scholarly journals Development and Validation of a Cloak-Shaped Device for Sham Pediatric Tuina: a Randomized Controlled Study

2021 ◽  
Author(s):  
Jianxiong Cai ◽  
Lin Dai ◽  
Lingjia Yin ◽  
Taoying Lu ◽  
Li Wang ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Sham Group ◽  
Trial Registration ◽  
Controlled Study ◽  
Pediatric Tuina ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Significant Difference ◽  
Sham Intervention ◽  
Development And Validation

Abstract Background: To date, no well-recognized placebo device or procedure for pediatric Tuina (PT) has been reported. We developed a cloak-shaped device and designed an RCT to detect whether the device is effective as a placebo in PT research.Methods: It was a two-arm, parallel-group RCT design. Children were randomly assigned to the genuine Tuina or sham Tuina group at a 1:1 ratio. The genuine and sham Tuina interventions were delivered using the same standardized procedure by adopting a cloak-shaped device. The primary outcomes were the judgement rates of the type of Tuina that participants received based on caregivers’ and observers’evaluations. The analysis explored whether parents' attitude towards PT was related to their judgment rate.Results: A total of 60 participants were enrolled (37 boys [61.7%]; 16.0[2.3] months). Thirty children received genuine PT, and 30 received sham PT. There was no significant difference in parents' judgment of the interventions received between the two groups (χ2=0.65,P=0.421) or based on observers' judgments (χ2=0.07, P=0.795). In terms of parents' attitude towards PT or compliance with PT, parents whose children were in the genuine Tuina group were not significantly different from those in the sham group(z=0.01, P=0.99; z=0.34, P=0.73). Of the participants in the sham group, none of their parents recorded receiving the sham intervention.Conclusions: The placebo device for sham PT was found to be a credible control for PT. This study supports its use in prospective, sham-controlled, randomized trials.Trial registration: ClinicalTrials.gov, NCT03474172. Registered in March 2018.

scholarly journals Effects of Regular Kefir Consumption on Gut Microbiota in Patients with Metabolic Syndrome: A Parallel-Group, Randomized, Controlled Study

Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2089 ◽  
Author(s):  
Ezgi BELLIKCI-KOYU ◽  
Banu Pınar SARER-YUREKLI ◽  
Yakut AKYON ◽  
Fadime AYDIN-KOSE ◽  
Cem KARAGOZLU ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Metabolic Syndrome ◽  
Gut Microbiota ◽  
Relative Abundance ◽  
Controlled Study ◽  
Microbiota Composition ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Significant Difference ◽  
Gut Microbiota Composition

Several health-promoting effects of kefir have been suggested, however, there is limited evidence for its potential effect on gut microbiota in metabolic syndrome This study aimed to investigate the effects of regular kefir consumption on gut microbiota composition, and their relation with the components of metabolic syndrome. In a parallel-group, randomized, controlled clinical trial setting, patients with metabolic syndrome were randomized to receive 180 mL/day kefir (n = 12) or unfermented milk (n = 10) for 12 weeks. Anthropometrical measurements, blood samples, blood pressure measurements, and fecal samples were taken at the beginning and end of the study. Fasting insulin, HOMA-IR, TNF-α, IFN-γ, and systolic and diastolic blood pressure showed a significant decrease by the intervention of kefir (p ≤ 0.05, for each). However, no significant difference was obtained between the kefir and unfermented milk groups (p > 0.05 for each). Gut microbiota analysis showed that regular kefir consumption resulted in a significant increase only in the relative abundance of Actinobacteria (p = 0.023). No significant change in the relative abundance of Bacteroidetes, Proteobacteria or Verrucomicrobia by kefir consumption was obtained. Furthermore, the changes in the relative abundance of sub-phylum bacterial populations did not differ significantly between the groups (p > 0.05, for each). Kefir supplementation had favorable effects on some of the metabolic syndrome parameters, however, further investigation is needed to understand its effect on gut microbiota composition.

scholarly journals Assessment of the Short-Term Effects after High-Inductive Electromagnetic Stimulation of Pelvic Floor Muscles: A Randomized, Sham-Controlled Study

2020 ◽  
Vol 9 (3) ◽  
pp. 874 ◽  
Author(s):  
Kuba Ptaszkowski ◽  
Bartosz Malkiewicz ◽  
Romuald Zdrojowy ◽  
Lucyna Ptaszkowska ◽  
Malgorzata Paprocka-Borowicz
Keyword(s):  
Pelvic Floor ◽  
Sham Group ◽  
Pelvic Floor Muscles ◽  
Controlled Study ◽  
Short Term ◽  
Electromagnetic Stimulation ◽  
Intergroup Comparison ◽  
Significant Difference ◽  
Sham Intervention ◽  
Semg Activity

