scholarly journals Topical corticosteroid for treatment of hand osteoarthritis: study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yuanyuan Wang ◽  
Sultana Monira Hussain ◽  
Desmond Gan ◽  
Yuan Z. Lim ◽  
Mahnuma Mahfuz Estee ◽  
...  
Keyword(s):  
Topical Corticosteroid ◽  
Controlled Trial ◽  
Trial Registration ◽  
Joint Disease ◽  
Hand Osteoarthritis ◽  
Primary Analysis ◽  
Public Health Importance ◽  
Double Blind ◽  
Intention To Treat ◽  
Randomised Controlled

Abstract Background Hand osteoarthritis is a common and disabling chronic joint disease with a lack of effective therapies. Emerging evidence suggests the role of local inflammation in causing pain in hand osteoarthritis. Corticosteroids are potent anti-inflammatory drugs used in many rheumatic diseases. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether topical corticosteroid reduces pain over 6 weeks in patients with hand osteoarthritis. Methods One hundred participants with hand osteoarthritis will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either topical Diprosone OV or placebo ointment administered 3 times daily on the painful hand joints for 6 weeks. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 weeks. The secondary outcomes include changes in pain and function assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Michigan Hand Outcomes Questionnaire, and tender and swollen joint count at 6 weeks. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. Discussion This study will provide high-quality evidence to determine whether topical corticosteroid reduces pain over 6 weeks in patients with hand osteoarthritis, with major clinical and public health importance by informing clinical practice guidelines for the management of hand osteoarthritis and reducing the burden of the disabling disease. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000599976. Registered 22 May 2020.

scholarly journals METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yuanyuan Wang ◽  
Andrew J. Teichtahl ◽  
Graeme Jones ◽  
Helen I. Keen ◽  
Catherine L. Hill ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Trial Registration ◽  
Positive Trial ◽  
Hand Osteoarthritis ◽  
Double Blind ◽  
Structural Progression ◽  
Randomised Controlled

Abstract Background Hand osteoarthritis is a common and disabling problem without effective therapies. Accumulating evidence suggests the role of local inflammation in causing pain and structural progression in hand osteoarthritis, and hand osteoarthritis with synovitis is a commonly encountered clinical phenotype. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. The aim of this multicentre, randomised, double-blind, placebo-controlled trial is to determine whether methotrexate reduces pain over 6 months in patients with hand osteoarthritis and synovitis. Methods Ninety-six participants with hand osteoarthritis and synovitis will be recruited through the Osteoarthritis Clinical Trial Network (Melbourne, Hobart, Adelaide, and Perth), and randomly allocated in a 1:1 ratio to receive either methotrexate 20 mg or identical placebo once weekly for 6 months. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 months. The secondary outcomes include changes in physical function and quality of life assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, Short-Form-36, tender and swollen joint count, and grip strength, and structural progression assessed using progression of synovitis and bone marrow lesions from magnetic resonance imaging and radiographic progression at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. Discussion This study will provide high-quality evidence to address whether methotrexate has an effect on reducing pain over 6 months in patients with hand osteoarthritis and synovitis, with major clinical and public health importance. While a positive trial will inform international clinical practice guidelines for the management of hand osteoarthritis, a negative trial would be highly topical and change current trends in clinical practice. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000877381. Registered 15 June 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373124

scholarly journals Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial

Thorax ◽  
2020 ◽  
Vol 75 (5) ◽  
pp. 413-421 ◽  
Author(s):  
Henrik Hansen ◽  
Theresa Bieler ◽  
Nina Beyer ◽  
Thomas Kallemose ◽  
Jon Torgny Wilcke ◽  
...  
Keyword(s):  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Drop Out ◽  
Group Differences ◽  
Primary Analysis ◽  
Intention To Treat ◽  
Registration Number ◽  
Randomised Controlled

RationalePulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).ObjectiveTo investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR.MethodsIn this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks’ follow-up from baseline. The primary analysis was based on the intention-to-treat principle.Measurements and main resultsThe primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: −6.6 to 24.9)) or at 22 weeks’ follow-up (−5.3 metres (95% CI: −28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ2 test p<0.01).ConclusionPTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.Trial registration numberClinicalTrials.gov (NCT02667171), 28 January 2016.

