Randomised controlled trial of physical therapy in ankle sprains

ISRCTN	ISRCTN74033088
DOI	https://doi.org/10.1186/ISRCTN74033088
Secondary identifying numbers	MCT-94833

Submission date: 02/09/2009
Registration date: 04/09/2009
Last edited: 23/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Robert Brison
Scientific

Department of Emergency Medicine
Empire 3
Kingston General Hospital
76 Stuart St
Kingston
K7L 2V7
Canada

Email	brisonr@kgh.kari.net

Study information

Study design	Single-centre parallel-group randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	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(s)	Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board, 21/07/2009
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2009
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	Both
Target number of participants	504
Key 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
Key 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)
Date of first enrolment	01/10/2009
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

Canada

Study participating centre

Kingston General Hospital

Kingston
K7L 2V7
Canada

Sponsor information

Queen's University (Canada)
University/education

99 University Avenue
Kingston, Ontario
K7L 3N6
Canada

Email	brisonr@kgh.kari.net
Website	http://www.queensu.ca/
"ROR"	https://ror.org/02y72wh86

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (ref: MCT-94833)
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	16/11/2016		Yes	No

Editorial Notes

23/01/2017: The following changes were made to the trial record:
1. The overall trial start date was changed from 14/09/2009 to 01/10/2009.
2. The overall trial end date was changed from 31/08/2011 to 01/04/2013.
3. The target number of participants was changed from 512 to 504.

18/11/2016: Publication reference added.