Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization (PED_HUIL1223)

January 15, 2024 updated by: ÁNGEL PUEYO, MD, MSc, Hospital Universitario Infanta Leonor

Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization. Clinical Trial, Randomized, in Pediatric Population

Ankle sprains represent a prevalent pathology among the pediatric population that can result in residual effects when treated incorrectly. However, there is a lack of scientific studies defining the most appropriate therapeutic approach. Our hypothesis is that patients treated solely with general measures, without external device support, experience a faster recovery compared to those treated with ankle immobilization. A clinical trial will be carried out by randomly assigning patients to either the functional bandaging group or the control group (general measures only). Prospective follow-up will be carried out by telephone, checking the functionality of the injured ankle using 'the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)', in addition to pain control and patient satisfaction with the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design: A randomized, parallel, open-label, single-center clinical trial will be conducted at an intermediate-complexity hospital. The study received approval from our center's ethics committee.

Procedure: Every patient presenting with ankle trauma will undergo assessment by the attending physician in the emergency department. All physicians in the pediatric department will participate in patient enrollment. In cases of grade I or mild sprains, patients and their guardians will be invited to participate in the study after a thorough explanation of the study's purpose and procedures. The severity of the sprain will be assessed using The West Point Ankle Grading System, with the final grading left to the discretion of the clinician. Adequate analgesia will be ensured during the emergency department consultation.

Upon agreeing to participate in the study and signing the informed consent, randomization and assignment to either the control group or intervention group (receiving a bandage applied by nursing) will take place before the final discharge from the emergency department. The discharge report will specify the standardized treatment based on the assigned group. The attending physician will complete an electronic study-specific record and will store the signed informed consent in a designated folder within the pediatric emergency department. This folder will be reviewed daily by the principal investigator or their collaborators. Demographic data and variables obtained in the emergency department will be entered into a database hosted in the REDcap software. Additionally, a coded patient number and the date of emergency care will be included in a database hosted in the center's electronic repository to determine the timing of follow-up.

At 7, 14, and 30 days, the guardians of the patients will be contacted by phone, and a survey will be administered to the patient to collect data on the patients' progress. This survey will be directly completed using forms in the REDcap software. In case of no response to the initial attempt, a follow-up call will be made on the same day. If the result remains the same, another attempt will be made the following day, with non-response recorded as a loss.

The data from the REDcap electronic database will be periodically reviewed by the principal investigator to monitore data entry and look for possible adverse effect.

Statistical Analysis: No previous studies have assessed non-immobilization in patients with ankle sprains, nor have any studies evaluated the OXAFQ-C outcomes in the evolution of ankle sprain patients. Therefore, the sample size will be calculated assuming a difference of more than 10 points in the OXAFQ-C percentage scale value, estimating a standard deviation of 25. Comparing two independent means with a bilateral test and a balanced random allocation (Group 1 size/Group 2 size ratio = 1), with a type I error of 5% (alpha risk) and a power of 80% (1-beta risk), the calculated sample size will be 212 patients (106 in each group). Assuming a dropout rate of 10%, the final established sample size will be 233 (116 in each group). Given the absence of previous data, a preliminary review with the first 50 patients will be conducted to recalculate the sample size.

Categorical variables will be described using percentages, and continuous variables will be presented as mean and standard deviation (SD) if normally distributed (Kolmogorov-Smirnov and/or Shapiro-Wilks) or as medians and interquartile ranges otherwise. Bivariable analysis of categorical variables will be performed using the Chi-square test or Fisher's exact test, and that of continuous variables will be done using the Student's T-test or its non-parametric equivalents.

Both intention-to-treat and per-protocol analyses will be conducted, assuming that some patients in the control group will use ankle support against recommendations. Finally, a non-inferiority analysis will be performed between both groups for both the primary variable and the degree of pain according to the visual analog scale (VAS) at different follow-ups.

All statistical tests will be considered with a significance level of 5%. The analysis will be conducted using the R software.

Missing Data:For all patients who do not complete at least two follow-ups, the electronic medical records of all public centers in the province where the study is conducted will be reviewed through the electronic Horus program to verify the absence of relevant adverse effects or diagnostic changes.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Comunidad De Madrid
      • Madrid, Comunidad De Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of grade I ankle sprain.
  • Patients aged between 5 and 16 years.
  • Less than 72 hours of evolution.
  • Informed consent signed by guardians

Exclusion Criteria:

  • Penetrating trauma.
  • Associated fracture.
  • Consultation more than 72 hours after the trauma.
  • Developmental disorders (cerebral palsy, previous gait disorders, autism, etc.).
  • Previous or concurrent disease that involves an increased risk of fractures (osteoporosis, bone diseases, etc).
  • Previous ankle pathology.
  • Impossibility of telephone contact

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No-bandaging group
Only general measures will be recommended without the use of external support devices.
Other: Control

All patients included in the study, both in the non-bandaging group and in the bandaging group, will receive a series of general measures as a recommendation, consisting of the following:

  • Administration of anti-inflammatory drugs as ibuprofen at 7.5 mg/kg/8 hours for 2-3 days. If pain continues, recommendation of paracetamol 15 mg/kg 4 hours after ibuprofen.
  • Application of local ice for a maximum of 10 minutes as required.
  • Elevation of the affected limb when resting.
  • Early mobilization and load according to tolerance, using crutches if required.
  • Sports rest at least for one week or until the patient is able to walk without pain, with gradual incorporation according to tolerance. During the following year, use of elastic ankle brace for sports activities.

