Clinical trial NCT03527121: Management of Acute Lateral Ankle Sprains
Official title: Management of Acute Lateral Ankle Sprains: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Sprains
Keywords: Ankle
Exercise
Activities of daily living
Treatment outcome
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Bispebjerg and Frederiksberg
name: Regionshospitalet Horsens
name: University of Copenhagen
name: Slagelse Hospital
First posted: 2018-05-17
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Lower extremity functional scale
timeFrame: 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:
measure: Foot and ankle ability measure (FAAM)
timeFrame: 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
measure: Reinjury rates
timeFrame: Primary endpoint: The difference in reinjury from baseline to 4 weeks. Secondary outcomes: 2 and 3 weeks, and 3, 6 and 12 months
measure: Global perceived effect (GPE)
timeFrame: Primary endpoint: After 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
measure: Adverse events (AE) and serious adverse events (SAE)
timeFrame: Recorded at all follow-ups: 1, 2, 3 and 4 weeks and 3, 6 and 12 months
Other outcomes:
measure: Pain at rest and with activity, assessed using a visual analogue scale (VAS)
timeFrame: Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
measure: The Cumberland ankle instability tool (CAIT)
timeFrame: Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
measure: Quality of life (EQ-5D-3L)
timeFrame: Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
measure: Patient acceptable symptom state (PASS)
timeFrame: Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
measure: Patient-reported treatment failure
timeFrame: Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.
measure: Analgesic use
timeFrame: Primary endpoint: The change from 1. to 4. week. Secondary outcomes: The change from week 1. to 2. and 3. weeks.
Locations:
city: Slagelse
country: Denmark
facility: The Emergency Department, Slagelse Hospital
state: Region Zealand
city: Horsens
country: Denmark
facility: The Emergency Department, The Regional Hospital in Horsens
state: The Central Region Of Denmark
Study officials:
affiliation: Department of Physiotherapy and Occupational Therapy, Slagelse Hospitals.
name: Christian P Olsen, PT, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen and Bispebjerg-Frederiksberg Hospital
name: Marius Henriksen, PT, Prof.
role: STUDY_CHAIR
affiliation: University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals.
name: Søren T Skou, PT, PhD
role: STUDY_CHAIR
affiliation: The Regional Hospital in Horsens
name: Mikael Elsborg, PT
role: STUDY_CHAIR
References: