Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial

Background: Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks’ immobilisation in a below-knee cast. Method/design: We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included. Discussion: The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external validity. Accordingly, if significant clinical benefits and cost-effectiveness are demonstrated, EMADE should become a worthwhile treatment option. A larger-scale, multicentre trial may be required to influence national guidelines. Trial registration: ISRCTN, ID: ISRCTN11212729. Registered retrospectively on 20 March 2017

EXACT: EXercise or Advice after ankle fraCTure. Design of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Ankle fractures are common. Management of ankle fractures generally involves a period of immobilisation followed by rehabilitation to reduce pain, stiffness, weakness and swelling. The effects of a rehabilitation program are still unclear. However, it has been shown that important components of rehabilitation programs may not confer additional benefits over exercise alone. The primary aim of this trial is to determine the effectiveness and cost-effectiveness of an exercise-based rehabilitation program after ankle fracture, compared to advice alone.</p> <p>Methods/Design</p> <p>A pragmatic randomised trial will be conducted. Participants will be 342 adults with stiff, painful ankles after ankle fracture treated with immobilisation. They will be randomly allocated using a concealed randomisation procedure to either an <it>Advice </it>or <it>Rehabilitation </it>group. Participants in the <it>Advice </it>group will receive verbal and written advice about exercise at the time of removal of immobilisation. Participants in the <it>Rehabilitation </it>group will be provided with a 4-week rehabilitation program that is designed, monitored and progressed by a physiotherapist, in addition to verbal and written advice. Outcomes will be measured by a blinded assessor at 1, 3 and 6 months. The primary outcomes will be activity limitation and quality-adjusted life years.</p> <p>Discussion</p> <p>This pragmatic trial will determine if a rehabilitation program reduces activity limitation and improves quality of life, compared to advice alone, after immobilisation for ankle fracture.</p

Nature or nurture in low back pain? : results of a systematic review of studies based on twin samples

Twin studies are becoming popular to investigate risk factors for low back pain (LBP) because they consider the genetic factor and allow for more precise estimates of risks. We aimed to identify and summarize the results of studies based on twin samples investigating risk factors for LBP. The MEDLINE, CINAHL, LILACS, Web of Science and EMBASE databases were searched. Prospective and cross-sectional observational studies of LBP involving twins were included. The exposure factors could be genetics (heritability) or environmental such as smoking, alcohol consumption, body mass index and medical history. Pooling was attempted using an inverse variance weighting and fixed effects model. Twenty-seven studies were included. Estimates of heritability effects ranged from 21% to 67%. The genetic component was higher for more chronic and disabling LBP than acute and less disabling LBP. Smoking was significantly associated with LBP [pooled odds ratio (OR) = 3.0; 95% confidence interval (CI) 2.8–3.3] with a longitudinal and a cross-sectional study also identifying a dose–response relationship in people with chronic LBP. Obesity was associated with LBP (pooled OR = 1.9; 95% CI 1.6–2.2) with a cross-sectional study identifying a dose–response relationship. No association between alcohol consumption and LBP was identified. Co-morbidities such as asthma, diabetes and osteoarthritis were associated with LBP (pooled OR ranging from 1.6 to 4.2). The contribution of genetics to LBP appears to be dependent on the severity of the condition. Twin studies could be better used to explore possible causation paths between lifestyle factors, co-morbidities and LBP

Diagnostic accuracy of the Ottawa Ankle and Midfoot Rules : a systematic review with meta-analysis

Objective: To review the diagnostic accuracy of the Ottawa Ankle and Midfoot Rules and explore if clinical features and/or methodological quality of the study influence diagnostic accuracy estimates. Design: Systematic review with meta-analysis. Data sources: MEDLINE, EMBASE, CINAHL, SPORTDiscus and Cochrane Library. Eligibility criteria for selecting studies: Primary diagnostic studies reporting the accuracy of the Rules in people with ankle and/or midfoot injury were retrieved. Diagnostic accuracy estimates, overall and for subgroups (patient’s age, profession of the assessor and setting of application), were made. Sensitivity analyses included studies with a low risk of bias and studies where all patients received radiographs. Results: 66 studies were included. Ankle and Midfoot Rules presented similar accuracies, which were homogeneous and high for sensitivity and negative likelihood ratios and poor and heterogeneous for specificity and positive likelihood ratios (mean, 95% CI pooled sensitivity of Ankle Rules: 99.4%, 97.9% to 99.8%; specificity: 35.3%, 28.8% to 42.3%). Sensitivity of the Ankle Rules was higher in adults than in children, but the profession of the assessor did not appear to influence accuracy. Specificity was higher for Midfoot than for Ankle Rules. There were not enough studies to allow comparison according to setting of application. Studies with a low risk of bias and where all patients received radiographs provided lower accuracy estimates. Specificity heterogeneity was not explained by assessor training, use of imaging in all patients and low risk of bias. Conclusions: Study features and the methodological quality influence estimates of the diagnostic accuracy of the Ottawa Ankle and Midfoot Rules

Diagnostic accuracy of the Ottawa Ankle and Midfoot Rules : a systematic review with meta-analysis

Objective: To review the diagnostic accuracy of the Ottawa Ankle and Midfoot Rules and explore if clinical features and/or methodological quality of the study influence diagnostic accuracy estimates. Design: Systematic review with meta-analysis. Data sources: MEDLINE, EMBASE, CINAHL, SPORTDiscus and Cochrane Library. Eligibility criteria for selecting studies: Primary diagnostic studies reporting the accuracy of the Rules in people with ankle and/or midfoot injury were retrieved. Diagnostic accuracy estimates, overall and for subgroups (patient’s age, profession of the assessor and setting of application), were made. Sensitivity analyses included studies with a low risk of bias and studies where all patients received radiographs. Results: 66 studies were included. Ankle and Midfoot Rules presented similar accuracies, which were homogeneous and high for sensitivity and negative likelihood ratios and poor and heterogeneous for specificity and positive likelihood ratios (mean, 95% CI pooled sensitivity of Ankle Rules: 99.4%, 97.9% to 99.8%; specificity: 35.3%, 28.8% to 42.3%). Sensitivity of the Ankle Rules was higher in adults than in children, but the profession of the assessor did not appear to influence accuracy. Specificity was higher for Midfoot than for Ankle Rules. There were not enough studies to allow comparison according to setting of application. Studies with a low risk of bias and where all patients received radiographs provided lower accuracy estimates. Specificity heterogeneity was not explained by assessor training, use of imaging in all patients and low risk of bias. Conclusions: Study features and the methodological quality influence estimates of the diagnostic accuracy of the Ottawa Ankle and Midfoot Rules