Single-blind Trial Research Articles

Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients: A Proof-of-Concept Phase 2, Randomized, Placebo-Controlled, Single-Blind Clinical Trial

The SARS-CoV-2 pandemic has revolutionized the scientific and medical world in recent years. Methylene blue (MB) is a well-known molecule. The aim of our study was to assess the efficacy of MB against early-phase SARS-CoV-2 infections. All patients with a positive swab for SARS-CoV-2 were eligible for the trial. The intervention was a starting dose of 200 mg MB or placebo in the morning and 100 mg in the evening on the first day and afterwards the standard daily dose of 200 mg. Patients were followed up for safety and efficacy until day 84. We analyzed 21 patients for the safety profile and 19 for the efficacy objective: of these, there were 11 in the MB group and 8 in the placebo one. In both groups, patients had undetectable RNA from day 3 and 10 out of 11 subjects in the MB group were virus free by day 12 vs. 6 out of 8 in the placebo one. None of the patients experienced serious adverse events. MB has proved to be a safe and well-tolerated drug. We did not find superiority of efficacy or viral clearance of MB compared to the placebo. Given the good in vitro efficacy, larger studies are needed to assess MB efficacy against COVID-19 in vivo.

The Effectiveness of Anemia Treatment with Injectable Iron within 48 to 72 Hours before Coronary Artery Bypass Surgery on Cardiac Function and Postoperative Outcome: A Randomized Clinical Trial

Background: Anemia is considered as one of the risk factors affecting the outcomes after cardiac surgery. Accordingly, the improvement of iron deficiency anemia through injection or oral may be associated with the improvement of post-procedure results, especially the improvement of cardiovascular function. This study was aimed at investigating the effectiveness of iron treatment shortly before surgery in reducing the need for blood transfusion and improving myocardial performance parameters (left ventricular ejection fraction) in coronary bypass surgery patients. Methods: This study was a single-blind randomized clinical trial. In total, 60 candidates for coronary bypass surgery having iron deficiency anemia before the operation were randomly divided into two groups treated with injectable iron supplement (iron sucrose at a dose of 200 mg/200 ml of normal saline injected in 30 minutes) 48 to 72 hours before surgery or without therapeutic intervention. The patients were examined during and after the operation in terms of surgical outcomes. Results: Treatment with injectable iron before surgery was associated with improvement in serum hemoglobin level after surgery and a significant reduction in the need for intraoperative and postoperative transfusions. Preoperative treatment of iron deficiency was associated with a reduction in the length of hospitalization of the patients after surgery. Conclusion: Treatment of iron deficiency anemia within 48 to 72 hours before surgery will improve the condition of patients’ anemia and compensate serum hemoglobin, reduce the need for blood transfusion during surgery and the length of hospitalization of the patients after surgery.

The Severity of Wound Infection in Washing the Primary Prep Area with 70% Alcohol and Normal Saline in the Orthopedic Surgery Prepped with Povidone-Iodine: A Randomized Clinical Trial

Background: Despite significant advances in patient treatment, infection remains a complication after surgery. The present study compared the incidence and severity of wound infection with two methods of washing the primary prep area with 70% alcohol and normal saline in patients who are candidates for orthopedic surgery in Kowsar Hospital of Sanandaj, Iran. Methods: This single-blinded randomized clinical trial was conducted on 190 candidates for upper limb orthopedic surgery aged 18 to 65. Patients were randomly assigned to two alcohol and normal saline groups based on the table of random numbers. The primary outcome of this clinical trial was the incidence and severity of wound infection after surgery, which was measured by the standard scale of the Asepsis index. The results were analyzed using SPSS version 23, and statistical values less than 0.05 were considered significant. Results: Patients’ hospitalization duration in the intervention group was (3.02±1.04 days) and in the control group (2.86±1.03 days) showed no significant statistical difference (p=0.297). The frequency of wound infection in the alcohol group was lower than in the normal saline group. this difference was statistically significant (p=0.023). Also, the severity of wound infection in the 70% alcohol group (Mean=5.12, SD=3.19) was lower than in the normal saline group (Mean=7.69, SD=4.12). This difference was statistically significant (p<0.001). Conclusion: The present clinical trial showed that the incidence and severity of wound infection after surgery were lower in the group washing the skin of the surgical area with alcohol compared to the group washing with normal saline.

