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

Nursemaid Elbow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01562535
• Other study ID #: CMBE-ITESM-2
• Status: Not yet recruiting
• Phase: N/A
• First received: March 21, 2012
• Last updated: March 23, 2012
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2012
• Source: Instituto Tecnologico y de Estudios Superiores de Monterey
• Contact: Carlos A Cuello-Garcia, MD
• Phone: +52(81)-81430200
• Email: carlos.cuello[@]itesm.mx
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Nursemaid Elbow
• Pulled Elbow

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Mexico	School of Medicine and Health Sciences	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Tecnologico y de Estudios Superiores de Monterey

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes