Contact information
Type
Scientific
Primary contact
Dr Robert Brison
ORCID ID
Contact details
Department of Emergency Medicine
Empire 3
Kingston General Hospital
76 Stuart St
Kingston
K7L 2V7
Canada
-
brisonr@kgh.kari.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-94833
Study information
Scientific title
Efficacy of a physical therapy intervention for the early treatment of acute ankle sprains identified in the emergency department: a randomised controlled trial
Acronym
Study hypothesis
What is the efficacy of a standardised physical therapy intervention plus usual emergency medical care, versus usual emergency medical care alone, in enhancing functional recovery at 3 months post-injury?
Ethics approval
Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board, 21/07/2009
Study design
Single-centre parallel-group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Ankle sprain
Intervention
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 advice provided by ED nursing and physician staff according to their practice, supported by
3. A printed set of standard discharge instructions
Experimental arm:
Eligible study subjects assigned to the experimental arm will receive usual care (as per control arm) plus a standardised physical therapy intervention aimed at returning the patient to his/her full pre-morbid activity level. Individuals will be seen by one of two therapists within 2 business days of receiving a referral, and will be seen by the same therapist throughout the treatment course. A treatment plan consisting of thirty minute sessions and home exercise will be developed for each patient based on a standard approach requiring assessment of recovery and progression through 4 stages. We expect most patients will require between 3 and 5 sessions. Those with risk factors for chronic ankle instability (e.g. anterior and inversion laxity, functional insufficiency) may require more.
Stage I is focused on managing the acute/subacute symptoms using modalities to decrease pain and swelling and protecting the joint from secondary inflammation and further injury due to instability while promoting pain-free weight bearing as tolerated. These treatment activities may continue into Stage II, although with reduction in pain, more emphasis on improving passive and active range of motion (ROM) through stretching, mobilisation and progressive resistance exercises introduced. In Stage III a more aggressive approach to regaining full ROM in all movement directions, and building strength and endurance in all muscle groups is adopted to increase joint stability and strength. Individualised progressive resistance programs using isometric, isotonic and isokinetic exercises to strengthen muscle groups throughout the ROM and also combined movements (e.g. circumduction). As the patient achieves full weight-bearing and can tolerate resistance exercise at slow and fast velocities without pain, then proprioception training and activity-specific training can be initiated - the focus of Stage IV. This advanced stage prepares the individual to return to full activity by restoring full strength and joint mobility, reducing mechanical and functional insufficiencies that are risk factors for chronic ankle instability and recurrent injury. Depending on the activity level and risk factors for recurrence and chronic instability, protection may be prescribed during activity.
As part of their treatment, patients will receive a home exercise program which they are encouraged to complete 2 - 3 times/day. These programs will be progressed in difficulty as the individual's strength and tolerance improves.
Outcomes will be measured at 3 and 6 months with the 3-month data being used for the primary analyses.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Excellent recovery at 3 months from the effects of the ankle sprain as measured using the FAOS
Secondary outcome measures
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
Overall trial start date
01/10/2009
Overall trial end date
01/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
504
Participant 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)
Recruitment start date
01/10/2009
Recruitment end date
01/04/2013
Locations
Countries of recruitment
Canada
Trial participating centre
Kingston General Hospital
Kingston
K7L 2V7
Canada
Sponsor information
Organisation
Queen's University (Canada)
Sponsor details
99 University Avenue
Kingston
Ontario
K7L 3N6
Canada
-
brisonr@kgh.kari.net
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (ref: MCT-94833)
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR, IRSC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27852621