ANZCTR search results

The primary aim is to determine the safety, feasibility, and efficacy of the Wim Hof Method (WHM) for the treatment of pain associated with endometriosis. The study will measure self-reported pain and biological markers of inflammation. Objectives include assessing the impact of WHM on pelvic pain, psychological status, endometriosis lesion characteristics, autonomic nervous system, endocrine system responses and innate immune system responses.

All the patients with Rett Syndrome, previously on CBDV as part of the phase I trial, will be offered transition to Epidyolex, with monitoring for change in seizure frequency and severity, sleep behaviours and emergence of withdrawal symptoms. The study hypothesis is that patients with refractory epilepsy and Rett syndrome will respond to CBD (similar seizure frequency, seizure severity) when transitioned from CBDV.

Musculoskeletal pain is the second leading cause of disease burden in Australia and there is a need to investigate new models of care to cope with increasing demand on health services. This randomised controlled trial (RCT) will investigating whether a physiotherapist-led triage and treatment service is non-inferior for improving function at 6-months, and superior for reducing waiting times, compared to usual clinic-based care for adults with musculoskeletal pain referred to public hospital outpatient physiotherapy clinics. 368 participants (184 per arm) will be recruited from six public hospitals located in metropolitan Sydney, Australia. Adult patients will be eligible as new referrals (referred within the last 6 weeks) to a public hospital physiotherapy outpatient clinic with a musculoskeletal condition or musculoskeletal pain typically managed with physiotherapy. Example referrals include but are not limited to; back or neck pain, osteoarthritis, whiplash-associated disorders, ankle sprains, rehabilitation post-orthopaedic surgery, sporting injury (e.g. ankle sprains). Eligible patients will be randomised to either physiotherapist-led triage and treatment service or usual clinic-based care. The physiotherapist-led triage and treatment service group will be matched to different modes and types of care based on their risk of poor outcome (as assessed by the Keele STarT MSK tool), presence of potential non-progressive radiculopathy or requiring post-operative rehabilitation. The low-risk group will receive a telephone call, the medium risk group will receive telehealth (videoconference) physiotherapy and the high-risk group will receive clinic-based physiotherapy tailored to their presentation. Participants randomised to the usual care group will be offered a course of clinic-based (in-person) physiotherapy as is usually provided at the participating public hospital clinics. Clinic-based physiotherapy may include a combination of any advice and education to support self-management (e.g., advice to exercise, modify activities, lose weight, or take simple pain medications if needed), exercise tailored to patients’ activity goals and level of function, graded activity, graded exposure, and manual therapy. The co-primary outcomes are physical function as assessed by the Patient Specific Functional Scale (PSFS) at 6-months post-randomisation and treatment waiting time (from randomisation to first treatment). Secondary outcomes (e.g. physical function), health resource use (e.g. number of appointments), potential mediators (e.g. pain self-efficacy), process measures (e.g. adherence) and additional outcomes (e.g. harms) will also be assessed.

Most children with cerebral palsy (CP) have a speech difficulty called dysarthria, which makes their speech unclear and difficult to understand. Sometimes dysarthria is so severe that the child is unable to speak at all. Dynamic Tactile Temporal Cuing (DTTC) is a motor speech intervention designed for young children with severe motor speech disorders including childhood apraxia of speech (CAS), a similar condition to dysarthria in CP. DTTC focusses on learning how to move the muscles required for speaking while learning to say words. This may be particularly suitable for children with CP and dysarthria, as CP is primarily a disorder of movement so the individual has difficulty is in moving and coordinating muscles, including the muscles used for speech. This study aims to investigate if DTTC improves speech clarity and intelligibility, leading to increased participation in conversations, and if these improvements last beyond therapy. We will also explore the perspectives of he parents/ guardians and the speech pathologists with DTTC via semi-structured interviews and a questionnaire. If the study confirms that DTTC improves speech, we will conduct a larger, externally funded study. This research aims to improve the lives of these children by enhancing their communication abilities and overall participation in daily conversations.

