ANZCTR search results

The purpose of this study is to identify whether spinal analgesia with intrathecal morphine alone is superior to spinal analgesia with intrathecal morphine combined with intrathecal clonidine and bupivacaine for patients undergoing major abdominal surgery. Who is it for? The study will include adult patients undergoing liver and pancreatic resection surgery. This is a retrospective study to test the hypothesis that the intrathecal morphine combined with clonidine and bupivacaine results in reduced postoperative opioid use and enhanced postoperative analgesia and recovery in patients undergoing major liver and pancreatic resections using a standardized enhanced recovery after surgery (ERAS) protocol. Study details The aim of this study is to quantify the cumulative oral morphine equivalent daily dose in milligrams (oMEDD) in the postoperative period and evaluate maximum pain scores at rest and on movement after surgery. It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the use of intrathecal morphine in patients undergoing major liver and pancreatic surgery.

Peripheral artery disease (PAD) involves blockages in the leg arteries, leading to exertional lower-limb pain and reduced physical capacity and quality of life. Supervised exercise therapy is an effective treatment for impaired walking due to peripheral artery disease. However, availability and uptake of supervised exercise therapy is limited, perhaps due to the requirement to attend a central facility. The TEAL trial is a multi-centre, prospective, parallel-group, randomized controlled and assessor-blinded trial. 236 eligible participants with peripheral artery disease will be recruited and consented to the study. In this randomised controlled trial (RCT) the effectiveness and acceptability of TEAL is compared to usual care. Participants will be randomly allocated to one of these groups for 6 months: TEAL, a supervised home base exercise program delievered using telehealth. AEPs will supervised patients and use worn accelerometer to monitor exercise behaviour. The usual group will receive monthly telehealth contact which are unrelated to exercise The primary outcome is maximium distance walked during a six minute walk test. Secondary outcomes include health-related quality of life (HRQOL), cardiovascular risk factors, engagement with the program, and participant satisfaction assessed by a survey and, in a sub-set of participants, through interviews.

Diabetes-related foot disease (DFD), such as ulcers, infection or gangrene, causes ~30,000 hospital admissions and ~4,500 amputations (the highest global amputation rate) at a cost of ~$2 billion a year in Australia. The key risk factors leading to DFD are driven by hyperglycemia, high blood pressure and dyslipidemia. Tele-DFD is a one-year prospective, randomised, multi-centre trial aimed to improve modifiable risk factor control measured based on improvement in DFD-score following Tele-DFD intervention. 142 participants with moderate or high risk of diabetic foot disease will be consented and recruited to this trial. In this RCT, usual care is compared to Tele-DFD with participants randomly allocated to one of the following groups: Usual care, where participants will receive standard care by participants' general practitioners for regular clinical monitoring, endocrinologists for risk factor control, and face-to-face consulting in the outpatient clinics for support and ongoing monitoring of patient’s health and prognosis. Tele-DFD will use an integrated multi-disciplinary approach via a technology-facilitated prevention program consisting of remote medical management, remote footwear management and foot health monitoring, education and behaviour change support to optimise DFD risk factors. The primary outcome will be a change in DFD score with secondary outcomes looking at quality of life, participant engagement and satisfaction, cardiovascular event and DFD complications

With improving developments in technology rehabilitation, use of technology devices and modalities are becoming more integrated into clinical practice. While there is good evidence for robotics and virtual reality in rehabilitation for improvement of sensorimotor outcomes (e.g. strength, range of motion) of the arm, evidence gaps persist for translation to functional outcomes which continue to be poor. Further, majority of research to date has focused on single-technology modality use (e.g. stand-alone robotics or virtual reality focus only) with little comparative research on sensor-based therapy as an emerging technology enabler for upper limb rehabilitation. This randomized controlled trial will test efficacy of a combination of robotics, virtual reality and sensor-based therapy used for upper limb rehabilitation for inpatients with neurological deficits compared to usual care and will explore feasibility in a hospital setting. It is hypothesized that hybrid technology-enabled upper limb rehabilitation is feasible within a hospital setting, will lead to better therapy intensity and functional outcomes for the upper limb compared to usual care and that participants will show satisfaction for this novel therapy.

