Sealed Envelopes Research Articles

Evaluation and Comparison of the Efficacy and Safety of Cryotherapy and Electrosurgery in the Treatment of Sebaceous Hyperplasia, Seborrheic Keratosis, Cherry Angioma, and Skin Tag: A Blinded Randomized Clinical Trial Study.

Cryotherapy and electrosurgery are two commonly used methods to remove sebaceous hyperplasia, seborrheic keratosis, cherry angioma, and skin tags, which can be bothersome and uncomfortable. We compare the effectiveness and adverse effects of cryotherapy and electrosurgery in treating these skin conditions. The study was conducted as an assessor-blind trial. The 32 lesions in each lesion group were divided into two treatment groups, cryotherapy and electrosurgery, using sealed envelopes. We collected baseline information, which included age, gender, lesion location, and consent, from the patients. Follow-up visits were scheduled at 2 weeks, 1 month, and 3 months after the initial treatment session to evaluate the response rate of the lesions. Based on before-after clinical images, this evaluation encompassed patient and physician satisfaction (no change, little, somewhat, good, and excellent), and any potential complications. The mean age of cryotherapy group was 52.04 ± 11.59 years, while the mean age in the electrosurgery group was 50.48 ± 10.70 years (p > 0.05). Regarding gender, 15 (23.4%) in the cryotherapy and 24 (37.5%) in the electrosurgery were female (p > 0.05). Physician and patient satisfaction increased significantly over time in the cryotherapy and electrosurgery groups (p < 0.001). For sebaceous hyperplasia, cherry angioma and skin tags, the degree of satisfaction of patients and physicians was significantly higher for electrosurgery than cryotherapy during follow-up (p < 0.05). However, seborrheic keratosis responded better to cryotherapy. Hypopigmentation and depigmentation occurred in 2 (3.1%) and 4 (6.3%) of the cryotherapy cases, respectively. Hypopigmentation and atrophic scars also occurred in 4 (6.3%) and 2 (3.1%) of the cases in the electrosurgical group in different sessions. It appears that electrosurgery is more effective in the treatment of sebaceous hyperplasia, cherry angioma and skin tags, while cryotherapy is more effective in the treatment of seborrheic keratosis.

Early high-dose cryoprecipitate to reduce mortality in adult patients with traumatic haemorrhage: the CRYOSTAT-2 RCT with cost-effectiveness analysis.

Traumatic haemorrhage is common after severe injury, leading to disability and death. Cryoprecipitate, a source of fibrinogen, may improve outcomes for patients with traumatic haemorrhage. To investigate the effects of early fibrinogen supplementation in the form of 3 pools (15 units, approximately 6g of fibrinogen) of cryoprecipitate on 28-day mortality. A randomised, parallel-group, unblinded, multicentre, international trial and economic evaluation. Patients were randomised to either the intervention (early cryoprecipitate) or the comparator (standard major haemorrhage protocol) arm via opaque, sealed envelopes in the emergency department or the transfusion laboratory/blood bank. All analyses were performed on an intention-to-treat basis. A cost-effectiveness analysis was undertaken. Twenty-five major trauma centres in the UK and one level 1 trauma centre in the USA. Adults who had traumatic haemorrhage following severe injury requiring activation of the major haemorrhage protocol and had received a blood transfusion. Early cryoprecipitate - 3 pools (equivalent to 15 single units of cryoprecipitate or 6 g of fibrinogen supplementation), infused as rapidly as possible, within 90 minutes of arrival at hospital in addition to standard major haemorrhage protocol or standard major haemorrhage protocol only. The primary outcome was all-cause mortality at 28 days. The secondary outcomes were all-cause mortality at 6 hours, 24 hours, 6 months and 12 months from admission; death from bleeding at 6 hours and 24 hours; transfusion requirements at 24 hours from admission; destination of participant at discharge; quality-of-life measurements (EuroQol-5 Dimensions, five-level version and Glasgow Outcome Scale) at discharge/day 28 and 6 months after injury; and hospital resource use up to discharge or day 28 (including ventilator-days, hours spent in critical care and inpatient stays). Eight hundred and five patients were randomised to receive the standard major haemorrhage protocol (control arm). Seven hundred and ninety-nine patients were randomised to receive an additional three pools of cryoprecipitate in addition to standard care (intervention arm). Baseline characteristics appeared well matched. Patients had a median age of 39 (interquartile range 26-55) years, and the majority (79%) were male. All-cause 28-day mortality (n=1531 patients; intention to treat) was 25.3% in the intervention arm compared with 26.1% in the control arm (odds ratio 0.96; p=0.74). There was variability in the timing of cryoprecipitate administration, with overlap between the treatment arms, limiting the degree of intervention separation. There was no evidence that early empiric administration of high-dose cryoprecipitate reduced the risk of death in unselected patients with traumatic haemorrhage. There was also no difference in adverse events. The cost-effectiveness of the intervention was similar to that of standard care. Research to evaluate if fibrinogen replacement is more beneficial for selected patients, for example those with low fibrinogen blood levels, is needed, as is further exploration of whether there is a difference in outcome according to mechanism of injury. This trial is registered as ISRCTN14998314. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/57/02) and is published in full in Health Technology Assessment; Vol. 28, No. 76. See the NIHR Funding and Awards website for further award information.

