Efficacy and Safety of the Phytochemical Product Linfadren in the Management of Patients With Persistent Ankle Edema Following Trauma or Surgery: A Randomized Controlled Trial.

BACKGROUND: Persistent posttraumatic/postsurgery ankle edema (PPAE) is edema that persists from 2 weeks to 3 months after injury or surgery. PPAE has negative effects on the healing process and quality of life. This study aimed to evaluate the efficacy of a phytochemical product containing diosmin, coumarin, and arbutin (Linfadren) in addition to the conventional treatment, in patients with PPAE. METHODS: Between October 2018 and February 2020, 60 outpatients with PPAE (42 with ankle fractures and 18 with ankle sprains) were enrolled and randomized (1:1 ratio) to receive either 6-week conventional treatment plus Linfadren (study group) or conventional treatment alone (control group). Primary outcome was ankle edema as measured by the "figure-of-8-20" method. Secondary outcomes were ankle function measured by the Lower Extremity Functional Scale (LEFS), and patient's overall perceived treatment efficacy. Tolerability of Linfadren was also evaluated. Assessments were performed at baseline, at end of treatment (6 weeks after baseline), and 3 months after the end of treatment (follow-up). A subgroup analysis was also conducted for the injury type (fracture/sprain) to identify if this factor affected the results of the primary outcome measure. RESULTS: At the end of treatment, the study group had a significantly greater improvement in ankle edema, improved ankle function, and more patients who considered this treatment effective compared with the control group. The measured difference in circumference by the figure-of-8-20 method averaged 4% at 6 weeks and 5% at 3 months. No difference between groups was seen in rescue medication. No adverse events were recorded. Subgroup analysis revealed no significant influence of the injury type on the primary outcome measure. CONCLUSION: Linfadren in addition to conventional treatment was more effective than conventional treatment alone in patients with PPAE. LEVEL OF EVIDENCE: Level I, randomized controlled trial.

Comparison of intravenous ibuprofen and tenoxicam efficiency in ankle injury: a randomized, double-blind study.

BACKGROUND AND AIM: Pain after soft tissue injuries in and around the ankle is a troublesome process in terms of patient comfort and mobilization. The aim of this study was to compare the analgesic efficacy of intravenous ibuprofen and intravenous tenoxicam in patients with acute musculoskeletal pain due to ankle injury. METHODS: We conducted a prospective, double-blind, randomized controlled study in a tertiary hospital. The patients were divided into two groups as those administered IV 400 mg ibuprofen and IV 20 mg tenoxicam. After the treatment of the patients, visual analog scale (VAS) scores were recorded at 15, 30, 60, and 120 min. VAS scores were compared with the effectiveness of drugs, their side effects, and the need for rescue drugs. RESULTS: One hundred and twenty-four patients were included in the study. There were 62 patients in the tenoxicam group and 62 patients in the ibuprofen group. When VAS scores were compared, it was found that the VAS scores of the ibuprofen group were statistically significantly lower (p < 0.001). When the ΔVAS scores were compared, it was observed that the ΔVAS scores of the ibuprofen group were statistically significantly higher from 30 min (p < 0.001). There was a statistically significant difference in favor of ibuprofen between the two drug groups in terms of the need for rescue analgesics (p < 0.001). Conclusion. The analgesic efficacy of intravenous ibuprofen and tenoxicam is equal after an ankle injury. However, after 30 min of drug administration, ibuprofen provides more effective analgesia than tenoxicam.

Bloqueo de nervios del tobillo guiado por ultrasonido como tratamiento adyuvante en dolor crónico posterior a lesiones por accidente laboral / Ultrasound-guided ankle nerve block as adjuvant therapy in chronic pain after occupational injury

