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Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10313534 |
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Introduction | disorder of the otic capsule, Otosclerosis | VASCULAR PROLIFERATION, OTOSCLEROSIS | Otosclerosis is a remodeling disorder of the otic capsule where foci of resorbed bone were present, associated with newly formed bone, together with vascular proliferation [ | PMC10313534 |
Patients and methods | otosclerosis | MIDDLE EAR, EXTERNAL EAR, DEHISCENCE, OTOSCLEROSIS | This study was a prospective single blinded randomized clinical study carried out between September 2021 and September 2022. Approval from Institutional ethics committee was obtained (code: MS.21.11.1758). The study was conducted among 60 patients with clinical evidence of otosclerosis who were randomly divided into two equal groups (each containing 30 patients) using computer generated block randomization. Patients in group 1 underwent endoscopic classic stapedotomy while patients in group 2; on the other hand; underwent endoscopic reversal stapedotomy.All involved patients had clinically evidenced otosclerosis including gradual progressive diminution of hearing with intact tympanic membrane, an audiogram showing ABG > 20 dB at the frequencies of 0.5, 1, 2 and 3 kHz together with absent stapedial reflex. Revision cases, cases with obliterative type of otosclerosis, and cases with facial nerve dehiscence were all excluded. Since narrow footplate is a contraindication for reversal stapedotomy, we also excluded all cases with narrow footplate to make the whole patients amenable for both classic and reversal stapedotomies. We defined narrow footplate as a footplate that could not accommodate a 0.7 mm manual perforator.A 0° endoscope, 17 cm length and 4 mm diameter (Karl Storz, Germany) which was coupled to a high-definition (HD) camera head connected with a monitor (Karl Storz, Germany) were used. All surgeries were performed under local anesthesia (2% lidocaine with 1:50,000 epinephrine). The surgery began with 4 quadrant injection of the local anesthetic solution. Incision of the skin of the external ear canal was performed followed by tympano-meatal flap elevation towards the tympanic annulus. Entry to the middle ear was then carried out by raising of the tympanic annulus out of its sulcus. Curettage of the posterosuperior canal wall was carried out till the following structures were fully exposed: the stapes footplate, the facial nerve, the stapedial tendon and the pyramid. The ossicular chain mobility was then assessed to confirm the true diagnosis of otosclerosis. Measurement of the size of footplate was then done by using a 0.7 mm manual perforator. Cases where the footplate could not accommodate the 0.7 mm perforator were excluded because this would be a narrow footplate which is a contraindication for reversal stapedotomy. | PMC10313534 |
Group 1 | Classic stapedotomy was done starting by removal of the stapes superstructure (Fig. Steps of endoscopic classic stapedotomy: | PMC10313534 |
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Group 2 | perforation | Reversal stapedotomy was performed which began by perforation of the footplate (Fig. Steps of endoscopic reversal stapedotomy: | PMC10313534 |
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Follow-up | The initial scheduled visit for follow-up was carried out 1 week after surgery where the covering gauze was removed, and antibiotic ear drops were prescribed for 1 week. Audiological assessment was done 3 months after surgery in line with the guidelines of the American Academy of Otolaryngology- Head and Neck Surgery Committee on Hearing and Equilibrium. Pre- and post-operative air conduction (AC) thresholds and bone conduction (BC) thresholds were estimated at the frequencies 0.5, 1, 2, and 3 kHz. To calculate the 3 kHz results, the results for 2 and 4 kHz had to be averaged. The air bone gap (ABG) was estimated by calculating the difference between AC and BC thresholds [ | PMC10313534 |
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Data collection and statistical analysis | Pre- and post-operative data were collected, tabulated, and analyzed. The data were presented in the form of mean ± standard deviation (SD). Analysis was done using SPSS for Windows version 28. statistical software program (Statistical Package for Social Sciences = SPSS Inc., Chicago, IL, USA). The paired | PMC10313534 |
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Results | COMPLICATIONS | Sixty patients were involved in this study. Group 1 comprised 30 patients: 19 females (63.33%) and 11 males (36.67%). Their mean age ± SD was 41.43 ± 10.76 years. Group 2 consisted of 30 patients: 21 females (70%) and 9 males (30%). Their mean age ± SD was 44.33 ± 8.14 years. Statistically non-significant differences in both sex and age between the two groups were found (Table Comparison between groups 1 and 2 as regard mean AC, BC, ABG, SRT and SDSPost-operative closure of the ABG within 10 dB was attained in 23 cases in group 1 (76.67%) and in 24 cases in group 2 (80%). Such difference was statistically non-significant (Table Difference in complications between the 2 groups: | PMC10313534 |
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Discussion | perforations, taste disturbance, vertigo, subluxation, hearing outcome and post-operative complications, otosclerosis, Injury of the chorda tympani typically | SENSORINEURAL HEARING LOSS, NEURAL HEARING LOSS, COMPLICATION, OTOSCLEROSIS, POST-OPERATIVE PROBLEMS, HEARING LOSS, COMPLICATIONS | Surgical techniques for treatment of otosclerosis have been improved, updated, or adjusted over time to lower intraoperative and post-operative problems and boost overall effectiveness [Not only the order of surgical steps was debatable but also the surgical tool, whether to use the microscope or the endoscope. Different studies compared microscopic with endoscopic stapedotomy. Although hearing outcome and post-operative complications were comparable, the endoscope gives a very important advantage which is the excellent visualization [The utilization of endoscope in stapes surgery has many advantages. The wide angle of view offered by endoscope allows better exposure of both stapes and its footplate. In addition, it facilitates detection of any anatomical variations or pathological changes. Moreover, it allows confirmation of the proper insertion of the prosthesis [Throughout the literatures, many studies were conducted to compare classic and reversal stapedotomies. All these studies were performed using the microscope. To our knowledge, our current study is the first in the literatures that compared classic and reversal stapedotomies using the endoscope.In our study, statistically significant reductions in post-operative AC thresholds, ABGs and SRTs were obtained in both groups indicating that both techniques were effective in management of associated hearing loss. When both groups were compared, no statistically significant differences in post-operative AC thresholds, ABGs or SRTs were found. Moreover, closure of the ABG within 10 dB was attained in 76.67% and 80% of cases in groups 1 and 2 respectively, with statistically non- significant difference. All these findings suggested that endoscopic classic and reversal techniques were comparable as regards hearing outcome. Such finding was in agreement with the previously published studies [Sensorineural hearing loss is relatively uncommon complication [During stapes surgery, small perforations of the tympanic membrane are usually closed with fascial graft at the end of the surgery with excellent result. Injury of the chorda tympani typically occurs during curettage or during its mobilization to expose the oval window. Such complication was estimated to occur in about 3% of cases in the literatures [In our study, no sensory neural hearing loss was encountered in any of the cases of both groups. In addition, no statistically significant differences were reported between the two groups as regards post-operative vertigo and taste disturbance. All these findings were comparable to the previously published studies [Floating footplate is one of the major complications that may be encountered during stapes surgery. In this condition, the footplate is accidently mobilized and may be pushed into the vestibule. Such complication may occur when the footplate is pushed too strong with manual perforator or even with microdrill. To avoid this complication, perforation should be done before removal of the stapes superstructure (as in reversal stapedotomy). Such support provided by the stapes superstructure will prevent footplate mobilization during perforation. Another method of prevention of such complication was the utilization of COIncus subluxation was another complication that may be encountered during stapes surgery. It was reported to occur if removal of stapes superstructure was done before insertion of the prosthesis. Thus, it is also unsurprising to encounter such complication in classic stapedotomy than in reversal type [Since this study; to our knowledge; is the first randomized controlled trial that compared classic and reversal stapedotomy techniques endoscopically, the authors are encouraging further studies with relatively larger sample size. | PMC10313534 |
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10313534 |
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Availability of data and materials | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10313534 |
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Declarations | PMC10313534 |
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Conflict of interest | All authors declare that they had no conflicts of interest. | PMC10313534 |
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Research involving human participants and/or animals | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments. | PMC10313534 |
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Informed consent | Informed consent was obtained from all individual participants involved in the study. | PMC10313534 |
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References | PMC10313534 |
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Supplementary Information | stroke, death, AF | ATRIAL FIBRILLATION (AF), ADVERSE EVENTS, STROKE, ATRIAL FIBRILLATION, THROMBOEMBOLISM |
The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) cluster-randomized trial showed that a mobile health (mHealth)-implemented ‘Atrial fibrillation Better Care’ (ABC) pathway approach reduced the risk of adverse events in atrial fibrillation (AF) patients. Whether this benefit can be applied to both males and females is unclear, especially given the suboptimal management and poorer cardiovascular outcomes in females with AF. In this post-hoc analysis, we performed a sex-stratified analysis of the mAFA-II trial. Between June 2018 and August 2019, adult AF patients were enrolled across 40 centers in China. The primary outcome was the composite of stroke, thromboembolism, all-cause death, and re-hospitalization. The effect of mAFA intervention according to sex was evaluated through adjusted Cox-regression models. Among the 3,324 patients enrolled in the trial, 2,062 (62.0%) patients were males (mean age: 67.5 ± 14.3 years; 1,021 allocated to mAFA intervention) and 1,262 (38.0%) were females (mean age: 70.2 ± 13.0; 625 allocated to mAFA intervention). A significant risk reduction of the primary composite outcome in patients allocated to mAFA intervention was observed in both males (adjusted hazard ratio [aHR] and 95% confidence interval [CI] 0.30 [0.17–0.52]) and females (aHR [95%CI] 0.50 [0.27–0.92]), without statistically significant interaction (The online version contains supplementary material available at 10.1007/s11739-022-03188-2. | PMC10017580 |
Keywords | PMC10017580 |
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Introduction | atrial arrhythmia, AF | ATRIAL FIBRILLATION, ATRIAL ARRHYTHMIA, ATRIAL FIBRILLATION (AF) | Atrial fibrillation (AF) is the most common atrial arrhythmia worldwide and is projected to affect 14 million patients in 2060 in Europe alone [Female AF patients also show a higher burden of AF-related symptoms and a lower quality of life compared to males [
The ‘Atrial Fibrillation Better Care’ (ABC) pathway has been proposed to streamline the implementation of a holistic and integrated care program and improve the prognosis of AF patients, based on three pillars [The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) trial evaluated the efficacy of a mobile health (mHealth)-implemented ABC pathway approach (mAFA intervention) in reducing the risk of adverse outcomes among AF patients [Nevertheless, it is unclear if the effect of mAFA intervention is consistent in both sexes; moreover, the importance of reporting sex-disaggregated data and sex-specific analyses in medical research has been repeatedly underlined, to improve our understanding of sex-based differences and ultimately lead to tailored and effective strategies in both females and males [ | PMC10017580 |
Methods | A detailed description of the rationale, design, and primary results of the mAFA-II trial has been previously published and can be found elsewhere [In this post hoc ancillary analysis, we evaluated the effect of mAFA intervention according to the sex of the participants. | PMC10017580 |
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mAFA intervention | thromboembolic, hypertension, bleeding | VASCULAR DISEASES, BLEEDING, HYPERTENSION, HEART | The mAFA intervention group implemented the ABC pathway according to the following criteria:‘A’ criterion: anticoagulation prescription according to regular assessment of thromboembolic and bleeding risk, with dose adjustment based on renal and liver function reassessment;‘B’ criterion: regular monitoring of patient-reported symptoms (which were assessed according to the European Heart Rhythm Association classification), and management of symptoms that included antiarrhythmics and rhythm control treatments;‘C’ criterion: active management and treatment optimization of concurrent comorbidities (e.g., hypertension management according to blood pressure monitoring, statin treatment in patients with vascular diseases, etc.). Patients were also provided with educational material and lifestyle recommendations.Conversely, patients allocated to “usual care” were managed according to local practices. | PMC10017580 |
Outcomes and follow-up | Follow-up was performed 6 and 12 months after the inclusion. Consistent with the primary trial analysis, the | PMC10017580 |
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Statistical analysis | PAD, CAD, peripheral artery disease | PERIPHERAL ARTERY DISEASE, DIABETES MELLITUS, PAD, SECONDARY, HYPERTENSION, CAD | Baseline characteristics were reported as mean and standard deviation (SD) for normally distributed continuous variables, or median and interquartile range [IQR] for non-normally distributed continuous variables. Binary and categorical variables were reported as frequency and percentage.For the purpose of this analysis, we analyzed the interactions between sex and the effect of mAFA intervention on the primary and secondary outcomes, using Cox proportional hazard models. All the models were adjusted for age, type of AF, comorbidities (hypertension, diabetes mellitus, CAD, history of HF, history of IS, peripheral artery disease (PAD)), previous AF treatments, and cluster effect. Survival curves were also reported for the risk of the primary composite outcome according to mAFA allocation and sex.A two-sided | PMC10017580 |
Risk of major outcomes according to mAFA intervention | SECONDARY |
Survival curves for the primary composite outcome according to sex and mAFA allocation are reported in Fig. Survival curves for the primary composite outcome, stratified by sex and mAFA allocation. Cox-regression analysis on the interaction between sex and mAFA intervention on the risk of primary and secondary outcomes. | PMC10017580 |
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Discussion | death, bleeding, PAD, stroke, CAD | BLEEDING, STROKE, PATHOPHYSIOLOGY, PAD, SECONDARY, EVENTS, CAD | In this ancillary analysis of the mAFA-II trial, our principal findings are as follows: (i) the mAFA intervention reduced the risk of the primary composite outcome of IS, TE, all-cause death, and re-hospitalization in both sexes; (ii) the magnitude of the risk reduction appeared higher among males; and (iii) a sex-based interaction was observed for some of the exploratory secondary outcomes, including all-cause death and bleeding events, with the effect of mAFA intervention being higher among male patients.There has been growing interest in the potential sex-based differences in AF patients, from the pathophysiology and the accumulation of risk factors to the risk of adverse outcomes, including stroke [Recent international guidelines [In this post hoc analysis from the mAFA-II trial, we showed how a mHealth-technology implemented ABC pathway consistently reduces the risk of the primary composite outcome of IS/TE, all-cause death, and re-hospitalizations in both sexes, without a statistically significant sex-based interaction. Nevertheless, we observed a trend toward a higher magnitude of risk reduction among male patients, and this finding was consistent with the analysis of the exploratory secondary outcomes, which showed a sex-based interaction for the effect of the ABC pathway on the risk of all-cause death, bleeding events, and the composite of non-fatal cardiovascular outcomes.Several hypotheses may contribute to the results observed. First, in our study, male patients allocated to mAFA intervention were younger than those allocated to usual care, and with an overall lower burden of comorbidities at baseline, including CAD, PAD, and history of previous IS and bleeding events. On the other side, women allocated to mAFA showed higher prevalence of HF, PAD. and a history of IS. Taken together, while these imbalances in baseline characteristics can be explained by the cluster randomization design of the trial, they may have contributed to the higher magnitude of the effect observed among male patients compared to females allocated to mAFA intervention.Moreover, both males and females allocated to mAFA intervention more frequently received OAC—and, specifically, NOACs—when compared to those who received usual care. The higher uptake of OAC can be seen both as a direct effect of the implementation of the mAFA intervention in these patients (with optimisation of stroke prevention as part of the mHealth-implemented ABC pathway), and one key determinants of the beneficial effects of mAFA in these patients. These findings reinforce the hypothesis that a holistic or integrated care approach improves management of AF patients, leading to better outcomes.Nonetheless, it has already been shown that women may present with atypical symptoms of AF [Finally, the role of social determinants of health in influencing the natural history and outcomes in AF is increasingly recognized [Overall, while confirming the efficacy of the ABC pathway in both sexes for the primary composite outcome, our findings are consistent with the previously reported trend of a potential sex-based difference in the efficacy of the ABC pathway [ | PMC10017580 |
Strengths and limitations | Our study is the first analysis to provide a sex-stratified analysis on the efficacy of a mHealth-implemented ABC pathway, and will be particularly useful to inform sex-specific recommendations and guidance, especially given the urgent need for sex-disaggregated data in this scenario [Nonetheless, our study has some limitations. First, this was a post hoc analysis of a cluster-randomized trial and may lack statistical power for some of the outcomes investigated, and for the specific subgroups examined about which the trial was not originally powered. Second, there were some imbalances on the baseline characteristics in both males and females allocated to mAFA intervention vs. usual care. While this is compatible with the randomized cluster design of the trial, this may have contributed, at least partly, to the results observed. Third, we were unable to evaluate the role of the social determinants of health (SDOH) in determining the results observed. Further studies are required to evaluate the role of SDOH and the potential sex-based differences in this clinical context. Fourth, although we adjusted our analyses for several potential moderators, we cannot exclude the effect of unaccounted confounders on the findings observed. | PMC10017580 |
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Conclusion | EVENTS | In this post hoc analysis of the mAFA-II trial, we found that a mHealth-technology implemented ABC pathway was similarly effective in reducing the risk of adverse clinical events both in male and female patients. Secondary outcomes showed greater benefits of mAFA intervention in men.
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Acknowledgements | We are grateful to all participants in the mAFA programme for their contribution. | PMC10017580 |
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Funding | This research was funded by the National Natural Science Foundation of China (82170309). This study was an investigator-initiated project, with limited funding by independent research and educational grants | PMC10017580 |
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Data availability | Data supporting the current study are available from the corresponding author upon reasonable request. | PMC10017580 |
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Declarations | PMC10017580 |
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Conflict of interest | GYHL has been consultant and speaker for BMS/Pfizer, Boehringer Ingelheim and Daiichi-Sankyo. No fees are directly received personally. All the disclosures happened outside the submitted work. All other authors have nothing to declare. | PMC10017580 |
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Ethical approval | The study was approved by the Central Medical Ethic Committee of Chinese PLA General Hospital and by local institutional
review boards, and was conducted in accordance with the Declaration of Helsinki and the Consolidated Standards of Reporting
Trials (CONSORT) reporting guideline. | PMC10017580 |
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Informed consent | All the patients gave their written informed consent. | PMC10017580 |
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References | PMC10017580 |
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Background | pain | The needle insertion pain to perform hemodialysis is the main challenge and a common problem that requires pain management techniques for patients’ comfort. | PMC9990356 |
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Aim | pain | This study aimed to compare the effects of cooling and lidocaine sprays on needle insertion pain in hemodialysis patients. | PMC9990356 |
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Methods | pain | In this randomized cross-over clinical trial study, the hemodialysis patients were selected through convenience sampling according to inclusion criteria and randomly assigned to three intervention groups using the block randomization method. Each patient received three interventions in a cross-over design: Cooling spray or 10% lidocaine spray or placebo spray. There was a 2-week wash-out time between each intervention. The pain score was measured four times for each patient by the Numerical Rating Scale. | PMC9990356 |
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Results | pain | Forty-one hemodialysis patients were included. The results showed a significant interaction between time and group (p < 0.05), so only observations of time 1 with adjustment for baseline values were used to evaluate the effect of the intervention. Patients receiving cooling spray reported 2.29 less pain score on average compared to placebo (B=-2.29, 95% CI: -4.17 to -0.43; p < 0.05); Also, patients receiving cooling spray reported a 1.61 lower pain score than those receiving lidocaine spray, but this difference was not statistically significant (95% CI: -0.26 to 3.48; p > 0.05). | PMC9990356 |