Effect of Propofol and Isoflurane on Hemodynamic changes during Spinal Surgery Under General Anesthesia

Background: Hemodynamic stability are vital requirements of up-to-date anesthesia. Both propofol and isoflurane meet these criteria though the clinical effects like postoperative nausea vomiting after administering propofol and isoflurane have been studied in various surgeries but have not been much evaluated or studied in patients undergoing major surgical procedures like spine surgeries, There’ is definite advantage of one technique over the other. Isoflurane has a low blood gas partition coefficient, which contributes to rapid induction and emergence from anaesthesia than with other volatile anesthetics in current clinical use. Propofol has been established as the intravenous agent that provides faster and smoother recovery &amp; peri operative hemodynamic stability. Objective: To compare the effects of isoflurane and propofol regarding hemodynamic status in spinal surgery under general anaesthesia. Methods: After getting ethical approval, a randomized controlled trial study design was performed where patients were selected in the pre-anesthetic checkup room based on inclusion and exclusion criteria for those who were scheduled for spine surgeries under general anesthesia is admitted in the Department of Neurosurgery in East West Medical College from January 2023 – December 2024. A total number of 40 patients were selected. 20 patients were enrolled each in group A and group B by lottery method in a sealed envelope. They were divided into two groups by randomization; Group A and Group B. A written informed consent was taken from all selected patients. Patients were advised to fast for at least 8 hours before intervention. In Group A, anesthesia is maintained with propofol infusion, nitrous oxide (66%), and oxygen (33%) while in Group B, anesthesia is maintained with Isoflurane, nitrous oxide (66%), and oxygen (33%). All patients were given N2O in oxygen and 1.25% inspired concentration of Isoflurane (MAC -1.15). In Group A propofol infusion at rate of 80 μg/kg/min (fixed from the beginning). All data was collected at –Just after starting, 15 minutes, 30-minute, 1 hour, and &gt;1 hour interval per operatively. Data was compiled, edited and plotted in tabular and figure form. P value was determined as significant when it was &lt;0.05. Results: 40 patients yielded the following results. The mean age of Group A and B were 32.56±12.55 years and 34.6±12.5 years. Mean difference of heart rate was lower in Group A than that of Group B. Other parameters in both groups were confined to good and acceptable categories. But interestingly, there was a statistically significant difference found between Group A and Group B in Systolic Blood Pressure (SBP) &amp; Diastolic Blood Pressure (DBP). The scoring was far better in Group A than Group B. Mean SBP was higher in Group B than Group A (p= &gt;0.05). Similarly, mean DBP was also higher in Group B than Group A (p = &gt;0.05). Conclusion: Propofol is better for maintaining hemodynamic status than Isoflurane for Spine surgery under General anaesthesia. EWMCJ Vol. 12, No. 1&amp;2, January-July 2024: 21-26

Comparing the Sedative Effect of Dexmedetomidine and Propofol in Mechanically Ventilated Patients Using Salivary Alpha-Amylase as a Stress Marker: A Randomized Open-Label Trial

Background: Patients receiving mechanical ventilation (MV) in the intensive care unit (ICU) experience significant distress, which triggers a stress response. Objectives: This study aimed to assess the effectiveness of dexmedetomidine and propofol in reducing stress levels, using salivary alpha-amylase (SAA) as a specific indicator of stress. Methods: A randomized, open-label trial was conducted involving 40 patients newly placed on MV. In a parallel study design, participants were randomly assigned into two equal groups (n = 20) through the sealed envelope method using computer-generated randomization. Group D received dexmedetomidine at a dosage of 0.2 to 1.4 μg/kg/h, while group P received propofol at a dosage of 0.3 to 4 mg/kg/h for sedation. Salivary alpha-amylase levels were measured according to the kit manufacturer's protocol. Results: Salivary alpha-amylase levels were significantly lower in group D than in group P at 12, 24, 36, and 48 hours after the initiation of MV (P &lt; 0.05). Heart rate and mean arterial pressure were also significantly lower in group D at 12, 18, and 24 hours (P &lt; 0.05). The duration of MV was significantly shorter in group D compared to group P (4.4 ± 1.85 vs 6.1 ± 2.45 days, P = 0.018). There were no significant differences in ICU length of stay, mortality, or adverse events between the groups. Conclusions: Dexmedetomidine demonstrated superior stress-reducing effects compared to propofol in MV patients, as evidenced by lower SAA levels and improved hemodynamic stability. The shorter duration of MV in the dexmedetomidine group further suggests potential clinical benefits of its use in managing stress in MV patients.

