Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-31 @ 10:19 AM
Study NCT ID:
NCT05725460
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Median Nerve Hydrodissection Using Dextrose
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': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups comparing the efficacy of dextrose water 5 % in median nerve hydrodissection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain relief in 2 weeks follow up', 'timeFrame': '6 months', 'description': 'difference in sensory and functional symptoms post median nerve hydrodissection using dextrose and compare this effect with steroid population arm using Boston questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'to compare the efficacy of dextrose 5% with steroid hydrodissection in patients with carpal tunnel syndrome', 'detailedDescription': 'in some cases there is prohibition to use steroid with example the patient rejection to use steroid the maneuver planned median nerve hydrodissection using ultrasound and 10 mld of dextrose 5%, unleash the median nerve for the surrounding structure and short follow up planned to be 2 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsevere carpal tunnel syndrome failed medical management -\n\nExclusion Criteria:\n\nprevious failed surgery previous failed injection previous failed trial of hydrodissection cervical or brachial nerve entrapment wrist osteoarthritis or rheumatoid pregnant diabetes mellitus\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05725460', 'briefTitle': 'Ultrasound Guided Median Nerve Hydrodissection Using Dextrose', 'organization': {'class': 'OTHER', 'fullName': 'Iraqi Board of medical specialties'}, 'officialTitle': 'Efficacy of Dextrose 5% in Comparison With Steroid in Median Nerve Ultrasound Guided Hydrodissection in Patients With Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'iraqiboard'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dextrose 5%', 'description': '10 mls of dextrose under ultrasound to separate the median nerve from adjacent structures', 'interventionNames': ['Procedure: dextrose 5% median nerve hydrodissection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'steroid', 'description': '10 mls of steroid used to separate the median nerve from adjacent structures', 'interventionNames': ['Procedure: dextrose 5% median nerve hydrodissection']}], 'interventions': [{'name': 'dextrose 5% median nerve hydrodissection', 'type': 'PROCEDURE', 'description': 'planned to be a good alternative to steroid hydrodissection', 'armGroupLabels': ['dextrose 5%', 'steroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Baghdad Medical City', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iraqi Board of medical specialties', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}