Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization. Clinical Trial, Randomized, in Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Intensity of pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of grade I ankle sprain.
- •Patients aged between 5 and 16 years.
- •Less than 72 hours of evolution.
- •Informed consent signed by guardians
排除标准
- •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
结局指标
主要结局
Intensity of pain
时间窗: 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.
recurrence of ankle sprain
时间窗: at 5, 14 and 30 days.
dichotomous variable reflecting the presence of new ankle sprains
Percentage score on the Oxford Ankle and Foot Questionare for Children (OXAFQ-C)
时间窗: 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.
次要结局
- patient satisfaction with emergency department care(after 5 days)
- Days of use of anti-inflammatory drugs(after 5 days)
- Presence of functional bandaging complications(after 5 days)
- Patient satisfaction with functional evolution.(after 30 days)
- Days with pain(at 5, 14 and 30 days.)
- Use of ankle brace(at 5, 14 and 30 days.)
- Patient satisfaction with the treatment received.(after 5 days)
- Tolerance of the functional bandage(after 5 days)
- Use of crutches(after 5 days)
- Days on crutches(after 5 days)
研究者
ÁNGEL PUEYO, MD, MSc
Pediatric Specialist Physician
Hospital Universitario Infanta Leonor