Clinical Evaluation of a Novel Compression Device For Ultrasound-Guided Repair of Femoral Artery Pseudoaneurysms: A Double-Blind Clinical Trial

Background: Femoral artery pseudoaneurysm is a well-known complication after conventional angiography. Today, the treatment of choice for this condition is noninvasive repair using manual ultrasound-guided compression. Objectives: This study aimed to evaluate the efficacy of a novel compression device in improving angiography-induced pseudoaneurysm treatment compared to manual ultrasound-guided compression repair. Patients and Method: A double-blind, randomized clinical trial was performed on patients with femoral angiography-induced pseudoaneurysm in the Radiology Department of Ghaem Hospital, Mashhad, Iran. Based on color Doppler ultrasound exams, patients diagnosed with a pseudoaneurysm within 72 hours of angiography were included in the study. Patients were excluded if they had complete blockage, complete pseudoaneurysm thrombosis, abscess, surface tissue infection, or open wound in the area. The patients were allocated to a manual ultrasound-guided compression group or a device-assisted compression group using simple randomization with a sealed envelope method. After collecting demographic data, the patients underwent an ultrasound exam of the groin to determine and record the size of the pseudoaneurysm and the ratio of thrombosis to open lumen. The therapeutic success rate was defined as complete lumen thrombosis after conducting the compression procedure one to three times. Also, the pain score was measured during compression using the Visual Analog Scale based on a scale of 0 - 10. The duration of successful procedures was also documented. The patients were monitored for 6 hours for any side effects. The level of statistical significance was set at P &lt; 0.05 for all tests. Results: The study was performed on 22 patients (13 males/9 females) with a mean age of 65.5 ± 3.5 years divided into two groups of device-assisted (n = 11) and manual ultrasound-guided (n = 11) compression repair. The two groups did not differ significantly in terms of demographic variables or initial ultrasound variables associated with the pseudoaneurysm. The device-assisted compression group was found to have lower pain intensity (5.0 ± 1.0 vs. 6.0 ± 0.8; P = 0.024) and a significantly higher success rate (100% vs. 45.5%; P = 0.004) compared to the manual compression group. None of the patients showed any side effects. Conclusion: This preliminary study showed that the proposed device is completely safe and may improve the success rate while decreasing pain scores during ultrasound-guided compression procedures. Using a large multicenter study design, evaluating the efficacy of the novel device for hemostasis during sheath removal and adding new equipment to the device, such as manometers to apply controlled pressure, are suggested for future studies.

Navigation of video-assisted thoracoscopic surgery using electromagnetic versus CT-guided localization (NOVEL): a study protocol for comparing procedural success and complication rates in a prospective, multicenter, randomized controlled, non-inferiority phase III trial.

The rise of low-dose computed tomography (LDCT) has increased the detection of small pulmonary nodules, demanding more effective localization techniques for their resection. Minimally invasive resection utilizing video-assisted thoracoscopic surgery (VATS) is a critical method for treating these nodules. However, traditional computed tomography (CT)-guided localization has limitations such as invasiveness and patient discomfort. The current gap in knowledge relates to the potential advantages of electromagnetic navigation bronchoscopy (ENB) in reducing complications and improving procedural efficiency. The NOVEL trial evaluates the non-inferiority of ENB-guided labeling against CT-guided puncture for lung nodule localization. This multicenter, randomized, controlled, non-inferiority phase III trial includes 156 participants across four Chinese hospitals, randomized to undergo either ENB-guided or CT-guided localization prior to VATS sub-lobar resection. Randomization is performed using sealed opaque envelopes to ensure allocation concealment. Primary outcomes are the procedural success rates and complication rates of both techniques, with secondary outcomes including procedure times and lesion margins. The NOVEL trial aims to provide a detailed comparison of ENB-guided versus CT-guided localization for small pulmonary nodules. Establishing the safety and efficacy of the ENB method could significantly influence clinical practices and improve patient outcomes. This trial was registered with the Medical Research Registration Platform (https://www.medicalresearch.org.cn), registration number MR-31-24-018575.

The impact of closed suction wound drainage on chronic pain and health-related quality of life after posterior spinal fusion in patients with adolescent idiopathic scoliosis.

Closed suction subfascial drainage is widely used after instrumented posterior spinal fusion in patients with a spinal deformity. The aim of this study was to determine the effect of this wound drainage on the outcomes in patients with adolescent idiopathic scoliosis (AIS). This was a further analysis of a randomized, multicentre clinical trial reporting on patients after posterior spinal fusion using segmental pedicle screw instrumentation. In this study the incidence of deep surgical site infection (SSI) and chronic postoperative pain at two years' follow-up are reported. We conducted a randomized, multicentre clinical trial on adolescents undergoing posterior spinal fusion for AIS using segmental pedicle screw instrumentation. A total of 90 consecutive patients were randomized into a 'drain' or 'no drain' group at the time of wound closure, using the sealed envelope technique (1:1). The primary outcomes in the initial study were the change in the level of haemoglobin in the blood postoperatively and total blood loss. A secondary outcome was the opioid consumption immediately after surgery. The aim of this further study was to report the rate of deep SSI and persistent postoperative pain, at two years' follow-up. As previously reported, the mean 48-hour opioid consumption was significantly higher in the no drain group (2.0 mg/kg (SD 0.8) vs 1.4 mg/kg (SD 0.7); p = 0.005). There were no delayed deep SSIs. At two years' follow-up, the mean Scoliosis Research Society 24-item questionnaire (SRS-24) total score did not differ between the groups (4.11 (SD 0.47) vs 4.16 (SD 0.33); p = 0.910). The mean SRS-24 pain score was 4.28 (SD 0.48) in the no drain group compared with 4.33 (SD 0.66) in the drain group (p = 0.245). Seven patients (19%) in the no drain group and six in the drain group (14%) reported moderate to severe pain (numerical rating scale ≥ 4) at two years' follow-up (p = 0.484). The general self-image domain score was significantly higher in the no drain group compared with the drain group (4.02 (SD 0.74) vs 4.59 (SD 0.54); p < 0.001). The main finding in this study was that more severe pain immediately after surgery did not result in a higher incidence of chronic pain in the no drain group compared with the drain group. Back pain and health-related quality of life at two years' follow-up did not differ between the groups. The patient-reported self-image domain was significantly better in the no drain group compared with the drain group.

