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

Ankle Sprain Clinical Trial

Official title:

A Pilot Study Towards a Randomized Clinical Trial of Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01446341
• Other study ID #: H11-01150
• Status: Not yet recruiting
• Phase: N/A
• First received: August 19, 2011
• Last updated: October 4, 2011
• Start date: November 2011

Study information

• Verified date: October 2011
• Source: University of British Columbia
• Contact: Nicholas Rose, MD, PhD
• Phone: 604-875-5242
• Email: nrose[@]interchange.ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Procedure:
• Below knee plaster casting
Subjects will be randomly assigned to either immobilization of their lateral ankle sprain with a below knee cast or to enter a functional rehabilitation program
• Functional rehabilitation
Subjects will be randomly assigned to either immobilization of their lateral ankle sprain with a below knee cast or to enter a functional rehabilitation program

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Workers' Compensation Board of BC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.		Measured at 0, 1, and 3 months	No