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Topical Ketoprofen Versus Placebo in Children Presenting With Ankle Sprain to the Emergency Department: A Randomized Controlled Study.
Serinken, M, Eken, C, Tünay, K, Gölcük, Y
Pediatric emergency care. 2020;(8):e447-e450
Abstract
OBJECTIVE Despite the favorable data concerning topical agents use in outpatient clinics, they are not commonly in emergency departments (EDs). The present study aimed to compare the effect of 2.5% topical ketoprofen (gel form) to placebo in children presenting with ankle sprain to the ED. STUDY DESIGN Children between 7 and 18 years old presenting with ankle sprain composed the study population. Study patients were randomized into 2 study arms: 2.5% ketoprofen gel and placebo administered in a 5-cm area locally. Pain improvements at 15 and 30 minutes were measured by visual analog scale. RESULTS Median pain reductions at 15 minutes for ketoprofen and placebo groups were 27.5 (16-39) and 5 (4-10), respectively. Median changes in pain intensity at 30 minutes for ketoprofen and placebo gel groups were 48 (43-52) and 9 (6-16), respectively. When compared 2 arms for the pain improvement at 15 and 30 minutes, the differences between 2 study drugs were 20 (13-28) and 35 (29-41), respectively. There were 7 (12.7%) rescue drug needs in the placebo group and 1 (1.7%) in the ketoprofen group (difference, 10.9%; 95% confidence interval, -6% to 7%; P = 0.83). There were no adverse effects in either group. CONCLUSIONS Ketoprofen gel is superior to placebo in ceasing pain in children presenting with ankle sprain to the ED with a high safety profile.
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Multisegment Foot Models and Clinical Application After Foot and Ankle Trauma: A Review.
van Hoeve, S, Poeze, M
The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons. 2019;(4):748-754
Abstract
Since the end of the 1990s, several multisegment foot models (MSFMs) have been developed. Several models were used to describe foot and ankle kinematics in patients with foot and ankle pathologies; however, the diagnostic value for clinical practice of these models is not known. This review searched in the literature for studies describing kinematics in patients after foot and ankle trauma using an MSFM. The diagnostic value of the MSFMs in patients after foot and ankle trauma was also investigated. A search was performed on the databases PubMed/MEDLINE, Embase, and Cochrane Library. To investigate the diagnostic value of MSFMs in patients after foot and ankle trauma, studies were classified and analyzed following the diagnostic research questions formulated by Knottnerus and Buntinx. This review was based on 7 articles. All studies were published between 2010 and 2015. Five studies were retrospective studies, and 2 used an intervention. Three studies described foot and ankle kinematics in patients after fractures. Four studies described foot and ankle kinematics in patients after ankle sprain. In all included studies, altered foot and ankle kinematics were found compared with healthy subjects. No results on patient outcome using MSFMs and costs were found. Seven studies were found reporting foot and ankle kinematics in patients after foot and ankle trauma using an MSFM. Results show altered kinematics compared with healthy subjects, which cannot be seen by other diagnostic tests and add valuable data to the present literature; therefore, MSFMs seem to be promising diagnostic tools for evaluating foot and ankle kinematics. More research is needed to find the additional value for MSFMs regarding patient outcome and costs.
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Evaluating the effectiveness of a self-management exercise intervention on wound healing, functional ability and health-related quality of life outcomes in adults with venous leg ulcers: a randomised controlled trial.