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Conclusion | pain | The cooling spray was effective in reducing the needle insertion pain. Although it was impossible to compare the pain scores at different times and following different interventions, the present study results can help supplement the existing knowledge regarding cooling and lidocaine sprays. | PMC9990356 |
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Keywords | PMC9990356 |
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Introduction | Pain, AVF, HD, pain, arteriovenous fistula | ANESTHESIA OF MUCOUS MEMBRANE | Pain is defined as an unpleasant sensation and emotional experience [The HD is the most frequently used renal replacement therapy, and an arteriovenous fistula (AVF) is the gold standard for vascular access in these patients [On the other hand, a painful procedure can instill a sense of distrust in medical staff; the patient’s pain intolerance also increases the risk of occupational accidents, such as inserting an infected needle in the nurse’s hand [For pain reduction, some methods have been suggested and studied, including the use of topical anesthetics, such as lidocaine [The injectable anesthetics are not used for venipuncture or intramuscular injection alone because their injection is as painful as venipuncture or injection [Another form of topical analgesic includes sprays. One of the most well-known types of these sprays is lidocaine spray. Lidocaine spray is used for the topical anesthesia of mucous membranes and skin. The beginning of its practical effect and its easy-to-use method has led to its widespread use, compared to other methods [Furthermore, the existing evidence on the usefulness of cooling sprays is of medium quality and cannot be relied on [ | PMC9990356 |
Methods | PMC9990356 |
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Study design and setting | MAY | This study was a single-center, open-label, randomized, three-period, three-treatment, sequence crossover clinical trial carried out within May 2019 to October 2019. The research setting was the Hemodialysis Ward of Imam Ali hospital in Bojnurd, North Khorasan province, Iran. | PMC9990356 |
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Population and sampling method | abnormal reaction, HD, skin allergy, allergies | SKIN ALLERGY, ALLERGIES | The research population included all patients under treatment with HD, meeting inclusion criteria, and hemodialyzed in the Hemodialysis Center of Imam Ali hospital in Bojnurd, Iran, through an AVF. The inclusion criteria included age of over 18 years, alertness, the ability to speak and understand Persian or the presence of a Persian-speaking translator, no pacemaker or known heart problem, the onset of HD at least 3 months ago, no known allergies to lidocaine, no damaged skin, no use of analgesics and opioids during the last 24 h, no history of using lidocaine cream or products in the past, HD through an AVF, no history of antiarrhythmic drugs (especially class Ш, such as amiodarone), and HD three times a week. The exclusion criteria included the occurrence of skin allergy or abnormal reaction at the vascular access site, not referring for HD in the next session, and lack of venipuncture with the first attempt in each stage.The convenience sampling method was used in this study. With the effect size of 0.81 obtained from Asgari et al.’s [ | PMC9990356 |
Data collection and interventions | NRS, pain | Before the first intervention, informed and written consent was obtained from the patients, and the pain rating scale was trained. The first needle insertion was considered the primary intervention for all patients, and the vascular access procedure was performed without any intervention. The pain score was determined and recorded one minute after needle insertion by the Numerical Rating Scale (NRS). Each patient received one of the interventions in the next HD session (2 days later), including cooling spray (ethyl chloride), 10% lidocaine spray, or placebo spray. Patients who first received a cooling spray (i.e., 2 days after the initial non-intervention needle insertion) received lidocaine spray 2 weeks later and placebo spray 4 weeks later. Patients who first received lidocaine spray received the placebo spray 2 weeks later and the cooling spray 4 weeks later. Patients who first received placebo spray received cooling spray 2 weeks later and lidocaine spray 4 weeks later [
The design of the studyIn the case of using a cooling spray, after disinfecting the skin, the spray was sprayed on the skin for 3 to 4 s at a distance of 15 to 20 cm, allowing the spray to evaporate from the skin for 10 s, and vascular access occurred after the disinfection of skin [A particular container for lidocaine spray was emptied, washed, and filled with drinking water to prepare the placebo spray. All three sprays’ exterior parts were covered with paper to look almost identical. In all three cases, 1 min after vascular access, the patient’s pain score was determined by asking the patient and using the NRS [ | PMC9990356 |
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Outcome measurement | NRS, pain | DISEASE | The research tools included a demographic and disease information questionnaire and the NRS. An identical watch was used to measure time at all stages. The demographic and disease information questionnaire, including age, gender, addiction status, cause of illness, duration of HD onset, and comorbidities, was completed through interviews and the research unit file. The NRS measured the study’s primary outcome, pain during needle insertion. This scale is a valid, short, and easy tool for the assessment of pain, rated within 0–10. A score of 0 is the characteristic scale of lack of pain, and a score of 10 is the characteristic of the most severe pain felt by the patient. The validity and reliability of the NRS have been investigated and proven in several studies [ | PMC9990356 |
Data analysis | LME | MINOR | This study utilized a crossover design trial; accordingly, for each person, the related-to-each other and longitudinal data were recorded; therefore, a linear mixed-effect (LME) model was used to analyze the data and evaluate the sequence, period, and carry-over effects. Crossover design is a type of longitudinal study, and the LME model has been widely used to analyze the data in longitudinal studies [Patients were entered into the model as a random effect (nested in different sequences) to control within-subject effects. The sequence effect, period effect, carry-over effect (in the form of the interaction between time and group), and treatment effect with adjustment for the baseline values of outcome were examined.This analysis was performed using SPSS software (version 24). The tests were considered two-tailed, and the significance level was set to 0.05. The LME analysis method is robust to the minor violation of the normality assumption. Therefore, this method can be used for the NRS score variable (i.e., an ordinal variable) [ | PMC9990356 |
Results | pain | According to the inclusion criteria, 41 patients under treatment with HD were included in the study. None of the patients was excluded and left the treatment half-finished. The mean and standard deviation of age and HD treatment duration were 52.98 ± 14.10 and 3.8 ± 3.1 years, respectively. In addition, 25 patients (61%) in this study were male. The results showed a significant interaction between time and group (P = 0.007). In other words, there were carry-over effects. The period (P = 0.67) and sequence (P = 0.36) effects were not significant (Table
The results of the linear mixed-effect model to assess group, carry over, period, and sequence effect on final pain with adjusted for baseline painDependent Variable: PainCooling spray group (A) first (Time 1) received cooling spray; then after 2 weeks (Time 2), the group received lidocaine spray; finally, after 2 weeks (Time 3), the group received placebo spray. Lidocaine spray group (B) first (Time 1) received lidocaine spray; then, after 2 weeks (Time 2), the group received placebo spray; finally, after 2 weeks (Time 3), the group received cooling spray. Placebo spray group (C) first (Time 1) received placebo spray; then, after 2 weeks (Time 2), the group received cooling spray; finally, after 2 weeks (Time 3), the group received lidocaine spray.As shown in Fig.
