Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT03210792
Status:
UNKNOWN
Last Update Posted:
2017-07-07
First Post:
2017-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Manufactured Rib Splint With Hand-made Rib Splint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2017-07-04', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration', 'timeFrame': 'We check a pain scale at 30 minutes after splint application', 'description': 'Comparison CCO Rib splint with Handmade Rib splint about pain reduction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Acute']}, 'descriptionModule': {'briefSummary': 'A pilot study for a prospective randomized clinical trial was conducted to compare subjects using the CCO (Group-A) with those using the ER-splint (Group-B) before and after the intervention.\n\nThe primary outcome was difference in the level of pain based on the visual analogue scale (VAS) between before and after intervention in each group during forceful and resting respiration.\n\nVAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis', 'detailedDescription': 'Investigators performed VAS assessments to determine the level of pain in the subjects with RFs during resting and forceful respiration. Investigators applied either the CCO rib splint or the ER splint to the RF subjects in a randomized order. At 30 minutes after splint application, investigators repeated the VAS assessments during resting and forceful respiration. Subsequently, additional pain control was provided via intravascular drug injection.\n\nRF : Rib fractures VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have rib fractures and age was over 18 years old\n\nExclusion Criteria:\n\n* Investigators excluded subjects with cardiopulmonary dysfunction, poly-trauma, flail chest, damage to an internal organ, or alcoholism and subjects who did not consent to participate.'}, 'identificationModule': {'nctId': 'NCT03210792', 'acronym': 'CMRSHRS', 'briefTitle': 'Comparison Manufactured Rib Splint With Hand-made Rib Splint', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University'}, 'officialTitle': 'Comparison of the Effectiveness in Pain Reduction Between a Rib Splint Produced in the ER and a Manufactured Rib Splint: Preliminary Clinical Study', 'orgStudyIdInfo': {'id': 'RIBSPLINTPRESTUDY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CCO Rib Splint', 'description': 'Subjects were applied Chrisofix® Chest Orthosis (Manufactured Rib Splint) for Rib Fractures treatment.', 'interventionNames': ['Device: Application of Rib Splint']}, {'type': 'EXPERIMENTAL', 'label': 'Handmade Rib Splint', 'description': 'Subjects were applied Handmade Rib Splint for Rib Fractures treatment.', 'interventionNames': ['Device: Application of Rib Splint']}], 'interventions': [{'name': 'Application of Rib Splint', 'type': 'DEVICE', 'description': 'Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.', 'armGroupLabels': ['CCO Rib Splint', 'Handmade Rib Splint']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'LEE YOON-JE', 'investigatorAffiliation': 'Hanyang University'}}}}