A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
Recruitment status was Not yet recruiting
|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|
- 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.
- 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.
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562535
|Contact: Carlos A Cuello-Garcia, MD||+52(81)-email@example.com|
|School of Medicine and Health Sciences||Not yet recruiting|
|Monterrey, Nuevo Leon, Mexico, 64710|
|Contact: Carlos A Cuello-Garcia, MD 1-81430200 firstname.lastname@example.org|
|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|