Management of Acute Lateral Ankle Sprains: A Randomized Controlled Trial
Phase: NA
Conditions: Ankle Sprains
Sponsor: Christian Olsen

 
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CLINICAL STUDY PROTOCOL  
Management of acute lateral ankle sprains: A randomized, controlled trial 
 
 
 
 
Principal Investigator: 
Christian Olsen, PT, MSc., PhD 
Candidate 
 
Investigators: 
 
 
Marius Henriksen, PT, PhD, Professor 
 
Søren Thorgaard Skou, PT, PhD  
 
Sponsor:  
Department of Physiotherapy and 
Occupational Therapy, Næstved-Slagelse-
Ringsted Hospitals. 
NCT ID:  
Not yet assigned    
Unique Protocol ID:  
SJ-628 
Date: 
3/5 2018 
 
 
 
 

 
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1.0 
STUDY COMMITTEES 
Protocol Development Committee: 
Name 
Title & Position 
Affiliation 
Christian Olsen 
PT, MSc, PhD Candidate 
Næstved-Slagelse-Ringsted Hospitals 
Marius Henriksen 
PT, PhD, Professor 
Bispebjerg-Frederiksberg Hospital 
Søren Thorgaard Skou 
PT, PhD, Head of Research 
Næstved-Slagelse-Ringsted Hospitals 
Mikael Elsborg 
PT 
The Regional Hospital in Horsens 

 
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2.0 
FLOW CHARTS 
2.1 Enrollment process 
 
Figure 1 Enrollment process 
 
 
 
 

 
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2.2 Study flow chart 
 
Figure 2 Study flow chart 
 
 
 

 
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2.3 Visit schedule 
 
Figure 3 Visit schedule 
 

 
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3.0 
TABLE OF CONTENTS 
1.0 
STUDY COMMITTEES  .................................................................................................................................................. 2 
2.0 
FLOW CHARTS  ................................................................................................................................................................ 3 
2.1 
Enrollment process .......................................................................................................................................................... 3 
2.2 
Study flow chart............................................................................................................................................................... 4 
2.3 
Visit schedule ................................................................................................................................................................... 5 
3.0 
TABLE OF CONTENTS .................................................................................................................................................. 6 
4.0 
TRIAL IDENTIFIER ......................................................................................................................................................10 
4.1 
Full title of trial .............................................................................................................................................................. 10 
4.2 
Short title......................................................................................................................................................................... 10 
4.3 
Acronym.......................................................................................................................................................................... 10 
4.4 
Health Research Ethics Committee Number ............................................................................................................ 10 
4.5 
Trial registration identifier and date ........................................................................................................................... 10 
4.6 
Version number and date.............................................................................................................................................. 10 
4.7 
Revision history ............................................................................................................................................................. 10 
4.8 
Sponsor............................................................................................................................................................................ 11 
5.0 
BACKGROUND INFORMATION .............................................................................................................................12 
6.0 
STUDY HYPOTHESIS...................................................................................................................................................12 
6.1 
Hypothesis ...................................................................................................................................................................... 12 
7.0 
STUDY DESIGN ..............................................................................................................................................................12 
7.1 
Description of the protocol .......................................................................................................................................... 12 
7.1.1 
Justification of a pragmatic trial design..................................................................................................... 13 
7.2 
Duration of study participation ................................................................................................................................... 13 
8.0 
SELECTION AND ALLOCATION OF PARTICIPANTS ..................................................................................14 
8.1 
Number of participants planned .................................................................................................................................. 14 
8.2 
Inclusion Criteria ........................................................................................................................................................... 14 
8.3 
Exclusion Criteria .......................................................................................................................................................... 14 
8.3.1 
Grading of LAS ............................................................................................................................................. 14 
8.3.2 
Chronic ankle instability .............................................................................................................................. 15 
8.4 
Allocation of participants and sequence generation ................................................................................................ 15 
8.5 
Blinding........................................................................................................................................................................... 15 
9.0 
TREATMENTS .................................................................................................................................................................15 

 
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9.1 
Usual care ....................................................................................................................................................................... 15 
9.2 
Physiotherapy ................................................................................................................................................................. 16 
9.2.1 
ESP physiotherapy ........................................................................................................................................ 16 
9.2.2 
Exercise program for the physiotherapy group ........................................................................................ 16 
9.3 
Concomitant Therapy ................................................................................................................................................... 17 
10.0 
OUTCOME ASSESSMENTS/VARIABLES .......................................................................................................17 
10.1 
Primary Outcome ..................................................................................................................................................... 17 
10.1.1 
Lower extremity functional scale ............................................................................................................... 17 
10.2 
Secondary outcomes ................................................................................................................................................ 17 
10.2.1 
Pain at rest and with activity, assessed using a visual analogue scale (VAS)..................................... 17 
10.2.2 
Foot and ankle ability measure (FAAM)19 .............................................................................................. 18 
10.2.3 
The Cumberland ankle instability tool (CAIT)22 ..................................................................................... 18 
10.2.4 
Reinjury rates ................................................................................................................................................. 18 
10.2.5 
Quality of life (EQ-5D-3L)24 ....................................................................................................................... 18 
10.2.6 
Global perceived effect (GPE)25 ................................................................................................................. 19 
10.2.7 
Patient acceptable symptom state (PASS)26.............................................................................................. 19 
10.2.8 
Analgesic use.................................................................................................................................................. 19 
10.3 
Data collection methods.......................................................................................................................................... 19 
11.0 
DISCONTINUATION ...............................................................................................................................................20 
11.1 
Participant withdrawal............................................................................................................................................. 20 
11.2 
Discontinuation of clinical sites............................................................................................................................. 20 
11.3 
Discontinuation of Entire Study............................................................................................................................. 21 
12.0 
STUDY PROCEDURES ............................................................................................................................................21 
12.1 
Trial related clinical visits ...................................................................................................................................... 21 
12.2 
Assessment windows............................................................................................................................................... 21 
12.3 
Baseline assessment................................................................................................................................................. 21 
12.4 
Study completion...................................................................................................................................................... 22 
12.5 
Collection of data from hospital records .............................................................................................................. 22 
13.0 
DETERMINATION OF SAMPLE SIZE AND STATISTICAL ANALYSIS PLAN...............................22 
13.1 
Determination of Sample Size ............................................................................................................................... 22 
13.2 
Participants description ........................................................................................................................................... 22 

