ANZCTR search results

Title: A double blind randomised controlled trial assessing the effect of oral ibuprofen on outcome of flexor tendon repairs Short Title: Ibuprofen Flexor Tendon Trial (IFTT) Design: Double Blind Randomised Controlled Trial Hospital/s: Gold Coast Hospital and Health Service Study Question: Does oral ibuprofen influence outcome in patients post flexor tendon repair? Primary purpose of the study: This study has been designed to assess the effect of using oral ibuprofen after repair of hand flexor tendons on function and final outcome of hand . Study hypothesis is that use of oral ibuprofen after flexor tendon repair will result in improved outcome in comparison to when ibuprofen is not given.Ibuprofen should also result in decreased swelling of fingers. Many work hours will be saved and quality of life will be improved in flexor tendon repair patients if the study hypothesis is found to be true and a cheap and easily available drug like ibuprofen can reduce financial burden of these injuries on society and community. Study Objectives: Primary Objectives: Assessment of the effect of oral ibuprofen on outcome of flexor tendon repairs in humans: 1) Range of motion assessment using Strickland criteria 2) Range of motion assessment using ASSH criteria 3) Grip strength assessment 4) Michigan Hand Outcomes Questionnaire for evaluation of hand outcome Secondary Objectives: 1) Assessment of finger circumference 2)Assessment for delayed wound healing 3) Assessment for rupture of tendons 4) Assessment of need for tenolysis or follow up surgeries. Inclusion Criteria: 18 years of age and above Exclusion Criteria: Contraindication to NSAIDs/ibuprofen, systemic conditions/diseases like cardiac, renal, CNS, GI and others, documented allergy to NSAIDs Number of Planned Subjects: 66 Investigational product: Oral Ibuprofen Safety considerations: Coexisting cardiovascular, gastrointestinal and renal diseases; certain drugs Statistical Methods: Two arm trial- interventional and control. Two-sample t-test for a type 1 error (alpha) of 0.05 and a power of 90% for sample size calculation.

Background: Muscle force production is usually impaired in people with spinal cord injury (SCI). However, the use of high-intensity NMES strength training can help promote metabolically active lean muscle mass and thus, increase muscle mass and provide physical health and quality of life (QoL) benefits. Nonetheless, NMES is usually used at low-stimulation intensities (e.g. functional electrical stimulation) and there is limited evidence regarding the effects of high-intensity NMES strength training for increasing muscle force capacity and mass, ameliorating symptoms of spasticity or improving physical health markers and quality of life (QoL) in people with SCI. The primary purpose of this study was to investigate the effects of electrical stimulation of the thigh muscles using pads into improving the muscle size, muscle force, physical health, symptoms of spasms in the muscles and well-being in people who suffered from an accident and their legs are paralysed. The study hypotheses was that 12-weeks of electrical stimulation used as a muscle strength tool will improve muscle mass, muscle size, physical health, symptoms of spasms in the muscles and well-being in people who suffered from an accident and their legs are paralysed. Methods: Five individuals with SCI completed five 10-repetition sets of high-intensity isometric knee extension NMES strength training sessions for 12 weeks in both right (R) and left (L) quadriceps muscles. Quadriceps femoris isometric knee extensor torque was measured on a dynamometer and cross-sectional area (CSA- quadriceps femoris (QF)) were measured with extended-field-of-view ultrasonography. Venous blood samples were collected for blood lipid profiling and c-reactive protein (CRP) analyses. The Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) was used to assess symptoms of spasticity and the quality of life index (QLI) SCI version III was used for QoL measures.

People in hospital with broken ribs can experience a lot of chest pain which makes it hard to take a deep breath, cough and move around. The treatment of broken ribs includes various types of pain relief and physiotherapy to improve breathing ability and help you get up and moving. However, people with broken ribs may still have pain despite this treatment. We are doing a study to see if kinesiotaping is helpful for people with broken ribs. Kinesiotape is an elastic, adhesive, cotton-based tape that is applied to the skin. Its elastic properties mean it can be stretched over the involved area to support the tissues underneath. Kinesiotape is most often used for sporting injuries (e.g. knee, shoulder), but little research has been done about its effectiveness for people with broken ribs. While our usual practice at the Royal Adelaide Hospital has been to not use any type of taping after broken ribs, we are interested in doing a study to look at the effectiveness of kinesiotaping for people with broken ribs. This is an introductory study and if we find that kinesiotaping is beneficial and has no side effects we may consider doing a larger study in the future. The Royal Adelaide Hospital admits approximately 100 patients per year with rib fractures. Given our relative inexperience with kinesiotaping and the heterogeneity of this patient group we do not believe a randomised controlled trial would be a practicable study design in the first instance. Instead, this introductory study will comprise a series of 5 single-subject studies using an ABAB design. Depending on the ease of recruitment, sensitivity of the outcome measures and the results, a randomised controlled trial may be considered in the future. Two of the investigators will screen all in-patients admitted with rib fractures regarding their eligibility to participate. This screening is already part of physiotherapy routine clinical practice. For pragmatic reasons concerning the availability of the investigators and ability to follow-up with taping interventions and outcome measurements over the 4-day study period, patients will only be recruited on Mondays and Tuesdays. Any decision to exclude an otherwise eligible person will be reviewed by one of the other study investigators to minimise the potential for selection bias. When a potential participant is identified, one of the investigators will approach the person regarding participation from 0800 on that day. A written information form that explains the aims and format of the study will be supplied. Informed consent will be obtained from those willing to participate. If the patient agrees to participate, the study period will commence later that same morning. Apart from the application of taping, no other aspect of medical, nursing or allied health management will be changed.

