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

• ClinicalTrials.gov Identifier: NCT01562535
• Recruitment Status: Unknown
• First Posted: March 26, 2012
• Last Update Posted: March 26, 2012
• Sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
• Information provided by (Responsible Party): Carlos Alberto Cuello-Garcia, Instituto Tecnologico y de Estudios Superiores de Monterey

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nursemaid Elbow; Pulled Elbow	Other: Pronation; Other: Supination	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
• Study Start Date: June 2012
• Estimated Primary Completion Date: June 2013
• Estimated Study Completion Date: September 2013

Arms and Interventions

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 Name: 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 Name: Supination technique

Outcome Measures

Primary Outcome Measures :

1. Successful reduction [ Time Frame: 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 :

1. Pain of the procedure [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.)

Contacts and Locations

Contacts

Contact: Carlos A Cuello-Garcia, MD; +52(81)-81430200; carlos.cuello@itesm.mx

Locations

Mexico

School of Medicine and Health Sciences

Monterrey, Nuevo Leon, Mexico, 64710

Contact: Carlos A Cuello-Garcia, MD 1-81430200 carlos.cuello@itesm.mx

Sub-Investigator: Yetiani M Roldan-Benitez, MD

Sub-Investigator: Teresa Lopez, MD

Sub-Investigator: Susana Villarreal, MD

Sponsors and Collaborators

Instituto Tecnologico y de Estudios Superiores de Monterey

Investigators

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

More Information

• Responsible Party: Carlos Alberto Cuello-Garcia, Director of the Center for Evidence Based Medicine & Knowledge Translation, Instituto Tecnologico y de Estudios Superiores de Monterey
• ClinicalTrials.gov Identifier: NCT01562535
• Other Study ID Numbers: CMBE-ITESM-2
• First Posted: March 26, 2012
• Last Update Posted: March 26, 2012
• Last Verified: March 2012

Keywords provided by Carlos Alberto Cuello-Garcia, Instituto Tecnologico y de Estudios Superiores de Monterey:

pulled elbow; nursemaid elbow