scholarly journals Clinical effects of high-intensity laser therapy on patients with chronic refractory wounds: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e045866
Author(s):  
Qian Lu ◽  
Zhifei Yin ◽  
Xuefeng Shen ◽  
Jinhua Li ◽  
Panpan Su ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
High Intensity ◽  
Wound Dressing ◽  
Wound Care ◽  
Controlled Trial ◽  
Control Group ◽  
High Intensity Laser ◽  
Randomised Controlled ◽  
Intensity Laser

ObjectiveTo investigate the effectiveness of high-intensity laser therapy (HILT) on chronic refractory wounds.DesignRandomised controlled trial.SettingThe outpatient wound care department of the Affiliated Jiangsu Shengze Hospital of Nanjing Medical University from August 2019 to June 2020.ParticipantsSixty patients were enrolled in this study and were randomised into control (n=30) and treatment (n=30) groups.Interventions and outcome measuresThe control group was treated only with conventional wound dressing, whereas the treatment group received irradiation with HILT in addition to standard wound care, such as debridement, wound irrigation with normal saline solution and application of dressing and sterile gauze. Patient scores on the Bates-Jensen Wound Assessment Tool (BWAT) and Pressure Ulcer Scale for Healing (PUSH) were evaluated before and after 1, 2 and 3 weeks of treatment.ResultsOne patient was excluded from the control group, and a total of 59 subjects completed the trial. The BWAT scores significantly decreased in the treatment group compared with the control group at the end of 3-week treatment (difference=−3.6; 95% CI −6.3 to–0.8; p<0.01). Similarly, patients in treatment group showed a significant reduction of PUSH scores compared with the control group (difference=−5.3; 95% CI −8.1 to –2.6; p<0.01).ConclusionsThe therapeutic effects of HILT on chronic refractory wounds are significant and far more superior to those of conventional wound dressing.Trial registration numberChinese Clinical Trial Registry; ChiCTR1900023157. URL: http://www.chictr.org.cn/showproj.aspx?proj=38866

scholarly journals Hyperbaric oxygen as an adjuvant treatment for patients with COVID-19 severe hypoxaemia: a randomised controlled trial

2021 ◽  
pp. emermed-2021-211253
Author(s):  
Mariana Cannellotto ◽  
Mariano Duarte ◽  
Guillermo Keller ◽  
Ramiro Larrea ◽  
Eleonora Cunto ◽  
...  
Keyword(s):  
Acute Respiratory Distress Syndrome ◽  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Interim Analysis ◽  
Distress Syndrome ◽  
Controlled Trial ◽  
Control Group ◽  
Safety And Efficacy ◽  
Severe Hypoxaemia ◽  
Randomised Controlled

BackgroundHyperbaric oxygen (HBO2) therapy has been proposed to treat hypoxaemia and reduce inflammation in COVID-19. Our objective was to analyse safety and efficacy of HBO2 in treatment of hypoxaemia in patients with COVID-19 and evaluate time to hypoxaemia correction.MethodsThis was a multicentre, open-label randomised controlled trial conducted in Buenos Aires, Argentina, between July and November 2020. Patients with COVID-19 and severe hypoxaemia (SpO2 ≤90% despite oxygen supplementation) were assigned to receive either HBO2 treatment or the standard treatment for respiratory symptoms for 7 days. HBO2 treatment was planned for ≥5 sessions (1 /day) for 90 min at 1.45 atmosphere absolute (ATA). Outcomes were time to normalise oxygen requirement to SpO2 ≥93%, need for mechanical respiratory assistance, development of acute respiratory distress syndrome and mortality within 30 days. A sample size of 80 patients was estimated, with a planned interim analysis after determining outcomes on 50% of patients.ResultsThe trial was stopped after the interim analysis. 40 patients were randomised, 20 in each group, age was 55.2±9.2 years. At admission, frequent symptoms were dyspnoea, fever and odynophagia; SpO2 was 85.1%±4.3% for the whole group. Patients in the treatment group received an average of 6.2±1.2 HBO2 sessions. Time to correct hypoxaemia was shorter in treatment group versus control group; median 3 days (IQR 1.0–4.5) versus median 9 days (IQR 5.5–12.5), respectively (p<0.010). OR for recovery from hypoxaemia in the HBO2 group at day 3 compared with the control group was 23.2 (95% CI 1.6 to 329.6; p=0.001) Treatment had no statistically significant effect on acute respiratory distress syndrome, mechanical ventilation or death within 30 days after admission.ConclusionOur findings support the safety and efficacy of HBO2 in the treatment of COVID-19 and severe hypoxaemia.Trial registration numberNCT04477954.

