scholarly journals Randomized Controlled Trial Comparing the Efficacy and Safety of Epidural Infiltration of Particulate Versus Nonparticulate Steroids in the Treatment of Patients with Sciatic Pain

Author(s):  
Nazia Nazir ◽  
Savita Gupta ◽  
Vikas Saxena

Introduction: Epidural corticosteroid injections are widely used to treat low back pain, but doubts exist about the relative efficacy of particulate versus non-particulate corticosteroids. Epidural corticosteroid injections were performed in 75 patients with chronic radicular pain were evaluated for epidural corticosteroid injections to determine if there was a difference in the efficacy of triamcilone acetate, methylprednisolone acetate, and dexamethasone. Methods: 75 patients presenting with debilitating radicular pain were randomized to receive an injection of triamcilone acetate 40 mg/ml, methylprednisolone acetate 40 mg/ml, and dexamethasone phosphate 7.5 mg/ml at equal doses. Data were collected at 1-month and 3-month follow-up. The primary outcome of the present study was reduction in pain on a visual analog scale (VAS) at 3 months, while the secondary outcome was the type and number of complications in the study group. Results: Regardless of baseline score VAS, pain score decreased in all patients at one and three months. The patients with VAS of very severe also showed a statistically significant success rate at one and three month follow-up [p= 0.043]. No serious complications occurred in all three groups. Conclusion: According to this study, pain relief and functional improvement are similar among all three methylprednisolone acetate, triamcilone acetate and dexamethasone phosphate at 3 months.

2020 ◽  
pp. 1-12 ◽  
Author(s):  
Erandi Hewawasam ◽  
Carmel T. Collins ◽  
Beverly S. Muhlhausler ◽  
Lisa N. Yelland ◽  
Lisa G. Smithers ◽  
...  

Abstract Infants born preterm miss out on the peak period of in utero DHA accretion to the brain during the last trimester of pregnancy which is hypothesised to contribute to the increased prevalence of neurodevelopmental deficits in this population. This study aimed to determine whether DHA supplementation in infants born preterm improves attention at 18 months’ corrected age. This is a follow-up of a subset of infants who participated in the N3RO randomised controlled trial. Infants were randomised to receive an enteral emulsion of high-dose DHA (60 mg/kg per d) or no DHA (soya oil – control) from within the first days of birth until 36 weeks’ post-menstrual age. The assessment of attention involved three tasks requiring the child to maintain attention on toy/s in either the presence or absence of competition or a distractor. The primary outcome was the child’s latency of distractibility when attention was focused on a toy. The primary outcome was available for seventy-three of the 120 infants that were eligible to participate. There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0·08 s, 95 % CI –0·81, 0·97; P = 0·86). Enteral DHA supplementation did not result in improved attention in infants born preterm at 18 months’ corrected age.


2018 ◽  
Author(s):  
Jacqueline Burgess ◽  
Kerrianne Watt ◽  
Roy M Kimble ◽  
Cate M Cameron

BACKGROUND New technologies, widespread availability of the internet, the rise of social media and increased ownership of smartphones provide new opportunities for health researchers to communicate and engage with target audiences. OBJECTIVE This new technology was used to recruit mothers of young children to a smartphone application (app) to increase their knowledge about childhood burns (specifically hot beverage scalds) and correct burn first-aid. This six-month intervention deployed on the Cool Runnings app, used gamification techniques to reinforce intervention messages and engage participants. METHODS A two-group, parallel, single blinded, randomized controlled trial (RCT) to evaluate the efficacy of a smartphone app-based burn prevention intervention. Participants were women aged 18+, living in Queensland, Australia, with at least one child aged 5-12 months at the time of enrolment. The primary outcome measure was change in knowledge around burn risk and correct burn first-aid assessed via two methods: overall score; and categorised as adequate (score =4) vs inadequate (score less than 4). The secondary outcome measure was the efficacy of gamification techniques (measured by: app opens, photo uploads, pop quiz completions and content views). RESULTS In total, 498 participants were recruited via social media and enrolled. At 6-month follow-up, 244 participants completed the post-test questionnaire. Attrition rates in both groups were similar. Participants who remained in the study did not differ from those who were lost to follow up on any characteristics except for education level. Although similar at baseline, intervention group participants achieved significantly greater improvement in overall knowledge post-test than control group participants on both primary outcome measures (overall knowledge intervention: mean=2.68± 1.00 vs control mean:2.13±1.03; intervention: 20.47% adequate vs control: 7.3%). Consequently, the NNT was 7.46. Logistic regression showed participants exposed to the highest level of disadvantage were 7.3 times more likely to improve overall knowledge scores than participants in other levels of disadvantage. There were also significant correlations between each of the four gamification techniques and knowledge change (p<0.001). In addition, participants with low/moderate ‘app activity’ were 8.59 times more likely to have improved knowledge between baseline and 6-month follow-up than those who had no app activity (95%CI=2.9-25.02); participants with high app activity were 18.26 times more likely to have improved knowledge (95%CI=7.1-46.8). CONCLUSIONS Despite substantial loss to follow-up, this RCT demonstrates the Cool Runnings app was an effective intervention for improving knowledge about hot beverage scald risks and burn first-aid in mothers of young children. The benefits of combining gamification elements in the intervention were also highlighted. Given the low cost and large reach of smartphone apps to deliver content to, and engage with targeted populations, results from this RCT provides important information on how smartphone applications can be used for widespread injury prevention campaigns, and public health campaigns generally. CLINICALTRIAL This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000019404)


2021 ◽  
Vol 14 (10) ◽  
pp. 1063
Author(s):  
Elena P. Calandre ◽  
Javier Hidalgo-Tallon ◽  
Rocio Molina-Barea ◽  
Fernando Rico-Villademoros ◽  
Cristina Molina-Hidalgo ◽  
...  