This project constitutes the pilot study of a direct-to-brain Bionic Eye. In this study, up to 3 blind participants will have four small devices placed over the area of the brain responsible for vision. This area is called the visual cortex, which is located at the back of the brain. Each device contains an array of microelectrodes (which are like tiny wires as thin as strands of hair) and electronic circuitry that is capable of delivering small electrical pulses to the brain via the microelectrodes. The devices are powered and controlled wirelessly, so no wires need to be implanted. When the visual cortex is electrically stimulated, small points of light are seen by the participant, which can be assembled into basic images after adequate training. This study aims to teach blind participants to ‘see’ using these basic images, thereby demonstrating the safety and utility of the direct-to-brain Bionic Eye.

Stelis Biopharma has developed a biosimilar formulation of Teriparatide which has been proven to be qualitatively comparable with approved product Forsteo® (EU) and Forteo® (US) being marketed by Eli Lilly through several analytical methods. This Phase-1 study is designed to compare the pharmacokinetics, safety, tolerability, and pharmacodynamics of the biosimilar formulation developed by Stelis Biopharma with the reference formulation Forsteo® (EU) and Forteo® (US) being marketed by Eli Lilly and establish it's clinical comparability.

This trial aims to determine the ability of the PEPtrac to record airway clearance sessions performed at home by adults with cystic fibrosis utilising commonly used positive pressure airway clearance devices when compared to participant self-reports. Participants will use the PEPtrac and an airway clearance device for a one week period, performing a treatment session at least once daily At the completion of each treatment session, participants will complete a treatment diary entry. After one week, participants will also complete a questionnaire examining their experience of using the PEPtrac and any suggested design modifications that they may have.

Background: ‘At-risk’ patterns of alcohol use are prevalent in many countries with significant costs to individuals, families and society. Screening and brief interventions (SBI), including with web delivery, are effective but with limited translation into practice to date. Previous observational studies of the Hello Sunday Morning program have found that their unique participatory health communication approach has resulted in a reduction of at-risk alcohol use between baseline and three months. This study will systematically evaluate different versions of the site and support resources in reducing at-risk alcohol use. Design/Methods: New participants enrolling on the Hello Sunday Morning website will be eligible to be randomised to receive either i) the “Daybreak” program or ii) the “Daybreak” program plus online coaching support. We will recruit 467 people per group to detect an effect of f=0.10. The primary outcome measure will be the reduction in Alcohol Use Disorders Identification Test-consumption scores. Secondary outcomes include: mental health (Kessler’s K-10), alcohol consumed measured with a seven day drinking diary in standard 10g drinks, days out of role (Kessler), and alcohol related harms (CORE alcohol and drug survey). We will collect data at baseline, three and six months and analyse them with random effects models, given the correlated data structure. The Daybreak program provides evidence-based information on how to change drinking patterns combined with a supportive online environment, with all content produced by participants. Conclusions: A randomised trial is required to provide robust evidence of the impact of the Hello Sunday Morning website, including over an extended period.

New approaches to enhancing Aboriginal and/or Torres Strait Islander mental health are clearly needed. This study aims to development of a culturally relevant and appropriate model of mental health that addresses some of the core issues of disconnection, disrupted attachments and trauma experienced by so many Aboriginal people. We propose adapting compassion-focused therapy (CFT) so that it is culturally appropriate for Aboriginal clients; and will evaluate its effectiveness. As such, this is a pilot study. Our aims are as follows: 1. To develop an Aboriginal-adapted culturally appropriate form of CFT, based initially on feedback from an Aboriginal health professional group. It is anticipated that there will be some further modifications as necessary over the course of the project. 2. To determine if this Aboriginal-adapted form of CFT is viewed as an acceptable and promising approach by Aboriginal health professionals and Aboriginal clients. 3. To conduct a preliminary evaluation of the impact of CFT within the constraints of the timeline, the service contexts, the absence of available control groups and an acceptable evaluation design that meets AHRMC and other ethical guidelines The participants will be clients of three different services: Namatjira Drug and Alcohol Rehabilitation Centre, Bunjum Corporation and Rekindling the Spirit. Different groups will be held in each of the services for their respective clients.. The clients of Namatjira Haven are in the early stages of drug or alcohol rehabilitation and are in-patients; The clients of the other two services live in the community, and may or may not have current mental health problems. People who are assessed as having severe mental health problems (e.g. psychosis, current suicidal ideation) will not be included in the groups.

The Premier's Youth Initiative (PYI) is an endeavour by the New South Wales Government to prevent young people transitioning from out-of-home care (OOHC) from becoming homeless. This study intends to assess the effectiveness of PYI in preventing or delaying homelessness among young people leaving OOHC. Overall, the evaluation will consist of three strands, (i) an outcomes evaluation, (ii) a process evaluation and (iii) an economic evaluation. The outcomes evaluation will use a Randomised Controlled Trial (RCT) to provide robust evidence of the effects of PYI on youth homelessness in the target population.

The purpose of this study is to establish and validate new laboratory techniques required for accurately classifying newly diagnosed central nervous system (CNS) tumours (including brain and spinal cord tumours) in children. Who is it for? You may be eligible to join this study if you are aged 0 - 21 years old and have been diagnosed with a CNS cancer and undergone surgical resection. Study details All participants will have blood and tumour samples sent to Monash Health in Clayton, Victoria, where molecular profiling will occur. Concurrently, participants will have standard diagnostic radiology and pathology diagnostic testing at their centres. If the molecular diagnosis matches diagnosis achieved at the local centre, a report will be sent to the study sponsor (ANZCHOG) and the local treating oncologist. If the results are discrepant, these cases will be subject to central pathology analysis and an expert Tumour Board will review all the results and reach a consensus diagnosis. Participant health records will be assessed yearly to record treatment approaches and responses for up to 10 years. This study will provide valuable data for personalised treatment decisions to optimise survival outcomes and minimise long-term complications