Introducción: Los traumatismos de tobillo y pie pueden generar dolor crónico, causar limitación funcional e incapacidad laboral prolongada. El bloqueo de nervios periféricos guiado por imagen es una alternativa de tratamiento en pacientes con dolor crónico con baja respuesta a otras estrategias terapéuticas. Objetivo: Evaluar los efectos del bloqueo de nervios del tobillo guiado por ultrasonido (US), en pacientes con dolor crónico posterior a lesiones de tobillo y pie ocasionadas por accidente de trabajo.Métodos: Estudio pre y post intervención de temporalidad retrospectiva, que incluyó las historias clínicas de pacientes con dolor crónico posterior a trauma de tobillo y pie, a quienes se les había practicado bloqueo de nervios del tobillo guiado por ultrasonido . Para la valoración del dolor se utilizó la escala numérica (EN) y el Índice de Lattinen (IL). El dolor y el uso de medicamentos se evaluó un mes después del procedimiento. Resultados: Se analizaron los registros clínicos de 41 pacientes; 24 (58,5%) hombres y 17 (41,5%) mujeres, con edad media de 42,5 años (±12,2). Todos los pacientes presentaban dolor crónico posterior a lesiones de tobillo y pie, con tiempo promedio de evolución de 16,8 (±12,1) meses. Un mes después del procedimiento, se evidencia disminución significativa de la intensidad del dolor en el grupo de pacientes según EN (p = 0,000) y en la puntuación global del IL (p = 0,000). En la evaluación de seguimiento, 26 (63,4%) pacientes registran disminución en el número de medicamentos para el dolor. Conclusión: El bloqueo de nervios del tobillo guiado por US, puede considerarse como adyuvante analgésico en dolor crónico posterior a trauma de tobillo-pie y contribuir a disminuir el uso de medicamentos.(AU)

Introduction: Ankle and foot injuries can generate chronic pain, lead to functional limitation and long-term work disability. Image-guided peripheral nerve block is an alternative treatment in patients with chronic pain and poor response to other therapeutic strategies. Objective: To evaluate the effects of ultrasound-guided ankle nerve block in patients with chronic pain after ankle and foot injuries caused by an occupational accident. Methods: Pre- and post-intervention retrospective study, which included the medical records of patients with chronic pain after ankle and foot trauma, who had undergone peripheral nerve block of the ankle using ultrasound guidance. The numerical scale (NS) and the Lattinen Index (LI) were used to assess pain. Pain and medication use were assessed one month after the procedure. Results: The clinical records of 41 patients were analyzed. 24 (58.5%) men and 17 (41.5%) women, with a mean age of 42.5 years (±12.2). All patients had chronic pain after ankle and foot injuries, with an average evolution time of 16.8 (±12.1) months. One month after the procedure, there is evidence of a significant decrease in pain intensity in the group of patients according to the NS (p = 0.000) and in the total LI score (p = 0.000). In the follow-up assessment, 26 (63.4%) patients recorded a decrease in the number of pain medications. Conclusion: Ultrasound-guided ankle nerve block can be considered as an analgesic adjuvant in chronic pain after ankle-foot trauma and help reduce the use of medications.(AU)

Randomized, double-blind, noninferiority study of diclofenac diethylamine 2.32% gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily in patients with acute ankle sprain.

BACKGROUND: Diclofenac diethylamine (DDEA) gel has demonstrated efficacy for treatment of ankle sprains in both the 1.16% four-times-daily (QID) and 2.32% twice-daily (BID) formulations. The objective of this study was to compare, for the first time, the efficacy of DDEA 2.32% gel BID and DDEA 1.16% gel QID. METHODS: This was a phase 3, randomized, double-blind, multicenter, active-controlled, parallel-group study conducted in China from October 2019 to November 2020, designed to determine the noninferiority of DDEA 2.32% gel BID relative to DDEA 1.16% gel QID for treatment of grade I-II ankle sprain. At study entry, patients must have had pain on movement (POM) ≥50 mm on a 100-mm visual analogue scale (VAS), and not received any pain medication. The primary efficacy endpoint was the noninferiority of DDEA 2.32% gel BID vs DDEA 1.16% gel QID for POM as assessed by the patient using the 100-mm VAS, conducted on day 5. Secondary endpoints included measures of ankle tenderness, joint function, swelling, and patient-reported pain intensity and pain relief. RESULTS: A total of 302 patients were randomized and 95.4% completed the study. The mean (SD) change in POM from baseline to day 5 using the 100-mm VAS was - 42.8 mm (19.7 mm) with DDEA 2.32% gel BID and - 43.1 mm (18.1 mm) with DDEA 1.16% gel QID for the per-protocol population. The least squares mean difference (DDEA gel 2.32% - DDEA gel 1.16%) at this timepoint was 1.11 mm (95% CI - 3.00, 5.22; P = 0.595), and the upper limit (5.22 mm) of the 95% CI was less than the noninferiority margin of 13 mm, demonstrating that DDEA 2.32% gel BID was noninferior to DDEA 1.16% gel QID. Similar trends were seen for the secondary efficacy endpoints. There was no significant difference in the incidence of treatment-emergent adverse events or adverse events adjudicated as being treatment related. All treatment-related adverse events were dermatological; one patient discontinued from the DDEA 2.32% gel BID arm due to application-site inflammation. CONCLUSIONS: DDEA 2.32% gel BID offers a convenient alternative to DDEA 1.16% gel QID, with similar pain reduction and relief, anti-inflammatory effects, and tolerability. TRIAL REGISTRATION: NCT04052620.

