Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT02566616
Status:
WITHDRAWN
Last Update Posted:
2017-04-05
First Post:
2015-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Nerve Stimulation of the Ulnar Nerve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020430', 'term': 'Cubital Tunnel Syndrome'}], 'ancestors': [{'id': 'D020424', 'term': 'Ulnar Neuropathies'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017769', 'term': 'Ulnar Nerve Compression Syndromes'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'EMG', 'timeFrame': 'Pre-op and 3 month post op visit', 'description': 'Electromyelopgraph to confirm ulnar nerve neuropathy and improvement at 3 months post op'}, {'measure': 'Monofilament test', 'timeFrame': '5 minutes, pre op and each post op visit', 'description': 'Measure sensation on fingers'}, {'measure': '2 point discrimination', 'timeFrame': '5 minutes, pre op and each post op visit', 'description': 'Measure 2 point discrimination on fingers'}, {'measure': 'Pinch Strength', 'timeFrame': '5 minutes, pre op and each post op visit', 'description': 'Measure Pinch strength'}, {'measure': 'Grip strength', 'timeFrame': '5 minutes, pre op and each post op visit', 'description': 'Measure hand grip strength'}], 'primaryOutcomes': [{'measure': 'Patient Related Ulnar Nerve Evaluation', 'timeFrame': '10 minutes', 'description': 'PRUNE Survey with 0-100 score'}], 'secondaryOutcomes': [{'measure': 'QuickDASH', 'timeFrame': '10 minutes, pre op and each post op visit', 'description': 'Survey'}, {'measure': 'Michigan Hand Questionnaire', 'timeFrame': '20 minutes, pre op and each post op visit', 'description': 'Survey'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cubital Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'Cubital tunnel syndrome is caused by compression of the ulnar nerve at the elbow. This leads to symptoms such as chronic hand weakness, numbness and pain. This is usually treated with a surgical procedure where the nerve is decompressed. Research has shown that nerve simulators speed up the recovery of nerves following injury. The purpose of our research is to examine the difference in patient outcomes after the nerve decompression surgery with and without nerve stimulation.\n\nOur research questions is: What are the differences in long term functional outcomes of patients that have ulnar nerve decompression surgery with and without nerve stimulation?', 'detailedDescription': '1. Patients will be seen in University of Chicago clinics, if they are diagnosed with Cubital Tunnel Syndrome, they will be approached to be enrolled in our study\n2. If they fit inclusion and exclusion criteria, failed conservative management, and consent to be part of the study, they will be scheduled for Cubital Tunnel Surgery and randomized into intervention/non-intervention group\n3. Patients will have pre-operative subjective pain and upper extremity function surveys and objective hand strength/sensation measurements done by a blinded Occupational Therapist in University of Chicago Occupational Therapy Clinic. Patient will also have a pre-operative EMG done.\n4. Patient will be discharged following surgery and followed up at 6 weeks, 3 months, 6 months, 12 months. EMG will be done at 3 months and the same outcome measurements (Pain scores, PRUNE evaluation, QuickDash Questionnaire, Michigan hand Questionnaire, grip strength, sensation measurements) will be taken at each postoperative visit by the same blinded occupational therapist\n5. Data will be compared pre and postoperatively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria\n\n* EMG confirmed ulnar nerve neuropathy at cubital tunnel with or without these symptoms:\n\n * Paresthesia or numbness of the small finger and/or ring finger\n * Complaints of hand weakness\n * Exam shows positive flexion compression test at elbow and/or positive tinel's sign at the cubital tunnel\n* Failed conservative management for 6 weeks\n\n ○ Has completed a combination of these for 6 weeks and still has symptoms\n * Night splinting in 45-60 degrees of flexion and forearm neutral\n * Padding of elbow with an elbow pad during the day\n * Daily NSAIDs if able to take them\n * Cubital tunnel steroid injection\n* Age restriction: 18--65years old\n\nExclusion criteria\n\n* Psychiatric conditions\n* Workman's compensation patients\n* Neurologic conditions (ex. MS)\n* Inflammatory rheumatologic conditions (Connective tissues disease, RA… etc)\n* Associated elbow and upper extremity fractures\n* Previous Cubital Tunnel Surgeries\n* Previous C-Spine Surgeries\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT02566616', 'acronym': 'ESTIM', 'briefTitle': 'Electrical Nerve Stimulation of the Ulnar Nerve', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?', 'orgStudyIdInfo': {'id': '14-0646'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Cubital Tunnel Release with stimulator for nerve location\n\n1 hour of Ulnar nerve stimulation', 'interventionNames': ['Device: Ulnar Nerve Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Intervention', 'description': 'Cubital Tunnel Release with stimulator for nerve location NO prolonged ulnar nerve stimulation', 'interventionNames': ['Device: Ulnar Nerve Stimulation']}], 'interventions': [{'name': 'Ulnar Nerve Stimulation', 'type': 'DEVICE', 'otherNames': ['Stimulation'], 'description': '1 hour of continued stimulation of the ulnar nerve using a hand held stimulator', 'armGroupLabels': ['Intervention', 'Non-Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jovito Angeles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}