Ankle sprain Injury, Occupational Diseases, Poisoning Dislocation, sprain and strain of joints and ligaments at ankle and foot level
Conditions
Interventions
Control arm:
Eligible study subjects assigned to the control arm will receive usual care only. This consists of:
1. Ruling out of ankle fractures and grade 3 ligament ruptures
2. Assessment and advic
Sponsors
Queen'?s University (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excellent recovery at 3 months from the effects of the ankle sprain as measured using the FAOS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of recovery for total FAOS and domain-specific scores measured as a continuous variable 2. Functional recovery, as assessed by FAOS, at 1 month and 6 months post-injury (in addition to the primary 3 month endpoint) 3. Clinical and laboratory-based outcome measures of ankle recovery 4. Recurrence of sprain injury in the same ankle | — |
Countries
Canada
Outcome results
None listed