 
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13.2.1 
Disposition of Participants ........................................................................................................................... 22 
13.3 
Study Population definitions .................................................................................................................................. 23 
13.3.1 
Intention to treat population (ITT).............................................................................................................. 23 
13.3.2 
Per protocol (PP) ........................................................................................................................................... 23 
13.3.3 
As-observed population (AO) ..................................................................................................................... 23 
13.4 
Data analysis considerations .................................................................................................................................. 23 
13.5 
General statistical approach.................................................................................................................................... 23 
13.5.1 
Concomitant medication and/or therapy.................................................................................................... 23 
13.6 
Primary analysis ....................................................................................................................................................... 24 
13.6.1 
Primary outcome analysis ............................................................................................................................ 24 
13.6.2 
Data transformation before analysis, if any .............................................................................................. 24 
14.0 
STUDY COMMITTEES  ...........................................................................................................................................24 
14.1 
Protocol Development Committee ........................................................................................................................ 24 
14.1.1 
Membership .................................................................................................................................................... 24 
14.1.2 
Roles and responsibilities............................................................................................................................. 24 
14.2 
Executive Committee .............................................................................................................................................. 24 
15.0 
ETHICS..........................................................................................................................................................................25 
15.1 
General considerations ............................................................................................................................................ 25 
15.2 
Oral information ....................................................................................................................................................... 25 
15.3 
Written information ................................................................................................................................................. 26 
15.4 
Informed consent...................................................................................................................................................... 26 
15.5 
Research ethics -the interventions ......................................................................................................................... 26 
15.5.1 
Physiotherapy ................................................................................................................................................. 26 
15.5.2 
Usual care ....................................................................................................................................................... 26 
15.6 
Research ethics – the outcome measures ............................................................................................................. 27 
15.6.1 
Questionnaires................................................................................................................................................ 27 
15.7 
Research ethics approval......................................................................................................................................... 27 
16.0 
CASE REPORT FORM COMPLETION ............................................................................................................27 
16.1 
Case Report Forms ................................................................................................................................................... 27 
17.0 
REGULATORY STANDARDS ..............................................................................................................................27 
17.1 
Notification to the Danish Data Protection Agency ........................................................................................... 27 

 
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17.2 
Financing and insurance information  ................................................................................................................... 27 
18.0 
PUBLICATION ...........................................................................................................................................................28 
19.0 
INVESTIGATOR'S AGREEMENT......................................................................................................................29 
20.0 
REFERENCE LIST....................................................................................................................................................30 
21.0 
APPENDICES  ..............................................................................................................................................................33 
21.1 
Appendix 1 – S.O.P. ................................................................................................................................................ 33 
21.2 
Appendix 2 – Exercise program ............................................................................................................................ 34 
21.3 
Appendix 3 – Outcomes.......................................................................................................................................... 36 
21.4 
Appendix 4 – Baseline form................................................................................................................................... 44 
21.5 
Appendix 8 – Informed consent form................................................................................................................... 45 
 

 
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4.0 
TRIAL IDENTIFIER 
4.1 Full title of trial 
Management of acute lateral ankle sprains: A randomized, controlled trial 
4.2 Short title 
Management of acute lateral ankle sprains 
4.3 Acronym 
Pending 
4.4 Health Research Ethics Committee Number 
SJ-628 
4.5 Trial registration identifier and date 
Pending 
4.6 Version number and date 
Version 1.0 (first draft for committee review; pre-authorisation version) 
Version 1.1 (Updated with changes, as specified by the secretary, before presentation to the 
health research ethics commitee) 
Version 1.2 (Updated with changes, as specified by the regional health research ethics 
committee) 
Version 1.3 (Updated with changes, as specified by reviewers from www.clinicaltrials.com) 
4.7 Revision history 
Version # 
Issue date 
List of major changes 
1.0 
May 29, 2017 
This is the first draft 
1.1 
June 8, 2017 
All questionnaires will be translated to Danish before trial 
start. 
The Study will be carried out following “The Act on 
Processing of Personal Data” 
All positive, negative or inconclusive results will be 
published at www.clinicaltrials.gov.  

 
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1.2 
July 25, 2017 
Mikael Elsborg is included in the study committee. 
The economic properties for this study is included in the 
written information. 
1.3 
May 3, 2018 
Translated all information to English before publication 
on www.clinicaltrials.com.  
Updated the first page to include the unique Human 
Subjects Review board number: SJ-628 and date. 
Finn Erland Nielsen has withdrawn his participation in 
this study and thus removed from the protocol 
development committee. 
4.8 Sponsor 
The Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted 
Hospitals. 
 
 

 
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5.0 
BACKGROUND INFORMATION  
Lateral ankle sprains (LAS) is the most common injury in the active population 1–4. Not only is 
the injury prevalent within organized sports, but also display high prevalence in the general 
population presenting at the emergency departments (ED) 2,5. LAS accounts for about 3-5% of all 
visits to the ED, but total LAS incidence rates are increasing in the general population6 10. 
Acute LAS is defined by Delahunt et al.8 and endorsed by the International ankle consortium9 as: 
“An acute traumatic injury to the lateral ligament complex of the ankle joint as a result of 
excessive inversion of the rear foot or a combined plantar flexion and adduction of the foot.” 
The treatment of LAS in the emergency department consists of initial assessment and acute 
management of the injured foot, traditionally done by a physician. The typical assessment 
consists of ruling out severe injury, i.e. fracture, using the Ottawa ankle foot rules 10,11.  The 
acute management of the injured ankle is typically composed of a treatment approach consisting 
of Rest, Ice, Compression and Elevation (RICE).  
Extended Scope of Practice (ESP) physiotherapists in EDs have shown to generate high levels of 
patient satisfaction12,13, reduce patient waiting times14 and have high clinical effectiveness13, yet 
high quality randomized trials investigating the clinically effectiveness of ESP physiotherapy are 
lacking. Acute LAS is one of the most common injuries managed in EDs and poor functional 
status within the initial 2 weeks after injury is predictive of development of chronic ankle 
instability (CAI)15, which can be a serious barrier for future physical activity and occupational 
performance. Early and targeted interventions provided in the emergency department by ESP 
physiotherapists may therefore prove to be beneficial for the patients and the society.  
We therefore propose this trial that aims to assess the effectiveness of ESP physiotherapy as a 
mean to enhance the outcome of acute LAS following presentation to an emergency department.  
6.0 
STUDY HYPOTHESIS 
6.1 Hypothesis 
The functional outcome following presentation to an ED with an acute LAS is superior when 
managed by an ESP physiotherapist compared to usual procedures. 
7.0 
STUDY DESIGN 
7.1 Description of the protocol 
This is a randomized, pragmatic, superiority study with 1, 2, 3 and 4 weeks, and 3, 6 and 12 
months of follow-up (figure 2). The study will be carried out in the emergency department at 2 

 
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large public hospitals in Slagelse and Horsens, Denmark. Two-hundred-twenty-six adults with 
an acute lateral ankle sprain will be included in this study.  
 
The participants will be randomly allocated to one of two treatment strategies:  
Strategy A: A single session with advice and instructions from an ESP 
physiotherapist in rest, ice, compression and elevation AND pain guided early 
weight bearing plus a written home-based exercise program (ESP physiotherapy 
group).  
or  
Strategy B: A single session with advice and instructions from a physician in rest, 
ice, compression and elevation (usual care).  
 
The randomized allocation will be equal (1:1).  
 
7.1.1 
Justification of a pragmatic trial design 
The pragmatic trial design has the benefit of making employees and decision-makers in the 
emergency department aware of the protentional benefits in early weight bearing and exercise in 
the large group of people presenting with an acute LAS. Participants receiving information and 
advice from a physiotherapist in the emergency department, will be giving instructions in early 
weight bearing and exercise and the participants receiving usual care will not, because it is the 
effects of these two strategies, when administered in the emergency department, we want to 
compare. The pragmatic design means that the trial will provide valuable information that will 
help clinicians and decision-makers decide if advice from a physiotherapist in the emergency 
department improves the clinical outcomes of acute LAS.  
 
7.2 Duration of study participation 
The study’s duration is 12 months after randomization.  
 

 
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8.0 
SELECTION AND ALLOCATION OF PARTICIPANTS 
8.1 Number of participants planned 
It is anticipated that 226 participants will be enrolled in this study. A participant may be enrolled 
in this study provided he/she has met all the inclusion criteria and has not met any of the 
exclusion criteria.  
 
8.2 Inclusion Criteria 
An individual will be eligible for study participation if he/she meets the following criteria: 
1. A grade 1 or 2 LAS sustained within 24 hours of randomization 
2. To be a minimum age of 18  
3. Signed informed consent 
 
8.3 Exclusion Criteria 
A participant will be excluded from the study if he/she meets any of the following criteria: 
1. A grade 3 LAS injury sustained 
2. Diagnosed with chronic ankle instability (CAI) on the affected limb 
3. Fracture diagnosed by X-ray 
4. Previous enrollment in the same study 
5. Major lower limb surgery or other severe lower extremity injury in the past 3 months on 
the affected limb 
6. Under the influence of drugs or alcohol  
7. A condition that, in the opinion of the investigator, would preclude participation in the 
study (e.g., not having access to the internet, immobilization etc.) 
 
8.3.1 
Grading of LAS 
The grading of each patient is following Standard Operating Procedures (S.O.P.) (Appendix 1).  
1.° LAS (At present the patient can bear weight) 
2.° LAS (Pronounced limping, major pain) 
3.° LAS (The patient cannot bear weight on the foot) 

 
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8.3.2 
Chronic ankle instability 
The participant should report a minimum of one major LAS injury sustained a minimum of 12 
months prior to assessment for eligibility of enrolment in the study. After this injury, the 
participant should have experienced the classical signs of decreased function and swelling.  
Participants should report at least two episodes of ‘giving way’ or have sustained two or more 
ankle sprains to the same ankle in the 6 months prior to the study enrolment to be diagnosed with 
CAI 9. 
We endorse the definition of giving way as: “The regular occurrence of uncontrolled and 
unpredictable episodes of excessive inversion of the rear foot (usually experienced during initial 
contact during walking or running), which do not result in an acute lateral ankle sprain” 8. 
 
8.4 Allocation of participants and sequence generation 
We will stratify the randomization by 
- 
Site (2 levels; Slagelse Hospital and The Regional Hospital in Horsens) 
The allocation ratio will be 1:1. 
Randomization lists will be computer-generated based upon permuted random blocks of variable 
size (3 to 6 in each block).  
 
8.5 Blinding 
Data analysts will be blinded to treatment allocation.  
 
9.0 
TREATMENTS 
9.1 Usual care 
Participants allocated to usual care (Strategy B) will receive instructions in managing their acute 
LAS accordingly to the S.O.P. at the site (Appendix 1). These guidelines consist of advice 
provided by the physician at work in; Rest, Ice, Compression and Elevation. Avoiding new 
stretches/ sprains for a few months after the injury is advised and gradually putting more weight 
on the ankle, progressing to running and twisting.  
 

 
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9.2 Physiotherapy 
Participants allocated to ESP physiotherapy (Strategy A) will receive instructions on how to 
manage their acute LAS and a written homebased exercise program by an ESP physiotherapist. 
The instructions on how to manage their acute LAS will consist of written and oral advice. The 
protocol consists of advice in accelerated weight bearing, already at discharge. It is advised to 
bear weight and exercise with pain up to, but not exceeding, VAS 5. The written homebased 
exercise program should be initiated at discharge from the hospital. When patients are 
experiencing pain exceeding VAS 5 they will follow the same guidelines as the usual care group 
consisting of Rest, Ice, Compression and Elevation.     
Compression, with an elastic bandage, is administered in the ED and instructions on how to 
apply and manage the bandage correctly, will be given. The bandage should be worn all day, 
including at night for 3 weeks. The elastic bandage should also be worn as protection when 
performing exercises and activities that increases the risk of reinjury for a minimum of 3 month 
after injury. 
 
9.2.1 
ESP physiotherapy 
An ESP Physiotherapist is a clinical physiotherapy specialist with an extended scope of practice. 
This implies working beyond the recognized scope of physiotherapy practice, for example 
requesting investigations e.g. X-rays; using the results of investigations to assist clinical 
diagnosis and appropriate management of patients; and referring to other professionals. The ESP 
physiotherapist will have a minimum of 2 years of relevant clinical experience in assessment, 
diagnosing and treating of patients with minor musculoskeletal injuries. The ESP physiotherapist 
has taken or are currently enrolled in supplementing their basic professional training with 
additional courses in musculoskeletal physiotherapy. 
 
9.2.2 
Exercise program for the physiotherapy group 
The exercise program from baseline to 4 weeks follow-up will consist of ankle rehabilitation 
exercises focusing on walking with full weight bearing, neuromuscular training, balance 
training, muscle strengthening and jumping. The participants will be asked to perform the 
exercises on a daily basis. The exercises should be performed with pain up to but not exceeding 
5 on an 0-10 VAS pain scale. If the patient experience VAS pain ≥6 he/she should follow the 
standard guidelines of rest, ice, compression and elevation. The patient will receive information 
on how to perform the exercises by the ESP physiotherapist and an exercise program will be 

 
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handed out in the ED (Appendix 2). A link will be sent to the participants with the same exercise 
program including online videos describing the exercise in detail. 
 
9.3 Concomitant Therapy 
Participants will be asked to register the type and frequency of any concomitant therapy. There 
will be no restrictions in concomitant therapy.  
 
10.0 
OUTCOME ASSESSMENTS/VARIABLES 
10.1 Primary Outcome 
10.1.1 
Lower extremity functional scale 
The primary outcome measure is the change from baseline in the Lower extremity functional 
scale (LEFS)16 assessed at 4 weeks after randomization. LEFS will also be assessed at 1, 2 and 3 
weeks, and 3, 6 and 12 months, these timepoints will be regarded as secondary outcomes.  
The Lower extremity functional scale is a self-completed questionnaire providing a total score 
based on the patients subjective ankle function. The scale consists of 20 functional leg activities, 
each scored on a five point scale (0 impossible, 4 no difficulty), giving a minimum score of 0 
(worst) to 80 (best). The questionnaire will be translated into Danish using a dual-panel 
approach before trial start. The LEFS will be scored online by the trial participant. This approach 
avoids the requirement for follow-up visits in a clinic.  
 
10.2 Secondary outcomes 
The following secondary outcomes will be measured, at baseline and the 1, 2, 3 and 4 weeks, 
and 3, 6 and 12 months follow-ups, unless stated otherwise. All of the secondary outcomes will 
be scored online by the trial participant. This approach avoids the requirement for follow-up 
visits in a clinic. 
 
10.2.1 
Pain at rest and with activity, assessed using a visual analogue scale (VAS) 
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in 
diverse adult populations17,18. The scale is a continuous scale comprised of a horizontal line, 

 
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anchored by 2 verbal descriptors, one for each symptom extreme (0 no pain, 10 the worst 
imaginable pain). We will measure pain VAS at rest and pain VAS with activity.     
 
10.2.2 
Foot and ankle ability measure (FAAM)19  
The FAAM scale is a region-specific outcome instrument divided in two separate subscales, the 
FAAM activities of daily living (adl) and the FAAM Sports subscales. Evidence of validity to 
support the use of the FAAMadl and FAAMsport is available in individuals with a wide array of 
ankle and foot disorders19–21. The questionnaire will be measured at 1, 2, 3 and 4 weeks, and 3, 
6 and 12 month follow-ups and used in secondary analysis. The questionnaire will not be 
measured at baseline. The questionnaire will be translated into Danish using a dual-panel 
approach before trial start. 
 
10.2.3 
The Cumberland ankle instability tool (CAIT)22 
The CAIT is a simple, validated, and reliable tool to measure severity of functional ankle 
instability9,22. The CAIT consists of 9 questions that are answered separately for the right and 
left ankle. It is scored on a 30-point scale, with lower scores indicating decreased stability. The 
minimal clinically important difference (MCID) for patients with chronic ankle instability is  ≥3 
points23. The questionnaire will be translated into Danish using a dual-panel approach before 
trial start. 
 
10.2.4 
Reinjury rates  
Reinjury rates will be recorded during follow-up assessments at weeks 1-4 and 3-12 months. We 
endorse the definition of an ankle sprain as: “An acute traumatic injury to the lateral ligament 
complex of the ankle joint as a result of excessive inversion of the rear foot or a combined 
plantar flexion and adduction of the foot. This usually results in some initial deficits of function 
and disability”8,9. Reinjury will not be considered as a stopping rule for further participation in 
this study. Reinjures will be measured at 1, 2, 3 and 4 weeks, and 3, 6 and 12 month follow-ups 
and used in secondary analysis. 
 
10.2.5 
Quality of life (EQ-5D-3L)24 
The EQ-5D-3L is a measure of current health status developed by the EuroQol Group for 
clinical and economic appraisals. The questionnaire consists of five questions assessing five 

 
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dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each 
dimension is rated on three levels: no problems, some problems and extreme problems.  
 
10.2.6 
Global perceived effect (GPE)25  
Perceived effect of treatment will be measured using a transition questionnaire (TRANS-Q) on 
which the participants will answer if their current LAS-related health status is “unchanged”, 
“worse” or “better” compared to their pre-LAS status. An “unchanged” equals a transition score 
of 0. If the participant answers “worse”, he/she is asked to rate the degree of worsening on a 7 
point Likert scale, and the corresponding scores range from -1 to -7. If a participant answers 
“better”, he/she is asked to rate the degree of improvement on a 7 point Likert scale, and the 
corresponding scores range from 1 to 7.  
 
10.2.7 
Patient acceptable symptom state (PASS)26 
The PASS is the value beyond which patients consider themselves well. Patients’ opinions of 
their state will be recorded by answering ‘‘Yes’’ or ‘‘No’’ to the question: ‘‘Taking into account 
all the activities you have during your daily life, your level of pain, and also your functional 
impairment, do you consider your current state is satisfactory?’’.   
 
10.2.8 
Analgesic use 
The participants self-reported use of analgesics will be collected at baseline and at follow-up 
week 1-4. Participants will be asked to note their use of analgesic drugs within the week before 
baseline and the follow-up.  
 
10.3 Data collection methods 
For consenting patients, we will at Baseline collect data on age, height, body weight, previous 
lateral ankle sprain, limb dominance, injured limb left/right, time since injury, education, 
employment, patient’s contact details (Appendix 4). The information will be derived using an 
online platform on an Ipad available in the emergency department. Baseline data will be 
collected after randomization, but before treatment, E.g. in the waiting room after medical 
imaging.     

 
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The questionnaires will be sent to the participants in the study at 1, 2, 3 and 4 weeks and 3, 6, 
and 12 months. The data will be collected using an internet-based platform (Easytrial), with 
personal links sent to the participants on the day the window for follow-up opens. The window 
for completion of data registration will be small during the first 4 weeks allowing only a ±2-day 
registration window. At the 3, 6 and 12-month follow-up, reminders will be sent one and two 
weeks before and one week after the follow-up date. This will give a window of 4 weeks for 
completion of the assessments. See Appendix 7 for a copy of the covering letters.  
To improve response rates participants will be offered the option of completing the 
questionnaires in paper versions to be returned by post. We will send pre-notification 
messages/emails/letters. 
 
11.0 
DISCONTINUATION 
11.1 Participant withdrawal 
As this is a study performed in the emergency department, participants will not be able to have a 
24-hour consideration period before inclusion in the study. We consider the study and its 
procedures to be justified from a health research ethics perspective. There are no risks or 
predictable harms associated with this approach.  
A participant is advised to contact the investigators by telephone if they wish to withdraw from 
the study. A participant will be able to withdraw at any time point throughout the study period 
without this impacting on any future investigations and/or treatments.  
If a participant withdraws from the study, the primary and secondary outcomes are sought 
collected before discontinuation.  
 
11.2 Discontinuation of clinical sites 
The Sponsor has the right to terminate the participation of a clinical site at any time. Reasons 
may include the following, but are not restricted to: 
 The incidence of events at the site that indicate a potential health hazard to participants 
and which is not considered sporadic (i.e. events could be expected to occur at other sites 
as well). 
 Unsatisfactory participant enrolment at the site. 
 Unsatisfactory data completeness at the site. 

 
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 The incidence of protocol violations at the site which is not considered sporadic or very 
severe (i.e. events could be expected to occur at other sites as well). 
 
11.3 Discontinuation of Entire Study 
The Sponsor has the right to terminate this study at any time. Reasons may include the 
following, but are not restricted to: 
 The incidence of events in this or other studies that indicate a potential health hazard to 
participants. 
 Unsatisfactory participant enrolment. 
 
12.0 
STUDY PROCEDURES 
12.1 Trial related clinical visits 
There will be no trial-related clinical assessments. Follow-up will be done only via internet-
based assessments.   
 
12.2 Assessment windows 
The assessment windows are as follows:   
 Baseline measurements will be taken after randomization but before treatment in the ED. 
 Outcome assessment at 1, 2, 3 and 4 weeks can be taken within ± 2 day for the scheduled 
assessment 
 Outcome assessments at 3, 6, and 12 months can be taken within ± 2 weeks before or 
after the scheduled assessment. 
 
12.3 Baseline assessment 
Baseline tests and procedures must be performed and reviewed before allocation. The following 
information/assessments will be collected at the baseline visit: 
1. Inclusion/exclusion criteria review 
2. Collection of baseline information (Appendix 4) 

 
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3. Collection of primary and secondary outcomes 
4. Randomization 
 
12.4 Study completion 
The end-of-study is defined as the date of the last participant's last scheduled assessment, 12 
months after enrollment.  
 
12.5 Collection of data from hospital records 
All relevant information on participants will be collected using online Case Report Forms 
(CRF). No additional information will be collected from the included participant’s hospital 
records. 
13.0 
DETERMINATION OF SAMPLE SIZE AND STATISTICAL ANALYSIS PLAN  
13.1 Determination of Sample Size 
The study will be powered to detect a difference in change of 9 points between the two groups in 
the primary outcome (LEFS) from baseline to 6 months follow-up. The 9 point change has 
previously been recommended and applied in similar studies as the minimal clinically important 
difference in LEFS27. To detect this difference, we will need 94 patients in each group (assuming 
a common SD of 19, power = 90%, alpha level = 0.05). We plan to recruit 226 patients to 
account for loss to follow-up (20%).  
 
13.2 Participants description 
13.2.1 
Disposition of Participants 
The total number of randomized participants will be summarized by site using counts and 
percentages. The number of patients either completing or discontinuing the study will be 
summarized using counts and percentages.  
 

 
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13.3 Study Population definitions 
13.3.1 
Intention to treat population (ITT) 
The ITT population consists of all randomized patients regardless of whether the patient 
received study intervention or failed to comply with the study protocol, in the treatment group to 
which the participant was assigned (see Figure 2). 
 
13.3.2 
Per protocol (PP) 
The per protocol population consists of participants in the ITT population with a valid baseline 
measurement of the variable to be analyzed.  
 
13.3.3 
As-observed population (AO) 
The AO population consists of participants who has the outcome of interest assessed at a given 
time point of interest (i.e. no imputation of missing data will be done). 
 
13.4 Data analysis considerations 
The primary outcome is change from baseline in the lower extremity functional scale and will be 
analyzed using the ITT population. 
 
13.5 General statistical approach 
For quantitative variables we will calculate mean, standard deviation, median, range and number 
of missing data. 
All summary tables for qualitative variables will display counts, percentages and number of 
missing data (if relevant) by treatment group. 
All statistical tests will be two-sided and statistical significance will be claimed if the computed 
p-value is equal to or less than 0.05. 
 
13.5.1 
Concomitant medication and/or therapy 
The use of concomitant medications and/or therapies (e.g. GP consultations, physiotherapy, etc.) 
will be summarized in each treatment group.  

 
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13.6 Primary analysis 
13.6.1 
Primary outcome analysis 
The primary endpoint is the change from baseline in the lower extremity functional scale at the 
4-week follow-up. The primary analysis will be done on the ITT population. 
 
13.6.2 
Data transformation before analysis, if any 
No data transformation will be applied to raw data. 
14.0 
STUDY COMMITTEES 
14.1 Protocol Development Committee 
14.1.1 
Membership 
The Protocol Development Committee of this study is composed of scientific, technical, and 
administrative persons from participating sites and other collaborating participants. There are no 
restrictions to the number of members in the committee. 
 
14.1.2 
Roles and responsibilities 
This committee, led by its chairman Christian Olsen, is responsible for development, refinement, 
and finalization of this protocol and planning of activities related to the study. 
This study was conceptualized by Christian Olsen (Study Chairman and principal investigator). 
The initial version of the protocol (version 1.0) was developed by Christian Olsen. 
 
14.2 Executive Committee 
The research group consists of the PhD student Christian Olsen M.Sc. in physiotherapy who will 
be the central study coordinator and principal investigator. Christian Olsen has experience as an 
ESP in the ED at Slagelse Hospital.  
Marius Henriksen, Professor of Physiotherapy at the University of Copenhagen. Marius Henriksen 
has a special interest in research in musculoskeletal injuries and diseases and has experience with 
the implementation of large multicenter studies. 

 
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Søren Thorgaard Skou, PhD Physiotherapist, head of research at the Department of Physiotherapy 
and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals. Søren has experience with the 
design, conduct and reporting of RCT studies and coordinating large multicenter cohorts in 
musculoskeletal conditions.  
Finn Erland Nielsen is head of Research and Chief Physician in the emergency department at 
Slagelse Hospital. Finn Nielsen has clinical epidemiology, register based research and emergency 
medicine as main interests. He has acquired a doctorate in medicine and a master degrees in 
applied statistics and public management. Finn Nielsen is research supervisor for doctors and 
medical students and has been assessor of a large number of PhD theses’.  
Mikael Elsborg, physiotherapist, is managing the ESP physiotherapists working at The Regional 
Hospital in Horsens. He has a great interest in collection of data, and working with research 
projects. Mikael will be responsible for the coordination of data collection at the Horsens site in 
this study. 
15.0 
ETHICS 
15.1 General considerations 
Prior to assessment for eligibility the trial participants will be informed, both orally and in 
writing, about the purpose of this trial, the overall duration and potential risks, as well as costs 
and benefits for participation. The leaflet “Forsøgspersoners rettigheder i et 
sundhedsvidenskabeligt forskningsprojekt” will be handed out and participants will be 
encouraged to read it before trial enrolment. All participants are informed of their rights to 
withdraw from the study. The participant may withdraw oral, written or with other clear 
indications about the attend to resign from the research project. If the participant withdraws their 
consent, this will not affect their right to present or future treatment or any other rights they may 
have. After the information is delivered, read and understood, voluntary informed consent is 
given by the participant by signing a consent form before trial participation can take place. 
 
15.2 Oral information 
When a potential participant is identified during initial assessment in the ED he/she will be given 
information about this trial. If further investigations are needed to determine eligibility for 
enrollment, the information will be given after completion of these. It will be stressed that the 
investigator is asking the participant to consider participation in the trial, and that the potential 

 
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trial participant has the right to bring a companion to the information interview, if possible. The 
written information material will be handed out in the ED by the trial investigator. The 
participants will not be able to have a 24-hour consideration period before inclusion in the study, 
but will have sufficient time to consider inclusion. The oral information will be given in a 
language easily understood without technical or value-laden terms. The information will be 
given in a considerate way that is tailored to each potential trial participants. The conversation 
will take place without interference. It is the responsibility of the interviewer to ensure that the 
potential trial participant has understood all the information giving. Guidelines for the oral 
information are given in Appendix 6. 
 
15.3 Written information 
A written information material has been prepared and is attached this protocol as Appendix 5. 
 
15.4 Informed consent 
Consent to participation in the trial is given on the basis of the written and oral information. An 
informed consent form (Appendix 8) has been prepared. The form must be signed and dated by 
the participants prior to participation in the trial. A copy of the form is provided to the 
participants. The investigator or his designated delegates can receive the signed consent form.  
 
15.5 Research ethics -the interventions 
15.5.1 
Physiotherapy 
The study will be conducted in accordance with the Helsinki declaration and follow ICH9 Good 
Clinical Practice guidelines. We consider the study and its procedures to be justified from a 
health research ethics perspective. There are no risks or predictable harms associated with the 
physiotherapy intervention that at worst are considered harmless.  
 
15.5.2 
Usual care 
As this is defined as usual clinical care it is not considered to be associated with research ethical 
issues. 
 

