Management of Acute Lateral Ankle Sprains

NCT ID: NCT03527121

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2020-12-15

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.

Conditions

Ankle Sprains

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

R.I.C.E.+ (ESP physiotherapy)

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.

Group Type: EXPERIMENTAL

ESP physiotherapy

Intervention Type: OTHER

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)

A single session with advice and instructions from a physician in rest, ice, compression and elevation.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Usual care

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

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: collaborator

Regionshospitalet Horsens

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Slagelse Hospital

OTHER

Sponsor Role: collaborator

Christian Olsen

OTHER

Sponsor Role: lead

Responsible Party

Christian Olsen

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christian P Olsen, PT, Msc

Role: PRINCIPAL_INVESTIGATOR

Department of Physiotherapy and Occupational Therapy, Slagelse Hospitals.

Marius Henriksen, PT, Prof.

Role: STUDY_CHAIR

University of Copenhagen and Bispebjerg-Frederiksberg Hospital

Søren T Skou, PT, PhD

Role: STUDY_CHAIR

University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals.

Mikael Elsborg, PT

Role: STUDY_CHAIR

The Regional Hospital in Horsens

Locations

The Emergency Department, Slagelse Hospital

Slagelse, Region Sjælland, Denmark

The Emergency Department, The Regional Hospital in Horsens

Horsens, The Central Region of Denmark, Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

SJ-628

Identifier Type: -

Identifier Source: org_study_id