Ankle SprainsNCT03527121
Management of Acute Lateral Ankle Sprains
A study testing ESP physiotherapy in people with Ankle Sprains, run by Christian Olsen at 2 sites in Denmark.
Trial summary
This study evaluates the effectiveness of pain guided early weight bearing as a means to enhance the outcome of acute lateral ankle sprain. Half of the participants will receive advice and instructions in pain guided early weight bearing plus a written home-based exercise program, while the other half will receive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- ESP physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesDenmark
- Study dates
- 22 May 2018to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A grade 1 or 2 LAS sustained within 24 hours of randomization
- To be a minimum age of 18
- Signed informed consent
Who cannot join
- A grade 3 LAS injury sustained
- Diagnosed with chronic ankle instability (CAI) on the affected limb
- Fracture diagnosed by X-ray
- Previous enrollment in the same study
- Major lower limb surgery or other severe lower extremity injury in the past 3 months on the affected limb
- Under the influence of drugs or alcohol
- 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.)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
The Emergency Department, The Regional Hospital in Horsens
Horsens, The Central Region of Denmark, 8700
The Emergency Department, Slagelse Hospital
Slagelse, Region Sjælland, 4200
About this study
Official title: Management of Acute Lateral Ankle Sprains: A Randomized Controlled Trial
This study evaluates the effectiveness of pain guided early weight bearing as a means to enhance the outcome of acute lateral ankle sprain. Half of the participants will receive advice and instructions in pain guided early weight bearing plus a written home-based exercise program, while the other half will receive advice and instructions following standard operating procedures at site.
Read the detailed description
Lateral ankle sprains (LAS) is the most common injury in the active population. Not only is the injury prevalent within organized sports, but also display high prevalence in the general population presenting at the emergency departments (ED). LAS accounts for about 3-5% of all visits to the ED, but total LAS incidence rates are increasing in the general population.
Acute LAS is defined by Delahunt et al. and endorsed by the International ankle consortium 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. 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 satisfaction, reduce patient waiting times and have high clinical effectiveness, 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), 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.
The aim of this RCT is to investigate if pain guided early weight bearing provided by ESP physiotherapists is superior to advice and instructions following standard operating procedures provided by a physician in improving the selfreported functional outcome in patients with LAS.
The study hypothesis is that patients randomized to pain guided early weight bearing will improve significantly more in the lower extremity functional scale after 4 weeks than those randomized to standard care.
- Conditions
- Ankle Sprains
- Being tested
- ESP physiotherapy, Usual care
- Keywords
- Ankle, Exercise, Activities of daily living, Treatment outcome
- Medical subject headings
- Ankle Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP physiotherapyOther
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.
Usual careOther
A single session with advice and instructions from a physician in rest, ice, compression and elevation (usual care group).
| Study group | Role | What they receive |
|---|---|---|
| R.I.C.E.+ (ESP physiotherapy) | Experimental | Participants will receive 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. Receives: Other: ESP physiotherapy |
| R.I.C.E.(Usual care) | Active comparator | A single session with advice and instructions from a physician in rest, ice, compression and elevation. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity functional scale
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.
Measured: Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: The change from baseline to 1, 2 and 3 weeks, and 3, 6 and 12 months.
Secondary outcomes (4)
Foot and ankle ability measure (FAAM)
The Foot and ankle Ability Measure is a 29-item region-specific outcome instrument. The FAAM ADL subscale consist of 21-items and the FAAM sports consist of 8-items. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. N/A responses are not counted. Item total scores range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, with higher scores representing better function. For both subscales, the score on each item are added together to get the item score total. The number of items with a response is multiplied by 4 to get the highest potential score. The item score total is divided by the highest potential score. This value is multiplied by 100 to get a final percentage score. Evidence of validity to support the use of the FAAMadl and FAAMsport is available in individuals with a wide array of ankle and foot disorders. The questionnaire will be translated into Danish using a dual-panel approach before trial start.
Measured: Primary endpoint: The change from 1 to 4 weeks. Secondary outcomes: The change from 1. week to 2. and 3. weeks, and 3, 6 and 12 months
Reinjury rates
The investigators 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". Reinjury will not be considered as a stopping rule for further participation in this study.
Measured: Primary endpoint: The difference in reinjury from baseline to 4 weeks. Secondary outcomes: 2 and 3 weeks, and 3, 6 and 12 months
Global perceived effect (GPE)
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.
Measured: Primary endpoint: After 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
Adverse events (AE) and serious adverse events (SAE)
Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. AEs will be categorized into index foot or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments.
