Abstract:
BACKGROUND:Osteoarthritis (OA) is a common chronic disease in older adults. Currently, there are no effective therapies to reduce disease severity and progression of knee OA (KOA), particularly in mid- to late-stages. This study aims to examine the effect of methotrexate (MTX) on knee effusion-synovitis and pain in symptomatic patients with mid- to late-stage KOA. METHODS/DESIGN:This protocol describes a multicentre randomised placebo-controlled clinical trial aiming to recruit 200 participants with mid- to late-stage symptomatic KOA and with effusion-synovitis grade of ≥ 2. Participants will be randomly allocated to the MTX group (start from 5 mg per week for the first 2 weeks and increase to 10 mg per week for the second 2 weeks and 15 mg per week for the remaining period if tolerated) or the placebo group. Primary outcomes are effusion-synovitis size measured by magnetic resonance imaging (MRI) and knee pain assessed by visual analogue scale (VAS). Secondary outcomes are signal intensity alteration within infrapatellar fat pad (IPFP) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and subscores, and the Outcome Measures in Rheumatology Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responders. Both intention-to-treat and per-protocol analyses will be performed. DISCUSSION:If MTX intervention can relieve symptoms and reduce inflammation in patients with mid- to late-stage KOA, it has the potential for significant clinical and public health impact as this low-cost and commonly used intervention would delay the time to knee replacement, leading to substantial cost savings and improve quality of life. TRIAL REGISTRATION:ClinicalTrials.gov NCT03815448 . Registered on 21 January 2019.
journal_name
Trialsjournal_title
Trialsauthors
Zhu Z,Yu Q,Leng X,Han W,Li Z,Huang C,Gu J,Zhao Y,Wang K,Li T,Mei Y,Xu J,Zhang Z,Hunter D,Cicuttini F,Zeng X,Ding Cdoi
10.1186/s13063-020-04687-3subject
Has Abstractpub_date
2020-09-16 00:00:00pages
795issue
1issn
1745-6215pii
10.1186/s13063-020-04687-3journal_volume
21pub_type
杂志文章相关文献
Trials文献大全abstract:BACKGROUND:Low back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill this knowledge gap, this protocol proposes an appropriately powered, prospective, evaluator-blinded, ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-020-04271-9
更新日期:2020-05-11 00:00:00
abstract:BACKGROUND:Hypothyroidism is a prevalent endocrine condition. Individuals with this disease are commonly managed through supplementation with synthetic thyroid hormone, with the aim of alleviating symptoms and restoring normal thyroid stimulating hormone levels. Generally this management strategy is effective and well ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-11-106
更新日期:2010-11-15 00:00:00
abstract:BACKGROUND:The Swiss health ministry launched a national quality program 'QualiCCare' in 2011 to improve health care for patients with COPD.The aim of this study is to determine whether participation in the COPD quality initiative ('QualiCCare') improves adherence to recommended clinical processes and shows impact on p...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-96
更新日期:2014-03-27 00:00:00
abstract:BACKGROUND:Coronary artery disease is the leading cause of morbidity and mortality in patients with type 2 diabetes. Screening for asymptomatic coronary artery disease with treatment by means of revascularization seems to be an appealing option for prevention. The utility of such a strategy has never been challenged in...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-10-119
更新日期:2009-12-23 00:00:00
abstract:BACKGROUND:Depression is not a normal side effect of aging, however it is one of the most prevalent mental health issues in later life, imposing a tremendous burden on patients, their families, and the healthcare system. We describe the experimental implementation of a collaborative, stepped-care model for the treatmen...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-351
更新日期:2014-09-06 00:00:00
abstract:BACKGROUND:Pruritus (itch) is a frequent, burdensome and difficult-to-treat symptom in patients with cholestasis. Fibrates are currently under investigation for the treatment of primary biliary cholangitis in patients with a suboptimal response to ursodeoxycholic acid. Moreover, there is empirical evidence for a possib...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-017-1966-8
