Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-05-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization

NCT06222229

Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle Sprain

RECRUITING NA

Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

NCT01586390

Acute Ankle Sprain Ankle Ligament Rupture Ankle Injuries

COMPLETED PHASE2

Smartphone App to Improve Functional Outcomes in Ankle Sprains

NCT03564015

Ankle Sprains

TERMINATED NA

Lateral Ankle Sprain and Platelet Rich Plasma

NCT02609308

Ankle Injuries

COMPLETED NA

A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries

NCT05785533

Ankle Sprains

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Ankle Sprain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization sequence was created using the Epidat 4.2 software, ensuring allocation concealment, with a single, constant 1:1 allocation ratio

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Due to the nature of the intervention, it will not be feasible to mask the received treatment at the time of care. Additionally, masking of the treatment group during clinical reviews will not be attainable, as some collected variables will be inherently related to the intervention itself. The data analyst specialist will also be unblinded to the group assignments.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No-bandaging group

Only general measures will be recommended without the use of external support devices.

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

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.

Bandaging group

functional bandage for 5 days and general measure.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

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 bandage

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ÁNGEL PUEYO, MD, MSc

Pediatric Specialist Physician

Responsibility Role PRINCIPAL_INVESTIGATOR