ANZCTR search results

The purpose of this proposed project is to replicate the efficacy of, and assess the cost-effectiveness, an established internet-delivered self-management program, the Pain Course, for chronic pain, when administered with optional clinician guidance versus a waitlist control. Participants in this research trial will be randomly allocated to receive the Course with optional telephone guidance from a clinician, or to a delayed-treatment control group. Hypotheses: 1. The Pain Course will result in statistically and clinically significant improvements in symptoms of disability, anxiety and depression from pre-treatment to post-treatment compared to the treatment-as-usual Waitlist Control Group. 2. The Pain Course will be more cost-effective at common willingness-to-pay thresholds compared with treatment as usual. 3. Observed clinical improvements in symptoms of disability, anxiety and depression will be maintained at 3-month follow-up.

Description: Post-herpetic neuralgia (PHN) is a condition in which there are few effective therapies, and most of those which do show some efficacy have an unfavourable side effect profile. This study will explore whether a widely used clinical complementary therapy may have a role in the treatment of PHN. In addition to confirming whether SJW is effective in PHN, this research will help to build an evidence base for complementary therapies. Despite being widely used, most complementary therapies remain unstudied. This research will help to uncover the effectiveness, or lack thereof, of SJW in PHN. Objectives: Primary – The effectiveness of a herbal treatment on clinical measures of post-herpetic neuralgia. Secondary – Tolerability of a herbal medicine treatment in the treatment of post-herpetic neuralgia Study design: Double-blind randomised cross-over clinical trial Planned sample size: 40-60 (pilot) Selection criteria: Persons with a confirmed diagnosis of herpetic neuralgia. Study procedures: The design of the study is a randomised, placebo controlled pilot trial recruiting 40-45 adults (18-65) with post-herpetic neuralgia (PHN). The clinical trial will be conducted over 9 weeks in 3 phases. All the participants will receive placebo application for the 1st phase (washout-placebo phase - 1 week), then group 1 (determined via randomisation) will continue to take placebo for 4 weeks, while group 2 will receive the active St. John’s Wort topical application (SJW). The next phase involves both groups 1 and 2 crossing over for 4 weeks. The topical application will be applied to the area affected by PHN twice daily, this will differ depending on the severity and extent of PHN in individual patients. Statistical considerations: As a pilot study of a treatment in common clinical use, but with no data to calculate effect size, a pilot trial of 40-60 persons will be conducted. Study duration: 4 weeks (participant). Recruitment will last for 1 year (12 months)

The purpose of this project is to evaluate the usability, acceptability and impact of the Mindfulness and Gamification eTool and its capacity to promote wellbeing. The eTool is designed to improve user engagement with an existing program, Smiling Mind, by increasing gamified features and elements.

Asthma is a major health problem globally. Clinical research and management mainly focus on moderate to severe asthma, however most adults with asthma have mild disease. Short Acting Beta Agonist (SABA) reliever therapy alone is currently the internationally recommended treatment in mild asthma. However, there is substantial morbidity in this population and previous studies have shown that those with intermittent or mild persistent asthma who were Inhaled Corticosteroid (ICS) free experienced severe exacerbations. Evidence suggests that a combination Inhaled Corticosteroid/ Long Acting Beta Agonist (ICS/LABA) inhaler used as reliever therapy may be preferable to SABA only reliever therapy and represent an alternative to maintenance ICS and SABA reliever therapy. The major advantage of the combination ICS/LABA as needed over SABA monotherapy is the ICS therapy is being self-titrated according to symptoms in a group of patients that would not otherwise receive ICS. It may improve adherence to ICS use and enable high dose ICS therapy to be promptly delivered by patients with worsening asthma. We are therefore investigating the safety and efficacy of 3 treatment regimens in mild asthma: 1. A combination inhaled corticosteroid (ICS) and Long Acting Beta Agonist (LABA) as required 2. SABA only as required 3. Regular ICS maintenance, and SABA as required.

Currently, opinion amongst obstetric anaesthetists is divided as to whether an intravenous (IV) route is superior to the per rectum (PR) route for perioperative mangagement of post caesarean section pain. Recently, a prospective audit was conducted at the Northern Hospital. This audit assigned 50 women to receive IV analgesia and a further 50 women received PR analgesia post caesarean section, which was either an elective or an emergency procedure. Analysis of the data revealed that the group who had received IV analgesia had a lower 48 hour oxycodone usage of 148.9 +/- 36.7 compared to the PR analgesia group, which had a 48 hour oxycodone usage of 170.0 +/- 47.5 mg. This difference is a 12.4% reduction. Despite this apparent difference in opioid requirements, there did not appear to be a difference in pain scores as reflected by the fact that for three of the four pain questionnaires, all of which were unidimensional measurements of pain, there was no statistical difference between the two groups. For the fourth pain questionnaire, which measures the multidimensional aspect of pain, a statistical difference was found favouring the group who had received IV analgesia. Therefore, we wish to expand upon these findings and would like to propose a non-blinded randomised controlled trial comparing the IV route to the PR route. Based on data previously obtained, if the IV route provided better analgesia, we propose that there should be a 20% reduction in the total pain score as determined by the multidimensional pain questionnaire (SF-MPQ).

