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

October 4, 2011 updated by: University of British Columbia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immobilization
50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast
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
Active Comparator: Functional Rehabilitation
50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain
Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Workers' Compensation Board of BC

Investigators

  • Principal Investigator: Nicholas Rose, MD, PhD, University of British Columbia - Vancouver Coastal Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

October 5, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11-01150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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