Bmc Musculoskel Dis
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Bmc Musculoskel Dis · Jan 2008
Randomized Controlled TrialA randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol.
Back pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment, is better than best current care at reducing long-term disability from low back pain. ⋯ This paper presents detail on the rationale, design, methods and operational aspects of the trial.
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Bmc Musculoskel Dis · Jan 2008
Randomized Controlled Trial Multicenter StudyStudy to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design.
Surgeons agree on the benefits of operative treatment of tibial fractures - the most common of long bone fractures - with an intramedullary rod or nail. Rates of re-operation remain high - between 23% and 60% in prior trials - and the two alternative nailing approaches, reamed or non-reamed, each have a compelling biological rationale and strong proponents, resulting in ongoing controversy regarding which is better. ⋯ The primary outcome was re-operation to promote healing, treat infection, or preserve the limb (fasciotomy for compartment syndrome after nailing). The primary outcome was a composite comprising the following re-operations: bone grafts, implant exchanges, and dynamizations, in patients with fracture gaps less than 1 cm post intramedullary nail insertion. Infections and fasciotomies were considered events irrespective of the fracture gap. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures. S.P.R.I.N.T is the largest collaborative trial evaluating alternative orthopaedic surgical interventions in patients with tibial shaft fractures. The methodological rigor will set new benchmarks for future trials in the field and its results will have important impact on patient care. The S.P.R.I.N.T trial was registered [ID NCT00038129] and received research ethics approval (REB#99-077).
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Bmc Musculoskel Dis · Jan 2008
Randomized Controlled TrialTai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial.
Knee Osteoarthritis (KOA) is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our study examines the effects of a 12-week Tai Chi program compared with an attention control (wellness education and stretching) on pain, functional capacity, psychosocial variables, joint proprioception and health status in elderly people with KOA. The study will be completed by July 2009. ⋯ In this article, we present the challenges of designing a randomized controlled trial with long-term follow up. The challenges encountered in this design are: strategies for recruitment, avoidance of selection bias, the actual practice of Tai Chi, and the maximization of adherence/follow-up while conducting the clinical trial for the evaluation of the effectiveness of Tai Chi on KOA.
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Bmc Musculoskel Dis · Jan 2008
Randomized Controlled TrialDiagnosis and treatment of musculoskeletal chest pain: design of a multi-purpose trial.
Acute chest pain is a major health problem all over the western world. Active approaches are directed towards diagnosis and treatment of potentially life threatening conditions, especially acute coronary syndrome/ischemic heart disease. However, according to the literature, chest pain may also be due to a variety of extra-cardiac disorders including dysfunction of muscles and joints of the chest wall or the cervical and thoracic part of the spine. The diagnostic approaches and treatment options for this group of patients are scarce and formal clinical studies addressing the effect of various treatments are lacking. ⋯ This study may potentially demonstrate that a chiropractor is able to identify a subset of patients suffering from chest pain predominantly of musculoskeletal origin among patients discharged from an acute chest pain clinic with no apparent cardiac condition. Furthermore knowledge about the benefits of manual treatment of patients with musculoskeletal chest pain will inform clinical decision and policy development in relation to clinical practice.
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Bmc Musculoskel Dis · Jan 2008
Randomized Controlled TrialEfficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640].
Vertebroplasty is a promising but as yet unproven treatment for painful osteoporotic vertebral fractures. It involves radiographic-guided injection of various types of bone cement directly into the vertebral fracture site. Uncontrolled studies and two controlled quasi-experimental before-after studies comparing volunteers who were offered treatment to those who refused it, have suggested an early benefit including rapid pain relief and improved function. Conversely, several uncontrolled studies and one of the controlled before-after studies have also suggested that vertebroplasty may increase the risk of subsequent vertebral fractures, particularly in vertebrae adjacent to treated levels or if cement leakage into the adjacent disc has occurred. As yet, there are no completed randomised controlled trials of vertebroplasty for osteoporotic vertebral fractures. The aims of this participant and outcome assessor-blinded randomised placebo-controlled trial are to i) determine the short-term efficacy and safety (3 months) of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures; and ii) determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years. ⋯ The results of this trial will be of major international importance and findings will be immediately translatable into clinical practice.