Effectiveness of foot orthoses for the prevention of lower limb overuse injuries in naval recruits: a randomised controlled trial

2017 ◽  
Vol 52 (5) ◽  
pp. 298-302 ◽  
Author(s):  
Daniel R Bonanno ◽  
George S Murley ◽  
Shannon E Munteanu ◽  
Karl B Landorf ◽  
Hylton B Menz
Keyword(s):  
Lower Limb ◽  
Plantar Fasciitis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Achilles Tendinopathy ◽  
Overuse Injuries ◽  
Control Group ◽  
Medial Tibial Stress Syndrome ◽  
Foot Orthoses ◽  
Randomised Controlled

ObjectivesTo evaluate the effectiveness of prefabricated foot orthoses for the prevention of lower limb overuse injuries in naval recruits.MethodsThis study was a participant-blinded and assessor-blinded, parallel-group randomised controlled trial. Three-hundred and six participants aged 17–50 years who undertook 11 weeks of initial defence training at the Royal Australian Navy Recruit School (Cerberus, Australia) were randomised to a control group (flat insoles, n=153) or an intervention group (contoured, prefabricated foot orthoses, n=153). The combined incidence of medial tibial stress syndrome, patellofemoral pain, Achilles tendinopathy and plantar fasciitis/plantar heel pain during the 11-week training period were compared using incidence rate ratios (IRR). Data were analysed using the intention-to-treat principle.ResultsSixty-seven injuries (21.9%) were recorded. The control and intervention group sustained 40 (26.1%) and 27 (17.6%) injuries, respectively (IRR 0.66, 95% CI 0.39 to 1.11, p=0.098). This corresponds to a 34% reduction in risk of developing medial tibial stress syndrome, patellofemoral pain, Achilles tendinopathy or plantar fasciitis/plantar heel for the intervention group compared with the control group. Participants in the prefabricated orthoses group were more likely to report at least one adverse event (20.3% vs 12.4%; relative risk (RR) 1.63, 95% CI 0.96 to 2.76; p=0.068; number needed to harm 13, 95% CI 6 to 253). The most common adverse events were foot blisters (n=20, 6.6%), arch pain (n=10, 3.3%) and shin pain (n=8, 2.6%).ConclusionPrefabricated foot orthoses may be beneficial for reducing the incidence of lower limb injury in naval recruits undertaking defence training.Trial registration numberAustralian New Zealand Clinical Trials Registry: ACTRN12615000024549.

scholarly journals Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: a randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029225 ◽  
Author(s):  
Elizabeth Webb ◽  
Teresa Neeman ◽  
Jamie Gaida ◽  
Francis J Bowden ◽  
Virginia Mumford ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Lower Limb ◽  
Controlled Trial ◽  
Intervention Group ◽  
Prophylactic Antibiotic ◽  
Compression Therapy ◽  
Control Group ◽  
Supporting Evidence ◽  
Randomised Controlled ◽  
The Impact

IntroductionCellulitis represents a significant burden to patients’ quality of life (QOL) and cost to the healthcare system, especially due to its recurrent nature. Chronic oedema is a strong risk factor for both an initial episode of cellulitis and cellulitis recurrence. Expert consensus advises compression therapy to prevent cellulitis recurrence in individuals with chronic oedema, however, there is little supporting evidence. This research aims to determine if the management of chronic oedema using compression therapy effectively delays the recurrence of lower limb cellulitis.Methods and analysisA randomised controlled trial with cross-over will be used to assess the impact of compression therapy on clinical outcomes (time to next episode of cellulitis, rate of cellulitis-related hospital presentations, QOL and leg volume). Using concealed allocation, 162 participants will be randomised into the intervention (compression) or control (no compression) group. Randomisation will be stratified by prophylactic antibiotic use. Participants will be followed up at 6 monthly intervals for up to 3 years or until 45 episodes of cellulitis occur across the cohort. Following an episode of recurrent cellulitis, control group participants will cross-over to the intervention group. Survival analysis will be undertaken to assess the primary outcome measure of time to cellulitis recurrence. The hypotheses are that compression therapy to control lower limb chronic oedema will delay recurrent lower limb cellulitis, reduce the rate of associated hospitalisations, minimise affected limb volume and improve the QOL of this population.Ethics and disseminationEthics approval has been obtained from the ethics committees of all relevant institutions. Results will be disseminated through relevant peer-reviewed journal articles and conference presentations.Trial registration numberACTRN12617000412336; Pre-results. The ICTOC trial is currently in progress. Participant recruitment started in May 2017 and is expected to continue until December 2019.