The control group will not receive any special intervention.
Active Comparator: Bandaging group
functional bandage for 5 days and general measure.
Other: Control

All patients included in the study, both in the non-bandaging group and in the bandaging group, will receive a series of general measures as a recommendation, consisting of the following:

  • Administration of anti-inflammatory drugs as ibuprofen at 7.5 mg/kg/8 hours for 2-3 days. If pain continues, recommendation of paracetamol 15 mg/kg 4 hours after ibuprofen.
  • Application of local ice for a maximum of 10 minutes as required.
  • Elevation of the affected limb when resting.
  • Early mobilization and load according to tolerance, using crutches if required.
  • Sports rest at least for one week or until the patient is able to walk without pain, with gradual incorporation according to tolerance. During the following year, use of elastic ankle brace for sports activities.

The control group will not receive any special intervention.

Procedure: Functional bandage

The functional bandage will consist of a standardized wrapping in several phases. First, with 6 mm silk tape, open anchors were placed in the distal region of the metatarsals of the foot and in the middle third of the affected leg. Next, a strip of tape was applied in stirrup fashion, starting from the proximal anchor and exerting pressure cranially on the side of the affected ligament. This support was interspersed three times with another strip of tape, starting from the foot anchor and wrapping behind the ankle. Once complete, it was covered with a 7.5 cm Tensoplast spiral bandage, taking care to apply gentle pressure. The emergency nurses underwent dual training, consisting of an instructional video and a half-hour practical session. Reminder posters were also displayed in the technique box where such procedures are typically performed.

As the control group, general measures will be recommended.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage score on the Oxford Ankle and Foot Questionare for Children (OXAFQ-C)
Time Frame: at 5, 14 and 30 days.
It is a questionnaire validated in pediatric population to determine the functionality of the ankle and/or foot in patients with pathology at this level. It consists of a survey in which 14 items belonging to three different spheres are collected: physical, social/daily activities and emotional. Each item is scored on a frequency scale: never (4), rarely (3), sometimes (2), frequently (1), always (0). The higher the score, the better the functionality. This scale can also be transformed into a percentage scale, being 100% the maximum score.
at 5, 14 and 30 days.
Intensity of pain
Time Frame: at the emergency department and at 5, 14 and 30 days.
intensity of pain felt by the patient, assessed subjectively on an ordinal scale, with 0 being no pain at all and 10 the maximum pain possible.
at the emergency department and at 5, 14 and 30 days.
recurrence of ankle sprain
Time Frame: at 5, 14 and 30 days.
dichotomous variable reflecting the presence of new ankle sprains
at 5, 14 and 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction with emergency department care
Time Frame: after 5 days
assessed subjectively on an ordinal scale, being 0 being the worst punctuation and 10 being the best.
after 5 days
Patient satisfaction with the treatment received.
Time Frame: after 5 days
assessed subjectively on an ordinal scale, being 0 being the worst punctuation and 10 being the best.
after 5 days
Patient satisfaction with functional evolution.
Time Frame: after 30 days
assessed subjectively on an ordinal scale, being 0 being the worst punctuation and 10 being the best.
after 30 days
Presence of functional bandaging complications
Time Frame: after 5 days
dichotomous variable (yes/no).
after 5 days
Tolerance of the functional bandage
Time Frame: after 5 days
ordinal scale (very bad, bad, average, good and very good).
after 5 days
Use of crutches
Time Frame: after 5 days
dichotomous variable (yes/no).
after 5 days
Days on crutches
Time Frame: after 5 days
quantitative variable (days)
after 5 days
Days of use of anti-inflammatory drugs
Time Frame: after 5 days
quantitative variable (days)
after 5 days
Days with pain
Time Frame: at 5, 14 and 30 days.
quantitative variable (days)
at 5, 14 and 30 days.
Use of ankle brace
Time Frame: at 5, 14 and 30 days.
dichotomous variable (yes/ no)
at 5, 14 and 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Infanta Leonor

Investigators

  • Principal Investigator: SARA SUAREZ-CABEZAS, MD, Hospital Universitario Infanta Leonor
  • Principal Investigator: MARIA CABRERIZO-ORTIZ, MD, Hospital Universitario Infanta Leonor
  • Principal Investigator: CARMEN GOMEZ GEREZ, MD, Hospital Universitario Infanta Leonor
  • Principal Investigator: MONICA HORTIGUELA APARICIO, MD, Hospital Universitario Infanta Leonor
  • Principal Investigator: BEGOÑA PEREZ-MONEO AGAPITO, MD, Hospital Universitario Infanta Leonor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

May 18, 2022

Study Completion (Actual)

May 18, 2022

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED_HUIL1223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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