ANZCTR search results

Faecal incontinence (FI) is a chronic, debilitating condition with enormous consequences for patients and the community. Numerous studies have documented the tremendous negative impact of FI on quality of life. FI has also been shown to be associated with substantial economic costs for the local health system. Since FI is believed to be a heterogeneous disorder, initial management is symptom based. Addressing the underlying abnormal bowel habits, if present, is the first step. Additional conservative therapies include dietary, medical and psychological modifications, and are estimated to benefit a quarter of patients. When a conservative approach fails, treatment with biofeedback (BF) is often recommended. A multitude of perspective and randomized trials have persistently shown short and long-term improvement in around 60% to 70% of patients treated with BF. Neuromodulation is an established therapeutic modality in the treatment of patients suffering from different pelvic floor disorders. For patients with FI failing BF, the only well-established option at present is neuromodulation by an implantable sacral nerve stimulator. This treatment is invasive and costly, has potential significant complications and is associated with significant financial burden for the local health system. Therefore, there is a need for a less invasive and costly method of performing neuromodulation. Percutaneous tibial nerve stimulation (PTNS) has the potential to address these disadvantages. With this method, neuromodulation is delivered through the posterior tibial nerve using a disposable needle electrode. Although PTNS is a well-proven and recognized treatment for urge urinary incontinence, in the last decade its role in treating patients with FI is slowly being elucidated. A recent systemic review included 6 prospective studies of PTNS for treating FI, and showed that PTNS results in significant improvements in some outcome measures of these patients. In all of these studies, patients were required to fail conservative management, but not specifically biofeedback, and in none of the studies was PTNS evaluated in combination with BF. We thus hypothesize that the combination of PTNS and BF for treating patients with FI, especially patients with urge incontinence, who are at high risk for BF failure, will be more effective than the current standard of care of BF treatment only. The impact of this combined efficacy will translate into improving the care of our patients, reducing the negative impact on the patients and their families’ quality of life, and reducing the costs for our local health system. Our main study objective is to determine the feasibility of combining PTNS with BF for the treatment of patients with faecal incontinence. Our secondary objectives are (1) To determine the physiological effect of combination therapy of PTNS and BF on anorectal dysfunction and (2) To assess the efficacy of combination therapy of PTNS and BF for FI.

Aims: To investigate the role of the rotator cuff muscles in limiting glenohumeral joint translation. This study will compare the electromyographic (EMG) activity of rotator cuff muscles in response to an external translation force in a healthy and pathological population. Participants: There will be a total of 40 participants in this trial - 20 each in the comparison and experimental groups. The participants will be more than 18 years old. The experimental group participants will have diagnosed rotator cuff pathology – typically a tear. The comparison group participants will be gender- and age-matched (within 5 years) and have normal healthy shoulders with no present history of pain or shoulder dysfunction. Brief Description: The rotator cuff is a musculotendinous unit consisting of four muscles (supraspinatus, subscapularis, infraspinatus and teres minor) whose tendons blend into and reinforce the glenohumeral joint capsule (Moore & Dalley, 2006). The close proximity of the rotator cuff muscles to the shoulder joint means they are ideally located to act concurrently, providing dynamic stability that could potentially limit the amount of unwanted translation and increase stability at the shoulder joint (Hess, 2000; Magarey & Jones, 2003). The high prevalence of rotator cuff pathology in shoulder injuries (Murrell & Walton, 2001) and the poor diagnostic accuracy of the clinical tests currently used to diagnose rotator cuff disease (Hughes, Taylor, & Green, 2008) emphasizes the importance of gaining a more thorough understanding of the rotator cuff’s function in dynamic control of shoulder motion. The ability of all rotator cuff muscles in limiting glenohumeral translation in young healthy shoulders has been measured in our previous study (Rathi et al, 2015). This method of measurement will now be replicated in patients with rotator cuff pathology in the present study. This comparative study will determine whether pathology of rotator cuff muscles affects the shoulder movements, specifically glenohumeral joint translations. Intramuscular bipolar fine wire electrodes will be inserted in the rotator cuff muscles to measure muscle activity. Participants will be seated upright in a chair with their affected upper limb fully supported through the use of straps. Elbow, hand and wrist orthoses will be used to allow the limb to maintain position without the use of muscle activity. A vertical board will be strapped across the chest to stabilize the trunk to the chair, particularly during translation procedures. Participants will be tested in two shoulder positions: in neutral and with the shoulder abducted 90º and externally rotated. A standardised procedure will be used for the setting up of the equipment, for instructions to the participants and for the placement of electrodes. These procedures and electrode placements have been established in previous studies in our laboratory. Methods of Data Analysis: To assess whether significant differences exist between the translation of humeral head with and without rotator cuff muscles’ activation will be analysed using independent ANOVAs for each shoulder position (neutral, abduction+ external rotation). Each ANOVA will have three factors: translation force (none, anterior, posterior), activity (none, isometric internal rotation force, and isometric external rotation) and group (patient vs control) with level of significance set at p<0.05.

