Using intra-articular allogenic lyophilized growth factors in primary knee osteoarthritis: a randomized pilot study

2021 ◽  
Vol 16 (2) ◽  
pp. 113-115
Author(s):  
Rasmia El-Gohary ◽  
Amany Diab ◽  
Hala El-Gendy ◽  
Hossam Fahmy ◽  
Kamel Heshmat Gado
Keyword(s):  
Growth Factors ◽  
Pilot Study ◽  
Knee Osteoarthritis ◽  
Small Sample Size ◽  
Intervention Group ◽  
Small Sample ◽  
Injection Pain ◽  
Post Injection ◽  
Open Label ◽  
Clinical Trial Registration

Objective: Investigating the safety in addition to clinical and structural efficacy of allogenic lyophilized growth factors (L-GFs) in patients with symptomatic primary knee osteoarthritis. Design: A prospective, open-label pilot study. A total of 31-patients randomized into non-intervention and intervention groups. Materials & methods: The intervention group received two intra-articular doses at baseline and after 2-months. Post-injection complications were documented, and the efficacy was assessed by Western Ontario and McMaster Universities Osteoarthritis Index scores and ultrasonography. Results: One dropout from the intervention group. The percentage of improvement of mean Western Ontario and McMaster Universities Osteoarthritis Index-scores and ultrasonography-detected effusion were statistically significant in the intervention group compared with the non-intervention. A brief, mild, post-injection pain was reported by all intervention group. Conclusion: This study provides the safety of intra-articular injection of allogenic L-GFs in knee osteoarthritis. The conclusion of efficacy was limited by small sample size and lack of control injection. Clinical trial registration: NCT04331327 (ClinicalTrials.gov, retrospectively registered).

scholarly journals Open-label, add-on trial of cetirizine for neuromyelitis optica

2018 ◽  
Vol 5 (2) ◽  
pp. e441 ◽  
Author(s):  
Ilana Katz Sand ◽  
Michelle T. Fabian ◽  
Russell Telford ◽  
Thomas A. Kraus ◽  
Mirna Chehade ◽  
...  
Keyword(s):  
Pilot Study ◽  
Neuromyelitis Optica ◽  
Standard Therapy ◽  
Small Sample Size ◽  
Small Sample ◽  
Open Label ◽  
End Point ◽  
Disease Modifying Therapy ◽  
Significant Difference ◽  
Disease Modifying

ObjectiveThis pilot study preliminarily examined the efficacy and tolerability of cetirizine as an add-on to standard therapy for neuromyelitis optica (NMO).MethodsEligible participants met the Wingerchuk 2006 diagnostic criteria or had a single typical episode along with positive NMO immunoglobulin G. After baseline clinical and laboratory assessments, participants began treatment with cetirizine 10 mg orally daily, in addition to their usual disease-modifying therapy for NMO, and continued for 1 year. The primary end point was the annualized relapse rate (ARR) while on the same disease-modifying therapy before starting cetirizine compared with after taking cetirizine. Additional end points included disability (Expanded Disability Status Scale [EDSS]), relapse severity, tolerability, especially with respect to drowsiness measured by the Epworth Sleepiness Scale (ESS), and laboratory parameters.ResultsThe ARR before cetirizine was 0.4 ± 0.80 and after cetirizine was 0.1 ± 0.24 (p = 0.047). There was no statistically significant difference in the EDSS (mean 3.9 ± 2.18 before the start of the study and 3.2 ± 2.31 at the conclusion of the study, p = 0.500). The ESS remained fairly consistent throughout the study (mean 6.5 ± 5.33 at baseline and 6.9 ± 4.50 at month 12, p = 0.740). Laboratory studies were unrevealing.ConclusionsIn this pilot study, cetirizine was well tolerated, and the prespecified primary efficacy end point was satisfied. However, the open-label design and the small sample size of this pilot study preclude definitive conclusions. Further research is needed.Classification of evidenceThis study provides Class IV evidence that in patients with NMO, the addition of cetirizine to standard therapy is safe, well tolerated, and reduces relapses.

scholarly journals Acupotomy for Osteoarthritis of the Knee; A Systematic Review and Meta-Analysis

2021 ◽  
Vol 38 (2) ◽  
pp. 96-109
Author(s):  
Seung Min Lee ◽  
Cham Kyul Lee ◽  
Kyung Ho Kim ◽  
Eun Jung Kim ◽  
Chan Yung Jung ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Western Medicine ◽  
Small Sample Size ◽  
Meta Analysis ◽  
Intervention Group ◽  
Effective Rate ◽  
Small Sample ◽  
Control Group ◽  
Osteoarthritis Of The Knee ◽  
Randomized Controlled

The purpose of this study was to evaluate the effectiveness and safety of acupotomy for the treatment of patients with knee osteoarthritis. There were 9 databases searched to retrieve randomized controlled trials until August 3, 2019 regarding acupotomy versus conventional Western medicine, conventional Western medicine treatment with and without acupotomy, and Korean medicine treatment with and without acupotomy, and meta-analysis was performed. Of 303 potentially relevant studies retrieved, 43 were systematically reviewed. All studies were conducted in China. Effective rate, visual analogue scale, and Western Ontario and McMaster Universities Osteoarthritis index were used as the evaluation scales. The Ashi point was selected most frequently. In all studies, the intervention group was more effective than the control group. Meta-analysis revealed that acupotomy showed statistically significant beneficial results. Although acupotomy had a beneficial effect on knee osteoarthritis, the risk of bias of the included studies was not low. The majority of the results from the evaluation scales used were highly heterogeneous (> 50%) which reduced confidence in the estimation of effect, or had a small sample size. Further clinical research and development is required in the future.

scholarly journals The Symbiotic Mutualism between Co-Creation and Entrepreneurship

2021 ◽  
Vol 13 (11) ◽  
pp. 6285
Author(s):  
Sandra Misiak-Kwit ◽  
Małgorzata Wiścicka-Fernando ◽  
Kelaniyage Shihan Dilruk Fernando
Keyword(s):  
Pilot Study ◽  
Small Sample Size ◽  
Strong Association ◽  
Sampling Technique ◽  
Small Sample ◽  
Entrepreneurial Intentions ◽  
Added Value ◽  
Primary Data ◽  
Exploratory Research ◽  
Symbiotic Mutualism

In this manuscript, the authors aim to explore firstly the association between entrepreneurial mindset and co-creation experience, secondly the association between co-creation experience and entrepreneurial intentions, and thirdly the association between entrepreneurial mindset and entrepreneurial intentions within the sustainability context. In this paper, the authors present the results of the pilot study. Primary data were collected from 500 university students from China, Georgia, Poland, Romania, and Sri Lanka by using a convenient sampling technique, and a literature review was the primary method of the concept development. The authors selected the above-mentioned countries to collect primary data by using a convenient sampling technique based on accessibility; they also visited all analysed countries in order to conduct the pilot survey personally. Descriptive statistics and the Spearman’s rank correlation coefficient were applied as primary statistical methods. The findings reveal that there is a very strong association between co-creation experience and entrepreneurial intentions, a very weak negative association between entrepreneurial mindset and co-creation experience, and, surprisingly, a weak association between entrepreneurial mindset and entrepreneurial intentions. The added value of the conducted pilot research involves filling in a gap regarding the relationship between experience and the subjective norm. In the presented pilot research, co-creation experience was compared with not only entrepreneurial mindset but with entrepreneurial intentions as well. An additional value of this exploratory research is compiling an international comparison. The main contribution of this pilot study is examining the symbiotic mutualism between co-creation and entrepreneurship. Among many platforms of associations, the following can be differentiated: creativity, innovativeness, openness, engagement, awareness, motivation, trust (level of social capital), and recognizing the significance of social and sustainable development objectives. Due to the small sample size, the results cannot be generalised. Results refer only to the respondents. However, the findings of the pilot study are the basis for further research studies on symbiotic mutualism between entrepreneurship and co-creation.

scholarly journals Blinding in electric current stimulation in subacute neglect patients with current densities of 0.8 A/m2: a cross-over pilot study

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Anna Gorsler ◽  
Ulrike Grittner ◽  
Nadine Külzow ◽  
Torsten Rackoll
Keyword(s):  
Pilot Study ◽  
Electric Fields ◽  
Standard Care ◽  
Small Sample Size ◽  
Small Sample ◽  
Related Factors ◽  
Attentional Deficits ◽  
Age Related ◽  
Current Densities ◽  
Improve Standard