scholarly journals Effectiveness of a Fortified Drink in Improving B Vitamin Biomarkers in Older Adults: A Controlled Intervention Trial

2021 ◽  
Author(s):  
Maria Heffernan ◽  
Leanne C Doherty ◽  
Roberta Hack Mendes ◽  
Michelle Clarke ◽  
Stephanie Hodge ◽  
...  
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
B Vitamins ◽  
Double Blind ◽  
Intention To Treat ◽  
Vitamin Status ◽  
Randomised Controlled ◽  
B Vitamin ◽  
To Receive

Abstract BackgroundOlder adults are reported to have sub-optimal B vitamin status; targeted food-based solutions may help to address this. The objectives of the OptiAge food intervention study were to develop and investigate the effectiveness of a B vitamin-fortified drink in improving B vitamin biomarkers in older Irish adults with a primary outcome of change in B vitamin biomarker concentrations.MethodsA multicentre double-blind randomised controlled trial was performed in University College Dublin and Ulster University. Participants aged > 50 years were recruited following screening for exclusion criteria i.e. taking medications known to interfere with B vitamin metabolism, supplements containing B vitamins, consuming >4 portions of B-vitamin fortified foods per week or diagnosed with gastrointestinal, liver or pulmonary disease. Recruited participants were randomised with gender and centre as factors in the randomisation to receive either B vitamin-fortified or placebo drinks (developed by Smartfish, Norway) daily for 16 weeks.ResultsA total of 95 participants were randomised, of which 81 commenced the trial. Of these, 70 completed - 37 in the active and 33 in the placebo groups. Intention to treat (ITT) analysis of the B vitamins demonstrated a significant improvement in all B vitamins biomarkers in the active compared to placebo groups (p<0.01 for Folate, Vitamin B12, Vitamin B6, and Riboflavin). A significant lowering of plasma homocysteine from 11.9 (10.3-15.1) µmol/L to 10.6 (9.4-13.0) µmol/L (functional marker of B vitamin status) was also observed in response to the active treatment (P<0.001). Similar results were seen in a per-protocol analysis.ConclusionsThe results demonstrate that a B vitamin-fortified drink was effective in optimising B vitamin status, making this a useful intervention strategy to improve B vitamin status in older adults. Trial registration: ISRCTN, ISRCTN61709781. - Retrospectively registered, https://www.isrctn.com/ISRCTN61709781

scholarly journals Efficacy of high-volume injections with and without corticosteroid compared with sham for Achilles tendinopathy: a protocol for a randomised controlled trial

2021 ◽  
Vol 7 (4) ◽  
pp. e001136
Author(s):  
Peter Malliaras ◽  
David Connell ◽  
Anders Ploug Boesen ◽  
Rebecca S Kearney ◽  
Hylton B Menz ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
High Volume ◽  
Primary Outcome Measure ◽  
Achilles Tendinopathy ◽  
Double Blind ◽  
Sham Injection ◽  
Intention To Treat ◽  
Randomised Controlled

IntroductionAchilles tendinopathy (AT) is a common and disabling musculoskeletal condition. First-line management involving Achilles tendon loading exercise with, or without, other modalities may not resolve the problem in up to 44% of cases. Many people receive injections. Yet there are no injection treatments with demonstrated long-term efficacy. The aim of the trial is to examine the 12-month efficacy of high-volume injection (HVI) with corticosteroid and HVI without corticosteroid versus sham injection among individuals with AT.Methods and analysisThe trial is a three-arm, parallel group, double-blind, superiority randomised controlled trial that will assess the efficacy of HVI with and without corticosteroid versus sham up to 12 months. We will block-randomise 192 participants to one of the three groups with a 1:1:1 ratio, and both participants and outcome assessors will be blinded to treatment allocation. All participants will receive an identical evidence-based education and exercise intervention. The primary outcome measure will be the Victorian Institute of Sport Assessment – Achilles (VISA-A) at 12 months post-randomisation, a validated, reliable and disease-specific measure of pain and function. Choice of secondary outcomes was informed by core outcome domains for tendinopathy. Data will be analysed using the intention-to-treat principle.Ethics and disseminationEthics approval was obtained via the Monash University Human Ethics Committee (no: 13138). The study is expected to be completed in 2024 and disseminated via peer review publication and conference presentations.Trial registration numberAustralia and New Zealand Clinical trials registry (ACTRN12619001455156)

scholarly journals Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study)