A protocol for a randomized clinical trial assessing the efficacy of hypertonic dextrose injection (prolotherapy) in chronic ankle instability.

BACKGROUND: Lateral ankle sprain (LAS) is a common injury. Conservative care is not uniformly effective. Chronic ankle instability (CAI) results in up to 70% of patients with LAS in the physically active population. LAS, together with subsequent osteochondral lesions and pain in many patients, leads to the development of post-traumatic osteoarthritis, resulting in a substantial direct and indirect personal and societal health burden. Dextrose prolotherapy (DPT) is an injection-based therapy for many chronic musculoskeletal conditions but has not been tested for CAI. This protocol describes a randomized controlled trial to test the efficacy of DPT versus normal saline (NS) injections for chronic ankle instability (CAI). METHODS AND ANALYSIS: A single-center, parallel-group, randomized controlled trial will be conducted at a university-based primary care clinic in Hong Kong. A total of 114 patients with CAI will be randomly allocated (1:1) to DPT and NS groups. The primary outcome will be the Cumberland Ankle Instability Tool scores at 1 year. The secondary outcomes will be the number of re-sprains in 1 year, the Star Excursion Balance Test, the 5-level of EuroQol 5-dimension questionnaire, and the Foot and Ankle Ability Measure. All outcomes will be evaluated at baseline and at 16, 26, and 52 weeks using a linear mixed model. DISCUSSION: We hypothesized the DPT is a safe, easily accessible, and effective treatment for patients with CAI. This RCT study will inform whether DPT could be a primary non-surgical treatment for CAI. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000040213 . Registered on 25 November 2020.

Ensayo clínico comparando el uso de tornillos y del sistema TighRope® Knotless en el tratamiento de las lesiones agudas de la sindesmosis / A randomized clinical trial comparing screws and the TighRope® Knotless system in the treatment of acute injuries of syndesmosis

Antecedentes y objetivo: Clásicamente el tratamiento de las lesiones agudas de la sindesmosis se ha realizado mediante tornillos. Hace unos años aparecieron implantes más flexibles que han evolucionado hasta el moderno TighRope® Knotless. El objetivo del presente estudio es comparar los resultados de ambos implantes. Material y métodos: Desde abril de 2019 hasta septiembre de 2020 reclutamos 68 pacientes diagnosticados de lesión aguda de la sindesmosis que fueron aleatorizados para tratamiento quirúrgico con tornillo o con TighRope® Knotless. Realizamos control posquirúrgico con tomografía axial computarizada, y a los 3, 6 y 12 meses se recogieron datos del rango articular, valores de escalas funcionales y se realizaron estudios de radiología simple. Resultados: Los pacientes tratados con tornillos no presentaban diferencias estadísticamente significativas en la escala AOFAS frente al grupo tratado con TighRope® Knotless a los 3 meses (83,1 vs. 81,80; p=1,03), ni a los 6 meses (88,27 vs. 88; p=0,26) ni a los 12 meses (93,03 vs. 92,10; p=0,93). Igualmente recogimos resultados similares en la escala de Olerud-Molander a los 3 meses (65 vs. 61,50; p=3,5), 6 meses (82,33 vs. 80,67; p=1,67) y 12 meses (92,67 vs. 90; p=2,67). Tampoco hubo diferencias en la tasa de malreducción posquirúrgica (ningún caso en ambos grupos), pérdida de reducción (3 en el grupo tratado con tornillo frente a 4 del grupo del TighRope® Knotless, p=0,54) o complicaciones (p=1). Conclusiones: El tratamiento de las lesiones agudas de la sindesmosis con tornillos o con TighRope® Knotless es similar tanto en resultados clínicos como radiológicos.(AU)

