Condition category
Injury, Occupational Diseases, Poisoning
Date applied
02/09/2009
Date assigned
04/09/2009
Last edited
18/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

14/09/2009

Overall trial end date

31/08/2011

Reason abandoned

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

512

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

14/09/2009

Recruitment end date

31/08/2011

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

http://www.queensu.ca/

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

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27852621

Publication citations

Additional files

Editorial Notes

RP 18/11/2016: Publication reference added.