Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT06766318
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2025-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cryo-ultrasound Versus LASER Therapy on Ankle Sprain in Tennis Players
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': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-11', 'studyFirstSubmitDate': '2025-01-04', 'studyFirstSubmitQcDate': '2025-01-04', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity a', 'timeFrame': '2 months', 'description': 'We will assess pain intensity before and after intervension by numeric pain rating scale, which is numerical from 0 indicate no pain and 10 indicate the worest pain'}, {'measure': 'Foot and Ankle Disability Index', 'timeFrame': '2 months', 'description': 'Foot and Ankle Disability Index (FADI) at baseline (T0) at the end of treatment (T1), after one month (T2), and two months after treatment (T3).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryoultrasound', 'laser', 'Ankle sprain', 'Tennis players', 'Elite girl'], 'conditions': ['Ankle (Ligaments); Instability (Old Injury)']}, 'descriptionModule': {'briefSummary': 'the effect cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.', 'detailedDescription': 'Acute lateral ankle sprains are common injuries among athletes, but the optimal treatment strategies in elite athletes are still debated. This proof-of-concept study aimed to assess the impact of cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ranged from 12-16 years.\n* elite girls;\n* semi-professional tennis players;\n* I-II grade lateral ankle sprain injury;\n* no persistent instability phenomena or chronic sprains;\n* acute injury (within 2 weeks from trauma);\n* no evidence of bone edema or skin disorder, once the area of intense pain in motion was delimited, the lack of neurological disturbances was investigated and assessed.\n\nExclusion Criteria:\n\n* history of recurrent dislocation of the ankle or hyperlaxity of any joint;\n* severe rheumatic diseases and/or collagen diseases;\n* athletes who have received any form of local physical therapy and NSAIDs within the last 2 months prior to injury;\n* athletes who admit to using steroids;\n* any contraindication and/or limitation to the use of a physical agent modality (implantable electrophysiological devices, active neoplasms). Taking medications.\n* Athletic adult.'}, 'identificationModule': {'nctId': 'NCT06766318', 'briefTitle': 'Cryo-ultrasound Versus LASER Therapy on Ankle Sprain in Tennis Players', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Cryo-ultrasound Versus LASER Therapy on Ankle Sprain in Tennis Players', 'orgStudyIdInfo': {'id': 'REC/012/005532'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cryo-ultrasound group (n = 20): received cryo-ultrasound therapy', 'description': 'received cryo-ultrasound therapy combined with conventional physical therapy', 'interventionNames': ['Device: group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two months']}, {'type': 'EXPERIMENTAL', 'label': 'Laser group', 'description': 'receive LASER therapy combined with conventional physical therapy', 'interventionNames': ['Device: LASER therapy']}], 'interventions': [{'name': 'group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two months', 'type': 'DEVICE', 'description': 'Cryo-ultrasound therapy combines two therapeutic methods: cryotherapy (using cold) and ultrasound (using sound waves). The ultrasound component provides a therapeutic heating effect, improving blood circulation and tissue flexibility, while the cold component reduces pain and inflammation', 'armGroupLabels': ['cryo-ultrasound group (n = 20): received cryo-ultrasound therapy']}, {'name': 'LASER therapy', 'type': 'DEVICE', 'description': 'group B will receive LASER therapy combined with conventional physical therapy.', 'armGroupLabels': ['Laser group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kerolous Ishak Shehata Kelini', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Kerolous Ishak Kelini, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AL-Zaytoonah University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Kerolous Ishak Shehata', 'investigatorAffiliation': 'October 6 University'}}}}