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e035672
Author(s):  
Xiaoqian Liu ◽  
Sarah Robbins ◽  
Jillian Eyles ◽  
Tatyana Fedorova ◽  
Sonika Virk ◽  
...  
Keyword(s):  
Adverse Events ◽  
Participatory Design ◽  
Controlled Trial ◽  
Symptomatic Relief ◽  
Joint Disease ◽  
Bark Extract ◽  
Hand Osteoarthritis ◽  
Scientific Publications ◽  
Boswellia Serrata ◽  
Double Blind

IntroductionHand osteoarthritis (HOA) is a highly prevalent disabling joint disease. The current management regimens are limited. Potentially as a consequence, many people turn to complementary and alternative medicines for symptomatic relief. A combination of two or more supplements is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to investigate the efficacy of a supplement combination for treating symptomatic HOA in comparison to placebo.Methods and analysisThe RADIANT study is an internet-based, parallel, superiority, double-blind, placebo-controlled, randomised, two-arm clinical trial. A participatory design is used to facilitate the study procedures. One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containingBoswellia serrataextract, pine bark extract and methylsulfonylmethane and (2) curcumin or placebo for 12 weeks. The primary outcome will be 12-week change in hand pain on a visual analogue scale (VAS). Main secondary outcomes include adverse events, change in hand function, patient global assessment of disease activity and quality of life. A range of additional measures will be recorded, and an individual patient placebo response will be performed. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored weekly throughout the study.Ethics and disseminationThis protocol has been approved by the University of Sydney Human Research Ethics Committee (HREC No. 2018/766). Dissemination will occur through conferences, social media, scientific publications and PhD thesis.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12619000835145); Pre-results

scholarly journals Early PARacetamol (EPAR) trial: a study protocol for a randomised controlled trial of early paracetamol to promote closure of the ductus arteriosus in preterm infants

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031428 ◽  
Author(s):  
Tim Schindler ◽  
John Smyth ◽  
Srinivas Bolisetty ◽  
Joanna Michalowski ◽  
Kei Lui
Keyword(s):  
Preterm Infants ◽  
Controlled Trial ◽  
Ductus Arteriosus ◽  
Primary Analysis ◽  
Double Blind ◽  
Safe Alternative ◽  
Target Sample Size ◽  
Intravenous Paracetamol ◽  
Registration Number ◽  
Randomised Controlled

IntroductionThe optimal management of patent ductus arteriosus (PDA) remains contentious. The medications used to treat PDA are often non-steroidal anti-inflammatory drugs, which are associated with a number of unwanted adverse effects. Paracetamol is a medication with an excellent safety profile in infants and has been suggested as a safe alternative medication in situations where other medications have failed or are contraindicated. There are limited data on the use of early, intravenous paracetamol in preterm infants.Methods and analysisThis trial aims to address whether early treatment with paracetamol will reduce the number of infants requiring intervention for PDA. This is a randomised, double-blind, placebo-controlled trial in preterm infants <29 weeks’ gestation. At 6 hours of life, infants with a ductus arteriosus >0.9 mm will be randomised to receive either (1) intravenous paracetamol at a dose of 15 mg/kg initially, followed by every 6 hours at a dose of 7.5 mg/kg for 5 days; or (2) intravenous 5% dextrose every 6 hours for 5 days. The primary outcome is the need for any intervention for management of PDA up to 5 days. Secondary outcomes include closure of the ductus arteriosus at 5 days, size of the ductus arteriosus, ductal reopening, systemic blood flow, mortality and significant morbidities. The target sample size of 100 infants yields >80% power, at the two-sided 5% level significance, to detect a 50% reduction in the need for intervention assuming that approximately 60% of infants in this study would otherwise have required intervention for PDA.Ethics and disseminationA report on the results of the planned analyses will be prepared. The results of the primary analysis of all end points will be presented at medical conferences and submitted for publication in peer-reviewed journals. Separate manuscripts pertaining to the second aim of the study may be written, and these will also be submitted for publication in peer-reviewed journals.Trial registration numberACTRN12616001517460.

