Comparison of Supination/Flexion Maneuver to Hyperpronation Maneuver in the Reduction of Radial Head Subluxations: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Rate of first attempt failure
研究概览
简要总结
This study is designed as a randomized controlled study. The investigators aim to compare the success of supination-flexion and hyperpronation maneuvers in the treatment of preschool children presenting to the emergency department with radial head subluxation.
All children aged 0-6 years, who are diagnosed with radial head subluxation secondary to traction of the forearm, had no evidence of direct trauma to the arm or fracture in the arm (no deformity, swelling, ecchymosis), had no history of musculoskeletal disease, and are approved to participate in the study by their legal guardians, will be included in the study. Patients who are considered to have radial head subluxation initially but had an X-ray performed by the physician and had a fracture in the arm will be excluded from the study.
In the study, patients will be randomized and assigned to two treatment groups: the supination-flexion group and the hyperpronation group. In the supination-flexion group, the forearm will be supinated first, followed by full flexion of the elbow joint. In the hyperpronation group, the forearm will be pronated with the child's palm facing down. In both groups, maneuvers will be performed by 3 emergency medicine specialists with at least 2 years of experience.
First-attempt failure is determined as the primary outcome of the study. Failure in the second attempt, ultimate failure, recurrence, patient satisfaction during the procedure, pain intensity (assessed by the Face, Legs, Activity, Cry, Consolability - FLACC pain scale), and treatment-related adverse events are determined as secondary outcomes of the study.
The investigators calculated the sample size and decided to include 117 patients in each group.
详细描述
INTRODUCTION Radial head subluxation also called nursemaid's elbow and pulled elbow, usually results from a sudden pull on the outstretched arm and is the most common cause of upper extremity injuries in preschool children. The diagnosis is made clinically and there is no need for routine imaging. The child complains of pain and refuses to use the affected arm. Radial head subluxation is treated with manual reduction of the subluxated radial head. Among the various reduction maneuvers available, the commonly used methods are supination-flexion and hyperpronation maneuvers.
The issue of which maneuver is more successful is still controversial. Supination-flexion is generally accepted as the standard maneuver and is the most preferred method. However, the hyperpronation technique was reported to be superior in a 2017 Cochrane review with 8 articles. But in a more recent randomized controlled trial on 152 patients it was reported that the supination-flexion maneuver was more successful. Controversial is not just the contradiction of previous study results. In addition, the quality of evidence is also controversial, as previous studies carry a high risk of bias. There is a serious risk of selection bias in most of the studies due to the lack or insufficiency of randomization or allocation concealment. Again, since there is no assessor blinding in the majority of the studies, the risk of detection bias is inevitable. Furthermore, in most of the previous randomized controlled trials, the sample size was not calculated. As a result, as highlighted in the Cochrane review, most previous randomized controlled trials, have a high risk of bias. The investigators think that well-planned, low-bias randomized controlled trials, are needed to answer this clinical question, both due to the high risk of bias in previous studies and conflicting results regarding which maneuver is superior in published reports.
In this randomized controlled study, the investigators aimed to compare the success of supination-flexion and hyperpronation maneuvers in the treatment of preschool children presenting to the emergency department with radial head subluxation.
METHODS This study will be conducted and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement.
Design This parallel group open-label randomized controlled trial will be conducted between May 2023 and May 2024 in a tertiary education and research hospital.
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
- Single (Outcomes Assessor)
盲法说明
The primary outcome accessors will be blinded to the study. They will not know which group is supination-flexion group or hyperpronation group from the data set. Group names will be included in the dataset as group 1 and group 2.
入排标准
- 年龄范围
- 1 Day 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of radial head subluxation
- •No evidence of direct trauma to the arm
- •No fracture in the arm
- •No history of musculoskeletal disease
排除标准
- •Refusing to participate in the study
结局指标
主要结局
Rate of first attempt failure
时间窗: 10 minutes after the first-attempt, the outcome will be evaluated.
After the first attempt (the maneuver according to group), the patient will re-examined and the success of the treatment will be evaluated. If additional treatment was needed or if the child still avoided using his/her arm after the procedure, it was considered as treatment failure
次要结局
- Rate of second attempt failure(10 minutes after the second-attempt, the outcome will be evaluated.)
- Rate of third attempt failure (ultimate failure)(10 minutes after the third-attempt, the outcome will be evaluated.)
- Adverse events detected during the first attempt of the maneuver(Side effect assessment will begin immediately after the reduction maneuver is performed. The patient will be followed up for side effects for a week and any side effects seen during this period will be recorded.)
- Number of patients presenting with recurrence of radial head subluxation(72 hours after of first admission with same diagnosis.)
- Pain intensity of the patients during the first attempt of the maneuver(Just before (1 minute) and during the first attempt of the maneuver.)
研究者
Gökhan AKSEL
Associate Professor
Umraniye Education and Research Hospital