Abstract Objective Neglect after stroke is a disabling disorder and its rehabilitation is a major challenge. Transcranial direct current stimulation (tDCS) seems to be a promising adjuvant technique to improve standard care neglect therapy. Since electric fields are influenced by age-related factors, higher current densities are probably needed for effective treatment in aged stroke patients. Validation of treatment efficacy requires sham-controlled experiments, but increased current densities might comprise blinding. Therefore, a pilot study was conducted to test sham adequacy when using current density of 0.8 A/m2. Whether especially neglect patients who mainly suffer from perceptual and attentional deficits are able to differentiate beyond chance active from sham tDCS was investigated in a randomized cross-over design (active/sham stimulation) in 12 early subacute patients with left-sided hemineglect. Stimulation (0.8 A/m2) was performed simultaneous to standard care neglect therapy. Results Odds ratio of correct guessing an atDCS condition compared to wrongly judge an atDCS condition as sham was 10.00 (95%CI 0.65–154.40, p = 0.099). However, given the small sample size and high OR, although likely somewhat overestimated, results require careful interpretation and blinding success in neglect studies with current densities of 0.8 A/m2 should be further confirmed.

Pain perception in chronic knee osteoarthritis with varying levels of pain inhibitory control: an exploratory study

2020 ◽  
Vol 20 (4) ◽  
pp. 651-661
Author(s):  
Paulo E. P. Teixeira ◽  
Hanan I. Zehry ◽  
Swapnali Chaudhari ◽  
Laura Dipietro ◽  
Felipe Fregni
Keyword(s):  
Knee Osteoarthritis ◽  
Pain Intensity ◽  
Pain Perception ◽  
Small Sample Size ◽  
Linear Regression Analysis ◽  
Small Sample ◽  
Pain Modulation ◽  
Clinical Variables ◽  
Pain Scores ◽  
Intensity Perception

AbstractBackground and aimsPain is a disabling symptom in knee osteoarthritis (KOA) and its underlying mechanism remains poorly understood. Dysfunction of descending pain modulatory pathways and reduced pain inhibition enhance pain facilitation in many chronic pain syndromes but do not fully explain pain levels in chronic musculoskeletal conditions. The objective of this study is to explore the association of clinical variables with pain intensity perception in KOA individuals with varying levels of Conditioned Pain Modulation (CPM) response.MethodsThis is a cross-sectional, exploratory analysis using baseline data of a randomized clinical trial investigating the effects of a non-invasive brain stimulation treatment on the perception of pain and functional limitations due to KOA. Sixty-three subjects with KOA were included in this study. Data on pain perception, mood perception, self-reported depression, physical function, quality of life, and quantitative sensory testing was collected. Multiple linear regression analysis was performed to explore the association between the clinical variables with pain perception for individuals with different levels of CPM response.ResultsFor KOA patients with limited CPM response, perception of limitations at work/other activities due to emotional problems and stress scores were statistically significantly associated with pain scores, F(2, 37) = 7.02, p < 0.01. R-squared = 0.275. For KOA patients with normal CPM response, general health perception scores were statistically significantly associated with pain scores, F(1, 21) = 5.60, p < 0.05. R-squared = 0.2104. Limitations of this study include methodology details, small sample size and study design characteristics.ConclusionsPain intensity perception is associated differently with clinical variables according to the individual CPM response. Mechanistic models to explain pain perception in these two subgroups of KOA subjects are discussed.

Perceptions and Understanding of Diabetes Mellitus Technology in Adults with Type 1 or Type 2 DM: A Pilot Survey from Pakistan

2021 ◽  
pp. 193229682110111
Author(s):  
Sarah Nadeem ◽  
Uswah Siddiqi ◽  
Russell Seth Martins ◽  
Kaleemullah Badini
Keyword(s):  
Diabetes Mellitus ◽  
Pilot Study ◽  
Diabetes Care ◽  
Online Survey ◽  
Small Sample Size ◽  
Developed Countries ◽  
Small Sample ◽  
Cost Of Care ◽  
Cross Sectional ◽  
Specific Patient

