A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow

Study Overview
=================
Brief Summary
-----------------
Nursemaid elbow or pulled elbow is a condition commonly seen in the emergency department. It is the sudden pull of the radial head (a bone in the elbow) in toddlers. Usually occur when a parent tries to pull the child by the arm and a clic or clunk is felt with immediate pain and unwilling to move the arm. It is not a dangerous condition although it is distressing for kids and their parents/caretakers.

Detailed Description
-----------------
The usual therapy consists of one of two maneuvers: supination maneuver or pronation maneuver. They both are safe to perform but none of them have been statistically superior over the other. More studies are needed to confirm or discard the tendency of the studies to favor the pronation maneuver. The investigators intend to perform a randomized trial evaluating which of these techniques is better than the other in terms of returning the mobility of the affected arm and decreasing pain.

Official Title
-----------------
A Randomized Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow

Conditions
-----------------
Nursemaid Elbow, Pulled Elbow

Intervention / Treatment
-----------------
* Other: Pronation
* Other: Supination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulled elbow suspected in any child presenting one of the following: History of an adult or bigger person that had pulled the child's elbow non-intentionally Presence of intense pain at the arrival at the emergency department and unwilling to move the arm. Exclusion Criteria: Any suspect of injury that could be intentional (child abuse) Any suspicion child of suffering a possible fracture (the mechanism of the injury was not from pulling the child's arm, the arm presents obvious deformity, ecchymoses, edema, etc.) The mechanism was from multiple trauma Any chronic disease affecting the adequate bone mineralization (vitamin D deficiency, osteogenesis, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pronation group<br>In this group, participants will receive the pronation procedure. The technique is described below | Other: Pronation<br>* In this technique the arm is flexed 90 degrees and a gentle pronation is applied to the arm; then the arm is further flexed to 45 degrees until the clinician feels a click in the elbow meaning the re-accommodation of the radial head has been accomplished.<br>* Other names: Hyper-pronation technique;|
| Active Comparator: Supination group<br>Participants in this group will be performed the supination technique. Description below. | Other: Supination<br>* The affected arm is in a 90 degrees flexion. The clinician will hold the arm by the elbow and then makes a gentle supination of the affected arm and flexion of the elbow until feeling the click and the child is able to move the arm without pain.<br>* Other names: Supination technique;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful reduction | ✦ Patient can move his/her arm without pain in the next 20 minutes after the technique is applied: i.e., the mother asks the child to hold an object (toy) and the toddler can hold it without problem. | 10 to 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain of the procedure | The mother will asses after the protocol is completed the perceived pain on her child from the maneuver. This will be assessed in a Likert scale. | 1 to 5 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulled elbow, nursemaid elbow