The effect of a probiotic blend on gastrointestinal symptoms in constipated patients: a double blind, randomised, placebo controlled 2-week trial

2019 ◽  
Vol 10 (6) ◽  
pp. 617-627 ◽  
Author(s):  
K. Airaksinen ◽  
N. Yeung ◽  
A. Lyra ◽  
S.J. Lahtinen ◽  
T. Huttunen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Area Under The Curve ◽  
Functional Constipation ◽  
Colonic Transit ◽  
Primary Analysis ◽  
Double Blind ◽  
Probiotic Group ◽  
Intention To Treat ◽  
Bowel Movement Frequency

Selected strains of lactobacilli and bifidobacteria are known to ameliorate constipation-related symptoms and have previously shown efficacy on digestive health. In this clinical trial, the safety and effectiveness of a probiotic blend containing lactobacilli and bifidobacteria were evaluated in adults with self-reported bloating and functional constipation. Constipation was diagnosed by the Rome III criteria. A total of 156 adults were randomised into this double-blind and placebo-controlled trial. Participants consumed the combination of Lactobacillus acidophilus NCFM (1010 cfu), Lactobacillus paracasei Lpc-37 (2.5×109 cfu), Bifidobacterium animalis subsp. lactis strains Bl-04 (2.5×109 cfu), Bi-07 (2.5×109 cfu) and HN019 (1010 cfu) (n=78), or placebo (microcrystalline cellulose) (n=78) for two weeks. After treatment the following were measured: primary outcome of bloating and secondary outcomes of colonic transit time, bowel movement frequency, stool consistency, other gastrointestinal symptoms (flatulence, abdominal pain, and burbling), constipation-related questionnaires (PAC-SYM and PAC-QoL) and product satisfaction. Faecal recovery of consumed strains was determined. The enrolled population was defined as constipated, however, the initial bloating severity was lower than in previous similar studies. No clinically significant observations related to the safety of the product were reported. Product efficacy was not shown in the primary analysis for bloating nor for the secondary efficacy analyses. The placebo functioned similarly as the probiotic product. In post-hoc analysis, a statistically significant decrease in flatulence in favour of the probiotic group was observed; day 7 (intention-to-treat (ITT): P=0.0313; per-protocol (PP): 0.0253) and on day 14 (ITT: P=0.0116; PP: P=0.0102) as measured by area under the curve (AUC) analysis. The mean AUC of all symptoms decreased in favour of the probiotic group, indicating less digestive discomfort. The study was registered at the ISRCTN registry (ISRCTN41607808).

TP1-3 Final phase of recruitment and statistics analysis plan for Dex-CSDH trial

2019 ◽  
Vol 90 (3) ◽  
pp. e10.4-e11
Author(s):  
E Edlmann ◽  
A Kolias ◽  
E Thelin ◽  
D Gatt ◽  
Y Al-Tamimi ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Statistical Analysis Plan ◽  
Primary Outcome Measure ◽  
Favourable Outcome ◽  
Absolute Difference ◽  
Primary Analysis ◽  
Double Blind ◽  
Intention To Treat

ObjectivesReview recruitment progression and statistical analysis plan for Dex-CSDH trial.DesignA UK multi-centre, randomised, double-blind, placebo-controlled trial of dexamethasone versus placebo for CSDH.SubjectsSymptomatic, adult CSDH patients admitted to a participating neurosurgical unit.MethodsTrial participants receive a 2 week course of dexamethasone in addition to standard care, including surgery. The primary outcome measure is the modified Rankin Scale (mRS) at 6 months. An mRS of 0–3 requires the patient to be independently mobile and we have considered this a favourable outcome, with scores 4–6 (non-mobile) as unfavourable. The primary analysis will be performed on an intention-to-treat basis, estimating the absolute difference between the two treatment arms in the proportions achieving a favourable outcome. Secondary analysis will be done with an ordinal analysis of mRS scores and proportional odds logistic regression of the original mRS score adjusting for baseline covariates (age, GCS).Results629/750 patients (84%) have been recruited to the Dex-CSDH trial which is on-going as of 20-06-2018. Recruitment progress and follow-up at time of presentation will be reviewed alongside full statistical analysis plan.ConclusionsThe Dex-CSDH trial is drawing close to target following excellent recruitment across 22 UK centres. Transparent communication of the statistical analysis plan is essential prior to unblinding of the data. Up-to-date recruitment and primary endpoint completion rates will also be reviewed.

