ANZCTR search results

Osteoarthritis (OA) is a major and costly cause of chronic musculoskeletal pain and disability in Australia. Patient self-management strategies are urgently needed. In knee OA, increased joint loading (forces acting across the joint) leads to worse knee pain and progressive structural joint deterioration. This project will investigate the impact of daily cane use, an easy and inexpensive self-help tool known to unload the knee, applied for 3 months on bone marrow lesion size on MRI in people with medial knee OA.

The Circle of Security parent DVD training is an 8-week relationship-based group program designed to enhance the parent-child relationship and attachment. We aim to examine the effectiveness of the DVD-based program for enhancing the parent-child relationship with multiproblem families, as well as improve other symptoms, such as parental mental health, and child internalizing and externalizing symptoms. Given the suggestion that group-based interventions may not be suitable for at risk families, we will examine the suitability of modifying the DVD protocol for use on an individual basis. Participants will be parents with a child aged 12-months to 6-years. Parents will be randomly assigned to one of two groups: (1) Circle of Security intervention or (2) supported waitlist control. The intervention group will complete the 8-week COS protocol involving one weekly 1-1.5 hour session with a trained Circle of Security facilitator. Parents in the waitlist control group will receive weekly supportive phone contact.

Depressive disorders in adolescents are common, disabling and at times life-threatening conditions. Safe and effective biological treatments are few. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive intervention, in which a potent and brief magnetic pulse is generated by an external coil applied to the scalp. rTMS has a remission rate when used in depressed adults of 30% to 40%. The Food and Drug Administration (FDA) approved rTMS for use in depressed adults in 2008. While rTMS has been shown to be safe and effective in adults, there is very limited information about the safety or efficacy of rTMS in depressed adolescents. This is a pilot study to explore the safety and effectiveness in the use of rTMS for adolescents with Major Depressive Disorder. In the proposed study, we will investigate the relative efficacy of low frequency right-sided rTMS compared with high frequency left-sided rTMS for depressed adolescents. It is hypothesized that left-sided high frequency TMS and right-sided low-frequency TMS will be of similar therapeutic benefit in the treatment of adolescent patients with Major Depressive Disorder. It is believed that there will be minimal side effects with overall benefits in depressive and anxiety symptoms. The study will involve 40 adolescent participants with MDD diagnosed by a trained clinician. The 40 participants will be randomly allocated to one of either low frequency right-sided rTMS (20 subjects) or high frequency left-sided rTMS (20 subjects). Both groups of subjects will receive daily treatment for 5 days per week, over 4 weeks (20 sessions) with the respective treatment. Following initial treatment, responders to this will be followed up following treatment and one month after the end of treatment with Children Rating Scale Revised.

Preterm birth (<34 weeks’ gestation) increases the risk for impairments in physical, mental health and academic functioning in children compared with term controls, with approximately 50% of preterm children affected. An estimated 40% of mothers of preterm infants report significant symptoms of depression, and many parents report an ongoing negative influence of preterm birth on family functioning. This important pilot study will evaluate the efficacy of the first web based intervention designed to promote child development and parental mental health for parents with infants born <34 weeks’ gestation. The primary aim of this randomised controlled trial is to assess the efficacy of a web-based intervention (e-prem) compared with standard care on child cognitive development at 24 months’ corrected age. Secondary outcomes of child behaviour and parent mental health will be compared between groups. e-prem is a web-based program with age-dependent content completed by parents from birth (starting in the neonatal intensive care unit) to the child’s first birthday (corrected). The program includes activities, resources, and an individualised fortnightly-monthly session over the phone. This study will recruit 100 infants born <34 weeks’ gestation (and their primary caregivers) from the Royal Women’s Hospital in Melbourne, Victoria. Families will be randomly allocated to either the intervention group and participate in the e-prem program, or control group and receive standard care. Child cognitive development will be assessed at 24 months’ corrected age. Primary caregivers will complete questionnaires on symptoms of anxiety and depression at recruitment, when infants are 12 months’ corrected age (post-intervention), and 24 months’ corrected age. Primary caregivers will complete questionnaires on child social-emotional development at 24 months’ corrected age. The parent-child relationship will be assessed at 12 months' corrected age. Program costs will be calculated. Outcomes will be compared between intervention and control groups.

