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

Ankle Sprain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134653
• Other study ID #: IRB07-00110
• Secondary ID: 663110
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: February 2015

Study information

• Verified date: June 2019
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

Inclusion Criteria:

• 3 day post injury

Exclusion Criteria:

• fracture

• chronic sprain

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain
• Sprains and Strains

Intervention

Other:
• Jump Stretch
distraction with early mobilization

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days until return to activities	days until return to activities	discharge
Secondary	VAS scale	scale to measure pain 1 week post enrollment	1 week
Secondary	strength	change in strength	1 week
Secondary	Figure of Eight Measurement	change in size of ankle in figure 8 measurement to swelling	1 week