scholarly journals PREBIOTIC: A Study Protocol of a Randomised Controlled Trial to Assess Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Feasibility Study

2021 ◽  
Author(s):  
Samuel Chan ◽  
Carmel M Hawley ◽  
Elaine M Pascoe ◽  
Christopher Cao ◽  
Katrina L Campbell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Kidney Transplant ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Trial Registration ◽  
Feasibility Trial ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Randomised Controlled

Abstract BackgroundModulating the microbiota in the large intestine of kidney transplant recipients through prebiotic supplementation may prevent infectious complications from occurring. To date, there have been no interventional trials which have investigated this novel treatment in kidney transplantation. The aim of PREBIOTIC is to assess the feasibility of performing a randomised controlled trial of prebiotics in reducing infections and gastrointestinal symptoms in kidney transplant recipients.MethodsSixty kidney transplant patients will be recruited to a double-blind, placebo-controlled, randomised feasibility trial. Patients will be provided with prebiotic therapy or placebo for four to six weeks. Outcomes will include recruitment, adherence, tolerance, retention, laboratory parameters (including serum indoxyl sulphate, ρ-cresyl sulphate and stool collection), patients’ self-assessed quality of life, gastrointestinal symptoms and clinical outcomes.DiscussionThis trial will assess the feasibility of prebiotic supplementation in kidney transplant recipients. Prebiotics may not only alter the gut microbiota and their inherent metabolism and production of uraemic toxins, but may also prevent infections from occurring in kidney transplant recipients.Trial RegistrationAustralian New Zealand Clinical Trials Registry number ACTRN12618001057279p. The date of registration was 25th June 2018, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375370&isReview=true.

scholarly journals Fluoxetine therapy in depersonalisation disorder: Randomised controlled trial

2004 ◽  
Vol 185 (1) ◽  
pp. 31-36 ◽  
Author(s):  
Daphne Simeon ◽  
Orna Guralnik ◽  
James Schmeidler ◽  
Margaret Knutelska
Keyword(s):  
Serotonin Reuptake ◽  
Controlled Trial ◽  
Serotonin Reuptake Inhibitors ◽  
Double Blind ◽  
Intention To Treat ◽  
Dissociative Experiences ◽  
Efficacious Treatment ◽  
Randomised Controlled ◽  
Treat Analysis ◽  
Clinical Global Impression Improvement

BackgroundDespite anecdotal reports that serotonin reuptake inhibitors may improve depersonalisation, there is no proven efficacious treatment for depersonalisation disorder.AimsTo investigate the efficacy of fluoxetine in the treatment of depersonalisation disorder.MethodFifty-four people who met DSM-IV criteria for depersonalisation disorder were recruited through newspaper advertisements, and 50 were randomised to a 10-week, double-blind trial of fluoxetine 10–60 mg/day or placebo. Primary outcome measures were the Dissociative Experiences Scale-epersonalisation Factor, the Depersonalization Severity Scale and the Clinical Global Impression-Improvement (CGI-1) scale.ResultsIntention-to-treat analysis revealed that fluoxetine (mean dosage 48 mg/day) was not superior to placebo except for a clinically minimal but statistically significantly greater improvement in CGI-I score in the fluoxetine group prior to covarying for anxiety and depression (2.9 v. 3.6). Depersonalisation was significantly more likely to improve if comorbid anxiety disorder improved.ConclusionsFluoxetine was not efficacious in treating depersonalisation disorder, despite the commonly reported clinical use of serotonin reuptake inhibitors for this condition.

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