Background: Emerging data suggest that direct oral anticoagulants may be a suitable choice for anticoagulation for cerebral venous thrombosis (CVT). However, conducting high-quality trials in CVT is challenging as it is a rare disease with low rates of adverse outcomes such as major bleeding and functional dependence. To facilitate the design of future CVT trials, SECRET (Study of Rivaroxaban for Cerebral Venous Thrombosis) assessed (1) the feasibility of recruitment, (2) the safety of rivaroxaban compared with standard-of-care anticoagulation, and (3) patient-centered functional outcomes. Methods: This was a phase II, prospective, open-label blinded-end point 1:1 randomized trial conducted at 12 Canadian centers. Participants were aged ≥18 years, within 14 days of a new diagnosis of symptomatic CVT, and suitable for oral anticoagulation; they were randomized to receive rivaroxaban 20 mg daily, or standard-of-care anticoagulation (warfarin, target international normalized ratio, 2.0–3.0, or low-molecular-weight heparin) for 180 days, with optional extension up to 365 days. Primary outcomes were annual rate of recruitment (feasibility); and a composite of symptomatic intracranial hemorrhage, major extracranial hemorrhage, or mortality at 180 days (safety). Secondary outcomes included recurrent venous thromboembolism, recanalization, clinically relevant nonmajor bleeding, and functional and patient-reported outcomes (modified Rankin Scale, quality of life, headache, mood, fatigue, and cognition) at days 180 and 365. Results: Fifty-five participants were randomized. The rate of recruitment was 21.3 participants/year; 57% of eligible candidates consented. Median age was 48.0 years (interquartile range, 38.5–73.2); 66% were female. There was 1 primary event (symptomatic intracranial hemorrhage), 2 clinically relevant nonmajor bleeding events, and 1 recurrent CVT by day 180, all in the rivaroxaban group. All participants in both arms had at least partial recanalization by day 180. At enrollment, both groups on average reported reduced quality of life, low mood, fatigue, and headache with impaired cognitive performance. All metrics improved markedly by day 180. Conclusions: Recruitment targets were reached, but many eligible participants declined randomization. There were numerically more bleeding events in patients taking rivaroxaban compared with control, but rates of bleeding and recurrent venous thromboembolism were low overall and in keeping with previous studies. Participants had symptoms affecting their well-being at enrollment but improved over time. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03178864.
Posterior tibial tendon dysfunction (PTTD) and tarsal tunnel syndrome (TTS) are debilitating conditions reported to occur after ankle sprain due to their proximity to the ankle complex. The objective of this study was to investigate the incidence of PTTD and TTS in the 2 years following an ankle sprain and which variables are associated with its onset. In total, 22,966 individuals in the Military Health System diagnosed with ankle sprain between 2010 and 2011 were followed for 2 years. The incidence of PTTD and TTS after ankle sprain was identified. Binary logistic regression was used to identify potential demographic or medical history factors associated with PTTD or TTS. In total, 617 (2.7%) received a PTTD diagnosis and 127 (0.6%) received a TTS diagnosis. Active-duty status (odds ratio [OR] 2.18, 95% confidence interval [CI] 1.70–2.79), increasing age (OR 1.03, 95% CI 1.02–1.04), female sex (OR 1.58, 95% CI 1.28–1.95), and if the sprain location was specified by the diagnosis (versus unspecified location) and did not include a fracture contributed to significantly higher (p < 0.001) risk of developing PTTD. Greater age (OR 1.06, 95% CI 1.03–1.09), female sex (OR 2.73, 95% CI 1.74–4.29), history of metabolic syndrome (OR 1.73, 95% CI 1.03–2.89), and active-duty status (OR 2.28, 95% CI 1.38–3.77) also significantly increased the odds of developing TTS, while sustaining a concurrent ankle fracture with the initial ankle sprain (OR 0.45, 95% CI 0.28–0.70) significantly decreased the odds. PTTD and TTS were not common after ankle sprain. However, they still merit consideration as postinjury sequelae, especially in patients with persistent symptoms. Increasing age, type of sprain, female sex, metabolic syndrome, and active-duty status were all significantly associated with the development of one or both subsequent injuries. This work provides normative data for incidence rates of these subsequent injuries and can help increase awareness of these conditions, leading to improved management of refractory ankle sprain injuries.
Introduction: Puerto Rico is among the top five territories in the USA to be affected by human immunodeficiency virus (HIV), which is why our goal is to help the island with service trips. Studies have reported the professional and personal benefits students can gain by participating in service activities. However, the benefits obtained by the Hispanic-Latino participants living with HIV in Puerto Rico, have not been outlined. The purpose of this study was to discuss the perceived benefits of a short-term week-long service trip for the students, participants, and personnel. Methods: A total of 11 physical therapy students and one professor travelled to Puerto Rico for a one-week service trip. The group partnered with an established organization named ‘La Perla de Gran Precio,’ which works with low-income Hispanic-Latino USA citizens participants that have been diagnosed with HIV. Students were involved in both academic and cultural components by providing physical therapy services to the participants. At the end of the week, surveys were given to all parties involved. Results: Students, personnel and participants reported the service trip as extremely positive. Students suggested that its integration should be considered in any physical therapy curriculum to improve the future of this profession further. Participants reported learning from this experience and have been able to implement the methods into their routine. Conclusions: The Puerto Rico service trip enhanced the education of physical therapy students and their ability to increase cultural awareness, boost communication skills, provide opportunities to overcome challenges, and foster a sense of purpose. Also, the Puerto Rico service trip was a beneficial and positive experience for all people involved. Consideration should be made to incorporate this initiative a much larger scale in a population that is vastly underserved.
PurposeThis study aimed to investigate the burden of knee, hip, and lumbar spine disorders occurring in the year after an ankle sprain and the influence therapeutic exercise (TE) has on this burden.MethodsA total of 33,361 individuals diagnosed with ankle sprain in the Military Health System between 2010 and 2011 were followed for 1 yr. The prevalence of knee, hip, and lumbar care-seeking injuries sustained after sprain was identified. Relationships between demographic groups, ankle sprain type, and use of TE with rate of proximal injuries were evaluated using Cox proportional hazard models to determine hazard rate effect modification by attribute. The observed effect of TE for ankle sprain on rate of injury to proximal joints was evaluated using Kaplan–Meier survival analyses.ResultsOf the total cohort, 20.5% (n = 6848) of patients sustained a proximal injury. Specifically, 10.1% of the cohort sustained a knee (n = 3356), 2.9% a hip (n = 973), and 10.3% a lumbar injury (n = 3452). Less than half of the cohort received TE after initial sprain. Patients that did were less likely to have subsequent knee (HR = 0.87, 95% confidence interval [CI] = 0.80–0.94), hip (HR = 0.68, 95% CI = 0.58–0.79), or lumbar (HR = 0.82, 95% CI = 0.76–0.89) injuries.ConclusionsOne in five individuals that sought care for an ankle sprain experienced a proximal joint injury in the following year. TE for the management of the initial ankle sprain reduced the likelihood of proximal injury diagnosis and should be considered in treatment plans for return to work and sport protocols after ankle sprains.
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