A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
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|ClinicalTrials.gov Identifier: NCT01562535|
Recruitment Status : Unknown
Verified March 2012 by Carlos Alberto Cuello-Garcia, Instituto Tecnologico y de Estudios Superiores de Monterey.
Recruitment status was: Not yet recruiting
First Posted : March 26, 2012
Last Update Posted : March 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Nursemaid Elbow Pulled Elbow||Other: Pronation Other: Supination||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Experimental: Pronation group
In this group, participants will receive the pronation procedure. The technique is described below
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.
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562535
|Contact: Carlos A Cuello-Garcia, MD||+52(81)-firstname.lastname@example.org|
|School of Medicine and Health Sciences|
|Monterrey, Nuevo Leon, Mexico, 64710|
|Contact: Carlos A Cuello-Garcia, MD 1-81430200 email@example.com|
|Sub-Investigator: Yetiani M Roldan-Benitez, MD|
|Sub-Investigator: Teresa Lopez, MD|
|Sub-Investigator: Susana Villarreal, MD|
|Principal Investigator:||Carlos A Cuello-Garcia, MD||Instituto Tecnologico y de Estudios Superiores de Monterey|