Background: Physiotherapy should be performed by patients with stress or mixed urinary incontinence (SUI and MUI) to increase the strength and endurance of the pelvic floor muscles (PFMs). A method that can positively affect the pelvic floor is stimulation with high-inductive electromagnetic stimulation (HIES). The aim of the study was to evaluate the PFMs after the application of HIES in women with SUI and MUI by using surface electromyography (sEMG). Methods: This was a prospective, randomized, single-blind study with a sham intervention group. The participants were randomly assigned to the HIES group or sham group. The outcomes were features of the bioelectrical PFM activity assessed using sEMG and endovaginal probes. A single-session intervention in the HIES group included 20 min of HIES with an electromagnetic induction intensity of 2.5 T. Results: In the HIES group, there was a statistically significant difference in the PFM sEMG activity during “contractions” (p < 0.001) and “quick flicks” (p = 0.005). In the intergroup comparison, higher PFM sEMG activity after the intervention (“contraction”) was observed in the HIES group than in the sham group (after: p = 0.047; 1 h after: p = 0.017). Conclusions: The assessed HIES method seems effective for SUI and MUI patients in the short term and shows an advantage over the sham intervention in the assessment of PFM contractions.

scholarly journals Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: A Randomized controlled clinical studies

2021 ◽  
Author(s):  
Weilian Geng ◽  
Changxing Chen ◽  
Xingfeng Sun ◽  
Shaoqiang Huang
Keyword(s):  
Optic Nerve ◽  
Optic Nerve Sheath Diameter ◽  
Optic Nerve Sheath ◽  
Controlled Study ◽  
Anesthesia Induction ◽  
Gynecological Surgery ◽  
Time Points ◽  
Randomized Controlled ◽  
Nerve Sheath ◽  
Significant Difference

Abstract Background The results of studies on changes in intracranial pressure in patients undergoing laparoscopic surgery are inconsistent. Meanwhile, previous neurosurgery studies have suggested that propofol and sevoflurane have inconsistent effects on cerebral blood flow and cerebrovascular self-regulation. The purpose of this study is to compare changes in the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery under anesthetic maintenance with propofol versus sevoflurane. Methods This study included 110 patients undergoing laparoscopic gynecological surgery with an estimated operative time of more than 2 hours under general anesthesia. The study was a randomized controlled study. The optic nerve sheath diameter（ONSD）at various time points was measured by ultrasound, including when the patients entered the operating room (Tawake), after successful anesthesia induction and endotracheal intubation (Tinduction), when the body position was adjusted to the Trendelenburg position and the CO2 pneumoperitoneum pressure reached 14 mmHg, which was recorded as T0. Then, measurements were conducted every 15 minutes for the first 1 hour and then once every hour until the end of the surgery（T15,T30,T45 ,T1h ,T2h…）, after the end of surgery and the tracheal tube was removed (Tend), and before the patients were transferred to the ward (Tpacu).Results A significant difference in optic nerve sheath diameter was found between two groups at T15, T30, T45 (4.64±0.48mm and 4.50±0.29mm, respectively, p=0.031;4.77±0.45mm and 4.62±0.28mm, respectively, p=0.036;4.84±0.46mm and 4.65±0.30mm, respectively, p=0.012), while there was no significant difference at Tawake and other time points. Conclusion During laparoscopic gynecological surgery lasting more than 2 hours, the optic nerve sheath diameter was slightly larger in the propofol group than that in the sevoflurane group in the first 45 minutes. No significant difference was observed between the two groups 1 hour after surgery. Trial registration clinicaltrials.gov，NCT03498235. Retrospectively registered 1 March2018,https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0007UMM&selectaction=Edit&uid=U00040C5&ts=39&cx=c7i8icThe manuscript adheres to CONSORT guidelines.

scholarly journals A randomized, controlled study to compare the effects of intravenous labetalol and esmolol on haemodynamic changes during laryngoscopy and intubation

