Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT01499966
Status:
COMPLETED
Last Update Posted:
2011-12-26
First Post:
2011-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002133', 'term': 'Calcium Sulfate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-23', 'studyFirstSubmitDate': '2011-10-31', 'studyFirstSubmitQcDate': '2011-12-23', 'lastUpdatePostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain, karlsson score', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lateral Ankle Sprain', 'Plaster of Paris', 'Tubigrip'], 'conditions': ['Ankle Injuries']}, 'referencesModule': {'references': [{'pmid': '24671488', 'type': 'DERIVED', 'citation': 'Naeem M, Rahimnajjad MK, Rahimnajjad NA, Idrees Z, Shah GA, Abbas G. Assessment of functional treatment versus plaster of Paris in the treatment of grade 1 and 2 lateral ankle sprains. J Orthop Traumatol. 2015 Mar;16(1):41-6. doi: 10.1007/s10195-014-0289-8. Epub 2014 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'Until now very few studies have been done to compare the efficacy of tubigrips or plaster of paris in the treatment of lateral ankle sprains, the investigators aim to compare the tubigrip against plaster of paris in the treatment of lateral ankle sprains.', 'detailedDescription': '200 patients were enrolled after meeting inclusion criteria.All patients gave the verbal as well as written consent for inclusion in the study. The hospital committee ethical review board gave the permission for this study. Only 126 patients agreed to participate in the study. After informed consent was obtained the patients were randomized such that each patient was allocated to use either a Tubigrip (Group A) or Plaster of Paris (Group B)using the Block randomization. The patients in TG group receive the Tubigrip treatment and the patients in POP group were given a below knee plaster cast. Patients were instructed to follow up at 2 weeks and then at 6 weeks. The functional score and pain were used as outcomes of the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-40 years\n* grade 1 and 2 ankle sprains\n* permanent residents in place of study\n* no concomitant bone pathology\n* have not been recruited in other trial simultaneously\n\nExclusion Criteria:\n\n* Patients with age \\<18 years\n* injury \\>48 hours, fractures\n* multiple injuries\n* any neurological or musculoskeletal illness\n* any co-morbid associated with long term disabilities\n* grade 3 lateral ankle sprains'}, 'identificationModule': {'nctId': 'NCT01499966', 'acronym': 'POPTuLAS', 'briefTitle': 'Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains', 'organization': {'class': 'OTHER', 'fullName': 'Liaquat National Hospital & Medical College'}, 'officialTitle': 'Assessment of Tubigrip Versus Plaster of Paris in the Treatment of Grade 1 and 2 Lateral Ankle Sprains', 'orgStudyIdInfo': {'id': 'NRahimnajjad'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group POP', 'description': 'PLASTER OF PARIS', 'interventionNames': ['Procedure: Plaster of Paris/ Tubigrip']}, {'type': 'EXPERIMENTAL', 'label': 'TG', 'description': 'TUBIGRIP', 'interventionNames': ['Procedure: Plaster of Paris/ Tubigrip']}], 'interventions': [{'name': 'Plaster of Paris/ Tubigrip', 'type': 'PROCEDURE', 'description': 'After informed consent was obtained the patients were randomized such that each patient was allocated to use either a Tubigrip (Group A) or Plaster of Paris (Group B). The standardized treatment in the form of RICE (Rest, Ice, Compression and Elevation) protocol was given to all patients. The Patients were randomized using the Block randomization. One hundred and twenty six white papers were taken and "TG" for Tubigrip and "POP" for Plaster of Paris were written and the patients were allowed to pick the envelope of their choice. The authors were blinded till the opening of the envelope by the patients. Patient\'s usage of analgesia in form of Paracetamol was specifically noted. The patients in TG group receive the Tubigrip treatment and the patients in POP group were given a below knee plaster cast. Patients were instructed to follow up at 2 weeks and then at 6 weeks', 'armGroupLabels': ['TG', 'group POP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74200', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Liaquat National Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Zaki Idrees, FRCS', 'role': 'STUDY_CHAIR', 'affiliation': 'Liaquat National Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaquat National Hospital & Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}