Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization
Condition: Mild Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

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.
    

Intervention name(s): Control; Functional bandage
Intervention type(s): Other; Procedure
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization sequence was created using the Epidat 4.2 software, ensuring allocation concealment, with a single, constant 1:1 allocation ratio
Masking: None (Open Label)
Primary purpose: Treatment