Comparative efficacy of probiotic mixture Bifidobacterium longum KABP042 plus Pediococcus pentosaceus KABP041 vs. Limosilactobacillus reuteri DSM17938 in the management of infant colic: a randomized clinical trial

We aimed to compare the efficacy of Bifidobacterium longum KABP042 + Pediococcus pentosaceus KABP041 (BL + PP) vs. Limosilactobacillus reuteri DSM17938 (LR) in alleviating the symptoms of infant colic, as commercially available formulations. A randomized, multicenter, parallel, single-blind (investigator) trial was conducted in 112 colicky infants diagnosed as per Rome IV criteria and randomly allocated to receive BL + PP orally (109 colony-forming units [CFU]/day, n = 55) or LR (108 CFU/day, n = 57) for 21 days. Primary study outcomes were percentage of responders (≥ 50% reduction in crying and fussing time from baseline, as reported by parents in a structured diary) and daily crying and fussing time (minutes/day) on days 7, 14, and 21 after randomization. Study groups were comparable at baseline. Responder rate was significantly higher in BP + PP group vs. LR group at days 7 (61.1% vs. 37.5%, p = 0.013) and 14 (84.6% vs. 59.3%, p = 0.004). Crying and fussing time (median [IQR]) became significantly lower in BL + PP group vs. LR group on day 7 (119 [60–210] vs. 180 [110–270]; p = 0.028), day 14 (60.0 [30–105] vs. 120 [60–180]; p = 0.017), and day 21 (29 [0–85] vs. 67 [30–165]; p = 0.011). No significant differences were found in the number of adverse events between the groups. Conclusion: The specific formulation of B. longum KABP042 and P. pentosaceus KABP041 achieved a higher response rate and a larger reduction in crying and fussing time in colicky infants. Both probiotic interventions were well tolerated.Trial registration: The study was retrospectively registered as NCT05271747 on February 28th, 2022.What is Known:• L. reuteri DSM17938 (LR) is the most researched probiotic strain for infant colic against placebo in randomized, controlled clinical trials, and is recommended in various guidelines. A novel probiotic combining strains B. longum KABP042 and P. pentosaceus KABP041 (BL + PP) has also demonstrated efficacy in infant colic against placebo.What is New:• This randomized study provides the first direct comparison of two probiotics for infant colic. BL + PP seems to be superior to LR in reducing crying time.

Tuina versus physiotherapy or a combination of both for the management of chronic nonspecific low back pain: A randomized controlled trial

ObjectiveTo rigorously evaluate the short-term and long-term effectiveness of Tuina (TN), alone and in combination with physiotherapy (PT), for Chronic nonspecific low back pain (CNLBP) through a comprehensive, high-quality clinical trial. MethodsThis randomized, single-blind trial was conducted from September 2020 to July 2023, involving 204 CNLBP patients from the First Affiliated Hospital of Jinan University. Participants underwent a baseline assessment, 6 treatment sessions over 8 weeks, a post-treatment evaluation in the 9th week, and a 20-week follow-up. Participants were randomly assigned to TN, PT, or a combination of TN and PT (TP) groups. Each treatment involved 6 sessions with a minimum 7-day interval, each lasting 30 minutes. Primary outcome was the change in Visual Analog Scale (VAS) for pain. Secondary outcomes included the Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), Range of Motion (ROM) of the spine, Traditional Chinese Medicine Syndrome Scale (TCMSS), and adverse events (AE). ResultsAmong the 204 participants, 67.16 % were female, and 88.73 % completed the 20-week follow-up. All groups showed significant reductions in VAS scores post-treatment and at follow-up. Secondary outcomes improved significantly, with notable decreases in ODI and TCMSS scores. Pairwise comparisons within groups indicated statistical significance, particularly in ODI scores, with clinical relevance. No significant differences were found between the groups. ROM and SF-36 showed statistical but not clinical significance. Only one AE (0.49 %) was reported, with no severe incidents. ConclusionAll treatment groups, including TN, TP, and PT, demonstrated significant reductions in VAS scores for CNLBP patients, with effects lasting up to 20 weeks. While TN and TP showed substantial improvements in secondary outcomes, particularly in ODI scores, no significant differences were found between the groups. These findings suggest that all treatments can be effective for managing CNLBP, supporting clinical practitioners in selecting appropriate interventions for patients, especially for those unable to engage in active exercises, utilizing passive movements like TN to enhance health outcomes.