Effects of anodal transcranial direct current stimulation on postural stability in subacute stroke: A randomized control trial.

Anodal transcranial direct current stimulation (tDCS) promotes neuromodulation and neuroplasticity in the brain. The aim of this study was to determine the long-term effects of the anodal tDCS on postural and trunk stability, physical performance, anticipatory postural adjustment and quality of life in sub-acute stroke patients. Thirty-six participants with sub-acute stroke were divided into experimental and control groups using sealed envelope randomization. Outcome measures comprised the Postural Assessment Scale for Stroke, Trunk Impairment Scale, Time Up and Go Test, Functional Reach Test, and Stroke-Specific Quality of Life Scale. Assessments were conducted at 0, 3, 6, 9, and 12 weeks. Within-group analysis revealed significant improvement in both the experimental (p-value < 0.05) and control groups (p-value < 0.005). Notably, significant effects were observed in postural stability after intervention, and during one of the detraining assessments, the experimental group showed superior results compared to the control group in subacute stroke. Anodal tDCS yield significant short- and long-term effects on postural stability, while short term effects on trunk stability. Additionally, long term effects were observed on the physical performance and anticipatory postural adjustments while no effects at quality of life either short or long term basis among the subacute stroke patients.

Increase in colonic PRopionate as a method of prEVENTing weight gain over 12 months in adults aged 20–40 years (iPREVENT): a multi-centre, double-blind, randomised, parallel-group trial

Obesity drives metabolic disease development. Preventing weight gain during early adulthood could mitigate later-life chronic disease risk. Increased dietary fibre intake, leading to enhanced colonic microbial fermentation and short-chain fatty acid (SCFA) production, is associated with lower body weight. Despite national food policy recommendations to consume 30g of dietary fibre daily, only 9% of adults achieve this target. Inulin-propionate ester (IPE) selectively increases the production of the SCFA propionate in the colon. In previous studies, IPE has prevented weight gain in middle-aged adults over 6 months, compared with the inulin control. IPE is a novel food ingredient that can be added to various commonly consumed foods with a potential health benefit. This 12-month study aimed to determine whether using IPE to increase colonic propionate prevents further weight gain in overweight younger adults. This multi-centre randomised-controlled, double-blind trial was conducted in London and Glasgow, UK. Recruited participants were individuals at risk of weight gain, aged between 20 and 40 years and had an overweight body mass index. Sealed Envelope Software was used to randomise participants to consume 10g of IPE or inulin (control), once per day for 12 months. The primary outcome was the weight gained from baseline to 12 months, analysed by an 'Intention to Treat' strategy. The safety profile and tolerability of IPE were monitored through adverse events and compliance. This study is registered with the International Standard Randomised Controlled Trials (ISRCT) Database (ISRCT number: 16299902). Participants (n=135 per study arm) were recruited from July 2019 to October 2021. At 12 months, there was no significant difference in baseline-adjusted mean weight gain for IPE compared with control (1.02kg, 95% CI:-0.37 to 2.41; p=0.15; n=226). Neither the IPE (+1.22kg) nor the control arm (+0.07kg) unadjusted mean gains in body weight reached the expected 2kg threshold. In the IPE arm, fat-free mass was greater by 1.07kg (95% CI: 0.21-1.93), and blood glucose elevated by 0.11mmol/L (95% CI: 0.01-0.21). Compliance, determined by intake of ≥50% sachets, was reached by 63% of IPE participants. There were no unexpected adverse events or safety concerns. Our study indicates that at 12 months, IPE did not differentially affect weight gain, compared with the inulin control, in adults between 20 and 40 years of age, at risk of obesity. NIHR EME Programme (15/185/16).

Aerobic Exercise Versus Plyometrics in Reducing Anxiety Levels in College Students With Mild Generalized Anxiety Disorder.