scholarly journals Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040108
Author(s):  
Rowan W Johnson ◽  
Sian A Williams ◽  
Daniel F Gucciardi ◽  
Natasha Bear ◽  
Noula Gibson
Keyword(s):  
Exercise Prescription ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Programme ◽  
Home Exercise ◽  
Control Group ◽  
Neurodevelopmental Disabilities ◽  
Home Exercise Programme ◽  
Exercise Programmes ◽  
Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

scholarly journals A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M. A. Greidanus ◽  
A. E. de Rijk ◽  
A. G. E. M. de Boer ◽  
M. E. M. M. Bos ◽  
P. W. Plaisier ◽  
...  
Keyword(s):  
Return To Work ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Work Outcomes ◽  
Feasibility Trial ◽  
Control Group ◽  
Secondary Effect ◽  
Quality Of Working Life ◽  
Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

scholarly journals Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e026086
Author(s):  
Yasutake Tomata ◽  
Fumiya Tanji ◽  
Dieta Nurrika ◽  
Yingxu Liu ◽  
Saho Abe ◽  
...  
Keyword(s):  
Financial Incentives ◽  
Primary Outcome ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Intervention Group ◽  
Sample Size Calculation ◽  
Community Dwelling ◽  
Control Group ◽  
Modifiable Factors ◽  
Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

scholarly journals Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Charlotte Loumann Krogh ◽  
Charlotte Ringsted ◽  
Charles B. Kromann ◽  
Maria Birkvad Rasmussen ◽  
Tobias Todsen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Global Rating ◽  
Training Performance ◽  
Significant Difference ◽  
Training Format ◽  
Peer Performance ◽  
And Performance ◽  
Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hatem Hussein El-Gamal ◽  
Walid El-Basuony Mohammad ◽  
Ahmed Samir Mohamed Zeerban
Keyword(s):  
Quality Of Life ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Expectant Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Caesarean Scar Defect ◽  
Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

scholarly journals The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change

2019 ◽  
Author(s):  
Caroline Laker ◽  
Matteo Cella ◽  
Felicity Callard ◽  
Til Wykes
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Occupational Status ◽  
Intervention Group ◽  
Direct Care ◽  
Care Staff ◽  
Control Group ◽  
Staff Perceptions ◽  
Barriers To Change ◽  
Randomised Controlled

Abstract Background Staff and service users have expressed concerns that service improvements in U.K. mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation. Method A cluster randomised controlled trial called DOORWAYS was conducted on eight inner-city U.K. acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses’ perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered. Results Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N=120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group. Conclusion Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards.

scholarly journals Up to a quarter of patients with certain chronic recalcitrant tendinopathies may have central sensitisation: a prospective cohort of more than 300 patients

2018 ◽  
Vol 13 (3) ◽  
pp. 137-144
Author(s):  
Patrick C Wheeler
Keyword(s):  
Lower Limb ◽  
Plantar Fasciitis ◽  
Pain Syndrome ◽  
Achilles Tendinopathy ◽  
Control Group ◽  
Greater Trochanteric Pain Syndrome ◽  
Duration Of Symptoms ◽  
Central Sensitisation ◽  
Clinical Records ◽  
Insertional Achilles Tendinopathy

