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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
Sponsor:
Information provided by (Responsible Party):
Carlos Alberto Cuello-Garcia, Instituto Tecnologico y de Estudios Superiores de Monterey

Tracking Information
First Submitted Date  ICMJE March 21, 2012
First Posted Date  ICMJE March 26, 2012
Last Update Posted Date March 26, 2012
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
Official Title  ICMJE A Randomized Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nursemaid Elbow
  • Pulled Elbow
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Pronation group
    In this group, participants will receive the pronation procedure. The technique is described below
    Intervention: Other: Pronation
  • Active Comparator: Supination group
    Participants in this group will be performed the supination technique. Description below.
    Intervention: Other: Supination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 23, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562535
Other Study ID Numbers  ICMJE CMBE-ITESM-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carlos Alberto Cuello-Garcia, Instituto Tecnologico y de Estudios Superiores de Monterey
Study Sponsor  ICMJE Instituto Tecnologico y de Estudios Superiores de Monterey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos A Cuello-Garcia, MD Instituto Tecnologico y de Estudios Superiores de Monterey
PRS Account Instituto Tecnologico y de Estudios Superiores de Monterey
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP