Sham Device Research Articles

Prospective Study of Masimo NSS-2 BRIDGE; as a Non-Pharmacological Treatment for Acute Opioid Withdrawal Symptoms

PurposeOpioids are commonly employed for treatment of acute and chronic pain. However, continued opioid use can lead to opioid use disorder. Opioid withdrawal symptoms can be severe, and avoidance of the discomfort is a key barrier to voluntary discontinuation. The NSS-2 BRIDGE™ (Masimo Corporation, Irvine, CA) is a percutaneous nerve field stimulator that can decrease symptoms of acute opiate withdrawal. The device fits behind the ear and stimulates branches of Cranial Nerves V, VII, IX, X, and periauricular occipital nerves, which synapse with nuclei involved in processing perception of pain and pleasure, as well as in addiction. The objective of this prospective study was to investigate the effects of NSS-2 BRIDGE™ on outpatients experiencing acute opioid withdrawal symptoms. We hypothesized that participants using the active NSS-2-BRIDGE™ device would have a reduction in Clinical Opioid Withdrawal Scale (COWS) scores compared to those using the sham device, when monitored at 30-minute intervals. MethodsAdult patients (≥18 years old) who voluntarily presented to the Zephyr outpatient clinic (Santa Anna, CA) were enrolled in the study and fitted with the NSS-2 BRIDGE™ device. Initial COWS scores were recorded at baseline and at 30 minutes intervals, up to 120 minutes. ResultsThe study included 16 participants, 8 subjects in each group. The mean COWS score of the active group decreased from 17.125 at baseline to 5.75 at 30 minutes, a mean decrease of 11.375 (P<0.001). The mean COWS score of the sham group decreased from 16.25 at baseline to 12.875 at 30 minutes, a mean decrease of 3.375 (P=0.186). ConclusionThe active device group showed a statistically and clinically significant mean drop in COWS score compared to the sham group. This study demonstrated that NSS-2 BRIDGE™ can assist in opioid withdrawal and may increase initial treatment retention.

PD23-06 FELINE AMBULATORY BLADDER PRESSURE AND VOLUME TRANSMITTED BY A CATHETER-FREE WIRELESS INTRAVESICAL MONITOR

You have accessJournal of UrologyCME1 Apr 2023PD23-06 FELINE AMBULATORY BLADDER PRESSURE AND VOLUME TRANSMITTED BY A CATHETER-FREE WIRELESS INTRAVESICAL MONITOR Steve Majerus, Brett Hanzlicek, Dario Cabal, Mohamed Elazab, Margot Damaser, and Dennis Bourbeau Steve MajerusSteve Majerus More articles by this author , Brett HanzlicekBrett Hanzlicek More articles by this author , Dario CabalDario Cabal More articles by this author , Mohamed ElazabMohamed Elazab More articles by this author , Margot DamaserMargot Damaser More articles by this author , and Dennis BourbeauDennis Bourbeau More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003296.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: As with clinical urodynamics, investigations into lower urinary tract physiology using animal models require catheter-based systems to measure bladder pressure while filling the bladder, often under anesthesia. However, anesthesia, and rapid catheter filling of the bladder can affect filling pressures, urinary leakage and voiding reflexes. To enable recordings representative of normal physiology, we developed a catheter-free, wireless, intravesical sensor which is implanted in the feline bladder lumen and wirelessly transmits bladder pressure and volume data. We validated sensor function by recording volume and pressure over 4-week implantations in felines. METHODS: The Urological Monitor of Conscious Activity (UroMOCA) measured 18×12×5.6mm and transmitted data to a radio placed worn by the animal. The UroMOCA battery was recharged wirelessly via a charging mat placed under the subject. Platinum electrodes measuring urine concentration and conductance estimated urine volume and were paired with an onboard pressure sensor. Under anesthesia, a UroMOCA was implanted into the bladder lumen via cystotomy in male felines. Baseline cystometry was performed. Anesthetized cystometry with UroMOCA recording and imaging were repeated 2 and 4 weeks post-implantation. Ambulatory recordings of up to two hours were performed multiple times during the four weeks prior to device explantation. Sham surgeries and sham devices were implanted in some animals to assess the impact of the UroMOCA on the bladder. Bladder tissue was saved for histology. RESULTS: Ten feline cats were enrolled: 3 were sham implants (no device), 1 received an inactive device, and 6 received a functional UroMOCA. Non-anesthetized recordings were performed for more than 73 hours over 33 ambulatory data collection sessions. After 2 weeks, all animals resumed normal voiding volume. Urinary retention requiring intermittent catheterization was seen in 1 feline; there was no evidence of obstruction. Wireless pressure data linearly correlated with anesthetized cystometry (R2=0.96). Volume measurement was variable but decreased during voiding and increased during filling. Histology showed normal bladder tissue. CONCLUSIONS: A small, wireless, catheter-free, intravesical sensor enabled conscious recordings of bladder function in felines during natural bladder filling over 4 weeks. The volume sensor enabled detection of bladder filling and emptying phases. Source of Funding: This work was funded by the NIH Stimulating Peripheral Activity to Relieve Conditions (SPARC) program, NIH grant number OT2OD023873 © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e672 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Steve Majerus More articles by this author Brett Hanzlicek More articles by this author Dario Cabal More articles by this author Mohamed Elazab More articles by this author Margot Damaser More articles by this author Dennis Bourbeau More articles by this author Expand All Advertisement PDF downloadLoading ...

Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial

IntroductionPhysical rehabilitation restores lost function and promotes brain plasticity in people with Multiple Sclerosis (MS). Research groups worldwide are testing the therapeutic effects of combining non-invasive neuromodulation with physical therapy (PT) to further improve functional outcomes in neurological disorders but with mixed results. Whether such devices enhance function is not clear. We present the rationale and study design for a randomized controlled trial evaluating if there is additional benefit to the synergistic pairing of translingual neurostimulation (TLNS) with PT to improve walking and balance in MS. Methods and analysisA parallel group [PT + TLNS or PT + Sham], quadruple-blinded, randomized controlled trial. Participants (N = 52) with gait and balance deficits due to relapsing-remitting or progressive MS, who are between 18 and 70 years of age, will be recruited through patient registries in Newfoundland & Labrador and Saskatchewan, Canada. All participants will receive 14 weeks of PT while wearing either a TLNS or sham device. Dynamic Gait Index is the primary outcome. Secondary outcomes include fast walking speed, subjective ratings of fatigue, MS impact, and quality of life. Outcomes are assessed at baseline (Pre), after 14 weeks of therapy (Post), and 26 weeks (Follow Up). We employ multiple methods to ensure treatment fidelity including activity and device use monitoring. Primary and secondary outcomes will be analyzed using linear mixed-effect models. We will control for baseline score and site to test the effects of Time (Post vs. Follow-Up), Group and the Group x Time interaction as fixed effects. A random intercept of participant will account for the repeated measures in the Time variable. Participants must complete the Post testing to be included in the analysis. Ethics and disseminationThe Human Research Ethics Boards in Newfoundland & Labrador (HREB#2021.085) & Saskatchewan (HREB Bio 2578) approved the protocol. Dissemination avenues include peer-reviewed journals, conferences and patient-oriented communications.

Study design and methods of the Wells and Enteric disease Transmission (WET) Trial: a randomised controlled trial

IntroductionThe burden of disease attributed to drinking water from private wells is not well characterised. The Wells and Enteric disease Transmission trial is the first randomised controlled trial to estimate...

Brain Response Induced by Peroneal Electrical Transcutaneous Neuromodulation Invented for Overactive Bladder Treatment, as Detected by Functional Magnetic Resonance Imaging

ObjectivesIn this study, we aimed to investigate whether peroneal electrical Transcutaneous Neuromodulation invented for overactive bladder (OAB) treatment elicits activation in brain regions involved in neural regulation of the lower urinary tract. Materials and MethodsAmong 22 enrolled healthy female volunteers, 13 were eligible for the final analysis. Functional magnetic resonance imaging (fMRI) (Siemens VIDA 3T; Erlangen, Germany) was used to compare the brain region activation elicited by peroneal electrical Transcutaneous Neuromodulation with the activation elicited by sham stimulation. Each subject underwent brain fMRI recording during eight 30-second periods of rest, alternating with 30-second periods of passive feet movement using the sham device, mimicking the motor response to peroneal nerve stimulation. Subsequently, fMRI recording was performed during the analogic “off-on” stimulation paradigm using peroneal electrical transcutaneous neuromodulation. Magnetic resonance imaging data acquired during both paradigms were compared using individual and group statistics. ResultsDuring both peroneal electrical Transcutaneous Neuromodulation and sham feet movements, we observed activation of the primary motor cortex and supplementary motor area, corresponding to the cortical projection of lower limb movement. During peroneal electrical Transcutaneous Neuromodulation, we observed significant activations in the brain stem, cerebellum, cingulate gyrus, putamen, operculum, and anterior insula, which were not observed during the sham feet movement. ConclusionsOur study provides evidence that peroneal electrical Transcutaneous Neuromodulation elicits activation of brain structures that have been previously implicated in the perception of bladder fullness and that play a role in the ability to cope with urinary urgency. Our data suggest that neuromodulation at the level of supraspinal control of the lower urinary tract may contribute to the treatment effect of peroneal electrical Transcutaneous Neuromodulation in patients with OAB.

