Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-28 @ 6:05 AM
Study NCT ID:
NCT01562535
Status:
UNKNOWN
Last Update Posted:
2012-03-26
First Post:
2012-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011403', 'term': 'Pronation'}, {'id': 'D013484', 'term': 'Supination'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2012-03-21', 'studyFirstSubmitQcDate': '2012-03-23', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful reduction', 'timeFrame': '10 to 20 minutes', 'description': '✦ 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.'}], 'secondaryOutcomes': [{'measure': 'Pain of the procedure', 'timeFrame': '1 to 5 min', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pulled elbow', 'nursemaid elbow'], 'conditions': ['Nursemaid Elbow', 'Pulled Elbow']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pulled elbow suspected in any child presenting one of the following:\n\n 1. History of an adult or bigger person that had pulled the child's elbow non-intentionally\n 2. Presence of intense pain at the arrival at the emergency department and unwilling to move the arm.\n\nExclusion Criteria:\n\n* Any suspect of injury that could be intentional (child abuse)\n* 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.)\n* The mechanism was from multiple trauma\n* Any chronic disease affecting the adequate bone mineralization (vitamin D deficiency, osteogenesis, etc.)"}, 'identificationModule': {'nctId': 'NCT01562535', 'briefTitle': 'A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Tecnologico y de Estudios Superiores de Monterey'}, 'officialTitle': 'A Randomized Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow', 'orgStudyIdInfo': {'id': 'CMBE-ITESM-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pronation group', 'description': 'In this group, participants will receive the pronation procedure. The technique is described below', 'interventionNames': ['Other: Pronation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supination group', 'description': 'Participants in this group will be performed the supination technique. Description below.', 'interventionNames': ['Other: Supination']}], 'interventions': [{'name': 'Pronation', 'type': 'OTHER', 'otherNames': ['Hyper-pronation technique'], 'description': '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.', 'armGroupLabels': ['Pronation group']}, {'name': 'Supination', 'type': 'OTHER', 'otherNames': ['Supination technique'], 'description': '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.', 'armGroupLabels': ['Supination group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64710', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'contacts': [{'name': 'Carlos A Cuello-Garcia, MD', 'role': 'CONTACT', 'email': 'carlos.cuello@itesm.mx', 'phone': '1-81430200'}, {'name': 'Yetiani M Roldan-Benitez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Teresa Lopez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Susana Villarreal, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'School of Medicine and Health Sciences', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'centralContacts': [{'name': 'Carlos A Cuello-Garcia, MD', 'role': 'CONTACT', 'email': 'carlos.cuello@itesm.mx', 'phone': '+52(81)-81430200'}], 'overallOfficials': [{'name': 'Carlos A Cuello-Garcia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Tecnologico y de Estudios Superiores de Monterey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Tecnologico y de Estudios Superiores de Monterey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Center for Evidence Based Medicine & Knowledge Translation', 'investigatorFullName': 'Carlos Alberto Cuello-Garcia', 'investigatorAffiliation': 'Instituto Tecnologico y de Estudios Superiores de Monterey'}}}}