Introduction: Diabetes mellitus technology (DMT) is increasingly used for routine management in developed countries, yet its uptake in developing countries is not as consistent. Multiple factors may influence this, including country specific patient perception regarding DMT. We conducted a pilot study in Pakistan to understand this important question which has not been studied yet. Methods: A cross-sectional pilot study was conducted in Pakistan. An anonymous survey exploring perceptions of diabetes technology was circulated on social media platforms, collecting responses over 2 weeks. Target population included adults (≥18 years) living in Pakistan, with DM1 or 2. Results: A total of 40 responses were received. The majority (36/40) reported using conventional glucometers. Nine used continuous glucose monitoring (CGM). Thirty-two of 40 patients believed DMT improved diabetes care, 22 felt it helped decreased risk of Diabetes-related complications. 15/40 stated that DMT results in increased cost of care. Sixteen reported their diabetes care teams had never discussed wearable DMT options whereas 11 disliked them because they did not want a device on their self. Conclusion: In our pilot study we have identified broad themes of opportunity and challenges to DMT use in Pakistan. Patients’ perceptions regarding DMT were generally positive but significant barriers to its acceptance included high cost, lack of discussion between doctor and patient about available technology and personal hesitation. Limitations of our study include sampling bias (online survey) and small sample size, but this data can help inform larger studies, to look at this important topic in greater detail.

Internet-based intervention compared to brief intervention for smoking cessation in Brazil: a pilot study (Preprint)

2021 ◽  
Author(s):  
Nathalia Machado ◽  
Henrique Gomide ◽  
Heder Bernardino ◽  
Telmo Ronzani
Keyword(s):  
Smoking Cessation ◽  
Brief Intervention ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Healthcare Providers ◽  
Intervention Group ◽  
Small Sample ◽  
The Internet ◽  
Intention To Treat ◽  
Internet Based Intervention

BACKGROUND Smoking is still the leading cause of preventable death. Governments and healthcare providers should make available more and accessible resources to help tobacco users stop. OBJECTIVE This study describes a pilot longitudinal study that evaluated the efficacy of a computerized intervention compared to the brief intervention for smoking cessation among Brazilians. METHODS Smokers were recruited and randomly assigned to one of the two intervention groups. RESULTS The results showed similar rates of cessation and reduction for both intervention groups. The internet-based intervention was a little more effective for smoking cessation, while the brief intervention was more effective in reducing the number of cigarettes smoked per day. Despite this, this difference was small and had no statistical significance even after adjusting for intention-to-treat analysis. These results should be interpreted with caution, especially due to the small sample size. CONCLUSIONS Forty-nine smokers were enrolled in this study (25 in the brief intervention group; 24 in the internet-based intervention group). The mean age was 44.46 years old; most were male (59.2%), had elementary school (44.9%), smoked an average of 14.5 cigarettes per day, had a mean score of 4.65 for nicotine dependence, and score of 5.7 for motivation to quit. Measures were drawn from comparing cessation rate, motivation score and sought treatment between groups. Thirty-five participants answered the follow up 1 and 19 answered to the second.

scholarly journals Comparison of statistical methods for analysis of small sample sizes for detecting the differences in efficacy between treatments for knee osteoarthritis

2020 ◽  
Author(s):  
Chia-Lung Shih ◽  
Te-Yu Hung
Keyword(s):  
Knee Osteoarthritis ◽  
Sample Size ◽  
Statistical Methods ◽  
Statistical Power ◽  
Permutation Test ◽  
Small Sample Size ◽  
Small Sample ◽  
T Test ◽  
Sample Sizes ◽  
Knee Oa

Abstract Background A small sample size (n < 30 for each treatment group) is usually enrolled to investigate the differences in efficacy between treatments for knee osteoarthritis (OA). The objective of this study was to use simulation for comparing the power of four statistical methods for analysis of small sample size for detecting the differences in efficacy between two treatments for knee OA. Methods A total of 10,000 replicates of 5 sample sizes (n=10, 15, 20, 25, and 30 for each group) were generated based on the previous reported measures of treatment efficacy. Four statistical methods were used to compare the differences in efficacy between treatments, including the two-sample t-test (t-test), the Mann-Whitney U-test (M-W test), the Kolmogorov-Smirnov test (K-S test), and the permutation test (perm-test). Results The bias of simulated parameter means showed a decreased trend with sample size but the CV% of simulated parameter means varied with sample sizes for all parameters. For the largest sample size (n=30), the CV% could achieve a small level (<20%) for almost all parameters but the bias could not. Among the non-parametric tests for analysis of small sample size, the perm-test had the highest statistical power, and its false positive rate was not affected by sample size. However, the power of the perm-test could not achieve a high value (80%) even using the largest sample size (n=30). Conclusion The perm-test is suggested for analysis of small sample size to compare the differences in efficacy between two treatments for knee OA.

