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The effectiveness of quadriceps strengthening with and without blood flow restriction in the treatment of knee cap pain (patellofemoral pain)
Expand descriptionPatellofemoral pain is common in people who participate in activities and sports that involve running. Improved treatment outcomes in patellofemoral pain are required as recent research has established a link between patellofemoral pain and future osteoarthritis of the knee. Common interventions such as quadriceps strengthening exercises are effective at reducing pain for many people with patellofemoral pain. Quadriceps strengthening is likely to have an effect in improving patellofemoral pain because of resultant increases in quadriceps size and strength. However some people with patellofemoral pain are unable to perform exercises with a resistance that significantly strengthens the quadriceps because pain limits their ability to perform the exercises. Blood flow restricted training can increase muscle size and strength at lower resistance than typical strengthening programs, and may therefore be a suitable method of improving quadriceps size and strength in those unable to perform traditional quadriceps strengthening exercises effectively. Blood flow restricted training involves placing an inflatable cuff around a limb before performing strengthening exercises. The placement of the cuff reduces blood flow within the limb during the exercise. It is hypothesised that limited blood flow causes the muscle to work harder than in normal blood flow conditions, and therefore improvements in muscle size and strength can be obtained at lower resistance than conventional exercises. This study will compare 8 weeks of low resistance quadriceps strengthening with blood flow restriction to the current gold standard treatment of 8 weeks of quadriceps strengthening. Participants will be assessed at 0, 4, 8, 24 and 52 weeks.
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Evaluation of a novel glucose sensor in type 1 diabetes
Expand descriptionGlucose sensor technology has been evolving with an ultimate goal of achieving a level of accuracy required to replace finger prick glucose testing, together with a level of reliability for use in an artificial pancreas. While there have been recent advances in glucose sensing technology, further improvements relating to sensor accuracy and reliability are required. A glucose sensor based on a novel technology platform has been developed. Studies in animals and humans during development of this sensor have shown positive results, and this will be the first study in humans to formally compare the novel glucose sensor to a glucose sensor based on the traditional sensing platform.
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Can early active repetitive motor training prevent development of upper limb contracture after stroke? A randomised trial.
Expand descriptionThe primary aim of this study is to investigate whether five weeks of up to one hour daily of early, active, repetitive motor training in addition to usual upper limb therapy can prevent upper limb contractures after stroke or other types of ABI. Secondary aims are to determine the effect of this intervention on upper limb function and upper limb pain, and to investigate patients’ perspectives of the intervention. The study will be a parallel group, randomized controlled trial, with blinding of assessors and concealed randomization. Pre-intervention outcome measures will be taken prior to participants being randomized into either the experimental or the control group. Participants in the experimental group will receive a maximum of 1 hour a day of early active repetitive motor training using the SMART Arm device plus usual upper limb therapy, five days a week, for five weeks, in addition to the usual upper limb therapy. Participants in the control group will receive usual upper limb therapy only. The intervention will cease at the end of 5 weeks and outcome measures for both groups will be collected at that time. Follow-up outcome measures will be collected at 7 weeks. Qualitative interviews with ten participants from the experimental group will be undertaken at the end of the intervention period.
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The role of Intraperitoneal Ropivacaine in Laparoscopic Appendicectomy: A prospective, double blinded randomised control study
Expand descriptionThis study investigates the analgesic effect of intraperitoneal injection of a long acting local anaesthetic agent (Ropivacaine) during laparoscopic (keyhole) appendicectomy. Trial participants will be randomly divided into two groups. One group will receive intraperitoneal Ropivacaine during laparoscopic appendicectomy while the other will receive normal saline. The consumption quantity of total Fentanyl analgesia, the presence of shoulder tip pain and post surgery nausea or vomiting will be recorded up to 16 hours post surgery. The study aims to determine whether the use of Ropivacaine during laparoscopic appendectomy is an useful analgesic adjunct. The primary aim of this study will be to determine whether using Ropivacaine will reduce total amount of analgesia used, hence reducing post-operative pain, and its effect on the incidence of post laparoscopic appendicectomy shoulder tip pain and nausea or vomiting.
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Pregnancy Outcomes after Pre-pregnancy weight loss in obese women (POP Study)
Expand descriptionThis is a two arm parallel group randomised controlled trial to determine if substantial weight loss is superior to modest weight loss in reducing maternal glucose at 26-28 weeks gestation and therefore preventing adverse maternal and neonatal pregnancy outcomes.
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Does menopausal hormone therapy (MHT), exercise or a combination of both, improve pain and function in post-menopausal women with greater trochanteric pain syndrome (GTPS)? A randomised controlled trial.
Expand descriptionGreater trochanteric pain syndrome (GTPS) causes severely debilitating pain on the outside of the hip, resulting in limited activity, employment and decreased capacity to exercise. The pain of GTPS has been shown to be as severe and debilitating as osteoarthritis of the hip in those waiting for hip replacement. It most commonly affects post-menopausal women and limits capacity for physical activity that is critical for older women to achieve healthy ageing. In addition to tendon injury, ageing women suffer a myriad of conditions and diseases that burden both the individual and society, all of which can be ameliorated by physical activity (cardiovascular disease, obesity and osteoporosis). Conservative management is the first line treatment, although evidence is limited and the condition can be resistant to treatment. Thus, the aim of this study is to investigate the effect of menopausal hormone therapy and exercise on pain and function in post-menopausal women with GTPS. Eighty women will be recruited and randomised to one of four groups: (i) Exercise therapy, placebo MHT cream; (ii) Sham exercise, MHT cream; (iii) Sham exercise, placebo MHT cream or (iv) Exercise therapy, MHT cream. Interventions will be 12 weeks in duration and outcomes (6 questionnaires) will be examined at baseline, 3 months, and 12 months. We hypothesise that as tendon cells contain hormone-specific receptors, supplemental hormones may be beneficial for reducing pain and dysfunction measured by a clinical significant change in VISA-G scores (using responder analysis).
