ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33057 results sorted by trial registration date.
  • Does The Explanation of Tendon Sensitivity Affect Pain and Function in people with Achilles Tendinopathy?

    Contemporary thinking suggest that pain may be enhanced by the messages that health practitioners convey to patients in their initial meeting as they have been shown to have a strong influence upon their prior beliefs . Despite there being a very weak relationship between observable tissue pathology and symptoms research suggests that clinicians commonly use tissue based structural descriptions to explain clinical status in people with persistent musculoskeletal pain problems . The aim of this study therefore is to examine the instantaneous effect of diagnostic messaging on pain and function in people with AT. To achieve this, we will assess pain and leg stiffness with hopping in people with AT before and after a standard diagnostic discussion that includes discussion of tendon pathology and compare these results with participants who receive a diagnostic explanation that does not reference tendon pathology.

  • The effect of an immediate pre-operative haemoglobin blood test on hip fracture patient outcomes: A before and after cohort study

    In patients with hip fracture, low haemoglobin (Hb) levels are associated with post-operative complications, mortality, and increased hospital Length of Stay (LOS). A pre-operative Hb is taken on admission to the Emergency Department at Sir Charles Gairdner Hospital (SCGH). At the time of surgery, admission Hb levels may not be reliable indicators of current patient Hb status due to continual acute fracture-related blood loss, haemo-concentration and delays to surgery. This cohort study will investigate if an intervention of an Hb test immediately before surgery will improve patient outcomes. We will compare outcomes between 300 prospective patients and 300 retrospective patients. The outcome measures include hospital LOS, use of blood transfusions, Post-Anaesthetic Care Unit LOS, post-operative complications, admission to critical care areas, and survival to discharge. We foresee the results of this study may improve patient outcomes.

  • A wellbeing and performance enhancement program for Professional Dancers

    There continues to be a culturally embedded perspective that performing artists may need to “suffer for their art” and often wellness and artistry are treated as if they are unrelated. This randomised controlled trial will compare the effect of a 7week wellbeing and performance enhancement program with mindfulness, to a waitlist control group who receive the education only (without the mindfulness component), for Professional Ballet Dancers employed at The Australian Ballet. Dancers will be asked to complete electronic questionnaires and semistructured interviews in addition to completing the wellbeing program.

  • Lignocaine versus Opioids in Coronary Intervention: Assessing Antiplatelet Activity and Ticagrelor Levels (LOCAL) study

    This randomised study will evaluate the efficacy of intravenous lignocaine as an alternative analgesic in patients undergoing percutaneous coronary intervention to fentanyl which is standard of care. The rationale behind this study relates to multiple biochemical studies demonstrating delayed absorption of antiplatelet agents when opioid analgesia is administered. Furthermore, these studies demonstrate that by delaying gastric absorption, the antiplatelet effects of ticagrelor based on platelet function are also delayed. Retrospective analysis of large clinical studies suggest poorer clinical outcomes in patients treated wtih opioid analgesia. Patients admitted and consented for coronary angiography will be recruited from The Alfred Hospital, Victoria. Patients presenting with STEMI, cardiogenic shock, out of hospital cardiac arrest, previous opioid or P2Y12 administration, coagulopathy or allergy to opioids or lignocaine will be excluded. Patients undergoing percutaneous coronary intervention will be randomised to receive either lignocaine or fentanyl as follows: For patients allocated to lignocaine: - Lignocaine 1mg/kg (maximum dose 100mg) will be given as a bolus at the start of the case - During the case, if analgesia is required a further bolus of 0.5mg/kg will be given. - If satisfactory analgesia is not achieved then patient will crossover to fentanyl arm - Total lignocaine dose will be recorded For patients allocated to fentanyl: - If under 70 years of age 0.75mcg/kg of Fentanyl IV will be given at the start of the case. If >70 years of age 0.5mcg/kg will be given at the start of the case. - Further IV fentanyl boluses can be given at the discretion of the interventional cardiologist if further analgesia is required during the case - Fentanyl IV 0.5mcg/kg mcg will be given at the end of the case at the time of administration of ticagrelor. Study endpoints will evaluate the efficacy of intravenous lignocaine in terms of analgesic efficacy and assess the interaction in terms of platelet function studies and pharmacokinetic analysis. This will determine if lignocaine is a safe, effective alternative analgesic which does not interact with antiplatelet agents.

  • A randomised controlled trial comparing video-assisted informed medical consent to traditional doctor patient consent for Mohs micrographic surgery.

  • An investigation of new methods to improve body image among people with eating disorders

    This study is to investigate the effectiveness of Imagery Rescripting (IR) in treatment eating disorders. It is common for people with eating disorders to report that memories of early negative experiences related to their body or eating (e.g., being teased about weight), or even unrelated to their body or eating (e.g., being rejected by a friend), are still relevant to how they feel emotionally about their body and eating today. With the use of IR, we go back in our imagination to experience the past event from a new perspective. We hypothesized that eating disorders treatment is more effective in decreasing disordered eating behaviours and improving body image among people with an eating disorder than with IR is used as a treatment adjunct.

  • Rotational Thromboelastometry (ROTEM)-guided blood product in patients with cirrhosis undergoing invasive procedures

    The aim of this project is to examine the role of a ‘global’ coagulation assay called Rotational Thromboelastometry (ROTEM) in the guidance of prophylactic blood product in patients with liver cirrhosis undergoing invasive procedures. Currently available laboratory tests (such as platelet count, International Normalised Ratio (INR) and activated partial thromboplastin time (aPTT)) are suboptimal for the assessment of bleeding risk in patients with chronic liver disease. These tests may overestimate the risk of bleeding, and their use may result in unnecessary transfusion of blood and coagulation products, exposing the patients to risk of serious adverse events and potentially overuse of scarce blood products. During the past few years, ‘global’ coagulation tests such as ROTEM have been developed to provide an overall measurement of the clotting system. These point of care tests provide quick results and have been used to assess coagulation and better guide blood product transfusion in a number of surgical and trauma multi-transfusion settings. However, the value of these global tests in predicting bleeding outcomes and guiding blood component transfusion in liver disease has not been well studied. We plan a multi-centre randomised-controlled trial (RCT) examining ROTEM-based decisions to guide FFP and platelet use in patients with cirrhosis undergoing invasive procedures. We hypothesise that using ROTEM to guide blood product delivery in this setting, will lead to reduced usage of blood products whilst maintaining optimal clinical outcomes.

  • The effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in chronic non-specific low back pain: a pilot randomised controlled trial

    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.

  • A Pilot Randomised Controlled Trial of Cognitive Behavioural Therapy for Insomnia (CBT-I) and Imagery Rehearsal Therapy (IRT) for Ex-Service Personnel with Insomnia and Nightmares in the Context of Posttraumatic Stress Disorder (PTSD) and Obstructive Sleep Apnoea (OSA).

    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.

  • Does Visualisation Affect Pain and Function in people with Achilles Tendinopathy?

    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.

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