scholarly journals Modulation of Cardiac Injury by ACE inhibitor/ARB in Patients with Severe COVID-19

2020 ◽  
Author(s):  
Beibei Du ◽  
Daoyuan Si ◽  
Bo Yang ◽  
Guohui Liu ◽  
Qian Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Small Sample Size ◽  
Cardiac Injury ◽  
Ventilatory Support ◽  
Small Sample ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Significant Difference ◽  
Ctni Level

Abstract Introduction: Cardiac injury occurs in 7-22% of patient hospitalized with COVID-19 and an elevation in troponin is associated with a 4.2-fold increase in the risk of mortality. Preliminary data showed ACEi/ARB usage might not increase mortaily in COVID-19 patients. However, it is unknown if cardiac injury in patients with severe COVID-19 can be modulated by ACEi/ARB usage during evolution of the cardiac injury.Methods: In 154 COVID-19 patients with cardiac injury, the effect of ACEi/ARB treatment (17 patients) was compared with 137 patients without ACEi/ARB treatment. Cardiac injury was indicated by cTnI level.Results: In ACEi/ARB treatment group and no ACEi/ARB treatment group, peak cTnI level did not show significant difference (150.5 pg/ml [31.75-1179], vs 207 pg/ml [54.65-989.4], respectively, P = 0.21). Evolution of Cardiac injury (temporal change of cTnI at day 6, 9, 12, 15, 18, 21, 24, 27, 30, and 33) showed no statistical difference. Mortality (ACEi/ARB group vs no ACEi/ARB group; 52.9% vs 69.9%, P = 0.17), atrial arrhythmias (11.7% vs 24.4%, P = 0.36), requirement for invasive ventilatory support (29.4% vs 48.2%, P = 0.14) also showed no significant difference in two groups.Conclusions: ACEi/ARB usage during the COVID-19 was not associated with exacerbation of cardiac injury. These data should be interpreted as essentially hypothesis-generating due to small sample size.Clinical Trial Registration: This retrospective study was registered in Chinese clinical trial registry (ChiCTR 2000031301).

scholarly journals A study of effect of topical anaesthetics on injection pain during immunization in infants

2020 ◽  
Vol 7 (7) ◽  
pp. 1463
Author(s):  
Magesh Kumar ◽  
V. Venkateshwar
Keyword(s):  
Intervention Group ◽  
Injection Pain ◽  
Control Group ◽  
P Value ◽  
Open Label ◽  
Topical Anesthetic ◽  
Vaccine Injection ◽  
Pain Scores ◽  
Significant Difference ◽  
Group B

Background: Immunization is a necessary aspect of health care of children and injections are there for unavoidable. Many factors affect injection pain during immunization in infants. This study aims to see the effect of use of local anesthetics delivered by various modes for attenuation of vaccine related injection pain in infants and to compare them.Methods: An Open Label Four-Arm Randomized Control Trial of 300 healthy infants of age group 6 weeks to 6 months reported to immunization clinic for immunization with DPT-HiB-Hepatitis B combination vaccine were taken for study. The enrolled subjects were allocated into control group and intervention group (who were applied some form of local anesthesia).Results: Among the four groups of the patients studied we observed a statistical difference in the mean pain scores of the patients recorded at 15 second, 60 second and 5 min after vaccine injection (p value 0.0024 - 0.000). Group A (Infants with topical occlusive LA cream) showed minimum pain scores values at 15 second, 60 second and 5 min after vaccine injection, followed by Group C (Infants with topical LA spray with vapocoolant) whereas Control group (Infants not received any local anaesthesia) and Group B (Infants with topical LA spray without vapocoolant) exhibited the maximum pain scores.Conclusions: Topical occlusive local anesthetic cream and topical LA spray with vapocoolent, were found to be better than topical LA spray without vapocoolant or no topical anesthetic. Use of topical occlusive LA cream led to a lowest pain score. There was no significant difference in the profile of side effects following injection in the four group.

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