Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization (PED_HUIL0124)

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

Multicentre, Randomized, Clinical Trial in Children With Mild Ankle Sprain: Bandaging vs. no Immobilization

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. The 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 a online survey send by SMS, 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

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design: A randomized, parallel, open-label, multi-center clinical trial will be conducted at 3 intermediate-complexity hospitals. The study received approval from the center's ethics committee.

Procedure: Every patient presenting with ankle trauma will undergo assessment by the attending physician in the emergency department. The collaborating researchers of the different hospitals 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. 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 a physical study-specific record and will store the signed informed consent in a designated folder within the pediatric emergency department. The researcher in charge of each center will enter demographic data and variables obtained in the emergency department into a database hosted in the REDcap software. The data of the recruited patients should be entered in the REDcap database at least twice per week. The principal investigator or collaborators will review this REDcap database daily to check the recruited patients and prepare the SMS with the online survey to be sent. 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. The SMS will be sent using the SMS sending system of the coordinating hospital of the study.

At 7, 14, and 30 days, the guardians of the patients will receive a SMS with a link that will direct them to the REDcap online survey. In case of no response to the initial attempt, another attempt will be made the following day, and, if no response is received in 48 hours, a telephone call will be made to the patients' guardians. Non-response at 72 hours will be 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: 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 15, due to a previous study. 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), and assuming a dropout of 30%, the calculated sample size will be 112 patients (56 in each group) for superiority analysis or 90 patients (45 in each group) for non-inferiority analysis.

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. Anyway, a worst-case scenario strategy will be used in the statistical analysis to assess the losses.

Study Type

Interventional

Enrollment (Estimated)

150

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 Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
        • Contact:
        • Sub-Investigator:
          • MARIA CABRERIZO-ORTIZ, MD
        • Sub-Investigator:
          • MONICA HORTIGUELA APARICIO, MD
        • Sub-Investigator:
          • BEGONA PEREZ-MONEO AGAPITO, MD

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
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.
Use of crutches
Time Frame: after 5 days
dichotomous variable (yes/ no)
after 5 days

Collaborators and Investigators

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

Sponsor

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED_HUIL0124

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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