Surgical prevention of femoral neck fractures in elderly osteoporotic patients: a randomised controlled study on the prevention nail system device

Introduction: Hip fractures represent an enormous challenge for our health care system. The aim of this randomised controlled trial was to assess both efficacy and safety of a novel device called Prevention Nail System (PNS) and developed for the surgical prevention of a contralateral femoral neck fracture (FNF) in elderly osteoporotic patients. Methods: Primary outcome was to evaluate, in patients suffering from osteoporotic FNF, the effectiveness of PNS in reducing the incidence of a contralateral hip fracture. Secondary outcome was to evaluate the safety of this device therefore intra- and postoperative complications were recorded. Results: 72 patients, with an age ⩾65 years old, were enrolled (38 study group (group A) and 34 control group (group B). 3 and 5 contralateral FNF were recorded respectively in group A and B. An interim analysis showed a non-effectiveness of the device therefore enrollment was suspended. Discussion: In all group A failures a difficult positioning of the PNS was recorded: surgical techniques errors may have affected the result. Nevertheless, it is improbable to hypothesise that, without substantial modifications to the PNS design, this could significantly reduce the incidence of FNF. Considering that current pharmacological approach can achieve, at best, a marginal reduction in FNF especially in patients at high risk, complementary approaches to provide immediate prevention of hip fractures may need to be developed. Clinical Trial Protocol: N° 263. 03 June 2008.

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A Controlled Trial of Home-Based Acute Psychiatric Services

The British Journal of Psychiatry ◽

10.1192/bjp.163.1.49 ◽

1993 ◽

Vol 163 (1) ◽

pp. 49-54 ◽

Cited By ~ 90

Author(s):

Tom Burns ◽

Alan Beadsmoore ◽

Ashok V. Bhat ◽

Andrew Oliver ◽

Carola Mathers

Keyword(s):

Controlled Trial ◽

Controlled Study ◽

Control Group ◽

Community Based ◽

Home Based ◽

Randomised Controlled Study ◽

One Year ◽

Randomised Controlled ◽

Clinical Measures ◽

Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

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EVALUATION OF EFFECTIVENESS OF AROGYA KASHAYAM-20 IN COVID-19 CASES - A RANDOMIZED CONTROLLED STUDY

10.31219/osf.io/au3ct ◽

2021 ◽

Author(s):

Umesh Shukla ◽

Nitin Ujjaliya

Keyword(s):

Controlled Trial ◽

Care Center ◽

Large Population ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Rt Pcr ◽

Randomized Controlled ◽

Group A ◽

Negative Conversion

Introduction: The characteristic clinical features of Covid-19 disease range between asymptomatic to mild-moderate symptoms. Studies suggest that a large population (80%) presents its asymptomatic or milder form. Remaining 20 percent, owing to severity of the diseases, need hospital-based care. Many treatment protocols and strategies have been promoted and recommended by authorities including WHO, but nothing has actually been finalized till date. The present study was planned to evaluate the effectiveness of an Ayurvedic formulation viz. Arogya Kashayam-20 in the hospitalized cases of Covid-19.Aim: To evaluate the effectiveness of Arogya Kashayam-20 in the cases of COVID-19 particularly the negative conversion of RTPCR in 10 days duration.Material and Methods: This was a randomized controlled trial conducted at COVID-19 Care Center, Pt. Khushilal Sharma Government Ayurveda College & Institute, Bhopal, Madhya Pradesh with a sample size of 112 participants, aged between 16 to 60 years of either sex. Participants were divided in two groups viz. group A and B. Both the groups received Hydroxychloroquine (HCQ), vitamin C and Zinc as per the prevailing ICMR guidelines and group 'A' received additionally Arogya Kashayam-20 for 10 days. Outcome measure of the study was to see the negative conversion RT-PCR test after intervention period of 10 days. CTRI Registration: CTRI/2020/06/026221. Results: Among the 60 cases registered in study group (group A), 51 cases (85.00%) were reported with negative RTPCR on 10th day. Out of 52 cases registered in control group (group B); 39 cases (75.00%) were tested negative RTPCR on 10th day. In both the groups all the cases were discharged asymptomatically on 10th day as per the prevailing ICMR guidelines. No ADR/AE observed during the intervention period.Conclusion: The study observes that the add on intervention group has a better outcome in terms of RT-PCR negative reports after 10 days comparing to the control group.

