Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains

Not Applicable

• Conditions: Ankle Sprain
• Interventions: Procedure: Below knee plaster casting; Procedure: Functional rehabilitation

• Registration Number: NCT01446341
• Lead Sponsor: University of British Columbia

Brief Summary

Acute, severe lateral ankle sprains are estimated to comprise between 3-5% of emergency department visits and are the most common musculoskeletal injury in the physically active population. Although the current accepted treatment of ankle sprains is to encourage early mobilization with functional rehabilitation, there is little high-quality evidence directing this clinical practice.

This pilot study is to:

* provide quantitative data for estimation of mean outcome scores and standard deviations to allow subsequent sample size calculations

* evaluate the feasibility of the proposed study design

* assess patient enrollment issues specific to randomization into an active rehabilitation program compared to below knee immobilization.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-19
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-04
• Last Update Submitted: 2011-10-04
• Study First Posted: 2011-10-05
• Last Update Posted: 2011-10-05
• Study Start: 2011-11
• Primary Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age over 18
• meet clinical criteria for unilateral grade II-III ankle sprains (inability to weight bear)

Exclusion Criteria

• bony injury on x-ray or computed tomography
• contraindications to recurrent icing
• high risk of deep-vein thrombosis
• injury greater than 3 days old
• ongoing recovery from previous acute ankle sprain
• age greater than 60
• non-English speaking patients, those patients unable to provide informed consent or patients with insufficient contact information for follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immobilization	Below knee plaster casting	50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast
Functional Rehabilitation	Functional rehabilitation	50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain

Primary Outcome Measures

Name	Time	Method
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.	Measured at 0, 1, and 3 months