Nursemaid ElbowNCT01562535
A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
A study testing Pronation and Supination in people with Nursemaid Elbow and Pulled Elbow, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Nursemaid Elbow, Pulled Elbow
- What is being tested?
- Pronation and Supination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site
School of Medicine and Health Sciences
Monterrey, Nuevo León, 64710
Carlos A Cuello-Garcia, MD, 1-81430200, carlos.cuello@itesm.mx
Yetiani M Roldan-Benitez, MD
About this study
Official title: A Randomized Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
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.
Read the 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.
- Conditions
- Nursemaid Elbow, Pulled Elbow
- Being tested
- Pronation, Supination
- Keywords
- pulled elbow, nursemaid elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PronationOther
Also called Hyper-pronation technique
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.
SupinationOther
Also called Supination technique
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.
| Study group | Role | What they receive |
|---|---|---|
| Pronation group | Experimental | In this group, participants will receive the pronation procedure. The technique is described below Receives: Other: Pronation |
| Supination group | Active comparator | Participants in this group will be performed the supination technique. Description below. Receives: Other: Supination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 to 20 minutes
Secondary outcomes (1)
Pain of the procedure
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.
Measured: 1 to 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursemaid ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Alberto Cuello-Garcia, Instituto Tecnologico y de Estudios Superiores de Monterey
- Investigators
- Carlos A Cuello-Garcia, MD, Principal investigator, Instituto Tecnologico y de Estudios Superiores de Monterey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562535
- Sponsor's protocol ID
- CMBE-ITESM-2
- Status last verified
- Mar 2012
- First submitted
- 21 Mar 2012
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
- ClinicalTrials.gov ID
- NCT01562535
- Acronym / sponsor ID
- CMBE-ITESM-2
- Conditions
- Nursemaid Elbow, Pulled Elbow
- Keywords
- pulled elbow, nursemaid elbow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pronation group | Experimental | Other: PronationIn this group, participants will receive the pronation procedure. The technique is described below |
| Supination group | Active comparator | Other: SupinationParticipants in this group will be performed the supination technique. Description below. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pulled elbow suspected in any child presenting one of the following:
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PronationAlso: Hyper-pronation techniqueIn 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 | Pronation group |
| SupinationAlso: Supination techniqueThe 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 | Supination group |
Primary outcome
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.
1 secondary outcome
Pain of the procedure
Time frame: 1 to 5 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Cuello-Garcia, MD principal investigator
Instituto Tecnologico y de Estudios Superiores de Monterey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pronation and Supination in people with Nursemaid Elbow and Pulled Elbow, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos A Cuello-Garcia, MD (+52(81)-81430200, carlos.cuello@itesm.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful reduction (time frame: 10 to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.