Comparison of sterile polyacrylate wound dressing with activated carbon cloth and a standard non-adhesive hydrocellular foam dressing with silver: a randomised controlled trial protocol

2019 ◽  
Vol 28 (11) ◽  
pp. 722-728
Author(s):  
Sebastian Probst ◽  
Camille Saini ◽  
Monika Buehrer Skinner
Keyword(s):  
Wound Healing ◽  
Activated Carbon ◽  
Randomised Controlled Trial ◽  
Wound Dressing ◽  
Wound Care ◽  
Controlled Trial ◽  
Wound Dressings ◽  
Carbon Cloth ◽  
Activated Carbon Cloth ◽  
Randomised Controlled

Objective: Hard-to-heal wounds such as leg (LU) or diabetic foot ulcers (DFU) are slow healing, have a high recurrence rate and are associated with infection, smell and exudate. Current therapeutic approaches are multifaceted and focus on improving wound healing and preventing recurrences. Advanced wound dressings, especially super absorbent dressings are an important aspect of wound care, as hard-to-heal wounds tend to produce excessive amounts of exudate, which may contribute to maceration and excoriation, thus delaying wound healing. Additionally, excessive wound exudate is associated with malodour. Therefore, an important aspect of care is the management of exudate and odour. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in wound size reduction between wounds dressed with either a sterile polyacrylate wound dressing with activated carbon cloth or a hydrocellular foam dressing with silver. Method: A randomised controlled trial with 248 participants in one wound care outpatient clinic is proposed. Randomisation will be concealed. The outcome assessor will be blinded to the group allocation of participants. Conclusion: This research project compares two wound dressings in an everyday care setting. Since the cost of hard-to-heal wounds to individuals, the economy and society is high, an evaluation of which wound dressing leads to a faster reduction of wound size and subsequent wound healing is an important issue/question for the individuals affected, their families, society and the health-care system.

The effect of cooperative high-intensity interval training on creativity and emotional intelligence in secondary school: A randomised controlled trial

2017 ◽  
Vol 25 (2) ◽  
pp. 355-373 ◽  
Author(s):  
Alberto Ruiz-Ariza ◽  
Sara Suárez-Manzano ◽  
Sebastián López-Serrano ◽  
Emilio J Martínez-López
Keyword(s):  
Emotional Intelligence ◽  
Randomised Controlled Trial ◽  
High Intensity ◽  
Controlled Trial ◽  
Interval Training ◽  
Well Being ◽  
Control Group ◽  
High Intensity Interval Training ◽  
High Intensity Interval ◽  
Randomised Controlled

Evidence suggests that moderate physical activity (PA) positively relates to creativity and emotional intelligence (EI) in adolescents. However, it is unknown whether cooperative PA (physical exercises in pairs or small groups to enhance motivation, self-efficacy, and pro-social behaviours), performed over less time but at higher intensity, could have similar effects within a school setting. The aim was to analyse the effect of cooperative high-intensity interval training (C-HIIT) on creativity and EI in adolescents aged 12–16 years, and whether improvement effects are different according to weekly PA level. A randomised controlled trial was conducted with a control group (CG, n = 94), which did static stretching, and an experimental group (EG, n = 90), which performed C-HIIT. Both groups performed the activity during 16 minutes at the beginning of physical education (PE) classes. Creativity was assessed with one factor, and EI through four factors (well-being, self-control, emotionality, and sociability). Age and body mass index (BMI) were used as confounders. Both were measured twice (baseline and after 12 weeks). The EG increased well-being and sociability factors after the C-HIIT programme (both p < 0.001). More specifically, inactive adolescents in the EG showed significant improvements in comparison to the CG in creativity, well-being, and sociability ( p = 0.028, p < 0.001, and p < 0.003, respectively). However, we did not find changes among active adolescents. A programme of C-HIIT in PE is a novel strategy to improve creativity and EI, especially in physically inactive adolescents. Starting PE classes with 16 minutes of C-HIIT could be recommended, independently of other activities planned for the session.

scholarly journals Randomised controlled trial of tetanus treatment with antitetanus immunoglobulin by the intrathecal or intramuscular route

BMJ ◽  
2004 ◽  
Vol 328 (7440) ◽  
pp. 615 ◽  
Author(s):  
Demócrito de Barros Miranda-Filho ◽  
Ricardo Arraes de Alencar Ximenes ◽  
Antônio Alci Barone ◽  
Vicente Luiz Vaz ◽  
Aderbal Gomes Vieira ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Control Group ◽  
Clinical Progression ◽  
Intramuscular Route ◽  
Mechanical Ventilation Duration ◽  
Randomised Controlled ◽  
Respiratory Assistance