Background and aim: Classically acute syndesmosis injuries have been treated using screws. A few years ago more flexible implants appeared evolving to current TighRope® Knotless. The primary aim of this study is to compare clinical and radiographic outcome of both implants. Material and methods: From April 2019 to September 2020 68 patients diagnosed with acute syndesmosis injury were randomized to use screws or TighRope® Knotless. Syndesmosis reduction was assessed using bilateral CT potsoperatively. Outcomes were clinically and radiologically assessed at three, six, and twelve months after surgery. Results: No significant differences were identified in the AOFAS Scale between groups at three months (83.1 vs. 81.80; P=1.03), nor at six (88.27 vs. 88; P=.26) or at twelve (93.03 vs. 92.10; P=,93). There were also no differences in Olerud-Molander scale at three (65 vs. 61.50; P=3.5), six (82.33 vs. 80.67; P=1.67) and twelve months (92.67 vs. 90; P=2.67). Likewise, there were no differences in rate of postoperative malreduction (no cases in both groups), loss of reduction (three cases in screw group vs. four in TighRope® Knotless group, P=.54) or complications (P=1). Conclusions: Treatment of acute syndesmosis injuries with screws or the TighRope® Knotless implant is similar in both clinical and radiological results.(AU)

[Translated article] A randomised clinical trial comparing screws and the TighRope® Knotless system in the treatment of acute injuries of syndesmosis / Ensayo clínico comparando el uso de tornillos y del sistema TighRope® Knotless en el tratamiento de las lesiones agudas de la sindesmosis

Antecedentes y objetivo: Clásicamente el tratamiento de las lesiones agudas de la sindesmosis se ha realizado mediante tornillos. Hace unos años aparecieron implantes más flexibles que han evolucionado hasta el moderno TighRope® Knotless. El objetivo del presente estudio es comparar los resultados de ambos implantes. Material y métodos: Desde abril de 2019 hasta septiembre de 2020 reclutamos 68 pacientes diagnosticados de lesión aguda de la sindesmosis que fueron aleatorizados para tratamiento quirúrgico con tornillo o con TighRope® Knotless. Realizamos control posquirúrgico con tomografía axial computarizada, y a los 3, 6 y 12 meses se recogieron datos del rango articular, valores de escalas funcionales y se realizaron estudios de radiología simple. Resultados: Los pacientes tratados con tornillos no presentaban diferencias estadísticamente significativas en la escala AOFAS frente al grupo tratado con TighRope® Knotless a los 3 meses (83,1 vs. 81,80; p=1,03), ni a los 6 meses (88,27 vs. 88; p=0,26) ni a los 12 meses (93,03 vs. 92,10; p=0,93). Igualmente recogimos resultados similares en la escala de Olerud-Molander a los 3 meses (65 vs. 61,50; p=3,5), 6 meses (82,33 vs. 80,67; p=1,67) y 12 meses (92,67 vs. 90; p=2,67). Tampoco hubo diferencias en la tasa de malreducción posquirúrgica (ningún caso en ambos grupos), pérdida de reducción (3 en el grupo tratado con tornillo frente a 4 del grupo del TighRope® Knotless, p=0,54) o complicaciones (p=1). Conclusiones: El tratamiento de las lesiones agudas de la sindesmosis con tornillos o con TighRope® Knotless es similar tanto en resultados clínicos como radiológicos.(AU)

Background and aim: Classically acute syndesmosis injuries have been treated using screws. A few years ago more flexible implants appeared evolving to current TighRope® Knotless. The primary aim of this study is to compare clinical and radiographic outcome of both implants. Material and methods: From April 2019 to September 2020 68 patients diagnosed with acute syndesmosis injury were randomized to use screws or TighRope® Knotless. Syndesmosis reduction was assessed using bilateral CT potsoperatively. Outcomes were clinically and radiologically assessed at three, six, and twelve months after surgery. Results: No significant differences were identified in the AOFAS Scale between groups at three months (83.1 vs. 81.80; P=1.03), nor at six (88.27 vs. 88; P=.26) or at twelve (93.03 vs. 92.10; P=,93). There were also no differences in Olerud-Molander scale at three (65 vs. 61.50; P=3.5), six (82.33 vs. 80.67; P=1.67) and twelve months (92.67 vs. 90; P=2.67). Likewise, there were no differences in rate of postoperative malreduction (no cases in both groups), loss of reduction (three cases in screw group vs. four in TighRope® Knotless group, P=.54) or complications (P=1). Conclusions: Treatment of acute syndesmosis injuries with screws or the TighRope® Knotless implant is similar in both clinical and radiological results.(AU)

Foot and Ankle Injections in Athletes.

