Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01446341
Recruitment Status : Unknown
Verified October 2011 by University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2011
Last Update Posted : October 5, 2011
Sponsor:
Collaborator:
Workers' Compensation Board of BC
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date  ICMJE August 19, 2011
First Posted Date  ICMJE October 5, 2011
Last Update Posted Date October 5, 2011
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months. [ Time Frame: Measured at 0, 1, and 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
Official Title  ICMJE A Pilot Study Towards a Randomized Clinical Trial of Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankle Sprain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Immobilization
    50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast
    Intervention: Procedure: Below knee plaster casting
  • Active Comparator: Functional Rehabilitation
    50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain
    Intervention: Procedure: Functional rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 4, 2011)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01446341
Other Study ID Numbers  ICMJE H11-01150
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Workers' Compensation Board of BC
Investigators  ICMJE
Principal Investigator: Nicholas Rose, MD, PhD University of British Columbia - Vancouver Coastal Health Research Institute
PRS Account University of British Columbia
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP