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

Tracking Information

• First Submitted Date: March 21, 2012
• First Posted Date: March 26, 2012
• Last Update Posted Date: March 26, 2012
• Study Start Date: June 2012
• Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Nursemaid Elbow
• Pulled Elbow

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 23, 2012): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2013
• Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility 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.)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 6 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT01562535
• Other Study ID Numbers: CMBE-ITESM-2
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Carlos Alberto Cuello-Garcia, Instituto Tecnologico y de Estudios Superiores de Monterey
• Study Sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
• Collaborators: Not Provided

Investigators

• 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