The pain score according to periods and groups of the study | PMC9990356 |
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Discussion | Pain, HD, pain, ’ pain, NRS | The present study was conducted to compare the effects of cooling and lidocaine sprays on needle insertion pain in HD patients using a crossover design. Because pain is subjective and pain is what the patient tells us according to the literature, it is difficult to compare patients’ pain scores to each other. On the other hand, patients undergoing HD frequently experience needle pain, which also affects their perception of pain; as a result, comparing the pain score of patients after receiving various interventions to themselves creates a more accurate picture of the effect of the intervention on pain control. Therefore, a crossover design was used in this study in a way that the participants can be compared to themselves, controlling for any possible confounding variables.Moreover, this crossover design allows the comparison of various interventions. Although it was impossible to compare the pain scores at different times and after different interventions due to a carry-over effect, the present study results can help supplement the existing knowledge regarding cooling and lidocaine sprays. On the other hand, despite a two-week wash-out time, a carry-over effect in the crossover design was a significant issue that requires further investigation and more evidence on time needed to wash out the effects of similar interventions on pain in future studies.The interventions’ effects were compared for the first time, controlling for baseline scores. Although the results showed no significant difference between cooling spray and lidocaine spray interventions, the difference in the scores of the two interventions was significant. More reliable results can be obtained by conducting further studies with a more extended wash-out period and a larger sample size.The effects of cooling spray and lidocaine in various forms have been investigated in different studies, and different results have been reported. For example, Page and Taylor’s study on venous cannulation-induced pain showed that the pain reduction of cooling spray was less than topical lidocaine [Moreover, Dalvandi et al.’s study revealed that the pain after receiving a cooling spray was significantly less than the control group (in the case of cannulation without any intervention) and more than the EMLA cream [The results of Moon et al.’s study investigating the effectiveness of cooling spray and lidocaine injection in propofol injection pain showed that both groups receiving cooling and lidocaine sprays experienced less pain than the control group; however, there was no significant difference between the two groups of lidocaine and cooling sprays in terms of pain score [Limited studies have shown that cooling spray is ineffective in reducing pain [The NRS has inherent time and shortcomings. Furthermore, additional contributors to patients’ pain, such as catastrophizing tendencies, might be evident if additional or different rating scales were used to better clarify the patients’ phenotype.Because HD patients need to be connected to the dialysis machine after needle insertion, it was difficult to evaluate the pain score immediately after the needle insertion; therefore, this evaluation was carried out in all patients within one minute after the needle insertion into the skin. The issue of whether the pain scores one minute after the needle insertion can be different from the score reported by the patient immediately after the needle insertion needs further investigation.To the best of our knowledge, a limited number of studies compared the effect of cooling and lidocaine sprays in a crossover design. Therefore, compared to other studies, one of the advantages of this study is that it exposed a group of patients to three forms of intervention. On the other hand, the investigation of the sequence, period, and carry-over effects is one of the advantages of this study. The presence of a carry-over effect despite the 2-week wash-out period can raise one of the most important issues for further investigation in the field of pain studies.This study has some limitations. Pain is subjective, and its evaluation can be associated with problems. On the other hand, patients undergoing HD treatment frequently experience needle pain that affects their perception of pain. Repeating a painful procedure (e.g., venous cannulation) might also shape patient expectations and preferences, and any intervention insulted by these issues might produce nocebo or placebo effects. The characteristics of vascular access can also be effective in pain perception. An attempt was made to cover this limitation using a crossover design. However, due to the significant carry-over effect, it was not possible to compare the scores after different interventions at different times in one group, which is another limitation of this study. Moreover, blinding was not possible in this study due to the cooling nature of the cooling spray and the apparent difference between lidocaine and placebo sprays. However, an attempt was made to ensure that covering lidocaine and placebo sprays was the same. Another limitation of this study was the small sample size. | PMC9990356 |
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Acknowledgements | Not applicable. | PMC9990356 |
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Authors’ contributions | THA | AKHP and SH contributed to the conceptualization and design of the study. AK, THA and ME collected the data. SH and MRA analyzed and interpreted the data, AKHP, SH, AK, THA, MRA, and ME prepared the manuscript draft. All authors reviewed the results and approved the final version of the manuscript. All authors agreed both to be personally accountable for the author’s own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. | PMC9990356 |
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Funding | This study was supported by North Khorasan University of Medical Sciences. The funder had no role in the design and writing of the manuscript and will have not in data collection and analysis of data. | PMC9990356 |
||
Data availability | The datasets used and analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request. | PMC9990356 |
||
Declaration | PMC9990356 |
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Ethical approval and consent to participate | The participants were assured that their data would remain confidential. Written informed consent was obtained from the participants. The research proposal has been registered in the Iranian Clinical Trial Registration Center prospectively (IRCT20180826040868N1) (Date of full registration: 15.9.2018). Also, it has been approved by the Ethics Committee of North Khorasan University of Medical Sciences (code: IR.NKUMS.REC.1397.035). All methods were carried out in accordance with relevant guidelines and regulations. | PMC9990356 |
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Consent for publication | Not applicable. | PMC9990356 |
||
Competing interests | The authors declare that they have no competing interests. | PMC9990356 |
||
Abbreviations | HemodialysisArteriovenous FistulaNumerical Rating ScaleEutectic Mixture of Local AnestheticsLinear Mixed-EffectAnalysis of Covariance | PMC9990356 |
||
References | PMC9990356 |
|||
Background | stroke | STROKE | Upper extremity (UE) stroke rehabilitation requires patients to perform
exercises at home, yet patients show limited benefit from paper-based home
exercise programs. | PMC9896541 |
Objective | To compare the effectiveness of 2 home exercise programs for reducing UE
impairment: a paper-based approach and a sensorized exercise system that
incorporates recommended design features for home rehabilitation
technology. | PMC9896541 |
||
Methods | stroke, spasticity, VAP | STROKE | In this single-blind, randomized controlled trial, 27 participants in the
subacute phase of stroke were assigned to the sensorized exercise (n = 14)
or conventional therapy group (n = 13), though 2 participants in the
conventional therapy group were lost to follow-up. Participants were
instructed to perform self-guided movement training at home for at least
3 hours/week for 3 consecutive weeks. The sensorized exercise group used
FitMi, a computer game with 2 puck-like sensors that encourages movement
intensity and auto-progresses users through 40 exercises. The conventional
group used a paper book of exercises. The primary outcome measure was the
change in Upper Extremity Fugl–Meyer (UEFM) score from baseline to
follow-up. Secondary measures included the Modified Ashworth Scale for
