Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 1:14 AM
Study NCT ID:
NCT04434105
Status:
UNKNOWN
Last Update Posted:
2020-06-16
First Post:
2020-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-15', 'studyFirstSubmitDate': '2020-06-14', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale', 'timeFrame': 'Change from 3 months after last injection and 6 months after last injection', 'description': 'Scale for assessement the degree of pain along 0-10 scale'}, {'measure': 'measuring motor and sensory nerve conduction studies of median nerve using a standardized technique', 'timeFrame': 'Change from 3 months after last injection and 6 months after last injection', 'description': 'electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique'}, {'measure': 'cross-sectional area (CSA) of the median nerve at the level of the pisiform.', 'timeFrame': 'Change from 3 months after last injection and 6 months after last injection', 'description': 'ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRP injection', 'Local injection', 'CTS'], 'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '26807124', 'type': 'BACKGROUND', 'citation': 'Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4705801/', 'label': 'effect of PRP on CTS'}]}, 'descriptionModule': {'briefSummary': 'Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.', 'detailedDescription': 'Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.\n\nEach group will be injected twice with 2 weeks intervals. All procedures were done after informed consent. Evaluation of the patients at baseline, 3 and 6 months after last injection was done clinically by measuring visual analogue scale (VAS), electrophysiologically (by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique) and ultrasonographic study by measuring cross sectional area (CSA) of median nerve at the level of pisiform.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild or moderate idiopathic CTS (diagnosed clinically, ultrasonography \\& electrophysiologically and classified according to the American Association of neuromuscular diagnostic medicine monograph).\n\nExclusion Criteria:\n\n* Patients with severe or secondary type of CTS'}, 'identificationModule': {'nctId': 'NCT04434105', 'briefTitle': 'Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP group', 'description': 'patients received ultrasound-guided injection of 2 mL PRP into the affected carpal tunnel.patients will be injected twice with 2 weeks intervals', 'interventionNames': ['Drug: platlet rich plasma (PRP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid group', 'description': 'patients received ultrasound-guided injection of 2 mL steroids (40 mg triamcinolone acetonide). into the affected carpal tunnel. patients will be injected twice with 2 weeks intervals', 'interventionNames': ['Drug: Triamcinolone Acetonide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'patients received ultrasound-guided injection of 2 mL saline patients will be injected twice with 2 weeks intervals', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'platlet rich plasma (PRP)', 'type': 'DRUG', 'description': 'Platelet-rich plasma (PRP) promotes angiogenesis, neurogenesis, and nerve regeneration, also it could reduce swelling and inflammation of the flexor tenosynovitis.', 'armGroupLabels': ['PRP group']}, {'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'description': '40 mg triamcinolone acetonide', 'armGroupLabels': ['Steroid group']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Saline', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University Hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohammed Hassan Abu-Zaid', 'investigatorAffiliation': 'Tanta University'}}}}