Osteoarthritis (OA) is the leading cause of pain and disability in Australia and the knee is commonly affected. OA is the 11th highest contributor to global disability and in 2008-9 was the eighth most-managed problem by Australian GPs. Exercise is a core component of best-practice management, yet access by Australians to appropriately-qualified health care providers for exercise prescription and advice is very limited. Furthermore, uptake of exercise by people with knee OA in Australia is grossly inadequate, and long-term adherence is poor. This randomised controlled trial (RCT) will evaluate the effectiveness of telephone-delivered exercise advice and behaviour change support by physiotherapists for improving knee pain and function in people with knee OA. The service will be embedded into the Musculoskeletal Help Line that is provided by Arthritis & Osteoporosis Victoria.

Low birth weight is an important risk factor for adult ischemic heart disease. Those born small-for-gestational-age (<10th percentile for gestational age and gender) are at the highest risk for adult cardiovascular disease. Children and adults born small for gestational age have increased arterial intima-media thickness – a noninvasive marker of subclinical atherosclerosis, the underlying disease process responsible for the majority of cardiovascular events. Birth weight is inversely associated with blood pressure – a major cardiovascular risk factor, in both children and adults. Published data from populations of children and young adults suggest that omega-3 fatty acid supplementation will have beneficial effects in reducing arterial intima-medial thickness and systolic blood pressure in children who were born small for gestational age. This hypothesis has not been tested in a randomized controlled trial. This study is designed to test the effectiveness of omega-3 fatty acid supplementation from 6 to 18 months of age in reducing aortic intima-media thickness and systolic blood pressure in children born small-for-gestational-age. The study will be conducted as an open label randomized controlled trial over a 1 year intervention (when the infant is 6-18 months old) where aortic intima media thickness and systolic blood pressure will be measured at recruitment, 6, 12 and 18 months of age.

Current stroke guidelines recommend as much physical practice as possible in the first 6 months after stroke. A number of recent reviews concluded that therapy should include intensive repetitive task training to improve functional outcomes (such as the ability to transfer and walk). However, a number of factors can lead to patients remaining inactive, particularly once home. 1) Limitations of outpatient therapy: Frequency of appointments is low and programs are time limited in duration. 2) Motivation and confidence: Low motivation and lack of a therapist monitoring practice can contribute to poor adherence to exercise. Providing accurate feedback, goal setting and rewards can enhance compliance and self efficacy. 3) Geographical location: Patients may live in remote or rural areas resulting in less access to specialist rehabilitation services or have limited access to transport to attend therapy. Novel, cost-effective and enjoyable ways are needed to increase the intensity of practice outside of centre-based therapy. Therefore, the purpose of this study is to investigate whether for people who have had a stroke: 1. a smart device application and activity monitor (AM) can be used to increase repetitions of a functional exercise outside of centre-based therapy 2. the activity monitor and smart device application package is enjoyable, acceptable and easy to use. 3. progression of intensity of practice can be delivered remotely by a therapist via the internet.