Comprehensive assessment of heavy slow resistance training and high-dose therapeutic ultrasound in managing patellar tendinopathy, a randomized single-blind controlled trial

BackgroundPatellar tendinopathy (PT) is a common sport injury prone to recurrence. Heavy Slow Resistance Training (HSR) and High-Dose Therapeutic Ultrasound (TUS) are frequently used interventions for PT. However, the combined effectiveness of these therapies remains unclear. This study investigated the impact of combination therapy on functional outcomes in patients with PT.MethodsFifty-one college students aged 18–25, diagnosed with PT via musculoskeletal ultrasound, were randomly assigned to one of three groups (n = 17 per group): combined HSR and high-dose TUS, HSR training alone, or high-dose TUS alone. The eight-week intervention included assessments using the Victorian Institute of Sport Assessment-Patella (VISA-P), Visual Analogue Scale (VAS), Y-balance Test (YBT), Modified Thomas Test (MTT), Horizontal Jumping Distance, Maximum Isometric Muscle Strength Test, and musculoskeletal ultrasound for patellar tendon thickness and blood flow. Assessments were conducted at baseline and post-intervention, with a follow-up VISA-P assessment at week 16. This randomized, single-blind controlled trial was registered on ISRCTN11447397 (www.ISRCTN.com) on February 17, 2024 (retrospectively registered).ResultsAll groups demonstrated significant improvements in VISA-P scores at the end of the intervention compared to baseline (p < 0.01), with the combined group showing the greatest improvement (21 points). Follow-up at week 16 revealed continued improvement in VISA-P scores for the combined and HSR groups, while the TUS group showed a slight decrease (from 74 to 70). All groups displayed significantly reduced VAS scores post-intervention (p < 0.01) compared to baseline, indicating decreased pain. While no significant between-group differences were observed in pre-intervention VAS scores, post-intervention results revealed significant differences between the combined and HSR groups (p < 0.05), as well as between the combined and TUS groups (p < 0.01).ConclusionBoth exercise intervention and high-dose TUS appear effective in reducing pain and improving motor function in individuals with PT. However, the therapeutic effect of high-dose TUS alone seems limited compared to exercise intervention. The combined application of both methods yielded the most significant improvements in pain relief and motor function enhancement.

Quality-of-Life- and Cognitive-Oriented Rehabilitation Program through NeuronUP in Older People with Alzheimer's Disease: A Randomized Clinical Trial.

(1) Background: Alzheimer's disease (AD) is a progressive neurodegenerative disorder marked by cognitive decline and functional impairment. The NeuronUP platform is a computer program whose main function is cognitive stimulation through three types of activities that change so that the user does not manage to learn it. This program provides opportunities to work on various domains, including activities of daily living (ADLs), social skills, and cognitive functions. The main objective of this randomized clinical trial was to assess the impact of integrating the NeuronUP platform with conventional occupational therapy to enhance or maintain cognitive, perceptual, and quality of life (QoL) abilities in people with AD compared to a control group. (2) Methods: A randomized, single-blind clinical trial was conducted. The sample was randomized using a software program, OxMar, which allowed the separation of the sample into a control group (CG) that received their conventional occupational therapy sessions and an experimental group (EG) that received therapy with NeuronUP, in addition to their conventional occupational therapy sessions. An eighteen-week intervention was conducted. (3) Results: The study included 20 participants, and significant differences were observed in most variables analyzed, indicating improvements after the intervention, particularly in measures of QoL and cognitive status. (4) Conclusions: Our findings demonstrate that an eighteen-week experimental protocol, incorporating the NeuronUP platform alongside conventional occupational therapy, led to improvements in cognitive status and QoL in older adults with AD. Thus, integrating the NeuronUP platform as a complementary tool to occupational therapy can be a valuable resource for enhancing the QoL of individuals with AD. However, due to the small sample size, further studies are needed to corroborate these findings.

Comparative effectiveness trial: Modular behavior approach for young autistic children compared to comprehensive behavioral intervention.

This 24-week single-blind trial tested a modular approach for young autistic children (MAYAC) that was delivered for fewer hours per week and modified based on child progress and parental input compared to comprehensive behavioral intervention treatment as usual (CBI, TAU). Participants were autistic children, ages 18-60 months of age. MAYAC was initially 5 h of intervention per week, one of which was parent training and the other four direct therapy focusing on social communication and engagement, but additional modules could be added for up to 10 h per week. Comprehensive behavior intervention was delivered for ≥15 h per week. Outcome measures included the Vineland Adaptive Behavior Scales; VABS, the Ohio Autism Clinical Improvement Scale - Autism Severity; OACIS - AS and the Pervasive Developmental Disorder Behavior Inventory - Parent; PDDBI-P. Implementation and parent satisfaction measures were also collected. Fifty-six children, mean age of 34 months, were randomized. Within-group analysis revealed significant improvements from baseline to week 24 for both MAYAC (p < 0.0001) and CBI, TAU (p < 0.0001) on the VABS. The noninferiority test was performed to test between group differences and MAYAC was not inferior to CBI, TAU on the VABS (p = 0.0144). On the OACIS - AS, 48.0% of MAYAC and 45.5% of CBI were treatment responders there were no significant changes on the PDDBI-P, for either group. Treatment fidelity was high for both groups (>95%) as was parent satisfaction. Findings from this small trial are promising and suggest MAYAC may be an alternative for some young autistic children and their families to CBI, TAU.

The neural plasticity and efficacy of acupuncture for post-stroke dysphagia: protocol for a randomized controlled trial with fMRI and DTI

BackgroundDysphagia, a common complication of acute stroke, is associated with increased mortality and morbidity. Acupuncture, a widely used swallowing therapy in China, has been suggested as an effective therapy for treating Post-Stroke Dysphagia (PSD) by recent meta-analyses and guidelines. The use of resting-state functional Magnetic Resonance Imaging (rs-fMRI) and Diffusion Tensor Imaging (DTI) could explore the change of regional spontaneous neural activity, functional relationships between brain regions, and white matter connectivity patterns after acupuncture intervention for PSD. This trial aims to evaluate the efficacy of acupuncture treatment for PSD and explore its central mechanism by neuroimaging.Methods/designThis randomized controlled trial will recruit 40 PSD patients. All patients will be randomized to either the Real Acupuncture (RA) or Sham Acupuncture (SA) group by a ratio of 1:1. All patients will receive immediate acupuncture treatment in the MRI scanning room, followed by four weeks of long-term acupuncture treatment. The primary outcomes are the rs-fMRI and DTI indicators, which will be evaluated after the immediate and long-term acupuncture treatment. The secondary outcomes are the scales that assess the efficacy, including the Functional Oral Intake Scale (FOIS), Water Swallowing Test (WST), Swallowing Quality Of Life Questionnaire (SWAL-QOL), and National Institute of Health Stroke Scale (NIHSS). The modified version of the Massachusetts General Hospital Acupuncture Sensation Scale (M-MASS) and fMRI sensation record table will also be evaluated.DiscussionThis protocol presents the design of a randomized, single-blind trial that will evaluate the efficacy and explore the neural plasticity of acupuncture treatment for PSD. This trial will deepen our insight into the clinical value of acupuncture for PSD and initially probe into the time-dosage-effect mechanism of acupuncture.Trial registration numbersChinese Clinical Trial Registry (www.chictr.org.cn) ChiCTR2300067480. This study was registered on 9th January 2023.

Effect of herbal soup on immunological parameters of people living with HIV, Kenya - a parallel single blind randomized control trial

Effect of herbal soup on immunological parameters of people living with HIV, Kenya - a parallel single blind randomized control trial

Effect of Caffeine and Nitrates Combination on Exercise Performance, Heart Rate and Oxygen Uptake: A Systematic Review and Meta-Analysis.

The evidence about the synergy of combining caffeine (CAF) and nitrates on exercise performance has not been summarized, although there is a possibility of additive/synergistic effects of the co-ingestion of these substances given their different mechanisms of action in central (CAF) and peripheral tissues (nitrates). The aim was to analyze the effects of co-supplementation of CAF and nitrates on sports performance in comparison to the isolated ingestion of these substances. The databases of PubMed, Web of Science, Medline, CiNAHL and SPORTDiscus were used until June 2024 following PRISMA guidelines. Randomized controlled trials, at least one single-blind trial, conducted in adults were considered. A meta-analysis was performed using the random effects model to calculate the standardized mean difference estimated by Hedges' g and 95% confidence intervals (CIs) for studies with four arms. Six studies were included (N = 95). The meta-analysis revealed that caffeine and nitrates supplementation (CAF+nitrates) did not enhance performance in time trials (TTs) over the CAF alone (g = -0.06; 95% CI = -0.46 to 0.35; p = 0.78) or nitrates alone (g = 0.29; 95% CI = -0.12 to 0.70; p = 0.17). CAF+nitrates did not affect heart rate during submaximal exercise trials over CAF alone (g = 0.04; 95% CI = -0.31 to 0.40; p = 0.80) or nitrates alone (g = -0.15; 95% CI = -0.50 to 0.20; p = 0.40). Likewise, CAF+nitrates did not affect oxygen uptake during submaximal exercise trials over CAF alone (g = -0.04; 95% CI = -0.45 to 0.37; p = 0.84) or nitrates alone (g = -0.29; 95% CI = -0.70 to 0.12; p = 0.16). CAF+nitrates did not offer further benefits on exercise performance or physiological variables from the isolated intake of CAF and nitrates.

Optimizing Corticosteroid Sinonasal Irrigation Outcomes Through 3D Printing: A Randomized Pilot Clinical Trial.

Topical corticosteroid irrigation plays critical role in the management of chronic rhinosinusitis (CRS). Yet, its efficacy can be highly variable. We sought to determine if personalized, 3-dimensional (3D)-printed nasal models can optimize head positioning and irrigation parameters, therefore improving patient outcomes. Randomized, single-blinded clinical trial. Tertiary medical center from November 2021 to July 2023. Sixty-two patients with CRS were randomized into either control (CG), backfill (BG), or model (MG) groups; daily 2 mg mometasone irrigations were then performed for 2 months with either standard head-forward and natural side-tilt position (CG), a head tilt of 90° to the side with fluid entering the lower nostril (BG), or in an optimized position as determined by a patient-specific 3D printed irrigation model (MG), respectively. A total of 36 patients completed the trial (CG: N = 14/23; BG N = 11/23, MG: N = 11/16). Significant posttreatment improvement in Lund-Mackay (LM) scoring was only observed in the MG (-3.73, 95% confidence interval = -5.71, -1.75; P < .001). Patient-reported outcome measures (Nasal Obstruction Symptom Evaluation, Sinonasal Outcome Test-22, and Visual Analog Scale of nasal congestion) improved significantly among all groups. Optimal model penetration scores significantly correlated to posttreatment MG LM score (Spearman's r = 0.65, P < .05). Among all groups, patients with prior endoscopic sinus surgery (ESS) (n = 19) had objectively less opacification at baseline; however, experienced the same degree of opacification reduction and symptom reduction as those without prior ESS (n = 17). The use of 3D printing to personalize head positioning may significantly improve objective corticosteroid irrigation outcomes. Mometasone irrigation may have similar subjective and objective effects on patients regardless of prior surgical history. Level 1 prospective, randomized, single-blinded clinical trial NCT06118554.

Safety and efficacy of a novel quantitative phase I exercise in patients after cardiopulmonary bypass: a single-blind, prospective, non-randomized study.

Despite the positive effect of early post-cardiac surgery exercises, the concern of safety issues is high, indicating the need for standardized and quantitative mobility indicators to enhance early mobilization monitoring in the intensive care unit while ensuring patient safety. This study aimed to compare the safety and efficacy of quantitative phase I exercise versus usual care in patients who have undergone cardiac surgery. In this non-randomized, single-blind trial, patients following on-pump cardiac surgery were allocated to either quantitative exercise (intervention group, n=114) or usual care (control group, n=114) based on their willingness. Continuous cycling ergometer was used for intervention, and the peak power was recorded for setting next exercise intensity. Noninvasive cardiac output monitoring during exercise was used for safety management. Patients received one time per day, seven sessions in total. Two-way repeated-measure analysis of variance demonstrated significant group and test time difference for forced expiratory volume in 1 s (FEV1) (P=0.01), maximum expiratory pressure (MEP) (P=0.02), peak expiratory flow (PEF) rate (P=0.045), and 6-minute walking distance (6MWD) (P=0.001); more improvement of 6MWD in intervention group (P<0.001). Intervention group showed significant post-test improvements except FEV1/forced vital capacity (FVC). Post-test differences between groups were observed in FEV1 (P=0.02), FVC (P=0.02), MEP (P=0.02), 6MWD (P<0.001), and △6MWD (P<0.001). Analysis of covariance with smoking as covariate showed consistent results. Postoperative stay in intensive-care unit in the intervention group [mean ± standard deviation (SD), 3.0±1.3] was shorter than that in the control group (mean ± SD, 3.5±2.2) (P=0.03). Quantitative phase I exercise applied to patients following cardiopulmonary bypass is safe and recovers respiratory and physical capacity more quickly.

Ultrasound-Guided Quadratus Lumborum Block Using Bupivacaine versus Bupivacaine–Magnesium Sulfate as Postoperative Analgesia in Open Appendectomy in Middle Age Group

Abstract Background The QLB is an effective analgesic technique for various abdominal wall incisions. The QLB covers T7 to L1 dermatomes by the spread of LA drugs either into the paravertebral space or in the thoracolumbar plane, through iliohypogastric and ilioinguinal nerves, A and C fiber nociceptors, mechanoreceptors and high-density network of lumbar sympathetic fibers. Objective To assess the analgesic sparing effect of adding magnesium sulfate to Bupivacaine in Quadratus lumborum block in patients undergoing open appendectomy under general anesthesia. Patients and Methods After approval of the anaesthesiology department and scientific and ethical committees, this prospective single blind randomized clinical trial study was conducted in Ain Shams University Hospitals. Sixty patients scheduled for open appendectomy under general anaesthesia were included in this study. Patients were randomized using a random number table and the use of a closed envelopes technique to receive quadratus lumborum either magnesium sulphate and bupivacaine or bupivacaine only, each group constitutes of 30 patients. Results We found that the addition of magnesium sulfate to bupivacaine in QLB in open appendectomy in middle age group provides a prolonged duration of postoperative analgesia, with reduced analgesic requirements, a better quality of analgesia in terms of NRS compared to bupivacaine alone group. Conclusion The addition of magnesium sulfate to Bupivacaine in lateral QLB in open appendectomy surgery provides a prolonged duration of postoperative analgesia, with reduced analgesic requirements, a better quality of analgesia in terms of NRS compared to bupivacaine alone group.

Effect of Intravenous versus Intrathecal Dexmedetomidine on Potentiation of Spinal Anesthesia in Lower Abdominal Surgeries in Pediatric Patients

Abstract Background regional anesthesia in children was first studied by August Bier in 1899. Since then, spinal anesthesia was practiced for years, and several cases were published in 1909- 1910. After some years, it fell into disuse owing to the introduction of various muscle relaxants and inhalational agents. Aim of the Work to compare the effectiveness and feasibility of dexmedetomidine intravenously and intra-thecally in potentiation and prolongation of spinal anesthesia in pediatric population undergoing lower abdominal surgeries. Patients and Methods this study is a prospective randomized single-blind Clinical trial. study setting pediatric surgery operating theatre, Ain Shams University Hospitals, Cairo, Egypt. Study Period 6 months. This study was carried out on children aging from 1year till 7 years of age who were undergo elective lower abdominal surgeries. Results the major obstacle for routine use of spinal anesthesia in pediatric patients is the short block duration provided with the plain SAB hence the use of adjuvants to overcome this defect were considered. The current clinical trial attempts to synthesize the evidence regarding the safety and efficacy of dexmedetomidine as an adjuvant with the most common spinal anesthetic, bupivacaine. The intrathecal route appear more effective in prolongation of duration of motor block and maintaining an adequate sensory level with slower two segment regression course which can be explained by the previously speculated anti-nociceptive effects of the intrathecal route of dexmedetomidine and its action at the level of spinal cord. Intravenous route seems to provide deeper level of sedation when compared to intrathecal route which can be explained by its higher level and bioavailability in the blood which provides a more satisfactory centrally inhibiting action. Conclusion dexmedetomidine as an adjunct to spinal anesthesia in pediatric lower abdominal surgeries either intravenous or intrathecal can potentiate the motor and sensory block and provide good postoperative analgesia without exerting hemodynamic compromise or significant adverse events. While intrathecal route provide better prolongation of the motor and sensory blockade and also provide longer postoperative analgesia than intravenous route.

Comparative evaluation of various biomaterials as pulpotomy agents in molars with symptomatic irreversible pulpitis: A randomized single-blinded single-center control trial.