The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue in Participants With Primary Sjögren’s Syndrome

ObjectivesFatigue is one of the most important symptoms needing improvement in Primary Sjögren's syndrome (PSS). Previous data from our group suggest that noninvasive stimulation of the vagus nerve (nVNS) may improve symptoms of fatigue. This experimental medicine study uses the gammaCore device (electroCore) and a sham device to investigate the relationship between nVNS and fatigue in PSS, and to explore potential mechanisms involved. Materials and MethodsForty participants with PSS were randomly assigned to use active (n = 20) or sham (n = 20) nVNS devices twice daily for 54 days in a double-blind manner. Patient-reported measures of fatigue were collected at baseline and day 56: Profile of Fatigue (PRO-F)-Physical, PRO-F-Mental and Visual Analogue Scale of abnormal fatigue (fVAS). Neurocognitive tests, immunologic responses, electroencephalography alpha reactivity, muscle acidosis, and heart rate variability were compared between devices from baseline to day 56 using analysis of covariance. ResultsPRO-F-Physical, PRO-F-Mental, and fVAS scores were significantly reduced at day 56 in the active group only (p = 0.02, 0.02, and 0.04, respectively). Muscle bioenergetics and heart rate variability showed no change between arms. There were significant improvements in digit span and a neurocognitive test (p = 0.03), and upon acute nVNS stimulation, frontal region alpha reactivity showed a significant negative relationship with fatigue scores in the active group (p < 0.01). ConclusionsWe observed significant improvements in three measures of fatigue at day 56 with the active device but not the sham device. Directly after device use, fatigue levels correlate with measures of alpha reactivity, suggesting modulation of cholinergic system integrity as a mechanism of action for nVNS.

Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial

Repeated low-level red-light (RLRL) therapy is an emerging treatment for myopia control. Nevertheless, previous studies are limited by open-label design. Our study aimed to assess the efficacy and safety of RLRL therapy in controlling myopia progression compared to a sham device with only 10% of the original power. Randomized, double-blind, controlled clinical trial. A total of 112 Chinese children aged 7 to 12 years with myopia of at least -0.50 diopter (D), astigmatism of 1.50 D or less, and anisometropia of 1.50 D or less. Participants were assigned randomly in a 1:1 ratio to the RLRL group or the sham device control group, following a schedule of 3 minutes per session, twice daily, with an interval between sessions of at least 4 hours. The RLRL therapy was provided by a desktop red-light therapy device and administered at home. The sham device was the same device but with only 10% of the original device's power. Cycloplegic refraction and axial length (AL) were measured at baseline and 6 months. Changes in cycloplegic spherical equivalence refraction (SER) and AL between 2 groups were compared using a generalized estimating equation (GEE). A total of 111 children were included in the analysis (n= 56 in the RLRL group and n= 55 in the sham device control group). The mean SER change over 6 months was 0.06 ± 0.30 D in the RLRL group and -0.11 ± 0.33 D in the sham device control group (P= 0.003), with respective mean increases in AL of 0.02 ± 0.11 mm and 0.13 ± 0.10 mm (P < 0.001). In the multivariate GEE models, children in the RLRL group showed less myopia progression and axial elongation than those in the sham device control group (SER: coefficient, 0.167 D; 95% confidence interval [CI], 0.050-0.283 D; P= 0.005; AL: coefficient, -0.101 mm; 95% CI, -0.139 to -0.062 mm; P < 0.001). No treatment-related adverse events were reported. In myopic children, RLRL therapy with 100% power significantly reduced myopia progression over 6 months compared with those treated with a sham device of 10% original power. The RLRL treatment was well tolerated without treatment-related adverse effects.