Measured: Recorded at all follow-ups: 1, 2, 3 and 4 weeks and 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start22 May 2018
- Primary completion15 Dec 2019
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Olsen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Regionshospitalet Horsens, University of Copenhagen, Slagelse Hospital
- Responsible party
- Sponsor-investigator, Christian Olsen, Slagelse Hospital
- Investigators
- Christian P Olsen, PT, Msc, Principal investigator, Department of Physiotherapy and Occupational Therapy, Slagelse Hospitals.Marius Henriksen, PT, Prof., Study chair, University of Copenhagen and Bispebjerg-Frederiksberg HospitalSøren T Skou, PT, PhD, Study chair, University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals.Mikael Elsborg, PT, Study chair, The Regional Hospital in Horsens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527121
- Sponsor's protocol ID
- SJ-628
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Acute Lateral Ankle Sprains: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03527121
- Acronym / sponsor ID
- SJ-628
- Conditions
- Ankle Sprains
- Keywords
- Ankle, Exercise, Activities of daily living, Treatment outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Christian OlsenUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Regionshospitalet Horsens, University of Copenhagen, Slagelse Hospital
- Study start
- 22 May 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of pain guided early weight bearing as a means to enhance the outcome of acute lateral ankle sprain. Half of the participants will receive advice and instructions in pain guided early weight bearing plus a written home-based exercise program, while the other half will receive advice and instructions following standard operating procedures at site.
Detailed description
Lateral ankle sprains (LAS) is the most common injury in the active population. Not only is the injury prevalent within organized sports, but also display high prevalence in the general population presenting at the emergency departments (ED). LAS accounts for about 3-5% of all visits to the ED, but total LAS incidence rates are increasing in the general population.
Acute LAS is defined by Delahunt et al. and endorsed by the International ankle consortium 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. 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 satisfaction, reduce patient waiting times and have high clinical effectiveness, 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), 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.
The aim of this RCT is to investigate if pain guided early weight bearing provided by ESP physiotherapists is superior to advice and instructions following standard operating procedures provided by a physician in improving the selfreported functional outcome in patients with LAS.
The study hypothesis is that patients randomized to pain guided early weight bearing will improve significantly more in the lower extremity functional scale after 4 weeks than those randomized to standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R.I.C.E.+ (ESP physiotherapy) | Experimental | Other: ESP physiotherapyParticipants will receive 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. |
| R.I.C.E.(Usual care) | Active comparator | Other: Usual careA single session with advice and instructions from a physician in rest, ice, compression and elevation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A grade 1 or 2 LAS sustained within 24 hours of randomization
- To be a minimum age of 18
- Signed informed consent
Key exclusion criteria (7 listed)
- A grade 3 LAS injury sustained
- Diagnosed with chronic ankle instability (CAI) on the affected limb
- Fracture diagnosed by X-ray
- Previous enrollment in the same study
- Major lower limb surgery or other severe lower extremity injury in the past 3 months on the affected limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESP physiotherapyA 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. | Other | R.I.C.E.+ (ESP physiotherapy) |
| Usual careA single session with advice and instructions from a physician in rest, ice, compression and elevation (usual care group). | Other | R.I.C.E.(Usual care) |
Primary outcome
Lower extremity functional scale
Time frame: Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: The change from baseline to 1, 2 and 3 weeks, and 3, 6 and 12 months.
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.
4 secondary outcomes
Foot and ankle ability measure (FAAM)
Time frame: Primary endpoint: The change from 1 to 4 weeks. Secondary outcomes: The change from 1. week to 2. and 3. weeks, and 3, 6 and 12 months
Reinjury rates
Time frame: Primary endpoint: The difference in reinjury from baseline to 4 weeks. Secondary outcomes: 2 and 3 weeks, and 3, 6 and 12 months
Global perceived effect (GPE)
Time frame: Primary endpoint: After 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
Adverse events (AE) and serious adverse events (SAE)
Time frame: Recorded at all follow-ups: 1, 2, 3 and 4 weeks and 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprains
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Enovis High Ankle Sprain Brace Testing
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian P Olsen, PT, Msc principal investigator
Department of Physiotherapy and Occupational Therapy, Slagelse Hospitals.
Marius Henriksen, PT, Prof. study chair
University of Copenhagen and Bispebjerg-Frederiksberg Hospital
Søren T Skou, PT, PhD study chair
University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP physiotherapy in people with Ankle Sprains, run by Christian Olsen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity functional scale (time frame: Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: The change from baseline to 1, 2 and 3 weeks, and 3, 6 and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.