Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-30 @ 9:27 PM
Study NCT ID:
NCT05344495
Status:
UNKNOWN
Last Update Posted:
2022-06-15
First Post:
2022-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-11', 'studyFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': '6 months', 'description': 'visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain'}], 'secondaryOutcomes': [{'measure': 'Boston questionnaire', 'timeFrame': '6 months', 'description': 'symptom severity ... function severity'}, {'measure': 'median nerve sonogrphy', 'timeFrame': '6 months', 'description': 'cross sectional area'}, {'measure': 'Nerve electrophysiology', 'timeFrame': '6 months', 'description': 'sensory velocity and distal motor latency ... 1m/sec is the least and 10m/sec is the highest'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Neuropathic']}, 'descriptionModule': {'briefSummary': 'Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (30 - 70 years old) complaining of carpal tunnel syndrome of 3 month duration or more , diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study refractory to medical treatment for 2 months .\n\nExclusion Criteria:\n\n* Diabetic patients\n* Pregnant population .\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT05344495', 'briefTitle': 'Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome:', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome: A Randomized, Clinical Trial.', 'orgStudyIdInfo': {'id': '277/4-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hyalse group', 'description': 'ultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5%', 'interventionNames': ['Drug: hyalase group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'midazolam group', 'description': 'ultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5%', 'interventionNames': ['Drug: midazolam group']}], 'interventions': [{'name': 'hyalase group', 'type': 'DRUG', 'otherNames': ['Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5%'], 'description': 'bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.', 'armGroupLabels': ['hyalse group']}, {'name': 'midazolam group', 'type': 'DRUG', 'otherNames': ['Sonar guided median nerve hydrodissection by midazolam and bupivacaine 0.5%'], 'description': '2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5%', 'armGroupLabels': ['midazolam group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6115', 'city': 'ALMinya', 'state': 'Minya Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mina raouf', 'role': 'CONTACT', 'email': 'drmina2015@gmail.com', 'phone': '01015752424'}], 'facility': 'Mina Raouf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and ICU', 'investigatorFullName': 'Mina Maher', 'investigatorAffiliation': 'Minia University'}}}}