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

University of British Columbia

Status: Unknown

Conditions: Ankle Sprain

Treatments: Procedure: Functional rehabilitation; Procedure: Below knee plaster casting

Study type: Interventional

Funder types: Other

Identifiers

NCT01446341

H11-01150

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Immobilization

Active Comparator group

Description:

50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast

Treatment:

Procedure: Below knee plaster casting

Functional Rehabilitation

Active Comparator group

Description:

50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain

Treatment:

Procedure: Functional rehabilitation