scholarly journals PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace

PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0255264
Author(s):  
Elias Diarbakerli ◽  
Anastasios Charalampidis ◽  
Allan Abbott ◽  
Paul Gerdhem

Introduction Idiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Patients are treated mainly with thoracolumbosacral orthosis (TLSO) if indicated. This form of brace treatment has been shown to be cumbersome and tough on growing individuals. However, computer aided design and manufactured (CAD/CAM) braces might increase comfortability and ultimately outcome if compliance is improved. In a multicenter, randomized controlled trial, we aim to compare CAD/CAM designed Boston 3D-brace to standard Boston brace. Methods Subjects: 170 previously untreated and skeletally immature children diagnosed with idiopathic scoliosis, aged 9–17 years of age (curve magnitude Cobb 25–40 degrees) will be included. Interventions: Both groups will receive a physical activity prescription according to the World Health Organization recommendations. Randomization will be performed 1:1 to a 3D CAD/CAM designed Boston 3D-brace or a standard Boston brace, both with prescribed daily wear time of 20 hours. Outcome: The subjects will participate in the study until curve progression or until skeletal maturity. The primary outcome variable is failure of treatment, defined as progression of the Cobb angle more than 6 degrees compared to the baseline x-ray. The progression is confirmed if seen on two consecutive standing spinal x-rays. Radiographs will be taken at each six-month follow-up. Secondary outcome measures include patient and clinical reported outcomes, including number of individuals requiring surgical intervention. Discussion This study will show if efficacy in brace treatment can be improved with new brace designs. Trial registration The protocol has been registered on ClinicalTrials.gov, identifier: NCT04805437.

Author(s):  
Michele Nieri ◽  
Veronica Giuntini ◽  
Umberto Pagliaro ◽  
Monica Giani ◽  
Lorenzo Franchi ◽  
...  

Background: The aim of this single-use, four-treatment, four-period (visit), cross-over, mono-centered, examiner-blind, cross-over randomized controlled trial (RCT) was to evaluate the efficacy in dental plaque removal of a U-shaped automatic electric toothbrush (U) compared to a conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N). Methods: Eligible participants were volunteer students. Primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing. The secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS. Results: Twenty-two participants were randomized to the treatments in the four periods of the study. The differences between treatments in FMPS reduction after brushing were statistically significant (p < 0.0001). The differences were statistically significant between the U and P groups (difference −48; 95% CI from −54 to −41) favoring the P group, and between the U and H groups (difference −45; 95% CI from −52 to −39) favoring the H group. On the contrary, the difference between the U and N groups was not significant (difference 5; 95% CI from −2 to 12) favoring the U group. The differences between treatments in clean mouth VAS was statistically significant (p < 0.0001) favoring the P and H groups. Conclusions: The U-shaped automatic electric toothbrush tested in this study proved to be not effective in removing dental plaque.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ambrina Qureshi ◽  
Syed Akhtar Hussain Bokhari ◽  
Zeba Haque ◽  
Akhtar Ali Baloch ◽  
Sidra Zaheer

Abstract Background Treating periodontitis through non-surgical periodontal therapy (NSPT) may improve glycemic control in type-2 Diabetes Mellitus (T2DM) patients. However, the evidence to maintain this improvement beyond four months is insufficient. Hence, this trial was conducted to assess clinical efficacy of NSPT on glycemic control in T2DM patients. Methods This three-arm randomized controlled trial recruited 150 known T2DM participants (35–65 years), suffering from moderate to severe periodontitis, having HbA1c level ≥ 6.5% at baseline. Participants were followed up at 3 and 6 months. Intervention for test group-1 included scaling and root planing (SRP) with metronidazole (MET) and oral hygiene instructions (OHI). Test group-2 was intervened with SRP + OHI and control group with OHI only. Stata v. 14 was used to observe inter and intragroup mean changes in glycemic [glycated hemoglobin (HbA1c), fasting blood glucose (FBG)] and periodontal variables [bleeding on probing (BOP), periodontal pocket depth (PPD), clinical attachment loss (CAL)] using ANOVA and RMANOVA. Proportion of change in outcome variable (HbA1c) was assessed between treatment groups using chi-square test. Change was considered significant at p-value ≤ 0.05. Results A significant reduction was observed in BOP, PPD, CAL, HbA1c and FBG over time [p < 0.05]. Significant reductions were observed in same variables in both test groups in comparison to control arm [p < 0.05]. No change between the two test groups was observed [p > 0.05]. Conclusion Scaling and root planing improves glycemic control of T2DM patients independently of the use of MET. Therefore, SRP after every 6 months may be suggested and included as a part of overall diabetes management for patients suffering from T2DM. Clinical trial registration NCT 03,343,366 [Date of Registration: 17/11/2017]


Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 7.1-8
Author(s):  
A. Luquini ◽  
Y. Zheng ◽  
H. Xie ◽  
C. Backman ◽  
P. Rogers ◽  
...  

