CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 113 enrolled
Drug / intervention
Control +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06189625
NCT06189625N/ACompleted

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

Hospital Universitario Infanta Leonor·interventional·Posted Jan 3, 2024·Updated Jan 17, 2024

In Brief

A clinical study evaluating Control and Functional bandage for Mild Ankle Sprain. Completed, enrolled 113 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 3, 2024
Enrollment StartSep 1, 2021
Primary CompletionMay 18, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.5 years ago

Interventions

Controlother

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.

Functional bandageprocedure

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.