Clinical trial NCT06189625: Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization
Official title: Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization. Clinical Trial, Randomized, in Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Ankle Sprain
Lead sponsor: Hospital Universitario Infanta Leonor
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 113
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization sequence was created using the Epidat 4.2 software, ensuring allocation concealment, with a single, constant 1:1 allocation ratio
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage score on the Oxford Ankle and Foot Questionare for Children (OXAFQ-C)
timeFrame: at 5, 14 and 30 days.
measure: Intensity of pain
timeFrame: at the emergency department and at 5, 14 and 30 days.
measure: recurrence of ankle sprain
timeFrame: at 5, 14 and 30 days.
Secondary outcomes:
measure: patient satisfaction with emergency department care
timeFrame: after 5 days
measure: Patient satisfaction with the treatment received.
timeFrame: after 5 days
measure: Patient satisfaction with functional evolution.
timeFrame: after 30 days
measure: Presence of functional bandaging complications
timeFrame: after 5 days
measure: Tolerance of the functional bandage
timeFrame: after 5 days
measure: Use of crutches
timeFrame: after 5 days
measure: Days on crutches
timeFrame: after 5 days
measure: Days of use of anti-inflammatory drugs
timeFrame: after 5 days
measure: Days with pain
timeFrame: at 5, 14 and 30 days.
measure: Use of ankle brace
timeFrame: at 5, 14 and 30 days.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
state: Comunidad De Madrid
Study officials:
affiliation: Hospital Universitario Infanta Leonor
name: SARA SUAREZ-CABEZAS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Infanta Leonor
name: MARIA CABRERIZO-ORTIZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Infanta Leonor
name: CARMEN GOMEZ GEREZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Infanta Leonor
name: MONICA HORTIGUELA APARICIO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Infanta Leonor
name: BEGOÑA PEREZ-MONEO AGAPITO, MD
role: PRINCIPAL_INVESTIGATOR
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