Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-27 @ 10:32 AM
Study NCT ID:
NCT02527603
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2015-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012783', 'term': 'Shoulder Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'C118296', 'term': 'dexketoprofen trometamol'}], 'ancestors': [{'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2015-08-15', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Pain that the patient experiences during the reduction procedure', 'timeFrame': 'Patients will be assessed throughout their visit to the Trauma Unit. No further following should be necessary.There will be no change in pain measurement, only the amount of pain felt during the manoeuvre.', 'description': 'Pain the patient feels during the reduction maneuver. The patient will be asked after reduction to fill out a form with a analog visual scale with scores ranging from 0 \\[no pain\\] to 10 \\[worst possible pain\\].'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Shoulder Dislocation']}, 'descriptionModule': {'briefSummary': 'To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for anterior shoulder dislocation and the Spaso method performed by a physician.', 'detailedDescription': 'Introduction: There are many described maneuvers in literature describing how to reduce an anterior shoulder dislocation. Most of these maneuvers are performed by a trained physician, however, seldom are these taught to patients in case of recurrence or accidental dislocations that may occur far from a trained professional to treat. The Boss-Holzach-Matter maneuver is a simple, easy to understand and easy to perform self assisted method that has not been compared to any other method.\n\nHypothesis: The Boss-Holzach-Matter method is a less painful maneuver compared to the Spaso method assuming an equal success rate.\n\nObjective: To determine whether the Boss-Holzach-Matter method is a less painful method for anterior shoulder dislocations compares to the Spaso method assuming equal success rate.\n\nMethodology: Fifty six patients presenting acute anterior shoulder dislocation will be randomized, at the time of the admission , to either Spaso reduction method performed by a physician or the self-assisted Boss-Holzach-Matter method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an acute anterior shoulder dislocation that are diagnosed in our hospital trauma area.\n\nExclusion Criteria:\n\n* Fracture luxation of the same shoulder.\n* Inability to cooperate due to mental or physical condition.'}, 'identificationModule': {'nctId': 'NCT02527603', 'briefTitle': 'Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Randomized Clinical Trial Comparing the Spaso Maneuver Versus the Self-assisted Boss-Holzach-Matter for Anterior Shoulder Dislocations', 'orgStudyIdInfo': {'id': 'CSPTCOT201501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spaso Method', 'description': 'Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral', 'interventionNames': ['Procedure: Spaso method', 'Drug: Anti-Inflammatory Agents, Non-Steroidal']}, {'type': 'EXPERIMENTAL', 'label': 'Boss-Holzach-Matter Method', 'description': 'Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral', 'interventionNames': ['Procedure: Boss-Holzach-Matter method', 'Drug: Anti-Inflammatory Agents, Non-Steroidal']}], 'interventions': [{'name': 'Boss-Holzach-Matter method', 'type': 'PROCEDURE', 'otherNames': ['Self-assited Method'], 'description': 'The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced', 'armGroupLabels': ['Boss-Holzach-Matter Method']}, {'name': 'Spaso method', 'type': 'PROCEDURE', 'description': 'The physician holds the dislocated arm of the patient in a supine position and proceeds with gentle, soft movements of adduction, flexion and external rotation of the limb in this order until reduction is accomplished.', 'armGroupLabels': ['Spaso Method']}, {'name': 'Anti-Inflammatory Agents, Non-Steroidal', 'type': 'DRUG', 'otherNames': ['Pain Killer, "Enantyum®"'], 'description': 'All patients will be administered a dose of NSAI intra-muscular or orally ("Dexketoprofen", "Enantyum®") it is part of the normal treatment of these patients to cope with pain.', 'armGroupLabels': ['Boss-Holzach-Matter Method', 'Spaso Method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporación sanitaria Parc Taulí de Sabadell', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'David Marti, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharing for other RCT, reviews, Meta analysis. Available from August 2017 Contact: famarcano@tauli.cat'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Francesc A. Marcano-Fernández', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}