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OpenTrials
Completed

NCT Number: NCT01134653

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

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.

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Key information

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43221, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3 day post injury

Exclusion criteria

  • fracture
  • chronic sprain

Treatment and study plan

Jump Stretch

Other

distraction with early mobilization

Primary outcomes

  1. days until return to activities

    Time frame: discharge

    days until return to activities

Secondary outcomes

  1. VAS scale

    Time frame: 1 week

    scale to measure pain 1 week post enrollment

  2. strength

    Time frame: 1 week

    change in strength

  3. Figure of Eight Measurement

    Time frame: 1 week

    change in size of ankle in figure 8 measurement to swelling

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Efficacy of Stretch Band Ankle Traction Technique in the Treatment of Acute Ankle Sprains.

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jun 2, 2010
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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