2017 ◽  
Vol 5 (9) ◽  
pp. 4003
Author(s):  
Atit Kumar ◽  
Prashant Kumar Mishra ◽  
Saurabh Shukla
Keyword(s):  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Cardiovascular Stress ◽  
Significant Difference ◽  
Haemodynamic Changes ◽  
Β Blocker ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background: Direct laryngoscopy and endotracheal intubation frequently induce cardiovascular stress response characterised by hypertension and tachycardia due to reflex sympathetic stimulation. Considering the clinical significance of these changes stress attenuation is needed to blunt these responses. β- blockers are used to reduce the unwanted hemodynamic responses. Esmolol is ultra-short acting cardio selective β blocker. Labetalol is useful in not only attenuating the response to laryngoscopy and intubation but also in preventing perioperative cardiovascular events. Present study compared the efficacy of esmolol and labetalol for attenuation of sympathomimetic response to laryngoscopy and intubation.Methods: It was a prospective, randomized, controlled study carried out in 75 adult patients with ASA 1 and ASA 2 posted for elective surgeries. Patients were allocated randomly into Group-1 (esmolol) and Group-2 (labetalol) and Group-3 (placebo) of 25 patients each. Inj. esmolol (1mg/kg) or Inj. labetalol (0.4 mg/kg) or placebo (0.9NS) dissolved up to 5 ml in distilled water was injected intravenously 5 minutes prior to intubation. All patients premeditated with Inj. glycopyrrolate (4µg/kg). Patient were then induced with Inj. propofol (2mg/kg), Inj. scoline (2mg/kg) given followed by laryngoscopy and intubation. Haemodynamic readings were noted at T0 (baseline before injecting the drug), T1 (1 minute after injecting the drug), T2 (after intubation), T3 (2 minutes after intubation), T4 (4 minutes after intubation), T5 (6 minutes after intubation), T6 (8 minutes after injection), T7 (10 minutes after injection).Results: Gr-1, Gr-2 and Gr-3, when compared with each other for systolic BP, diastolic BP, mean BP, and HR, showed a statistically significant difference at different intervals.Conclusions: Both the drugs are found to be effective in attenuation of hemodynamic reflex without any side effects. Further studies are recommended to substantiate the findings in present study.

Mitomycin C–Enhanced Revision Endoscopic Dacryocystorhinostomy

2012 ◽  
Vol 147 (5) ◽  
pp. 937-942 ◽  
Author(s):  
Sameh M. Ragab ◽  
Hossam S. Elsherif ◽  
Emad M. Shehata ◽  
Ahmed Younes ◽  
Ahmed M. Gamea
Keyword(s):  
Mitomycin C ◽  
Controlled Study ◽  
Safe Procedure ◽  
Endoscopic Dacryocystorhinostomy ◽  
Randomized Controlled ◽  
Group I ◽  
Significant Difference ◽  
Endoscopic Dcr ◽  
Causes Of Failure

Objectives (1) To conduct an adequately powered randomized controlled trial investigating the safety and efficacy of mitomycin C–enhanced revision endoscopic dacryocystorhinostomy (DCR) and (2) to analyze causes of failure after primary endoscopic DCR. Study Design A randomized controlled study. Setting General hospital. Subjects and Methods Seventy-six revision endoscopic DCRs were randomized into 2 groups: endoscopic DCR with mitomycin (group I), where 0.5 mg/mL mitomycin C was applied for 10 minutes, and endoscopic DCR without mitomycin (group II). Follow-up settings were done to document the patient’s subjective improvement, to judge ostium patency on irrigation, and to record any complications. Results Causes of failure in the original 92 patients included canalicular obstruction (14%), small misplaced bony window (43%), very small nasolacrimal stoma due to development of synechia (23%), and complete closure of nasolacrimal stoma with tough fibrous tissue (63%). There was no significant difference between the 2 groups in subjective and objective success rates and adverse events. Group I demonstrated a significantly longer operative time and a significantly lower number of debridement sessions (mean of 1.2 vs 1.9). Conclusions Recurrent nasolacrimal duct obstruction after primary endoscopic DCR is mainly due to reclosure of the nasolacrimal stoma with synechia and fashioning of the small misplaced bony window. Mitomycin C does not increase the success rate of revision endoscopic DCR. It is a safe procedure and may be of value only in patients inaccessible to strict follow-up because it induces a better healing profile in terms of mucosal recovery, wound healing, and less need for debridement sessions.

