ANZCTR search results

This pilot randomised controlled trial aims to evaluate the acceptability and clinical efficacy of a novel, immersive virtual reality (VR) intervention as an adjunct form of analgesia to help manage acute post-surgical pain. It will compare two randomly allocated participant groups, with participants recruited 48 hours after undergoing a surgical procedure under general anaesthesia. The control group will receive usual care (standard pain treatment), while the intervention group will receive usual care in addition to the experimental VR intervention. The intervention involves four sessions of immersive VR, delivered over two days. During each session, the participant is immersed into a virtual environment by wearing a head-mounted display while interacting with a novel VR program using a hand-held controller. Scores of pain severity, pain-related distress, heart rate and the incidence of possible side effects (such a nausea, disorientation and dizziness) will be assessed before and after each VR session. At the completion of the study intervention period, participants will complete a study-specific questionnaire rating their satisfaction and acceptability of the intervention. Their use of pharmacological analgesia (as part of usual care) during the two-day study period will also be measured.

Objective: to determine the impact of a letter encouraging patients to visit their GP on increasing appropriate statin re-initiation Hypothesis: the letter will significantly increase statin re-initiation over 6 months compared to no letter among individuals who have previously discontinued statin therapy.

Insomnia or difficulty falling and/or staying asleep is experienced by 30% of the general population. Medicinal cannabis has been shown to improve sleep quality, length, and associated quality of life. This randomised cross-over double-blind placebo-controlled study of 6 weeks duration aims to assess the tolerability and effectiveness of a medicinal cannabis oil on sleep in adults with insomnia.

Historically, the management of knee OA has been variable, and often limited to pharmaceutical management and total joint replacement. Recently, evidence-based recommendations for the management of knee OA have been developed by scientific societies and health organisations. Best-practice guidelines for the treatment of knee OA focus on conservative (non-operative) multidisciplinary management that encompasses education, exercise, lifestyle modification and weight-loss where relevant, while promoting self-management. This body of evidence demonstrates that multidisciplinary conservative management of knee OA is efficacious. However, conservative management can only be efficacious if it is implemented into everyday clinical practice. This pilot project aims to test the feasibility of implementing a physiotherapy led, multidisciplinary model of care for the management of knee osteoarthritis in community practice.

Who is it for? You may be eligible for this study if you are 18 years or older, and have been diagnosed with a “Malignant Hilar Biliary Stricture” (or MHS), and require a stent. Purpose of the Study To assess two types of established stent placement techniques: Stent-By-Stent (SBS) and Stent-In-Stent (SIS). They will be compared in terms of stent patency, technical success, and complication rates, which will be assess at the end of the procedure day, and two follow-up visits. Study Details All participants will undergo an Endoscopic Retrograde Cholandio-Pancreatography (or ERCP). This is performed under sedation, and you are not likely to feel the entire processs. The ERCP procedure uses a thin tube with a camera which passes into your throat so we can have a better view of your gastrointestinal tract. The scope will travel down into the place where the bile duct meets the small intestine. A special dye will be injected into the affected bile ducts and an x-ray will be used to watch the flow of the dye to see where the blockage is. Then the stents will be put inside the relevant bile ducts using small guide-wires. Once the stent is inserted in the right place the wire is removed, and the bile duct will be unblocked and should drain normally. Because of your condition, you will require two stents placed in the ‘left’ and ‘right’ hepatic ducts within the liver. If you agree to participate, you have an equal chance of being randomised to receive one of the two stent placement techniques; SBS or SIS. (1) For the SBS group, two separate guide-wires will be fed into the left and right bile ducts at the same time. The first stent will be deployed into the left duct, and then the second stent will then be deployed into the right duct, and the guide-wires are removed. (2) For the SIS group, the first guide-wire will be fed into the left or right duct, and the stent will then be deployed and the guide-wire will be removed. Then, the second guide-wire will pass through the mesh of the first stent, into the remaining duct, and the second stent will be deployed while sitting through the first stent (creating a “Y” shape). You will be asked to attend a review visit with the investigator at 3 months and 6 months following your procedure. Your ongoing treatment and follow up will then be planned by your treating practitioner. We are particularly interested in investigating the choice of placement with a type of metallic stent, which has shown superior patency to plastic stents in recent studies. However, it is not clear which type of placement is favoured for metal stents for MHSs. We hope this research will help provide further information on the safety and usefulness of stent insertion techniques of MHSs and potentially other gastrointestinal disorders that require stents

