scholarly journals Optimising outcomes of exercise and corticosteroid injection in patients with subacromial pain (impingement) syndrome: a factorial randomised trial

2020 ◽  
pp. bjsports-2019-101268
Author(s):  
Edward Roddy ◽  
Reuben O Ogollah ◽  
Raymond Oppong ◽  
Irena Zwierska ◽  
Praveen Datta ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Corticosteroid Injection ◽  
Randomised Trial ◽  
Clinical Effectiveness ◽  
Impingement Syndrome ◽  
Ultrasound Guided ◽  
Exercise Interventions ◽  
Intention To Treat ◽  
Registration Number ◽  
And Function

ObjectivesTo compare the clinical effectiveness of (1) physiotherapist-led exercise versus an exercise leaflet, and (2) ultrasound-guided subacromial corticosteroid injection versus unguided injection for pain and function in subacromial pain (formerly impingement) syndrome (SAPS).MethodsThis was a single-blind 2×2 factorial randomised trial. Adults with SAPS were randomised equally to one of four treatment groups: (1) ultrasound-guided corticosteroid injection and physiotherapist-led exercise, (2) ultrasound-guided corticosteroid injection and an exercise leaflet, (3) unguided corticosteroid injection and physiotherapist-led exercise and (4) unguided corticosteroid injection and an exercise leaflet. The primary outcome was the Shoulder Pain and Disability Index (SPADI), collected at 6 weeks, 6 and 12 months and compared at 6 weeks for the injection interventions and 6 months for the exercise interventions by intention to treat.ResultsWe recruited 256 participants (64 treatment per group). Response rates for the primary outcome were 94% at 6 weeks, 88% at 6 months and 80% at 12 months. Greater improvement in total SPADI score was seen with physiotherapist-led exercise than with the exercise leaflet at 6 months (adjusted mean difference −8.23; 95% CI −14.14 to -2.32). There were no significant differences between the injection groups at 6 weeks (−2.04; −7.29 to 3.22), 6 months (−2.36; −8.16 to 3.44) or 12 months (1.59; −5.54 to 8.72).ConclusionsIn patients with SAPS, physiotherapist-led exercise leads to greater improvements in pain and function than an exercise leaflet. Ultrasound guidance confers no additional benefit over unguided corticosteroid injection.Trial registration numberISRCTN42399123.

scholarly journals Cast versus functional brace in the rehabilitation of patients treated for an ankle fracture: protocol for the UK study of ankle injury rehabilitation (AIR) multicentre randomised trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e027242 ◽  
Author(s):  
Rebecca Samantha Kearney ◽  
Rebecca McKeown ◽  
Siobhan Stevens ◽  
Nicholas Parsons ◽  
Helen Parsons ◽  
...  
Keyword(s):  
Ankle Fracture ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Operative Management ◽  
Plaster Cast ◽  
Reference Case ◽  
Intention To Treat ◽  
Functional Brace ◽  
Registration Number ◽  
The Uk

IntroductionEach year in the UK over 120 000 people fracture their ankle. It is not known what the best rehabilitation strategy is for these people. Traditionally standard care has involved immobilisation in a plaster cast but an alternative is a functional brace, which can be removed to allow early movement. This paper details the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with an ankle fracture.Methods and analysisWe will recruit adults with a fractured ankle, for which the treating clinician would consider plaster cast to be a reasonable management option. Randomisation will be on a 1:1 basis, stratified by centre, operative or non-operative management and age. Participants will be allocated to either plaster cast or a functional brace, both treatments are widely used. To have 90% power to detect a difference of 10 points on the primary outcome (Olerud and Molander Ankle Score) at the primary outcome time point (16 weeks), we need to randomise a minimum of 478 people. Quality of life and resource use will be collected at 6, 10, 16, 24 weeks and 12, 18, 24 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The economic evaluation will adhere to the recommendations of the National Institute for Health and Care Excellence reference case.Ethics, registration and disseminationNational Research Ethic Committee approved this study on 4 July 2017 (17/WM/0239). The first site opened to recruitment 9 October 2017. The results of this trial will be submitted to a peer-reviewed journal and will inform clinical practice.Trial registration numberISRCTN15537280; Pre-results.

