Single-blind Randomized Clinical Trial Research Articles

Propofol Versus Midazolam for Sedation in Patients With Cirrhosis Undergoing Upper Endoscopy: A Single-Blind Randomized Clinical Trial

Background: Patients with hepatic cirrhosis are frequently screened for the complications of portal vein hypertension using upper endoscopy. The current study aimed to compare the efficacy and safety of midazolam and propofol for sedation in patients with cirrhosis undergoing upper endoscopy. Methods: This single-blind randomized clinical trial included 60 cirrhotic patients aged 18-80 years referred to Shahid Mohammadi hospital, Bandar Abbas, Iran from May 22, 2019, to May 21, 2020, for upper endoscopy. The age, gender, weight, and height of the patients were recorded, and they were randomized into two groups. Patients in the midazolam group (n=30) received 0.05 mg/ kg midazolam for induction which continued with a 1 µg/kg/min dose, and those in the propofol group received 1 mg/kg propofol which continued with a 25-75 µg/kg/min dose. Blood pressure, oxygen saturation (SpO2 ), respiratory rate (RR), and heart rate (HR) were measured before induction, immediately, 1, and 5 minutes after induction, and in the recovery unit. Finally, the time to reach the target sedation (Ramsay sedation scale≥5), sedation duration, and recovery time were noted as well. Results: Patients in both groups were comparable regarding age, gender, weight, and height. There were no significant differences between groups regarding hemodynamic parameters at any given time point, except for RR 1 minute after induction, which was significantly higher in the propofol group (P=0.012). Changes in HR from baseline to recovery were significant in both groups. Moreover, changes in SpO2 from baseline to recovery were only significant in the midazolam group (P<0.001). The time to reach the target sedation and sedation duration were significantly lower in the propofol group (P<0.001 and P=0.003, respectively); however, there was no significant difference between groups with regard to the recovery time. Grade II encephalopathy (West Haven criteria) developed in one patient in the midazolam group. Conclusion: Based on the results of the current study, although propofol was superior to midazolam for upper endoscopy in cirrhotic patients with respect to the time to reach the target sedation and sedation duration, the two drugs were rather comparable in terms of hemodynamic stability. However, hepatic encephalopathy with midazolam remains a major concern.

Protocol for a single-blind randomized clinical trial to test the efficacy of bilateral transcranial magnetic stimulation on upper extremity motor function in patients recovering from stroke

BackgroundNo consensus currently exists regarding the optimal protocol for repetitive transcranial magnetic stimulation (rTMS) treatment of upper-extremity motor dysfunction after stroke. Studies have shown that combined low- and high-frequency stimulation (LF-HF-rTMS) of the bilateral cerebral hemispheres is more effective than sham stimulation or stimulation of one cerebral hemisphere alone in treating motor dysfunction in the subacute stage of stroke. The efficacy of this protocol in the convalescence phase of stroke has rarely been reported, and its mechanism of action has not been clarified. In this study, we designed a prospective, single-blind, randomized controlled trial to investigate the efficacy and safety of different stimulation regimens for the treatment of upper extremity motor disorders in patients with convalescent stage stroke and aimed to explore the underlying mechanisms based on biomarkers such as brain-derived neurotrophic factor (BDNF).MethodsSeventy-six subjects will be randomly divided into combined, low-frequency, high-frequency, and control groups based on the proportion of 1:1:1:1, with 19 cases in each group. All groups will have conventional rehabilitation, on top of which the combined group will receive 1 Hz rTMS in the unaffected hemisphere and 10 Hz rTMS in the affected hemisphere. The low-frequency group will be administered 1 Hz rTMS in the unaffected hemisphere and sham stimulation in the contralateral hemisphere. The high-frequency group will be administered 10 Hz rTMS in the affected hemisphere and contralateral sham stimulation. The control group will receive bilateral sham stimulation. Assessments will be performed at baseline, after 2 weeks of treatment, and at post-treatment follow-up at week 6. The primary outcomes are FMA-UE (Fugl-Meyer assessment-upper extremity), latency, and serum BDNF levels. The secondary outcomes are the National Institute of Health Stroke Scale (NIHSS), Brunnstrom staging (BS), modified Ashworth scale (MAS), Modified Barthel Index (MBI), central motor conduction time (CMCT), precursor proteins of mature BDNF (proBDNF), and matrix metalloproteinase-9 (MMP-9) levels. Adverse events, such as headaches and seizures, will be recorded throughout the study.DiscussionThe findings of this study will help develop optimal stimulation protocols for motor recovery in stroke patients and identify biomarkers that respond to post-stroke motor rehabilitation, for better guidance of clinical treatment.Trial registrationThe study protocol was passed by the Medical Research Ethics Committee of the General Hospital of Ningxia Medical University on January 1, 2022 (no. KYLL-2021–1082). It was registered into the Chinese Clinical Trials Registry on May 22, 2022 (no. ChiCTR2200060201). This study is currently in progress.Graphical