DOSE-UP will bring us closer to understanding what the optimal dose of upper limb therapy to delivery to people after stroke. Our project will identify the maximum tolerated dose regimen (MTDR) of upper limb therapy at two different recovery points after stroke. The early in recovery subgroup will recruit participants 3 to 14 days post stroke and late in recovery subgroup will recruit participants 3 to 24 months post stroke. At time of consent, participants will be allocated a dose of therapy to test, and their response will determine the dose to be tested with future participants. We expect this study to provide answers to the question, what is the tolerable dose of upper limb training and support better development of intervention protocols for testing with stroke survivors in clinical trials.

Research Question Hip and/or groin pain is common in young and middle-aged people, and may represent hip osteoarthritis (OA) in its early stages. These people have persistent pain, difficulty participating in work and functional activity and have worse quality of life compared to healthy people. This is at a time of peak work and family commitments. Improving the capacity of these individuals to participate fully in work and functional activity will have large positive personal and societal benefits. If modifiable risk factors associated with pain, quality of life, functional and work participation limitations are identified in the early stages of hip OA, the impact of the disease could be reduced. This study aims to establish modifiable risk factors associated with worsening of pain and quality of life in people aged 18-55 years with hip and/or groin pain Methodology This prospective longitudinal cohort study will be conducted in Tasmania, Australia. 100 people aged 18-55 years with hip and/or groin pain, fulfilling eligibility criteria will be recruited. Participants will undergo baseline radiographs, clinical and demographic assessment and complete patient-reported outcome measures. Participants will be followed up at 6 and 12 (primary endpoint) months. Modifiable risk factors at baseline that predict increase in pain and worsening of quality of life (primary outcome) and changes in physical activity, sports participation, work participation and progression to hip surgery (secondary outcomes) at 6 and 12 months will be determined. Signficance of the project to physiotherapy This information will assist physiotherapists and other health professionals in providing targeted rehabilitation programs, and will enable informed decisions regarding resource provision to optimise future health care.

This study of ultramicronized PEA (particle size between 0.6 and 10 µm) will investigate the safety, tolerability, PK of single and multiple ascending doses of ultramicronized PEA compared to placebo in healthy subjects. The effect of food on the absorption of the ultramicronized PEA will also be assessed..

In this randomised, double-blind, placebo-controlled study, 105 adults experiencing mild-to-moderate anxiety/stress will be randomly assigned to receive tablets containing a daily dose of either Echinacea angustifolia (40mg) (LOW DOSE), Echinacea angustifolia (80mg) (HIGH DOSE), or placebo for 6 weeks. We will assess changes in symptoms through the completion of validated questionnaires assessing anxiety, mood, quality of life, and sleep.

This study is an open-label, single-arm study in which each subject will serve as his/her own control. The study will assess the effect of DCP treatment on ascites formation in cirrhotic subjects with RA, by examining the frequency of LVP and the volume of ascitic fluid drained. All subjects will participate in a Dose exposure assessment visit, followed by a 90 day open label treatment period, followed by a 90-day follow-up period of additional data collection from medical records. Ascites history (relevant medications, LVP dates, and volume of drained fluid) for the 90 days prior to treatment and the 90 days after treatment will be collected and used for comparison with on-treatment frequency and volume. The study will be conducted in two parts. At the start of the study, subjects will be enrolled into Part A. When a sufficient number of subjects have been enrolled into Part A to provide information about preliminary efficacy, safety, and exposure, additional subjects will then be enrolled into Part B.