This study aims to look at the effectiveness of rehabilitation for improving prospective memory in everyday life. Prospective memory refers to remembering to carry out things you intend to do in the future, like remembering to attend an appointment or to take medication. Previous research has shown that people with traumatic brain injury often have prospective memory difficulties which can impact on their independent living, social participation and work. Compensatory rehabilitation approaches which involve training people to use a range of strategies to circumvent the problem (i.e. diaries, note-taking, alarms) are successful in improving prospective memory function. However, research has also shown that strategy use and everyday memory performance can be enhanced by using a 'metacognitive' treatment approach designed to improve self-awareness of changes post injury. This study will compare two treatment approaches: a compensatory rehabilitation approach and a compensatory plus metacognitive rehabilitation approach designed to develop self-awareness of prospective memory problems and train strategy use to improve everyday prospective memory function. The study will also explore whether improvements are maintained (3 months and 6 months) after the rehabilitation is finished.

One third of all heart attacks are repeat events. It is unknown whether the risk of having another cardiac event can be reduced by simply sitting less. We will assess sitting time, physical activity and the ‘active couch potato’ phenomenon in those with heart disease attending cardiac rehabilitation (CR) over 12 months. We will assess the potential independent impact of these behaviours on the CR participants’ cardio-metabolic health, health-related quality of life, exercise capacity, anxiety and depression, both locally and internationally. Outcomes will inform CR research, policy and practice and lead to better health outcomes for those with heart disease.

The private automobile is the preferred and most utilised transport option for older people in Australia. Longitudinal studies of ageing in Australia have examined driving patterns and transport use of older people and have found that people are continuing to drive well into later life, to a much greater extent than previous generations. While people 65 years or older represent 13% of the total Australian population in 2004, this is expected to double to 26% by 2051. Although a large proportion of older adults are safe drivers, studies indicate that older drivers are overrepresented in crashes per distance travelled, particularly with regard to serious injuries or death as a consequence of crash involvement. Our research and that of others indicate that older adults with cognitive, sensory and physical functional decline are more likely to be unsafe drivers, and our recent has successfully developed and validated off-road assessment tools for accurate identification of at-risk older drivers. Here, we propose to develop and trial a training program to improve the driving skills of older adults. Such a program will increase road safety, while maintaining mobility and independence for older drivers and promote healthy, productive ageing.

Chronic obstructive pulmonary disease (COPD) is characterised by airflow obstruction that is incompletely reversible by short acting bronchodilators, which causes typical symptoms of breathelessness on exertion, cough, sputum production and sometimes wheeze. Nocturnal symptoms can also occur, which may be related directly to the severity of airflow obstruction but there may be other factors that affect sleep quality such as upper airway obstruction, obesity, medications, genetic variability and systemic inflammation. There has been little published work on sleep abnormalities in COPD, but sleep related symptoms in COPD appear to be common. Research questions and hypotheses In this project, we address the questions of how prevalent and what is the nature of sleep disturbance in COPD? We also propose the answer the question of how the sleep disturbances relate to changes in lung function, systemic and airway inflammation, genetic variations, activity levels and day-to-day variations in spirometry. Hypotheses Sleep disturbance in COPD is due to overnight changes in lung function, and associated with subjective overnight and early morning symptoms and worse quality of life. Our secondary hypotheses are that overnight changes in lung function are related to airway and systemic inflammation, and variations in genes that influence circadian variation. The significance of the findings will be increased understanding of the prevalence and mechanisms of sleep disturbance and symptoms in COPD. This may influence management of COPD in terms of physical and pharmacological treatment.

There is an urgent need for the development of novel approaches to the treatment of Alzheimer’s disease (AD). AD is characterised by progressive decline in cognitive functioning in most areas, including in memory, attention, visuospatial ability, language and executive function. Although there are medications that can slow the progression of symptoms somewhat, there are currently no effective treatments for these hallmark symptoms of AD. Recent research has indicated that the progressive cognitive decline seen in AD may be a result of decreased functional connectivity throughout what is known as the default mode network (DMN), a brain network whose anatomy closely mirrors the pattern of cortical atrophy seen in AD patients (i.e. prefrontal, posterior parietal, and medial temporal). An approach that is able to specifically target this network in order to enhance connectivity, and thus functioning, could result in a highly effective therapy for the cognitive impairments in AD. Non-invasive brain stimulation (NIBS) techniques have considerable promise in this regard. NIBS has been shown to modulate activation throughout large scale cortical networks, such as the one implicated in cognitive impairment in AD, to enhance cognition in a number of disorders and to produce long lasting behavioural effects. In particular, Theta Burst Stimulation (TBS) is a highly effective form of NIBS and allows for multi-site stimulation within a single treatment session. The use of TBS for the treatment of cognitive impairment in AD is an area of significant potential, and one that has yet to be adequately explored. We propose to conduct a double-blind placebo-controlled randomised pilot study comparing a treatment course of active TBS to sham TBS (i.e. 21 daily treatment sessions over six weeks). In each treatment sessions TBS will be sequentially provided to four brain regions, the left and right dorsolateral prefrontal cortex (lDLPFC, rDLPFC) and the left and right posterior parietal cortex (lPPC, rPPC).