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.


10.2196/13005 ◽  
2019 ◽  
Vol 7 (8) ◽  
pp. e13005
Author(s):  
Lianne Gonsalves ◽  
Winnie Wangari Njeri ◽  
Megan Schroeder ◽  
Jefferson Mwaisaka ◽  
Peter Gichangi

Background Evidence is lacking on the efficacy of sexual and reproductive health (SRH) communication interventions for youth (aged 15-24 years), especially from low- and middle-income countries. Therefore, the World Health Organization initiated the Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) program, a free, menu-based, on-demand text message (SMS, short message service) platform providing validated SRH content developed in collaboration with young people. A randomized controlled trial (RCT) assessing the effect of the ARMADILLO intervention on SRH-related outcomes was implemented in Kwale County, Kenya. Objective This paper describes the implementation challenges related to the RCT, observed during enrollment and the intervention period, and their implications for digital health researchers and program implementers. Methods This was an open, three-armed RCT. Following completion of a baseline survey, participants were randomized into the ARMADILLO intervention (arm 1), a once-a-week contact SMS text message (arm 2), or usual care (arm 3, no intervention). The intervention period lasted seven weeks, after which participants completed an endline survey. Results Two study team decisions had significant implications for the success of the trial’s enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu. As a result, three weeks after recruitment began, 660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were “stuck” at the language menu. The research team called 231 of these nonengaging participants and successfully reached 136 to learn reasons for nonengagement. Thirty-two phone numbers were found to be either not linked to our participants (a wrong number) or not in their primary possession (a shared phone). Among eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam. Twenty-seven participants were confused by some aspect of the system. Eleven were apathetic about engaging. Twenty-four nonengagers experienced some sort of technical issue. All participants eventually started their seven-week study period. Conclusions The ARMADILLO study’s implementation challenges provide several lessons related to both researching and implementing client-side digital health interventions, including (1) have meticulous phone data collection protocols to reduce wrong numbers, (2) train participants on the digital intervention in efficacy assessments, and (3) recognize that client-side digital health interventions have analog discontinuation challenges. Implementation lessons were (1) determine whether an intervention requires phone ownership or phone access, (2) digital health campaigns need to establish a credible presence in a busy digital space, and (3) interest in a service can be sporadic or fleeting. Clinical Trial International Standard Randomized Controlled Trial Number (ISRCTN): 85156148; http://www.isrctn. com/ISRCTN85156148


2020 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial


2017 ◽  
Vol 4 (7) ◽  
pp. 2291
Author(s):  
Rajasekaran C. ◽  
Vijaykumar K. ◽  
Arulkumaran M. ◽  
Meera S. S.

Background: Incisional hernia forms the most common delayed morbidity following midline laparotomy surgeries- causing mental trauma to the patient impairing their quality of life and scars the name and fame of the surgeon. So, the need for possible attributes on surgeon’s aspect to prevent the incisional hernia is the need of the hour. We planned a randomized controlled trial to compare two different abdominal closure techniques to reduce the incidence of Incisional hernia following midline laparotomy incisions. We advocated Hughes abdominal repair which includes a series of two horizontal and two vertical mattresses within single suture whereby the tension load of suture is distributed both along and across the suture line.Methods: 1:1 Randomized controlled trial in which the patient is blinded and obviously operating surgeon is non-blinded. Evaluating examiner and radiologist are blinded.100 patients who underwent emergency and elective midline laparotomies were enrolled in the study and intra-operatively randomized into two groups in 1:1 pattern. Ethical clearance obtained from the Institutional ethical committee. The primary outcome measure is the incidence of burst abdomen at the end of 15 days by the evaluating surgeon (non-operated surgeon who is blinded). The secondary outcome is the incidence of incisional hernia at the end of one year-evaluated by detailed clinical examination with radiological proof using CT abdomen.Results: The incidence of incisional hernia is significantly low in Hughes abdominal repair than conventional abdominal closure.Conclusions: Hughes abdominal wall closure is superior to conventional closure in both emergency and elective laparotomy cases, in prevention of wound dehiscence and Incisional hernias later. Present study encourages us that Hughes abdominal wall repair is comparable to mesh repairs. This study needs to be continued further to a vast sample size to perfectly assess the statistical significance.


Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.


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