ANZCTR search results

With the general ageing of the population attributed to Baby Boomers and the increase in life expectancy, attention of health consumers is turning from simply the treatment of chronic illness to increasing the span of good health (healthspan) as people age. The inflamma-ageing hypothesis proposes that much of the ageing process per se as well as chronic disease, even in healthy persons, is underpinned by chronic low-level inflammation. In pilot human studies undertaken by NatMed Research looking at their proprietary green-lipped mussel-based products as an anti-inflammatory treatment of osteoarthritis, the observation was made of changes in body composition in those persons receiving active medication. The current proposal is to undertake a randomised controlled trial in middle-aged healthy study population (without osteoarthritis) to determine if improvements in body composition and strength can be determined under double-blind conditions.

This study will compare four different techniques for reducing the incidence of shoulder tip pain after total laparoscopic hysterectomy. Shoulder tip pain occurs commonly after the procedure and although the exact cause is unknown, it is thought that the carbon dioxide (CO2) gas that is introduced into the abdomen to allow laparoscopic surgery to be performed safely may be the cause. We believe that by combining two techniques - closed drainage and the pulmonary recruitment maneuver - after surgery may allow CO2 gas to be removed more effectively from the abdomen and allow patients to experience less shoulder tip pain than if these techniques are used on their own or not used at all.

Fractured neck of femur (FNF) is a common condition, affecting 25,000 Australians per annum. Total hip arthroplasty (THA), which involves replacing the ball and socket of the hip joint, is the current standard of care for fractured neck of femur in community-dwelling patients with minimal co-morbidities. However, despite superior pain and functional scores compared to the alternative treatment, partial hip replacement (hemiarthroplasty), THA exposes patients to an increased risk of prosthesis dislocation. Prosthesis dislocation involves separation of the prosthetic head and acetabular cup, and may require a patient to undergo revision THA, a procedure associated with increased costs and morbidity. Dual mobility cups (DMC) are an alternative THA design in common use in Australia, and are hypothesised to reduce the risk of dislocation. This trial will compare the outcomes of conventional THA versus DMCs in the FNF population.

We hypothesise that, in a surgical setting for hip arthroplasty, the PENG (pericapsular nerve group) regional block is more effective in reducing post-operative pain than placebo. We propose a study to investigate the effect of the PENG block, compared to placebo in a blinded format The participant, anaesthetist and surgeon will be blinded to the study medication administered. The post-operative pain team, at FMC and Noarlunga known as the Acute Pain Service (APS), will also be blinded. This team routinely follows up all participants who have undergone a hip arthroplasty. They will know that the participant has received a regional technique, but not whether it is with ropivacaine or placebo. Post-operatively, each participant will be visited on the ward by the Acute Pain Service which is a routine part of their care. In this consultation they will discuss their pain levels, pain medication use, and ability to mobilise since their surgery, all part of the standard questions asked by this service. As part of this study, Dr Lin (study investigator) shall post-operatively conduct a series of questionnaires, including one or more of the anxiety, depression and delirium assessments. In addition to this, we shall collect general information from the medical records, which will be kept confidential.

The aim of this study is to confirm earlier studies demonstrating safety and tolerability of inhaled aerosolised ethanol in adult volunteer participants. The ethanol will be administered to the upper and lower airways using a specifically-designed closed-circuit nebuliser system which improves delivery efficiency by minimising escape of volatile ethanol vapor during nebulisation and at the same time meets WHO requirements for safety and protection of nearby personnel from environmental aerosol exposure and exhaled virus particles. Confirmation of safety and tolerability will reassure physicians that inhaled ethanol can be used to treat COVID-19 and other viral and bacterial respiratory infections.

Osteoarthritis is a common joint disorder for which there is no cure. Knee osteoarthritis is the most common form of osteoarthritis. Exercise is a core treatment for knee osteoarthritis. Muscle strengthening exercise has been shown to improve pain and function and is recommended by clinical guidelines. Yoga is a mind-body exercise intervention that can provide increased flexibility, muscle strength, physical balancing, improved fitness, and has demonstrated pain-relieving properties. Yoga, with its potential for improving musculoskeletal function, nervous system, and sympathetic activity, may therefore have greater benefits than commonly used strengthening exercise. Previous studies of yoga in knee osteoarthritis patients have been of low-quality with a high risk of bias and did not perform subgroup analyses to identify patients who may specifically benefit from yoga. This randomised controlled trial aims to compare the effectiveness of the 24-week yoga program vs strengthening exercise (12 weeks (2x/week of group-based + 1x/week of home-based) + 12 weeks of (3x/week) home-based) on knee pain in knee osteoarthritis patients with a priori subgroup analysis of knee osteoarthritis patients with neuropathic pain compared to strengthening exercise. If successful, yoga can be easily implemented as a complementary treatment along with conventional treatment to improve the management of knee osteoarthritis.

