Randomised controlled trial of physical therapy in ankle sprains

Not Applicable

Completed

• Conditions: Ankle sprain; Injury, Occupational Diseases, Poisoning; Dislocation, sprain and strain of joints and ligaments at ankle and foot level

• Registration Number: ISRCTN74033088
• Lead Sponsor: Queen'?s University (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-04
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

1. Subject presents for medical treatment to one of two emergency departments (EDs) in Kingston, Ontario, within 48 hours of injury
2. Aged 16 years and older, both sexes
3. Mentally competent
4. Incident grade 1 or 2 ankle sprain, defined as an initial visit for an acute injury to the lateral and/or medial ligament ankle complex (includes avulsion fractures less than 5 mm at ligament insertion sites)
5. Agrees to attend for laboratory testing and follow-up telephone calls

Exclusion Criteria

1. Baseline Foot and Ankle Outcome Score (FAOS) greater than 450
2. Initial diagnosis of ankle fracture or grade 3 ligament rupture
3. Need for fixed immobilisation or surgery declared by attending medical staff
4. Other soft tissue injuries including direct blows or abrasions
5. Multiple injuries that may impair functional recovery of the ankle (including injury to both ankles)
6. Prior diagnosis of (same) ankle sprain in 6 months preceding ED presentation
7. Other mobility limiting condition (e.g. arthritis or neurological disease/injury affecting lower limb)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Excellent recovery at 3 months from the effects of the ankle sprain as measured using the FAOS

Secondary Outcome Measures

Name	Time	Method
1. Assessment of recovery for total FAOS and domain-specific scores measured as a continuous variable<br>2. Functional recovery, as assessed by FAOS, at 1 month and 6 months post-injury (in addition to the primary 3 month endpoint)<br>3. Clinical and laboratory-based outcome measures of ankle recovery<br>4. Recurrence of sprain injury in the same ankle