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

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

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.

Study Overview

• Status: Unknown
• Conditions: Nursemaid Elbow; Pulled Elbow
• Intervention / Treatment: Other: Pronation; Other: Supination

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64710
      • School of Medicine and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pronation group; In this group, participants will receive the pronation procedure. The technique is described below	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.; Other Names: Hyper-pronation technique
Active Comparator: Supination group; Participants in this group will be performed the supination technique. Description below.	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.; 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

Collaborators and Investigators

• Sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
• Investigators: Principal Investigator: Carlos A Cuello-Garcia, MD, Instituto Tecnologico y de Estudios Superiores de Monterey

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (Estimate): March 26, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 23, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: pulled elbow; nursemaid elbow
• Other Study ID Numbers: CMBE-ITESM-2