scholarly journals Analgesic Effect of Dexamethasone after Arthroscopic Knee Surgery: A Randomized Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-6
Author(s):  
Jairo Moyano ◽  
Maria García ◽  
Maria Caicedo
Keyword(s):  
Postoperative Pain ◽  
Pain Intensity ◽  
Knee Surgery ◽  
Controlled Study ◽  
Opioid Use ◽  
Arthroscopic Knee Surgery ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Intraoperative Period ◽  
Arthroscopic Knee

Background.Dexamethasone is sometimes used as a coanalgesic because of its anti-inflammatory properties.Objective. To evaluate opioid use, postoperative pain intensity, and side effects after a single dose of dexamethasone in patients undergoing arthroscopic knee surgery.Methods. In this randomized controlled study patients were randomized to receive either 10 mg of intravenous dexamethasone (DM group) or 0.9% normal saline (NS group) during the intraoperative period. Primary outcomes were pain intensity and total morphine and codeine use after surgery.Results. Seventy-eight patients were included in the study. The DM group showed statistically significant higher pain intensity at the fourth postoperative hour (DM: 3.96/10, standard deviation [SD] 0.54; NS: 2.46/10, SD 0.45;p=0.036). No statistically significant difference in total opioid use (morphine plus codeine) was identified with 15.9 (SD 1.97) codeine tablets used in DM group and 20 (SD 2.14) in NS group (p=0.25).Discussion. Pain intensity tended to decrease in both groups suggesting morphine as the main source of analgesia.Conclusions. Intravenous dexamethasone during the intraoperative period has no clinical impact on postoperative pain intensity during the first 48 h after arthroscopic knee surgery. This trial is registered withR000020892.

Can intubation be improved with endotracheal tubes marked with a color scale? Randomized controlled study.

2021 ◽  
Author(s):  
Juan Pablo Berazategui ◽  
Ramon Pio Larcade ◽  
Nestor Vain ◽  
Adriana Andrea Castro ◽  
Rose Mari Soria ◽  
...  
Keyword(s):  
Controlled Study ◽  
Endotracheal Tubes ◽  
Correct Placement ◽  
Randomized Controlled ◽  
Color Scale ◽  
Clinical Scenarios ◽  
Significant Difference ◽  
Different Color ◽  
Time Required ◽  
Selection Of

Objective: To assess if a color scale in the endotracheal tube (ETT) helps operators to correctly select the size and depth of placement of the ETT and decrease the time required, compared with the usual numeric ETT scale, in a mannequin model. Design/Methods: The study was conducted in 8 centers. Each size of the ETT was identified with different color by size. All experimental ETT had two painted zones: the mouthpiece and an area of 1 cm marked with the same color (to identify where the ETT should be taped above the lip). The operators were trained as part of the protocol using a video. Four clinical scenarios requiring endotracheal intubation were designed and randomly assigned. Each operator had to select the size and depth of ETT based on the BW, and then had to perform 4 intubation procedures. Results: 108 operators performed 432 intubations. No difference were found in the correct placement and selection of the ETT. Median time (in seconds) required for intubation using numeric vs. experimental tube was: for ETT Ø 2.5, 11.5 vs. 8 (p<0.001), ETTØ3,12 vs. 10 (p<0.001), ETT Ø 3.5, 15.5 vs.12 (p 0.003), ETT Ø4 12 vs.11 (p 0.019). Conclusions: No significant difference was observed in the selection and correct placement of the ETT. However, the intubation time was significantly shorter using the experimental ETT. This device could improve the effectiveness of intubation by reducing the time needed to properly place the ETT at mid trachea.

scholarly journals Comparison of periarticular multidrug infiltration and epidural catheter use in total knee arthroplasty: A prospective randomized controlled study

2020 ◽  
Vol 28 (1) ◽  
pp. 230949902091066
Author(s):  
Taku Ukai ◽  
Hamahashi Kosuke ◽  
Goro Ebihara ◽  
Masahiko Watanabe
Keyword(s):  
Total Knee Arthroplasty ◽  
Epidural Catheter ◽  
Knee Arthroplasty ◽  
Knee Flexion ◽  
Whole Body ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Catheter Group ◽  
Significant Difference ◽  
Total Knee