CONTEXT: Injections are commonly used by health care practitioners to treat foot and ankle injuries in athletes despite ongoing questions regarding efficacy and safety. EVIDENCE ACQUISITION: An extensive literature review was performed through MEDLINE, Google Scholar, and EBSCOhost from database inception to 2021. Keywords searched were injections, athletes, sports, foot and ankle, corticosteroids, platelet-rich plasma, and placental tissue. Search results included articles written in the English language and encompassed reviews, case series, empirical studies, and basic science articles. STUDY DESIGN: Clinical review. LEVEL OF EVIDENCE: Level 4. RESULTS: Corticosteroids, platelet-rich plasma/autologous blood, anesthetic, and placental tissue injections are commonly used in the treatment of foot and ankle injuries. Primary indications for injections in athletes include plantar fasciitis, Achilles tendinosis, isolated syndesmotic injury, and ankle impingement with varying clinical results. CONCLUSIONS: Despite promising results from limited case series and comparative studies, the data for safety and efficacy of injections for foot and ankle injuries in athletes remain inconclusive.

Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial.

BACKGROUND: Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain. However, there is insufficient evidence regarding the effects of DS on ankle sprains. Accordingly, we assessed the efficacy and safety of DS for the treatment of acute lateral ankle sprain (ALAS). METHODS: This study was a multicenter (two Korean hospitals), randomized, double-blind, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio that included a per-protocol analysis and sub-analysis based on symptom severity. Forty-eight participants (n = 28 at Semyung University Korean Medicine Hospital in Chungju; n = 20 at DongShin University Gwangju Korean Medicine Hospital) with grade I or II ALAS that occurred within 72 h before enrollment were randomized to a DS (n = 24) or placebo (n = 24) group. Both groups received acupuncture treatment once daily for 5 consecutive days and the trial medication (DS/placebo capsule) three times a day for 7 consecutive days. Primary (visual analog scale [VAS] scores for pain) and secondary (Foot and Ankle Outcome Scores [FAOS], edema, and European Quality of Life Five-Dimension-Five-Level Scale [EQ-5D-5L] scores) outcome measures were recorded at baseline (week 0), the end of the intervention (week 1), and 4 weeks after treatment completion (week 5). RESULTS: Forty-six participants completed the trial (n = 23 each). Changes in VAS scores, FAOS Symptom/Rigidity, and FAOS Ache from week 1 to week 5 showed significant differences between the two groups. Sub-analyses showed significant differences in changes of FAOS Ache (week 0 to week 5) and VAS scores, total FAOS, and EQ-5D-5L scores (week 1 to week 5) between the two subgroups (grade II). There were no adverse events and significant negative changes in clinical laboratory parameters in both groups. CONCLUSIONS: Overall, the results of this study are in favor of DS combined with acupuncture and suggest that DS combined with acupuncture is a safe treatment with positive long-term effects in terms of pain reduction and symptom alleviation in patients with grade I or II ALAS. TRIAL REGISTRATION: Clinical Research Information Service KCT0002374 . Registered on July 11, 2017; retrospectively registered.

Pain Medication Administered and Prescribed to Patients With an Ankle Sprain Treated in an Emergency Department: A Record-Based Cohort Study.

INTRODUCTION: Recent data indicate that patients treated in the emergency department for an ankle sprain receive multiple medications. However, research has not been able to accurately identify all the medications because of study limitations. The primary purpose of this study was to document the type of medication, number of doses, and number of encounters given a prescription at discharge or instructions to take over-the-counter medication. The secondary purpose was to determine if the proportion of encounters given each type of medication varied on the basis of age, sex, race, and year. METHODS: A retrospective record-based cohort study design was used to review the electronic medical records (N = 1740) of encounters reporting to a southeast academic level 1 trauma center and diagnosed with an ankle sprain between 2013 and 2017. All relevant data were extracted for nonsteroidal anti-inflammatory drugs, muscle relaxants, opioids, and nonopioid analgesics. RESULTS: Fifty-eight percent of the encounters had at least 1 dose of medication administered in the emergency department. Twenty-eight percent received a prescription at discharge, and 54.5% were instructed to take over-the-counter medication. Cumulatively, opioids accounted for most of the medications, but the yearly rates declined from 2013 to 2017. A greater proportion of patients aged ≤15 years received nonsteroidal anti-inflammatory drugs or nonopioid analgesics. Most of the patients aged >15 years received opioid medication. DISCUSSION: Patients are primarily given an opioid or nonsteroidal anti-inflammatory drug in the emergency department. Fewer patients receive a prescription at discharge but are regularly instructed to take over-the-counter medication.

