---
title: Management of Acute Lateral Ankle Sprains
nct_id: NCT03527121
overall_status: UNKNOWN
phase: NA
sponsor: Christian Olsen
study_type: INTERVENTIONAL
primary_condition: Ankle Sprains
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03527121.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03527121"
ct_last_update_post_date: 2020-04-09
last_seen_at: "2026-05-12T07:26:57.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Management of Acute Lateral Ankle Sprains

**Official Title:** Management of Acute Lateral Ankle Sprains: A Randomized Controlled Trial

**NCT ID:** [NCT03527121](https://clinicaltrials.gov/study/NCT03527121)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 112
- **Lead Sponsor:** Christian Olsen
- **Collaborators:** University Hospital Bispebjerg and Frederiksberg, Regionshospitalet Horsens, University of Copenhagen, Slagelse Hospital
- **Conditions:** Ankle Sprains
- **Start Date:** 2018-05-22
- **Completion Date:** 2020-12-15
- **CT.gov Last Update:** 2020-04-09

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.)
```

## Arms

- **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.
- **R.I.C.E.(Usual care)** (ACTIVE_COMPARATOR) — A single session with advice and instructions from a physician in rest, ice, compression and elevation.

## 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.
- **Usual care** (OTHER) — A single session with advice and instructions from a physician in rest, ice, compression and elevation (usual care group).

## Primary Outcomes

- **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.

## 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)_

## Locations (2)

- The Emergency Department, Slagelse Hospital, Slagelse, Region Sjælland, Denmark
- The Emergency Department, The Regional Hospital in Horsens, Horsens, The Central Region of Denmark, Denmark

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the emergency department, slagelse hospital|slagelse|region sjælland|denmark` — added _(2026-05-12)_
- `locations.the emergency department, the regional hospital in horsens|horsens|the central region of denmark|denmark` — added _(2026-05-12)_

---

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