Untreated tooth decay in mature permanent dentition is a prevalent global issue, affecting 34.1% of people with 2.5 billion cases annually. Extensive decay often leads to irreversible pulpitis, characterized by pulp inflammation and pain. Pulpectomy, the standard treatment, involves complex procedures with potential complications. Modern endodontics favors minimally invasive treatment such as pulpotomy, which preserves pulp vitality. This study aims to compare the clinical as well as radiographic outcomes of different pulpotomy agents: Biodentine, mineral trioxide aggregate (MTA), Bio-C repair, and Endosequence Bio-ceramic root repair material (BCRRM) in mature permanent molars. This single-blind, single-center study involved 80 participants randomly assigned to four groups, each receiving one of the biomaterials. Ethical approval was obtained. Participants aged 14-60 years with symptomatic irreversible pulpitis were selected. Pulpotomy procedures were performed, and follow-up evaluations occurred at 24 h, 1 week, 4 weeks, 3, 6, and 12 months. Clinical success was measured by the absence of pain, sensitivity, and tenderness. Radiographic evaluation used the periapical index (PAI) scoring system. Pulpotomy significantly reduced postoperative pain in all groups. Endosequence BCRRM showed the maximum pain reduction at 24 h with a statistically significant difference from all the groups (at 1% probability level), followed by Bio-C repair, Biodentine, and MTA. At 1 week, Bio-C repair led in pain reduction with statistically nonsignificant results. All groups reported no pain at 3, 6, and 12 months. Endosequence BCRRM had the highest improvement in periapical findings at 1 year. Sensitivity to hot and cold improved significantly in all groups, with Endosequence BCRRM performing best. Endosequence BCRRM provided the best overall outcomes, emphasizing the importance of material choice in pulpotomy treatments. Further research on biomaterials' long-term clinical and radiographic outcomes is needed to enhance treatment efficacy.

Effect of brimonidine on visual indices in patients with acute optic neuritis: A single blind randomized clinical trial

PurposeThis study investigates brimonidine's potential effect on visual functions, particularly contrast sensitivity (CS), an indicator of retinal ganglion cell function. MethodsIn this single-blind, randomized clinical trial, 60 patients (aged 23–56) with first-episode acute optic neuritis within seven days of symptom onset were randomly assigned to brimonidine or control groups. The intervention group received brimonidine three times daily for three months, while the control group received synthetic tears with the same dosage and frequency. Primary outcomes were changes in CS, visual acuity (VA), and color vision at one and three months post-treatment. Repeated measures ANOVA was used to assess statistically significant and partial eta squared (η2) values, mean differences, and clinically significance important were reported. ResultsAll participants completed the study without complications. VA improved significantly in both groups by follow-up end (p < 0.001), with significant improvement from first to third month only in the brimonidine group (p < 0.001). The mean VA difference between groups was not statistically and clinically significant. CS showed statistically significant improvement within both groups (p < 0.001) and between groups (p < 0.001), with a large effect size (partial η2 = 0.28). The mean CS difference between groups (14.5) was clinically considerable. No significant changes in color vision were observed between groups (p = 0.96). ConclusionBrimonidine significantly improved contrast sensitivity compared to placebo and was well-tolerated. Its neuroprotective effects suggest it may be beneficial in treating optic neuritis and preserving retinal ganglion cell function. Trial registrationProspectively registered at Iranian Clinical Trial Registration; Registration date 3 December 2022; Registration number: IRCT20221127056631N1

Exergames and Immersive Virtual Reality as a Novel Therapy Approach in Multiple Sclerosis: Randomised Feasibility Study

Background: Multiple sclerosis is a chronic, inflammatory, neurodegenerative autoimmune disease caused by myelin loss in the central nervous system, which leads to motor and non-motor problems. The main objective of this study was to explore whether an immersive virtual reality (IVR) exercise programme would be feasible as a form of physical therapy for people with MS (pwMS). Methods: 18 participants (13 women; 45.06 years) were assigned to an experimental group (EG, n = 8) and a control group (CG, n = 10). The EG took part in a twice-weekly IVR exergame physical therapy programme—ExeRVIEM programme. A randomised, single-blind clinical trial was conducted and was registered in clinicaltrials (NCT05870254). Results: The intervention was feasible and safe. The participants completed the programme with no adverse effects (no symptoms on the Simulator Sickness Questionnaire), high usability (System Usability Scale 90.31%), and outstandingly positive post-game experiences (Game Experience Questionnaire 3.10/4). In addition, the GE significantly improved several of their functional capacities: increased lower limb strength (Five Times Sit-to-Stand Test p = 0.042), improved functional mobility, and reduced fall risk (Timed Up and Go Test-simple p = 0.009; Timed Up and Go Test-cognitive p = 0.003). There were no statistically significant differences between the groups. Conclusions: The findings support that the use of exergames and IVR as physical therapy in pwMS is feasible and safe. Furthermore, there is the suggestion of possible benefits to participants’ functional abilities, all of which position IVR as a promising tool for the rehabilitation of this neurodegenerative pathology affecting young adults.

