Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-04 @ 7:04 PM
Study NCT ID:
NCT03548259
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2018-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial (Parallel Assignment)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2018-05-24', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hand grip strength', 'timeFrame': '6 weeks', 'description': 'Hand grip strength measured with dynamometer'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '6 weeks', 'description': 'Pain measured with the Wong-Baker Faces Pain Rating Scale. The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst".'}, {'measure': 'Sympton severity', 'timeFrame': '6 weeks', 'description': 'Sympton severity measured with the sympton severity scale of the Boston Carpal Tunnel Syndrome Questionnaire. The Symptom Severity Scale (SSS) contains 11 questions and uses a five-point rating scale that generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.'}, {'measure': 'Functional status', 'timeFrame': '6 weeks', 'description': 'Functional status measured with the sympton severity scale of the Boston Carpal Tunnel Syndrome Questionnaire.The Functional Status Scale (FSS) contains 8 items and uses a five-point rating scale that generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.'}, {'measure': 'Wound healing', 'timeFrame': '6 weeks', 'description': 'Wound healing measured with the Southampton Wound Assessment Scale. Wounds are scored as 0, I, II, III, IV and V, with a higher score indicating worst healing.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'Platelet-rich plasma', 'Surgery'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'The Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of carpal tunnel syndrome (CTS). Here we propose to assess the effectiveness of PRP as co-adjuvant in surgical treatment of CTS by open carpal tunnel release.\n\nDesign: Randomized Controlled Trial. Setting: Local Hospital.', 'detailedDescription': 'Carpal tunnel syndrome (CTS) is a common disorder with an estimated annual incidence of 125-542 in adults, and an estimated prevalence of 1 to 5 percent in the general population. CTS is the most frequent compressive focal mononeuropathy and causes pain, paresthesia and weakness of the median nerve distribution in patients.\n\nThe treatment of the CTS includes both, conservative and surgical treatment depending on the severity of the symptoms.\n\nPlatelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of CTS, however its potential used as co-adjuvant in surgical treatment has not been assessed.\n\nWe propose a randomized clinical trial in patients in which the surgical treatment is indicated. Participants in the intervention group receive a PRP injection, and in the control group a platelet-poor plasma injection after open carpal tunnel release. The evaluation is performed pretreatment as well as on the 6st week after treatment. Outcome measures include: hand grip strength (primary outcome), pain, sympton severity and functional status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Carpal Tunnel Syndrome (CTS)\n* Conservative treatment failure\n\nExclusion Criteria:\n\n* Previous CTS surgery on the same side\n* Wrist fracture/trauma in history\n* Polyneuropathy\n* Diabetes mellitus\n* Cervical neuropathy'}, 'identificationModule': {'nctId': 'NCT03548259', 'acronym': 'PRP-CTS', 'briefTitle': 'Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized', 'orgStudyIdInfo': {'id': 'UNIVERSITY CARDENAL HERRERA-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Platelet-rich plasma', 'interventionNames': ['Procedure: Platelet-rich plasma', 'Procedure: Platelet-poor plasma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Platelet-poor plasma', 'description': 'Platelet-poor plasma', 'interventionNames': ['Procedure: Platelet-rich plasma', 'Procedure: Platelet-poor plasma']}], 'interventions': [{'name': 'Platelet-rich plasma', 'type': 'PROCEDURE', 'description': 'Platelet-rich plasma injection', 'armGroupLabels': ['Experimental', 'Platelet-poor plasma']}, {'name': 'Platelet-poor plasma', 'type': 'PROCEDURE', 'description': 'Platelet-poor plasma injection', 'armGroupLabels': ['Experimental', 'Platelet-poor plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46113', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Universidad CEU Cardenal Herrera', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Ignacio Pérez, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardenal Herrera University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Medicine', 'investigatorFullName': 'Juan F. Lisón Párraga, Dr', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}