 
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15.6 Research ethics – the outcome measures 
15.6.1 
Questionnaires 
Questionnaires are not considered to be associated with research ethical issues.  
 
15.7 Research ethics approval 
The study will be conducted in accordance with Danish law, the Helsinki declaration, and local 
research ethics committee requirements. 
The Sponsor is responsible for keeping the ethical committee informed of amendments or 
changes to the protocol, and the progress of the study. 
 
16.0 
CASE REPORT FORM COMPLETION 
16.1 Case Report Forms 
The study will use electronic CRFs using an online web-based clinical trial management 
application (EasyTrial). EasyTrial allows individual patients to supply data from home.  
The application meets all regulatory standards, and allows management of all activities related to 
clinical trials that ensures optimal resource use and safety according to good clinical practice and 
data protection legislation. 
 
17.0 
REGULATORY STANDARDS 
This study will be conducted in accordance to the Danish law: “The Act on Processing of 
Personal Data”. 
 
17.1 Notification to the Danish Data Protection Agency 
Because the study is carried out at hospital emergency departments, it is regarded as "public" in 
accordance with the Data Protection Agency guidance. The study will be notified to the Data 
Protection Agency before trial start. 
 
17.2 Financing and insurance information 
The study is funded by: 

 
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The Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted 
Hospitals. 
The Research Unit at Næstved, Slagelse and Ringsted Hospital. 
18.0 
PUBLICATION 
This study will be published in a peer-reviewed journal. In addition, the results will be presented 
at international conferences.  
In addition, the results will be regularly presented at an Annual National Seminar on ESP 
physiotherapists in the emergency room, arranged by the Department of Physiotherapy and 
Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Region Zealand. 
All positive, negative or inconclusive results will be published at www.clinicaltrials.gov.  

 
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19.0 
INVESTIGATOR'S AGREEMENT 
1. I have read this protocol and agree that the study is ethical. 
2. I agree to conduct the study as outlined and in accordance with all applicable            
regulations and guidelines. 
3. I agree to maintain the confidentiality of all information received or developed in 
connection with this protocol. 
 
Investigator name (printed) 
 
 
Date & Signature 
 
Christian Olsen______________ 
 
 
__________________________ 
Marius Henriksen____________ 
 
 
__________________________ 
Søren T. Skou_______________ 
 
 
__________________________ 
Finn Erland Nielsen__________ 
 
 
__________________________ 
__________________________ 
 
 
__________________________ 
__________________________ 
 
 
__________________________ 
__________________________ 
 
 
__________________________ 
__________________________ 
 
 
__________________________ 
__________________________ 
 
 
__________________________ 
__________________________ 
 
 
__________________________ 

 
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20.0 
REFERENCE LIST 
1.  
Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ. The epidemiology of 
ankle sprains in the United States. J Bone Joint Surg Am. 2010;92(13):2279-2284. 
doi:10.2106/JBJS.I.01537. 
2.  
Bridgman SA, Clement D, Downing A, Walley G, Phair I, Maffulli N. Population based 
epidemiology of ankle sprains attending accident and emergency units in the West 
Midlands of England, and a survey of UK practice for severe ankle sprains. Emerg Med J. 
2003;20(6):508-510. http://www.ncbi.nlm.nih.gov/pubmed/14623833. Accessed January 
18, 2017. 
3.  
Lambers K, Ootes D, Ring D. Incidence of Patients with Lower Extremity Injuries 
Presenting to US Emergency Departments by Anatomic Region, Disease Category, and 
Age. Clin Orthop Relat Res. 2012;470(1):284-290. doi:10.1007/s11999-011-1982-z. 
4.  
Siebe De Boer A, Schepers T, Panneman MJ, Van Beeck EF, Van Lieshout EM. Health 
care consumption and costs due to foot and ankle injuries in the Netherlands, 1986–2010. 
BMC Musculoskelet Disord. 2014;15:1-10. doi:10.1186/1471-2474-15-128. 
5.  
Brison RJ, Brison RJ, Day AG, et al. Effect of early supervised physiotherapy on recovery 
from acute ankle sprain: randomised controlled trial. BMJ. 2016;355. 
doi:10.1136/bmj.i5650. 
6.  
Lamb SE, Marsh JL, Hutton JL, Nakash R, Cooke MW. Mechanical supports for acute, 
severe ankle sprain: a pragmatic, multicentre, randomised controlled trial. Lancet. 
2009;373(9663):575-581. doi:10.1016/S0140-6736(09)60206-3. 
7.  
Kemler E, van de Port I, Valkenberg H, Hoes AW, Backx FJG. Ankle injuries in the 
Netherlands: Trends over 10-25 years. Scand J Med Sci Sport. 2015;25(3):331-337. 
doi:10.1111/sms.12248. 
8.  
Delahunt E, Coughlan GF, Caulfield B, Nightingale EJ, Lin CWC, Hiller CE. Inclusion 
criteria when investigating insufficiencies in chronic ankle instability. Med Sci Sports 
Exerc. 2010;42(11):2106-2121. doi:10.1249/MSS.0b013e3181de7a8a. 
9.  
Gribble PA, Delahunt E, Bleakley C, et al. Selection Criteria for Patients With Chronic 
Ankle Instability in Controlled Research: A Position Statement of the International Ankle 
Consortium. J Orthop Sport Phys Ther. 2013;43(8):585-591. 
doi:10.2519/jospt.2013.0303. 

