Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-28 @ 3:59 PM
Study NCT ID:
NCT06651034
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2024-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Intralesional Platelet Rich Plasma in Patients of De Quervain's Tenosynovitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053684', 'term': 'De Quervain Disease'}], 'ancestors': [{'id': 'D053682', 'term': 'Tendon Entrapment'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Quasi-experimental study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-18', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS Pain Score', 'timeFrame': '3-week', 'description': 'The patients were evaluated three weeks after treatment for efficacy. Efficacy was labeled as VAS pain score \\< 3 after 3 weeks of intralesional PRP injection.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['De Quervain Tenosynovitis']}, 'descriptionModule': {'briefSummary': "De Quervain's tenosynovitis (DQT) was originally identified by Swiss surgeon Fritz de Quervain in 1895. It is a condition involving the entrapment of tendons within the first dorsal compartment of the wrist. In DQT, the sheaths surrounding the abductor pollicis longus (APL) and extensor pollicis brevis tendons thicken as they pass through a fibro-osseous tunnel near the radial styloid of the distal wrist. This thickening leads to pain, which worsens with thumb movements and radial or ulnar deviation of the wrist. Traditional treatment methods, such as corticosteroid injections and physical therapy, often provide only temporary relief and may not address the underlying inflammation effectively. Intralesional platelet rich plasma (PRP) therapy has emerged as a promising alternative, utilizing the patient's own growth factors and cytokines to promote healing and reduce inflammation. By investigating the efficacy of intralesional PRP in patients with DQT, this research aims to provide evidence for a minimally invasive treatment option that could enhance recovery times, reduce pain, and improve functional outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Either gender,\n* Aged between 18 and 60 years\n* Presenting with de quervain's tenosynovitis\n\nExclusion Criteria:\n\n* Previous surgery or intervention forde quervain's tenosynovitis\n* Local skin infection or osteomyelitis\n* Pregnant or lactating mothers"}, 'identificationModule': {'nctId': 'NCT06651034', 'briefTitle': "Efficacy of Intralesional Platelet Rich Plasma in Patients of De Quervain's Tenosynovitis", 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': "Efficacy of Intralesional Platelet Rich Plasma in Patients of De Quervain's Tenosynovitis", 'orgStudyIdInfo': {'id': 'Mayo-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP', 'description': 'Intralesional Platelet rich plasma', 'interventionNames': ['Other: Platelet Rich Plasma']}], 'interventions': [{'name': 'Platelet Rich Plasma', 'type': 'OTHER', 'description': 'Under aseptic measures, a phlebotomist obtained the blood in vacutainers. Vacutainers was centrifuged and middle zone containing platelet rich plasma was aspirated in a 5 ml disposable syringe. The patient received intralesional injection', 'armGroupLabels': ['PRP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Department of Orthopedic surgery, KEMU/ Affiliated hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Muhammad Zarak Awais, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopedic Surgery, Mayo Hospital, Lahore, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}