Clinical Trials Logo

Clinical Trial Summary

This study evaluates the use of corticosteroids acutely as an adjuvant treatment of the high ankle sprain. Subjects will receive either a corticosteroid or a local anesthetic injection.

Clinical Trial Description

The term "high ankle sprain" refers to injury to the syndesmotic ligaments of the ankle. It has become a much more common injury comprising up to 24.6% of all ankle sprains , with an incidence of 2.4 per 1000 athlete exposures. These can present a significant therapeutic challenge for the sports physician and typically result in a prolonged morbidity and delayed return to activity. The literature shows a lack of information for definitive care of these athletes. Typical recovery for the high ankle sprain is almost twice as long as the more common lateral ankle inversion sprain with a mean time to return to play of 45 days. There is also a higher incidence of residual chronic pain comparing high ankle sprains to an isolated lateral ankle sprain. The current standard for treatment of this injury has been to depend on symptomatic treatment with an initial phase of rest and protected splinting. This is followed by the use of NSAID's with a graduated rehabilitation program to reduce swelling, improve range of motion, and regain strength and proprioception of the ankle. This is followed by protective taping or bracing and return to activities as tolerated. Inflammation is one of the body's first reactions to injury. Release of damaged cells and tissue debris occurs upon injury. These expelled particles act as antigens to stimulate a nonspecific immune response and to cause the proliferation of leukocytes. Local blood flow increases to transport the polymorphonuclear leukocytes, macrophages, and plasma proteins to the injured area. A redistribution of arteriolar flow produces stasis and hypoxia at the injury site. The resulting infiltration of tissues by the leukocytes, plasma proteins, and fluid causes the redness, swelling, and pain that are characteristic of inflammation. Initially, the inflammatory reaction serves several important purposes. The influx of leukocytes facilitates the process of phagocytosis and the removal of damaged cells and other particulate matter. Pain and tenderness remind the patient to protect the injured area; however, the inflammatory reaction eventually becomes counterproductive. The mechanism of corticosteroid action includes a reduction of the inflammatory reaction by limiting the capillary dilatation and permeability of the vascular structures. These compounds restrict the accumulation of polymorphonuclear leukocytes and macrophages and reduce the release of vasoactive kinins. They also inhibit the release of destructive enzymes that attack the injury debris and destroy normal tissue indiscriminately. Additionally, new research suggests that corticosteroids may inhibit the release of arachidonic acid from phospholipids, thereby reducing the formation of prostaglandins, which contribute to the inflammatory process. There are no previous prospective, randomized studies that look at utilization of corticosteroids in treatment of the high ankle sprain. Only anecdotal information is available in simple case reports for treatment. There was one study looking at treatment with platelet rich plasma injection which demonstrated shorter return to play times and less long term residual pain. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02892500
Study type Interventional
Source Sanford Health
Status Terminated
Phase Phase 2
Start date April 2016
Completion date September 21, 2018

See also
  Status Clinical Trial Phase
Completed NCT02609308 - Lateral Ankle Sprain and Platelet Rich Plasma N/A
Recruiting NCT01196338 - Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures N/A
Not yet recruiting NCT01205841 - A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma N/A
Completed NCT02276339 - Muscle Activation in Chronic Ankle Instability and the Effect of an Exercise Programme N/A
Completed NCT01945034 - 5% Topical Ibuprofen (IBU) for Ankle Sprain Phase 3
Not yet recruiting NCT02705690 - Benchmarking the iOS Balance Application Against the Berg Balance Test N/A
Active, not recruiting NCT03049423 - MRI Appearance of Injured Ligament and Tendon of the Ankle in Different Postures N/A
Completed NCT00986791 - Alcohol Cessation Intervention in an Acute Surgical Setting N/A
Completed NCT03312933 - Associated Joint Pain With Controlled Ankle Movement (CAM) Walker Boot Wear
Completed NCT02187406 - Ankle Athletic Taping Fatigue After a Standard Tennis Warm up N/A
Completed NCT00906672 - Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss Phase 3
Completed NCT01586390 - Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast Phase 2
Completed NCT00718302 - A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures N/A
Completed NCT00336752 - Operative Versus Non Operative Treatment for Unstable Ankle Fractures N/A
Completed NCT00690651 - Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture? N/A
Completed NCT01092286 - Effect of Neuromuscular Warm-up on Injuries in Female Athletes N/A
Active, not recruiting NCT01942772 - A Powered Ankle Foot Rehabilitation Orthosis N/A
Completed NCT01779804 - Triage-Based Application of OFAR on the Number of Radiographs Ordered N/A
Completed NCT01499966 - Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains N/A
Completed NCT00556010 - Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption N/A