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

NCT01562535 | Unknown DMC

• 1 other identifier: CMBE-ITESM-2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Nursemaid Elbow; Pulled Elbow

Keywords

pulled elbow; nursemaid elbow

Outcome Measures

Primary Outcomes (1)

• Successful reduction

  ✦ 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.

  10 to 20 minutes

Secondary Outcomes (1)

• Pain of the procedure

  1 to 5 min

Study Arms (2)

Pronation group

EXPERIMENTAL

In this group, participants will receive the pronation procedure. The technique is described below

Other: Pronation

Supination group

ACTIVE COMPARATOR

Participants in this group will be performed the supination technique. Description below.

Other: Supination

Interventions

Pronation OTHER

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.

Also known as: Hyper-pronation technique

Pronation group

Supination OTHER

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.

Also known as: Supination technique

Supination group

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pulled elbow suspected in any child presenting one of the following:
• History of an adult or bigger person that had pulled the child's elbow non-intentionally
• Presence of intense pain at the arrival at the emergency department and unwilling to move the arm.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Instituto Tecnologico y de Estudios Superiores de Monterey: lead

Study Sites (1)

School of Medicine and Health Sciences

Monterrey, Nuevo León, 64710, Mexico

Location

MeSH Terms

Interventions

Pronation; Supination

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carlos A Cuello-Garcia, MD

  Instituto Tecnologico y de Estudios Superiores de Monterey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos A Cuello-Garcia, MD

CONTACT

+52(81)-81430200; carlos.cuello@itesm.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Evidence Based Medicine & Knowledge Translation

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 26, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

ME (1)