 
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10.  
Stiell IG, McDowell I, Nair RC, et al. Use of radiography in acute ankle injuries: 
physicians’ attitudes and practice. CMAJ. 1992;147(11):1671-1678. 
http://www.ncbi.nlm.nih.gov/pubmed/1362372. Accessed May 11, 2017. 
11.  
Knudsen R, Vijdea R, Damborg F. Validation of the Ottawa ankle rules in a Danish 
emergency department. Dan Med Bull. 2010;57(5):A4142. 
http://www.ncbi.nlm.nih.gov/pubmed/20441713. Accessed May 11, 2017. 
12.  
McClellan CM, Greenwood R, Benger JR. Effect of an extended scope physiotherapy 
service on patient satisfaction and the outcome of soft tissue injuries in an adult 
emergency department. Emerg Med J. 2006;23(5):384-387. 
doi:10.1136/emj.2005.029231. 
13.  
McClellan CM, Cramp F, Powell J, Benger JR. A randomised trial comparing the clinical 
effectiveness of different emergency department healthcare professionals in soft tissue 
injury management. BMJ Open. 2012;2(6). doi:10.1136/bmjopen-2012-001092. 
14.  
Guengerich M, Brock K, Cotton S, Mancuso S. Emergency department primary contact 
physiotherapists improve patient flow for musculoskeletal patients. Int J Ther Rehabil. 
2013;20(8):396-402. doi:10.12968/ijtr.2013.20.8.396. 
15.  
Doherty C, Bleakley C, Hertel J, Caulfield B, Ryan J, Delahunt E. Recovery From a First-
Time Lateral Ankle Sprain and the Predictors of Chronic Ankle Instability: A Prospective 
Cohort Analysis. Am J Sports Med. 2016;44(4):995-1003. 
doi:10.1177/0363546516628870. 
16.  
Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale 
(LEFS): scale development, measurement properties, and clinical application. North 
American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999;79(4):371-383. 
http://www.ncbi.nlm.nih.gov/pubmed/10201543. Accessed May 16, 2017. 
17.  
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog 
Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain 
Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain 
Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF. Arthritis Care Res 
(Hoboken). 2011;63(S11):S240-S252. doi:10.1002/acr.20543. 
18.  
McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a 
critical review. Psychol Med. 1988;18(4):1007-1019. 

 
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http://www.ncbi.nlm.nih.gov/pubmed/3078045. Accessed August 4, 2016. 
19.  
Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity 
for the Foot and Ankle Ability Measure (FAAM). Foot ankle Int. 2005;26(11):968-983. 
http://www.ncbi.nlm.nih.gov/pubmed/16309613. Accessed August 4, 2016. 
20.  
Eechaute C, Vaes P, Aerschot L Van, et al. The clinimetric qualities of patient-assessed 
instruments for measuring chronic ankle instability: A systematic review. BMC 
Musculoskelet Disord 2007 81. 2007;8(1):112-116. doi:10.1186/1471-2474-8-6. 
21.  
Doherty C, Bleakley C, Hertel J, Caulfield B, Ryan J, Delahunt E. Recovery From a First-
Time Lateral Ankle Sprain and the Predictors of Chronic Ankle Instability: A Prospective 
Cohort Analysis. Am J Sports Med. 2016;44(4):995-1003. 
doi:10.1177/0363546516628870. 
22.  
Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle 
instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 
2006;87(9):1235-1241. doi:10.1016/j.apmr.2006.05.022. 
23.  
Wright CJ, Linens SW, Cain MS. Establishing the Minimal Clinical Important Difference 
and Minimal Detectable Change for the Cumberland Ankle Instability Tool. Arch Phys 
Med Rehabil. 2017. doi:10.1016/j.apmr.2017.01.003. 
24.  
Brooks R. EuroQol: the current state of play. Health Policy. 1996;37(1):53-72. 
http://www.ncbi.nlm.nih.gov/pubmed/10158943. Accessed May 28, 2017. 
25.  
Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal 
clinically important difference. Control Clin Trials. 1989;10(4):407-415. 
http://www.ncbi.nlm.nih.gov/pubmed/2691207. Accessed May 28, 2017. 
26.  
Kvien TK, Heiberg T, Hagen KB. Minimal clinically important improvement/difference 
(MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts 
mean? Ann Rheum Dis. 2007;66(Supplement 3):iii40-iii41. doi:10.1136/ard.2007.079798. 
27.  
Bleakley CM, O’Connor SR, Tully MA, et al. Effect of accelerated rehabilitation on 
function after ankle sprain: randomised controlled trial. BMJ. 2010;340(may10 1):c1964-
c1964. doi:10.1136/bmj.c1964. 
 

 
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21.0 
APPENDICES 
21.1 Appendix 1 – S.O.P. 
 
Standard operating procedure 
DS93.4 
DISTORSIO 
REGIONIS 
MALLEOLI 
 
1.° distorsion (At present the patient can 
bear weight):  
RICE 
2.° distorsion (Pronounced limping, 
major pain. Able to walk 4 steps): 
RICE + Pain management 
3.° distorsion (The patient cannot bear 
weight on the foot and walk 4 steps):  
RICE+ crutches +pain 
management 
 
 
No follow-up 
 
 
 
Follow-up at 
general 
practitioner 
 
 
 
 

 
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21.2 Appendix 2 – Exercise program 
 
 
 

 
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21.3 Appendix 3 – Outcomes 
 
 
Figur 4 - Lower extremity functional scale (English version). 
 
 
 
 
 

 
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Figur 5 - VAS Pain scale with rest 
 
Figur 6 - VAS Pain scale with activity 
 
 

 
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Figur 7 - Foot and ankle ability measure ADL subscale (English version). 
 

 
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Figur 8 - Foot and ankle ability measure Sports subscale (English version). 
 
 

 
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Figur 9 - The Cumberland ankle instability tool (English version). 

 
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Figur 10 - EQ-5D-3L (Danish version) 

 
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21.4 Appendix 4 – Baseline form 
 
Questions 
Answers 
Date of birth 
Dd/mm/YYYY 
Height 
Cm 
Weight 
Kg 
Previous lateral ankle sprain in the same 
ankle 
Yes/No 
Dominant leg  
Left/Wright 
Site of injury 
Left/Wright 
Time since injury 
Hours/minutes 
Years of education 
Years 
Yearly income 
DKr. 
Contact information 
Address, Phone number, e-mail.  
 
 
 
 

 
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21.5 Appendix 8 – Informed consent form