A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.
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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. |
- days until return to activities [ Time Frame: discharge ] [ Designated as safety issue: No ]
- 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 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
Rest Ice compression and elevation
|
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 |
Inclusion Criteria:
- 3 day post injury
Exclusion Criteria:
- fracture
- chronic sprain
Contacts and Locations| Contact: linda lowes, PT PhD | 614 722 4036 | Linda.lowes@nationwidechildrens.org |
| Contact: jim marrie, pt | 614 722-2000 | james.marrie@nationwidechildrens.org |
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43221 | |
| Contact: Jim Marie | |
| Principal Investigator: Linda P Lowes, PT PhD | |
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: | February 4, 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:
|
Sprains and Strains Ankle Injuries Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on June 18, 2013