ANZCTR search results

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

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31615 results sorted by trial registration date.
  • Ice versus “synthetic ice” gel polymer for the treatment of ankle sprain: a randomized, controlled clinical trial

    The standard treatment regimen for uncomplicated ankle sprains comprises ‘RICE’ (Rest, Ice, Compression and Elevation). Assuming the patient is compliant then rest, compression and elevation can be applied with some consistency. Anecdotally, however, the application of ice to the affected area is more variable. This results from the availability of ice itself and the variability in which it is applied. Large ice blocks, chipped ice and ‘frozen peas’ could be expected to have differing levels of effectiveness. Furthermore, the areas of the affected part actually in contact with this ‘ice’ may vary considerably, depending upon the technique. Frozen gel packs have been used as an alternative to ice. However, these can be too cold and have been known to induce skin and subcutaneous tissue damage. They also lack ‘compliance’ when frozen and may be difficult to wrap around the injured area effectively. Recently, a polymer gel has been developed that has the properties of gentle and sustained extraction of heat from the environment (convection) and contacting surfaces (conduction). This gel can be modified to continue heat extraction until its own temperature reaches a pre-determined level of 6oC. This polymer gel can be fashioned into small or large plates that can be inserted into a variety of cloth garments for application to a range of body parts. It has been successfully employed in cooling vests to avoid heat stress and improve the performance of elite athletes. Does treatment with a gel polymer cooling regimen result in better function and reduced pain compared to traditional ice in the acute management of uncomplicated ankle sprains? This study will be a non-blinded randomised controlled trial comparing the use of standard ice with a cloth booty containing cooling gel polymer as an adjunct for treating sprained ankles. 135 patients will be randomised to one of three groups: episodic ankle cooling with ice, episodic cooling with gel polymer booty and continuous daytime cooling with the gel polymer booty. Each cooling regimen will last for at least 48 hours and all other treatments provided will be follow usual guidelines. Outcome measures of pain and ankle function will be sought at 5 and 15 days post-injury by telephone follow up. The findings of this study will inform best practice management of this common injury.

  • Salt & Hypertension & Diabetes

    Lay Summary Project Title: Does habitual low dietary sodium intake augment the response to angiotensin receptor blockade and thiazide therapy in hypertensive patients with type 2 diabetes and elevated albumin excretion rate? Rationale: One of the complications of type 2 (adult) diabetes and high blood pressure (BP) is diabetic kidney disease. In this disorder, the kidneys leak protein (albumin) into the urine and in early stages this is known as microalbuminuria. In some patients this progressively worsens, leading to kidney failure. Some groups of blood pressure lowering medications also lower the blood pressure in the kidneys. This protects against kidney damage by slowing the progression of the protein leakage into the urine. The effectiveness of these groups of blood pressure tablets is reduced when the salt intake in the diet is high. Aims of this study: To determine if the effectiveness of the antihypertensive drug telmisartan, alone, and in combination with the drug hydrochlorothiazide, is increased by a low dietary salt (sodium chloride) intake, and if there is an additional beneficial effect on kidney function; In this study, participants with type 2 diabetes, high blood pressure and early diabetic kidney disease (microalbuminuria) will be recruited. Two groups will be compared - those who usually have a high salt intake in their diet versus those who usually have a low salt intake in their diet, as determined by previous urine sodium test results. All patients will take antihypertensive medication to control their blood pressure called verapamil, prazosin and methyldopa, these medications do not interfere with the test results. The participants will continue their usual diet and dietary salt intake throughout the study, however they will take salt and placebo capsules at various times during the study to look at the effects of additional salt intake on blood pressure and kidney function in patients with high versus those with low dietary sodium intake. Participants: The participants (n=32) includes men and non-pregnant women aged 20-80, with type 2 diabetes, high blood pressure, early diabetic kidney disease and a high or low dietary salt intake. Study Design and Procedures: Cross-over double blind study design. The study involves 12 scheduled visits over 28 weeks. The study consists of 3 phases: Two 8 week phases separated by a 6 week washout. Patients commence on verapamil ± prazosin ± methyldopa therapy and this is maintained throughout the 28 study period. The effect of telmisartan will be studied in each 8 week phase, and a thiazide will be added at week 4 to 8. The effect of salt or placebo will be examined in the last 2 weeks of each 4 week cycle. During the study, a total of approximately 210 ml (10 tablespoons) of blood will be collected. Potential side effects: There are potential side effects of blood pressure lowering medications however as all the patients have high blood pressure, they will be on blood pressure lowering medications. This study involves exposure to a very small amount of radiation during nuclear medicine MAG 3 tests to look at kidney function. This has been approved by the radiation research subcommittee. Provision of test results: Participants (and their general practitioner with their consent) will have access to all laboratory tests and when the final study report is produced by the investigator, this will be forwarded to study participants in lay terms.