Background Generalized anxiety disorder is one of the most prevalentmental disorders, characterized byexcessive anxiety and worry that affectboth mental and physical health. These pervasive illnesses have a crippling effect on people's everyday lives, quality of life, and wellness and are also highly linked with cardiovascular risk factors. Physical activity-based therapies have shown promising effects in treating a range of mental disorders, from psychosis to dementia. Out of many conventional therapies, aerobic exercise and plyometrics have been found to be effective in reducing anxiety levels. Aim This study aims to compare the effectiveness of aerobic exercise and plyometrics in reducing anxiety levels in college students with mild generalized anxiety disorder. Materials and methods A total of 96 subjects were selected for the studyusing a stratified sampling technique;48 subjects were assigned to the aerobic exercise group (Group A) and 48 to the plyometric group (Group P). Randomization was done using the sealed envelope method. This study includes students aged 18-25 years, both genders, with a body mass index of <30, a Beck Anxiety Inventory (BAI) score of 8-15, and at least six months without practicing any kind of physical activity. The exclusion criteria are subjects with other psychotic disorders, a history of cardiovascular disease, chronic kidney disease, inflammatory disease, malignant conditions, neurological disorders, anemia, with comorbid conditions, who were involved in supportive therapy for anxiety such as cognitive behavioral therapy, use of anxiolytic drugs, females with menstrual disorders, and subjects with recent trauma or injuries (fracture, ligament sprain, or muscle strain). The treatment duration for both groups was three days per week for a total of four weeks. Group A consists of five minutes of warm-up, 30 minutes of walking, and five minutes of cool-down, for a total of 40 minutes. Group P consists of warm-up of five minutes, high knees, single leg hop and jump squats of two sets and 10 repetitions for 30 minutes, and a cool-down of five minutes, for a total of 40 minutes. Conclusion The anxiety levels were analyzed using the BAI, revealing that bothgroups have shown improvements in Beck anxiety scores; however,Group A has shown a comparatively more significant improvement than Group P.

“Comparison between high-flow nasal cannula (HFNC) therapy and noninvasive ventilation (NIV) in children with acute respiratory failure by bronchiolitis: a randomized controlled trial”

BackgroundThe objective of this study was to compare HFNC therapy to noninvasive ventilation (NIV/BiPAP) in children with bronchiolitis who developed respiratory failure. We hypothesized that HFNC therapy would not be inferior to NIV.MethodsThis was a noninferiority open-label randomized single-center clinical trial conducted at a tertiary Brazilian hospital. Children under 2 years of age with no chronic conditions admitted for bronchiolitis that progressed to mild to moderate respiratory distress (Wood-Downes-Férres score < 8) were randomized to either the HFNC group or NIV (BiPAP) group through sealed envelopes. Vital signs, FiO2, Wood-Downes-Férres score and HFNC/NIV parameters were recorded up to 96 h after therapy initiation. Children who developed respiratory failure despite receiving initial therapy were intubated. Crossover was not allowed. The primary outcome analyzed was invasive mechanical ventilation requirement. The secondary outcomes were sedation usage, invasive mechanical ventilation duration, the PICU LOS, the hospital LOS, and mortality rate.ResultsA total of 126 patients were allocated to the NIV group (132 randomized and 6 excluded), and 126 were allocated to the HFNC group (136 randomized and 10 excluded). The median age was 2.5 (1–6) months in the NIV group and 3 (2–7) months in the HFNC group (p = 0,07). RSV was the most common virus isolated in both groups (72% vs. 71.4%, NIV and HFNC, respectively). Thirty-seven patients were intubated in the NIV group and 29 were intubated in the HFNC group (29% vs. 23%, p = 0.25). According to the Farrington-Manning test, with a noninferiority margin of 15%, the difference was 6.3% in favor of HFNC therapy (95% confidence interval: -4.5 to 17.1%, p < 0.0001). There was no significant difference in the PICU LOS or sedation duration. Sedation requirement, hospital LOS and invasive mechanical ventilation duration were lower in the HFNC group.ConclusionHFNC therapy is noninferior to NIV in infants admitted with mild to moderate respiratory distress caused by bronchiolitis that progresses to respiratory failure.Trial registration numbersU1111-1262-1740; RBR-104z966s. Registered 03/01/2023 (retrospectively registered). ReBEC: https://ensaiosclinicos.gov.br/rg/RBR-104z966s.

The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbar Disc Herniation Patients: A Single Blinded Randomized Clinical Trial.

Background: This study aimed to investigate the effect of manual therapy on pain, kinesiophobia, pain catastrophizing, anxiety, depression, and quality of life in patients with lumbar disc herniation (LDH). Methods: The study included 32 LDH patients. Patients were divided into the Manual therapy group (MTG-age 39.81 ± 9.45 years) and the Exercise group (EG-age 38.31 ± 9.21 years) by sealed envelope randomization. Patients were evaluated pre-study, post-study, and after a 3-month period using the McGill-Melzack Pain Questionnaire (MMPQ), Hospital Anxiety and Depression Scale (HADS), Tampa Kinesiophobia Scale (TKS), Pain Catastrophizing Scale (PCS) and Nottingham Health Profile (NSP). The exercise group received a total of ten sessions of stabilization exercises and sham spinal mobilization in five weeks, two sessions per week. In addition to the stabilization exercises, mobilization applications including Anterior-Posterior Lumbar Spinal Mobilization, Lumbar Spinal Rotational Mobilization, and Joint Mobilization in Lumbar Flexion Position, were applied to the manual therapy group. Results: It was found that the HADS and TKS values decreased in the MTG group compared to the pre-treatment period (p < 0.05), while there was no difference between these values in the EG group (p > 0.05). There was a statistically significant difference in the MMPQ, PCS, and NHP values after treatment in both the MTG and EG groups (p < 0.05). Conclusions: It was found that manual therapy had positive effects on psychological factors such as pain, kinesiophobia, pain catastrophizing, anxiety, depression, and quality of life in patients with LDH. Trial registration: NCT05804357 (27 March 2023) (retrospectively registered).