O'Brien, J, Finlayson, K, Kerr, G, Edwards, H
International wound journal. 2017;(1):130-137
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Abstract
Exercise that targets ankle joint mobility may lead to improvement in calf muscle pump function and subsequent healing. The objectives of this research were to assess the impact of an exercise intervention in addition to routine evidence-based care on the healing rates, functional ability and health-related quality of life for adults with venous leg ulcers (VLUs). This study included 63 patients with VLUs. Patients were randomised to receive either a 12-week exercise intervention with a telephone coaching component or usual care plus telephone calls at the same timepoints. The primary outcome evaluated the effectiveness of the intervention in relation to wound healing. The secondary outcomes evaluated physical activity, functional ability and health-related quality of life measures between groups at the end of the 12 weeks. A per protocol analysis complemented the effectiveness (intention-to-treat) analysis to highlight the importance of adherence to an exercise intervention. Intention-to-treat analyses for the primary outcome showed 77% of those in the intervention group healed by 12 weeks compared to 53% of those in the usual care group. Although this difference was not statistically significant due to a smaller than expected sample size, a 24% difference in healing rates could be considered clinically significant. The per protocol analysis for wound healing, however, showed that those in the intervention group who adhered to the exercise protocol 75% or more of the time were significantly more likely to heal and showed higher rates for wound healing than the control group (P = 0·01), that is, 95% of those who adhered in the intervention group healed in 12 weeks. The secondary outcomes of physical activity, functional ability and health-related quality of life were not significantly altered by the intervention. Among the secondary outcomes (physical activity, functional ability and health-related quality of life), intention-to-treat analyses did not support the effectiveness of the intervention. However, per protocol analyses revealed encouraging results with those participants who adhered more than 75% of the time (n = 19) showing significantly improved Range of Ankle Motion from the self-management exercise programme (P = 0·045). This study has shown that those participants who adhere to the exercise programme as an adjunctive treatment to standard care are more likely to heal and have better functional outcomes than those who do not adhere to the exercises in conjunction with usual care.
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Topical Ketoprofen Versus Placebo in Treatment of Acute Ankle Sprain in the Emergency Department.
Serinken, M, Eken, C, Elicabuk, H
Foot & ankle international. 2016;(9):989-93
Abstract
BACKGROUND Topical agents have been shown to be effective in soft tissue injuries and commonly used in outpatient clinics. However, the data regarding topical agents in the emergency department is insufficient, and they are not used often in the emergency department setting. The present study aimed to compare the effect of 2.5% topical ketoprofen (gel form) to placebo in patients presenting with ankle sprain to the emergency department. METHODS Patients presenting with ankle sprain composed the study population. Study patients were randomized into 2 study arms: 2.5% ketoprofen gel and placebo administered over a 5-cm area locally. Pain alleviation was measured by visual analog scale at 15 and 30 minutes. A total of 100 patients were included in the final analysis. RESULTS The median pain reduction in ketoprofen and placebo groups at 15 minutes was 27 (19.8-33.4) and 9 (7.6-17), respectively. The median pain reduction at 30 minutes for both groups was 42 (36-50.8) and 20 (17.6-24.4), respectively. Pain improvement either at 15 minutes (median difference: 16 [9-22]) or 30 minutes (median difference: 21 [15-27]) was better in the ketoprofen group than placebo. There were no adverse effects in either group. CONCLUSION Ketoprofen gel was superior to placebo at 30 minutes in alleviating pain secondary to ankle sprain in the ED with a high safety profile. Further studies are needed concerning the effect of ketoprofen gel for long-term effects. LEVEL OF EVIDENCE Level I, high quality prospective randomized study.
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Muscle Reaction Time During a Simulated Lateral Ankle Sprain After Wet-Ice Application or Cold-Water Immersion.
Thain, PK, Bleakley, CM, Mitchell, AC
Journal of athletic training. 2015;(7):697-703
Abstract
CONTEXT Cryotherapy is used widely in sport and exercise medicine to manage acute injuries and facilitate rehabilitation. The analgesic effects of cryotherapy are well established; however, a potential caveat is that cooling tissue negatively affects neuromuscular control through delayed muscle reaction time. This topic is important to investigate because athletes often return to exercise, rehabilitation, or competitive activity immediately or shortly after cryotherapy. OBJECTIVE To compare the effects of wet-ice application, cold-water immersion, and an untreated control condition on peroneus longus and tibialis anterior muscle reaction time during a simulated lateral ankle sprain. DESIGN Randomized controlled clinical trial. SETTING University of Hertfordshire human performance laboratory. PATIENTS OR OTHER PARTICIPANTS A total of 54 physically active individuals (age = 20.1 ± 1.5 years, height = 1.7 ± 0.07 m, mass = 66.7 ± 5.4 kg) who had no injury or history of ankle sprain. INTERVENTION(S): Wet-ice application, cold-water immersion, or an untreated control condition applied to the ankle for 10 minutes. MAIN OUTCOME MEASURE(S): Muscle reaction time and muscle amplitude of the peroneus longus and tibialis anterior in response to a simulated lateral ankle sprain were calculated. The ankle-sprain simulation incorporated a combined inversion and plantar-flexion movement. RESULTS We observed no change in muscle reaction time or muscle amplitude after cryotherapy for either the peroneus longus or tibialis anterior (P > .05). CONCLUSIONS Ten minutes of joint cooling did not adversely affect muscle reaction time or muscle amplitude in response to a simulated lateral ankle sprain. These findings suggested that athletes can safely return to sporting activity immediately after icing. Further evidence showed that ice can be applied before ankle rehabilitation without adversely affecting dynamic neuromuscular control. Investigation in patients with acute ankle sprains is warranted to assess the clinical applicability of these interventions.
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Balancing the risk of complications in foot and ankle surgical patients taking antithrombotic medication.
Miller, S, Nitzki-George, D, Caprini, JA
Foot & ankle specialist. 2014;(6):507-14
Abstract
UNLABELLED This review intends to provide guidance regarding perioperative management of anticoagulation and antiplatelet drug therapy as they relate to foot and ankle surgery. Venous and arterial thromboembolism are conditions in which the blood clots inappropriately, causing considerable morbidity and mortality. With an increase in awareness of thromboembolic risk factors and expansion of therapeutic options, more patients are routinely taking antithrombotic medication. When these patients require invasive procedures, a decision needs to be made if antithrombotic medication should be held perioperatively and if additional precautions are needed in the interim. Understanding the factors affecting the management of thromboembolism during the perioperative period can reduce the potential for complications. LEVELS OF EVIDENCE Therapeutic, Level V: Expert opinion.
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The Cost-Effectiveness of Measures to Prevent Recurrent Ankle Sprains: Results of a 3-Arm Randomized Controlled Trial.
Janssen, KW, Hendriks, MR, van Mechelen, W, Verhagen, E
The American journal of sports medicine. 2014;(7):1534-41
Abstract
BACKGROUND Ankle sprains are the most common sports-related injury, associated with a high rate of recurrence and societal costs. Recent studies have emphasized the effectiveness of both neuromuscular training and bracing for the secondary prevention of ankle sprains. PURPOSE To evaluate the cost-effectiveness of the separate and combined use of bracing and neuromuscular training for the prevention of the recurrence of ankle sprains. STUDY DESIGN Economic and decision analysis; Level of evidence, 2. METHODS A total of 340 athletes (157 male and 183 female; aged 12-70 years) who had sustained a lateral ankle sprain up to 2 months before inclusion were randomized to a neuromuscular training group (n = 107), brace group (n = 113), and combined intervention group (n = 120). Randomization was stratified by medical treatment of the inclusion sprain. Participants in the neuromuscular training group underwent an 8-week home-based exercise program. Participants in the brace group received a semirigid ankle brace to be worn during all sports activities for a period of 12 months. Participants allocated to the combined group underwent both interventions, with the ankle brace to be worn during all sports activities for a period of 8 weeks. The recurrence of ankle sprains and associated costs were registered during the 1-year follow-up. RESULTS There were no differences between groups at baseline with regard to age, sex, sports participation, previous injury, or knowledge of preventive measures. The incremental cost-effectiveness ratio (ICER) of the brace group in comparison with the combined group was -€2828.30 (approximately--US$3865.00), based on a difference in the mean cost of -€76.16 (approximately--US$104.00) and a difference in the mean effects of 2.68%. The ICER of the neuromuscular training group in comparison with the combined group was €310.08 (approximately US$424.00), based on a difference in the mean cost of -€28.37 (approximately--US$39.00) and a difference in the mean effects of 9.15%. CONCLUSION Bracing was found to be the dominant secondary preventive intervention over both neuromuscular training and the combination of both measures.
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Effect of vitamin C on prevention of complex regional pain syndrome type I in foot and ankle surgery.