Physical therapy referral and medication for ankle sprain visits to physician offices: an analysis of the national ambulatory medical care survey.

OBJECTIVES: Supervised physical therapy is the recommended care for an ankle sprain. Yet, recent evidence indicates some ankle sprain patients may not receive the recommended care, and instead, prescribed medication to alleviate symptoms. Therefore, the purpose of this study is to describe the percentage of patients reporting to an office-based physician in the U.S. that were or were not referred to physical therapy. Secondly, to describe the percentage of ankle sprain patients with or without medication administered, supplied or ordered. METHODS: This was a secondary analysis of the cross-sectional National Ambulatory Medical Care Survey (NAMCS) from 2007 to 2016. The NAMCS is a multi-stage probability sample survey of visits to office-based physicians. The percentage and associated 95% confidence intervals (CI) were calculated for visits that had a physical therapy referral or a non-steroidal anti-inflammatory drug (NSAID), opioid and non-opioid analgesics administered, supplied or ordered. Sampled data were weighted to produce national-level estimates. RESULTS: A physical therapy referral was given for 16.8% (95% CI: 13.2, 21.2) of ankle sprain visits. Approximately 34.5% (95%CI: 30.5, 38.7) of all ankle sprain visits had a medication administered, supplied or ordered. NSAIDs (72.1%; 95% CI: 66.9,76.8) and opioids (21.0%; 95% CI: 16.3, 26.5) were the two most common types of medication. CONCLUSIONS: NSAIDs and opioid medication combined were administered, supplied or ordered more frequently than a referral to physical therapy. These findings provide evidence that suggests many ankle sprain patients reporting to an office-based physician are not receiving the recommended care; physical therapy. Rather, medication appears to be the primary type of care provided to patients. These data are important because it gives a focused area to improve the treatment of an ankle sprain by developing strategies that ensure all patients are provided the recommended care from the onset of entering the healthcare system.

Regeneration of grade 3 ankle sprain, using the recombinant human amelogenin protein (rHAM+ ) in a rat model.

Lateral ligament tears, also known as high-grade ankle sprains, are common, debilitating, and usually heal slowly. Ten to thirty percent of patients continue to suffer from chronic pain and ankle instability even after 3 to 9 months. Previously, we showed that the recombinant human amelogenin (rHAM+ ) induced regeneration of fully transected rat medial collateral ligament, a common proof-of-concept model. Our aim was to evaluate whether rHAM+ can regenerate torn ankle calcaneofibular ligament (CFL), an important component of the lateral ankle stabilizers. Right CFLs of Sabra rats were transected and treated with 0, 0.5, or 1 µg/µL rHAM+ dissolved in propylene glycol alginate (PGA). Results were compared with the normal group, without surgery. Healing was evaluated 12 weeks after treatment by mechanical testing (ratio between the right and left, untransected ligaments of the same rat), and histology including immunohistochemical staining of collagen I and S100. The mechanical properties, structure, and composition of transected ligaments treated with 0.5 µg/µL rHAM+ (experimental) were similar to untransected ligaments. PGA (control) treated ligaments were much weaker, lax, and unorganized compared with untransected ligaments. Treatment with 1 µg/µL rHAM+ was not as efficient as 0.5 µg/µL rHAM+ . Normal arrangement of collagen I fibers and of proprioceptive nerve endings, parallel to the direction of the force, was detected in ligaments treated with 0.5 µg/µL rHAM+ , and scattered arrangement, resembling scar tissue, in control ligaments. In conclusion, we showed that rHAM+ induced significant mechanical and structural regeneration of torn rat CFLs, which might be translated into treatment for grades 2 and 3 ankle sprain injuries.

Comparison of Regularly Scheduled Ibuprofen Versus "Pro Re Nata" for Ankle Sprains in Children Treated in the Emergency Department: A Randomized Controlled Trial.

OBJECTIVE: We compared pain and degree of disability in patients with acute ankle sprains receiving regular scheduled ibuprofen versus pro re nata (PRN). METHODS: This study is a randomized single-blinded controlled trial of children aged 7 to 17 years presenting with acute ankle sprain to an emergency department. Patients were randomized to receive 10 mg/kg of ibuprofen per dose (maximum 600 mg) every 6 hours regular scheduled versus PRN. Outcome measures included a 100-mm visual analog scale pain and degree of disability at day 4. A sample size of 72 children had a power of 80% to detect a clinically meaningful difference of 20 mm between the regular and PRN group. RESULTS: We randomly assigned 99 patients to receive regular scheduled (n = 50) or PRN (n = 49) ibuprofen. Pain scores and degree of disability at day 4 showed no significant differences between groups. The rate of reported adverse effects was higher in the regular scheduled group (11.4% vs 9.5%) versus the PRN group. CONCLUSIONS: Our study suggests that there is little benefit from routinely using a regular scheduled ibuprofen regimen for acute pediatric ankle sprains.

Visit Characteristics Associated With Opioids Administered or Prescribed During Emergency Department Visits for Ankle Sprain Between 2010 and 2015.

BACKGROUND: Recent research has demonstrated that patients with ankle sprain who are discharged from the emergency department (ED) are prescribed an opioid. Minimizing the exposure to opioids is important to help prevent future abuse and misuse of these medications. OBJECTIVE: Identify ED visit characteristics for an ankle sprain that are associated with an opioid given in the ED, prescribed at discharge, or both. DESIGN: Retrospective analysis of the National Hospital Ambulatory Medical Care Survey (NHAMCS). SETTING: Hospital. PARTICIPANTS: Isolated ankle sprain visits to a United States ED. MAIN OUTCOME MEASUREMENTS: The main outcome was an opioid given in the ED, prescribed at discharge, or both between 2010 and 2015. Explanatory variables included age, sex, race, attending physician or resident, and geographic location of the hospital. A multiple logistic regression was performed to assess the independent association between an opioid given in the ED, prescribed at discharge, or both, and all explanatory variables. The analysis accounted for the cluster, strata, and probability weights for each year of the NHAMCS. RESULTS: Ankle sprain visits for patients ≤17 years of age had a lower odds of an opioid being given in the ED, prescribed at discharge, or both, compared to visits for patients 18 to 24 years of age (adjusted odds ratio [aOR] = 0.26 [95% confidence interval (CI) = 0.1, 0.5]; P < .001). Visits in the West (aOR = 2.5 [95% CI = 1.2, 5.4]) or South (aOR = 2.9 [95% CI = 1.6, 5.4]; P = .010) had higher odds of an opioid being given in the ED, prescribed at discharge, or both, compared to visits in the Northeast. CONCLUSIONS: Ankle sprain visits for patients ≤17 years of age had a lower odds of an opioid compared to visits for patients 18 to 24 years of age. Ankle sprain visits in the South or West had a higher odds of an opioid compared to visits in the Northeast. These findings provide a direction for future work aimed at minimizing exposure to opioids after an ankle sprain.

Effect of triage nurse-led application of the Ottawa Ankle Rules on number of radiographic tests and length of stay in selected emergency departments in Oman.

AIM: Ankle injuries are commonly seen in the emergency department (ED) and contribute to overcrowding. In Oman, injuries are a leading cause of years of life lost, disability-adjusted life years, and pose a burden to the healthcare system. This study aimed to evaluate the effectiveness of ED triage nurse-led application of the Ottawa Ankle Rules (OARs) toward improving the healthcare outcomes of ankle injury patients. METHODS: A quasi-experimental design was used to collect data (demographic characteristics, waiting time, length of stay, and number of radiographic tests) from 96 patients. The intervention group (n = 46) received ED triage nurse-led assessment and initiation of radiographic tests based on the OARs. The control group (n = 50) received usual care. RESULTS: The participants' mean age was 26.4 ± 7.90 years. The main causes of ankle injuries were football (36%), falls (31%) and twisting while walking (24%). There was a significant difference in number of ankle X-rays (t = 6.19; p < .001); length of stay (U = 549; p < .001); and waiting time (U = 167; p < .001) between the control and intervention group. The intervention reduced the mean waiting time and length of stay by 25.09 and 41.01 min, respectively. CONCLUSION: Application of the OARs by the ED triage nurse can decrease the number of unnecessary radiographic tests, waiting time and length of stay in the ED. Nurses' utilization of evidence-based clinical decision-making tools can improve ED care outcomes of common acute conditions such as ankle injuries.