AbstractObjective To evaluate the effect of intrathecal therapy with human antitetanus immunoglobulin on clinical progression of and mortality from tetanus.Design Randomised controlled trial.Setting Intensive care unit of a university hospital, Pernambuco, Brazil.Participants 120 patients with tetanus allocated to antitetanus immunoglobulin by either the intrathecal and intramuscular route (n = 58) or the intramuscular route (n = 62; control group).Main outcome measures Clinical progression of disease, duration of hospital stay, duration of occurrence of spasms, complications, respiratory infection, respiratory failure or mechanical ventilation, duration of respiratory assistance, and mortality.Results Patients in the treatment group showed a better clinical progression than those in the control group (χ2 for trend 7.752, P = 0.005; difference in proportion of patients with improvement 20%, 95% confidence interval 4% to 35%). The duration of occurrence of spasms, hospital stay, and respiratory assistance were all shorter in patients the treatment group: respectively, 14.96, 0.0001 (difference in proportion of patients with spasms lasting ≤ 10 days 36%, 18% to 55%); 4.56, 0.03; and 6.56, 0.01 (proportion of patients who needed assistance for ≤ 10 days 69.2% in the treatment group and 30.8% in the control group (difference 38%, 12% to 65%)).Conclusion Patients treated with antitetanus immunoglobulin by the intrathecal route show better clinical progression than those treated by the intramuscular route.

scholarly journals Diet and anthropometry at 2 years of age following an oral health promotion programme for Australian Aboriginal children and their carers: a randomised controlled trial

2017 ◽  
Vol 118 (12) ◽  
pp. 1061-1069 ◽  
Author(s):  
Lisa G. Smithers ◽  
John Lynch ◽  
Joanne Hedges ◽  
Lisa M. Jamieson
Keyword(s):  
Health Promotion ◽  
Oral Health ◽  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Culturally Appropriate ◽  
Oral Health Promotion ◽  
Randomised Controlled ◽  
Aboriginal Children

AbstractThere are marked disparities between indigenous and non-indigenous children’s diets and oral health. Both diet and oral health are linked to longer-term health problems. We aimed to investigate whether a culturally appropriate multi-faceted oral health promotion intervention reduced Aboriginal children’s intake of sugars from discretionary foods at 2 years of age. We conducted a single-blind, parallel-arm randomised controlled trial involving women who were pregnant or had given birth to an Aboriginal child in the previous 6 weeks. The treatment group received anticipatory guidance, Motivational Interviewing, health and dental care for mothers during pregnancy and children at 6, 12 and 18 months. The control group received usual care. The key dietary outcome was the percent energy intake from sugars in discretionary foods (%EI), collected from up to three 24-h dietary recalls by trained research officers who were blind to intervention group. Secondary outcomes included intake of macronutrients, food groups, anthropometric z scores (weight, height, BMI and mid-upper arm circumference) and blood pressure. We enrolled 224 children to the treatment group and 230 to the control group. Intention-to-treat analyses showed that the %EI of sugars in discretionary foods was 1·6 % lower in the treatment group compared with control (95 % CI −3·4, 0·2). This culturally appropriate intervention at four time-points from pregnancy to 18 months resulted in small changes to 2-year-old Aboriginal children’s diets, which was insufficient to warrant broader implementation of the intervention. Further consultation with Aboriginal communities is necessary for understanding how to improve the diet and diet-related health outcomes of young Aboriginal children.

Effects of High-Intensity Laser Therapy on Pain Sensitivity and Motor Performance in Patients with Thumb Carpometacarpal Joint Osteoarthritis: A Randomized Controlled Trial

Pain Medicine ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. 2357-2365
Author(s):  
Raquel Cantero-Téllez ◽  
Jorge Hugo Villafañe ◽  
Kirstin Valdes ◽  
Santiago García-Orza ◽  
Mark D Bishop ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Laser Therapy ◽  
High Intensity ◽  
Pain Sensitivity ◽  
Controlled Trial ◽  
Control Group ◽  
High Intensity Laser ◽  
Thumb Carpometacarpal ◽  
Intensity Laser ◽  
Experimental Group