Pilates mat versus cervical stabilization exercises on the craniovertebral angle, pain, function, and myoelectrical activity of the cervical muscles in forward head posture: a randomized controlled trial

IntroductionOne of the most prevalent postural problems involving the neck is called forward head posture (FHP), which is defined as the anterior head protruding from the sagittal plane and appearing to be positioned in front of the body. The incidence of FHP is 70% in young adults. This study aimed to compare Pilates mat versus cervical stabilization exercises on the craniovertebral angle (CVA), pain, function, and myoelectric activity of the upper trapezius (UT) and sternocleidomastoid (SCM) muscles in patients with FHP. Also, both experimental groups were compared to the control group in terms of CVA, pain, function, and myoelectric activity of the UT and SCM muscles.MethodsSixty participants (18 to 25 years old) with symptomatic FHP were randomly assigned to three groups using an opaque sealed envelope; Pilates mat and postural correction exercises were assigned group A, cervical stabilization and postural correction exercises were assigned group B, and solely postural correction exercises were assigned group C for 12 weeks at a frequency of 3 times/week. The patients were assessed before and after 12 weeks of interventions. The photogrammetric method was used to determine CVA, the visual analog scale (VAS) for pain intensity, the Arabic neck disability index (ANDI ) for neck function, and surface electromyography (sEMG) for the UT and SCM muscle root mean square during rest and activity.ResultsMultiple pairwise comparisons revealed statistically significant differences between pre and post-treatments for all variables in the Pilates, cervical stabilization, and control groups with a &lt;i&gt;p&lt;/i&gt; &lt; 0.05. Between groups, analyses showed that there were statistically significant differences (&lt;i&gt;p&lt;/i&gt; &lt; 0.05) at post-treatment between the Pilates and cervical stabilization groups and also between Pilates and the control, and finally between the cervical stabilization and control groups with more favor to the Pilates group.ConclusionsPilates mat and cervical stabilization exercises are both effective interventions for FHP, with Pilates mat exercises being superior.

An open-label, parallel-group, randomized clinical trial of different silver diamine fluoride application intervals to arrest dental caries

BackgroundSilver diamine fluoride (SDF) is an antimicrobial agent and alternative treatment option that can be used to arrest dental decay. While there is optimism with SDF with regard to caries management, there is no true consensus on the number and frequency of applications for children. The purpose of this study was to examine the effectiveness of 38% SDF to arrest early childhood caries (ECC) at three different application regimen intervals.MethodsChildren with teeth that met International Caries Detection and Assessment System codes 5 or 6 criteria were recruited from community dental clinics into an open-label, parallel-group, randomized clinical trial from October 2019 to June 2021. Participants were randomized to one of three groups using sealed envelopes that were prepared with one of three regimens inside: visits one month, four months, or six months apart. Participants received applications of 38% SDF, along with 5% sodium fluoride varnish (NaFV), at the first two visits to treat cavitated carious lesions. Lesions were followed and arrest rates were calculated. Lesions were considered arrested if they were hard on probing and black in colour. Statistics included descriptive and bivariate analyses (Kruskal one-way analysis of variance and Pearson’s Chi-squared test). A p-value of ≤ 0.05 was considered significant.ResultsEighty-four children participated in the study (49 males and 35 females, mean age: 44.4 ± 14.2 months). Treatment groups were well matched with 28 participants per group. A total of 374 teeth and 505 lesions were followed. Posterior lesions represented only 40.6% of affected surfaces. Almost all SDF treated lesions were arrested for the one-month (192/196, 98%) and four-month (159/166, 95.8%) interval groups at the final visit. The six-month group experienced the lowest arrest rates; only 72% (103/143) of lesions were arrested (p < 0.001). The duration of application intervals was inversely associated with improvements in arrest rates for all lesions.ConclusionsTwo applications of 38% SDF and 5% NaFV in one-month and four-month intervals were comparable and very effective in arresting ECC. Applications six months apart were less effective and could be considered inferior treatment.Trial registrationClinicalTrials.gov NCT04054635 (first registered 13/08/2019).

Effect of peritoneal and wound lavage with super-oxidized solution on surgical-site infection after open appendicectomy in perforated appendicitis (PLaSSo): randomized clinical trial.