Comparing two relaxation procedures to ease fatigue in multiple sclerosis: a single-blind randomized controlled trial

BackgroundVarious relaxation procedures have been proposed to reduce fatigue in multiple sclerosis (MS). However, it is unknown, which type of relaxation has the largest effect on fatigue reduction and on autonomic nervous system (ANS) activity.ObjectiveWe aimed to compare two biofeedback-supported relaxation exercises: a deep breathing (DB) exercise and progressive muscle relaxation (PMR), which may ameliorate MS fatigue and alter ANS activity.MethodsWe performed a single-blind randomized clinical trial, introducing MS patients (n = 34) to the DB or PMR exercise. We first tested cardiovagal integrity, reflected by changes in heart rate variability (HRV) in response to DB. Participants then performed a fatigue-inducing vigilance task, followed by the DB or PMR. State fatigue was recorded consecutively at baseline, after the vigilance task, and after the relaxation exercise, along with HRV reflecting ANS activity.ResultsOnly patients assigned to the PMR group experienced a significant drop in fatigue, whereas both relaxation exercises changed ANS activity. MS patients showed the expected autonomic response during the cardiovagal reflex test. The vigilance task elevated short-term feelings of fatigue and significantly reduced HRV parameters of parasympathetic activity. Trait fatigue was negatively correlated with HRV during the second half of the vigilance task.ConclusionPMR alleviates short-term feelings of fatigue in persons with MS. The vigilance task in combination with HRV measurements may be helpful for evaluating relaxation procedures as a treatment of fatigue. Hereby, future studies should ensure longer and more frequent relaxation exercises and focus on patients with weak to moderate fatigue.Trial registrationTrial Registry: DRKS00024358.

N-acetylcysteine vs placebo as adjunctive treatment in paediatric leukaemia: A single blind, randomized controlled trial

Background: Acute lymphoblastic leukaemia (ALL) accounts for about 25% of all cancer types in children. Many chemotherapeutic agents have been shown to be related to increased oxidative stress and hepatotoxicity which affect the survival rate. N-acetylcysteine (NAC) has been used as adjunctive treatment in malignancy. Objectives: To analyse the effect of NAC administration towards blood oxidant, transaminase enzyme, and bilirubin level in ALL children undergoing induction phase of chemotherapy. Method: This is a single-blind placebo-controlled randomized clinical trial carried out from August to December 2020 in Cipto Mangunkusumo National Hospital, Jakarta, Indonesia. Subjects were randomized consecutively into 2 groups treated with NAC or placebo. Inclusion criteria were newly diagnosed ALL-standard risk (SR) children undergoing chemotherapy induction. Exclusion criteria were subjects contraindicated to NAC, already diagnosed with liver dysfunction, and already taken antioxidants. Data were analysed using SPSS 21. Normality test was conducted followed by data analysis with unpaired t-test. Results: A total of 18 subjects were included in study and 2 of them were excluded. Malondialdehyde levels showed an increase of 0.17nmoL in the NAC group and a decrease of 0.19nmoL in the placebo group. Aspartate transaminase (AST) level increased in mean of 11.40 U/L in the NAC group compared to placebo group 5.67 U/L. Alanine transaminase (ALT) level in the NAC group showed an increase in mean of 23.24 U/L compared to placebo group which showed a decrease in mean of 3.5 U/L. Bilirubin level in the NAC group showed an increase of 0.7 mg/dL compared to placebo group 0.17 mg/dL. There was no significant difference in MDA levels, AST, ALT, and bilirubin levels in the 2 groups (p=0. 186; p=0.638; p=0.164; p=0.352, respectively). Conclusions: Higher malondialdehyde level was shown as a trend in subjects in both groups before chemotherapy was done. N-acetyl cysteine administration showed no significant difference in reducing MDA levels, transaminase enzymes, and bilirubin levels in ALL-SR patients compared to placebo.

Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients: a randomized controlled trial

BackgroundThis study aimed to compare the effects of cognitive functional therapy (CFT) and movement system impairment (MSI)-based treatment on pain intensity, disability, Kinesiophobia, and gait kinetics in patients with chronic non-specific low back pain (CNSLBP).MethodsIn a single-blind randomized clinical trial, we randomly assigned 91 patients with CNSLBP into CFT (n = 45) and MSI-based treatment (n = 46) groups. An 8-week training intervention was given to both groups. The researchers measured the primary outcome, which was pain intensity (Numeric rating scale), and the secondary outcomes, including disability (Oswestry disability index), Kinesiophobia (Tampa Kinesiophobia Scale), and vertical ground reaction force (VGRF) parameters at self-selected and faster speed (Force distributor treadmill). We evaluated patients at baseline, at the end of the 8-week intervention (post-treatment), and six months after the first treatment. We used mixed-model ANOVA to evaluate the effects of the interaction between time (baseline vs. post-treatment vs. six-month follow-up) and group (CFT vs. MSI-based treatment) on each measure.ResultsCFT showed superiority over MSI-based treatment in reducing pain intensity (P < 0.001, Effect size (ES) = 2.41), ODI (P < 0.001, ES = 2.15), and Kinesiophobia (P < 0.001, ES = 2.47) at eight weeks. The CFT also produced greater improvement in VGRF parameters, at both self-selected (FPF[P < 0.001, ES = 3], SPF[P < 0.001, ES = 0.5], MSF[P < 0.001, ES = 0.67], WAR[P < 0.001, ES = 1.53], POR[P < 0.001, ES = 0.8]), and faster speed, FPF(P < 0.001, ES = 1.33, MSF(P < 0.001, ES = 0.57), WAR(P < 0.001, ES = 0.67), POR(P < 0.001, ES = 2.91)] than the MSI, except SPF(P < 0.001, ES = 0.0) at eight weeks.ConclusionThis study suggests that the CFT is associated with better results in clinical and cognitive characteristics than the MSI-based treatment for CNSLBP, and the researchers maintained the treatment effects at six-month follow-up. Also, This study achieved better improvements in gait kinetics in CFT. CTF seems to be an appropriate and applicable treatment in clinical setting.Trial registrationThe researchers retrospectively registered the trial 10/11/2022, at https://www.umin.ac.jp/ with identifier number (UMIN000047455).

Effects of the combination of traditional Thai massage, scapular stabilization exercise, and chest mobilization in subjects with forward head posture: a single-blinded randomized clinical trial

BackgroundForward head posture (FHP) is a common condition where the head appears to be positioned in front of the vertical midline of the body. FHP is associated with shortening of the neck extensors and pectoral muscles, and the deep neck flexors and shoulder retractors are weakened. FHP is also found to cause decreases in respiratory function. Few clinical trials have investigated the effects of combination treatments to alleviate these problems. The aim of this study was to examine the effects of combination of traditional Thai massage, scapular stabilization exercise, and chest mobilization on forward head angle (FHA), forced vital capacity (FVC), and cervical flexion in subjects with FHP.MethodsForty-eight subjects with FHP were randomly allocated to a treatment group receiving a Combination of Traditional Thai massage, Scapular stabilization exercise, and Chest mobilization (CTSC group) (n = 24) and a control group (relaxed by lying supine) (n = 24). FHA, FVC, and cervical flexion were measured before and after the four-week intervention (Week 4) and one month after the intervention period (Week 8).ResultsThe CTSC group showed statistically significantly greater improvement in FHA and cervical flexion than the control group at Week 4 (FHA, mean difference − 6.05; 95% CI − 8.03, − 4.07; cervical flexion, mean difference 6.84; 95% CI 3.14, 10.55) and Week 8 (FHA, mean difference − 4.64; 95% CI ( − 6.71, − 2.58); cervical flexion, mean difference 5.21; 95% CI 0.84, 9.58). There were no significant between-group differences in FVC at week 4 (mean difference 0.09; 95% CI − 0.06, 0.23) and week 8 (mean difference 0.04; 95% CI − 0.11, 0.19).ConclusionThis study showed that CTSC had a positive effect on FHA and cervical flexion in subjects with FHP.Trial registration: Thai Clinical Trials Registry (TCTR) (Identification number: TCTR20211119001), registered 19 November 2021; https://www.thaiclinicaltrials.org/show/TCTR20211119001.

Effect of clear aligner attachment design on extrusion of maxillary lateral incisors: A multicenter, single-blind randomized clinical trial

Extrusion of maxillary lateral incisors during aligner treatment is a difficult movement to achieve accurately. Despite recommendations regarding attachment design, few studies and no prospective trials compare predictability among attachments. This study aimed to compare the efficacy between optimized and horizontal attachment designs for achieving maxillary lateral incisor extrusion during clear aligner treatment. The study included maxillary lateral incisors in 3 orthodontic practices requiring at least 0.3 mm of extrusion during the first series of 20-25 aligners in patients aged ≥16 years who were scheduled to begin clear aligner treatment (Invisalign; Align Technology, San Jose, Calif). Teeth were randomly assigned to receive optimized (O), rectangular horizontal nonbeveled (H), rectangular horizontal incisally-beveled (HIB), or rectangular horizontal gingivally-beveled (HGB) attachments. After the first series, a blinded evaluator measured extrusion using superimpositions with initial and predicted models. Linear models determined the difference in the predicted extrusion percentage achieved on the basis of attachment design. Other covariates were patient age, sex, number of trays, and self-reported compliance. Forty patients (74teeth) were enrolled, and 38 patients (71 teeth) completed the study. Intraexaminer and interexaminer reliability for extrusion measurements was high (intraclass correlation coefficient, 0.985 and 0.991, respectively). The achieved extrusion was significantly less than predicted (mean, 73%; P<0.0001). The average achieved extrusion was 62%, 79%, 78%, and 78% for O, H, HIB, and HGB attachments, respectively, with H significantly more effective than O (P= 0.0403). Horizontal attachments (H, HIB, and HGB combined) were significantly more effective than O attachments (P= 0.0060), with an average difference in achieved extrusion of 14% of the predicted amount (95% confidence interval, 4-23; estimated 76% vs 62%). Horizontal attachments were an estimated 22% more effective than O attachments for extruding maxillary lateral incisors. Horizontal attachments are more effective than O attachments for predicted maxillary lateral incisor extrusion between 0.3 and 2.5 mm. The 3 horizontal attachment designs evaluated performed similarly for achieving predicted extrusion. This randomized clinical trial was registered and reported at clinicaltrials.gov (NCT04968353). The protocol was not published before trial commencement. This study was funded in part by the Alexander Fellowship of the Virginia Commonwealth University School of Dentistry, the Southern Association of Orthodontists, and the Virginia Orthodontic Education and Research Foundation. No funding source influenced the study design, the collection, analysis or interpretation of data, writing of the report, or the decision to submit the article for publication.

Effects of a self-care educational program via telerehabilitation on quality of life and caregiver burden in amyotrophic lateral sclerosis: a single-blinded randomized clinical trial protocol.

The implementation of a telerehabilitation protocol for self-care in the routine of caregivers of individuals with amyotrophic lateral sclerosis (ALS) has been associated with reduced levels of stress and improved quality of life. Moreover, it may reduce the difficulty of traveling to perform physical or other self-care activities. Thus, this study designed a clinical trial protocol to investigate the effects of a self-care education program via telerehabilitation on the burden and quality of life of caregivers of individuals with ALS. This single-blinded randomized clinical trial will recruit 26 caregivers and randomly allocate them to the experimental (EG = 13) or control group (CG = 13). The EG will receive an informative booklet and participate in a 6-week synchronous telerehabilitation program with a neuropsychologist, nutritionist, and physiotherapist to discuss physical and mental health. The CG will receive an informative booklet on self-care and physical activity and weekly phone calls for 6 weeks to solve questions about the booklet. Outcomes will include the caregiver burden (Zarit scale), quality of life (World Health Organization Quality of Life BREF), pain (McGill Pain Questionnaire), stress (Perceived Stress Scale), and depression (Beck Depression Inventory), which will be evaluated at the baseline after the six-week program and 30 days after the program. Additionally, we will assess daily the nocturnal awakenings, sleep patterns, level of physical activity, and heart rate variability. This study aimed to investigate the effectiveness of telerehabilitation for caregivers of individuals with ALS. If effective, this program could be disseminated among health professionals, increasing the possibility of remotely monitoring individuals with difficulty performing physical activities. NCT05884034 (clinicaltrials.gov).

Comparison of telerehabilitation methods for patients with systemic sclerosis in the COVID-19 Era: A randomized controlled study

Study DesignThis was a single-blinded randomized clinical trial. IntroductionSystemic sclerosis (SSc) is an autoimmune connective tissue disease that progresses with fibrosis. Patients with SSc need to be protected against epidemic diseases and provided for in terms of rehabilitation needs. Purpose of the StudyTo compare the effects of real-time telerehabilitation (RTT) and asynchronous telerehabilitation (AT) on individuals with SSc. MethodsForty-two participants with SSc with a mean age of 44.17 ± 11.05 years were included in the study. The patients were randomly divided into three groups, RTT (n = 16), AT (n = 16), and control (n = 16) groups. A structured rehabilitation program was performed in real-time (RTT group) and asynchronously (AT group) for 40 minutes per day, in three sessions per week for 8 weeks. The participants' finger and wrist joint range of motion (ROM), upper extremity functions, grip strength, superficial sense of touch, activities of daily living (ADL), and general health status were assessed at baseline and after treatment. ResultsAfter 8 weeks, there were improvements in finger ROM (effect size [ES] = 0.23 to 0.60), wrist ROM (ES = 0.45 to 0.83), upper extremity functions (ES = 0.61 to 1.00), and ADL parameters (ES = 0.74) in the RTT group (p < 0.05). Also, there were improvements in finger ROM (ES = 0.16 to 0.45) and hand functions (ES = 0.54 to 0.55) in the AT group (p < 0.05). The RTT and AT groups had better hand functions and finger ROM than the control group in (p < 0.05). In addition, the RTT group had better wrist ROM than the control group (p = 0.008). RTT was superior to AT only in lateral pinch strength (p = 0.025). DiscussionExperimental groups achieved a statistically significant change in ROM, upper extremity functions and ADL over time in concordance with prior investigations. Changes in grip strength, superficial sense of touch, and general health status scores differed from previous investigations and the between-group comparison was not statistically significant. ConclusionsBoth RTT and AT may be effective in individuals with SSc, and RTT has additional benefits.

The efficacy in shoulder range of motion of a snapping manual maneuver added to a standardized exercise protocol in axillary web syndrome: a randomized controlled trial

Purpose Axillary Web Syndrome (AWS) is a common sequela after surgical axillary lymph node dissection (ALND) often manifesting with reduced range of motion (ROM) of the limb, which requires rehabilitation. Notwithstanding, a standardized rehabilitation protocol is currently lacking in clinical practice. Our primary objective was therefore to evaluate the effectiveness of the use of a snapping manual maneuver (SMM, used in our clinical practice) to increase ROM during abduction (ABD) when compared with a standardized stretching exercise (SSE) protocol. A three-year follow-up of the enrolled patients was also carried out to determine the incidence of Breast Cancer-Related Lymphedema (BCRL). Materials and methods Between July 2013 and January 2019, we conducted a single-blinded randomized clinical trial. A total of 60 patients, who underwent ALND in our hospital, came to our clinic under medical advice or on voluntary access and reported AWS symptoms. The patients were randomly assigned into two equally divided groups. The treatment of group one consists in the execution of a supervised SSEs protocol, while group two additionally received a manual snapping maneuver. Patients of both groups received two treatment sessions within two weeks. At the end of the session, they were asked to continue the exercises autonomously on a daily basis, three times per day, for one month. Results There were no statically significant differences in ROM at our one-month follow-up and the incidence of BCRL was equally distributed after three years. Conclusions The use of the manual snapping maneuver in addition to stretching once per week for two weeks does not appear to improve the outcome of the patients in comparison with stretching alone and does not appear to be related to lymphedema in our 3 years follow-up.

Efficacy of Mobile App-Based Cognitive Behavioral Therapy for Insomnia: Multicenter, Single-Blind Randomized Clinical Trial.

Cognitive behavioral therapy for insomnia (CBTi) is the first-line therapy for chronic insomnia. Mobile app-based CBTi (MCBTi) can enhance the accessibility of CBTi treatment; however, few studies have evaluated the effectiveness of MCBTi using a multicenter, randomized controlled trial design. We aimed to assess the efficacy of Somzz, an MCBTi that provides real-time and tailored feedback to users, through comparison with an active comparator app. In our multicenter, single-blind randomized controlled trial study, participants were recruited from 3 university hospitals and randomized into a Somzz group and a sleep hygiene education (SHE) group at a 1:1 ratio. The intervention included 6 sessions for 6 weeks, with follow-up visits over a 4-month period. The Somzz group received audiovisual sleep education, guidance on relaxation therapy, and real-time feedback on sleep behavior. The primary outcome was the Insomnia Severity Index score, and secondary outcomes included sleep diary measures and mental health self-reports. We analyzed the outcomes based on the intention-to-treat principle. A total of 98 participants were randomized into the Somzz (n=49, 50%) and SHE (n=49, 50%) groups. Insomnia Severity Index scores for the Somzz group were significantly lower at the postintervention time point (9.0 vs 12.8; t95=3.85; F2,95=22.76; ηp2=0.13; P<.001) and at the 3-month follow-up visit (11.3 vs 14.7; t68=2.61; F2,68=5.85; ηp2=0.03; P=.01) compared to those of the SHE group. The Somzz group maintained their treatment effect at the postintervention time point and follow-ups, with a moderate to large effect size (Cohen d=-0.62 to -1.35; P<.01 in all cases). Furthermore, the Somzz group showed better sleep efficiency (t95=-3.32; F2,91=69.87; ηp2=0.41; P=.001), wake after sleep onset (t95=2.55; F2,91=51.81; ηp2=0.36; P=.01), satisfaction (t95=-2.05; F2,91=26.63; ηp2=0.20; P=.04) related to sleep, and mental health outcomes, including depression (t95=2.11; F2,94=29.64; ηp2=0.21; P=.04) and quality of life (t95=-3.13; F2,94=54.20; ηp2=0.33; P=.002), compared to the SHE group after the intervention. The attrition rate in the Somzz group was 12% (6/49). Somzz outperformed SHE in improving insomnia, mental health, and quality of life. The MCBTi can be a highly accessible, time-efficient, and effective treatment option for chronic insomnia, with high compliance. Clinical Research Information Service (CRiS) KCT0007292; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22214&search_page=L.

Comparative evaluation of the caesarean section rate in term nulliparas with labour dystocia following augmentation with oxytocin alone versus with oxytocin and drotaverine

Background: Labour dystocia is the commonest indication for emergency caesarean section in nulliparas, and occurs when the progress of labour is abnormally slow. Labour dystocia may be caused by abnormalities in uterine contractions, slow cervical dilatation, or mechanical disproportion between the foetal presenting part and the maternal pelvis. Augmentation of labour with oxytocin is the traditional management for labour dystocia as it enhances uterine contractions. At times, despite good uterine contractions, dystocia persists due to cervical smooth muscle spasms or mechanical factors, thereby increasing the caesarean section rate. Drotaverine is a musculotropic antispasmodic and can relieve smooth muscle spasms. Aim/objective: This study compared the caesarean section rate in term nulliparas with labour dystocia that were augmented with oxytocin and placebo versus with oxytocin and drotaverine Methods: This study was a single-blinded randomized clinical trial conducted between January and August 2021. It involved 156 term nulliparous women with labour dystocia that were randomized into two groups for augmentation of labour. Each group had 78 parturients that were managed with either oxytocin with a placebo or oxytocin with drotaverine. They were monitored till delivery and the caesarean section rate in both groups was compared. Data obtained were analysed with SPSS version 23 software. The level of significance was set at 0.05, P&lt; 0.05 was statistically significant. Results: The two groups were similar in their sociodemographic characteristics. In this study 21(13.5%) women had emergency caesarean section while 135(86.5%) had vaginal delivery following augmentation. The caesarean section rate in the oxytocin-placebo was similar to the oxytocin-drotaverine group (10 (12.8%) vs 11 (14.1%), p=0.82). The majority, 14 (67%) of the caesarean sections were due to mechanical factors, 4 (19%) were due to functional dystocia and 3(14%) were due to foetal distress. Conclusion: The use of drotaverine with oxytocin in managing labour dystocia did not improve the caesarean section rate as the majority of the cases had mechanical dystocia.

Comparison of Immediate Effect of High-power Pain Threshold Ultrasound and Deep Transverse Friction Massage on Active Myofascial Trigger Points

Introduction: The study was conducted to compare the immediate effect of high-power pain threshold ultrasound (HPPTUS) and deep transverse friction massage (DTFM) as a traditional technique on the treatment of upper trapezius active myofascial trigger points in male patients with mechanical neck pain.&#x0D; Materials and Methods: In this parallel single-blind randomized clinical trial study, 60 men with mechanical neck pain (mean age: 30.57±6.19 years) who met the inclusion and exclusion criteria were randomly assigned to HPPTUS and DTFM as the control group. A visual analog scale (VAS), pain pressure threshold (PPT), and range of motion (ROM) of cervical lateral flexion (CLF) were assessed before and after treatment.&#x0D; Results: Analysis of pre- and post-treatment findings showed that the VAS (P&lt;0.01), PPT (P&lt;0.01), and ROM of CLF (P&lt;0.01) improved significantly in both groups while ROM of CLF increased significantly more in the HPPTUS group. An indirect correlation was found between the pre-treatment ROM of CLF and ROM of CLF improvement in both groups. A significant indirect correlation was observed between pre-treatment VAS and ROM of CLF improvement in the HPPTUS group. In the DTFM group a significant indirect correlation was found between pre-treatment ROM of CLF and VAS improvement.&#x0D; Conclusion: The results showed that HPPTUS can be used as an effective treatment for active trigger points (TP). It seems that this method is more effective than deep transverse friction massage.&#x0D;

519-P: Randomized Clinical Trial to Compare Cryopreserved and Lyopreserved Placental Cord Tissue to Treat Complex Diabetic Foot Surgical Wounds—A Proof of Concept Study

Objective: To compare the incidence of infection, healing and time to heal in patients treated with cryopreserved (CPAT) and lyopreserved amniotic tissue (LPAT) in complex diabetic surgical wound (CDFW). Methods: This single-blinded 12-week randomized clinical trial compared cryopreserved and lyopreserved amniotic cord tissue to treat complex diabetic foot wounds (CDFW). LPAT or CRAT was applied at baseline and again after four weeks. We enrolled subjects with UT2A-D and 3A-D wounds (depth to tendon, muscle, or bone with infection and/or PAD) and excluded subjects with ABI&amp;lt;0.5 or TBI&amp;lt;0.3, untreated osteomyelitis, and autoimmune diseases. We used a 3-D camera to evaluate wound area and volume. The Chi-squared test was used to compare clinical outcomes and the Wilcoxon Ranked Sum Test to compare wound area and volume. Results: The mean baseline wound areas were 12.9cm2 ±10.7 for CPAT and 11.7cm2 ±7.0 for LPAT. The mean baseline wound volume were 7.5cm3 ±8.1 for CPAT and 9.2cm3±10.2 for LPAT. There was no difference between CPAT and LPAT in healing (36.8% vs. 19.0%, p=0.21) and infection (10.5% vs. 9.5%, p=0.72). There was no difference in mean wound area reduction between CPAT and LPAT (75.9± 32.3% vs. 65.5±38.4%, p=0.41), nor in mean volume reduction (85.0±30.8% vs. 79.9±31.9%, p=0.61). When we stratified wound dimensions, there was no difference between CPAT and LPAT in subjects that had 90-99% wound volume reduction (36.8% vs. 47.6%), 70-89% wound volume reduction (15.8% vs 19.0%) and 0-69% wound volume reduction (10.5% vs. 19.0%). There was no difference between CPAT and LPAT in subjects that had 90-99% wound area reduction 90-99% (10.5% vs. 23.8%), 70-89% (26.3% vs. 19.0%) and 0-69% (26.3% vs. 38.1%). Conclusion: Cryopreserved and Lyopreserved amniotic tissue provided similar results in patients with complex diabetic foot wounds. Disclosure L.A.Lavery: Research Support; AstraZeneca, Tissue tech, American Diabetes Association, PolarityTE, Inc., Microbion, Jarvis, Integra Lifesciences Holdings Corp, Smith+Nephew. A.L.Killeen: Research Support; 3M/KCI, AstraZeneca, BioTissue surgical, Hologenix, LLC, Integra LifeSciences, Kent Imaging Inc., Microbion, PolarityTE, Inc., Smith+Nephew, Stark Enterprises, LLC, Xyken, VasoActiv, ViOptix. M.A.Suludere: None. P.Crisologo: None. Funding Smith &amp; Nephew

Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial.

Primary dysmenorrhea (PD) is a painful menstruation that can persist for the duration of a woman's fertile life. Non-steroidal anti-inflammatory drugs, hormonal therapy, physiotherapy techniques, etc., are the main treatments. The main objective of this study is to evaluate the effectiveness of transcutaneous posterior tibial nerve stimulation (TTNS) in PD patients. The study will consist of a single-blind randomized clinical trial, parallel-assigned with two arms. Women with PD (18-43 years) with regular menstrual cycles and at least 4 points in VAS will be randomly divided into experimental (TTNS) and placebo (simulated stimulation) groups during 12 treatment sessions (1 session/week) and several follow-ups: monthly during treatment and 1, 3 and 6 months after. Maximum and mean pain intensity, pain duration, pain severity, number of anti-inflammatory drugs, quality of life, sleep quality, overall improvement, treatment satisfaction and secondary effects will be measured once a month every 6 months and at 3 and 6 months. The Student's t-test for independent samples or the Mann-Whitney U test will be used. The literature shows effective physiotherapeutic techniques for PD in the short term, which do not act on causes and have limitations. The TTNS technique can be used in transcutaneous and percutaneous modalities, with similar effectiveness, but the transcutaneous causes less discomfort. TTNS modulates pain, and long-term benefits could be achieved at low cost and without patient discomfort.

Comparison of telehealth and supervised phase III cardiac rehabilitation in regional Australia: protocol for a non-inferiority trial

IntroductionExercise-based cardiac rehabilitation programmes (ExCRP) promote recovery and secondary prevention for individuals with cardiovascular disease (CVD). Despite this, enrolment and adherence to ExCRP in rural locations is low. Telehealth programmes...

The effects of virtual logotherapy on health-promoting lifestyle among single-parent adolescent girls during the coronavirus disease 2019 pandemic: a randomized clinical trial

Single-parent adolescents are vulnerable individuals and it is necessary to improve their health, particularly during epidemics. This study aimed to investigate the effects of virtual logotherapy (VL) on health-promoting lifestyle (HPL) among single-parent adolescent girls during the COVID-19 pandemic. This single-blind randomized clinical trial was conducted on 88 single-parent adolescent girls recruited from the support organization for vulnerable individuals in Tehran, Iran. They were randomly allocated to a control and an intervention group through block randomization. Participants in the intervention group received VL in three–five person groups in 90 min biweekly sessions. The Adolescent Health Promotion Short-Form was used to assess HPL. Data were analyzed using the SPSS software (v. 26.0) and through the independent-sample t, Chi-square, Fisher’s exact, and Mann–Whitney U tests. There was no significant difference between the intervention and the control groups respecting the pretest mean score of HPL (73.58±16.74 vs. 72.80±9.30; P=0.085). However, the posttest mean score of HPL in the intervention group (82 with an interquartile range of 78–90) was significantly more than the control group (71.50 with an interquartile range of 63.25–84.50) (P=0.001). Moreover, after adjusting the effects of the significant between-group differences respecting pretest mean scores, the pretest–posttest differences of the mean scores of HPL and all its dimensions in the intervention group were significantly more than the control group (P<0.05). VL is effective in significantly improving HPL among single-parent adolescent girls. Healthcare authorities are recommended to use VL for health promotion among single-parent adolescents.Trial registrationThis research was registered (17/05/2020) in the www.thaiclinicaltrials.org with registration number: TCTR20200517001.

The Effect of Topical Nifedipine versus Diltiazem on the Acute Anal Fissure: A Randomized Clinical Trial.