Post-concussion syndrome (PCS) impacts the injured and their families. Symptoms can occur at the time of injury or may be delayed and develop some time after the initial injury. Standard care for people with PCS includes sub-threshold exercise. Evidence also exists for the use of vestibular rehabilitation and manual therapy (mobilisation and manipulation of the neck and spine) in the management of PCS. As active management is becoming the preferred approach for patients with PCS, the aim of this study is to assess the feasibility of administering two combinations of active interventions to people with PCS: vestibular rehabilitation with exercise and manual therapy with exercise. The study will recruit 30 participants between the ages of 18 and 50 with sports-related PCS. Participants will be randomly allocated to one of three groups: exercise only; exercise plus vestibular rehabilitation; or exercise plus manual therapy. Participants will receive 8 intervention sessions over a 4-week period at the rate of 2 sessions per week. Outcome measurements will be administered at baseline,4, 8 and 12 weeks post-intervention.

Perceptual decision making is a fundamental cognitive process whereby sensory information is converted into meaningful perceptual interpretations of the environment for action. At a synaptic-level, the components of the decision process rely on a complex neuropharmacology, but the specific role of signalling pathways in supporting perceptual decisions is not well understood. Ketamine disrupts the brain's primary excitatory neurotransmitter, glutamate, by blocking glutamate receptors. This project will investigate the neuropharmacological basis of perceptual decisions by characterising the impact of glutamate challenge on key electrophysiological signatures of the decision process.

Caring for patients with behavioural concerns in the Emergency Department (ED) is a common occurrence. The aim of this project is to test the feasibility of the addition of the Emergency pharmacist to a multidisciplinary BOC response team. This will be a pilot un-blinded randomised controlled trial comparing EM pharmacist attendance at BOC calls versus standard care. It is expected that the pharmacist will provide additional resources for adherence to the guidelines, reducing subsequent distress and agitation.

Collaborative Assessment and Management of Suicide (CAMS) is a psychological therapy that outperforms other active interventions in reducing suicidal ideation, improving distress and hopelessness, reducing treatment disengagement and higher consumer satisfaction. Only two trials have investigated CAMS delivered within inpatient settings and neither have been conducted in Australia. Within this context, the aim of this study is to investigate whether it is feasible to deliver CAMS in the Australian inpatient setting, whether the treatment is acceptable to consumers and clinicians and ensure outcomes are in line with what would be expected. CAMS may be a good fit for Australian psychiatric inpatient settings, but the relevance and feasibility of this approach is yet to be established here.

This multi-method evaluation will assess the feasibility, acceptability, and effectiveness of a caregiver wellbeing program delivered by CaFHS in South Australia. The caregiver wellbeing program will deliver evidence-informed caregiver wellbeing psychoeducation into these routine services. Our evaluation aims to determine whether the caregiver wellbeing program is feasible and acceptable to deliver within these routine services and whether it is effective in improving the wellbeing of caregivers. To achieve our aims, we will conduct pre- and post- program surveys and post-program focus groups with caregivers who participated in the program, and staff who were involved in implementing or delivering the program. To support and evaluate a future statewide roll out, this study will also evaluate the feasibility of conducting a definitive trial.

This study aims to determined if a 3 week treatment using the Niagara® Cycloid® massage pad has an impact on chronic unilateral chronic oedema/lymphoedema of the legs arising because of treatment for cancer. Who is it for? You may be eligible for this study if you a patient clinically diagnosed with chronic oedema/lymphoedema (arising from treatment for cancer) of one leg, more than 1.5 years duration but less than 10 years, either Overweight or moderately obese. Study details Participants who meet the eligibility criteria in this study will be randomly selected to be part of one of two treatment groups: Group 1: participants will continue with their usual treatment for their oedema/lymphoedema, or Group 2: participants will use the massage pad for 3 weeks at home. Participants will then be followed up at 7 timepoints via ultrasound, questionnaire and other assessments for up to 1 month after completion of the 3 week intervention period. It is hoped that this treatment will primarily help reduce fluids in the affected leg, resulting in reduced pain and tension and heaviness as well as making the limb smaller.