spasticity (MAS) and the Visual Analog Pain (VAP) scale. | PMC9896541 |
Results | Participants who used FitMi improved by an average of 8.0 ± 4.6 points on the
UEFM scale compared to 3.0 ± 6.1 points for the conventional participants, a
significant difference ( | PMC9896541 |
||
Conclusions | A sensor-based exercise system incorporating a suite of recommended design
features significantly and safely reduced UE impairment compared to a
paper-based, home exercise program. | PMC9896541 |
||
Trial Registration: | ClinicalTrials.gov Identifier: NCT03503617 | PMC9896541 |
||
Introduction | chronic disability, Stroke | STROKE | Stroke is a leading cause of chronic disability in the United States.Recognizing the need for sustainably increasing the amount of movement practice that
individuals undertake, there has been a surge in the development of technologies for
enabling individuals to practice on their own at home.Summary of Recommended Design Features for Home Rehabilitation
Technology.FitMi was designed to incorporate most of these features, except for the
4 that are italicized, which can be grouped into 2 categories: ensuring
that high-quality movements are practiced and facilitating collaboration
with a therapist or caregiver. We generated this table based on a
systematic review of recommendations,FitMi (FitMi (produced by Flint Rehab, LLC) consists of 2 force and motion sensing
pucks and a companion “mixed-reality gym” software application. Top row:
FitMi hardware. Bottom row: FitMi software. Note, FitMi can be used with an
individual’s existing computing hardware (Top Right) or with a custom 10″
touchscreen tablet in a kiosk mode that only requires users to turn the
tablet on and touch an icon to access the application (Top Left). | PMC9896541 |
Methods | PMC9896541 |
|||
Device Design | The FitMi hardware consists of 2 wireless input devices (called pucks), a USB
receiver, a docking station for one-handed charging, and a silicone strap for
users who have difficulty grasping the pucks (see | PMC9896541 |
||
Trial Design | stroke | STROKE | This study was a single-site, single-blind randomized controlled trial comparing
home-based therapy with FitMi to conventional therapy for individuals in the
subacute phase of stroke. The study was performed at Rancho Los Amigos National
Rehabilitation Center in Downey, CA. Participants were invited for an initial
assessment to confirm they met the inclusion criteria and to establish baseline
measures. Participants provided informed written consent. Qualifying
participants were randomly assigned to either the FitMi group or the
conventional group. Participants in both groups were instructed to perform
self-guided therapy for at least 3 hours/week for 3 consecutive weeks. All
participants received weekly phone calls from a supervising therapist. After the
3-week exercise period, participants returned for an end-of-therapy assessment
and to return study materials. Participants returned 1 month later for a
follow-up assessment. The trial was pre-registered on ClinicalTrials.gov
(NCT03503617) and approved by the Rancho Research Institute, Inc. Institutional
Review Board at Rancho Los Amigos National Rehabilitation Center (IRB #263). | PMC9896541 |
Participants | pain, strokes | STROKES | Inclusion criteria were: experienced one or more strokes between 2 weeks and
4 months prior; baseline UEFM Score >5 and ≤55 out of 66; absence of moderate
to severe pain defined as a score of 4 or lower on the 10-point visual-analog
pain scale; ability to understand the instructions to operate FitMi; and aged 18
to 85 years old, to limit potential confounds due to naturally diminished
physical mobility and cognitive function associated with older age.Using an estimated Cohen’s Adaptive randomization was used to ensure matched levels of impairment between
the FitMi and conventional therapy groups. Specifically, subjects were
stratified by their UEFM Score into 3 levels (ie, 5-22, 23-39, 40-55) and then
randomized by alternating block allocation. | PMC9896541 |
Intervention | EVENTS | Participants randomized to the FitMi group were given a FitMi system with a
custom 10″ touchscreen tablet. They received 30 minutes of training on how to
set up and use the FitMi system. They were instructed to spend most of their
time performing UE exercises, but access to the trunk and leg exercises in the
FitMi software was not disabled. Participants randomized to the conventional
therapy group were given a booklet of paper exercises that were selected from
the same library of 40 exercises available in the FitMi software. The booklet
was placed in a sensorized folder which included an accelerometer to detect
movement events and a magnetometer and magnet on opposite sleeves to detect when
the folder was opened or closed. These events were recorded to a memory card by
an embedded microcontroller.For both groups, a supervising rehabilitation therapist selected the exercises
for each participant based on their specific impairments. All participants
received 30 minutes of training from the therapist on how to perform the
selected exercises correctly. After the 3-week exercise period, participants
returned for an end-of-therapy assessment. At this assessment, participants
returned the FitMi system or the sensorized booklet of exercises for data
collection. Participants returned 1 month later for a follow-up assessment. | PMC9896541 |
|
Outcomes | The primary outcome measure was the change in UEFM scoreTo assess adherence, the FitMi software recorded the date, time, and number of
repetitions completed for each exercise, and the sensorized folder used in the
conventional therapy measured the times at which the participants opened the
booklet. | PMC9896541 |
||
Statistical Methods | stroke | STROKE | Statistical analyses were performed using Matlab R2020 software. For measures
taken at baseline and follow-up, the change from baseline to follow-up was
calculated. Then the changes were compared between groups using an unpaired
two-tailed MAS scores were grouped by flexion or extension items and summed to obtain lumped
MAS extension and flexion values. We quantified items marked with a “+,” with an
additional 0.5 points for calculations. EQ-5D-L3 was analyzed
following.Several participants dropped out of the study (see Participant flow diagram. Subjects who did not return for an
end-of-therapy assessment were not considered for analysis. Missing data
was imputed as described in the statistical methods to maintain group
sizes across all analyses.To assess the ability of FitMi to motivate an appropriately high dose of home
therapy, we performed a post-hoc exploratory analysis comparing the total number
of repetitions that FitMi participants completed to a theoretical target dose of
2700 repetitions. A dose of 2700 repetitions of UE exercise corresponds to
300 repetitions/hour (5 reps/minute) over 9 hours of exercise, an intensity and
duration sufficient to provoke a forelimb rehabilitative effect in a rodent
model of stroke. | PMC9896541 |
Interim Analysis | RECRUITMENT | Due to the unexpected additional risks to participating in this study due to the
COVID-19 pandemic, an unplanned interim futility/efficacy analysis of the
primary outcome measure was conducted after recruitment was halted in March
2020. Group labels were removed, and the analysis was reviewed by an independent
investigator. For the futility analysis, a conditional power of 20% was
selected. For the efficacy analysis, a | PMC9896541 |
|
Results | PMC9896541 |
|||
Recruitment and Participant Flow | stroke, hemorrhagic, SD, Stroke | STROKE, STROKE | Participants were recruited from November 20, 2018, until March 12, 2020, when
the study was halted due to the COVID-19 pandemic. In the interim analysis, a
significant difference in the primary outcome measure was observed between
groups (two-tailed Participant enrollment and allocation details are shown following CONSORT
guidelines in Demographics of Recruited Participants at Baseline Aggregated by
Group.Abbreviations: H, Hispanic/Latino; N, not Hispanic/Latino; I,
ischemic; H, hemorrhagic; B, both ischemic and hemorrhagic.Where applicable, values are reported as Mean ± SD, [minimum,
maximum]. Weeks Post Stroke indicates the number of weeks between
the participant’s stroke and the date of their baseline
evaluation. | PMC9896541 |
Efficacy | spasticity, visual analog pain | SECONDARY | All measures recorded at baseline, end-of-therapy, and follow-up assessments are
reported in Results for Outcome Measures for FitMi and Conventional Therapy
Groups.Abbreviations: BL, baseline; EOT, end-of-therapy; FU, follow-up;
UEFM, Upper Extremity Fugl–Meyer; MAS, Modified Ashworth scale for
spasticity; VAP, visual analog pain; MAL, motor activity log;