Zolmitriptan is a 5HT1 agonist widely used for the treatment of migraine. Like other compounds in the triptan class, it has been shown to be effective and well-tolerated in placebo-controlled clinical trials. Zolmitriptan is available as a conventional release tablet (2.5 mg and 5.0 mg), a “fast melt” orally disintegrating tablet (2.5 mg and 5.0 mg) and a nasal spray (5.0 mg). The last two formulations were developed to potentially provide a more rapid onset of effect than the conventional release tablet, as speed of onset is an attribute that patients often cite as important in migraine relief products. The bioavailability of zolmitriptan conventional release tablets has been found to be between 41 and 48% mainly due to first-pass metabolism. Therefore, a product which which avoided first-pass metabolism, the potential for food interaction and lesser absorption during a migraine could have advantages over existing zolmitriptan formulations. Additionally, an important consideration for a non-oral formulation of zolmitriptan is the high incidence of nausea that occurs during a migraine attack. In 60-70% of migraine attacks, nausea is a significant symptom that patients experience. Hence, a product that can be administered without using the gastrointestinal system (and not being susceptible to being vomited up) could be advantageous for the subject experiencing a migraine. The aim of this study is to compare the pharmacokinetics of the parent compound and the metabolites, and tolerability of various doses of intracutaenous zolmitriptan doses to a standard oral dose (2.5 mg) of zolmitriptan. The study will provide preliminary information on the potential advantages of the ZP-Zolmitriptan system use for the treatment of migraine.

Conditions such as asthma, Atopic Dermatitis (AD) and food allergies are all characterised by abnormal immune responses to an external stimuli that ultimately leads to a potentially life threatening inflammatory state. One protein which is key to triggering this inflammatory cascade is the protein IL-33. Animal studies have shown that by inhibiting IL-33, the detrimental inflammatory cascade is suppressed. AnaptysBio Pty Ltd is developing the drug ANB020 to treat these and other related conditions also associated with abnormal inflammatory responses. ANB020 is a monoclonal antibody (mAb) meaning that it can specifically bind to and inhibit IL-33. This study will be conducted in two parts: the first part will investigate the effect of a single dose of ABN020 and the second part will investigate the effect of multiple (weekly) doses of ABN020 for 4 weeks. The single dose study will explore different doses of the study drug given either via a subcutaneous (under the skin) injection (SC) or via an intravenous (into the vein) infusion (IV). The results from this part will be used to determine the dose and route of administration to be used for the multiple dose part of the study. Over the entire study a total of 96 people will be enrolled over 12 dosing groups/ cohorts. In each group of 8 participants, 6 will receive the active drug, ANB020 and the other 2 will receive an equivalent placebo (an injection/ infusion that looks identical to the active drug, but contains no active drug). This study is a dose escalation study meaning that the first group/ cohort will receive the lowest dose of study drug. Results will be reviewed by a safety monitoring committee after each dose strength has been tested to make sure that it is safe to continue with the next higher dose strength in the next group. The next group will not be enrolled until the safety monitoring committee have confirmed it is safe to do so. The study can be stopped at any time, based on evaluation of the side effects of the study drug. As this is a first in human study, the primary objective of the study is to assess the safety and tolerability of single and multiple doses of ANB020 administered to healthy humans.

