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

Not Applicable

• Conditions: Nursemaid Elbow; Pulled Elbow
• Interventions: Other: Pronation; Other: Supination

• Registration Number: NCT01562535
• Lead Sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey

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.

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-23
• Last Update Submitted: 2012-03-23
• Study First Posted: 2012-03-26
• Last Update Posted: 2012-03-26
• Study Start: 2012-06
• Primary Completion: 2013-06
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pronation group	Pronation	In this group, participants will receive the pronation procedure. The technique is described below
Supination group	Supination	Participants in this group will be performed the supination technique. Description below.

Primary Outcome Measures

Name	Time	Method
Successful reduction	10 to 20 minutes	✦ 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.

Secondary Outcome Measures

Name	Time	Method
Pain of the procedure	1 to 5 min	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.

Trial Locations

Locations (1)

School of Medicine and Health Sciences; 🇲🇽 Monterrey, Nuevo Leon, Mexico