Current guidelines in Victoria do not recommend fit testing of N95 respirators (tight fitting face masks). In addition they recommend use of N95 respirators for 4 hours before changing. Therefore we sought to test this as our hypothesis. The purpose of the study was to test the N95 fit test rates after 4 hours of use in a real-world intensive care unit setting to help assess if they adequately protected healthcare workers.

Introduction: Pain is an adverse effect associated with vaccination. Ice may be used to reduce pain. This prospective randomised controlled trial aims to investigate the effect of applying an ice pack prior to immunisation on the outcome of pain in medical students receiving their flu vaccines. Methods and analysis: This double-blinded, multicentre, prospective randomised controlled trial is designed to investigate impact of ice packs in reducing injection-related pain in medical students receiving influenza vaccines. The study will include 90 patients who receive influenza vaccines. An ice pack (0°C) will be applied to the site of injection for 30 seconds in participants randomised to the intervention group (n = 45). A placebo cold pack (10°C) will be applied to those in the control group (n = 45) for the same duration immediately prior to vaccination. A standardised vaccination protocol will be used across both study arms. The primary objective is to test the hypothesis that applying an ice pack will significantly reduce pain in comparison to a cold pack. Secondary objectives aim to assess any potential adverse reactions. The study commenced in January 2019 and is due for completion by December 2020. The main analysis of data will follow the intention to treat principle. The measurement of pain, the primary dependent variable, in each of the two groups will be compared using an independent t-test or a Mann-Whitney U test. Multivariable logistic regression analysis will be used if necessary.

The past two decades have seen an increase in medicinal cannabis research, which has consequently led to a number of countries, including Australia, introducing legislations allowing its use. Research has shown that medicinal cannabis can reduce chronic pain, neuropathic pain, cancer pain, chemotherapy-induced nausea, spasticity in Multiple Sclerosis, epileptic seizures, depression, and anxiety, as well as improve sleep, and reduce opioid prescription numbers. In Australia, it is estimated that more than 15% of the adult population live with persistent chronic pain or recurring pain lasting longer than 6 months. Neuropathic pain is experienced by approximately 8% of the population, and about 86% of patients with Multiple Sclerosis. It is associated with higher rates of unemployment, poor physical, psychological, and social functioning, significantly impaired health-related quality of life (HRQL) and sleep, and higher depression and anxiety than those with other chronic pain, and those without pain. Less than 35% of patients respond to conventional therapy, with others often receiving incomplete pain relief, which is commonly accompanied by conventional treatment-related side effects. Patient reported outcomes (PROs) can include symptoms, function, health-related quality of life (HRQL), and perceptions of treatment. In contrast to life-threatening conditions where survival endpoints may dominate HRQL considerations, PROs play a key role in chronic conditions, and are regarded as the gold standard for the assessment of pain. Collecting PROs with validated and reliable standardised questionnaires also allows comparisons between groups, and over time. Health care professionals need to be able to monitor the outcome of any treatment, and the existing evidence on PROs for medicinal cannabis has limitations such as; small sample sizes, lack of data collected over time, not using validated questionnaires, or not using comprehensive questionnaires for the condition treated. Participants studied under the controlled environment of randomised clinical trials may not always be representative of the entire spectrum of disease and health status seen in the general population currently accessing medicinal cannabis. Therefore, while clinical trials provide evidence of the efficacy of medicinal cannabis, the true gauge of how effective it is in practice comes from real-world evidence. The proposed research will assess quality of life in a large sample of people accessing medical cannabis over a 12 month period, using validated and comprehensive questionnaires relevant to their health condition.

This study aims to find the best dose and route for naloxone to safely reverse the respiratory depression of opioid poisoning. This is a randomised controlled trial where adult patients with opioid poisoning and respiratory depression will receive a 100mcg intravenous bolus of naloxone and either a 1600mcg intramuscular bolus of naloxone or saline placebo. Patients will then be managed along the standard opioid poisoning pathway (where they are closely observed and receive titrated 100mcg IV boluses 5 minutely as required to reverse respiratory depression). We anticipate that the patients receiving the 1600mcg intramuscular bolus will have less recurrence of opioid toxicity and less requirement for a naloxone infusion without having an increased rate of opioid withdrawal symptoms.