  • 2006 Cholesterol challenge Study

    Aim: To test the efficacy of a strucured diet and lifestyle program for plasma cholesterol and weight reduction which can be used at point of care to reduce absolute cardiovascular risk and the need for lipid lowering drugs.

  • Comparison of two methods of immobilising torus fractures of the distal forearm

    AIM: To determine patient and family preferences for immobilisation of undisplaced buckle (greenstick) type fractures of the forearm near to the wrist (distal forearm). BACKGROUND: In the group of children who sustain fractures (breaks) of the forearm near to the wrist, which are undisplaced the mode and length of immobilisation in plaster has been variable. It has been shown that adequate treatment is to immobilize the arm for a two week period, remove the plaster cast then reassess the fracture site for tenderness. The treatment is then either to mobilise if there is minimal tenderness or to re-plaster for a further 1-2 weeks if there is still significant pain. The method of immobilising these injuries has traditionally been in a full, encircling plaster cast, which requires splitting for removal. Another method that has gained popularity recently is the plaster slab (half cast), fashioned and moulded to one side of the child’s forearm and wrist and held in place with a crepe bandage. The functional outcome anecdotally appears to be the same with these two techniques, but the patient preference and comfort have never been investigated. HYPOTHESIS: That plaster slab treatment of buckle fractures of the distal forearm is at least as acceptable to patients as full plaster casting, and that return to function will not be delayed. PROJECT DESIGN: this is to be a prospective randomised study of two techniques of immobilisation of buckle fractures of the distal forearm in children. All children < 17 years of age, with an undisplaced fracture of the radius or ulna, presenting to the Emergency Department of the Royal Children’s Hospital will be enrolled into the study and randomised into either application of a full plaster cast or a plaster slab (half cast) Parents will be asked to keep a daily diary of analgesia use, child complaints or perceived problems with the plaster. Follow up will be in the Emergency Department by one of the two investigators at 2 weeks post injury. At this time a patient and parent satisfaction questionnaire will be completed, the plaster will be removed and the forearm fracture reassessed. If there is minimal or no tenderness the patient will be allowed to mobilise and return to normal function. If there is pain the plaster, or plaster slab, will be replaced and review in a further 2 weeks will occur. RELEVANCE: This research is relevant to current clinical management of patients with the described injuries as it will provide information as to the most acceptable immobilisation from the patients and families point of view. It will also establish the time taken for different immobilisation techniques to return the children to full function. These results should guide future treatment of these injuries, both in the hospital and in general practice clinics.

  • Chronic pain self-management in elderly Australians

    This project will provide for the first time a sound Australian-sourced evidence base for the effective management of this intractable problem amongst the more severely disabled elderly chronic pain sufferers. This research proposal addresses National Research Priorities of improving the mental and physical capacities (and self-reliance) of chronically-ill ageing Australians, by helping to minimise disability, improve self-reliance, workforce participation (where relevant) and quality of life in chronically-ill elderly Australians.

  • Comparison of splinting interventions in treating mallet finger injuries

    Stubbing of the finger-tip is a common injury in sports such as basketball, volleyball, cricket and football. This can result in a Mallet finger deformity, where the end joint of a finger cannot be actively straightened out. In most mallet finger cases seen at The Alfred, the skin remains intact, and the impairment results from a tear of the extensor tendon or an avulsion (a small fracture where the tendon attaches to the bone). Treatment commonly involves immobilising the end joint of the finger in a splint for six or more weeks so patient compliance is a major factor in the quality of the outcome achieved. This study aims to compare two different types of splintage (the commonly used thermoplastic thimble splint and the aluminium-foam “Mexican hat” splint which is in use in Britain) with a control splint (thermoplastic prefabricated “stack splint” with tape). Outcome measures will include patient compliance with the splint, degree of extensor lag, active movement of the joint, and any complications.

  • Delayed versus immediate urethral catheterization following instillation of local anaesthetic gel in males: a Randomized Clinical Trial

    We aim to show if introducing a delay between instillation of local anaesthetic gel into the urethra and the performance of catheterisation produces less discomfort than immediate catheterisation. The assessor who administers the pain scale rating will be blinded to the assignment of the patient (delayed or immediate catheterisation). The participant and proceduralist will not be blinded to the assignment.

  • EMLA versus N2O for analgesia during intravenous cannulation of children in the emergency department

    IV cannulation can be painful. Both EMLA and nitrous oxide can be used for analgesia, especially in children. We aimed to determine which is better for pain relief in children for this procedure

  • Parenting Eating and Activity for Child Health

  • Healthy Eating and Activity through Positive Parenting - the HELPP trial

    This study evaluates the use of parenting skills training with or without nutrition and activity education during parent-led family child weight management

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