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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01134653
First Posted: June 2, 2010
Last Update Posted: February 4, 2015
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.
Information provided by (Responsible Party):
Linda Pax Lowes, Nationwide Children's Hospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Stretch Band Ankle Traction Technique in the Treatment of Acute Ankle Sprains.

Further study details as provided by Linda Pax Lowes, Nationwide Children's Hospital:

Primary Outcome Measures:
  • days until return to activities [ Time Frame: discharge ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 1 week ]
    VAS scale 1 week post enrollment

  • strength [ Time Frame: 1 week ]
    change in strength

  • swelling [ Time Frame: 1 week ]
    change in figure 8 measurement


Enrollment: 42
Study Start Date: January 2010
Study Completion Date: February 2015
Primary Completion Date: June 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3 day post injury

Exclusion Criteria:

  • fracture
  • chronic sprain
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134653


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

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 ( Other Grant/Funding Number: Foundation for Physical Therapy )
First Submitted: May 28, 2010
First Posted: June 2, 2010
Last Update Posted: February 4, 2015
Last Verified: February 2015

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

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