Purpose: The purpose of this study was to assess the effectiveness of periarticular multidrug infiltration (PMDI) and compare it with that of epidural catheter use. Methods: Fifty-eight patients (58 joints) who underwent total knee arthroplasty were included in this single-center, prospective, parallel, randomized, controlled trial. Preoperatively, patients were randomly categorized into the PMDI and epidural catheter groups. We evaluated postoperative pain (visual analog scale (VAS) and narcotic consumption), functional outcomes (range of motion (ROM) of knee flexion, the day patients could perform the straight-leg raising (SLR) test, and day of starting cane use), and laboratory data (white blood cell (WBC) and C-reactive protein (CRP)). Results: There was no significant difference in the VAS score, ROM of knee flexion, the day patients could do SLR, and the day of starting cane use between the PMDI and epidural catheter groups. However, the PMDI group could perform SLR on a postoperative day (POD) 1 ( p < 0.05). WBC level on POD 1 was significantly higher in the PMDI group ( p < 0.05), whereas the CRP levels on POD 1 ( p < 0.01), 3 ( p < 0.01), and 5 ( p < 0.01) were significantly lower in the PMDI group than in the epidural catheter group. The frequency of side effects was not significantly different between the groups. Conclusion: PMDI was as effective as epidural catheter use for pain control. A higher percentage of patients who underwent PMDI could perform SLR on POD 1; therefore, the functional recovery was earlier in the PMDI group than in the epidural catheter group. PMDI may suppress inflammation in the whole body because of steroids.

scholarly journals LO22: Does point-of-care ultrasonography improve diagnostic accuracy in emergency department patients with undifferentiated hypotension? An international randomized controlled trial from the SHoC-ED investigators

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S15
Author(s):  
P. Atkinson ◽  
M. Peach ◽  
S. Hunter ◽  
A. Kanji ◽  
L. Taylor ◽  
...  
Keyword(s):  
Cardiogenic Shock ◽  
Diagnostic Accuracy ◽  
Diagnostic Performance ◽  
Primary Outcome ◽  
Point Of Care ◽  
Statistical Tests ◽  
Controlled Study ◽  
Point Of Care Ultrasound ◽  
Randomized Controlled ◽  
Significant Difference

Introduction: Point of care ultrasound has been reported to improve diagnosis in non-traumatic hypotensive ED patients. We compared diagnostic performance of physicians with and without PoCUS in undifferentiated hypotensive patients as part of an international prospective randomized controlled study. The primary outcome was diagnostic performance of PoCUS for cardiogenic vs. non-cardiogenic shock. Methods: SHoC-ED recruited hypotensive patients (SBP &lt; 100 mmHg or shock index &gt; 1) in 6 centres in Canada and South Africa. We describe previously unreported secondary outcomes relating to diagnostic accuracy. Patients were randomized to standard clinical assessment (No PoCUS) or PoCUS groups. PoCUS-trained physicians performed scans after initial assessment. Demographics, clinical details and findings were collected prospectively. Initial and secondary diagnoses including shock category were recorded at 0 and 60 minutes. Final diagnosis was determined by independent blinded chart review. Standard statistical tests were employed. Sample size was powered at 0.80 (α:0.05) for a moderate difference. Results: 273 patients were enrolled with follow-up for primary outcome completed for 270. Baseline demographics and perceived category of shock were similar between groups. 11% of patients were determined to have cardiogenic shock. PoCUS had a sensitivity of 80.0% (95% CI 54.8 to 93.0%), specificity 95.5% (90.0 to 98.1%), LR+ve 17.9 (7.34 to 43.8), LR-ve 0.21 (0.08 to 0.58), Diagnostic OR 85.6 (18.2 to 403.6) and accuracy 93.7% (88.0 to 97.2%) for cardiogenic shock. Standard assessment without PoCUS had a sensitivity of 91.7% (64.6 to 98.5%), specificity 93.8% (87.8 to 97.0%), LR+ve 14.8 (7.1 to 30.9), LR- of 0.09 (0.01 to 0.58), Diagnostic OR 166.6 (18.7 to 1481) and accuracy of 93.6% (87.8 to 97.2%). There was no significant difference in sensitivity (-11.7% (-37.8 to 18.3%)) or specificity (1.73% (-4.67 to 8.29%)). Diagnostic performance was also similar between other shock subcategories. Conclusion: As reported in other studies, PoCUS based assessment performed well diagnostically in undifferentiated hypotensive patients, especially as a rule-in test. However performance was similar to standard (non-PoCUS) assessment, which was excellent in this study.

Daflon 500 mg: Symptoms and Edema

Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S25-S32 ◽  
Author(s):  
Albert-Adrien Ramelet
Keyword(s):  
Quality Of Life ◽  
Controlled Study ◽  
Venous Disease ◽  
Double Blind Study ◽  
Life Questionnaire ◽  
Double Blind ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Significant Difference

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.

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