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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2012 by Instituto Tecnologico y de Estudios Superiores de Monterey.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

Carlos Alberto Cuello-Garcia, Instituto Tecnologico y de Estudios Superiores de Monterey

ClinicalTrials.gov Identifier:

NCT01562535

First received: March 21, 2012

Last updated: March 23, 2012

Last verified: March 2012

History of Changes

Purpose

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	Intervention
Nursemaid Elbow Pulled Elbow	Other: Pronation Other: Supination


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow

Further study details as provided by Instituto Tecnologico y de Estudios Superiores de Monterey:

Primary Outcome Measures:

Successful reduction [ Time Frame: 10 to 20 minutes ] [ Designated as safety issue: No ]
✦ 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:

Pain of the procedure [ Time Frame: 1 to 5 min ] [ Designated as safety issue: Yes ]
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.


Estimated Enrollment:	90
Study Start Date:	June 2012
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	6 Months to 6 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562535

Contacts


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

Locations


Mexico
School of Medicine and Health Sciences	Not yet recruiting
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

No publications provided


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 History of Changes
Other Study ID Numbers:	CMBE-ITESM-2
Study First Received:	March 21, 2012
Last Updated:	March 23, 2012
Health Authority:	Mexico: Secretaria de Salud

Keywords provided by Instituto Tecnologico y de Estudios Superiores de Monterey:


pulled elbow nursemaid elbow

ClinicalTrials.gov processed this record on February 27, 2015

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