Abstract Objective To examine the effects of high-intensity laser therapy (HILT) on pain sensitivity and motor performance in patients with thumb carpometacarpal (CMC) osteoarthritis (OA). Design Prospective, triple-blinded, randomized, placebo-controlled trial. Setting Private practice, Malaga, Spain. Subjects Forty-three patients (mean ± SD age = 71 ± 12 years) with a diagnosis of thumb CMC OA grade 1–2 were randomized to the control group (N = 21) or experimental group (N = 22). Methods The experimental group (ExpG) received high-intensity laser therapy (HILT), and the control group (ConG) received a placebo treatment. The outcome measures were pain intensity (visual analog scale) and key pinch strength measurements (dynamometer). All outcome measures were collected at baseline, immediately following the intervention, at four weeks, and at 12 weeks following the intervention. Results Analysis of variance revealed a group × time interaction (F = 40.8, P &lt; 0.001) for pain intensity, with those patients receiving LT experiencing a greater reduction in pain compared with those receiving placebo therapy at the end of the intervention (P &lt; 0.001), as well as at 12 weeks after the intervention. Although mean values in the ExpG were higher than in the ConG for key pinch at assessment, these differences were not statistically significant. Conclusions HILT effectively diminishes pain intensity when used as an isolated treatment for patients with thumb CMC OA, but the effect of treatment decreases after 12 weeks.

Effectiveness of a novel, automated telephone intervention on time to hospitalisation in patients with COPD: A randomised controlled trial

2018 ◽  
Vol 26 (3) ◽  
pp. 132-139
Author(s):  
Eric Sink ◽  
Kunjan Patel ◽  
Jacob Groenendyk ◽  
Robert Peters ◽  
Avik Som ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Care Clinic ◽  
Automated System ◽  
Control Group ◽  
Number Needed To Treat ◽  
Care Clinic ◽  
Patient Reported ◽  
Randomised Controlled

Introduction Owing to its capacity to perform remote assessments, telemedicine is rising as a new force in chronic obstructive pulmonary disease (COPD) management. We conducted an eight month randomised-controlled-trial to study the effect of an automated telemedicine intervention on patients’ time-to-hospitalisation. Methods A total of 168 patients with a diagnosis of COPD in the past 24 months were enrolled to receive the intervention at a primary care clinic. The treatment group received daily phone messages from an automated system asking them to report if they were breathing better than, worse than, or the same as the day prior. Patients reported their breathing status by responding to the text message or call. If a patient reported breathing worse, an alert was sent directly to that patient’s provider within the clinic. The control group received the same daily phone messages as the treatment group. However, no proactive breathing alerts were ever generated to the provider for these subjects. The primary outcome was the subjects’ time-to-first-COPD-related hospitalisation following the start of messages. Results The treatment group’s time-to-hospitalisation was significantly different than the control group’s with a hazard ratio of 2.36 (95% confidence interval 1.02–5.45, p = 0.0443). The number needed-to-treat ratio was 8.62. Subject engagement consistently ranged between 60% and 75%. The treatment group received both proactive monitoring and follow-up care from the providers. Discussion Active monitoring with provider feedback enables the detection of exacerbation events early enough for subjects to avoid admissions. The use of non-smartphone interventions reduces barriers to care presented by more complicated and expensive technologies. This intervention represents a simple, innovative, and inexpensive tool for improved COPD management.

scholarly journals Tenofovir alafenamide fumarate therapy in subjects with positive HBV-DNA and normal levels of alanine transaminase: a study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e048410
Author(s):  
Lu Wang ◽  
Lina Wu ◽  
Xuejun Li ◽  
Ying Zhang ◽  
Jing Lai ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Hepatitis B ◽  
Study Protocol ◽  
Controlled Trial ◽  
Hbv Dna ◽  
Alanine Transaminase ◽  
Control Group ◽  
Tenofovir Alafenamide ◽  
Randomised Controlled

IntroductionThe current clinical guidelines do not recommend antiviral therapy for subjects with positive hepatitis B virus (HBV)-DNA and normal alanine transaminase (ALT). In this study, we will assess the safety and efficacy of tenofovir alafenamide fumarate (TAF) in the treatment of adults with positive HBV-DNA and normal ALT, including long-term prognosis.Methods and analysisThis study is a non-double-blind randomised controlled trial. Study participants will be randomised into the treatment group and the control group. In the treatment group, subjects will receive TAF monotherapy, while those in the control group will receive no antiviral treatment. Subjects will be followed up at the beginning of the study and every 12 or 24 weeks thereafter for review of laboratory findings and to record adverse events. The primary endpoint is the proportion of patients with serum hepatitis B surface antigen loss.Ethics and disseminationThis study protocol was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University for Human Study (reference number [2019]02-599-01). The results of this study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04231565.

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

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