Management of Acute Lateral Ankle Sprains

Ankle Sprains Clinical Trial

Official title:

Management of Acute Lateral Ankle Sprains: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03527121
• Other study ID #: SJ-628
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: April 2020
• Source: Slagelse Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 advice and instructions following standard operating procedures at site.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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

Exclusion 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.)

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Sprains and Strains

Intervention

Other:
• ESP physiotherapy
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 care
A single session with advice and instructions from a physician in rest, ice, compression and elevation (usual care group).

Locations

Country	Name	City	State
Denmark	The Emergency Department, The Regional Hospital in Horsens	Horsens	The Central Region Of Denmark
Denmark	The Emergency Department, Slagelse Hospital	Slagelse	Region Zealand

Sponsors (5)

Lead Sponsor	Collaborator
Christian Olsen	Regionshospitalet Horsens, Slagelse Hospital, University Hospital Bispebjerg and Frederiksberg, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 populations. The scale is a continuous scale comprised of a horizontal line, 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.	Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
Other	The Cumberland ankle instability tool (CAIT)	The CAIT is a simple, validated, and reliable tool to measure severity of functional ankle instability. 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 points.	Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
Other	Quality of life (EQ-5D-3L)	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 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.	Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
Other	Patient acceptable symptom state (PASS)	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?''.	Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
Other	Patient-reported treatment failure	Only answered by patients answering "no" to PASS. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?". Answered by "yes" or "no".	Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
Other	Analgesic use	The participants self-reported use of analgesics will be collected at baseline and at follow-up week 1, 2, 3 and 4. Participants will be asked to note their use of analgesic drugs within the week before baseline and the follow-up.	Primary endpoint: The change from 1. to 4. week. Secondary outcomes: The change from week 1. to 2. and 3. weeks.
Primary	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.	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	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.	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
Secondary	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.	Primary endpoint: The difference in reinjury from baseline to 4 weeks. Secondary outcomes: 2 and 3 weeks, and 3, 6 and 12 months
Secondary	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.	Primary endpoint: After 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
Secondary	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.	Recorded at all follow-ups: 1, 2, 3 and 4 weeks and 3, 6 and 12 months