scholarly journals Hypotension in Preterm Infants (HIP) randomised trial

2021 ◽  
pp. fetalneonatal-2020-320241
Author(s):  
Eugene M Dempsey ◽  
Keith J Barrington ◽  
Neil Marlow ◽  
Colm Patrick Finbarr O'Donnell ◽  
Jan Miletin ◽  
...  
Keyword(s):  
Brain Injury ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Intraventricular Haemorrhage ◽  
Standard Group ◽  
Double Blind ◽  
Group Assignment ◽  
Standard Management ◽  
Postmenstrual Age ◽  
Registration Number

ObjectiveTo determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation.DesignDouble-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.Setting10 sites across Europe and Canada.ParticipantsInfants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage.InterventionParticipants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).Primary outcomeSurvival to 36 weeks of PMA without severe brain injury.ResultsThe trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038).ConclusionThough this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area.Trial registration numberNCT01482559, EudraCT 2010-023988-17.

scholarly journals Evaluating a Values-Based Intervention for Adolescence with High Nonclinical Paranoia: A Schools-Based Randomised Control Trial

2021 ◽  
Author(s):  
A. Parker ◽  
J. Kingston
Keyword(s):  
Active Control ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Self Esteem ◽  
Randomised Control Trial ◽  
Intention To Treat ◽  
Low Intensity ◽  
Time Interaction ◽  
Potential Mediator

Abstract Background Paranoia in adolescents is common, but research on attenuating it is scarce. Focusing on values and enhancing value-based acts is a low intensity method for attenuating paranoia in adults. This randomised trial compared a brief (30-min, self-directed) values-plus-goals intervention to an active control for adolescents with high nonclinical paranoia (Paranoia Scale ≥ 53), delivered in schools. The study also investigated the role of self-esteem. Methods Ninety adolescents were randomly assigned to condition. Paranoia (primary outcome) and self-esteem (potential mediator) were assessed at baseline (T1), and two- (T2) and six-weeks (T3) after baseline. Results Results were analysed using intention to treat (ITT) and per protocol (PP) analysis. Using ITT analysis, the Condition*Time interaction was significant (F(2, 168) = 3.98, p = .02), paranoia was significantly lower at T3 following values-plus-goals as compared to control (d = 0.64). Differences were not significant using per protocol analysis (F(2, 106) = 1.61, p = .21). The between group effect size at T3 was (d = 0.61). The Condition*Time interaction for self-esteem was not significant (F(2, 112) = 2.86, p = .06). Conclusions Tentatively, findings suggest that a brief values-plus-goals intervention can reduce paranoia in adolescents relative to an active control.

scholarly journals A partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TB

2021 ◽  
Vol 25 (4) ◽  
pp. 305-314
Author(s):  
C. D. Tweed ◽  
G. H. Wills ◽  
A. M. Crook ◽  
E. Amukoye ◽  
V. Balanag ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Randomised Trial ◽  
Group Differences ◽  
Pulmonary Tb ◽  
Intention To Treat ◽  
Tb Treatment ◽  
Grade 3 ◽  
To Receive ◽  
Ongoing Evaluation ◽  
Post Randomisation

