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

Instituto Tecnologico y de Estudios Superiores de Monterey

Status: Unknown

Conditions: Pulled Elbow; Nursemaid Elbow

Treatments: Other: Pronation; Other: Supination

Study type: Interventional

Funder types: Other

Identifiers

NCT01562535

CMBE-ITESM-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Pronation group

Experimental group

Description:

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

Treatment:

Other: Pronation

Supination group

Active Comparator group

Description:

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

Treatment:

Other: Supination