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

NCT ID: NCT01134653

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-02-28

Brief 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.

Conditions

Ankle Sprain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Jump stretch

Distraction with early mobilization

Group Type: EXPERIMENTAL

Jump Stretch

Intervention Type: OTHER

distraction with early mobilization

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.

Group Type: ACTIVE_COMPARATOR

Jump Stretch

Intervention Type: OTHER

distraction with early mobilization

Interventions

Jump Stretch

distraction with early mobilization

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 3 day post injury

Exclusion Criteria

• fracture
• chronic sprain

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Alfano

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda p Lowes, PhD

Role: PRINCIPAL_INVESTIGATOR

columbus cri

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

663110

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB07-00110

Identifier Type: -

Identifier Source: org_study_id