Surgical-site infection following open appendicectomy for perforated appendicitis increases length of hospital stay and treatment costs while compromising patients' quality of life. Data from randomized clinical trials (RCTs) evaluating the role of super-oxidized solution in perforated appendicitis are lacking. The study objective was to determine the effect of peritoneal and wound lavage with super-oxidized solution in reducing risk of surgical-site infection following open appendicectomy for perforated appendicitis. In this multicentre RCT conducted between September 2020 and March 2022, patients aged 13 years and older with perforated appendicitis undergoing open appendicectomy were randomly assigned to receive peritoneal and wound lavage with either super-oxidized solution or normal saline. The primary outcome was surgical-site infection within 30 days after surgery. Randomization was computer-generated, with allocation concealment by opaque, sequentially numbered, sealed envelope. The patients, surgeons, outcome assessors and statisticians performing the analysis were blinded to treatment assigned. A total of 102 consecutive patients (51 in the super-oxidized solution group and 51 in the normal saline group) were randomized and included in the intention-to-treat analysis. The super-oxidized solution group showed a significant reduction in overall surgical-site infection (8 (15.6%) versus 19 (37.2%); relative risk (RR) 0.42; 95% c.i. 0.20 to 0.87; P = 0.014), and superficial surgical-site infection (5 (9.8%) versus 18 (35.3%); RR 0.28; 95% c.i. 0.11 to 0.69; P = 0.002), with a number-needed-to-treat of four patients. There were no adverse events in either group. Peritoneal and wound lavage with super-oxidized solution is superior to normal saline in preventing surgical-site infection after open appendicectomy for perforated appendicitis. ClinicalTrial.gov Identifier: NCT04512196.

Efficacy of Teleconsultation Versus Usual Care in Improving Quality of Life Among Geriatric Patients Aged 60 and Above: A Randomized Controlled Trial.

Introduction The geriatric population, aged 60 years and older, is rapidly growing worldwide. This demographic shift has led to a higher prevalence of chronic diseases, comorbidities, and functional impairments, placing immense pressure on healthcare systems. Teleconsultation, which uses telecommunication technologies to deliver healthcare services remotely, offers a potential solution. This study aimed to assess the efficacy of teleconsultation versus usual care in improving the quality of life among the geriatric population aged 60 years and older. Methods A parallel, randomized controlled trial with a 1:1 allocation ratio was conducted. Eligible participants, aged 60 and above, were recruited at the triage emergency department (ED) following a baseline eligibility assessment. Inclusion criteria included the ability to communicate in English or Hindi, possession of International Organization for Standardization (ISO-certified) instruments for self-monitoring, and willingness to comply with study procedures and provide written consent. Participants were randomly assigned to experimental and control arms using a computer-generated sequence, with allocation concealment achieved through sequentially numbered opaque sealed envelopes (SNOSEs), which were opened in front of participants after obtaining baseline data. A total of 2,000 participants (1,000 per arm) were enrolled and randomly assigned to either the teleconsultation or usual care group. Results In the teleconsultation group (n=1,000), 36.5% of participants (365) were female and 63.5% of participants (635) were male. Similarly, in the usual care group (n=1,000), 37.1% of participants (371) were female and 62.9% of participants (629) were male. The teleconsultation group significantly outperformed the usual care group in several domains pre-intervention, with higher mean scores in the physical health domain (11.16 vs. 10.96, P = 0.009), psychological domain (11.74 vs. 11.62, P = 0.020), and environment domain (12.44 vs. 12.26, P = 0.0001). No significant difference was observed in the social relationships domain (P = 0.452). The teleconsultation group significantly outperformed the usual care group in all domains post-intervention, with higher mean scores in the physical health domain (14.49 vs. 12.74), psychological domain (13.75 vs. 12.35), social relationships domain (14.05 vs. 12.90), and environment domain (13.91 vs. 12.94) (P < 0.001 for all). Conclusion These findings suggest that teleconsultation significantly improves the quality of life for elderly patients by providing a more accessible and convenient means of healthcare delivery and addressing the physical, emotional, and social challenges associated with chronic illnesses.

Acustimulation combined with pharmacological prophylaxis versus pharmacological prophylaxis alone in postoperative nausea and vomiting (PONV) prophylaxis among patients undergoing laparoscopy abdominal surgery: a research protocol for a randomised controlled trial

IntroductionThis study evaluates the efficacy of integrating percutaneous electrical nerve stimulation at the pericardium 6 (PC6) acupuncture point through a wearable acustimulation device with standard pharmacological prophylaxis to prevent postoperative...

Enhancing Guidewire Efficacy for Trans-radial Access: The EAGER Randomized Controlled Trial.