BACKGROUND: Treatment for TB is lengthy and toxic, and new regimens are needed.METHODS: Participants with pulmonary drug-susceptible TB (DS-TB) were randomised to receive: 200 mg pretomanid (Pa, PMD) daily, 400 mg moxifloxacin (M) and 1500 mg pyrazinamide (Z) for 6 months (6Pa200MZ) or 4 months (4Pa200MZ); 100 mg pretomanid daily for 4 months in the same combination (4Pa100MZ); or standard DS-TB treatment for 6 months. The primary outcome was treatment failure or relapse at 12 months post-randomisation. The non-inferiority margin for between-group differences was 12.0%. Recruitment was paused following three deaths and not resumed.RESULTS: Respectively 4/47 (8.5%), 11/57 (19.3%), 14/52 (26.9%) and 1/53 (1.9%) DS-TB outcomes were unfavourable in patients on 6Pa200MZ, 4Pa200MZ, 4Pa100MZ and controls. There was a 6.6% (95% CI –2.2% to 15.4%) difference per protocol and 9.9% (95%CI –4.1% to 23.9%) modified intention-to-treat difference in unfavourable responses between the control and 6Pa200MZ arms. Grade 3+ adverse events affected 68/203 (33.5%) receiving experimental regimens, and 19/68 (27.9%) on control. Ten of 203 (4.9%) participants on experimental arms and 2/68 (2.9%) controls died.CONCLUSION: PaMZ regimens did not achieve non-inferiority in this under-powered trial. An ongoing evaluation of PMD remains a priority.

scholarly journals Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040110
Author(s):  
Mikaela Smit ◽  
Annalisa Marinosci ◽  
Giovanni Jacopo Nicoletti ◽  
Thomas Perneger ◽  
Silvio Ragozzino ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Standard Of Care ◽  
Cluster Randomised Trial ◽  
Postexposure Prophylaxis ◽  
Open Label ◽  
Daily Monitoring ◽  
Intention To Treat ◽  
Cluster Randomised ◽  
Registration Number ◽  
Asymptomatic Individuals

IntroductionLopinavir/ritonavir (LPV/r) has been proposed as repurposed drugs for pre-exposure and postexposure prophylaxis as well as therapy of COVID-19. Coronavirus postexposure prophylaxis (COPEP) trial aims at assessing their efficacy as postexposure ring-prophylaxis among adults exposed to SARS-CoV-2.Methods and analysisCOPEP is a two-arm open-label cluster-randomised trial conducted in three cantons of Switzerland. Asymptomatic contacts (≥16 years) of individuals diagnosed with COVID-19 will be randomised (2:1) to either LPV/r (400 mg/100 mg two times per day) for 5 days, or a standard of care arm (no treatment). Asymptomatic individuals may be either SARS-CoV-2 positive or negative. Contacts living in the single household will form a cluster and will be randomised into the same arm. All participants will be followed-up for 21 days and undergo daily monitoring for COVID-19 symptoms. The primary endpoint is 21-day incidence of laboratory-confirmed COVID-19 with ≥1 compatible symptom, analysed in an intention-to-treat (ITT) analysis. The secondary endpoints include the 21-day incidence of COVID-19 as well as SARS-CoV-2 infection in a modified ITT analysis, excluding participants who had a positive SARS-CoV-2 RT-PCR from oropharyngeal swab and/or a positive SARS-CoV-2 IgG serology at baseline. Assuming a 21-day incidence for COVID-19 of 20% among contacts without postexposure chemoprophylaxis, to detect a relative risk reduction of 60% (ie, translating in an absolute reduction from 20% to 8%), with a power of 80%, an alpha of 5%. Accounting for design effect of cluster design of circa 1.1, we plan to enrol 200 participants to the LPV/r arm and 100 to the standard of care arm, 300 participants in total.Ethics and disseminationEthics approval has been granted by the Commission Cantonale d’Ethique de la Recherche, Ethikkommission Nordwest- und Zentralschweiz and Comitato Etico Cantonale (ref 2020-00864) and Swissmedic (2020DR3056). Results from this trial will be disseminated via journal articles and presentations at national and international conferences.Trial registration numberClinicaltrials.gov Registry (NCT04364022); Swiss National Clinical Trial Portal Registry (SNCTP 000003732).Registered report identifierCCER 2020-0864.

scholarly journals Effectiveness of Blind & Ultrasound Guided Corticosteroid Injection in Impingement Syndrome