更新日期:2017-05-23 00:00:00
abstract:BACKGROUND:Systematic use of observational pain tools has been advocated as a means to improve pain management for care home residents with dementia. Pain experts suggest that any observational tool should be used as part of a comprehensive pain management protocol, which should include score interpretation and verific...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-78
更新日期:2014-03-13 00:00:00
abstract:BACKGROUND:Evidence for benefit of high positive end-expiratory pressure (PEEP) is largely lacking for invasively ventilated, critically ill patients with uninjured lungs. We hypothesize that ventilation with low PEEP is noninferior to ventilation with high PEEP with regard to the number of ventilator-free days and bei...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2640-5
更新日期:2018-05-09 00:00:00
abstract:BACKGROUND:Graves' hyperthyroidism is an autoimmune disease causing hyperfunction of the thyroid gland. The concentration of selenium is high in the thyroid gland and two important groups of enzymes within the thyroid are selenoproteins, that is, they depend on selenium. Selenium may have beneficial effects on autoimmu...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-119
更新日期:2013-04-30 00:00:00
abstract:BACKGROUND:Bipolar disorder (BD) is commonly associated with cognitive and functional impairments even during remission periods, and although a growing number of studies have demonstrated the benefits of psychotherapy as an add-on to pharmacological treatment, its effectiveness appears to be less compelling in severe p...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-1896-5
更新日期:2017-03-28 00:00:00
abstract:BACKGROUND:Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that causes paralysis of limb, swallowing, and breathing muscles. Riluzole, the Food and Drug Administration-approved drug for ALS, provides minimal benefit, prolonging patient life by only 2-3 months. Previous studies have found a neur...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2557-z
更新日期:2018-04-13 00:00:00
abstract:BACKGROUND:The objective of this research was to evaluate data from a randomized clinical trial that tested injectable diacetylmorphine (DAM) and oral methadone (MMT) for substitution treatment, using a multi-domain dichotomous index, with a Bayesian approach. METHODS:Sixty two long-term, socially-excluded heroin inje...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-10-70
更新日期:2009-08-14 00:00:00
abstract:BACKGROUND:Adaptive servo-ventilation (ASV) therapy, which is a form of noninvasive positive pressure ventilation therapy and uses an innovative ventilator that has simple operability and provides good patient adherence, potentially has therapeutic benefits-suppression of the deterioration and progression of chronic he...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-014-0530-z
更新日期:2015-01-16 00:00:00
abstract:BACKGROUND:Evidence increases that a high or a standard dose of tranexamic acid (TA) reduces postpartum bleeding. The TRACES pharmacobiological substudy aims to establish a therapeutic strategy in hemorrhagic (H) Cesarean section (CS) with respect to the intensity of fibrinolysis by using innovative assays. METHOD/DES...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2421-6
更新日期:2018-03-01 00:00:00
abstract:BACKGROUND:Coronary artery disease (CAD) is one of the most common types of the cardiovascular disease. Previous pilot trials have suggested that Traditional Chinese Medicine (TCM) has brought clinical benefits for patients with CAD. We will conduct this trial to determine the efficacy and safety of Shenzhu Guanxin Rec...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3629-4
更新日期:2019-08-20 00:00:00
abstract:BACKGROUND:Knee osteoarthritis (KOA) is one of the most common bone and joint diseases. As one of the main non-drug therapies, acupuncture is widely used to treat KOA, although the evidence for its efficacy is inconclusive. The objective of this pilot trial is to clarify the clinical efficacy and safety of fire acupunc...