Study protocol for a parallel-group randomized controlled multi-center trial evaluating the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence (SENS-U trial)

BackgroundLower urinary tract dysfunction or functional urinary incontinence is a common condition with a prevalence up to 21% between 6 and 8 year-old children. It is associated with an impaired quality of life, lower self-esteem, and social stigmatization. Urotherapy is the first treatment of choice for functional daytime urinary incontinence (DUI) in children. Alarm therapy can be a part of urotherapy as it provides the child adequate feedback on wetting accidents. Current alarm systems notify either at a set interval or give a notification when wetting has already occurred to prompt the child to go to the toilet. These alarms do not teach the child the interpretation of the bladder sensation preceding wetting accidents. A new wearable bladder sensor, the SENS-U, recently became available. This is a relative small, wireless ultrasonic sensor, which continuously monitors bladder filling. The SENS-U is able to provide an alarm at the exact moment voiding is warranted. It facilitates the child to learn the sensation of bladder filling preceding voiding in an easier way, increasing the learning curve throughout treatment. Its additional effect in urotherapy on continence and cost-effectiveness is to be determined.Methods/designThis is a multi-center clinical superiority parallel-group randomized controlled trial including a total of 480 children. Participants between 6 and 16 years of age with functional DUI in which urotherapy is offered as the next treatment of choice are eligible. Four centers, two academic hospitals, and two general care (peripheral) centers are participating. Participants will be randomized at a 1:1:1 ratio into three groups: urotherapy (care as usual), urotherapy with the SENS-U added for 3 consecutive weeks throughout the training, or urotherapy with a SHAM device for 3 weeks. The primary outcome is number of wetting accidents per week after 3 months of training, compared between the SENS-U and the SHAM device. The magnitude of the placebo effect will be assessed by comparing the results of the SHAM group versus the control (care as usual) group.DiscussionTo our knowledge, this is the first trial studying not only the effect but also the cost-effectiveness of alarm interventions as commonly added in urotherapy.Trial registrationISRCTN44345202. Registered on March 2022

Effects of combining electrical stimulation of the calf and thigh muscles in patients with osteoarthritis of the knee: protocol for a double-blind, randomised, sham-controlled trial

IntroductionKnee osteoarthritis (KOA) is a leading cause of disability and is characterised by degenerative changes causing pain and loss of function. Neuromuscular electrical stimulation (NMES) has been shown to influence...

Age-Limited Effects of Low-Frequency Transcutaneous Electric Nerve Stimulation on Insomnia: A 4-Week Multi-Center, Randomized Controlled Study.

Objective Insomnia disorder is a common condition with considerable harmful effects on health. We investigated the therapeutic efficacy and safety of low-frequency transcutaneous electric nerve stimulation (LF-TENS) as an alternative treatment option for insomnia disorder. Methods A 4-week, multi-center, randomized controlled study was conducted. A total of 160 individuals aged 40 to 80 years with insomnia disorder were included and randomized to the experimental group receiving active device (n=81) or control group receiving sham device (n=79). Both groups used the device for four weeks, more than five days a week. The participants also completed pre- and post-intervention assessment with questionnaires, sleep diaries, wrist actigraphy, and blood tests. Results There was no significant between-group difference in the changes of mood and sleep parameters and blood test results among the two study groups. Meanwhile, in the exploratory sub-group analysis of patients aged over 60 years, the experimental group showed better improvement after intervention in the change of Pittsburgh Sleep Quality Index (PSQI) score (-2.63±3.25 vs. -1.20±2.28, p=0.039; Cohen’s d=0.99 vs. 0.45) and blood cortisol level (-1.65±3.37 μg/dL vs. -0.16±3.49 μg/dL, p=0.007; Cohen’s d=0.56 vs. 0.05). In addition, no serious adverse reaction occurred during the study period in both groups. Conclusion The effect of LF-TENS was limited to older patients aged over 60 years, which might be related to the modulation of hypothalamic-pituitary-adrenal axis activity.

LBA02-11 NOVEL ON-DEMAND TREATMENT FOR LIFELONG PREMATURE EJACULATION USING TRANSCUTANEOUS PERINEAL MINI-PATCH STIMULATOR

