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

NCT ID: NCT01562535

Last Updated: 2012-03-26

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Nursemaid Elbow Pulled Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pronation group

In this group, participants will receive the pronation procedure. The technique is described below

Group Type EXPERIMENTAL

Pronation

Intervention Type OTHER

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.

Supination group

Participants in this group will be performed the supination technique. Description below.

Group Type ACTIVE_COMPARATOR

Supination

Intervention Type OTHER

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.

Interventions

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Pronation

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.

Intervention Type OTHER

Supination

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.

Intervention Type OTHER

Other Intervention Names

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Hyper-pronation technique Supination technique

Eligibility Criteria

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Inclusion Criteria

* Pulled elbow suspected in any child presenting one of the following:

1. History of an adult or bigger person that had pulled the child's elbow non-intentionally
2. 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.)
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Tecnologico y de Estudios Superiores de Monterey

OTHER

Sponsor Role lead

Responsible Party

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Carlos Alberto Cuello-Garcia

Director of the Center for Evidence Based Medicine & Knowledge Translation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos A Cuello-Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Tecnologico y de Estudios Superiores de Monterey

Locations

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School of Medicine and Health Sciences

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

Central Contacts

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Carlos A Cuello-Garcia, MD

Role: CONTACT

+52(81)-81430200

Facility Contacts

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Carlos A Cuello-Garcia, MD

Role: primary

1-81430200

Other Identifiers

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CMBE-ITESM-2

Identifier Type: -

Identifier Source: org_study_id

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