Background: The 1.5mm 'Baby J' hydrophilic narrow J tipped wire is a development of the standard 0.035" 3mm J tipped peripheral guidewire, designed to improve efficiency of transradial coronary procedures by safely navigating small caliber radial arteries to the aorta. There is currently a lack of evidence comparing the procedural success and safety of different peripheral guidewires used in transradial cardiac procedures. We compared the efficacy and safety of a narrow J tipped hydrophilic 0.035" wire (intervention - Radifocus™ 'Baby J' guidewire, TERUMO Co., Tokyo, Japan). versus standard fixed core (FC) 0.035" J wire (control). Methods: Investigator initiated, blinded, Australian, multicenter randomized trial in patients undergoing clinically indicated coronary angiography and/or PCI. Randomized 1:1 via sealed envelope method to use either the control or the intervention guidewire. The primary endpoint (technical success) was defined as gaining aortic root access with the randomized guidewire. Results: 330 patients were randomized between October 2022 - June 2023 (median age 69 years, 36% female, BMI 29 kg/m²). The primary endpoint was achieved more frequently in the intervention group [96% v 84%; mean difference 12% (95% CI 5.7-18.3); p<0.001]. Women assigned to the control wire experienced a higher failure rate compared to men (31% v 8% in men; p<0.001). Fluoroscopy time was significantly shorter in the baby J group (median 344 versus 491 seconds; p=0.024). The main mechanisms of failure using the control wire were radial artery spasm (15/26; 57%) and subclavian tortuosity (5/26; 19.2%). There were no differences in overall procedure times, MACE, or vascular complications between guidewires. Conclusions: A narrow 1.5mm J tipped hydrophilic guidewire resulted in greater technical success and reduced fluoroscopy time compared to the standard 3mm J tip non-hydrophilic guidewire. The guidewire is safe and demonstrated key incremental benefits for the trans-radial approach particularly in women.

Nd: YAG laser irradiation in the treatment of live pulp preservation in pediatric cariogenic pulpitis.

Dental pulpitis significantly impacts oral function and quality of life. Treatments like direct pulp capping aim to preserve pulp vitality. This study aims to investigate the application value of Nd:YAG laser irradiation in preserving pulp vitality in children with caries-induced pulpitis. This study, conducted from June 2019 to June 2023, included 89 children undergoing pulp vitality preservation treatment for caries-induced pulpitis. The children were divided into two groups using sealed envelopes: 44 in the control group received pulp capping treatment, while the study group received Nd:YAG laser-assisted pulp capping treatment. The efficacy, oral indicators, oral function, changes in root apex diameter and root length, changes in gingival crevicular fluid inflammatory factors, and incidence of complications were compared between the two groups before and 3 months after treatment. The total effective rates were 97.78% in the study group and 95.45% in the control group, with no significant difference between the groups (p> 0.05). Before treatment, there were no differences in gingival index, plaque index, and probing bleeding index between the groups (p> 0.05). After treatment, both groups showed decreased periodontal indexes compared to before treatment, with the study group showing lower values than the control group (p< 0.05). Chewing and biting function scores were similar between the groups before and after treatment (p> 0.05), but both groups showed decreased scores after treatment (p< 0.05). The study group had a higher percentage decrease in root apex diameter and a greater increase in root length compared to the control group (p< 0.05). During treatment, one case of tooth discoloration occurred in the study group (2.27%), while the control group had two cases of tooth discoloration and one case of secondary caries, resulting in a complication rate of 6.67%. There was no significant difference in the incidence of complications between the groups (p> 0.05). Nd:YAG laser irradiation effectively preserves pulp vitality in children with caries-induced pulpitis, improving periodontal health, reducing root apex diameter, and increasing root length with high safety.

Comparison of the Outcome Between Ligasure and Conventional Suture tie Techniques in Patients Undergoing Thyroidectomy

Objective: To compare the outcome between ligasure and conventional suture tie techniques in patients undergoing thyroidectomy. Study setting and duration: This study was conducted in the department of general surgery, DHQ hospital Dera Ghazi Khan, over a period of one year from September 2022 to September 2023. Subject and methods: This randomized controlled study was conducted on 60 patients divided in two groups, group a (ligasure technique and group b (conventional suture technique) having age 30-65 years either male or female gender presented to undergo thyroidectomy. Patients undergoing chemotherapy, recurrent cases and bleeding diathesis (INR &gt; 1.5) were excluded. The participants were randomly assigned to group A and group B through draws method using sealed opaque envelopes. All the surgical procedures were performed as per institutional protocol by consultant surgeon with ? 5-year post-fellowship experience. All the patients received anesthesia as per hospital protocol. Results: This study was conducted on 60 patients divided in two groups equally, group a (ligasure technique) and group b (conventional technique). The mean age in group A was 47.80±11.54 years and 44.83±10.38 years in group B. among patient in group A 10 (33.3%) patients had total thyroidectomy while 20 (66.7%) patients had subtotal thyroidectomy and in group B 12 (10%) patients had total thyroidectomy while 18 (60%) patients had subtotal thyroidectomy. Group A had significantly shorter operative time (62.07±3.09 mins vs 69.70±3.18 mins, P = 0.0001) as compared to group B. According to the comparison of total blood loss between both groups, group A had significantly lower blood loss (56.27±2.50 ml vs 68.57±2.92) as compared to group B. Conclusion: It can be concluded that ligasure technique had better outcomes as compared to conventional suture tie technique. The mean operative time and blood loss was significantly lower in ligasure technique as compared to conventional suture technique. Keywords: Conventional technique, ligasure, mean operative time, post-operative blood loss, thyroidectomy