81. 7. Doiron-Cadrin P, et al. Shoulder Rotator Cuff Disorders: A Systematic Review of Clinical Practice Guidelines and Semantic Analyses of Recommendations. Arch Phys Med Rehabil. 2020;101(7):1233-42

A diagnosis of Fetal Alcohol Spectrum (FASD) can adversely affect wellbeing and functioning across the life-course. This highlights the importance of early intervention. The Australian Government is committed to reducing the health risks associated with alcohol and have, as one of their key priorities, better diagnosis and management of FASD (e.g., Australian Government Action Plans to Reduce Impact of FASD; National Disability Strategy 2010-2020). This project will compare two existing evidence-based interventions for supporting families with a child who has a diagnosis of FASD: the family-focused Parents Under Pressure program (PuP) and the Alert® child-focused self-regulation program. The research will examine if there are any differences between the approaches using a range of outcome measures (e.g., child socioemotional wellbeing, parent stress, quality of the caregiving relationship), and examine these changes alongside implementation considerations (e.g., costs) to inform future policy and practice. It is anticipated that child executive function and behavioural and/or emotional regulation - along with caregiver stress and emotion regulation - will improve after receiving either intervention. Due to the family-focused nature of the PuP program, it is anticipated that there will be a greater reduction in caregiver stress and greater improvement in caregiver emotion regulation and emotional availability for families who participate in the PuP program versus the Alert® intervention.

Current psychological treatments for child anxiety are well-established and evaluated, yet up to half of children still have an anxiety disorder after treatment. According to guidelines by RANZCP, following unsuccessful treatment with a psychological program, children should be moved to a course of SSRI medication. While this sounds like a logical suggestion, it is currently not based on any scientific evaluation. The aim of this pilot study is to evaluate both the effectiveness of this approach and its implementation in the Australian community. Children aged 7-12 years who have current anxiety disorders will be treated with a scientifically tested psychological program in university services. Following this, children who still have a diagnosable anxiety disorder will be randomly allocated to either treatment as usual (continued practice of learned skills) or will receive a referral with detailed information recommending SSRI treatment to their current medical practitioner. Improvements in diagnoses, anxiety symptoms and life impairment will be assessed 15 weeks later, along with feasibility, acceptability and other implementation data such as how many medical practitioners agree to prescribe.

The purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on sperm quality, integrity, content and epigenetic programming. Participants will receive dietary interventions of either a processed western dietary intake pattern - the “processed diet”, or an unprocessed, whole foods dietary intervention meeting the Australian Dietary Guidelines - the “unprocessed diet”. The main purpose of these interventions is to determine how and if the semen quality and epigenetic state of sperm are altered based on acute changes to dietary intake in men of reproductive age. We are specifically interested in determining how nutrient intake alters the epigenetic state of sperm, in a manner that has the potential to affect the development and health of offspring. This study will strengthen our understanding of how paternal lifestyle prior to conception may play a role in influencing the health and epigenetic status of future generations. It is hypothesized that men on the unprocessed diet versus men on the processed diet will induce different epigenetic changes to the sperm at regions involved in development and metabolism.

This study aims to compare the effect of a single bout of exercise on endocannabinoid (eCB) and affective (mood) responses in adults with cancer currently receiving chemotherapy treatment versus their healthy peers, and to evaluate relationships between eCB and mood responses to exercise. Who is this study for? You may be eligible for this study if you are a cancer patient aged 18 or older, and currently receiving chemotherapy treatment; and if you are an apparently healthy adult (age 18+) . Study details All participants will engage in a single testing session involving seated rest (30 min) followed by a moderate exercise bout on treadmill or exercise cycle (30 min). Participants will be asked to fill in mood surveys and provide blood samples before and after the seated rest and exercise conditions. It is hoped that findings from this study will help inform future trials investigating the benefits and barriers to exercise in cancer patients.

Currently, frailty is rarely identified prior to surgery and patients undergoing colorectal cancer surgery do not have prehabilitation optimization at Western Health (WH). Recent investigations of our WH population have identified poorer functional outcomes and lower quality of life associated with this population which indicated unmet psychosocial and occupational performance needs. With this study, we plan to introduce a novel approach to tailored treatment in our most at-risk group of patients. Who is it for? You may be eligible for this study if you are an adult who has a planned surgery for primary colorectal cancer at Western Health. Study details All patients enrolled in this study will undergo a frailty assessment and be prescribed a pre habilitation to be completed over a period of 4 weeks. This prehabilitation program will include nutritional adjustment by a dietician and improvement of exercise function by physiotherapy. Patient quality of life questionnaires, food diary, nutritional and physical fitness assessment will be carried out by dieticians and physiotherapists. It is hoped that this study will show that it is feasible for frail and at-risk colorectal cancer patients undergoing surgery to undergo prehabilitation. This aims to improve strength, mobility and flexibility, reduce frailty, and improve post-operational outcomes such as length of stay.

