Management of Acute Lateral Ankle Sprains

NCT03527121 | Unknown DMC

• 1 other identifier: SJ-628
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

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.

Conditions

Ankle Sprains

Keywords

Ankle; Exercise; Activities of daily living; Treatment outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Foot and ankle ability measure (FAAM)

  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

  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)

  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)

  Recorded at all follow-ups: 1, 2, 3 and 4 weeks and 3, 6 and 12 months

Other Outcomes (6)

• Pain at rest and with activity, assessed using a visual analogue scale (VAS)

  Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.

• The Cumberland ankle instability tool (CAIT)

  Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.

• Quality of life (EQ-5D-3L)

  Primary endpoint: The change from baseline to 4 weeks. Secondary outcomes: 1, 2 and 3 weeks, and 3, 6 and 12 months.

Study Arms (2)

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.

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.

Other: Usual care

Interventions

ESP physiotherapy 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.+ (ESP physiotherapy)

Usual care OTHER

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

R.I.C.E.(Usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A grade 1 or 2 LAS sustained within 24 hours of randomization
• To be a minimum age of 18
• Signed informed consent

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Christian Olsen: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Regionshospitalet Horsens: collaborator
• University of Copenhagen: collaborator
• Slagelse Hospital: collaborator

Study Sites (2)

The Emergency Department, Slagelse Hospital

Slagelse, Region Sjælland, 4200, Denmark

Location

The Emergency Department, The Regional Hospital in Horsens

Horsens, The Central Region of Denmark, 8700, Denmark

Location

MeSH Terms

Conditions

Ankle Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Behavior

Study Officials

• Christian P Olsen, PT, Msc

  Department of Physiotherapy and Occupational Therapy, Slagelse Hospitals.

  PRINCIPAL INVESTIGATOR

• Marius Henriksen, PT, Prof.

  University of Copenhagen and Bispebjerg-Frederiksberg Hospital

  STUDY CHAIR

• Søren T Skou, PT, PhD

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

  STUDY CHAIR

• Mikael Elsborg, PT

  The Regional Hospital in Horsens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 17, 2018
• Study Start: May 22, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)