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A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Linda Pax Lowes, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01134653
First received: May 28, 2010
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

Acute ankle sprain is one of the most common musculoskeletal injuries, accounting for an estimated 2 million injuries per year and 20% of all sports injuries in the United States. Ankle sprains can lead to prolonged periods of pain, difficulty with mobility, and lost work or play time. Current best practice guidelines for treatment of an acute ankle sprain are protection, rest, ice, compression and elevation (PRICE). However recent systematic reviews for ankle sprains call into question this treatment. Two critical components; immobilization and ice, have little or no evidence of efficacy for ankle sprain. Interestingly, mobilization appears to be more effective at reducing the pain, swelling and stiffness of musculoskeletal injuries including ankle sprains. Historically the limitation to early mobilization has been pain. Recently developed stretch bands have been introduced to the therapy market as a tool that allows pain-free active and resisted ankle movement after acute ankle sprain.

The investigators propose a double blind randomized controlled study to compare 2 ankle sprain treatments on their ability to speed recovery and reduce morbidities such as pain, swelling and weakness.


Condition Intervention
Ankle Sprain
Other: Jump Stretch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Stretch Band Ankle Traction Technique in the Treatment of Acute Ankle Sprains.

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • days until return to activities [ Time Frame: discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    VAS scale 1 week post enrollment

  • strength [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    change in strength

  • swelling [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    change in figure 8 measurement


Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Jump stretch
Distraction with early mobilization
Other: Jump Stretch
distraction with early mobilization
Active Comparator: RICE
Subject receive standard ankle sprain treatment of Rest Ice compression and elevation for one week. This is followed by traditional strength and range of motion therapy. The subject does not receive distraction treatments.
Other: Jump Stretch
distraction with early mobilization

  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3 day post injury

Exclusion Criteria:

  • fracture
  • chronic sprain
  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: NCT01134653

Contacts
Contact: linda lowes, PT PhD 614 722 4036 Linda.lowes@nationwidechildrens.org
Contact: jim marrie, pt 614 722-2000 james.marrie@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43221
Contact: Jim Marie         
Principal Investigator: Linda P Lowes, PT PhD         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Linda p Lowes, PhD columbus cri
  More Information

No publications provided

Responsible Party: Linda Pax Lowes, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01134653     History of Changes
Other Study ID Numbers: IRB07-00110, 663110
Study First Received: May 28, 2010
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
Acute ankle sprain in children and young adults

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

ClinicalTrials.gov processed this record on November 25, 2014