Introduction: To identify the possible prevalence of ‘central sensitisation’, in patients with chronic recalcitrant lower limb tendinopathy conditions, with the Central Sensitisation Inventory (CSI) questionnaire. Methods: Patients with chronic lower limb tendinopathy conditions treated within a single hospital outpatient clinic specialising in tendinopathy were identified from clinical records. As part of routine care, self-reported numerical markers of pain, global function (using the EuroQol-5D (EQ-5D) questionnaire) and the CSI score to investigate the possibility of central sensitisation were completed. Results: A total of 312 suitable patients with chronic lower limb tendinopathy and similar conditions were identified, who had completed a CSI questionnaire. Of these, 108 presented with greater trochanteric pain syndrome, 12 with patella tendinopathy, 33 with non-insertional Achilles tendinopathy, 48 with insertional Achilles tendinopathy and 110 with plantar fasciitis. A total of 66% of the patients were female, the median age was 54.9 years and the median duration of symptoms was 24 months. There was a median CSI score of 25%, with statistically significant differences noted between the different conditions studied. Overall, 20% of patients scored above a threshold of 40% on CSI questionnaire, indicating that central sensitisation was possible. Greater trochanteric pain syndrome and plantar fasciitis had the highest proportions in the conditions studied. Weak correlations were found between CSI and other pain scores studied. Conclusion: The CSI questionnaire may identify up to a quarter of patients with some chronic lower limb tendinopathy and associated conditions as being more likely to have central sensitisation, and these proportions differed between conditions. The clinical significance of this is unclear, but worth further study to see if/how this may relate to treatment outcomes. These are results from a single hospital clinic dealing with patients with chronic tendinopathy, and comparison with a control group is currently lacking. However, on the information presented here, the concept of central sensitisation should be considered in patients being treated for chronic tendinopathy.

scholarly journals Effects of two types of smartphone-based stress management programmes on depressive and anxiety symptoms among hospital nurses in Vietnam: a protocol for three-arm randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e025138 ◽  
Author(s):  
Kotaro Imamura ◽  
Thuy Thi Thu Tran ◽  
Huong Thanh Nguyen ◽  
Kazuto Kuribayashi ◽  
Asuka Sakuraya ◽  
...  
Keyword(s):  
Stress Management ◽  
Free Choice ◽  
Controlled Trial ◽  
Intervention Group ◽  
Anxiety Symptoms ◽  
Control Group ◽  
Hospital Nurses ◽  
Management Intervention ◽  
Stress Management Intervention ◽  
Randomised Controlled

IntroductionDue to an increasing demand for healthcare in low-income and middle-income countries in Asia, it is important to develop a strategy to manage work-related stress in healthcare settings, particularly among nurses in these countries. The purpose of this three-arm randomised controlled trial (RCT) is to examine the effects of a newly developed smartphone-based multimodule stress management programme on reducing severity of depressive and anxiety symptoms as primary outcomes at 3-month and 7-month follow-ups among hospital nurses in Vietnam.Methods and analysisThe target study population will be registered nurses working in a large general hospital (which employs approximately about 2000 nurses) in Vietnam. They will be invited to participate in this study. Participants who fulfil the eligibility criteria will be randomly allocated to the free-choice, multimodule stress management (intervention group A, n=360), the internet cognitive behavioural therapy (iCBT), that is, fixed-order stress management (intervention group B, n=360), or a treatment as usual control group (n=360). Two types (free-choice and fixed sequential order) of smartphone-based six-module stress management programmes will be developed. Participants in the intervention groups will be required to complete one of the programmes within 10 weeks after the baseline survey. The primary outcomes are depressive and anxiety symptoms, measured by using the Depression Anxiety and Stress Scales (DASS) at 3-month and 7 month follow-ups.Ethics and disseminationThe study procedures have been approved by the Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (no 11991) and the Ethical Review Board for Biomedical Research of Hanoi University of Public Health (no 346/2018/YTCC-HD3). If a significant effect of the intervention programmes will be found in the RCT, the programmes will be made available to all nurses in the hospital including the control group. If the positive effects are found in this RCT, the e-stress management programmes will be disseminated to all nurses in Vietnam.Trial registration numberUMIN000033139; Pre-results.

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