Background: Gastrointestinal symptomatology is frequent among patients with fibromyalgia, which increases disease burden and lacks specific treatment, either pharmacological or non-pharmacological. We aimed to evaluate the efficacy and tolerability of a multi-strain probiotic, VSL#3®, for the treatment of fibromyalgia-associated gastrointestinal manifestations. Methods: This randomized, placebo-controlled trial included 12 weeks of probiotic or placebo treatment followed by 12 weeks of follow up. The primary outcome variable was the mean change from the baseline to the endpoint in the composite severity score of the three main gastrointestinal symptoms reported by patients with fibromyalgia (abdominal pain, abdominal bloating and meteorism). Secondary outcome variables were the severity of additional gastrointestinal symptoms, fibromyalgia severity, depression, sleep disturbance, health-related quality of life and patients’ overall impression of improvement. Results: No differences were found between VSL#3® (n = 54) and the placebo (n = 56) in the primary outcome (estimated treatment difference: 1.1; 95% confidence interval [CI]: −2.1, 4.2; p = 0.501), or in any of the secondary outcomes. However, responders to VSL#3 were more likely to maintain any improvement during the follow-up period compared to responders in the placebo arm. Overall, VSL#3 tolerability was good. Conclusion: Our data could not demonstrate any beneficial effects of VSL#3® either on the composite score of severity of abdominal pain, bloating and meteorism or in any of the secondary outcome variables. More research is needed to elucidate specific factors that may predict a favourable response to treatment in patients with fibromyalgia.


2021 ◽  
pp. neurintsurg-2021-017341
Author(s):  
Devin V Bageac ◽  
Blake S Gershon ◽  
Jan Vargas ◽  
Maxim Mokin ◽  
Zeguang Ren ◽  
...  

BackgroundMost conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation.MethodsThis is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement.ResultsEach study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0–2%, and 10.26% were deceased.ConclusionsTracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.


Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mona Dietrichkeit ◽  
Marion Hagemann-Goebel ◽  
Yvonne Nestoriuc ◽  
Steffen Moritz ◽  
Lena Jelinek

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kil-yong Lee ◽  
Jaeim Lee ◽  
Youn Young Park ◽  
Seong Taek Oh

Abstract Background Routine colonoscopy is recommended to determine the coexistence of colon cancer after medical treatment for colon diverticulitis. However, in the case of uncomplicated diverticulitis diagnosed by computed tomography, the clinical relevance of routine follow-up colonoscopy has recently been debated. Yet, the role of follow-up colonoscopy for right colon diverticulitis, which tends to develop at a younger age than left colon diverticulitis, has not been specifically evaluated. Therefore, we aimed to evaluate the incidence of right colon cancer or colonic adenomatous polyps, detected by routine colonoscopy, after conservative management of acute uncomplicated right colon diverticulitis. Methods Patients with uncomplicated right colon diverticulitis (modified Hinchey stage Ia) diagnosed by computed tomography imaging, between 2011 and 2017, and who underwent follow-up colonoscopy surveillance after treatment were included. The primary outcome was the incidence of colon cancer, with the detection rate of adenoma being the secondary outcome. Information for analysis was retrieved retrospectively from patients’ medical records. Results The study group included 330 consecutive patients, with a mean age of 41.9 years, and 51.9% being men. For the primary outcome, the rate of colon cancer on follow-up colonoscopy was 0.3% (1/330 cases). The rate of adenoma detection was 20.9% (69/330 cases) and advanced adenoma (> 10 mm in diameter; or exhibiting a > 25% villous component or severe dysplasia), including colon cancer, was observed in 9 patients (2.7%). Conclusions In patients with acute uncomplicated right colonic diverticulitis, routine colonoscopy after conservative treatment may be necessary because although the colon cancer detection rate is low, it is possible to detect advanced colon adenoma.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.


Author(s):  
Katrin Brück ◽  
Kirsten Jacobi ◽  
Tobias Schmidt

BACKGROUND: Chronic neck pain (CNP) is a common health problem in western industrialized nations. In recent years, the fascial tissue has attracted the attention of therapists, and a treatment of the fasciae promises to be a meaningful approach in the therapy of patients with CNP. OBJECTIVE: The aim of this study was to investigate the effectiveness of a fascial treatment (FT) compared to manual therapy (MT) and to no intervention (control group, CG) in patients with CNP. METHODS: Sixty participants with CNP were randomized into three groups. Primary outcome parameters were pain intensity as measured by the visual analogue scale (VAS), and severity of illness as measured by the Neck Pain and Disability Scale (NPAD). Secondary outcome parameter was the range of motion (ROM) of the cervical spine. RESULTS: Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD: dR⁢M= 0.72). CONCLUSION: Our results confirmed the effectiveness of MT on pain and severity of illness in the treatment of patients suffering from CNP. Furthermore, the results demonstrated the effectiveness and clinical relevance of FT for this population.


2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.


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