Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-03-02 @ 5:53 PM
Study NCT ID:
NCT02986906
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perineural Injection Therapy for Ulnar Neuropathy at Elbow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from pain on 1st, 3rd, 6th month after injection', 'timeFrame': 'Pre-treatment, 1st, 3rd, 6th month after injection', 'description': 'Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.'}], 'secondaryOutcomes': [{'measure': 'Change from severity of symptoms and functional status on 1st, 3rd, 6th month after injection', 'timeFrame': 'Pre-treatment, 1st, 3rd, 6th month after injection', 'description': 'Taiwan Disabilities of the Arm, Shoulder and Hand (DASH) contains 11-item disability/symptom scale and each item has five levels of response scoring from 1 to 5. The higher score means more disability or severer symptoms.'}, {'measure': 'Change from nerve conduction velocity on 1st, 3rd, 6th month after injection', 'timeFrame': 'Pre-treatment, 1st, 3rd, 6th month after injection', 'description': 'Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.'}, {'measure': 'Change from cross-sectional area on 1st, 3rd, 6th month after injection', 'timeFrame': 'Pre-treatment, 1st, 3rd, 6th month after injection', 'description': 'Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.'}, {'measure': 'Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection', 'timeFrame': 'Pre-treatment, 1st, 3rd, 6th month after injection', 'description': 'The palmer finger pinch and grasp strength was measured using dynamometer (Fabrication Enterprises Inc., USA) before treatment and multiple time frame after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ulnar neuropathy at elbow', 'Dextrose', 'perineural injection'], 'conditions': ['Ulnar Neuropathy at Elbow']}, 'referencesModule': {'references': [{'pmid': '26218266', 'type': 'RESULT', 'citation': 'Chang KV, Hung CY, Ozcakar L. Snapping Thumb and Superficial Radial Nerve Entrapment in De Quervain Disease: Ultrasound Imaging/Guidance Revisited. Pain Med. 2015 Nov;16(11):2214-5. doi: 10.1111/pme.12867. Epub 2015 Jul 27. No abstract available.'}, {'pmid': '1518514', 'type': 'RESULT', 'citation': 'Campbell WW, Pridgeon RM, Sahni KS. Short segment incremental studies in the evaluation of ulnar neuropathy at the elbow. Muscle Nerve. 1992 Sep;15(9):1050-4. doi: 10.1002/mus.880150910.'}, {'pmid': '21623291', 'type': 'RESULT', 'citation': 'Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.'}]}, 'descriptionModule': {'briefSummary': 'Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy. Although many conservative managements of UNE, the effectiveness of these methods are unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment for entrapment neuropathy. However, current studies have not proved the effects of PIT on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. We design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.', 'detailedDescription': 'After obtaining written informed consent, 40 patients, clinically diagnosed with mild or moderate UNE were randomized into intervention or control group. Participants in intervention group received one-session of ultrasound-guided PIT injection with 5cc. 5% dextrose and control group received 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (total 5 cc) ultrasound-guided PIT injection. The primary outcome is Disabilities of the Arm, Shoulder and Hand (DASH) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity of the ulnar nerve, and strength of palmer finger pinch and grasp. The evaluation was performed pretreatment as well as on the 1st, 3rd and 6th month after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20-80 year-old.\n* Diagnosis was confirmed using an electrophysiological study\n\nExclusion Criteria:\n\n* Cancer\n* Coagulopathy\n* Pregnancy\n* Inflammation status\n* Cervical radiculopathy\n* Polyneuropathy, brachial plexopathy\n* Thoracic outlet syndrome\n* Previously undergone wrist surgery or steroid injection for ulnar neuropathy'}, 'identificationModule': {'nctId': 'NCT02986906', 'briefTitle': 'Perineural Injection Therapy for Ulnar Neuropathy at Elbow', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow', 'orgStudyIdInfo': {'id': 'PIT for ulnar neuropathy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5% dextrose', 'description': 'The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy', 'interventionNames': ['Drug: 5% dextrose', 'Device: Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2cc 0.9% normal saline+3cc Triamcinolone (30mg)', 'description': 'The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg)', 'interventionNames': ['Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg)', 'Device: Ultrasound']}], 'interventions': [{'name': '5% dextrose', 'type': 'DRUG', 'description': 'Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve', 'armGroupLabels': ['5% dextrose']}, {'name': '2cc 0.9% normal saline+3cc Triamcinolone (30mg)', 'type': 'DRUG', 'description': 'Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve', 'armGroupLabels': ['2cc 0.9% normal saline+3cc Triamcinolone (30mg)']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'The ultrasound was used for injection guidance', 'armGroupLabels': ['2cc 0.9% normal saline+3cc Triamcinolone (30mg)', '5% dextrose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'state': 'Neihu District', 'country': 'Taiwan', 'facility': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yung-Tsan Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician of Department of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Yung-Tsan Wu', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}