Background: The anal fissure is one of the most common anorectal diseases that is associated with reduced quality of life and productivity loss. We aimed to compare the efficacy of topical nifedipine and diltiazem for the treatment of acute anal fissure (AAF). Methods: This single-blind randomized clinical trial was conducted at Ziaeian hospital, Tehran. Patients with an acute fissure diagnosis were allocated to two groups. Group A applied 3 grams of 0.3% nifedipine cream on the peri-anal area, three times a day, for 8 weeks. Group B also applied the same amount of 2% diltiazem-ointment on the peri-anal area for the same period. The primary outcome was fissure remission in the 8th week of the treatments. The duration of pain relief, the side effect of treatment, and the recurrence rate were also compared between the groups. Results: After 8 weeks of treatment, a remission rate of 77.4% was shown in the nifedipine group which was significantly higher than the diltiazem group with a remission rate of 54% (P=0.01). Applying nifedipine ointment is associated with earlier pain relief compared with diltiazem (P<0.001). After 6 months of follow-up, the relapse rate was not statistically different between the nifedipine and diltiazem groups (16.3% versus 21.4%, respectively). Conclusion: The application of topical nifedipine is associated with shorter pain relief and more remission rate for AAF compared with topical diltiazem. However, both methods were not different in terms of related side effects and AAF recurrence rate.

Head elevation during preoxygenation can delay desaturation time: A randomized-controlled trial

BackgroundPreoxygenation before anesthesia induction is an important part of airway management to reduce the risk of hypoxemia when the patient is apneic. The effectivity of preoxygenation is influenced by several things such as patient's head position. This study aimed to compare preoxygenation between various degrees of head elevation (20°, 30°, and 45°) and 0° or no elevation position towards desaturation time before tracheal intubation in patients undergoing general anesthesia. MethodThis was a single-blinded randomized clinical trial of 48 patients, assigned into four groups (0°, 20°, 30°, and 45° head elevation group). All subjects were preoxygenated for 3 min with 100% oxygen. Induction of anesthesia was started with fentanyl and propofol, followed by rocuronium after the patient lost consciousness. Time was recorded from the beginning of induction until the oxygen saturation decreased to 93% or a time limit of 5 min was reached. ResultThe desaturation time in 45° head elevation group was significantly the longest, followed by 30°, 20°, and 0° group (224,0 ± 49,4; 196,4 ± 41,7; 187,2 ± 29,8; and 166,1 ± 51,3 s, respectively; P < 0.05). ConclusionsPatients with 45° head elevation had significant longer mean desaturation time compared to 0° and 20° head elevation group. In patients undergoing general anesthesia, preoxygenation with head elevation slowed down the time for desaturation before tracheal intubation compared to the conventional position. Clinical trial registrationNCT05688722.

A Comparative Study of Nasal Fiberoptic Intubation with Laryngeal Mask Airway Fiberoptic Intubation in Children with a Difficult Airway

Background: Considering that the gold standard for intubation in children with a difficult airway is the use of fiberoptic bronchoscopy, and few studies have evaluated its application in children, the present study aimed at comparing two bronchoscopic techniques of nasal fiberoptic tracheal intubation (FOI-Nasal) and fiberoptic intubation via laryngeal mask airway (FOI-LMA) in children with a difficult airway.&#x0D; Methods: A single-blind randomized clinical trial was performed on 40 six-month-old to six-year-old children that were divided into two groups each consisting of 20 patients. The participants were all candidates for elective surgery with clinical criteria for the anticipated difficult intubation. FOI-Nasal and FOI-LMA were performed in the first and second groups, respectively. Mean arterial pressure (MAP), heart rate (HR), and blood oxygen saturation levels (SpO2) were assessed and recorded before anesthesia (T1), immediately before bronchoscopy (T2), and immediately after intubation with endotracheal tube (T3). Moreover, ETCO2, the first successful insertion attempt, and the intubation time were recorded, as well.&#x0D; Results: The results of the present study revealed that parameters including MAP, HR, and SpO2 at times T1, T2, and T3 were not significantly different between the two groups after adjusting for potential confounding factors (P&gt; 0.05). However, ETCO2 in FOI-Nasal group with a mean of 38.40 ± 3.57 was significantly higher than that of the FOI-LMA group with a mean of 34.35 ± 3.15 (P = 0.001). In addition, the intubation time in the FOI-LMA group with a mean of 32.40 ± 7.45 was significantly shorter than that of the FOI-Nasal group with a mean of 51.75 ± 9.97 (P &lt;0.001). The success rate in the first attempt in the FOI-Nasal group with the value of 70% was lower than that of the FOI-LMA group with the value of 90%; however, this difference was not statistically significant (P&gt; 0.05).&#x0D; Conclusion: According to the results of the present study, the intubation time in the FOI-LMA group was significantly shorter than that of the FOI-Nasal group. Moreover, the success rate of the first attempt in the FOI-LMA group was higher than that of the FOI-Nasal group. Therefore, it can be stated that FOI-LMA as compared to FOI-Nasal can be regarded as an easier technique, with a shorter intubation time, a higher success rate, and a greater stability of children’s hemodynamic parameters.