This study is an open-label, Phase I safety and feasibility trial, named 'hrtDCS-Attention'. We aim to evaluate whether 10 weekdays of home-based, remotely supervised transcranial direct current stimulation (tDCS) for 20 minutes during attention training is feasible and tolerable in children aged 8-18 years with acquired brain injury. tDCS will be applied once daily on the scalp, over the left and right prefrontal cortex. Participants will be randomised to one of two trial arms, to receive either (1) 1 mA of tDCS or (2) 2 mA of tDCS. Participants will be blinded to which dose they have been assigned to. 15 participants will be assigned to each group, for a total of 30 participants in hrtDCS-Attention. The first hrtDCS-Attention session will take place in the clinic to ensure initial tolerability, provide information about the home sessions and training to conduct them, and answer any questions from participants. HD-EEG and other baseline neurocognitive outcomes will be recorded. After the first session, participants will conduct hrtDCS-Attention sessions at home using remote supervision (i.e. through video call) to ensure correct use of the device, adherence to the protocol, safety and support. As well as receiving prior training by tDCS personnel, participants will be given an information guide to use tDCS from home. hrtDCS-Attention will occur from Monday to Friday for two consecutive weeks for a total of 10 sessions. Participants will return to the clinic on tDCS Day 10, where the final (10th) session will take place in clinic, together with an EEG and neurocognitive outcomes. Follow up assessment at 1- and 4-weeks post-tDCS will be conducted remotely. The primary outcome is feasibility and tolerability, measured by sensations recorded during tDCS sessions, compliance to tDCS sessions, and the participant/family's views or comments about the sessions. We will also assess preliminary efficacy, according to changes in reaction time across the 10 days of tDCS and change in functional brain connectivity between baseline and day 10 of tDCS.

This study aims to investigate the effects of a resistance exercise program on the self-esteem, mental health and self-efficacy of people living with cancer. Who is it for? You may be eligible for this study if you are an adult ages 18 years or older, you have been diagnosed with any type of cancer, including metastatic or widespread cancers and you have received approval from your primary care doctor to complete an exercise program. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three treatment groups. Participants who are allocated to the first treatment group will start the exercise program within 1 week of enrolling in the study. The exercise program will involve attending 3x 1 hour sessions per week for 6 weeks (Monday, Tuesday & Friday). These sessions will be delivered one-on-one between participants and an accredited exercise physiologist who will create a personalised exercise regime for each participant and supervise them during each session. Exercises may involve repeated muscular contractions using weights, resistance bands, exercise machines, or participants' own body weight. Participants who are allocated to the second treatment group will not start their exercise program until 6 weeks after enrolling in the study. Participants who are allocated to the third treatment group will not start their exercise program until 12 weeks after enrolling in the study. During the waiting period, participants in both of these groups will be able to continue with their current exercise routines (if they have one). The exercise program will then be delivered to both of these groups in the same manner as for participants in the first treatment group. It is hoped this research will determine whether a resistance exercise program has a positive impact on the mental health, self-esteem and physical wellbeing of people living with cancer. If this study shows a positive impact on participants' wellbeing, it may be expanded to a larger number of hospital locations so that a greater number of people living with cancer may undertake this program as part of their usual care.

Endometriosis is an oestrogen-dependent, chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterus in the form of lesions, affecting around 1 in 9 women and those assigned female at birth in Australia (~830,000 people) and has no cure. My research has shown that patients often have to make impossible choices between being in pain, and the worry of dependence, addiction and impairment due to the current drug choices. Effective pain relief with a low to negligible risk of addiction is the holy grail for people with endometriosis. Various phytochemicals (mainly cannabinoids) from Cannabis spp have well described analgesic, anti-inflammatory, anxiolytic, anti-depressant and anti-emetic actions. Cannabis use in other chronic pain conditions has resulted in “substitution” of pharmaceuticals, commonly opioid analgesics, by cannabis. Our previous research has shown that women with endometriosis in Australia and New Zealand are using cannabis, mostly from illicit sources, to manage their pain and other symptoms. We hypothesise that usage of either CBD isolate alone or in combination with THC containing canabis flower will reduce pelvic pain severity, and presentations to the emergency department. The primary aim of this project is to determine the feasibility, safety and acceptability of two different medicinal cannabis interventions in people with endometriosis