The study is evaluating the safety, tolerability, and immunogenicity of ABP 710 in healthy subjects compared with US Food and Drug Administration (FDA)-licensed Infliximab and European Union (EU)-authorized Infliximab. Who is it for? You may be eligible to join this study if you are a healthy male and female subjects 18 to 45 years of age, inclusive. Non-Japanese subjects will have a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Japanese subjects must be first- or second-generation Japanese and have a BMI of 18.0 to 25.0 kg/m2, inclusive. Trial details Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group will receive 5mg/kg of ABP 710 (100mg vial) intravenously once only. Participants in the second group will receive 5mg/kg2 of FDA-licensed Infliximab (100mg vial) intravenously. Participants in the third group will receive 5mg/kg2 of EU-authorised Infliximab (100mg vial) intravenously. All participants will be followed-up at 57 days post allocation to one of the three drugs used in this trial.

Spinal cord stimulation (SCS) is a minimally invasive procedure used for the treatment of persistent, refractory and neuropathic pain. Conventional SCS systems require regular manual adjustments of the level of electrical stimulation after initial programming. These adjustments are necessary because the level of the spinal cord stimulation is dependent on the distance between the spinal cord and the implanted electrodes, which changes with patient’s daily activity (e.g., standing, lying down, seating, etc.). When a patient changes body position, the movement of the spinal cord relative to the implanted lead may result in uncomfortable or inconsistent stimulation. This may lead to suboptimal pain control and significantly reduce the effectiveness of the SCS therapy, which may impact heavily on patient’s quality of life. For instance, one of the most important daily activities – sleep, may be significantly affected by the inconsistent stimulation. This may compromise effective treatment and lead to increase in the levels of dissatisfaction and pain. The RestoreSENSOR (Medtronic Inc, USA) is the first in its class implantable pulse generator for spinal cord stimulation that automatically changes stimulation settings in response to position changes and provides objective patient activity data. It achieves this thanks to the inbuilt acceleration sensor that enables continuous motion sensing. The Medtronic RestoreSENSOR neurostimulator also records and stores the frequency of patient’s posture and activity changes. These objective data can be used by the clinician to understand whether the patient’s individual stimulation requirements are changing over time. If the SCS therapy with RestoreSENSOR improves patients’ quality of sleep and activity levels in this study, this will demonstrate superior effectiveness of position-adaptive stimulation technology in providing pain relief and convenience to patients suffering from chronic pain. Improvement in quality of sleep and daily activity levels will serve as an indicator of efficacy of the treatment.

This research study is looking at a combination of four herbs, which are common components of a healthy diet, in men who have been treated for prostate cancer, and have rising prostate specific antigen (PSA). Who is it for? You may be eligible to join this study if you are a male aged 18 years or above whose PSA is rising at a slow or moderate rate after surgery or radiotherapy for prostate cancer (referred to as 'biochemically recurrent prostate cancer'). Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take a combination of tablets and capsules containing green tea (Camellia sinensis), turmeric (Curcuma longa), resveratrol (which commonly occurs in grapes and wine) from giant knotweed (Polygonum cuspidatum) and broccoli sprout extract (Brassica oleracea). All of these are readily available over-the-counter in herbal combination products, and have all been tested in humans before. Participants in the other group will instead receive a placebo (inactive treatment). All participants will be asked to take two tablets and two capsules twice daily for 12 weeks. Participants will not know to which group they have been allocated until after the study is completed. Participants will have their PSA doubling time assessed at 3 months to determine any effect of treatment. It is thought that the natural herbal treatments may slow the rate at which PSA rises, and may also help to reduce any lingering side-effects following treatment, and improve quality of life. This is an initial small (pilot) study that may form the basis of a larger trial in the future.

The aim of this study is to evaluate the efficacy of a novel treatment for problematic anger in Defence members who are also experiencing PTSD. It is hypothesised that the novel anger focused intervention for Defence members will result in the primary outcome of improved (reduced levels of) anger. Secondary outcomes which may be hypothesised include improved outcomes in associated mental symptomatology including depression, anxiety, alcohol use and symptoms of posttraumatic stress.

This research aims to identify the prevalence of foot pathologies in a female population of persistent high heel footwear users compared to those who do not regularly wear high heel footwear. We seek to identify if there is a correlation between the persistency of high heel footwear use (how many years, how many hours per day) against the severity and number of foot pathologies versus those who use non high heel footwear. We hypothesize that the prevalence of foot pathologies (such as hallux valgus, metatarsalgia, hyperkeratosis, neuroma, digital deformity) in a female population who are habitual high-heel wearers will be significantly higher compared to non-high heel wearers.

The purpose of the study is to see how effective the psychological intervention "EMDR" is in reducing binge eating, reducing weight, improving self-esteem, improving motivation to exercise, and decreasing mental health symptoms. It is hypothysized that this treatment can improve weight, binge eating and related symptoms in 10 sessions or less better than current conventional therapies.