You have accessJournal of UrologyCME1 May 2022LBA02-11 NOVEL ON-DEMAND TREATMENT FOR LIFELONG PREMATURE EJACULATION USING TRANSCUTANEOUS PERINEAL MINI-PATCH STIMULATOR Ariki Shechter, Nicola Mondaini, Ege Can Serefoglu, Tal Gollan, Boaz Appel, and Ilan Gruenwald Ariki ShechterAriki Shechter More articles by this author , Nicola MondainiNicola Mondaini More articles by this author , Ege Can SerefogluEge Can Serefoglu More articles by this author , Tal GollanTal Gollan More articles by this author , Boaz AppelBoaz Appel More articles by this author , and Ilan GruenwaldIlan Gruenwald More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002670.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Background: Premature Ejaculation (PE) is a prevalent sexual dysfunction in men. Available treatments demonstrate limited efficacy and low treatment adherence. Objectives: To assess feasibility, safety, and efficacy of the Mini-patch, an on-demand transcutaneous perineal electrical stimulator, for the treating of PE. METHODS: Design, Setting, and Participants: Bi-center, international, prospective, randomized, double-blind, two-arm, sham-controlled, clinical study. After screening, intravaginal ejaculatory latency time (IELT) of candidates was measured. Eligibility was based on IELT values and medical/sexual history. Patients were randomized to Active and Sham device groups in a 2:1 ratio. Device safety profile was determined by incidence of treatment-emergent adverse events comparison. Outcome Measurements and Statistical Analysis: Clinical Global Impression of Change (CGIC) scores, Premature Ejaculation Profile (PEP) questionnaire outcomes, and Mini-patch safety profile. Statistical power was calculated. Primary endpoints assessed device efficacy by mean fold change in geometric mean IELT (Mini-patch vs. sham treatment compared to baseline values). Adjusted mean difference for treatments, adjusted treatment effects (Mini-patch – sham), 95% confidence intervals (CI), and 2-sided P values were obtained. RESULTS: Of 59 patients randomized, 51 completed the study: 34 in the Active and 17 in the Sham arm. Baseline geometric mean IELT was 67 seconds and significantly increased to 123 seconds (p<0.0001) in the Active group, compared to 63 seconds increasing insignificantly to 81 seconds (p=0.1653) in the Sham group. The IELT significantly increased by 3.22-fold in the Active as compared to the Sham group (p=0.0047). Overall Geometric Mean Time Fold increases of IELT in the Active compared to the Sham group were 1.7 (95% CI 1.5-2.1) vs. 1.2 (95% CI 1.0-1.6), respectively. No serious adverse events were reported. CONCLUSIONS: Mini-patch has the potential to become a leading on-demand, noninvasive, and drug-free treatments for PE. Source of Funding: Virility Medical Ltd; Hod-hasharon, Israel © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e1045 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ariki Shechter More articles by this author Nicola Mondaini More articles by this author Ege Can Serefoglu More articles by this author Tal Gollan More articles by this author Boaz Appel More articles by this author Ilan Gruenwald More articles by this author Expand All Advertisement PDF DownloadLoading ...

Effect of customised preformed foot orthoses on gait parameters in children with juvenile idiopathic arthritis: A multicentre randomised clinical trial

BackgroundChildren with juvenile idiopathic arthritis (JIA) can experience significant physical impairment of the lower extremity. Prolonged joint disease and symptoms may cause gait alterations such as reduced walking speed and increased plantar pressures in diseased areas of their feet. There is limited robust clinical trials investigating the effect of non-invasive mechanical therapies such as foot orthoses (FOs) on improving gait parameters in children with JIA. Research questionAre customised preformed FOs effective in improving gait parameters in children with JIA? MethodsA multicentre, parallel design, single-blinded randomised clinical trial was used to assess the gait impacts of customised preformed FOs on children with JIA. Children with a diagnosis of JIA, exhibiting lower limb symptoms and aged 5–18 were eligible. The trial group received a low-density full length, Slimflex Simple device which was customised chair side and the control group received a sham device. Peak pressure and pressure time integrals were used as the main gait outcomes and were measured using portable Tekscan gait analysis technology at baseline, 3 and 6 months. Differences at each follow-up were assessed using the Wilcoxon rank sum test. Results66 participants were recruited. Customised preformed FOs were effective in altering plantar pressures in children with JIA versus a control device. Reductions of peak pressures and pressure time integrals in the heel, forefoot and 5th metatarsophalangeal joint were statistically significant in favour of the trial group. This was associated with statistically significant increased midfoot contact with the trial device at baseline, 3 and 6-month data collections. The trial intervention was safe and well accepted by participants, which is reflected in the high retention rate (92%). SignificanceClinicians may prescribe customised preformed FOs in children with JIA to deflect pressure from painful joints and redistribute from high pressure areas such as the rearfoot and forefoot.