The primary aim of this study is to investigate the benefits of three sessions of imagery rescripting (ImR) compared to a waitlist control for depression. The secondary aim is to investigate the proposed mechanisms of action (i.e., negative interpretations of intrusive memories, depressive rumination, early maladaptive schemas and schema modes) that underpin ImR for depression. Participants in the treatment group will begin the intervention immediately, and their results will be compared with a waitlist control condition who will receive the same intervention after a three-week wait period.. Outcome measures will be administered at baseline, post treatment and 1-month follow-up. Based on existing studies of ImR for depression, and ImR for other disorders, it is hypothesised that: 1) ImR will be more effective in reducing symptoms of depression than waitlist control at post-treatment and follow up; and 2) ImR will yield greater improvements in negative interpretations of intrusive memories, depressive rumination, early maladaptive schemas and schema modes, compared to waitlist control.

Cancer patients often experience inflammation, which is thought to be associated with cancer development and progression, as well as being linked to side effects experienced during and after treatment. As exercise is known to have an effect on systemic inflammation, the aim of this project is to investigate the effect of exercise intensity on markers of inflammation in patients with cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with any cancer type, and are 3-12 months post-completion of primary cancer treatment with curative intent. Study details Participants who enrol in this study will be randomly allocated by chance (similar to flipping a coin) to begin with 2 weeks of either low- or high-intensity exercise involving stationary cycling. Participants will complete 3, 25 minute (total time required per visit: 1 hour) exercise sessions per week (i.e. 6 sessions in total) supervised by an accredited exercise physiologist. After completing the 2-week program, participants will take a 6-week break before switching over to the other intensity for a further two weeks. Blood samples and tests of muscle pain will be performed before each 2-week exercise period, after the first session of each exercise period, and at the end of each 2-week exercise period. It is hoped this research will help us to determine the intensity of exercise that best reduces markers of inflammation in cancer patients, with improvements in cancer pain.

Rationale: Transradial access for coronary angiogram is now standard for coronary angiography. It requires a guidewire to be directed up the radial artery to the aortic root to allow safe mobilization of catheters over it into the aorta to complete the procedure. The traditional guidewire made for femoral angiograms and predating transradial angiography is the peripheral 0.035” fixed core PTFE J-tipped wire (FC0.035) with a 3mm J tip curve radius. Radial arteries are smaller than femoral arteries and typically range from 2.2mm in diameter in women, to 2.7mm in men, both smaller than the J tip curve radius of 3mm in the FC0.035 wire which may predispose to radial spasm or vessel trauma. The hydrophilic J tip ‘baby J’ guidewire with a 1.5mm J tip radius has been designed to traverse areas of radial tortuosity and stenosis easier aiming for less spasm to improve success of passing catheters to the aortic root and is commonly used in coronary angiographic suites second line. However, the FC0.035 wire is still the traditional wire used in transradial coronary angiography, and direct comparison of their procedural success has not been studies to date. If indeed the baby J wire was demonstrated to have a higher success rate in gaining access to the aortic root compared to the FC0.035 wire, it would lead to less wire changes, and less need for alternate arterial punctures and subsequent predisposition to further vascular complications. If this were the case it would suggest it the baby J wire should be considered for use first line in transradial coronary angiography. The objective of this study is to determine if use of the baby J guidewire in transradial coronary angiogram has any difference in technical success compared to the traditionally used FC0.035” wire. The study design is a prospective randomised controlled trial with intention to treat analysis. The study population consists of Participants undergoing best practice coronary angiography or percutaneous intervention at Gosford District Hospital who consent to become enrolled in the trial. At least three hundred and ten Participants are aimed to be enrolled over 12 months. The main study endpoints include the primary outcome of technical success rates between guidewires. Secondary outcomes include crossover to alternative peripheral wire, crossover to alternative access site, bleeding rates (BARC criteria), vascular complications (VARC 2 criteria), radial spasm, haematoma formation (EASY criteria) time to wire entry of subclavian, aorta, and selective coronary intubation.