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Does resistance exercise training improve muscle strength and function in acute burn injury?
Expand descriptionIt is known that survivors of burn injury often experience impairments in strength and functional ability for the rest of their life. This is a result of losses in skeletal muscle mass and strength. This study aims to investigate the effect of resistance training on the muscle mass, strength and quality of life of a burns patient. It is expected that patients who undertake a structured resistance exercise training program will exhibit increased muscle mass, increased strength and an improved quality of life compared to the control group.
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An interdisciplinary model of care for early detection of lung damage, smoking cessation support and management of chronic obstructive pulmonary disease (COPD).
Expand descriptionRADICALS is an interdisciplinary model of care that brings together the expertise of different health professional groups to provide a solution for a major public health problem, chronic obstructive pulmonary disease (COPD). This community-based model mainly surrounds interdisciplinary collaboration to deliver intensive smoking cessation support, COPD management according to COPD-X guidelines, home medication review and a home-based exercise/self-management program. This study aims to evaluate the effectiveness and cost-effectiveness of the RADICALS program in reducing the burden of smoking and COPD through: (a) increasing the detection of COPD among long-term smokers, (b) improving the effectiveness of smoking cessation care provided in general practices; and (c) improving health-related quality of life (HRQoL) of people with COPD. It is hypothesised that: (a) A general practice-based screening program among smokers will result in early identification of COPD (b) Interdisciplinary care will result in higher abstinence rates at 6 months than ‘Quitline referral’ among smokers; and (c) Among people with COPD, interdisciplinary care will maintain HRQoL better than usual care at 6 months
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The vulvo-vaginal pain study: A study looking at the effectiveness of an intra-vaginal cream for treatment of chronic vulvo-vaginal pain. .
Expand descriptionA randomised, placebo-controlled study looking at the effectiveness of an intravulvo-vaginal cream Lyrica (registered trademark) for treatment of chronic pain in the vulvo-vagina. A research project is being conducted by Professor Chris Benness, Dr Elizabeth Willsteed and Dr Jane Manning to investigate a treatment for chronic vulvo-vaginal pain. Why is the research being done? The purpose of this project is to establish whether a prescription drug, Pregabalin (Lyrica - registered trademark) when applied topically as a vulvo-vaginal cream is a safe and effective means of treating vulvo-vaginal pain. Previous research has suggested that it may be effective. We hope it causes fewer side effects than Pregabalin when taken orally which is a standard treatment for the condition. This drug is not experimental or new, and is approved to treat chronic neuropathic pain. Method: Two creams, A and B will be prepared. One of which will contain pregabalin . Treatment allocation will be double blind and randomized. Participants who satisfy inclusion criteria will apply the cream for 6 weeks with dose adjustment allowed. They will then have the option to receive the active pregabalin cream (open label) for a further 6 weeks if they wish. They will complete questionnaires designed to detect relevant demograohic factors and factors that may potentially confound results. They will complete questionnaires on line or by mail at 0, 2 4 ,6 and 12 weeks. Participants: Those with vulvo-vaginal pain that has stopped tampon use or intercourse or regular internal examination for 6 months or more. Those over 17 Those not pregnant and are not planning to become pregnant (that is, you must be currently using effective contraception) Those with no known allergy to Pregabalin. Those whose pain is not due to cancer or past radiation treatment or to lichen planus or lichen sclerosis, or other treatable causes. Those who have time to participate over 6 weeks and who live within 200 km of Sydney NSW Australia Area Those who don’t have significant kidney disease. What would participants be asked to do? They will need to be available for a minimum of 2 visits over a minimum 6 weeks to assess response to a blinded treatment cream. The first visit will take approximately 1 hour. Participating in the study will involve: A vulvo-vaginal examination at the first visit Attending for a first visit and a possible visit at 2 weeks Completing five (5) Questionnaires which will be provided at visit 1, and again at weeks 2, 4, 6 and also week 12 if they wish to continue. These questions will ask about general health and the nature of the vulvo-vaginal pain. Some of these are sensitive questions asking about sexual function and possible abuse history. They will complete a 24 hour voiding diary (how often you go to the toilet) prior to the first visit. After the initial visit, online questionnaires or postal questionnaires will be possible to complete for all subsequent review, or if they wish they can attend in person. They will collect a study drug package, labelled either A or B at the 1st visit. All participants will apply cream throughout the 6 week study, but the contents of the cream will be either Lyrica (registered trademark) pregabalin or a placebo (not active medication). Participants will not be told which cream they receive. What are the risks and benefits of participating? Benefits Participating in this study may benefit your condition (vulvo-vaginal pain). Risks Although the cream base is neutral - local irritation may still occur Irritation with use of this vulvo-vaginal cream may occur for 14% of women. Sedation may still occur even though it has not been reported using this cream. Tiredness, dizziness, confusion is common with many oral medications used to treat vulvo-vaginal pain. How will privacy be protected? All information gained will be treated confidentially. It will be accessed, used, managed and stored in accordance with the NSW Health Records and Health Information Privacy Act 2002
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A study to determine how the bodies of healthy study participants handle axelopran and oxycodone given as a combined tablet compared with given as separate tablets.
Expand descriptionThe purpose of this study is to determine the pharmacokinetics (how the body absorbs the drug), safety, and tolerability of oxycodone and axelopran when given together and separately.