“We are an active family”: a randomized trial protocol to evaluate a family-system social identity intervention to promote child physical activity

BackgroundRegular engagement in moderate-to-vigorous physical activity (MVPA) during childhood yields a myriad of health benefits, and contributes to sustained MVPA behaviors into adulthood. Given the influence of parents on shaping their child’s MVPA behaviour, the family system represents a viable target for intervention. The purpose of this study is to compare the effects of two intervention conditions designed to increase child MVPA: (1) A standard education + planning intervention providing information about benefits, action planning, and coping planning; and (2) An augmented physical activity education + planning intervention that includes the components of the standard intervention, as well as a focus on family identity promotion and developing as an active member of the family.MethodsA two-arm parallel single-blinded randomized trial will compare the two conditions over 6 months. Eligible families have at least one child aged 6–12 years who is not meeting the physical activity recommendations within the Canadian 24-Hour Movement Guidelines (i.e.,<60 min/day of MVPA). Intervention materials targeting family identity promotion will be delivered online via zoom following baseline assessment, with booster sessions at 6-weeks and 3-months. Child MVPA will be measured by wGT3X-BT Actigraph accelerometry at baseline, 6-weeks, 3-months, and 6-months as the primary outcome. At these same time points, parent cognition (e.g., attitudes, perceived control, behavioral regulation, habit, identity) and support behaviours, and parent-child co-activity will be assessed via questionnaire as secondary outcomes. Child-health fitness measures will be also administered through fitness testing at baseline and 6-months as secondary outcomes. Finally, upon completion of the trial’s 6-month measures, a follow-up end-of-trial interview will be conducted with parents to examine parents’ experiences with the intervention.ResultsSo far, 30 families have been enrolled from the Southern Vancouver Island and Vancouver Lower Mainland area. Recruitment will be continuing through 2026 with a target of 148 families.DiscussionThis study will contribute to the understanding of effective strategies to increase child physical activity by comparing two intervention approaches. Both provide parents with education on physical activity benefits, action planning, and coping planning supports. However, one intervention also incorporates components focused on promoting an active family identity and involving all family members in physical activity together. The findings from this study have the potential to inform the design and implementation of public health initiatives aimed at improving physical activity participation in children and guide the development of more effective interventions that leverage the crucial role of parents and the family system in shaping children’s physical activity behaviors.Trial RegistrationThe clinical trial registration ID is NCT05794789. This trial was registered with clinicaltrials.gov on March 2nd, 2023, with the last updated release on September 28th, 2023.

The Effect of Topical 100% Sunflower Seed Oil (SSO) Extract on Trans Epidermal Water Loss (Tewl) and Skin PH Levels in a History of Atopic Dermatitis

The skin barrier function can be disturbed in various conditions, one of which is atopic dermatitis (AD). Efforts to improve the skin barrier can be done by using various types of moisturizers. Natural oil from sunflower seed oil (SSO) can be used as "skin barrier therapy" by reducing trans epidermal water loss (TEWL) and skin pH levels. A randomized single blind clinical trial with a two parallel group pre and post design was conducted on subjects with a history of AD who were treated at the Skin and Venereology Polyclinic at Sunan Kalijaga Hospital, Demak. Samples were randomized into 2 groups to receive 100% SSO or petrolatum as a control. TEWL and pH assessments were carried out at the beginning of the study and at week 4. Bathing habits and complaints about using moisturizers were also assessed. TEWL values ​​decreased in the SSO and petrolatum groups (-5.8±1.93 vs -6.1±9.08, p = 0.9). The pH value in AD patients also decreased after administration of SSO extract and petrolatum (-0.4±0.10 vs -0.2±0.75, p = 0.2). The decrease in TEWL and pH in both groups was not statistically significant. This may be related to differences in bathing habits and moisturizer use in the two groups. Most of the samples in the SSO group stated that they had no complaints regarding usage. The entire sample completed the study without any reports of allergic reactions or hypersensitivity. Administration of SSO extract was effective in reducing TEWL and pH in DA with the majority of samples stating that they had no complaints about use.