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Gamification as an entrepreneur well-being intervention: A study protocol for a single-blinded randomised controlled trial

10.21203/rs.3.pex-1323/v1 ◽

2021 ◽

Author(s):

Waqar M. Naqvi

Keyword(s):

Controlled Trial ◽

Life Quality ◽

Well Being ◽

Likert Scale ◽

Control Group ◽

Group A ◽

Measuring Scale ◽

Group B ◽

Randomised Controlled

Abstract Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout are reduced levels of physical and mental energy, reduced job efficiency and diminished productivity. Therefore, it is important to improve the health of entrepreneurs. Gamification has a positive relationship with improvements in health and well-being as it influences positive experiences and satisfaction. This trial aims to study how 30-minutes of virtual reality game use via Kinect Azure and Oculus platforms 3-times per week, for 4 weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. We will recruit entrepreneurs over the age of 18 for the gamification analysis. Analysis of previous power using G*Power will determine the sample size. We will divide the participants into 3 groups, wherein Group A will undergo gamification on the Kinect platform, Group B will undergo the Oculus Quest intervention, and Group C will be the control group. We will conduct the study at two sites, one at the HuMen research. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, burnout-measuring scale (BMS) for burnout, five-point Likert scale for performance and SF-12 for Quality of life. Since current strains pave ways to future accomplishment, entrepreneurs' eudemonic well-being might particularly relate to forward-looking challenge stressors and burnouts. The results will provide an insight into how gamification could help entrepreneurs to deal with work stress and maintain high well-being.

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Effects of golf training on cognition in older adults: a randomised controlled trial

Journal of Epidemiology & Community Health ◽

10.1136/jech-2017-210052 ◽

2018 ◽

Vol 72 (10) ◽

pp. 944-950 ◽

Cited By ~ 5

Author(s):

Hiroyuki Shimada ◽

Sangyoon Lee ◽

Masahiro Akishita ◽

Koichi Kozaki ◽

Katsuya Iijima ◽

...

Keyword(s):

Older Adults ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Controlled Trial ◽

Training Group ◽

Community Dwelling ◽

Secondary Outcome ◽

Control Group ◽

Logical Memory ◽

Randomised Controlled

BackgroundAlthough research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults.MethodsWe conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older. Participants were randomly assigned to either a 24-week (90–120 min sessions/week) golf-training group or a health education control group. Postintervention changes in Mini-mental State Examination (MMSE) and National Centre for Geriatrics and Gerontology-Functional Assessment Tool scores were regarded as primary outcome measures. Secondary outcome measures included changes in physical performance and Geriatric Depression Scale (GDS) scores.ResultsA total of 100 participants (golf training, n=53; control, n=47) completed the assessments after the 24-week intervention period. The adherence to the golf programme was 96.2% (51/53 participants). Analysis using linear mixed models revealed that the golf training group exhibited significantly greater improvements in immediate logical memory (p=0.033), delayed logical memory (p=0.009) and composite logical memory (p=0.013) scores than the control group. However, no significant changes in MMSE, word memory, Trail Making Test or Symbol Digital Substitution Test scores were observed. In addition, no significant changes in grip strength, walking speed or GDS were observed.ConclusionsGolf-based exercise interventions may improve logical memory in older adults, but no significant changes in other cognitive tests. Further follow-up investigations are required to determine whether the observed effects are associated with delayed onset of mild cognitive impairment or Alzheimer’s disease in older adults.Trial registration numberUMIN-CTR UMIN000024797; Pre-results.

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Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽

10.1136/bmjopen-2019-032799 ◽

2019 ◽

Vol 9 (10) ◽

pp. e032799 ◽

Cited By ~ 1

Author(s):

Titus Beyuo ◽

Emma Lawrence ◽

Elizabeth S Langen ◽

Samuel A Oppong

Keyword(s):

Randomised Controlled Trial ◽

Health Outcomes ◽

Magnesium Sulfate ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

University Of Michigan ◽

Clinical Trial Registry ◽

Randomised Controlled ◽

Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

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Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial

Primary Health Care Research & Development ◽

10.1017/s1463423619000720 ◽

2019 ◽

Vol 20 ◽

Cited By ~ 1

Author(s):

Iñaki Aguirrezabal ◽

Maria Soledad Pérez de San Román ◽

Raquel Cobos-Campos ◽

Estibalitz Orruño ◽

Arturo Goicoechea ◽

...

Keyword(s):

Primary Care ◽

Educational Intervention ◽

Controlled Trial ◽

Basque Country ◽

Intervention Group ◽

Cost Effective ◽

Response To Treatment ◽

Secondary Outcome ◽

Control Group ◽

Randomised Controlled

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.

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Does tension applied in kinesio taping affect pain or function in older women with knee osteoarthritis? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-041121 ◽

2020 ◽

Vol 10 (12) ◽

pp. e041121

Author(s):

Yago Tavares Pinheiro ◽

Germanna Medeiros Barbosa ◽

Hilmaynne Renaly Fonseca Fialho ◽

César Augusto Medeiros Silva ◽

Jaciara de Oliveira Anunciação ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Knee Osteoarthritis ◽