Efficacy and safety of skin-adhesive low-level light therapy for overactive bladder: a Phase III study

Introduction and hypothesisOveractive bladder (OAB) is a common condition that remains challenging to treat. We hypothesized that skin-adhesive low-level light therapy (LLLT) would be an effective treatment for OAB caused by bladder muscle contraction. Accordingly, we aimed to evaluate the efficacy and safety of an LLLT device for the treatment of OAB.MethodsThis prospective, randomized, double-blind, placebo-controlled, multicenter trial included patients with a clinical diagnosis of OAB who were treated at either of two university hospitals. Patients were instructed to apply an LLLT device (Color DNA-WSF) or a sham device at home three times daily for 12 weeks. The primary outcome was the change in the mean daily number of urge urinary incontinence (UUI) episodes between baseline and 12 weeks. The secondary outcomes were the mean changes in incontinence, voiding, and nocturia episodes from baseline and the likelihood of achieving a > 50% reduction in UUI and incontinence episodes after 12 weeks. All patients completed the Overactive Bladder Symptom Score (OABSS), Urogenital Distress Inventory-6 (UDI-6), and Impact Urinary Incontinence-7 (IIQ-7) questionnaires. Safety parameters included treatment-emergent adverse events.ResultsCompared with those in the sham group, the numbers of UUI and urinary incontinence episodes in the LLLT group were significantly decreased at week 12 (UUI, (-1.0 ± 1.7 vs. -0.4 ± 2.5, P = 0.003; urinary incontinence, -1.1 ± 1.9 vs. -0.5 ± 2.9, P=0.002). Furthermore, the OABSS, UDI-6, and IIQ-7 scores at week 12 tended to be better in the LLLT group than in the sham group. The incidence of device-related treatment-emergent adverse events was similar between groups.ConclusionsLLLT may be clinically useful and safe for the treatment of OAB.

Effects of home air purifiers in the quality of life of patients with chronic obstructive pulmonary disease in Mexico City: a phase III, single-center, triple-blinded, randomized controlled trial (GREAT-COPD)

Background: Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. Air pollution is associated with a decrease in lung function and an increase in inflammatory biomarkers, respiratory symptoms, and hospital admissions due to several causes, including COPD exacerbations. Nevertheless, uncertainty exists on whether indoor air quality improvement could lead to a reduction in morbidity associated with COPD. Therefore, we aim to prove the efficacy of High-Efficiency Particulate Air (HEPA) filters to reduce respiratory symptoms related to COPD exacerbations.Methods: We propose a single-center, parallel, controlled, randomized with a 1:1 allocation, double-blinded, phase III trial that will be performed on patients 45 years and older with moderate to severe COPD in Mexico city, comparing the use of HEPA filters with carbon air filters vs. sham devices. The main outcome will be the average change of the COPD Assessment Test (CAT) score between baseline and 4-month follow-up comparing intervention and control groups. Secondary outcomes will include CAT score measurements at 8 and 12 months, distance measured by a 6-minute walk test, Forced Expiratory Volume in 1 second, and number of and time to exacerbations measured at 4, 8, and 12 months.Discussion: With this intervention, we expect to reduce symptoms associated with COPD, therefore observing a reduction in emergency department visits, hospital admissions, and economic burden. The results of this study could potentially help assess future guidelines, economic analysis, and healthcare policies on the implementation of air cleaning strategies and healthcare policies, directing resources towards air quality improvement. Keywords: Chronic Obstructive Pulmonary Disease, Air Filters, Pollution, Exacerbations, Randomized Clinical Trial, COPD Assessment Test.

Ultrasound-Assisted Wound (UAW) Debridement in the Treatment of Diabetic Foot Ulcer: A Systematic Review and Meta-Analysis.

A systematic review and meta-analysis were carried out to investigate the effect of ultrasound-assisted wound (UAW) debridement in patients with diabetic foot ulcers (DFUs). All selected studies were evaluated using the Cochrane risk of bias tool to assess the risk of bias for randomized controlled trials. PubMed and Web of Science were searched in October 2021 to find randomized clinical trials (RCT) assessing the effect of UAW debridement on DFUs. RevMan v5.4. was used to analyze the data with the Mantel–Haenszel method for dichotomous outcomes. A total of 8 RCT met our inclusion criteria, with 263 participants. Concerning the healing rate comparing UAW versus the control group, a meta-analysis estimated the pooled OR at 2.22 (95% CI 0.96–5.11, p = 0.06), favoring UAW debridement, with low heterogeneity (x2 = 7.47, df = 5, p = 0.19, I2 = 33%). Time to healing was similar in both groups: UAW group (14.25 ± 10.10 weeks) versus the control group (13.38 ± 1.99 weeks, p = 0.87). Wound area reduction was greater in the UAW debridement group (74.58% ± 19.21%) than in the control group (56.86% ± 25.09%), although no significant differences were observed between them (p = 0.24). UAW debridement showed higher healing rates, a greater percentage of wound area reduction, and similar healing times when compared with placebo (sham device) and standard of care in patients with DFUs, although no statistically significant differences were observed between groups.