Topical Ketoprofen Versus Placebo in Children Presenting With Ankle Sprain to the Emergency Department: A Randomized Controlled Study.

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.

Medications Used in U.S. Emergency Departments for an Ankle Sprain: An Analysis of the National Hospital Ambulatory Medical Care Survey.

BACKGROUND: An ankle sprain is a common musculoskeletal injury treated in the emergency department. Rest, ice, compression, and elevation is the preferred method for managing the symptoms after an ankle sprain. However, many patients receive a medication, such as a nonsteroidal anti-inflammatory drug (NSAID) or an opioid. OBJECTIVES: We sought to quantify the type of medication(s) used for an ankle sprain and to examine those across age and sex. METHODS: This was a retrospective review of the publicly available data collected through the National Hospital Ambulatory Medical Care Survey from 2006-2015. All cases with an isolated diagnosis of an ankle sprain were identified. Medication listed for each case was classified based on its detailed category and further explored across all 10 years, age, and sex. RESULTS: An estimated 9,052,678 ankle sprain visits occurred in emergency departments from 2006-2015. NSAIDs (56.1%) and opioid analgesic combination (28.4%) were the 2 most common medications. Regardless of the type, most medications were prescribed at discharge. The use of NSAIDs appears to have increased while opioid analgesic combinations decreased in 2010. NSAIDs were the most common medication identified with each age cohort; however, there was no apparent trend in medication for sex. CONCLUSIONS: NSAIDs are the most common medication used for ankle sprain visits to the ED. Nevertheless, an opioid is also used at a relatively high rate for this injury. These findings provide awareness and opportunity to focus on strategies for reduction of opioid use.

Clinical Outcomes and Complications of Peroneal Tendon Sheath Ultrasound-Guided Corticosteroid Injection.

BACKGROUND: The treatment of symptomatic peroneal tendinopathy and tears traditionally begins with nonsteroidal anti-inflammatory drugs, activity modification, physical therapy, and immobilization, with surgery typically reserved for those failing nonoperative treatment. Ultrasound-(US)-guided peroneal tendon sheath (PTS) corticosteroid injection is an additional nonoperative modality, but limited data exist on its safety and efficacy. The purpose of this study was to assess clinical outcomes following US-guided PTS corticosteroid injection for chronic tendinopathy or tears. METHODS: We retrospectively identified patients who had undergone US-guided PTS corticosteroid injection for pain due to peroneal tendinopathy, tears, or subluxation at our institution from 2012 to 2018. Underlying diagnosis was based on clinical examination, magnetic resonance imaging (MRI) results, and/or intraoperative findings, when available. Medical record data were supplemented by e-mail or telephone follow-up. Collected information included patient age, sex, body mass index (BMI), smoking status, workers' compensation status, prior surgeries about the foot and ankle, duration of symptoms prior to injection, perceived improvement in pain following injection and its duration, number of injections, progression to surgery, and any adverse outcomes of injection. We identified 96 patients (109 injections). Thirty-seven (38.5%) had previous foot and ankle surgery, with 17 (17.7%) having surgery specifically on the peroneal tendons. RESULTS: Twenty-four of 96 (25%) progressed to have surgery on their peroneal tendons following injection. Following injection, 38/87 (43.7%) of patients reported 0-1 weeks of pain relief, 11/87 (12.6%) 2-6 weeks, 6/87 (6.9%) 7-12 weeks, and 32/87 (36.8%) greater than 12 weeks. Preinjection duration of symptoms was associated with postinjection duration of pain relief (P=.036). There were 2 reported complications (1.8%): 1 case of self-limited sural nerve irritation and 1 of peroneus longus tear progression. CONCLUSION: Our study demonstrates US-guided PTS corticosteroid injection was safe and relatively effective in patients with symptomatic peroneal tendon tears or tendinopathy, including those who had undergone prior surgery, and may be considered in a comprehensive protocol of nonoperative management. LEVEL OF EVIDENCE: Level IV, case series.