ANZCTR search results

This is a pragmatic trial designed to test the effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in chronic non-specific low back pain. It is a pragmatic design as it is testing two active interventions that people commonly seek for management of musculoskeletal pain, and the interventions are applied with real-world authenticity. The study aims to see if these interventions improve the pain and health status of participants, and whether the osteopathic healthcare intervention is any more effective than the standardised exercise and activity care plan. The core elements of the osteopathic healthcare intervention has been established through research, and includes assessment of musculoskeletal function, manual therapy, education, therapeutic exercise and health promotion advice. The exercise and activity care plan intervention is based on evidence based guidelines for chronic low back pain. After screening for the inclusion and exclusion criteria, participants will complete the first outcome measurements, and then be randomised into groups and receive four weekly consultations. The second outcome measurement will be completed immediately after the final consultation, the third 2 weeks after the interventions and a fourth 6 weeks after the end of interventions in order to test short and medium terms outcomes. Statistical approach is by Intention To Treat, and analysis will be undertaken using a multivariate approach and calculating effect sizes.

The primary aim of this study is to determine whether the addition of IRT to CBT-I improves sleep disturbances in ex-service personnel with PTSD, insomnia, and nightmares compared to CBT-I alone. This study also aims to explore if risk of obstructive sleep apnoea (OSA) negatively moderates treatment outcomes in ex-service personnel receiving either CBT-I or CBT-I+IRT. Participants will be a minimum of 60 ex-serving personnel with PTSD, insomnia, and nightmares. Eligible participants will be randomised to either CBT-I or CBT-I+IRT treatment groups. Participants will attend 8 x weekly 60 minute CBT-I group sessions or 8 x weekly 120 minute CBT-I+IRT group sessions. Participants will complete a series of outcome measures at three time points (baseline, post-intervention, and at three months post-intervention). It is expected that the addition of IRT to CBT-I treatment will result in greater reduction in sleep disturbances than treatment with CBT-I alone.

Research Question: Does Visualisation Affect Pain and Function in Achilles tendonopathy (AT)? Pain is clearly a complex process and involves integration of multiple streams of sensory information. An area of recent research interest has been the integration of what a person sees to augment or moderate the pain experience. Visually-induced analgesia is a term used to describe the reduction of pain intensity by directly viewing one’s own body-part when painful stimulation is applied. In chronic low back pain for example, patients’ visualisation of their lumbar spine reduced pain with movement. We hope to explore this phenomenon to see if, and to what extent, it exists in AT, and to simultaneously investigate the effect of vision on tendon function – something which no study of visually induced analgesia has done before. The aim of this study is therefore to examine the effect of visualisation on pain and function in people with AT. To achieve this, we will assess pain and leg stiffness with hopping in people with AT while they view a video image of their leg and compare these results with a no vision condition. This study will help inform whether non-nociceptive information sources are important in influencing pain in a clinical condition while performing a functionally relevant task, reveal if any changes in pain are associated with functional performance changes and may inform management strategies for the management of AT.

The purpose of this study is to assess whether the drug PAX-1 can delay cancer progression in patients with recurrence glioblastoma. Who is it for? You may be eligible for this study if you are aged 18 to 70, diagnosed with recurrent glioblastoma. Study details Participants who are resistant to SOC therapy will receive PAX-1 monotherapy alone until disease progression/recurrence or patient withdrawal (due to intolerance or withdrawal of consent).Patients will receive a maximum daily daily 15 mg oral dose of PAX-1 Every 8 weeks the patient will have a scan of their tumour to determine whether the therapy is working. It is hoped that information gained in this study will aid in the understanding of treatment of glioblastoma and help in the development of new approaches to its treatment and the care of future patients who share your condition.

A compassion-based digital health program (called CompassionateUs) to increase psychological wellbeing, for adults in the general community, will be evaluated. CompassionateUs is one of the digital health programs offered through the My Digital Health platform. People who consent to take part in the study will be randomly allocation to one of three conditions upon completion of the pre-program survey. The three conditions vary based on when program modules are released (i.e., all modules are open from first login; modules are released on a time schedule; modules released sequentially, following completion of the current module). The CompassionateUs program consists of 10 brief modules (i.e., 5 compassion-knowledge building and 5 compassion-skill building), delivered over 8 weeks. Each module will take 10-20 minutes to read and to consolidate learning, participants will be asked to complete various practise activities (10 minutes per day on average). Participants will also receive automated emails (e.g., when a module is released, once they have completed a module, when scheduled program assessments are due). It is expected that people who undertake the CompassionateUs program will show improvements in their psychological wellbeing (e.g., self-compassion levels) at post-intervention and follow-up assessment time points.