Besse, JL, Gadeyne, S, Galand-Desmé, S, Lerat, JL, Moyen, B
Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons. 2009;(4):179-82
Abstract
BACKGROUND The public health cost impact of complex regional pain syndrome type I (CRPS I) is considerable in both emergency and scheduled orthopaedic surgery. We proposed to assess the effectiveness of vitamin C in prevention of CRPS I in foot and ankle surgery. METHODS We carried out a "before-after" quasi-experimental study comparing two chronologically successive groups without (Group I: July 2002-June 2003) and with (Group II: July 2003-June 2004) preventive 1g daily vitamin C treatment. All patients having surgery on the foot or ankle were enrolled, with the exception of diabetic foot cases. Several factors were analysed: sex, age, type of pathology, history of CRPS I, psychological context, tourniquet time, and cast immobilisation time. RESULTS 420 feet (392 patients) were included in the study: 185 in Group I, 235 in Group II. CRPS I occurred in 18 cases in Group I (9.6%) and 4 cases in Group II (1.7%) (p<10(-4)), with history of CRPS I as a significantly correlated factor (relative risk=10.4). The psychological context (anxio-depressive state) showed a (sub-significant) tendency to increase the risk of CRPS I (relative risk=2.6). CONCLUSION Vitamin C has been shown to be effective in preventing CRPS I secondary to wrist fracture, but few data are available with respect to foot and ankle cases. The present study demonstrates the effectiveness of vitamin C in preventing CRPS I of the foot and ankle-a frequent complication in our control group (9.6%). The authors recommend preventive management by vitamin C.
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Cryotherapy does not affect peroneal reaction following sudden inversion.
Berg, CL, Hart, JM, Palmieri-Smith, R, Cross, KM, Ingersoll, CD
Journal of sport rehabilitation. 2007;(4):285-94
Abstract
CONTEXT If ankle joint cryotherapy impairs the ability of the ankle musculature to counteract potentially injurious forces, the ankle is left vulnerable to injury. OBJECTIVE To compare peroneal reaction to sudden inversion following ankle joint cryotherapy. DESIGN Repeated measures design with independent variables, treatment (cryotherapy and control), and time (baseline, immediately post treatment, 15 minutes post treatment, and 30 minutes post treatment). SETTING University research laboratory. PATIENTS OR OTHER PARTICIPANTS Twenty-seven healthy volunteers. INTERVENTION(S): An ice bag was secured to the lateral ankle joint for 20 minutes. MAIN OUTCOME MEASURES The onset and average root mean square amplitude of EMG activity in the peroneal muscles was calculated following the release of a trap door mechanism causing inversion. RESULTS There was no statistically significant change from baseline for peroneal reaction time or average peroneal muscle activity at any post treatment time. CONCLUSIONS Cryotherapy does not affect peroneal muscle reaction following sudden inversion perturbation.
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Efficacy of a comfrey root extract ointment in comparison to a diclofenac gel in the treatment of ankle distortions: results of an observer-blind, randomized, multicenter study.
Predel, HG, Giannetti, B, Koll, R, Bulitta, M, Staiger, C
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2005;(10):707-14
Abstract
In the treatment of minor blunt injuries several topical drugs are known to have anti-inflammatory and analgesic properties. They represent, however, two fundamentally different major pharmacological therapy approaches: the "chemical-synthetical" and the "phytotherapeutical" approach. The main objective of this trial (CODEC_2004) was to compare the efficacy and tolerability of an ointment of Comfrey extract (Extr. Rad. Symphyti) with that of a Diclofenac gel in the treatment of acute unilateral ankle sprain (distortion). In a single-blind, controlled, randomized, parallel-group, multicenter and confirmatory clinical trial outpatients with acute unilateral ankle sprains (n=164, mean age 29.0 years, 47.6% female) received either a 6 cm long ointment layer of Kytta-Salbe f (Comfrey extract) (n=82) or of Diclofenac gel containing 1.16 g of diclofenac diethylamine salt (n=82) for 7 +/- 1 days, four times a day. Primary variable was the area-under-the-curve (AUC) of the pain reaction to pressure on the injured area measured by a calibrated caliper (tonometer). Secondary variables were the circumference of the joint (swelling; figure-of-eight method), the individual spontaneous pain sensation at rest and at movement according to a Visual Analogue Scale (VAS), the judgment of impaired movements of the injured joint by the method of "neutral-zero", consumption of rescue medication (paracetamol), as well as the global efficacy evaluation and the global assessment of tolerability (both by physician and patient, 4 ranks). In this study the primary variable was also to be validated prospectively. It was confirmatorily shown that Comfrey extract is non-inferior to diclofenac. The 95% confidence interval for the AUC (Comfrey extract minus Diclofenac gel) was 19.01-103.09h*N/cm2 and was completely above the margin of non-inferiority. Moreover, the results of the primary and secondary variables indicate that Comfrey extract may be superior to Diclofenac gel.