2015 ◽  
Vol 8 (7) ◽  
pp. 179 ◽  
Author(s):  
Shila Haghighat ◽  
Parisa Taheri ◽  
Mohsen Banimehdi ◽  
Arash Taghavi
Keyword(s):  
Steroid Injection ◽  
Corticosteroid Injection ◽  
Medical Science ◽  
Impingement Syndrome ◽  
Control Group ◽  
Case Group ◽  
Ultrasound Guided ◽  
Shoulder Range Of Motion ◽  
Significant Difference ◽  
Corticosteroid Injections

<p>Local steroid injections are common for treatment of impingement syndrome. Corticosteroid injections methods are basically in two formats, blind or with image guidance. The aim of this study is to compare the effect of ultrasound-guided in comparison with blind corticosteroid injections in patients with impingement syndrome. This study is a randomized clinical trial study undertaken in patients with diagnosis of impingement syndrome done in Isfahan University of Medical Science clinics from February 2014 to February 2015. The number of all patients registered in the study is 48; and then 40 patients were allocated to either control group randomly which received blind steroid injection or case group that underwent ultrasound-guided steroid injection. The clinical symptoms were assessed using Shoulder Pain and Disability Index (SPADI) questionnaire, Visual Analogue Scale (VAS) and shoulder range of motion (ROM) using goniometer at baseline and six weeks after the injection. Data analysis revealed a significant difference in the mean of the VAS, SPADI and shoulder ROM in both groups 6 weeks after intervention (P &lt; 0.05). Patients with ultrasound guided corticosteroid injection had statistically significant improvements in function and shoulder ROM (abduction, flexion) compared to blind injection group after 6 weeks (P&lt;0.05). There was not significant differences in pain (VAS) and internal and external rotation between these two groups (p&gt;0.05). Our findings suggest that US image guided can improve the shoulder function of patients with impingement syndrome, and thus can be considered in comprehensive care programs of these patients for fast speed of rehabilitation.</p>

Clinical effectiveness of a Malaysian-manufactured CAPD product: A randomised trial

2021 ◽  
Vol 41 (3) ◽  
pp. 273-283 ◽  
Author(s):  
Wen Yao Mak ◽  
Chin Tho Leong ◽  
Loke Meng Ong ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Trial ◽  
Clinical Effectiveness ◽  
Open Label ◽  
Dialysis Dose ◽  
Intention To Treat ◽  
Significant Difference ◽  
Incident Rate ◽  
Randomised Controlled

Background:We compared the clinical effectiveness of a new peritoneal dialysis (PD) product with polyvinyl chloride-containing tubing (Stay Safe Link®, SSL) with the plastic-free alternative (Stay Safe®, STS) in patients on continuous ambulatory peritoneal dialysis (CAPD).Method:A multicentre, parallel, randomised, controlled, open-label, non-inferiority trial was conducted. Adult patients receiving CAPD were randomised in a 1:1 ratio to SSL or STS. The primary outcome was the rate of peritonitis after 1 year of follow-up.Results:A total of 472 subjects were randomised (SSL, n = 233; STS, n = 239). One subject in each group was excluded from the analysis as they withdrew consent before the first dialysis dose. Four hundred and seventy subjects (SSL, n = 232; STS, n = 238) were included in the modified intention-to-treat analysis. Non-inferiority between two groups was established as no significant difference was found in peritonitis rate (incident rate ratio: 0.91, 95% CI: 0.65–1.28). No significant difference was detected in weekly Kt/V ( p = 0.58) and creatinine clearance ( p = 0.55). However, the average ultrafiltration volume was significantly lower in SSL, with a mean difference of 93 ml ( p < 0.01). SSL also demonstrated a 2.57-times higher risk of device defect than STS (95% CI: 1.77–3.75).Conclusion:SSL was non-inferior in peritonitis rate compared to plastic-free STS over 1 year in patients requiring CAPD. There was no difference in the delivered dialysis dose, but there was a higher rate of device defects with SSL.

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