ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31330 results sorted by trial registration date.
  • Pain modulation characteristics in people with shoulder impingement and predictors of successful outcomes following physiotherapy treatment

    There is a growing body of evidence of altered sensory processing in people with shoulder pain however it is not known which pain modulation pathway is affected in this population. It has also been reported that manual therapy techniques for the shoulder complex improve outcomes in patients with shoulder impingement compared to standard physiotherapy, sham or control interventions; however some findings suggest that a subgroup of individuals with shoulder pain may exist who will respond dramatically to these interventions. The aims of this study are to determine 1) the dominant pain modulation process in shoulder impingement individuals and 2) prognostic factors from the history, physical examination and pain modulation process in individuals with shoulder impingement who are likely to experience improvements following physiotherapy associated with manual therapy techniques. In this instance the population will be individuals with shoulder impingement symptoms and healthy controls. For the first aim of the study, all the subjects will be assessed twice at the baseline, with an interval of 48 hours between the measurements. For the second aim of the study, subjects with shoulder impingement will be treated during 4 weeks with manual therapy, physiotherapy and, when necessary, shoulder taping, and then reassessed after the 4-weeks rehabilitation program. The primary outcome measures will be heat pain threshold, cold pain threshold, cold pressor threshold, conditioned pain modulation and temporal summation of pain. The results of this study will contribute to our understanding of the dominant pain modulation process as mechanism for success in this technique and to guide physical therapists in selecting which patients with shoulder pain may experience improved outcomes following physiotherapy and manual therapy treatment. To date no scientific study has been conducted to investigate the pain modulation pathways in this population neither the predictive factors for successful outcomes concerning pain modulation in people with shoulder pain.

  • Modafinil in debilitating fatigue after stroke

    Debilitating Fatigue is a common complaint in survivors of stroke and transient ischaemic attack (TIA) and can persist for years after the acute event, causing lack of physical activity and participation in rehabilitation and socialisation. Currently there are no pharmaceutical agents approved for the treatment of this fatigue. Modafinil has been shown to reduce fatigue in patients suffering other neurological conditions such as MS and Parkinson's disease, and to improve cognition and memory. This study will aim to measure the efficacy of modafinil in survivors of stroke and TIA experiencing self-reported fatigue.

  • Evaluation of intravenous fluid resuscitation with either 4% albumin or 20% albumin solution for patients admitted to the intensive care unit

    Administration fluids directly into a vein is commonly used to treat low blood pressure in critically ill patients, termed fluid resuscitation. The aim of fluid resuscitation is to restore and maintain organ function. Two commonly administered intravenous fluids are 20% albumin and 4% albumin. Intensive care doctors do not known if either of these two fluids should be used in preference to the other for fluid resucitation. In response, the aim of this study is to establish the feasibility, safety, biochemical and physiologicy efficacy of intravenous 20% albumin solution compared with intravenous 4% albumin soluation for fluid bolus therapy in critically ill patients. For a period of 48 hours from enrolment, patients that are enrolled in this study will receive either of the study fluids when their treating intensive care doctors deems it necessary. This study will enrol 400 patients for two intensive care units of hospitals located in Melbourne and Adelailde, Australia. If our findings support one intravnous fluid over the other then we would aim to conduct larger studies to assess its benefits in terms of patient-centred outcomes.

  • A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: the ASPREE-Fracture sub-study

    Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. During 2007, there were an average 262 fracture-related hospitalisations per day in Australia with the financial burden associated with direct treatment cost for fractures in Australia estimated at $1.9billion per year. A small number of low-quality observational studies examining the effect of aspirin on fracture risk in older people have demonstrated conflicting results. A large-scale controlled trial is required to provide more accurate information on this effect. The ASPREE-Fracture sub-study aims to investigate whether daily low-dose aspirin (100mg) is associated with decreased incidence of vertebral, hip and non-vert-non-hip fractures in healthy men and women aged 70 years and over; and whether the reduced fracture risk is explained, in part, by reducing risk of fall-related hospital presentations. The ASPREE-Fracture sub-study has the potential to change current fracture prevention practice and policies for older people by offering a population intervention. Even if small impacts are observed on fracture incidence, the net benefits of aspirin in terms of reduced fracture risk at a population level may be substantial.

  • Evaluating the effects on function and pain of two gels applied over the knee in people with mild to moderate osteoarthritis: a 2-week randomised control trial. The KnEe Guard (KEG) trial.