EQ-5D-3L, European Quality of Life five dimensions, three levels;
EQ-VAS, EuroQol Visual Analog Scale.For measures with a baseline assessment, the change from baseline to
follow-up was calculated. For each measure, the change was compared
between groups using unpaired, two-tailed Indicates a significant difference using the corrected α-value for
that assessment.For the primary outcome measure, the average change in UEFM from baseline to
follow-up for participants in the FitMi group (n = 14) was 8.0 ± 4.6 compared to
an average change of 3.0 ± 6.1 for participants in the conventional therapy
group (n = 11), a significant difference with a large effect size
((A) Average change in Upper Extremity Fugl–Meyer (UEFM) score for FitMi
group and conventional therapy group at each assessment. The error bars
represent 1 SD. (BL = Baseline) FitMi participants improved
significantly more than the conventional therapy group. *Indicates a
significant within-group difference between UEFM scores at each time
point compared to baseline (Abbreviations: EOT, end-of-therapy; FU, follow-up.The 2 groups’ scores did not change significantly differently for any of the
secondary outcomes.Mixed model ANOVA analysis for UFEM scores found a significant time effect
( | PMC9896541 |
Safety and Motivation | No significant harms related to the study were reported or observed over the
course of the study. For participants in the FitMi therapy group, no significant
change was found between baseline and end-of-therapy for MAS or VAP scores
(paired Participants interacted with the FitMi software for a median of 47% of the
21 days of the intervention period (range = 23%-100%). FitMi participants
interacted with the system for 5.4 ± 4.1 hours. Only 2 participants completed or
exceeded the recommended 9 hours of interaction time. Due to technical issues
with battery life, only 4 out of 13 sensorized folders provided to participants
in the conventional therapy group were returned with recoverable data. These 4
participants interacted with their folders for 41%, 73%, 45%, and 100% of the
21 days of the intervention.Of the 14 participants in the FitMi group, 9 out of 14 (64%) completed the
theoretical target dose of at least 2700 repetitions (as defined in the Methods)
over 3 weeks of exercise, with 7 participants completing more than 3 times this
amount (We tested whether less impaired participants achieved more repetitions with
FitMi. To do this, we ranked participants by baseline UEFM score and then split
them into evenly sized groups (n = 7) thus creating lower and higher UEFM groups
defined by a UEFM cutoff of 40. Comparing total repetitions between groups
(4427 ± 3648 [832, 8694] vs 15 890 ± 13 412 [2565, 42 256], respectively)
revealed a significantly greater amount of exercise in the higher UEFM group
(unpaired | PMC9896541 |
||
Discussion | subacute stroke, spasticity, pain | We compared the effectiveness of a sensorized exercise system, FitMi, with a
conventional exercise program specified using a paper booklet for at-home movement
training in subacute stroke. Participants who exercised with FitMi improved
significantly more on the primary outcome, the change in the UEFM scale from
baseline to follow-up, compared to the participants in the conventional therapy
group without increasing UE spasticity or pain. We first discuss the significance of
these results, followed by limitations and directions for future research. | PMC9896541 |
|
Toward Optimizing Home Rehabilitation Technology | As reviewed in An important question is whether the system was usable by more severely impaired
individuals, as there are fewer options available for such persons for
continuing movement practice. The lower half of participants with more severe
impairments (UEFM <40) still achieved on average 4427 repetitions, an amount
that exceeded the theoretical target dose of 2700 repetitions. Notably, most
participants were able to exceed the 2700-repetition target in a shorter amount
of time than was prescribed, because they achieved an average rate of exercise
of 41 ± 17 reps/minutes, which was greater than the 5 reps/minute we estimated a
priori. This indicates that FitMi was accessible and motivating for individuals
with a range of impairment levels, which is a key requirement for optimizing
home rehabilitation technology as it allows a single solution to be used across
a broad population.As shown in While home training with FitMi led to a significantly greater reduction in UE
impairment than paper-based exercise, an important question is whether the
amount of improvement was clinically significant. The Minimal Clinically
Important Difference (MCID) for the UEFM has been reported to be 4 points for
subacute patients, | PMC9896541 |
||
Limitations and Future Directions | stroke | STROKE | No female participants were recruited into the FitMi therapy group, which limits
the generalizability of the reported results. A smaller percentage of FitMi
participants were impaired on their dominant side than in the conventional group
(29% vs 38%). Alternating allocation has been shown to be prone to selection
biasFuture research could study how exercise technologies such as FitMi can best be
integrated into routine clinical practice. Providing stroke survivors with FitMi
in any waiting period between the end of their inpatient treatment and the start
of their outpatient treatment, or after they have used all the outpatient
therapy visits allotted by their health insurance, could improve outcomes. We
recently studied the use of the FitMi sensors in conjunction with an
activity-management app to assist in home rehabilitation. | PMC9896541 |
Supplemental Material | PMC9896541 |
|||
sj-doc-5-nnr-10.1177_15459683221146995 – Supplemental material for
Optimized Home Rehabilitation Technology Reduces Upper Extremity Impairment
Compared to a Conventional Home Exercise Program: A Randomized, Controlled,
Single-Blind Trial in Subacute Stroke | Stroke | STROKE | Click here for additional data file.Supplemental material, sj-doc-5-nnr-10.1177_15459683221146995 for Optimized Home
Rehabilitation Technology Reduces Upper Extremity Impairment Compared to a
Conventional Home Exercise Program: A Randomized, Controlled, Single-Blind Trial
in Subacute Stroke by Veronica A. Swanson, Christopher Johnson, Daniel K.
Zondervan, Nicole Bayus, Phylicia McCoy, BS, Yat Fung Joshua Ng, Jenna
Schindele, BS, David J. Reinkensmeyer and Susan Shaw in Neurorehabilitation and
Neural Repair | PMC9896541 |
sj-pdf-4-nnr-10.1177_15459683221146995 – Supplemental material for
Optimized Home Rehabilitation Technology Reduces Upper Extremity Impairment
Compared to a Conventional Home Exercise Program: A Randomized, Controlled,
Single-Blind Trial in Subacute Stroke | Stroke | STROKE | Click here for additional data file.Supplemental material, sj-pdf-4-nnr-10.1177_15459683221146995 for Optimized Home
Rehabilitation Technology Reduces Upper Extremity Impairment Compared to a
Conventional Home Exercise Program: A Randomized, Controlled, Single-Blind Trial
in Subacute Stroke by Veronica A. Swanson, Christopher Johnson, Daniel K.
Zondervan, Nicole Bayus, Phylicia McCoy, BS, Yat Fung Joshua Ng, Jenna
Schindele, BS, David J. Reinkensmeyer and Susan Shaw in Neurorehabilitation and
Neural Repair | PMC9896541 |
sj-pdf-6-nnr-10.1177_15459683221146995 – Supplemental material for
Optimized Home Rehabilitation Technology Reduces Upper Extremity Impairment
Compared to a Conventional Home Exercise Program: A Randomized, Controlled,
Single-Blind Trial in Subacute Stroke | Stroke | STROKE | Click here for additional data file.Supplemental material, sj-pdf-6-nnr-10.1177_15459683221146995 for Optimized Home
Rehabilitation Technology Reduces Upper Extremity Impairment Compared to a
Conventional Home Exercise Program: A Randomized, Controlled, Single-Blind Trial
in Subacute Stroke by Veronica A. Swanson, Christopher Johnson, Daniel K.
Zondervan, Nicole Bayus, Phylicia McCoy, BS, Yat Fung Joshua Ng, Jenna
Schindele, BS, David J. Reinkensmeyer and Susan Shaw in Neurorehabilitation and
Neural Repair | PMC9896541 |
sj-tif-1-nnr-10.1177_15459683221146995 – Supplemental material for
Optimized Home Rehabilitation Technology Reduces Upper Extremity Impairment
Compared to a Conventional Home Exercise Program: A Randomized, Controlled,
Single-Blind Trial in Subacute Stroke | Stroke | STROKE | Click here for additional data file.Supplemental material, sj-tif-1-nnr-10.1177_15459683221146995 for Optimized Home
Rehabilitation Technology Reduces Upper Extremity Impairment Compared to a
Conventional Home Exercise Program: A Randomized, Controlled, Single-Blind Trial
in Subacute Stroke by Veronica A. Swanson, Christopher Johnson, Daniel K.