Using a randomised controlled trial methodology, this project will investigate the effectiveness of a universal, whole school social connectedness intervention (Sources of Strength) to promote help-seeking for suicidal behaviours in adolescence. Sixteen high schools from NSW and the ACT will participate in the trial, with eight schools forming the intervention condition and eight schools forming the control condition. With the support of adult mentors, peer leaders from diverse social groups within the intervention schools will be trained to conduct whole school messaging activities that are intended to change peer group norms, attitudes and behaviours. The program harnesses the social networks of the peer leaders to diffuse the programs messages. More specifically, the peer leaders are taught to model and encourage friends to: (a) reinforce and create an expectancy that friends ask adults for help for suicidal friends, thereby increasing the acceptability of seeking help and reducing implicit suicide acceptability, (b) name and engage trusted adults to improve communication and connections between youth and adults, and (c) identify and use interpersonal (e.g., family, positive friends) and formal coping resources (e.g., mental health services, positive activities) to promote healthy coping attitudes. An integral part of the program is the identification and utilisation of eight key protective factors, referred to as sources of strength. These sources encompass family support, positive friends, caring adults, positive activities, generosity, spirituality, mental health access and medical access. Overall, the program acts to reduce suicidal behaviours by more effectively connecting suicidal youth with capable adults, and prevent the development of suicidal behaviour by promoting positive coping for psychological distress (e.g., depression, anxiety). As this is a whole school intervention, all students in participating year groups (from Years 7-11 depending on individual schools) in participating schools will be invited to complete pre-intervention, post-intervention, and follow-up questionnaires.

The purpose of this study is to compare dysplasia detection rates of conventional forward-viewing colonoscopy against Full Spectrum Endoscopy (FUSE) colonoscopy in an inflammatory bowel disease (IBD)-dysplasia surveillance population. Who is it for? You may be eligible to join this study if you are aged between 18 to 80 years and are eligible for inclusion into the IBD Surveillance Program according to the NHMRC guidelines - that is patients with colitis (at least 1/3 extent of the bowel) of at least 8 years duration. Those with concurrent primary sclerosing cholangitis or prior colonic dysplasia are eligible immediately (rather than at 8 years) Study details All participants in this study will undergo a conventional colonoscopy and a Full Spectrum Endoscopy (FUSE) back-to-back in a single day. The order of the procedures will be randomly allocated, i.e. by chance. Full Spectrum Endoscopy (FUSE) is a new imaging technology that adds two side camera lenses to the right and left sides of the colonoscope to the forward viewing lens. The combination of three lenses delivers a 330 degree panoramic mucosal view as opposed to the 170 degree view from conventional forward viewing colonoscopes. Dysplasia detection rates will be compared between procedures. The safety of both procedures will also be evaluated. The results of this study will help us to determine which method of early detection/screening is the most accurate.

Indigenous Australian children have the world’s highest published rates of hospitalised pneumonia and chronic lung disease including bronchiectasis (BE). Children from developing countries are also at a similar risk. Yet, optimal treatment of pneumonia and how to prevent its long-term effects remain unclear. Trials have focused upon short-term (1-2 wk) outcomes and reduced antibiotic (AB) courses in children with non-severe (viral) pneumonia. However, in high-risk populations from Australia and Malaysia, a longer course of ABs may enhance bacteria clearance and thus reduce the risk of chronic lung disease after severe bacterial pneumonia in young children whose lungs are still developing. Our international multicentre, double-blind RCT is designed to answer our primary question: Does a longer course of ABs (13-14 days) compared to a short course (5-6 days) improve short and long-term outcomes of young children hospitalised with chest xray-proven pneumonia? We will randomise 314 children (aged 3 months to 5 yrs) from 4 sites. Children will be seen at clinically important time points (4 wk, 12 and 24 months) and blood, nasopharyngeal swabs and chest x-rays collected, based on pilot data. Data from this first such study worldwide will substantially advance child pneumonia treatment with implications for future lung health, especially in high-risk Indigenous children. Results would lead to changes in national and international guidelines. As a longer AB treatment for all children may increase AB resistance and lead to ‘over-treatment’ in some, we will address these 2 issues by monitoring for AB resistance and embark on a discovery program to identify biomarkers that predict poor long-term respiratory health outcomes. Availability of novel biomarkers from host gene expression will help clinicians decide which children are at high risk, and therefore in need of more intensive follow up, and may enable targeting of longer AB treatment to those at highest risk of BE.