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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of British Columbia.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Workers' Compensation Board of BC
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01446341
First received: August 19, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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.

Condition Intervention
Ankle Sprain
Procedure: Below knee plaster casting
Procedure: Functional rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study Towards a Randomized Clinical Trial of Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months. [ Time Frame: Measured at 0, 1, and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446341

Contacts
Contact: Nicholas Rose, MD, PhD 604-875-5242 nrose@interchange.ubc.ca

Sponsors and Collaborators
University of British Columbia
Workers' Compensation Board of BC
Investigators
Principal Investigator: Nicholas Rose, MD, PhD University of British Columbia - Vancouver Coastal Health Research Institute
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01446341     History of Changes
Other Study ID Numbers: H11-01150
Study First Received: August 19, 2011
Last Updated: October 4, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Ankle sprain
Functional rehabilitation
Immobilization

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 23, 2014