Zondervan, Nicole Bayus, Phylicia McCoy, BS, Yat Fung Joshua Ng, Jenna
Schindele, BS, David J. Reinkensmeyer and Susan Shaw in Neurorehabilitation and
Neural Repair | PMC9896541 |
sj-tiff-2-nnr-10.1177_15459683221146995 – Supplemental material for
Optimized Home Rehabilitation Technology Reduces Upper Extremity Impairment
Compared to a Conventional Home Exercise Program: A Randomized, Controlled,
Single-Blind Trial in Subacute Stroke | Stroke | STROKE | Click here for additional data file.Supplemental material, sj-tiff-2-nnr-10.1177_15459683221146995 for Optimized Home
Rehabilitation Technology Reduces Upper Extremity Impairment Compared to a
Conventional Home Exercise Program: A Randomized, Controlled, Single-Blind Trial
in Subacute Stroke by Veronica A. Swanson, Christopher Johnson, Daniel K.
Zondervan, Nicole Bayus, Phylicia McCoy, BS, Yat Fung Joshua Ng, Jenna
Schindele, BS, David J. Reinkensmeyer and Susan Shaw in Neurorehabilitation and
Neural Repair | PMC9896541 |
References | PMC9896541 |
|||
Background | This study aimed to compare the efficacy of different gap filling materials in immediate implant in anterior and premolar regions of maxilla. | PMC10704731 |
||
Materials and methods | bone loss | BONE LOSS | Thirty-six implants were inserted in patients seeking for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant. Patients were randomly distributed into three equal groups, twelve implants in each group. Group 1 received Platelet Rich Fibrin (PRF) into the jumping distance, Group 2 received Xenograft into the jumping distance and Group 3 received Alloplastic bone grafting material into the jumping distance. Implant stability by measuring the changes in Resonance Frequency Analysis (RFA), peri-implant pocket depth, marginal bone loss and changes in buccal bone thickness were evaluated during follow up periods. All the clinical and radiographic data were subjected to statistical analysis by One Way ANOVA test and the Post Hoc Tukey test. | PMC10704731 |
Results | bone loss | BONE LOSS | This study involved 19 female patients and 17 male patients who received 36 dental implants. There was no significant difference between the study groups regarding implant stability, peri-implant pocket depth and palatal bone loss, while there was a significant difference between PRF Group (Group 1) and the other Groups regarding buccal bone loss and changes in buccal bone thickness. | PMC10704731 |
Conclusion | bone loss | BONE LOSS | PRF can be used as a gap filling material in conjunction with immediate implant placement, but other bone grafting materials give superior result regarding buccal bone loss and changes in buccal bone thickness. | PMC10704731 |
Trial registration | The study was listed on | PMC10704731 |
||
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10704731 |
||
Background | peri-implant, infection, tooth | INFECTION, CLOT, ALVEOLAR BONE LOSS, SECONDARY | The indications for dental implant treatment options have greatly expanded in recent years due to development in biomaterials and clinical procedures [Original protocol (gold standard) recommended a 6- to 12-month waiting time before implant placement in cases where a tooth had to be extracted and replaced. New methods that involve implant placement during tooth extraction have been developed. This protocol is called immediate implant placement [Immediate implant placement has an overall survival rate of 98.5%, while delayed implant placement has a survival rate of 98.9% [In contrast, immediate implant placement has some disadvantages including, lack of control of the final implant position, difficulty of achieving primary stability, incomplete soft tissue closure over the extraction socket, inability to inspect all aspects of the extraction site for infection and difficulty in preparing the osteotomy due to bur movement (chatter) on the walls of the extraction site [After tooth extraction, the alveolar socket frequently has dimensions larger than the implant's diameter, creating a space between the implant's surface and the alveolar bone walls in the recipient site. This area is designated as the jumping distance or the peri-implant gap. The peri-implant gap affects osseointegration and implant stability [The buccal aspect of an implant is of great concern, especially in the aesthetic zone (between the second contralateral premolars), because the buccal bony plate is thin and its resorption can result in soft tissue recession [Defects < 2 mm can be filled with bone without the need for bone grafts or the usage of barriers. The success of immediate implant procedures may be adversely affected by large gaps, as has been reported [Regarding the best methods to achieve the following goals—optimal bone fill in the gap, the highest level of coronal bone to implant contact (BIC), the least amount of buccal bone resorption, and the least amount of soft tissue recession— the best surgical approach for treating the buccal gap is debatable and unclear [The peri-implant gap has been filled using several bone grafting materials. Autograft is the gold standard for bone grafting materials but it has some limitations such as the need of a second surgical site, limited volume and size mismatch [Growth factors, such as Platelet Rich Fibrin (PRF) and bone morphogenic proteins, have been used to stimulate bone formation in the defective sites, as has been reported in several studies [The fibrin clot formed during the production of traditional PRF or its modification, is a three-dimensional scaffold that replaces the extracellular matrix in cell regeneration and newly formed vessels. Platelets trapped between fibrin fibers, B and T lymphocytes, monocytes, stem cells and neutrophils, as well as secreted growth factors such as TGF-1, PDGF, and VEGF, play a role in healing [The purpose of this study was to compare the efficacy of different gap filling materials in immediate implant in anterior and premolar regions of maxilla. The primary objective was to assess alveolar bone loss and changes in buccal bone thickness radiologically using cone-beam computed tomography (CBCT) and the secondary objective was to assess various clinical parameters such as implant stability by measuring the changes in Resonance Frequency Analysis (RFA) and peri-implant pocket depth.The hypothesis was that the peri-implant alveolar bone loss, changes in buccal bone thickness and soft tissue health in immediate implants with a jumping distance grafted with PRF would be the same as those grafted with Xenograft or Alloplastic bone grafting materials. | PMC10704731 |
Materials and methods | PMC10704731 |
|||
Patient selection | Thirty-six patients, nineteen females and seventeen males with an average age 33 years (range from 19 to 47), were included in this study. They were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt, for replacement of non-restorable maxillary anterior and 1 | PMC10704731 |
||
Sample size calculation | The total sample size was determined to be 10 implants in each group using G*power version 3.0.10 to calculate sample size-based t test = 2.31, 2-tailed, α error = 0.05 and power = 90.0% with effect size (2.63). To account for potential attrition by 20%, two additional implants were added to the total sample size (12 implants in each group). This calculation was based on a previous study by Oates and colleagues [ | PMC10704731 |
||
Randomization | One of the department's senior residents, who was not involved in the study and was not aware of any relevant treatment protocols, carried out the randomization. 36 candidates were randomly distributed into three equal groups, 12 implants for each by using a computer-generated randomization list (SPSS v25.0). The distribution of the groups was Group 1 received PRF into the jumping distance, Group 2 received Xenograft into the jumping distance and Group 3 received Alloplastic bone grafting material into the jumping distance. The study design can be seen in Fig. Flowchart representation of groups distribution | PMC10704731 |
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