Effect of Pulsed Low-Intensity Ultrasonography on Symptom Relief and Tibiofemoral Articular Cartilage Thickness Among Veterans Affairs Enrollees With Knee Osteoarthritis

Osteoarthritis (OA) is a major cause of disability in the US, with no approved treatments to slow progression, but animal models suggest that pulsed low-intensity ultrasonography (PLIUS) may promote cartilage growth. To evaluate the efficacy of PLIUS in providing symptom reduction and decreased loss of tibiofemoral cartilage thickness in patients with knee OA. A phase 2A, sham-controlled, parallel, double-blind randomized clinical trial was conducted at 2 Veterans Affairs hospitals in Salt Lake City, Utah, and San Diego, California, from May 22, 2015, to January 31, 2019. Data were analyzed from June 27, 2020, to October 20, 2020. Participants recruited through the US Department of Veterans Affairs (N = 132) with clinical and radiographic evidence of early knee OA were randomly assigned to receive PLIUS or a sham device, self-administered for 20 minutes daily over the medial compartment of the knee. All enrollees participated in a 4-week prerandomization sham run-in period, followed by a 48-week treatment period. Randomization was stratified by study site and Kellgren-Lawrence grades 1 (n = 15), 2 (n = 51), and 3 (n = 66). Participants either received 48 weeks of PLIUS or sham ultrasonography. The trial incorporated 2 coprimary outcomes: symptomatic improvement assessed by Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International Responder Criteria (ie, met if either >50% improvement in pain and function with at least a 20% absolute improvement of at least 2 of the following 3 factors: improvement by at least 20% [pain, function, and patient global assessment] with at least a 10-mm absolute improvement), and cartilage preservation assessed as change in central medial femoral condyle cartilage thickness by magnetic resonance imaging. Intention-to-treat analysis was used. The mean (SD) participant age was 63.6 (10.7) years and 119 were men (90.2%). The mean (SD) duration of OA symptoms was 13.4 (12.3) years. In the PLIUS group, 70.4% (95% CI, 58.2%-82.6%) of the participants experienced symptomatic improvement, compared with 67.3% (95% CI, 54.9%-79.7%) of participants in the sham group (P = .84); there was no statistically significant difference in response rates between the treatment groups, and the between-group rate difference of 3.1% (95% CI, -14.3% to 20.5%) did not meet the predefined 10% threshold for clinically significant symptomatic improvement from application of PLIUS. At 48 weeks of treatment, central medial femoral condyle cartilage thickness decreased by a mean (SD) of 73.8 (168.1) μm in the PLIUS group and by 42.2 (297.0) μm in the sham group. This 48-week mean change between the 2 groups did not reach statistical significance (P = .44), and the between-group 48-week difference of -31.7 μm (95% CI, -129.0 μm to 65.7 μm) did not meet the predefined threshold. There were 99 nonserious adverse events in the PLIUS group and 89 in the sham group during the trial. No serious adverse events were deemed related to the study device. PLIUS, as implemented in this study, demonstrated neither symptomatic benefit nor a decrease in loss of tibiofemoral cartilage thickness in knee OA. ClinicalTrials.gov Identifier: NCT02034409.

Effectiveness and safety assessment of orthopedic device (LSM-01) for low back pain: A randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial.

Background:More than 80% of the population suffer from low back pain at some time during their lives. An orthopedic device (LSM-01) will be used to alleviate back pain caused by muscle tension. LSM-01, which has a rotating roller, stimulates meridian-muscles around the governor vessel, bladder meridian, and gall bladder meridian.Methods:This study will be a randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial. Subjects will be randomly allocated to the treatment group (LSM-01) or the control group (sham device). The duration of the clinical trial will be 2 weeks. The primary outcomes will be measured using the visual analog scale; the secondary outcomes will include pressure pain threshold, Oswestry Disability Index, and Patient Global Impression of Change. Statistical analysis will be performed for the full study population. Analysis of covariance will be conducted to identify differences in pain before and after the application of the device.Discussion:This clinical trial will evaluate the safety and efficacy of the LSM-01 device. As a pilot study, this investigation includes a limited number of subjects. The results of this pilot trial will form a basis for a large-scale clinical trial, which will be conducted in the future.Clinical trial registration:This study protocol is registered with the Clinical Research Information Service (CRIS) of Korea. Clinical trial registration number: CRIS-KCT0006425. Registered: October 5, 2021; https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&search_page=L&pageSize=10&page=undefined&seq=20056&status=5&seq_group=20056

Positive Expiratory Pressure Therapy on Oxygen Saturation and Ventilation After Abdominal Surgery: A Randomized Controlled Trial.