journal_title:Trials
pub_type: 杂志文章,多中心研究
doi:10.1186/s13063-019-3744-2
更新日期:2019-12-04 00:00:00
abstract:BACKGROUND:Chest tube insertion is a standard intervention for management of various injuries of the thorax. Quick and accurate execution facilitates efficient therapy without further complications. Here, we propose a new training concept comprised of e-learning elements as well as continuous rating using an objective ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-1799-5
更新日期:2017-02-06 00:00:00
abstract:BACKGROUND:Dietary interventions have limited success in promoting sustainable weight loss; new treatments allowing better compliance with hypocaloric diets should be developed. The aim of this trial is to describe the effects of a protocol combining repetitive active transcranial direct current stimulation (tDCS) with...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2776-3
更新日期:2018-07-16 00:00:00
abstract:BACKGROUND:Emerging evidence has shown that vitamin D and magnesium have anti-inflammatory and anti-depressant effects. Dietary intake of magnesium is associated with reduced body mass index, waist circumference, body fat percentage, as well as inflammatory biomarkers and depressive symptoms. Vitamin D deficiency has b...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4122-9
更新日期:2020-02-26 00:00:00
abstract:BACKGROUND:Small incision lenticule extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If success...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-13-75
更新日期:2012-05-31 00:00:00
abstract:BACKGROUND:Acute mountain sickness (AMS) is a cluster of symptoms that commonly occur in those ascending to high altitudes. Symptoms can include headaches, nausea, insomnia and fatigue. Exposure to high altitude can also lead to high-altitude cerebral oedema (HACE), which is a potential cause of death whilst mountainee...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3681-0
更新日期:2019-10-24 00:00:00
abstract:BACKGROUND:Understanding why people take part in health research is critical to improve research efficiency and generalisability. The aim of this overview of systematic reviews was to identify psychosocial determinants of research participation and map them to psychological theory and empirical recruitment research, to...
journal_title:Trials
pub_type: 杂志文章,评审
doi:10.1186/s13063-020-4197-3
更新日期:2020-03-12 00:00:00
abstract:BACKGROUND:AirSeal is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide (CO₂) recirculation during laparoscopic surgery. Comparison data to standard CO₂ pressure pneumoperitoneum insufflators is scarce. The aim of this study is to ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-239
更新日期:2014-06-20 00:00:00
abstract:BACKGROUND:Colorectal cancer remains a considerable challenge in healthcare nowadays. Most patients' disease develops via the adenoma-carcinoma sequence; colonoscopy with polypectomy effectively reduces both mortality and incidence by removing precancerous adenomas. Previous studies showed that polypectomy without elec...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2743-z
更新日期:2018-07-06 00:00:00
abstract:BACKGROUND:The physical and mental health of college students tends to continuously decline around the world. Since they are in a significant transition period which presents opportunities and challenges in health promotion, it is important to improve their health in this period. As a traditional Chinese exercise form ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-422
更新日期:2013-12-05 00:00:00
abstract:BACKGROUND:Coronary heart disease (CHD) has become a common cardiovascular disease that seriously threatens the health of people. As reperfusion in the early phase and drug therapy, especially percutaneous coronary intervention (PCI), have become widely used in the clinic, the mortality of acute myocardial infarction i...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4208-4
更新日期:2020-03-20 00:00:00
abstract:OBJECTIVES:To evaluate the safety of therapeutic plasma exchange (TPE) in adult patients with serious/life-threatening COVID-19 requiring intensive care unit (ICU) admission, and associated 28-day mortality. Serious and life threatening COVID-19 are defined as per published literature (please, refer to the full protoco...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-020-04454-4
更新日期:2020-06-08 00:00:00
abstract:BACKGROUND:Depression occurs in up to 50% of patients after stroke and limits rehabilitation and recovery. Mood disorders are also highly prevalent in carers; their mental health intertwined with the physical and mental wellbeing of the person they are caring for. We argue that working with families, rather than patien...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-105
更新日期:2011-04-30 00:00:00
abstract:BACKGROUND:The logrank test is routinely applied to design and analyse randomized controlled trials (RCTs) with time-to-event outcomes. Sample size and power calculations assume the treatment effect follows proportional hazards (PH). If the PH assumption is false, power is reduced and interpretation of the hazard ratio...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4153-2
更新日期:2020-04-06 00:00:00
abstract:BACKGROUND:As people live longer, their risk of disability increases. Disability affects quality of life and increases health and social care costs. Preventing or delaying disability is therefore an important objective, and identifying an effective intervention could improve the lives of many older people. Observationa...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0610-8
更新日期:2015-03-13 00:00:00