A multi-centre randomised design will be utilised to compare control centre normal practice conditions with intervention centres receiving physical literacy educator professional development and curriculum support. Approximately 60 educators and 300 children (age 4 to 5 years) will be recruited from 16 Early Learning Centres in Queensland and NSW. Centres will be randomly allocated (stratified cluster randomization) to either intervention, or control over a 24-week period. The reach, effectiveness, adoption, implementation, of the intervention will be examined. Change in aspects of children’s physical literacy will also be assessed. Assessments will be conducted at baseline and 6 months (end of intervention),It is hypothesised that educators receiving the intervention will improve the provision of physical literacy activities to children and that children receiving the intervention will have greater improvements in physical literacy.

Improvements in the management of critically ill patients have resulted in improved survival. However, these survivors are at an increased risk of cognitive, psychiatric and physical disability. This constellation of symptoms is known as Post-ICU Syndrome (PICS). One particular component of PICS is the development of chronic pain. Clinically and epidemiologically, chronic pain has been defined as pain that persists for 3 months or more Currently, the incidence of chronic pain in survivors of intensive care in Australia is unknown. The current literature from overseas estimates the incidence of chronic pain to be between 40-60% of ICU survivors. To date, there are no studies that have identified modifiable risk factors that therapeutic interventions can target to prevent the development of chronic pain. In addition, there is no literature about long-term opioid use in survivors of ICU. Hence, noting that there is a high incidence of chronic pain in ICU survivors, we aim to confirm this and hypothesise that risk factors associated with analgesic management, sedative management and immobility are implicated in the development of chronic pain. We plan to do this by conducting a large cohort study that accurately measures chronic pain using internationally recommended definitions. In addition, we will evaluate the impact of chronic pain (i.e. requirement of opioids, quality of life, interference, neuropathic components, psychiatric comorbidities, employment) using validated scales. We will also identify modifiable risk factors to develop targeted therapeutic interventions that aim to reduce the incidence of chronic pain, which will inform larger therapeutic clinical trials.

The purpose of this study is to determine the efficacy of vitamin D3 with or without HMB on the physical function, skeletal muscle mass, strength, bone turnover and bone microarchitecture in community-dwelling men and women aged 65 years with osteosarcopenia. This is a single-centre randomised, double-blind, placebo-controlled study design with approximately 88 osteosarcopenic patients randomised to daily oral treatments: vitamin D3 (1,000 IU/d) plus HMB or placebo in tablet form. The study will consist of a 24-week treatment period followed by a 12-week follow-up period. Assessments will be performed at the time of randomisation and at Weeks 12, 24 and 36.

This study will evaluate the effect of providing feedback to clinics on experiences of psychosocial care in cancer patients, in improving the quality of psychsocial care provided to patients. Who is it for? You may be eligible to join this study if you are aged 18 and above, have a confirmed diagnosis of cancer (any type) and attending a cancer clinic or receiving treatment as an outpatient. Study details All cancer clinics will start in the control arm to collect 8 weeks of data. The intervention will then commence for a period of 12 months. Clinics will receive monthly feedback reporting patient experiences of care over the previous data collection period and asked to set targets for improvement. Clinics that fail to demonstrate improvements after a 3 month period of intervention will receive additional support through visits from the cancer services director to devise more intensive strategies for improvement. Patient experiences of care, quality of life and levels of anxiety and depression will be assessed using questionnaires before, during and after the intervention period. If effective, this approach will be able to be utilised by clinics to obtain regular feedback from patients regarding their experiences of care and to determine priorities for quality improvement. Ultimately, we expect this will result in better quality of care, and improved psychosocial outcomes for cancer patients.

This research study looks into new ways to detect the use of low doses of testosterone for doping in women. The lure of fame and fortune through competitive success in elite sports will always tempt some athletes to cheat including by doping using performance enhancing drugs. At present, testosterone is known to be illegally among to enhance athletic performance. Testosterone is the most powerful and widely used in doping to gain unfair advantages in athletic performance. Anti-doping detection tests, based on urine samples are used to detect, deter and penalise cheating athletes who use testosterone in elite athletics or training. However, it is not clear how quick to detect these tests are especially for women and there is a concern that low doses of testosterone may be missed by the standard urine tests. This study is designed to address this important gap in knowledge in anti-doping science as well as aiming to develop better, more responsive tests. This study is for the first time studying in detail the use of blood tests to see how well they add to and improve on the standard urine tests to detect use of testosterone.