    Osteoarthritis (OA) is a common problem for many people, with pain and reduced function the main symptoms. As there is no cure and with many treatment interventions still under investigation, current management strategies are focused at reducing pain and improving joint function. These treatment options include medication, surgery, joint replacement, exercise etc. Studies have shown that a history of injury/trauma to a joint increases the risk of developing OA as you age. It has been reported that there is a greater than 5 fold increased risk of developing knee OA in those with a history of knee injury. Those with significant prior knee injury are therefore a key group to target for preventative interventions and are worthy of investigation and development. OA is characterised by wear and tear of the cartilage between the joint surfaces. Clinical trials have reported that the medications “chondroitin sulphate” and “glucosamine sulphate”, when taken orally have some beneficial effects on pain and function although results have been variable. Chondroitin and glucosamine therefore appear to offer potential benefits as a means of limiting the development of OA and have been supported by the recommendations of international guidelines. As issues regarding the effectiveness of these medications taken orally have arisen, alternative methods are being investigated. This study will assess the effectiveness of a newly developed knee guard device and its diamagnetic technology in people with knee injury/ previous knee surgery, who are at increased risk of developing osteoarthritis. Therefore this study endeavours to determine the effectiveness of the knee guard and investigate if the improvement in physical function with the knee guard device is equivalent to the improvement produced by an established non-steroidal anti-inflammatory (NSAID) formulation. AIMS OF STUDY: This study aims to determine if daily use of a knee guard device will improve physical function in individuals who engage in regular exercise but have knee discomfort related to previous knee injury/surgery. The knee guard product is a knee support intended to help users maintain a healthy knee joint and enhance their recovery from injury. It uses diamagnetic force to deliver therapeutic ingredients through the skin and into the body more effectively than creams or oral supplements. Another aim is to determine if the improvement in physical function with the knee guard device is equivalent to the improvement produced by a well-known non-steroidal anti-inflammatory formulation (NSAID gel).

  • Can Dietary Fibre Consumption Alter Fat Absorption in Ileostomates

    This study aims to quantify whether the co-consumption of a high fibre beverage can alter dietary fat absorption of a high fat breakfast meal in ileostomates.

  • The Health Anxiety Program: a pilot trial of an online program for people who worry excessively about their health

    The project aims to evaluate the acceptability and clinical efficacy of the online Health Anxiety Program. Up to 25 people with elevated health anxiety (either IAD or SSD) will be assigned to the active treatment group. The treatment group will commence the Health Anxiety Program immediately. The efficacy of the Health Anxiety Program will be determined by comparing the health anxiety symptom levels before and after treatment, and at 3 month follow-up.

  • A pilot study to assess feasibility, safety and efficacy of artificially introducing an air-pleura interface for detection of pleural nodules by computed tomography

    This study will evaluate the use of an artificial air-pleura interface by introducing air into the chest for a computed tomography (CT) scan to detect abnormalities in patients with known or suspected malignant pleural effusion. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have known or suspected malignant pleural effusion and have a chest drain in-situ. Study details: All participants will have two CT scans: one standard CT scan and one CT scan with an artificial air-pleura interface. The artificial air-pleura interface will be created by introducing 500mL of air via an in-situ chest drain [such as intercostal catheter (ICC) or indwelling pleural catheter (IPC)]. The air is introduced using a syringe connected to the chest drain. The findings on pleura detected by the two CT scans will be compared. No previous studies have specifically assessed pleural abnormalities through this technique. We hypothesize for this study that artificially creating an air-pleura interface will make the small pleural nodules (~1cm) more conspicuous and will allow significantly better detection of previously undetectable pleural abnormalities/ nodules by CT scan.

  • The Effects Of Dual, Inhaled Long-Acting Bronchodilators on Complex Lung Mechanics in Chronic Obstructive Pulmonary Disease

    This projects aims to study the effects of different inhaled bronchodilator medications used in the management of COPD. Clinical trials have demonstrated their effects on the large airways of the lungs, however their effects on the small airways are not yet known. This project will use sensitive tests of small airway function to identify the effects of bronchodilator therapy on the small airways in COPD. Specifically, we aim to determine if two different classes of bronchodilators have a greater effect when given in combination than when given alone. We hope to use this information to enhance our knowledge of how these medications work, which may help us improve the treatment of patients with COPD.

  • TROG 15.01 (SPARK) Efficacy of Kilovoltage Intrafraction Monitoring (KIM) in men with prostate cancer undergoing stereotactic prostate radiotherapy

    This study will determine the efficacy of the addition of Kilovoltage Intrafraction Monitoring during stereotactic prostate adaptive radiotherapy in prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have histologically proven prostate adenocarcinoma with low or intermediate disease risk. Study details All participants will receive multi-fraction stereotactic prostate adaptive radiotherapy at 36.25 Gy in 5 fractions over 2-5 weeks. A new technology, known as Kilovoltage Intrafraction Monitoring (KIM), will be used which allows images of a tumour to be taken in real-time while the treatment is occurring. This enables strategies such as patient shifting or beam shifting during treatment which could potentially improve the accuracy of the treatment and reduce the patient’s side effects. In addition, due to the accuracy of KIM in targeting tumours, the number of treatment sessions this group of patients will require will be reduced to five as opposed to the 40 sessions required using more conventional treatment methods. Efficacy of KIM will be assessed by the dose accumulation method for each session. Participants will be followed for up to 2 years, in order to determine patient treatment outcomes, and toxicity. The researchers expect this trial to result in better targeted prostate cancer patient outcomes with lower toxicity. The potential application of KIM to other tumour sites will pave the way for additional trials with Australasian radiation oncology leading the world.

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