Trials
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Multicenter Study
Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial.
Qualitative research has been used to explore patients' and healthcare professionals' experiences of surgical randomised controlled trials (RCTs). From this research, reasons why patients accept or decline participation and barriers to engaging clinicians in trials have been identified. In a trauma setting, recruitment to surgical trials can be particularly difficult as patients may require urgent treatment and their ability to consider their options, ask questions and reach a decision may be hindered by the impact of their injury. Little research, however, has explored patients' and healthcare professionals' experiences of surgical RCTs in a trauma setting. This study aimed to understand patients' and staff's experiences of an orthopaedic trauma trial. ⋯ Our findings highlight the pivotal role of research associates (RAs) in facilitating trial recruitment. RAs supported patients to enable them to make a decision about participation and assisted in developing a research culture within the team by promoting studies and communicating research to clinical staff. Our findings also reinforce surgeons' difficulty with equipoise and suggest that accepting community equipoise could facilitate recruitment.
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Comparative Study
Manual therapy versus therapeutic exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial.
The underlying mechanisms of non-specific chronic neck pain relapses are not clear, but they could be associated with a deficit and alteration of neck muscles propioception that play a decisive role in cervical joint position, motor control of the head, and postural stability. Numerous treatments for non-specific chronic neck pain have been described in the scientific literature. However, few studies analyze its influence on postural stability, since these alterations are not fully described, and various theories emerge about the reasons that cause it. Our primary aim is to analyze the differences in postural stability, pain, cervical disability, and the relation between them produced by a treatment based on manual therapy and another based on therapeutic exercise. ⋯ Our study aims to provide knowledge about postural stability and its relationship with pain in subjects with non-specific chronic neck pain. Analyzing the results produced by different types of therapy will allow us to draw conclusions about the mechanisms, structural or central, that may elicit these alterations.
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Heel pain is a common foot disorder that causes pain and functional limitations. The prevalence of disabling foot pain will increase as the population ages. Previous studies have reported the positive therapeutic effects of electroacupuncture, warm needling, or the combination of both for heel pain but with limitations in the study methodologies. The current study is a rigorously designed randomized controlled trial that aims to evaluate the clinical efficacy and safety of electroacupuncture plus warm needling therapy in patients with heel pain. ⋯ This study will provide evidence on the efficacy and safety of electroacupuncture plus warm needling therapy as an alternative treatment method for heel pain. The findings will determine whether the treatment protocol is efficacious in relieving pain and improving foot function among older adults with heel pain. The study will also provide information for subsequent large-scale randomized controlled trials in the future.
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Chronic tinnitus is a highly prevalent symptom, with many patients reporting considerable effects of tinnitus on quality of life. No clear evidence-based treatment options are currently available. While counseling-based methods are valuable in some cases, they are not sufficiently effective for all tinnitus patients. Neuromodulation techniques such as high-definition transcranial direct current stimulation (HD-tDCS) are proposed to have positive effects on tinnitus severity but, to date, these effects have not been proven conclusively. The proposed trial will investigate the hypothesis that chronic tinnitus patients receiving HD-tDCS will report a positive effect on the impact of tinnitus on daily life, as compared to patients receiving sham stimulation. ⋯ The objective of this study is to evaluate whether HD-tDCS can reduce the impact of tinnitus on daily life in chronic tinnitus patients. To date, published trials on the effects of HD-tDCS on tinnitus suffer from a lack of standardization and few randomized controlled trials exist. The proposed study will be the first adequately powered trial to investigate the effects of sequential dual-site HD-tDCS on tinnitus severity.
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As a common cause of low back pain, lumbosacral disc herniation (LDH) is usually dealt with using non-surgical interventions. In the face of concerns about prescription opioid abuse, alternative and complementary treatments may be promising, among which silver-needle warm acupuncture is considered as an upgrading option for its potential anti-inflammatory and strong analgesic effect for patients with chronic pain. In this proposed study, we aim to assess its clinical efficacy in comparison with conventional stainless steel filiform-needle warm acupuncture. ⋯ If the results show that participants treated with silver-needle warm acupuncture gain a greater improvement in terms of pain intensity, physical function, and quality of life, this study is expected to offer reliable evidence to widely push this treatment for LDH in clinical practice.