Older Women ◽

Controlled Trial ◽

Secondary Outcome ◽

Group Differences ◽

Control Group ◽

Kinesio Taping ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectiveTo analyse the short-term effects of kinesio taping (KT) with tension (KTT) or without tension (KTNT) in older women with knee osteoarthritis (KOA), and compare them to controls who did not receive KT.DesignRandomised controlled trial.SettingUniversity physiotherapy school clinic.ParticipantsForty-five older women (fifteen participants per group) with 66.8 (±5.6) years and clinical diagnosis of KOA were assessed pre, post and 3 days after intervention.InterventionsParticipants were randomly allocated to KTT, who received two simultaneous applications of KT with tension on the knee and rectus femoris; KTNT, who received the same application as the KTT group, but without tension and a control group that attended a class on KOA.Primary and secondary outcome measuresPrimary outcome was pain intensity and secondary outcomes were knee-related health status, functional capacity, muscle strength and global rating of change.ResultsNo between-group differences were observed in pain after the first intervention (KTT vs KTNT: mean difference (MD), −1.8 points; 95% CI −4.2 to 0.5; KTT vs control: MD, −1.2 points; 95% CI −3.6 to 1.2; KTNT vs control: MD, 0.66 points; 95% CI −1.7 to 3.0) or 3 days later (KTT vs KTNT: MD, −1.3 points; 95% CI −3.7 to 1.0; KTT vs control: MD, 0.13 points; 95% CI −2.2 to 2.5; KTNT vs control: MD, 1.4 points; 95% CI −0.9 to 3.8). The lack of between-group differences was also found for secondary outcomes.ConclusionThe short-term use of KT with or without tension in older woman with KOA had no beneficial effects on pain and function. These findings call into question the clinical use of KT as a non-pharmacological therapy for this population.Trial registration numberNCT03624075.

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Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽

10.1136/bmjopen-2018-024589 ◽

2019 ◽

Vol 9 (3) ◽

pp. e024589

Author(s):

Wen Yao Mak ◽

Loke Meng Ong ◽

Bak Leong Goh ◽

Sunita Bavanandan ◽

Lily Mushahar ◽

...

Keyword(s):

Peritoneal Dialysis ◽

Randomised Controlled Trial ◽

Continuous Ambulatory Peritoneal Dialysis ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Open Label ◽

Randomised Controlled ◽

End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

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Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study

BMJ Open ◽

10.1136/bmjopen-2017-019350 ◽

2018 ◽

Vol 8 (3) ◽

pp. e019350 ◽

Cited By ~ 1

Author(s):

Susanne van de Hei ◽

Steven McKinstry ◽

George Bardsley ◽

Mark Weatherall ◽

Richard Beasley ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Vitamin C ◽

Feasibility Study ◽

Common Cold ◽

Controlled Trial ◽

Secondary Outcome ◽

Pcr Analysis ◽

Control Group ◽

The Common ◽

Randomised Controlled

ObjectiveTo determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold.DesignOpen label, randomised, controlled feasibility study.SettingSingle-centre research institute in New Zealand recruiting participants from the community.Participants30 adult participants with symptoms of a common cold, presenting within 48 hours of the onset of symptoms.InterventionsParticipants were randomly assigned 2:1 to receive either 35 L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2 hours per day for up to 5 days (rhinothermy), or vitamin C 250 mg daily for 5 days (control).Primary and secondary outcome measuresThe primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling ‘a lot better’ compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability.ResultsIn all 30/79 (38%, 95% CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95% CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (−6.4, 95% CI −9.4 to −3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change.ConclusionsThis study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible.Trial registration numberACTRN12616000470493; Results.

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Effectiveness of mental simulations on the early mobilization of patients after cesarean section: a randomized controlled trial

Scientific Reports ◽

10.1038/s41598-021-02036-1 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Anna Prokopowicz ◽

Katarzyna Byrka

Keyword(s):

Process Simulation ◽

Psychological Intervention ◽

Controlled Trial ◽

Early Mobilization ◽

Mental Simulation ◽

Controlled Study ◽

Control Group ◽

Simulation Group ◽

Randomised Controlled ◽

Experimental Group

AbstractWe aimed to investigate whether psychological intervention (single mental simulation) among women after cesarean surgery (CC) can affect their willingness to verticalize, actual verticalization, and the duration of the first mobilization. In this prospective randomised, controlled study, 150 women after CC were divided into 3 groups: experimental group with process-simulation with elements of relaxation, experimental group with outcome-simulation with elements of relaxation and control group with elements of relaxation only. After a 5-h stay in the post-operative room, women listened to a recording with a stimulation. Pain and anxiety of verticalization were measured before and after listening to the recording and after verticalization. Almost 12% more patients verticalized in the process-simulation group than in the control group. Percentages of mobilized patients were: 39.4% the process-simulation group; 32.8% in the outcome-simulation group; 27.7% controls (p = 0.073). Mobilization was 5 min longer in the process-simulation group then in control (p < 0.01). Anxiety after the simulation was a significant covariate of the willingness to verticalize, actual verticalization and time spent in mobilization. We conclude that a single mental simulation can effectively motivate patients for their first verticalization after CC. Perceived anxiety before verticalization may affect the effectiveness of interventions, so we recommend to check it at the postoperative care.ClinicalTrials.gov Identifier: NCT04829266.

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