This research will investigate whether long-term methamphetamine use produces changes to driving ability in the absence of acute intoxication, and whether this can be effectively indexed and monitored through objective markers of performance. Using our high-fidelity driving simulator with advanced simultaneous eye-monitoring technologies, we will use real-time analysis of head position and eye movements to examine the relationship between gaze vector and driver behaviour to better understand the impact of methamphetamine addiction on driving performance in separate groups of 1.) individuals who use methamphetamine and 2) healthy adults who have no history of the use of psychostimulants and have no history of chronic/binge use of psychoactive substances. We expect that there will be a measurable difference in the patterns of eye movements displayed during driving by individuals who use methamphetamine versus those who have no history of the use of psychostimulants or no history of chronic/binge use of psychoactive substances

Peripheral artery disease is an atherosclerotic disease characterised by blocked arteries and impaired blood supply to the legs, which causes muscle pain and limits waking capacity and the ability to undertake daily activities. People with peripheral artery disease may undergo lower limb revascularisation to improve or restore leg blood flow. Supervised exercise is an effective therapy that can improve walking capacity and quality of life in people with peripheral artery disease. Supervised exercise training following lower limb revascularisation can further enhance the clinical outcomes of the revascularisation procedure. This is a randomised-controlled trial which will assess the efficacy of a community-based cardiovascular rehabilitation program versus usual care on exercise capacity and quality of life in people who have undergone lower limb revascularisation for peripheral artery disease. If successful, this trial will lead to improved clinical outcomes for people undergoing lower limb revascularisation for peripheral artery disease. This study will provide crucial knowledge for the inclusion and integration of patients with peripheral artery disease into community-based cardiovascular rehabilitation exercise programs.

The intervention involves placing four miniscrews (two on the maxilla and two on the mandible) which the frameworks will be fitted over, Class III elastics attached to the frameworks will be worn full-time until the skeletal Class III malocclusion is corrected. The aim of this trial is to evaluate the dental and skeletal changes of skeletal Class III patients treated with Bone- and Tooth-borne Maxillary protraction with Miniscrews and Class III Elastics. The null hypothesis is that there will be no dental and skeletal effects of maxillary protraction using miniscrews and Class III elastics, when comparing the pre- and post-treatment situation. The alternative hypothesis is there will be a dental and skeletal effects of maxillary protraction using miniscrews and Class III elastics.

This study aims to assess the effectiveness of a distance-delivered digital health program on improving physical activity self-efficacy among childhood cancer survivors aged 8-21 years, and to explore the barriers and facilitators to program uptake in these participants. Who is it for? You may be eligible for this study if you are aged between 8-21 years of age, you were diagnosed with cancer as a child prior to age 18 years, and you have completed active cancer treatment at least 6 months prior to the time of study participation OR is receiving maintenance therapy. Parents and caregivers of participants will also be asked to participate in interviews after delivery of the program. Study details All participants who choose to enrol in this study will be given access to an online co-designed program that includes evidence-based health behaviour education and physical activity engagement modules. Participants will be able to access the education modules and view physical activity videos at any time over an 8 week period. Participants will also be scheduled to attend up to 5 telehealth/online video consultations with an Accredited Exercise Physiologist. These consultations will be scheduled prior to participants gaining access to the online program, week 2 or 3 of the program (optional), at week 9 post-program completion, at 3-months and 6 months following program completion. Each consultation will be approximately 60 minutes and will be individualised to the participant and will include exercise assessments, health behaviour education, tailored goal-setting, and discussion of participant barriers and facilitators to exercise. Participants will also be asked to attend interviews with the study investigators to describe the aspects of the program that they enjoyed and the parts that they think could be improved upon. Overall participation in this study is anticipated to take up to 9 months. It is hoped this research will determine whether delivery of a physical activity and healthy lifestyle program via a digital platform that is supplemented with online consultations has a positive impact on the physical fitness and lifestyle choices of childhood cancer survivors. If the program is found to have a positive effect on these participants, it may be expanded to a greater number of childhood cancer survivors in the hope that it will improve their quality of life and reduce the development of chronic health conditions.