To evaluate the immediate effects of positive expiratory pressure therapy on oxygen saturation and ventilation after abdominal surgery. Positive expiratory pressure therapy to treat postoperative hypoxia is widespread, despite a lack of evidence of effect. This randomized, sham-controlled, crossover trial investigated adults 1-2 days after abdominal surgery at Umeå University Hospital, Sweden. The intervention was positive expiratory pressure of 10-15 cm H2O. The control was a sham device. The investigations were ended with deep-breathing maneuvers. Outcomes were the gradient of changes in peripheral oxygen saturation and transcutaneous carbon-dioxide partial pressure (PtcCO2). Eighty patients were included and randomized and 76 patients were analyzed. Oxygen saturation increased from a baseline mean of 92% to 95%, P < 0.001, during positive expiratory pressure breathing, while PtcCO2 decreased from a mean of 36 to 33 mm Hg, P < 0.001. This was followed by apnea, oxygen desaturations to a mean of 89%, P < 0.001, and increased PtcCO2 before returning to baseline values. The changes in oxygen saturation and PtcCO2 did not differ from sham breathing or deep-breathing maneuvers. Positive expiratory pressure breathing after abdominal surgery improves oxygen saturation during the maneuver because of hyperventilation, but it is followed by apnea, hypoventilation, and oxygen desaturation. The effect is not different from the expiration to a sham device or hyperventilation. It is time to stop positive expiratory pressure therapy after abdominal surgery, as there is no evidence of effect in previous trials, apart from the adverse effects reported here.

Rationale and design of the safe and timely antithrombotic removal - ticagrelor (STAR-T) trial: A prospective, multi-center, double-blind, randomized controlled trial evaluating reductions in postoperative bleeding with intraoperative removal of ticagrelor by the drugsorb™-ATR device in patients undergoing cardiothoracic surgery within 48 hours from last ticagrelor dose

Ticagrelor is often administered to patients with acute coronary syndromes. However, when these patients require urgent or emergent cardiothoracic (CT) surgery the presence of ticagrelor significantly increases surgical bleeding. The goal of the current trial is to evaluate the effectiveness and safety of the DrugSorb-ATR hemoadsorption device for the intraoperative removal of ticagrelor to reduce postoperative bleeding in the above patient population. The Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) Trial is a multi-center, double-blind, randomized, controlled trial enrolling patients who require cardiothoracic surgery on cardiopulmonary bypass (CPB) within 48 hours of last ticagrelor dose. Subjects will be randomized 1:1 to receive either the DrugSorb-ATR device or an identical sham device during CPB. The study will enroll up to 120 subjects at 20 U.S centers, and the primary outcome is the composite of fatal perioperative bleeding, moderate/severe/massive bleeding according to the Universal Definition of Perioperative Bleeding in Cardiac Surgery (UDPB), and 24 hours chest tube drainage. The components of the composite are hierarchically ranked according to clinical significance and the primary analysis will utilize the Win Ratio method. Percent change in ticagrelor levels before and after CPB (drug removal) will be the key secondary endpoint. An independent Clinical Events Committee will adjudicate all clinical endpoints including safety endpoints relating to postoperative thrombotic events. Subjects will be followed through 30 days after the index operation. The results from STAR-T, if positive, will potentially support FDA market approval for DrugSorb-ATR, and provide a solution to an important unmet clinical need.

A back table ultraviolet light decreases environmental contamination during operative cases

The purpose of this study is to assess the impact of a germicidal ultraviolet light-emitting diode (LED) on the contamination level of a back table in the operating room (OR) during total joint arthroplasty procedures. Eight Tryptic Soy Agar petri plates were placed on a table located near the operative field and exposed to air. One plate was removed on the hour over an 8-hour time span. The back table had either an UV-LED for disinfection or a sham UV-LED. This process was repeated in 12 different ORs (6 with UV light, 6 with sham device). The plates were then incubated for 48 hours at 36°C ± 1°C . Colony forming units (CFU) were recorded 24 and 48 hours after incubation. There was a statistically significant difference in total CFUs between the intervention vs sham at 24-hours (27 vs 95, P=.0001) and 48-hours (38 vs 122, P < .0001). The multivariate analysis revealed that the 24-hour and 48-hour count, the predictors UV light (P=.002) and hour of plate removal (P=.050) were statistically significantly associated with CFU counts. Together, the predictor variables explained 15.8% and 23.0% of the variance in CFU counts at 24- and 48-hours, respectively. A back table UV-LED may decrease environmental contamination near the operative field. This has potential to lead to a decrease in joint infection.