Trials
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Randomized Controlled Trial
Effect of tens on pain in relation to central sensitization in patients with osteoarthritis of the knee: study protocol of a randomized controlled trial.
Central sensitization has recently been documented in patients with knee osteoarthritis (OAk). So far, the presence of central sensitization has not been considered as a confounding factor in studies assessing the pain inhibitory effect of tens on osteoarthritis of the knee. The purpose of this study is to explore the pain inhibitory effect of burst tens in OAk patients and to explore the prognostic value of central sensitization on the pain inhibitory effect of tens in OAk patients. ⋯ Tens influences pain through the electrical stimulation of low-threshold A-beta cutaneous fibers. The responsiveness of central pain-signaling neurons of centrally sensitized OAk patients may be augmented to the input of these electrical stimuli. This would encompass an adverse therapy effect of tens. To increase treatment effectiveness it might be interesting to identify a subgroup of symptomatic OAk patients, i.e., non-sensitized patients, who are likely to benefit from burst tens.
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Randomized Controlled Trial
Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial.
Surgery induces insulin resistance that might be alleviated by a nutritional drink given preoperatively. The authors hypothesized that some of the beneficial effects of the drink could be attributed to the volume component (approximately 1 L) rather than to the nutrients. ⋯ Preoperative ingestion of tap water or a nutritional drink had no statistically significant effect on glucose clearance, insulin sensitivity, postoperative complications, or wellbeing in patients undergoing elective hip surgery.
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Randomized Controlled Trial
Reducing inappropriate, anticholinergic and psychotropic drugs among older residents in assisted living facilities: study protocol for a randomized controlled trial.
Use of inappropriate drugs is common among institutionalized older people. Rigorous trials investigating the effect of the education of staff in institutionalized settings on the harm related to older people's drug treatment are still scarce. The aim of this trial is to investigate whether training professionals in assisted living facilities reduces the use of inappropriate drugs among residents and has an effect on residents' quality of life and use of health services. ⋯ To our knowledge, this is the first large-scale randomized trial exploring whether relatively light intervention, that is, staff training, will have an effect on reducing harmful drugs and improving QOL among institutionalized older people.
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Randomized Controlled Trial Multicenter Study
Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial.
Low back pain (LBP) is a recognized public health problem, impacting up to 80% of US adults at some point in their lives. Patients with LBP are utilizing integrative health care such as spinal manipulation (SM). SM is the therapeutic application of a load to specific body tissues or structures and can be divided into two broad categories: SM with a high-velocity low-amplitude load, or an impulse "thrust", (HVLA-SM) and SM with a low-velocity variable-amplitude load (LVVA-SM). There is evidence that sensorimotor function in people with LBP is altered. This study evaluates the sensorimotor function in the lumbopelvic region, as measured by postural sway, response to sudden load and repositioning accuracy, following SM to the lumbar and pelvic region when compared to a sham treatment. ⋯ This study may provide clues to the sensorimotor mechanisms that explain observed functional deficits associated with LBP, as well as the mechanism of action of SM.
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Randomized Controlled Trial Multicenter Study
Prevention of: self harm in British South Asian women: study protocol of an exploratory RCT of culturally adapted manual assisted Problem Solving Training (C- MAP).
Suicide is a major public health problem worldwide. In the UK suicide is the second most common cause of death in people aged 15-24 years. Self harm is one of the commonest reasons for medical admission in the UK. In the year following a suicide attempt the risk of a repeat attempt or death by suicide may be up to 100 times greater than in people who have never attempted suicide. Research evidence shows increased risk of suicide and attempted suicide among British South Asian women. There are concerns about the current service provision and its appropriateness for this community due to the low numbers that get involved with the services. Both problem solving and interpersonal forms of psychotherapy are beneficial in the treatment of patients who self harm and could potentially be helpful in this ethnic group.The paper describes the trial protocol of adapting and evaluating a culturally appropriate psychological treatment for the adult British South Asian women who self harm. ⋯ This study will test the feasibility and acceptability of the C- MAP in British South Asian women. We will be informed on whether a culturally adapted brief psychological intervention compared with treatment as usual for self-harm results in decreased hopelessness and suicidal ideation. This will also enable us to collect necessary information on recruitment, effect size, the optimal delivery method and acceptability of the intervention in preparation for a definitive RCT using repetition of self harm and cost effectiveness as primary outcome measures.